-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, DQzSpZYMmgqo+ltipnQ8LTzF46QwYfxo1QCAZfiAyaVGM/PjRVPJpRidv2/NDjBC IXrb8xdhGpV3bOqT3ef1MQ== 0000945234-07-000108.txt : 20070301 0000945234-07-000108.hdr.sgml : 20070301 20070301153307 ACCESSION NUMBER: 0000945234-07-000108 CONFORMED SUBMISSION TYPE: 10-K PUBLIC DOCUMENT COUNT: 15 CONFORMED PERIOD OF REPORT: 20061231 FILED AS OF DATE: 20070301 DATE AS OF CHANGE: 20070301 FILER: COMPANY DATA: COMPANY CONFORMED NAME: QLT INC/BC CENTRAL INDEX KEY: 0000827809 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 000000000 STATE OF INCORPORATION: A1 FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 10-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-17082 FILM NUMBER: 07663087 BUSINESS ADDRESS: STREET 1: 887 GREAT NORTHERN WAY STREET 2: - CITY: VANCOUVER STATE: A1 ZIP: V5T 4T5 BUSINESS PHONE: 6047077000 MAIL ADDRESS: STREET 1: 887 GREAT NORTHERN WAY CITY: VANCOUVER STATE: A1 ZIP: V5T 4T5 FORMER COMPANY: FORMER CONFORMED NAME: QLT PHOTO THERAPEUTICS INC DATE OF NAME CHANGE: 19960618 FORMER COMPANY: FORMER CONFORMED NAME: QUADRA LOGIC TECHNOLOGIES INC DATE OF NAME CHANGE: 19941201 10-K 1 o34971e10vk.htm ANNUAL REPORT FOR THE YEAR ENDED DECEMBER 31, 2006 ANNUAL REPORT FOR THE YEAR ENDED DECEMBER 31, 2006
 

 
 
UNITED STATES SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
 
FORM 10-K
     
þ   ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the fiscal year ended December 31, 2006
OR
     
o   TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
Commission File No. 0-17082
QLT Inc.
(Exact Name of Registrant as Specified in its Charter)
     
British Columbia, Canada   N/A
(State or Other Jurisdiction of Incorporation or Organization)   (I.R.S. Employer Identification No.)
     
887 Great Northern Way, Vancouver, B.C., Canada   V5T 4T5
(Address of principal executive offices)   (Zip Code)
Registrant’s telephone number, including area code: (604) 707-7000
Securities registered pursuant to Section 12(b) of the Act:
Common Shares, without par value
Common Share Purchase Rights

(Title of class)
 
     Indicate by check mark if the Registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yeso     No þ
     Indicate by check mark if the Registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act. Yeso     No þ
     Indicate by check mark whether the registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months and (2) has been subject to such filing requirements for the past 90 days. Yesþ     No o
     Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation S-K is not contained herein, and will not be contained, to the best of the registrant’s knowledge, in definitive proxy or information statements incorporated by reference in Part III of this Form 10-K or any amendment to this Form 10-K. o
     Indicate by check mark whether the Registrant is a large accelerated filer, an accelerated filer, or a non-accelerated filer. See definition of “accelerated filer and large accelerated filer” in Rule 12b-2 of the Exchange Act.
Large accelerated filer þ      Accelerated filero      Non-accelerated filer o
     Indicate by check mark whether the Registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yeso      No þ
     As of June 30, 2006, the aggregate market value of the common shares held by non-affiliates of the registrant (based on the last reported sale price of the common shares of U.S $7.08, as reported on The NASDAQ Stock Market) was approximately U.S $624,120,911.
     As of February 26, 2007 the registrant had 75,272,239 outstanding common shares.
DOCUMENTS INCORPORATED BY REFERENCE
     Parts of the Company’s definitive proxy statement (to be filed pursuant to Regulation 14A within 120 days after Registrant’s fiscal year end of December 31, 2006) for its annual meeting to be held on May 17, 2007, are incorporated by reference in this Form 10-K in response to Part III, Items 10, 11, 12, 13 and 14.
 
 

 


 

Note regarding references to QLT
Throughout this Annual Report on Form 10-K (“Report”) , the words “we”, “us”, “our”, the “Company” and “QLT” refer to QLT Inc., and our wholly owned subsidiaries, QLT USA, Inc. (“QLT USA”), and QLT Therapeutics, Inc. unless stated otherwise.
Note regarding Currency and Accounting Standards
In this Report all dollar amounts are in U.S. dollars, except where otherwise stated, and financial reporting is made in accordance with U.S. generally accepted accounting principles, or U.S. GAAP. Effective December 31, 2002, we adopted U.S. GAAP as our primary basis of disclosure on Form 10-K. In addition, on December 31, 2002, we adopted the U.S. dollar as our reporting currency. Prior to that date we reported in Canadian dollars and in accordance with Canadian generally accepted accounting principles, or Canadian GAAP.
We use the U.S. dollar as our reporting currency, while the Canadian dollar is the functional currency for the parent company, QLT Inc., and the U.S. dollar is the functional currency for our U.S. subsidiaries, QLT USA and QLT Therapeutics, Inc.
Note regarding Exchange Rates
The table below shows relevant exchange rates which approximate the noon buying rates in New York City as reported by the Federal Reserve Bank of New York for cable transfers expressed in Canadian dollars for the five most recent fiscal years of the Company.
                                         
    2006     2005     2004     2003     2002
High
  $ 1.1726     $ 1.2703     $ 1.3970     $ 1.5750     $ 1.6128  
Low
    1.0989       1.1507       1.1775       1.2923       1.5108  
Average
    1.1340       1.2115       1.3017       1.4008       1.5704  
Period End
    1.1652       1.1656       1.2034       1.2923       1.5800  
NOTICE REGARDING WEBSITE ACCESS TO COMPANY REPORTS
We file electronically with the Securities and Exchange Commission our annual report on Form 10K, quarterly reports on Form 10-Q and current reports on Form 8-K pursuant to Section 13(a) or 15(d) of the Securities Exchange Act of 1934. You may obtain a free copy of our annual report on Form 10-K, quarterly reports on Form 10-Q, and current reports on Form 8-K, and any amendments to those reports, on the day of filing with the SEC and on our website at: www.qltinc.com.

2


 

QLT INC.
ANNUAL REPORT ON FORM 10-K
DECEMBER 31, 2006
Table of Contents
         
    4  
    4  
    8  
    10  
    10  
    12  
    13  
    15  
    15  
    15  
    16  
    18  
    19  
    21  
    21  
    22  
    22  
    24  
    34  
    34  
    35  
    37  
    38  
    42  
    44  
    68  
    68  
    113  
    113  
    114  
    114  
    114  
    115  
    115  
    116  

3


 

PART I
Item 1. BUSINESS
Overview
We are a global biopharmaceutical company dedicated to the discovery, development and commercialization of innovative therapies. Our research and development efforts are focused on pharmaceutical products in the fields of ophthalmology and dermatology. In addition, we utilize two unique technology platforms, photodynamic therapy and Atrigel®, to create products such as Visudyne® and Eligard®.
QLT was formed in 1981 under the laws of the Province of British Columbia, Canada. In November 2004, we acquired Atrix Laboratories, Inc., a Fort Collins, Colorado based biopharmaceutical company focused on advanced drug delivery. With our acquisition of QLT USA in 2004, we expanded and diversified our consolidated portfolio of approved products, products in development or under regulatory review, and proprietary technologies.
Our first commercial product was in the field of photodynamic therapy, or PDT, which uses photosensitizers (light activated drugs) in the treatment of disease. Our lead commercial product, Visudyne, utilizes PDT to treat the eye disease known as wet age related macular degeneration, or wet AMD, the leading cause of blindness in people over the age of 55 in North America and Europe.
Visudyne is commercially available in more than 75 countries, including the U.S., Canada, Japan and the European Union countries, for the treatment of a form of wet AMD known as predominantly classic subfoveal choroidal neovascularization, or CNV, and in more than 50 countries for the form of wet AMD known as occult subfoveal CNV. Visudyne is reimbursed in the U.S. by the Centers for Medicare & Medicaid Services for certain patients with the occult and minimally classic forms of wet AMD. It is also approved in more than 60 countries, including the U.S., Canada and the European Union countries, for the treatment of subfoveal CNV due to pathologic myopia (severe near-sightedness). In some countries, including the U.S. and Canada, Visudyne is also approved for presumed ocular histoplasmosis or other macular diseases. Visudyne was co-developed by QLT and Novartis Pharma AG of Switzerland (“Novartis Ophthalmics”) and is manufactured by QLT and sold by Novartis Ophthalmics under the terms of a co-development, manufacturing and commercialization agreement with Novartis Ophthalmics.
In addition to our lead commercial product Visudyne, we market (through commercial licensees) the Eligard line of products for the treatment of prostate cancer. The Eligard product line includes four different commercial formulations of our Atrigel® technology combined with leuprolide acetate for the treatment of prostate cancer. The U.S. Food and Drug Administration, or FDA, has approved all four products: Eligard 7.5-mg (one-month), Eligard 22.5-mg (three-month), Eligard 30.0-mg (four-month) and Eligard 45.0-mg (six-month). The Eligard 7.5-mg and Eligard 22.5-mg products are also approved in a number of other countries, including 25 European countries, Canada, Australia, New Zealand, India and a number of Latin American countries. In addition to the U.S., Eligard 30-mg (four-month) is approved in Canada, Australia, New Zealand and India while Eligard 45.0-mg (six-month) is approved in Germany, Canada, Australia and India.
Our most advanced proprietary dermatology product, Aczone™, was approved by the FDA in July 2005 and by Health Canada in June 2006. Although Aczone is approved in the U.S and Canada, it is not yet being marketed. Based on a post-approval commitment requested by the FDA, we conducted a Phase IV clinical trial of Aczone™ in more than 50 patients with G6PD deficiency and communicated to the FDA the positive outcome of this study in November 2006. We intend to submit a label revision supplement to the FDA during the second quarter of 2007. A decision with respect to the commercialization of Aczone is pending the outcome of a submission to and decision by the FDA to remove the restriction currently on the approved label for the product.
Our efforts to increase our portfolio of products are ongoing. We carry out research and pre-clinical projects in our core therapeutic areas of ophthalmology and dermatology. We also conduct research and development work on product candidates using the Atrigel drug delivery system in a number of other therapeutic areas that we are currently considering divesting or out-licensing at the appropriate time and from which we can potentially derive royalty and other revenue upon commercialization.
To focus our business on the research and development of proprietary products in our core therapeutic areas, in December 2006, the generic dermatology business, dental business and the manufacturing facility of QLT USA, in Fort Collins, Colorado, was sold to Tolmar, Inc.

4


 

OUR APPROVED PRODUCTS
             
Product/Indication   Location(s)   Licensee
Visudyne®        
 
           
 
  Predominantly classic subfoveal choroidal
neovascularization, or CNV, in wet
age-related macular degeneration, or AMD
  Over 75 countries including the U.S., Canada, Japan, Australia, New Zealand and those of the European Union   Novartis Ophthalmics
 
           
 
  Occult with no classic subfoveal CNV in AMD   Over 50 countries including Japan, Australia, New Zealand, Switzerland and those of the European Union   Novartis Ophthalmics
 
           
 
  Minimally Classic CNV in AMD   Japan   Novartis Ophthalmics
 
           
 
  Subfoveal CNV due to pathologic myopia   Over 60 countries including the U.S., Canada, and those of the European Union   Novartis Ophthalmics
 
           
 
  Predominantly classic subfoveal CNV due to presumed ocular histoplasmosis syndrome   U.S.   Novartis Ophthalmics
 
           
Eligardâ 7.5-mg one-month        
 
           
 
  Prostate cancer   Over 30 countries, including the U.S., Canada, Australia, New Zealand, 25 European countries, India and a number of Latin American countries   Sanofi-Synthelabo,
Mayne Pharma,
MediGene/Astellas,
Tecnofarma, Ranbaxy
 
           
Eligardâ 22.5-mg three-month        
 
           
 
  Prostate cancer   Over 30 countries, including the U.S., Canada, Australia, New Zealand, 25 European countries, India and a number of Latin America countries   Sanofi-Synthelabo,
Mayne Pharma,
MediGene/Astellas,
Tecnofarma, Ranbaxy
 
           
Eligardâ 30.0-mg four-month        
 
           
 
  Prostate cancer   U.S., Canada, Australia, New Zealand and India   Sanofi-Synthelabo,
Mayne Pharma,
Ranbaxy
 
           
Eligardâ 45.0-mg six-month formulation        
 
           
 
  Prostate cancer   U.S., Canada, Australia, New Zealand, India and Germany   Sanofi-Synthelabo, Mayne Pharma; MediGene/Astellas, Ranbaxy
 
           
Aczone        
 
           
 
  Acne vulgaris   U.S., Canada
A decision with respect to the commercialization of Aczone is pending the outcome of a submission to and decision by the FDA whether to remove the restriction currently on the approved label.
  Not partnered

5


 

OUR PRODUCTS UNDER REGULATORY REVIEW
             
Product/Indication   Location(s)   Status
Eligard® 7.5-mg one-month        
 
           
 
  Prostate Cancer   Six countries outside of North America   Marketing authorization application filed
 
           
Eligard® 22.5-mg three-month        
 
           
 
  Prostate Cancer   Five countries outside of North America   Marketing authorization application filed
 
           
Eligard® 30.0-mg four-month        
 
  Prostate Cancer   Two countries outside of North America   Marketing authorization application filed
 
           
Eligard® 45.0-mg six-month        
 
           
 
  Prostate Cancer   Two countries outside of North America. The mutual recognition procedure to obtain marketing approval in other European countries will start in 2007.   Marketing authorization application filed

6


 

OUR PRODUCTS IN DEVELOPMENT
             
Product/Indication   Location(s)   Status
Octreotide-Atrigel® — three-month        
 
           
 
  Carcinoid Syndrome   U.S. and Canada   Phase IIa PK study planned to begin enrolment in 2007
 
           
 
  Acromegaly   U.S.   On clinical hold pending submission to the FDA of toxicology results in second quarter of 2007 and a decision by the FDA whether to permit the study to proceed
 
           
GHRP -1- Atrigel® — one-month        
 
 
  Malnutrition in
end-stage-renal-disease patients
undergoing hemodialysis
  U.S.   Plan to complete Phase IIa study in 2007
 
           
Risperidone- Atrigel® — one-month        
 
           
 
  Schizophrenia   U.S.   Plan to complete the IND-enabling program by end of 2007
 
           
Eligardâ 7.5-mg one-month        
 
           
 
  Prostate Cancer   Japan   Application for marketing approval withdrawn. Currently assessing future development for this product in Japan.

7


 

Our Approved Products
Visudyne®
Visudyne is a photosensitizer which we developed with Novartis Ophthalmics of Switzerland for the treatment of choroidal neovascularization, or CNV, due to wet AMD, the leading cause of severe vision loss in people over the age of 55 in North America and Europe. We have been co-developing Visudyne with Novartis Ophthalmics since 1995 pursuant to a product co-development, manufacturing and distribution agreement. Under that agreement, we are responsible for manufacturing and product supply and Novartis Ophthalmics is responsible for marketing and distribution.
     About Wet AMD
Wet AMD is an eye disease characterized by the growth of abnormal blood vessels under the central part of the retina, called the macula. Because these vessels do not mature properly in the elderly, they begin to leak and, over time, cause photoreceptor damage that results in the formation of scar tissue and a loss of central vision. Although the progression of the disease varies by patient, the majority of patients with wet AMD become legally blind in the affected eye within approximately two years following the onset of the disease. Based upon proprietary market research, we estimate that worldwide approximately 500,000 new cases of wet AMD develop annually, of which approximately 200,000 develop in North America, approximately 200,000 develop in Europe and approximately 100,000 develop in the remainder of the world.
There are three forms of wet AMD: predominantly classic, minimally classic and occult. These forms are distinguished by the appearance of the lesions that form at the back of the eye.
     Visudyne® Approvals
          Predominantly Classic CNV in AMD
Visudyne has been approved for marketing for predominantly classic subfoveal CNV in AMD in over 75 countries, including the U.S., Canada, Japan, Australia, New Zealand and the European Union countries.
          Occult with no Classic CNV in AMD
Visudyne has been approved for the occult form of CNV in more than 50 countries, including Australia, New Zealand, Switzerland, Japan and the European Union countries. (For more information regarding the status of regulatory approval and reimbursement for Visudyne therapy in the occult form of the disease, see “Expansion and Improvement of Visudyne Therapy — Occult AMD” below).
          CNV due to Pathologic Myopia (PM)
     Pathologic myopia, or PM, is a degenerative form of near-sightedness that occurs largely in persons aged 30 to 50 and can result in CNV. Based on proprietary market research, we estimate that the worldwide incidence of CNV secondary to PM is approximately 50,000 new patients every year. We have received regulatory approval of Visudyne for the treatment of subfoveal CNV due to PM in more than 60 countries, including the U.S., Canada and the European Union countries.
          CNV due to Presumed Ocular Histoplasmosis Syndrome (OHS)
Presumed ocular histoplasmosis syndrome, or OHS, is a condition caused by a fungal infection endemic to certain areas in central and eastern U.S. It can lead to severe, irreversible vision loss and is a leading cause of blindness in adults who have lived in geographic areas where the soil mould Histoplasma capsulatum is found. There are an estimated 100,000 people who are at risk for vision loss within this endemic area. The FDA approved Visudyne for the treatment of subfoveal CNV secondary to OHS in 2001 and approval for this indication was obtained in Canada in 2004.

8


 

Eligard®
Eligard product for prostate cancer incorporates a luteinizing hormone-releasing hormone agonist, or LHRH agonist, known as leuprolide acetate with our proprietary Atrigel drug delivery system. The Atrigel technology allows for sustained delivery of leuprolide acetate for periods ranging from one month to six months.
Clinical trials have demonstrated that the sustained release of a LHRH agonist decreases testosterone levels to suppress tumor growth in patients with hormone-responsive prostate cancer. The Phase III results for the Eligard 7.5-mg one-month, 22.5-mg three-month, 30.0-mg four-month and 45.0-mg six-month products demonstrated low testosterone levels with 99% of completing patients achieving and maintaining suppression levels equivalent to castration.
Eligard is injected subcutaneously as a liquid. The polymers precipitate after injection forming a solid implant in the body that slowly releases the leuprolide as the implant is bioabsorbed.
     Eligard® 7.5-mg One-Month and 22.5-mg Three-Month Products
Eligard® 7.5-mg one-month and 22.5-mg three-month products have been approved for marketing for prostate cancer in over 30 countries, including the U.S., Canada, 25 European countries, Australia, New Zealand, India and a number of Latin American countries.
     Eligard® 30.0-mg Four-Month Product
Eligard® 30.0-mg four-month product has been approved for marketing for prostate cancer in the U.S., Canada, Australia, New Zealand and India.
     Eligard® 45.0-mg Six-Month Product
Eligard® 45.0-mg six-month product has been approved for marketing for prostate cancer in the U.S., Canada, Australia, New Zealand, India and Germany. Germany is the reference member state in the European Union for the Eligard six month product. With the recent German approval it is expected that approvals in other European Union countries will begin in 2007 under Europe’s mutual recognition procedure for drug approvals.
Aczone™
In July 2005, we received approval from the FDA for Aczone, our proprietary product for the treatment of acne vulgaris. Aczone incorporates dapsone, an anti-inflammatory and anti-microbial drug, with our proprietary solvent microparticle system or SMP™.
In approving Aczone, the FDA required a restriction to be placed on the label for Aczone requiring that patients be screened to detect if they are predisposed to one type of anemia (hemolytic anemia) because of a specific enzyme deficiency, G6PD (Glucose 6-phosphate dehydrogenase) deficiency. Patients who have this enzyme deficiency will need to be monitored by their physician with regular blood counts if they are prescribed Aczone. In the Aczone clinical trial program, 1.4% of about 3500 patients had this disorder which is consistent with the incidence in the general North American population. Certain populations, mainly males of African American descent, have a higher reported incidence of approximately 10-14%. As requested by the FDA, we undertook a post-approval Phase IV study in more than 50 acne patients who have G6PD deficiency. These patients were followed for approximately six months after enrollment (including three months treatment with Aczone). The positive findings of this clinical trial were released in November 2006. We intend to submit a label revision supplement to the FDA during the second quarter of 2007 in order to request that the FDA remove the label requirement for blood testing for all patients treated with Aczone. A decision with respect to the commercialization of Aczone is pending the outcome of this submission and the decision of the FDA whether or not to remove the restriction currently on the approved label for the product.
Aczone was approved by Health Canada in June 2006 with a similar label restriction as that required by the FDA.

9


 

Our Products under Regulatory Review
     Eligard® 7.5-mg one-month product
Our commercial licensees have filed marketing authorizations for Eligard 7.5-mg one-month product in six countries outside of North America.
     Eligard® 22.5-mg three-month product
Our commercial licensees have filed marketing authorizations for Eligard 22.5-mg three-month product in five countries outside of North America.
     Eligard® 30.0-mg four-month product
Our commercial licensees have filed marketing authorizations for Eligard 30.0-mg four-month product in two countries outside of North America.
     Eligard® 45.0-mg six-month product
Our commercial licensees have filed marketing authorizations for Eligard 45.0-mg six-month product in two countries outside of North America. Furthermore, having now received the approval of the 45.0-mg six-month product in Germany, a mutual recognition procedure (MRP) will be initiated in 2007 to seek approval to market this product in other European countries.
Our Products in Development
     Expansion of Visudyne® Therapy
We are continuing efforts to improve the effectiveness of Visudyne therapy by exploring combination therapies and the effect of lower light doses (for example through reduced rate of fluence) administered during the PDT process.
          Combination Trials
In view of the importance of understanding the clinical significance of the use of Visudyne in combination with other therapies for the treatment of wet AMD, we are supporting a number of investigator-sponsored studies (“ISS”) which are designed to evaluate the potential of such Visudyne combination therapies. The focus of these studies has evolved with emerging clinical data from other therapies. Initially, these studies focused on evaluating the combination of Visudyne with triamcinolone (a steroid). Novartis Ophthalmics and QLT have initiated a company-sponsored study, known as VERITAS, comparing the safety and efficacy of Visudyne in combination with triamcinolone to Visudyne in combination with Macugen. That study completed enrolment and preliminary results are expected to be available in 2007. The enrolment of two large ISS’ evaluating the combination of Visudyne and triamcinolone was also completed. The one year results from both of those ISS’ are also expected to be available during 2007.
This evolution in the focus from combination of Visudyne with triamcinolone to combinations of Visudyne with anti-vascular endothelial growth factor (anti-VEGF) drugs or to triple therapy using Visudyne with a steroid and anti-VEGF drug reflects the evolution in medical practice. Thus, another ISS, which was initiated by the National Eye Institute (NEI) at the National Institute of Health (NIH) and supported by us under a Collaborative Research Agreement, started with the intent of assessing the potential benefit of combining Visudyne with triamcinolone (steroid), and is now being amended to include the study of Visudyne in combination with both a steroid and an anti-VEGF agent.
In addition, we are now supporting additional ISS’, which are evaluating different combinations of Visudyne with an anti-VEGF drug either as bi-therapy (Visudyne, plus an anti-VEGF) or triple therapy (Visudyne, plus an anti-VEGF and a steroid). We anticipate that 6-month results of the first ISS that has completed enrolment will be presented in the first half of 2007. Furthermore, we have initiated a patient

10


 

registry to consolidate and study retrospective data obtained by retina specialists who have already used Visudyne as part of bi- or triple therapy. Based on the results of the ISS’ and available data, we are planning to initiate one or more company sponsored studies to investigate the use of Visudyne in combination with anti-VEGF agents and steroids.
     Furthermore, certain of the ongoing ISS’ are also investigating the potential benefit of reduced fluence, or low light levels, on the efficacy and safety of Visudyne.
     Eligard® 3.75-mg one-month Product
QLT USA was developing Eligard in Japan through a licensee, Sosei, for the treatment of prostate cancer. Sosei previously submitted the application for marketing approval of the Eligard 3.75 mg one-month formulation in Japan. After interaction with the Japanese Regulatory Authorities, they decided to withdraw the Eligard 3.75 mg one-month dossier from the Generic Division. As a result Sosei has notified us that it intends to terminate the license agreement for Eligard in Japan. We are currently assessing our future development plans for Eligard in Japan.
     Aczone
Aczone is under development for the treatment of Rosacea, a chronic skin disorder that most often affects the central face including also the nose, forehead, cheeks and chin. We initiated a Phase II study in November 2005 and 12-week follow-up results were obtained in the third quarter 2006. In the overall population, the results showed that Aczone was no better than vehicle in reducing the signs and symptoms of papulopustular rosacea. However, in patients with more severe signs and symptoms, the study analysis showed an advantage of Aczone over the vehicle control. A decision on whether to proceed with a Phase III program using Aczone in Rosacea for this group diagnosed with more severe rosacea is on hold until after we get a decision from the FDA to remove the label requirement for blood testing for all patients treated with Aczone.
     Octreotide Atrigel®- three-month Product
          Acromegaly
We have developed a formulation of octreotide in the Atrigel delivery system for the treatment of the symptoms of acromegaly. Acromegaly is a chronic disease of middle-aged persons characterized by elongation and enlargement of bones of the extremities and certain head bones, especially the frontal bone and jaws. In the first quarter of 2006, we filed an IND for this study but in May 2006 announced that we would delay the initiation of the Phase IIa Atrigel/octreotide program in acromegaly patients. This decision was made in cooperation with the U.S. Food and Drug Administration (FDA) following adverse event findings that occurred in an ongoing primate toxicology study designed to support repeated injections in patients. The FDA has required that we submit, and that the FDA be satisfied with, the final data from the ongoing toxicology study prior to initiating the 16-patient Phase IIa clinical program in acromegaly. We expect to submit the complete results of the toxicology study in the second quarter of 2007.
          Carcinoid Syndrome
We have developed a formulation of octreotide in the Atrigel delivery system for the treatment of carcinoid syndrome. Carcinoid syndrome refers to the group of symptoms that occur in patients secondary to carcinoid tumors. This syndrome is characterized by hot red flushing of the face, as well as severe and debilitating diarrhea. The carcinoid tumors occur primarily in the appendix, ileum, rectum, or bronchi. We intend to submit to the FDA a Phase II pharmacokinetics protocol in carcinoid syndrome patients in the second quarter of 2007 at the same time as we submit the toxicology study results related to both the acromegaly and carcinoid syndrome programs. Our current plan is to accelerate the development of Octreotide in Carcinoid syndrome ahead of any development program in acromegaly.
     GHRP-1-Atrigel® one-month Product
We have developed a formulation of Growth Hormone Releasing Peptide-1, or GHRP-1, in the Atrigel delivery system for the treatment of malnutrition in end-stage renal disease patients on hemodialysis. Malnutrition is common in maintenance dialysis patients and leads to poor dialysis outcome. We initiated a phase IIa clinical trial in 2006 with the first patient treated in late 2006. The results of this study are expected during 2007.

11


 

     Risperidone Atrigel®- three-month Product
We have developed a formulation of Risperidone in the Atrigel delivery system for the treatment of schizophrenia. This IND-enabling program was initiated at the end of 2006 and is expected to be completed before the end of 2007. Schizophrenia is a serious mental disorder that can cause significant disability and chronic problems. Approximately one percent of the population develops schizophrenia during their lifetime.
Our Proprietary Technologies
     Photodynamic Therapy
Our product Visudyne utilizes our patented photodynamic therapy, or PDT, technology.
PDT is a minimally invasive medical procedure that utilizes photosensitizers (light-activated drugs) to treat a range of diseases associated with rapidly growing tissue (such as the formation of solid tumors and abnormal blood vessels). PDT is a two-step process. First, the photosensitizer is administered to the patient by intravenous infusion or other means, depending on the condition being treated. Second, a pre-determined dose of non-thermal light is delivered at a particular wavelength to the target site to interact with the photosensitizer. The photosensitizer traps energy from the light and causes oxygen found in cells to convert to a highly energized form called “singlet oxygen” that causes cell death by disrupting normal cellular functions. Because the photosensitizer and light have no effect unless combined, PDT is a relatively selective treatment that minimizes damage to normal surrounding tissue and allows for multiple courses of therapy.
For ocular PDT applications, non-thermal lasers provide the necessary intensity of light required. For applications of PDT to internal organs, physicians use lasers and fiber optics to deliver the appropriate intensity of light to abnormal tissue.
     Atrigel® System for injectable sustained release drug delivery
The Eligard products utilize the Atrigel drug delivery system, our patented technology for the sustained release of drugs.
The Atrigel drug delivery system consists of biodegradable polymers, similar to those used in biodegradable sutures, dissolved in biocompatible carriers. Pharmaceuticals may be blended into this liquid delivery system at the time of manufacturing or, depending upon the product, may be added later by the physician at the time of use. When the liquid product is injected through a needle or placed into accessible tissue sites through a cannula, displacement of the carrier with water in the tissue fluids causes the polymer to precipitate, forming a solid film or implant. The drug encapsulated within the implant is then released in a controlled manner as the polymer matrix biodegrades over a specified time period. Depending upon the patient’s medical needs, the Atrigel system can deliver small molecules, peptides or proteins over a period ranging from days to months.
We believe that the Atrigel system may provide benefits over traditional methods of drug administration such as tablets or capsules, multiple injections and continuous infusion as a result of the following properties:
    Broad applicability—The Atrigel system is compatible with a broad range of pharmaceutical compounds, including water soluble and insoluble compounds and high and low molecular weight compounds, including peptides and proteins.
 
    Systemic drug delivery—The Atrigel system can also be used to provide sustained drug release into the systemic circulation.
 
    Customized continuous release and degradation rates—The Atrigel system can be designed to provide continuous release of incorporated pharmaceuticals over a targeted time period thereby reducing the frequency of drug administration.
 
    Biodegradability—The Atrigel system will biodegrade and does not require removal when the drug is depleted.
 
    Ease of application—The Atrigel system can be injected or inserted as flowable compositions, such as solutions, gels, pastes, and putties, by means of ordinary needles and syringes, or can be sprayed or painted onto tissues.

12


 

    Safety—All current components of the Atrigel system are biocompatible and have independently established safety and toxicity profiles.
     Solvent Microparticle System for topical drug delivery
Our Aczone product utilizes our patented proprietary Solvent Microparticle System, or SMP™. The SMP technology comprises a two-stage system designed to provide topical delivery of highly water-insoluble drugs to the skin. The combination of dissolved drug with a microparticle suspension of the drug in a single formulation allows a controlled amount of the dissolved drug to permeate into the epidermal layer of the skin, while a high level of the microparticle drug is maintained just above the outermost layer of the skin for later delivery.
Significant Collaborative Arrangements
Novartis Ophthalmics — PDT Product Development, Manufacturing and Distribution Agreement for Visudyne Worldwide
Since 1995 we have had an agreement with Novartis Ophthalmics, a division of Novartis Pharma AG, for the worldwide development and commercialization of PDT products for eye diseases, including Visudyne. Under the terms of our agreement with Novartis Ophthalmics, we are responsible for manufacturing and product supply of Visudyne and Novartis Ophthalmics is responsible for marketing and distribution of Visudyne. We and Novartis Ophthalmics share equally the profits realized on revenues from product sales after deductions for marketing costs and manufacturing costs (including any third-party royalties), all calculated according to a formula set out in our agreement.
Our agreement with Novartis Ophthalmics is in effect for a term expiring June 30, 2014, renewable by the parties for two further five year terms. Either we or Novartis Ophthalmics may terminate the agreement in the event of an unremedied breach by the other party, or upon the dissolution or insolvency of the other, or on 60 days notice to the other. The agreement provides that, if Novartis Ophthalmics were to terminate the agreement on 60 days notice to us, it would be required to pay us a reasonable royalty on sales of Visudyne thereafter. Under the terms of the agreement with Novartis Ophthalmics we provide certain indemnities with respect to the manufacture, transport, storage and sale of Visudyne to Novartis Ophthalmics and with respect to certain intellectual property matters set out in the agreement.
     Sanofi-Synthelabo, Inc. — Marketing of Eligard® in the U.S. and Canada
Since late 2000, QLT USA, has had a marketing agreement with Sanofi-Synthelabo under which Sanofi-Synthelabo is the exclusive marketer of our Eligard 7.5-mg one-month, 22.5-mg three-month, 30-mg four-month and 45-mg six-month prostate cancer products in the U.S. and Canada.
The agreement provides that we manufacture the Eligard products and receive an agreed upon transfer price from Sanofi-Synthelabo as well as royalties on product sales. The agreement with Sanofi-Synthelabo is in effect until its expiry, on a country-by-country basis, upon the expiration of the last applicable Atrigel patent right or QLT USA patents relating to the Eligard products in that country. Either QLT USA or Sanofi-Synthelabo may terminate the marketing agreement on mutual agreement, or in the event of an unremedied breach by the other party, or upon the dissolution or insolvency or the cessation of operations of the other. Sanofi-Synthelabo is entitled to terminate the marketing agreement with respect to its rights and obligations in any particular country where it determines that the purchase price for the applicable product is not commercially viable in that country and QLT USA and Sanofi-Synthelabo are unable to reach agreement on the product pricing.
Under the terms of the marketing agreement, QLT USA and Sanofi-Synthelabo have agreed to provide certain indemnities for losses arising out of a misrepresentation or breach of a warranty, covenant or agreement under the agreement. Further, QLT USA has provided certain indemnities to Sanofi-Synthelabo, including indemnities covering certain losses relating to product liability and infringement of a third party’s proprietary rights. Sanofi-Synthelabo has agreed to provide certain indemnities to QLT USA, including for losses arising from Sanofi-Synthelabo’ marketing and sale of the Eligard products.

13


 

     Medigene AG and Astellas — Marketing of Eligard® in Europe
Since 2001, Medigene has been QLT USA’s development and regulatory partner for Eligard in Europe. In 2004, QLT USA and Medigene selected Yamanouchi (now Astellas) as the exclusive marketer of the Eligard product line in Europe. Under the terms of the agreements with Medigene and Astellas, QLT USA manufactures Eligard products and receives from Medigene an agreed upon transfer price, development milestone payments, royalties from sales and certain reimbursement for development expenses.
The agreement with Medigene is in effect until its expiry, on a country-by-country basis, upon the expiration of the last applicable Atrigel patent right or QLT USA patents relating to the Eligard products in that country. Either QLT USA or Medigene may terminate the license agreement in the event of an unremedied breach by the other party, or upon the dissolution or insolvency or the cessation of operations of the other. Medigene is entitled to terminate the license agreement with respect to its rights and obligations in any particular country where it determines that the purchase price for the applicable product is not commercially viable in that country.
Under the terms of the license agreement, QLT USA and Medigene have agreed to provide certain indemnities for losses arising out of a misrepresentation or breach of a warranty, covenant or agreement under the agreement. Further, QLT USA has provided certain indemnities to Medigene, including for certain losses relating to product liability and infringement of a third party’s proprietary rights. Medigene has agreed to provide certain indemnities to QLT USA, including for losses arising from Medigene’s marketing, sale, distribution or promotion of the products, or its use of certain trademarks used in marketing the products.
     Other Eligard® marketing collaborations
QLT USA has licensed a number of other companies to market Eligard products in certain countries throughout the world. Our Eligard marketing collaborations are set out in the following table:
ELIGARD® MARKETING COLLABORATIONS
     
Company   Territory
 
Han All Pharmaceutical Co.
  Korea
 
   
Key Oncologics
  South Africa
 
   
Luxembourg Pharmaceuticals, Ltd.
  Israel
 
   
Mayne Pharma Pty, Ltd.
  Australia, New Zealand
 
   
MediGene AG through its sublicensee,
Astellas
  Albania, Andorra, Armenia, Austria, Azerbaijan, Belarus, Belgium, Bosnia and Herzegovina, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Georgia, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Monaco, Netherlands, Norway, Poland, Portugal, Republic of Moldova, Romania, Russian Federation, San Marino, Slovakia, Slovenia, Spain, Sweden, Switzerland, The former Yugoslav Republic of Macedonia, Turkey, Ukraine, and United Kingdom, the Vatican City and Yugoslavia.
 
   
Ranbaxy Laboratories Ltd.
  India
 
   
Sanofi-Synthelabo, Inc.
  U.S., Canada
 
   
Tecnofarma International Ltd.
  Argentina, Belize, Bolivia,
Brazil, Chile, Colombia, Costa
Rica, Dominican Republic,
Ecuador, El Salvador, French
Guiana, Guatemala, Guyana,
Honduras, Mexico, Nicaragua,
Panama, Paraguay, Peru,
Suriname, Uruguay, Venezuela

14


 

     Pfizer, Inc. — Out-license of products utilizing our drug delivery technology
In 2000, QLT USA entered into a non-exclusive comprehensive research and worldwide licensing agreement with Pfizer Inc., or Pfizer, to provide Pfizer with rights to our proprietary drug delivery systems in the development of new Pfizer products. The research agreement expired in late 2005. The licence agreement remains in effect with respect to Atrigel-CP-533,536 which Pfizer has in Phase II clinical trials for bone regeneration. Under the license agreement, we have co-manufacturing rights and will receive royalties on the sales of products that are successfully developed and commercialized under this agreement as well as certain milestone payments.
The license agreement with Pfizer is in effect until the expiration of the last of our patent rights licensed to Pfizer and Pfizer patent rights relating to the respective technologies of QLT USA and Pfizer being co-developed under the research agreement. Either of us may terminate the license agreement in the event of a misrepresentation or an unremedied breach by the other party. Pfizer may terminate the license agreement without reason with respect to any product in any country on 30 days notice to QLT USA. Under the terms of the license agreement, each of Pfizer and QLT USA has agreed to provide certain indemnities relating to its obligations under the license agreement.
Product Manufacturing
Visudyne is currently manufactured in stages by several contract facilities located in the U.S., Canada, Europe and Japan. We have supply agreements with Nippon Fine Chemicals of Japan, Parkedale Pharmaceuticals Co., Ltd., Hollister-Stier Laboratories LLC and Orgapharm S.A.S., a subsidiary of Orgasynth, for manufacturing activities in the commercial production of Visudyne. Raylo Chemicals Inc, also manufactures one of the intermediates in the Visudyne process. Raylo has given us notice of termination of that supply agreement which we believe is not effective until January 1, 2010. We are seeking an alternate supplier of that intermediate. The key starting materials for the Visudyne manufacturing process are secured by long-term supply agreements or through inventory safety stocking.
We have previously manufactured our full line of Eligard finished products and Aczone topical dermatological product at a 58,000 square foot manufacturing facility in Fort Collins, Colorado that QLT USA recently sold to Tolmar Pharmaceuticals Inc., or Tolmar. As part of this divestiture, we entered into long-term supply agreement with Tolmar for the supply of Eligard products. We also have other third party suppliers and manufacturers that assist with the supply and manufacture of the Eligard products.
We own substantially all of our laboratory and manufacturing equipment, which we consider to be adequate for our research, development and testing requirements for the foreseeable future.
Financial Information about Segments and Geographic Areas
The geographic information required herein is contained in Note 22 to our Consolidated Financial Statements “Segmented Information” of this Annual Report on Form 10-K and is incorporated by reference herein.
Supply of Medical Lasers Required for Visudyne Therapy
Visudyne therapy requires a physician to deliver a dose of non-thermal light at a particular wavelength to target tissue in the eye in order to activate the photosensitizer. We do not manufacture the lasers required to deliver this light. Diode laser systems required for Visudyne therapy are manufactured and sold by medical device companies, including Carl Zeiss-Meditic AG, Lumenis Ltd., and Quantel, Inc. All three companies have portable diode lasers that have been commercially approved for use with Visudyne in the U.S., Europe and elsewhere except that only the Carl Zeiss-Meditic diode laser is commercially available in Japan. Approximately 3,000 of these diode lasers have been placed with medical facilities around the world.

15


 

Patents, Trademarks and Proprietary Rights
We seek to protect our proprietary technology by obtaining patents to the extent we consider it advisable, and by taking contractual measures and other safeguards to protect our trade secrets and innovative ideas. We currently own or have acquired rights to a number of patents and patent applications for the technologies utilized in our commercial products and products under review and in development in the U.S., Canada and other jurisdictions.
Our policy is to file patent applications on a worldwide basis in those jurisdictions where we consider it beneficial, depending on the subject matter and our commercialization strategy. The most significant patents owned or licensed by us are described below.
     Visudyne®
Verteporfin, the active ingredient in Visudyne, is protected by granted patents in major markets. These patents are owned by the University of British Columbia, or UBC, and exclusively licensed by us. We entered into a license agreement with UBC in 1988 that granted us a worldwide exclusive royalty-bearing license to know-how and patents relating to porphyrin derivates, including verteporfin, the active ingredient in Visudyne, with the right to sublicense. The license terminates upon the expiration of all of the licensed patents. UBC has the right to terminate the license upon our bankruptcy or winding up, our failure to pay royalties owing, or our breach of contract which is not remedied within 30 days.
In the United States, verteporfin is covered by Patent Nos. 4,920,143 and 5,095,030. We were granted a term extension of Patent No. 5,095,030 from April 24, 2007 to September 9, 2011. The 4,920,143 Patent has an expiration date of April 24, 2007. In Europe, verteporfin is covered by European Patent 0352076, for which we applied for and received an extension of patent term until July 18, 2014. In Japan, verteporfin is covered by JP 2834294, having an expiration date of January 20, 2008 and JP 2137244, having an expiration date of July 19, 2009. We have applied for, and expect to receive, an extension of patent term for both of these patents.
We also have an exclusive worldwide license from the Massachusetts General Hospital, or MGH, of MGH’s rights in a U.S. patent relating to verteporfin which MGH owns jointly with us, and to all foreign equivalents (which rights are non-exclusive if exclusive rights are not available in any foreign jurisdiction). The term of the MGH license continues on a country by country basis for so long as any such patent right remains in effect. The U.S. patent expires in 2015. Under the MGH license, we make royalty payments to MGH based on Visudyne sales.
We own or exclusively license patents covering the Visudyne drug product relating to the lipid-based formulation of verteporfin. U.S. Patent No. 5,214,036, which expires on May 25, 2010, is owned by UBC and exclusively licensed by us. U.S. Patent No. 5,707,608 expires on August 2, 2015, with foreign equivalents expiring in 2016. U.S. Patent No. 6,074,666 expires on February 5, 2012, with foreign equivalents expiring in 2013. In addition to these patents, we own or license several patents and patent applications covering alternative formulations of verteporfin.
We own or license patents covering certain approved uses of Visudyne. U.S. Patent Nos. 4,883,790 and 5,283,225, both of which expire on January 20, 2007, cover methods of treating target tissues and destroying unwanted cells using Visudyne and are owned by UBC and exclusively licensed to us. U.S. Patent No. 5,756,541, expiring on March 11, 2016, with foreign equivalents expiring in 2017, is co-owned by Novartis and us and covers methods of using Visudyne to improve visual acuity in subjects having unwanted ocular neovasculature. U.S. Patent No. 5,798,349, which expires on August 25, 2015, is co-owned by us, Massachusetts General Hospital and Massachusetts Eye and Ear Infirmary and covers methods of treating AMD using Visudyne. U.S. Patent No. 5,770,619, which expires on November 20, 2012, with foreign equivalents expiring in 2013, is owned by UBC and exclusively licensed to us and covers methods of using Visudyne to treat neovasculature involving a reduced interval between drug and light administration. In addition to these patents covering on-label uses of Visudyne, we own or license several other patent applications relating to alternative methods of using Visudyne in the treatment of ocular diseases, including AMD. (See Item 3. Legal Proceedings)
We own or license additional patent applications relating to photodynamic therapy, including numerous other photosensitizers, and methods of using photosensitizers.

16


 

     Atrigel®
We own the following U.S. granted patents covering the Atrigel drug delivery system platform that is used to deliver leuprolide acetate, the active ingredient in the Eligard products, as well as other products in our pipeline developed using the Atrigel system: 4,938,763, expiring on October 3, 2008, 5,278,201, expiring on January 11, 2011, 5,324,519, expiring on June 28, 2011, 5,599,552, expiring on February 4, 2014, 5,739,176, expiring on October 3, 2008, and RE37950, expiring on October 3, 2008. The Atrigel drug delivery system is protected in Europe by European Patent 436667, expiring on September 27, 2009, and European Patent 539751, expiring on October 1, 2012 and in Japan by Japanese Patent 2,992,046, expiring on September 27, 2009.
The following U.S. patents cover devices and methods used for the lyophilization of Atrigel-based products during manufacturing: 6,566,144, 6,610,252 and 6,626,870, all expiring on March 27, 2020.
     Eligard®
In addition to patents described above which cover the Atrigel technology used in Eligard, the Eligard one-, three-, four- and six-month products are protected by granted patents in major markets. Our U.S. Patents Nos. 6,565,874 and 6,773,714 both expiring on October 28, 2018, cover the Eligard drug products, and methods of making and using them. Foreign equivalents of these patents are pending in Europe, Japan, Canada and other countries.
     Aczone™
We own a number of patents that protect Aczone in major markets. In the U.S., Aczone is covered by Patent Nos. 5,863,560 and 6,620,435 that both have the expiration date of September 11, 2016. In Europe, Aczone is covered by European Patent No. 957900. This patent has been granted and was subsequently validated in 17 European jurisdictions including France, Germany, Italy, Spain, and the United Kingdom. All of the resultant national patents have an expiration date of September 10, 2017. Equivalent applications or patents exist in Australia, Canada, and Japan. We also own patent applications covering Aczone. If granted, these patent rights will expire from 2022 to 2025.
     Lemuteporfin
Lemuteporfin is a proprietary photosensitizer to which we own or exclusively licensed all rights. Lemuteporfin is protected by granted patents in major markets. All of these patents are jointly owned by UBC and us. UBC has exclusively licensed these patents to us. In the U.S., lemuteporfin is covered by Patent No. 5,929,105 which has an expiration date of May 7, 2017. If lemuteporfin is approved by the FDA for marketing in the U.S., we plan to apply for a term extension for U.S. Patent No. 5,929,105 pursuant to U.S. legislation that allows the extension of the term of one patent relating to a product that is subject to FDA review. In Europe, we own European Patent No. 983273 covering lemuteporfin. This patent has been granted and was subsequently validated in 18 European jurisdictions including France, Germany, Italy, Spain, and the United Kingdom. All of the resultant national patents have an expiration date of May 6, 2018. Where national law allows, we plan to apply for Supplementary Protection Certificates for the patents resulting from European Patent 983273 pursuant to the relevant European Union Regulation. In Japan we own Japanese Patent 3378889 covering lemuteporfin, which has an expiration date of May 6, 2018. We intend to apply for a term extension for this patent. We own additional patent applications covering alternative formulations and methods of use of lemuteporfin.
     Other Patents, Trademarks and Proprietary Rights
In addition to patent protection, we also rely on trade secrets, proprietary know-how and continuing technological innovation to develop and maintain a competitive position in our product areas.
We require our collaborative partners and potential business partners, consultants and employees who might have access to or be provided with proprietary information to sign confidentiality undertakings.
Our patent position and proprietary technologies are subject to certain risks and uncertainties. Although a patent has a statutory presumption of validity, the issuance of a patent is not conclusive as to its validity or as to enforceability of its claims. Accordingly, there can be no assurance that our patents will afford legal protection against

17


 

competitors, nor can there be any assurance that the patents will not be infringed by others, nor that others will not obtain patents that we would need to license.
Unpatented trade secrets, improvements, confidential know-how and continuing technological innovation are important to our scientific and commercial success. Although we attempt to and will continue to protect our proprietary information through reliance on trade secret laws and the use of confidentiality agreements with our corporate partners, collaborators, employees and consultants and other appropriate means, there can be no assurance these measures effectively will prevent disclosure of our proprietary information or that others will not develop independently or obtain access to the same or similar information or that our competitive position will not be affected adversely thereby.
There are three pending lawsuits relating to our patent rights. We discuss those lawsuits in more detail in the section of this report headed “Item 3. Legal Proceedings”.
We have included information about these and other risks and uncertainties relating to protection of our proprietary information under the heading “Risk Factors”.
Our products and services are sold around the world under brand-name trademarks which we own or are authorized to use by others. We have several registered trademarks in the U.S. and Canada and in other jurisdictions.
Competition
The pharmaceutical and biotechnology industries are characterized by rapidly evolving technology and intense competition. Our competitors include major pharmaceutical and biopharmaceutical companies, many of which have financial, technical and marketing resources significantly greater than ours and substantially greater experience in developing products, conducting preclinical and clinical testing, obtaining regulatory approvals, manufacturing and marketing. In addition, many biopharmaceutical companies have formed collaborations with large, established pharmaceutical companies to support research, development and commercialization of products that may be competitive with our products. Academic institutions, government agencies and other public and private research organizations also are conducting research activities and seeking patent protection and may commercialize products on their own or through joint ventures. The existence of these products, or other products or treatments of which we are not aware, or products or treatments that may be developed in the future, may adversely affect the marketability of products developed by us.
     Visudyne®
In June 2006, Genentech, Inc., or Genentech, commercially launched Lucentis™, an anti-VEGF product, in the U.S. for the treatment of neovascular wet AMD. Although not approved for this use, Avastin® (bevacizumab) from Genentech is also being used extensively by physicians off-label for the treatment of wet AMD, either alone (as monotherapy) or in combination with Visudyne or other therapies. Lucentis and Avastin had a material negative impact on Visudyne sales in the U.S. in 2006 and are expected to continue to be competitive with Visudyne as those products become available in other countries or are used off-label. In early 2007, Novartis Ophthalmics, Genentech’s marketing partner for Lucentis outside of the U.S., announced that it had received approval to market Lucentis in the European Union for the treatment of wet AMD and competition from Lucentis and potentially Avastin in the European Union is expected to negatively affect Visudyne sales in Europe and elsewhere in the world in 2007.
In January 2005, Eyetech Pharmaceuticals, Inc. (now a part of OSI Pharmaceuticals, Inc.), in partnership with Pfizer, commercially launched its product Macugen®, which the FDA has approved for treatment of all forms of wet AMD. Macugen now competes with Visudyne. In February 2006, Eyetech stated that, it marketing partner, Pfizer, Inc., received approval in the European Union to market Macugen for the treatment of wet AMD.
In May 2005, Alcon, Inc. received an approvable letter from the FDA for its product Retaane®, for the treatment of wet AMD. As a result, Alcon may need to conduct further studies prior to obtaining registration in the U.S. In December 2005 Alcon announced approval of Retaane in Australia. In early March 2006, Alcon announced the withdrawal of its European marketing authorization application for Retaane. We believe Alcon may be pursuing registration in other countries.

18


 

In addition to the above, Regeneron Pharmaceuticals, Inc., Allergan/Sirna Therapeutics and a number of other companies are developing or may develop competitive therapies targeted for wet AMD employing different technologies. We also believe that Visudyne could be competing against surgical or other treatments for AMD, including macular translocation, submacular surgery and laser photocoagulation, among others.
     Eligard®
There are a number of approved products on the market which compete with our Eligard products. These include AstraZeneca’s Zoladex® product, Bayer Pharmaceuticals Corporation’s Viadur® product, Watson Pharmaceuticals, Inc.’s Trelstar LA® product, Valera Pharmaceuticals, Inc.’s Vantas® product and Lupron Depot® product owned by TAP Pharmaceuticals, Inc. in the U.S. and elsewhere by Takeda Chemicals or its affiliates or licensees. The patents for the Lupron Depot product have or will be expiring and, as a result, it is expected that generic versions of Lupron Depot will also enter the market and compete with Eligard and other marketed prostate cancer products.
     Aczone™
Our Aczone topical gel product, if commercialized, will directly compete against several other prescription topical products for the treatment of acne. These include erythromycin/benzoyl peroxide, clindamycin/benzoyl peroxide, tretinoin, and adapalene products. Aczone will also compete indirectly with systemic prescription products and topical over-the-counter therapies.
Government Regulation
The research and development, preclinical studies and clinical trials, and ultimately, the manufacturing, marketing and labeling of our products, are subject to extensive regulation by the FDA and other regulatory authorities in the U.S. and other countries. The U.S. Food, Drug and Cosmetic Act and its regulations govern, among other things, the testing, manufacturing, safety, efficacy, labeling, storage, record keeping, approval, clearance, advertising and promotion of our products. Preclinical studies, clinical trials and the regulatory approval process typically take years and require the expenditure of substantial resources. If regulatory approval or clearance of a product is granted, the approval or clearance may include significant limitations on the indicated uses for which the product may be marketed.
     FDA Regulation — Approval of New Drug Products
Visudyne, Eligard and Aczone are regulated in the U.S. as new drugs. The steps ordinarily required before a new drug may be marketed in the U.S. include:
    preclinical testing;
 
    the submission of an investigational new drug application, or IND, to the FDA, which must become effective before human clinical trials may commence;
 
    adequate and well-controlled human clinical trials to establish the safety and efficacy of the drug;
 
    the submission of a new drug application, or NDA, or abbreviated new drug application, or ANDA, to the FDA; and
 
    FDA approval of the application, including approval of all labeling.
Preclinical tests include evaluation of product chemistry and formulation as well as animal studies to assess the potential safety and efficacy of the product. The results of preclinical testing are submitted as part of an IND to the FDA. A 30-day waiting period after the filing of each IND is required prior to the commencement of clinical testing in humans. In addition, the FDA may, at any time during this 30-day period, or anytime thereafter, impose a clinical hold on proposed or ongoing clinical trials. If the FDA imposes a clinical hold, clinical trials cannot commence or recommence without FDA authorization.
Clinical trials to support NDAs are typically conducted in three sequential phases, but the phases may overlap. In Phase I, the initial introduction of the drug into healthy human subjects or patients, the drug is tested to assess metabolism, pharmacokinetics, drug interaction, bioavailability and bioequivalence, pharmacodynamics, and safety,

19


 

including side effects associated with increasing doses. Phase II usually involves studies in a limited patient population to:
    assess the efficacy of the drug in specific, targeted indications;
 
    assess dosage tolerance and optimal dosage; and
 
    identify possible adverse effects and safety risks.
If a compound is found to be potentially effective and to have an acceptable safety profile in Phase II evaluations, Phase III trials are undertaken to further demonstrate clinical efficacy and to further test for safety within an expanded patient population at multiple study sites. Phase I, Phase II or Phase III clinical studies may not be completed successfully within any specified time period, if at all, with respect to any of our products subject to such testing.
After successful completion of the required clinical testing, generally an NDA is submitted. Once the submission is accepted for filing, the FDA begins an in-depth review of the NDA. Under the Prescription Drug User Fee Act (PDUFA III), the FDA should review the NDA within 10 months (standard application) or within 6 months (priority review application). The FDA may refer the application to an appropriate advisory committee, typically a panel of clinicians, for review, evaluation and a recommendation as to whether the application should be approved. The FDA is not bound by the recommendation of an advisory committee. If the FDA evaluations of the NDA and the manufacturing facilities are favorable, the FDA may issue either an approval letter or an approvable letter. The approvable letter usually contains a number of conditions that must be met to secure final FDA approval of the NDA. When, and if, those conditions have been met to the FDA’s satisfaction, the FDA will issue an approval letter. If the FDA’s evaluation of the NDA or manufacturing facility is not favorable, the FDA may refuse to approve the NDA or issue a non-approvable letter that often requires additional testing or information. Even if regulatory approval is obtained, a marketed product and its manufacturing facilities are subject to continual review and periodic inspections. In addition, identification of serious side effects (such as those that are life-threatening) after a drug is on the market or the occurrence of major manufacturing problems could cause subsequent withdrawal of approval, reformulation of the drug, additional preclinical testing or clinical trials and changes in labeling.
Failure to comply with the FDA or other applicable regulatory requirements may subject a company to administrative sanctions or judicially imposed sanctions such as civil penalties, criminal prosecution, injunctions, product seizure or detention, product recalls, or total or partial suspension of production. In addition, non-compliance may result in the FDA’s refusal to approve pending NDAs or supplements to approved NDAs.
     FDA Regulations — Approval of Medical Devices
Our drug Visudyne requires a laser for light activation of the drug substance after injection. These lasers are classified as Class III devices and premarket approval (PMA) applications must be filed for review with FDA. The submitted documents must demonstrate that the laser is safe and effective for the proposed use.
After FDA review and panel recommendation, the FDA may then issue an approval order, an approvable letter, a not approvable letter or an order denying approval. Once an approval letter is received, the holder of the approved PMA has to submit PMA supplements before making any changes that affect the safety or effectiveness of the device.
     FDA Regulation — Post-approval requirements
Even if regulatory clearances or approvals for our products are obtained, our products and the facilities manufacturing our products are subject to continued review and periodic inspections by the FDA. Each U.S. drug and device-manufacturing establishment must be registered with the FDA. Domestic manufacturing establishments are subject to biennial inspections by the FDA and must comply with the FDA’s current good manufacturing practices, or cGMP, if the facility manufactures drugs, and quality system regulations, or QSRs, if the facility manufactures devices. In complying with cGMP and QSRs, manufacturers must expend funds, time and effort in the area of production and quality control to ensure full technical compliance. The FDA stringently applies regulatory standards for manufacturing.

20


 

The FDA also regulates labeling and promotional activities. Further, we must report adverse events involving our drugs and devices to the FDA under regulations issued by the FDA.
     EU Regulation — Approval of medicinal product
Our Visudyne and Eligard products are regulated in the European Union (EU) as medicinal products. Before 1995, the existing EU legislation for approval of medicinal products faced major problems of acceptance not only with the pharmaceutical industry but with the national regulatory agencies of the member states (MS) as well. In 1995, legislation was adopted which established a new and amended system for the registration of medicinal products in the EU. One of the most significant features of this system was the establishment of a European Agency for the Evaluation of Medicinal Products, or EMEA. Under this system, marketing authorization could be submitted using the centralized procedure or the mutual recognition procedure. Recently, new legislation was adopted which offers an additional third option for approval, known as the decentralized procedure. Visudyne was filed with the EMEA and received approval from the European Commission under the centralized procedure. Eligard 7.5mg one month and 22.5 mg three months were filed under the mutual recognition procedure with Germany as the reference member state and is approved in most EU countries. Eligard 45.0 mg six months was also approved by German Regulatory Authorities (Germany acting as the reference member state) with the mutual recognition procedure to be implemented for the other EU countries in 2007. Commercial licensees of QLT are the Marketing Authorisation Holders, or MAHs, and they are responsible for all post-approval regulatory activities and maintenance of the regulatory filings such as variations.
     Additional Regulatory Issues
Under the Drug Price Competition and Patent Term Restoration Act of 1984, a patent which claims a product, use or method of manufacture covering drugs and certain other products may be extended for up to five years to compensate the patent holder for a portion of the time required for research and FDA review of the product. This law also establishes a period of time following approval of a drug during which the FDA may not accept or approve applications for certain similar or identical drugs from other sponsors unless those sponsors provide their own safety and effectiveness data. We cannot provide assurance that we will be able to take advantage of either the patent term extension or marketing exclusivity provisions of this law.
Various aspects of our business and operations are regulated by a number of other governmental agencies including the U.S. Occupational Safety and Health Administration and the SEC.
Third-Party Reimbursement
Government and private insurance programs, such as Medicare, Medicaid, health maintenance organizations and private insurers, fund the cost of a significant portion of medical care in the U.S. Governmental imposed limits on reimbursement of hospitals and other health care providers have significantly impacted their spending budgets. Under certain government insurance programs, a health care provider is reimbursed a fixed sum for services rendered in treating a patient, regardless of the actual charge for such treatment. Private third-party reimbursement plans are also developing increasingly sophisticated methods of controlling health care costs through redesign of benefits and exploration of more cost-effective methods of delivering health care. In general, these government and private measures have caused health care providers to be more selective in the purchase of medical products.
Significant uncertainty exists as to the reimbursement status of newly approved health care products, and we cannot provide assurance that adequate third-party coverage will be available. Limitations imposed by government and private insurance programs and the failure of certain third-party payers to fully, or substantially reimburse health care providers for the use of the products could seriously harm our business.
Liability and Product Recall
The testing, manufacture, marketing and sale of human pharmaceutical products entail significant inherent risks of allegations of product defects. The use of our products in clinical trials and the sale of such products may expose us to liability claims alleged to result from the use of such products. These claims could be made directly by patients

21


 

or consumers, healthcare providers or others selling the products. In addition, we are subject to the inherent risk that a governmental authority may require the recall of one or more of our products. We currently carry clinical trials and product liability insurance in amounts that we consider to be consistent with industry standards to insure against certain claims that could arise during the clinical studies or commercial use of our products. Such coverage and the amount and scope of any coverage obtained in the future may be inadequate to protect us in the event of a successful product liability claim, and there can be no assurance that the amount of such insurance can be increased, renewed or both. A successful product liability claim could materially adversely affect the business, financial condition or results of operations.
Further, liability claims relating to the use of our products or a product recall could negatively affect our ability to obtain or maintain regulatory approval for our products. We have agreed to indemnify certain of our collaborative partners against certain potential liabilities relating to the manufacture and sale of our products. (See Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations — Liquidity and Capital Resources.)
Research and Development
During the years ended December 31, 2006, 2005, and 2004, our total research and development expenses were $56.4 million, $63.3 million and $48.7 million respectively. See: “Our Products in Development” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations.”
Human Resources
As of February 28, 2007, we had approximately 254 active employees, 160 of whom were engaged in research, development, clinical and regulatory affairs, medical devices, manufacturing and process development, and 94 of whom were engaged in administration, corporate communications, corporate development, finance, information technology, human resource, legal and marketing and sales planning. In December 2006, QLT USA divested its generic dermatology and dental businesses and related manufacturing facility. As a result, approximately 140 employees who work in those areas were transitioned to the purchaser. None of our employees belongs to a labor union and we consider our relationship with our employees to be good. We believe we offer competitive compensation.

22


 

OUR EXECUTIVE OFFICERS
The following table sets forth information about our executive officers as of March 1, 2007. The executive officers listed below serve in their respective capabilities at the discretion of our board of directors.
             
Name   Age   Position
Robert L. Butchofsky
    45     President and Chief Executive Officer
 
           
Cameron R. Nelson
    41     Vice President, Finance and Chief Financial Officer
 
           
Alain H. Curaudeau
    50     Senior Vice President, Portfolio and Project Management
 
           
Linda M. Lupini
    47     Senior Vice President, Human Resources and Organizational Development
 
           
Alexander R. Lussow
    44     Vice President, Business Development
 
           
Peter J. O’Callaghan
    47     Senior Vice President, Corporate Development and General Counsel
Robert L. Butchofsky was appointed as President and Chief Executive Officer of QLT in February 2006 following his earlier appointment as Acting Chief Executive Officer of QLT in September 2005. Mr. Butchofsky joined QLT in 1998 as Associate Director, Ocular Marketing and was appointed Vice President, Marketing and Sales Planning in September 2001. Mr. Butchofsky was promoted to Senior Vice President, Marketing and Sales Planning where he was responsible for the ongoing marketing of Visudyne as well as the potential creation of a specialty sales force to market new products currently in development. Prior to joining QLT, Mr. Butchofsky spent eight years at Allergan where he built an extensive background with ocular products and Botoxâ, including sales, health economics, worldwide medical marketing, and product management. Prior to joining Allergan, Mr. Butchofsky spent several years managing clinical trials at the Institute for Biological Research and Development. Mr. Butchofsky holds a Bachelor of Arts degree in Biology from the University of Texas and a Masters of Business Administration from Pepperdine University.
Cameron R. Nelson was promoted to Vice President, Finance and Chief Financial Officer of QLT in August 2005. Prior to his appointment as Chief Financial Officer, Mr. Nelson held the position of Vice President, Finance and before that held positions of increasing responsibility within the Finance group of QLT including Associate Director, Financial Analysis and Planning, Director, Financial Analysis and Planning and later Senior Director, Financial Reporting and Planning. Prior to joining QLT, Mr. Nelson held finance and accounting positions with Mattel Inc. and Equity Marketing Inc. in Los Angeles. Mr. Nelson earned his Bachelor of Commerce from the University of British Columbia and his Master of Business Administration from Dartmouth College.
Alain H. Curaudeau joined QLT in 2000 as Vice President, Project Planning and Management and was promoted to Senior Vice President, Project Planning and Management in July 2001. He came to QLT with extensive global experience in pharmaceutical R&D after serving more than 15 years with Rhone-Poulenc Rorer (RPR), a major international pharmaceutical company. Mr. Curaudeau’s tenure with RPR included 14 years of progressively senior positions in project management, in France and in the U.S. Before joining QLT, he was designated head of Project Management for aventis, a new company formed in 1999 by the merger between Rhone-Poulenc Rorer and Hoechst AG. Mr. Curaudeau holds Bachelors and Masters degrees in Pharmacy from the University of Chatenay-Malabry, Paris, France. He is also a graduate of the Toxicology and Pharmacokinetics Programs from the same university and received academic training in toxicological pathology from the National Veterinary School in Toulouse, France.

23


 

Linda M. Lupini was promoted to Senior Vice President, Human Resources and Organizational Development in February 2003. Ms. Lupini joined QLT in 1997 as Director, Human Resources, and was promoted to Vice President, Human Resources and Administration in March 2000. Ms. Lupini joined QLT after serving as Human Resources Director at MacDonald Dettwiler and Associates Ltd., a leading technology firm in Western Canada. Ms. Lupini, who holds a Bachelor of Arts degree in psychology from the University of British Columbia, is a member of several human resource and industry associations and serves as a board member of the Simon Fraser University MBD Program Advisory Committee and a board member of the BC Human Resources Council of Canada.
Alexander R. Lussow joined QLT in 2006 and is responsible for QLT’s business development activities, including product licensing, acquisitions and strategic partnering opportunities. From March 2001 to November 2004,, Dr. Lussow was the Chief Business Officer and Vice President of Business Development of Gryphon Therapeutics, Inc. where he was responsible for product licensing, strategic alliances, corporate communications and fund raising. Prior to that, from March 1994 to March 2001, Dr. Lussow was the head of business development at Sangstat Medical Corporation (now wholly owned by Genzyme Corp.). Dr. Lussow received his BSc at McGill University in Montreal and his PhD in immunology at the University of Geneva, Switzerland. From 2002 to 2004, Dr. Lussow was an adjunct professor of pharmacology at the University of North Carolina, USA and has worked for the World Health Organization in West Africa.
Peter J. O’Callaghan joined QLT in 2006 and brings more than 20 years of experience as a corporate finance and merger and acquisition lawyer. While in private practice Mr. O’Callaghan advised clients in connection with all types of corporate securities transactions, including public and private equity financings, take-over and issuer bids, providing independent counsel to investment dealers and boards of directors, and regulatory and stock exchange compliance work. Before joining QLT, Mr. O’Callaghan was a senior partner at Blake, Cassels & Graydon LLP. He has been an Adjunct Professor of Law at the University of British Columbia since the beginning of 2006. He is recognized in The Canadian Legal Expert Directory as one of the leading lawyers in Canada. Mr. O’Callaghan holds a Bachelor of Laws and Bachelor of Commerce degrees, both from the University of British Columbia.
Item 1A. RISK FACTORS
In addition to the other information included in this Report, you should consider carefully the following factors, which describe the risks, uncertainties and other factors that may materially and adversely affect our business, products, financial condition and operating results. The following is a description of important factors that may cause our actual results of operation in future periods to differ materially from those currently expected or discussed in forward-looking statements set forth in this Report relating to our financial results, operations and business prospects. Except as required by law, we undertake no obligation to update any forward-looking statements to reflect events or circumstances after the date on which it is made.
Risks Relating to Our Business
We may not be successful in addressing competition for Visudyne, Eligard or our other products.

24


 

We may be unable to contend successfully with current or future competitors. The pharmaceutical and biotechnology industries are characterized by rapidly evolving technology and intense competition. Our competitors include major pharmaceutical and biopharmaceutical companies, many of which have access to financial, technical and marketing resources significantly greater than ours and substantially greater experience in developing and manufacturing products, conducting preclinical and clinical testing and obtaining regulatory approvals. We are aware of a number of competitors and potential competitors to our products and the impact on the sales of our products and our revenue from the sales of our products may be material. Some of these competitors are also our collaborators. For example, Novartis Ophthalmics, who has the marketing rights to our product Visudyne, also has rights to market Lucentis outside of the United States, a product that is competitive with Visudyne.
More information on the competitors and potential competitors can be found under Item 1. Business-Competition.
If there is an adverse outcome in the ongoing litigation in which we are or may become involved, our business may be harmed.
We and certain of our subsidiaries are involved in litigation and may in the future become involve in various other litigation in the ordinary course of our business. We are currently a defendant in a number of lawsuits filed against QLT Inc. or QLT USA, Inc. which we consider to be potentially material to our business. Litigation is inherently unpredictable, and excessive verdicts do occur which may include a judgment with significant monetary award, including the possibility of punitive damages, a judgment that certain of our patent or other intellectual property rights are invalid or unenforceable and, as occurred in 2006 in the U.S. litigation with TAP Pharmaceuticals, the risk that an injunction could be issued preventing the manufacture, marketing and sale of our products that are the subject of the litigation. Furthermore, we will have to incur substantial expense in defending these lawsuits and the time demands of these lawsuits could divert management’s attention from ongoing business concerns and interfere with our normal operations. For a description of the material litigation in which we are currently involved, see Item 3 — Legal Proceedings.
We are also from time to time a defendant in other litigation that because either the amount claimed is not material or because we believe that the claim is covered by insurance and that, in our reasonable judgment, we do not expect the damages if we are found liable to exceed the insured limits. However, it is possible that as new information becomes available, the amount of damages in such cases exceeds our insured limits or our insurer ultimately denies full coverage that we may be subject to additional unforeseen damages that could ultimately be material and could have a material adverse effect on our business.
We are dependent on third parties to market Visudyne and Eligard.
We are dependent on third parties for the research, development, and commercialization of our products. A significant portion of our revenue depends on the efforts of Novartis Ophthalmics to market and sell Visudyne. Our strategy for the development and commercialization of our products includes entering into various arrangements with third parties and therefore is dependent on the subsequent success of these third parties in performing their responsibilities under such arrangements.
Although we believe that parties to our collaborative arrangements have an economic incentive to succeed in performing their contractual responsibilities, the amount and timing of resources to be devoted to these activities generally are not under our control. For example, the terms of our agreement with Novartis Ophthalmics do not restrict Novartis Ophthalmics from commercializing, whether by itself or in collaboration with third parties, non-PDT products that could be competitive with Visudyne. Novartis entered into a license arrangement with Genentech, Inc. in which Novartis Ophthalmics has been granted a license to the rights outside of the United States to Lucentis, a product that has been approved for the treatment of wet AMD, and is a competing product to Visudyne. We cannot predict whether such parties will perform their obligations as expected or whether significant revenue will be derived or sustained from such arrangements. To the extent such parties do not perform adequately under our various agreements with them, the development and commercialization of our products may be delayed, may become more costly to us or may be terminated, and may require us to expend significant amounts of time and money to find new collaborators and structure alternative arrangements. Disputes with a collaborator could delay a program on which we are working with the collaborator and could result in expensive arbitration or litigation, which may not be resolved in our favor.

25


 

The success of Visudyne, Eligard and our other products may be limited by governmental and other third-party payers.
The continuing efforts of governmental and third-party payers to contain or reduce the costs of health care may negatively affect the sale of Visudyne, Eligard and our other products. Our ability to commercialize Visudyne, Eligard and our other products successfully will depend in part on the timeliness of and the extent to which adequate reimbursement for the cost of such products and related treatments is obtained from government health administration authorities, private health insurers and other organizations in the U.S. and foreign markets. Product sales, attempts to gain market share or introductory pricing programs of our competitors could require us to lower our prices, which could adversely affect our results of operations. We may be unable to set or maintain price levels sufficient to realize an appropriate return on our investment in product development. Significant uncertainty exists as to the reimbursement status of newly approved therapeutic products or newly approved product indications.
In both the United States and some non-U.S. jurisdictions, there have been a number of legislative and regulatory proposals to change the healthcare system in ways that could affect our ability to sell our products profitably. In the United States, new legislation may be proposed at the federal and state levels that would result in significant changes to the healthcare system, either nationally or at the state level. Effective January 2004, the Medicare Prescription Drug, Improvement and Modernization Act, or MMA, changed the methodology used to calculate reimbursement for drugs such as Visudyne and Eligard that are administered in physicians’ offices in a manner intended to reduce the amount that is subject to reimbursement. In addition, beginning in January 2006, the legislation directs the Secretary of the Department of Health and Human Services, or HHS, to contract with procurement organizations to purchase physician-administered drugs from the manufacturers and provides physicians with the option to obtain drugs through these organizations as an alternative to purchasing from the manufacturers, which some physicians may find advantageous. These changes may also cause private insurers to reduce the amounts that they will pay for physician-administered drugs. In addition, the Center for Medicare and Medicaid Services, or CMS, the agency within HHS that administers Medicare and is responsible for reimbursement of the cost of Visudyne and Eligard, has asserted the authority of Medicare not to cover particular drugs if it determines that they are not “reasonable and necessary” for Medicare beneficiaries or to cover them at a lesser rate, comparable to that for drugs already reimbursed that CMS considers to be therapeutically comparable. Further federal and state proposals and healthcare reforms are likely. Our results of operations could be materially adversely affected by the Medicare prescription drug coverage legislation, by the possible effect of this legislation on amounts that private insurers will pay and by other healthcare reforms that may be enacted or adopted in the future.
There can be no assurance that any of our applications or re-applications for reimbursement for any of our products will result in approvals or that our current reimbursement approvals for Visudyne, Eligard and our other products will not be reduced or reversed in whole or in part. If we were to have reimbursement reduced or reversed, the market for the affected product may be materially impaired and could materially harm our business and future revenues from that product. For example, while we believe that the results seen in the Visudyne in occult, or VIO, study did not contradict results seen in prior studies, because the VIO study failed to meet its primary endpoint, there is a risk that reimbursement for Visudyne in the occult form of wet AMD could be re-evaluated in the U.S., Europe and elsewhere by the applicable governmental authorities. If they were to reduce or reverse prior reimbursement decisions for Visudyne in the occult form of wet AMD, this could materially adversely affect our future sales and revenue from Visudyne.
We may not successfully develop and launch replacements for our products that lose patent protection.
Most of our products are covered by patents that give us a degree of market exclusivity during the term of the patent. A description of the key patents protecting Visudyne, Eligard, Aczone, Atrigel and our other late stage products are set out in Item 1 under the heading “Patents, Trademarks and Proprietary Rights”. Upon patent expiration, our competitors may introduce products or, in the case of Atrigel, drug delivery technology, using the same technology. As a result of this possible increase in competition, we may need to charge a lower price in order to maintain sales of our products or may lose a competitive advantage and marketability of our Atrigel drug delivery technology which could have a material adverse effect on our business. If we fail to develop and successfully launch new products prior to the expiration of patents for our existing products, our revenue from those products could decline significantly. We may not be able to develop and successfully launch more advanced replacement products and/or drug delivery technologies before these and other patents expire. Competition in the pharmaceutical and biotechnology industry for new products is increasing and the amount required to be paid to acquire or in-license new products may be prohibitive and negatively affect our ability to successfully acquire or in-license new products.

26


 

We may not be able to obtain and enforce effective patents to protect our proprietary rights from use by competitors, and patents of other companies could require us to stop using or pay to use required technology.
We may not be able to obtain and enforce patents, to maintain trade secret protection for our technology and to operate without infringing on the proprietary rights of third parties. The extent to which we are unable to do so could materially harm our business.
We have applied for and will continue to apply for patents for certain aspects of Visudyne, Eligard, Aczone and our other products and technology. Such applications may not result in the issuance of any patents, and any patents now held or that may be issued may not provide us with a preferred position with respect to any product or technology. It is possible that patents issued or licensed to us may be challenged successfully. In that event, to the extent a preferred position is conferred by such patents, any preferred position held by us would be lost. If we are unable to secure or to continue to maintain a preferred position, Visudyne and our other products could become subject to competition from the sale of generic products. In addition, we have an exclusive worldwide license from the University of British Columbia, or UBC, (see “Patents, Trademarks and Proprietary Rights” above) for all of the patents and know-how owned by UBC relating to verteporfin (Visudyne), lemuteporfin and certain additional photosensitizers and their use as therapeutics or diagnostics. Under our license agreement with UBC, if we fail to make any required payments to UBC, it would have the right to terminate these licenses. Under our license agreement with Massachusetts General Hospital, or MGH, it would have the right to terminate the license if we defaulted under the agreement and failed to cure such default within 60 days.
Patents issued or licensed to us may be infringed by the products or processes of other parties. The cost of enforcing our patent rights against infringers, if such enforcement is required, could be significant, and the time demands could interfere with our normal operations.
It is also possible that a court may find us to be infringing validly issued patents of third parties. In that event, in addition to the cost of defending the underlying suit for infringement, we may have to pay license fees and/or damages and may be enjoined from conducting certain activities. Obtaining licenses under third-party patents can be costly, and such licenses may not be available at all. Under such circumstances, we may need to materially alter our products or processes or may lose the right to continue to manufacture and sell a product entirely for a period of time.
Unpatented trade secrets, improvements, confidential know-how and continuing technological innovation are important to our scientific and commercial success. Although we attempt to and will continue to attempt to protect our proprietary information through reliance on trade secret laws and the use of confidentiality agreements with our corporate partners, collaborators, employees and consultants and other appropriate means, these measures may not effectively prevent disclosure of our proprietary information, and, in any event, others may develop independently, or obtain access to, the same or similar information.
Resources devoted to research and development may not yield new products that achieve commercial success.
We devote substantial resources to research and development. The research and development process is expensive, prolonged and entails considerable uncertainty. Development of a new product, from discovery through testing and registration to initial product launch, typically takes between eight and fifteen years or more for a pharmaceutical product. Each of these periods varies considerably from product to product and country to country. Because of the complexities and uncertainties associated with research and development, products we are currently developing may not complete the development process or obtain the regulatory approvals required for us to market such products successfully. We can make no assurances that any of the products currently in our development pipeline will be commercially successful.
The incidence of wet AMD might be reduced if therapies currently in development or currently available prevent or reduce the risk of development of wet AMD which could adversely impact the sales of Visudyne.
We are aware that Alcon has initiated a Phase III clinical trial to evaluate the use of Retaane (Anacortave Acetate) as a treatment for patients with the dry form of AMD who are at high risk of developing wet AMD, with the objective of preventing the occurrence of wet AMD. There are also a number of other biotechnology and pharmaceutical companies conducting research towards other treatments for dry AMD. We are also aware of published reports of studies showing that supplemental vitamin therapies reduce the risk of development of wet AMD. If these studies show that new therapies are effective to treat dry AMD or if supplemental vitamin usage becomes common place in patients with dry AMD, the incidence of wet AMD, which often develops in patients initially diagnosed with dry AMD, might be reduced, and Visudyne sales and our revenues could be materially reduced.

27


 

We may be unable to manufacture or continue to efficiently manufacture Visudyne, Eligard or our other products in compliance with FDA and other regulatory requirements or our product specifications.
We depend on several third parties in the U.S., Canada, Europe and Japan to manufacture Visudyne and Eligard, and if such third parties fail to meet their respective contractual commitments, we may not be able to supply or continue to supply commercial quantities of the product or conduct certain future clinical testing.
(a) Visudyne
For the manufacture of Visudyne, we are dependent upon Nippon Fine Chemicals, Parkedale Pharmaceuticals Inc., Orgapharm S.A.S. and Hollister-Stier Laboratories LLC to manufacture Visudyne or components thereof. Raylo Chemicals manufactures an intermediate used in manufacturing Visudyne. As a result of the acquisition of Raylo Chemicals by a third party, Raylo Chemicals has given notice of its intention to terminate that manufacturing agreement, which termination we believe will be effective January 1, 2010. We believe we currently have sufficient quantities of that intermediate to meet our anticipated demand for Visudyne and are in the process of identifying alternative manufacturers. In the event we are unable to locate and qualify an alternate manufacturer to Raylo Chemicals, our future supply of Visudyne could be materially affected.
Our agreement with Nippon Fine Chemicals is in effect for a term ending on December 31, 2008. Our agreement with Parkedale Pharmaceuticals Inc. is in effect for a term expiring December 31, 2009. The agreement with Orgapharm is effective for a period of 5 years from the date of commercial approval of the Visudyne component by either the EU regulatory authorities, or the U.S. and the Canadian regulatory authorities, whichever is earlier. The agreement with Hollister-Stier is in effect for 5 years from the date of applicable regulatory approval for the component product, after which it will renew for additional 2 year periods unless one party provides the other with 36 months advance notice of its intention not to renew. Although none of these agreements is terminable by the other party for convenience, if we were to commit a default under or breach of any of such agreements, the other party could terminate such agreement. We may be unable to renew such agreements after their expiry on terms which are commercially acceptable to us.
(b) Eligard
For the manufacture of Eligard we are dependant upon a number of manufacturers and suppliers, principally Tolmar Inc. and Chesapeake Biological laboratories Inc. Tolmar has recently purchased our FDA approved sterile filling and lyophilization (freeze drying) facility in Fort Collins, Colorado. We currently contract with Tolmar for the sterile filling and lyophilization process for the drug syringe as well as the manufacture of the delivery system syringe and final packaging of our Eligard products. We continue to maintain Chesapeake Biological Laboratories (another approved contract manufacturer) as an alternate to outsource the filling and lyophilization of the drug syringe. We rely on these manufacturers for this highly specialized service. Our contract with Tolmar is for a period of seven years commencing December 22, 2006, and automatically extends for successive terms of four years each, unless either party notifies the other party that it does not intend to renew this agreement at least three years prior to the last day of the then current term. Our contract with Chesapeake Biological Laboratories is for a period of two years commencing January 23, 2004, and automatically renews for additional one-year terms unless either party provides notice on non-renewal more than 90 days prior to termination, which has not occurred at this time. If our relationship with Tolmar was to deteriorate or terminate, production of our Eligard products may be temporarily discontinued for several months and result in a material loss of revenue. If our relationship with Chesapeake Biological Laboratories, Inc. were to deteriorate or terminate, we could continue to manufacture the Eligard products at the Tolmar facility.
Our ability to conduct clinical trials and commercialize Visudyne, Eligard and our other products, either directly or in conjunction with others, depends, in large part, on our ability to have such products manufactured at a competitive cost and in accordance with FDA and other regulatory requirements as well as our product specifications. Our contract manufacturers’ manufacturing and quality procedures may not achieve or maintain compliance with applicable FDA and other regulatory standards or product specifications, and, even if they do, we may be unable to produce or continue to produce commercial quantities of Visudyne and our other products at an acceptable cost or margin.

28


 

If current manufacturing processes are modified, or the source or location of our product supply is changed (voluntarily or involuntarily), regulatory authorities will require us to demonstrate that the material produced from the modified or new process or facility is equivalent to the material used in the clinical trials or products previously approved. Any such modifications to the manufacturing process or supply may not achieve or maintain compliance with the applicable regulatory requirements or our product specifications. In many cases, prior approval by regulatory authorities may be required before any changes can be instituted.
If our manufacturers produce one or more product batches that do not conform to FDA or other regulatory requirements, or our product specifications, or if they introduce changes to their manufacturing processes, our manufacturing expenses may increase materially, our product inventories may be reduced to unacceptable levels and/or our ability to meet demand for Visudyne may be detrimentally impacted, possibly materially.
In the field of Photodynamic Therapy, or PDT, we are dependent on the success and continued supply of third-party medical device companies with complementary light source and light delivery devices by third party suppliers.
We currently depend on third-party suppliers, Carl Zeiss-Meditic, Lumenis and Quantel to provide the laser light delivery devices for Visudyne therapy and to service such devices. Because PDT requires a light source, and in some instances a light delivery system, to be used in conjunction with our photosensitizers, we are dependent on the success of these medical device companies in placing and maintaining light sources with the appropriate medical facilities, in distributing the light delivery systems and servicing such systems as required. Carl Zeiss-Meditic, Lumenis and Quantel supply such lasers to treating physicians directly, and neither QLT nor Novartis Ophthalmics has a supply or distribution agreement with either Carl Zeiss-Meditic, Lumenis or Quantel for the supply of such devices. The relationship between our Company or Novartis Ophthalmics and such suppliers, under which we or Novartis Ophthalmics provides support and assistance to such suppliers, is an informal collaboration only. If one or more of the medical device companies with whom we or Novartis Ophthalmics have such collaborations cease to carry on business, or if they no longer supply complementary light sources or light delivery systems or if they or we are unable to achieve the appropriate placements of light sources and ensure an uninterrupted supply and ongoing maintenance of light delivery systems to treating physicians, sales of Visudyne and our revenues from the sale of Visudyne may be materially adversely affected.
The expected lifecycle of the laser light delivery devices for Visudyne therapy is approximately five to eight years. Therefore, in the coming years, we expect that many of these lasers will need significant upgrades or will need to be replaced. Customers may decide not to invest in purchasing a new laser in light of emerging competitive therapies which do not require a medical device and this could negatively impact our future sales, possibly materially.
If our supply of finished products is interrupted, our ability to maintain our inventory levels could suffer and future revenues may be delayed.
We try to maintain inventory levels that are no greater than necessary to meet our current projections. Any interruption in the supply of finished products could hinder our ability to timely distribute finished products. If we are unable to obtain adequate product supplies to satisfy our customers’ orders, we may lose those orders and our customers may cancel other orders and seek monetary compensation if permitted under the agreement with the customer stock and sell competing products. This in turn could cause a loss of our market share and negatively affect our revenues.
Supply interruptions may occur and our inventory may not always be adequate. Numerous factors could cause interruptions in the supply of our finished products including shortages in raw material required by our manufacturers, changes in our sources for manufacturing, our failure to timely locate and obtain replacement manufacturers as needed and conditions affecting the cost and availability of raw materials.
We may face future product liability claims that may result from the sale of Visudyne, Eligard and our other products.
The testing, manufacture, marketing and sale of human pharmaceutical products entail significant inherent risks of allegations of product liability. Our use of such products in clinical trials and our sale of Visudyne, Eligard and our other product candidates may expose us to liability claims allegedly resulting from the use of these products. These claims might be made directly by consumers, healthcare providers or others selling our products. We carry clinical trials and product liability insurance to cover certain claims that could arise during the clinical trials for our product

29


 

candidates or during the commercial use of Visudyne, Eligard or our other products. Such coverage, and any coverage obtained in the future, may be inadequate to protect us in the event of a successful product liability claim, and we may not be able to increase the amount of such insurance or even renew it. A successful product liability claim could materially harm our business. In addition, substantial, complex or extended litigation could cause us to incur large expenditures and divert our management’s attention from ongoing business concerns and interfere with our normal operations.
Our business could suffer if we are unsuccessful in identifying, negotiating or integrating future acquisitions, business combinations or strategic alliances.
From time to time, we may engage in negotiations to expand our operations and market presence by future product, technology or other acquisitions and business combinations, joint ventures or other strategic alliances with other companies. We may not be successful in identifying, initiating or completing such negotiations. Competition for attractive product acquisition or alliance targets can be intense, and there can be no guarantee that we will succeed in completing such transactions on terms that are acceptable to us. Even if we are successful in these negotiations, these transactions create risks, such as the difficulties in assimilating the operations and personnel of an acquired business, the potential disruption to our ongoing business, and the potential negative impact on our earnings. We may not succeed in addressing these risks. If we are not successful, our business could suffer.
We are undergoing significant strategic and organizational change. Failure to manage disruption to the business or the loss of key personnel could have an adverse effect on our business.
As part of our new strategic direction we have made significant changes to both management and organizational structure. We recently announced further restructuring and the divestiture of our dental business and our non-core dermatology assets and related manufacturing facilities. As a result of this, morale may be lowered and key employees may decide to leave, or may be distracted from their usual roles. This could result in delays in development projects, failure to achieve targets or other disruption to the business.
Research, Development and Regulatory Risks
We may not be successful in our efforts to develop, license or acquire new products in targeted therapeutic segments.
A key element of our strategy is to develop a portfolio of new drugs in our targeted therapeutic areas. We are seeking to do so through our internal research programs and through licensing or otherwise acquiring the rights to potential new drugs and drug targets in targeted therapeutic segments. A significant portion of the research that we are conducting involves new and unproven technologies. Research programs to identify new disease targets and product candidates require substantial technical, financial and human resources whether or not we ultimately identify any candidates. Our research programs may initially show promise in identifying potential product candidates, yet fail to yield product candidates for clinical development.
We may be unable to license or acquire suitable product from third parties for a number of reasons. In particular, the licensing and acquisition of pharmaceutical products is a competitive area. A number of more established companies are also pursuing strategies to license or acquire products in the ophthalmic and other fields. These established companies may have a competitive advantage over us due to their size, cash resources and greater clinical development and commercial capabilities.
If we are unable to develop suitable potential product candidates through internal research programs or by obtaining rights to novel therapeutics from third parties, our business will suffer.
Our products in clinical trials may not achieve favorable results, may fail to achieve or maintain regulatory approvals or market acceptance, or may encounter difficulties with proprietary rights or manufacturing.
Our success depends on our ability to successfully develop and obtain regulatory approval to market new pharmaceutical products. Development of a product requires substantial technical, financial and human resources even if such product development is not successfully completed. The outcome of the lengthy and complex process of new product development is inherently uncertain.

30


 

We might fail to obtain the additional regulatory approvals we are seeking to expand our product line and the indications for which our products are approved. Those approvals may be delayed, may not be obtained or may be more limited than anticipated. We may lose market opportunities resulting from delays and uncertainties in the regulatory approval process.
If we do not achieve our projected development goals in the time frames we announce and expect, the commercialization of our products may be delayed and, as a result, our business could be harmed.
From time to time, we estimate the timing of the accomplishment of various scientific, clinical, regulatory and other product development goals, which we sometimes refer to as milestones. These milestones may include the commencement or completion of scientific studies and clinical trials and the submission of regulatory filings. From time to time, we publicly announce the expected timing of some of these milestones. All of these milestones are based on a variety of assumptions. The actual timing of these milestones can vary dramatically compared to our estimates, or they might not be achieved, in some cases for reasons beyond our control. If we do not meet these milestones as publicly announced, the commercialization of our products may be delayed and, as a result, our business could be harmed.
Patient enrollment may not be adequate for our current trials or future clinical trials.
Our future prospects could suffer if we fail to develop and maintain sufficient levels of patient enrolment in our current or future clinical trials. Delays in planned patient enrollment may result in increased costs, delays or termination of clinical trials, which could materially harm our future prospects.
Visudyne, Eligard or our other products may exhibit adverse side effects that prevent their widespread adoption or that necessitate withdrawal from the market.
Even after approval by the FDA and other regulatory authorities, Visudyne, Eligard or our other products may later exhibit adverse side effects that prevent widespread use or necessitate withdrawal from the market. Undesirable side effects not previously observed during clinical trials could emerge in the future. The manifestation of such side effects could cause our business to suffer. In some cases, regulatory authorities may require labeling changes that could add warnings or restrict usage based on adverse side effects seen after marketing a drug.
We may be unable to comply with ongoing regulatory requirements.
Our commercial products and our products under development are subject to extensive and rigorous regulation for safety, efficacy and quality by the U.S. federal government, principally the FDA, and by state and local governments. To the extent Visudyne, Eligard, our other commercial products or products under development are marketed abroad, they are also subject to export requirements and to regulation by foreign governments. The regulatory clearance process is lengthy, expensive and uncertain. We may not be able to obtain, or continue to obtain, necessary regulatory clearances or approvals on a timely basis, or at all, for any of our commercial products or any of our products under development, and delays in receipt or failure to receive such clearances or approvals, the loss of previously received clearances or approvals, or failure to comply with existing or future regulatory requirements could materially harm our business.
Drugs manufactured or distributed pursuant to the FDA’s approval are subject to pervasive and continuing regulation by the FDA, certain state agencies and various foreign governmental regulatory agencies such as the EMEA. Manufacturers are subject to inspection by the FDA and regulatory agencies from other jurisdictions. We must comply with a host of regulatory requirements that usually apply to drugs marketed in the U.S. and elsewhere, to our clinical development programs and to investigator sponsored studies that we may from time-to-time support, including but not limited to labeling regulations, Good Manufacturing Practice requirements, adverse event reporting and general prohibitions against promoting products for unapproved or “off-label” uses imposed by the FDA and regulatory agencies in other jurisdictions. Our failure to comply with applicable requirements could result in sanctions being imposed on us. These sanctions could include warning letters, fines, product recalls or seizures, injunctions, refusals to permit products to be imported into or exported out of the U.S. or elsewhere, FDA or other regulatory agency refusal to grant approval of drugs or to allow us to enter into governmental supply contracts, withdrawals of previously approved marketing applications and criminal prosecutions.
We, our contract manufacturers, all of our subsuppliers, as well as the suppliers of the medical lasers required for Visudyne and other PDT therapy, are subject to numerous federal, state and local laws relating to such matters as

31


 

safe working conditions, manufacturing practices, environmental protection, fire hazard control and disposal of hazardous or potentially hazardous substances. In addition, advertising and promotional materials relating to medical devices and drugs are, in certain instances, subject to regulation by the Federal Trade Commission, the FDA and other regulatory agencies in other jurisdictions. We, our contract manufacturers, subsuppliers and laser suppliers may be required to incur significant costs to comply with such laws and regulations in the future, and such laws or regulations may materially harm our business. Unanticipated changes in existing regulatory requirements, the failure of us, or any of these manufacturers, subsuppliers or suppliers to comply with such requirements or the adoption of new requirements could materially harm our business.
As noted above, all of our contract manufacturers must comply with the applicable FDA cGMP regulations, which include quality control and quality assurance requirements as well as the corresponding maintenance of records and documentation. If our contract manufacturers do not comply with the applicable cGMP regulations and other applicable regulatory requirements, the availability of marketed products for sale could be reduced and we could suffer delays in the progress of clinical trials for products under development. We do not have full control over our third-party manufacturers’ compliance with these regulations and standards. The loss of a contract manufacturer could have a negative effect on our sales, margins and market share, as well as our overall business and financial results.
In the future, in the event we are involved directly in the marketing or promotion of our products, our activities relating to the sale and marketing of our products are subject to regulation under the U.S. Federal Food, Drug and Cosmetic Act and other federal statutes. Violations of these laws may be punishable by criminal and/or civil sanctions, including fines and civil monetary penalties, as well as the possibility of exclusion from federal health care programs (including Medicare and Medicaid). We are also subject to various U.S. federal and state laws pertaining to healthcare fraud and abuse, including anti-kickback and false claims laws. Anti-kickback laws make it illegal for a prescription drug manufacturer to solicit, offer, receive, or pay any remuneration in exchange for, or to induce, the referral of business, including the purchase or prescription of a particular drug. Due to the breadth of the statutory provisions and the absence of guidance in the form of regulations or court decisions, it is possible that our practices might be challenged under anti-kickback or similar laws. False claims laws prohibit anyone from knowingly and willingly presenting, or causing to be presented for payment to third-party payers (including Medicare and Medicaid) claims for reimbursed drugs or services that are false or fraudulent, claims for items or services not provided as claimed, or claims for medically unnecessary items or services. Violations of fraud and abuse laws may be punishable by criminal and/or civil sanctions, including fines and civil monetary penalties, as well as the possibility of exclusion from federal health care programs (including Medicare and Medicaid). If a court were to find us liable for violating these laws, or if the government were to allege against or convict us of violating these laws, there could be a material adverse effect on our business, including on our stock price.
We are subject to environmental compliance risks.
Our research, development and manufacturing areas involve the controlled use of hazardous chemicals, primarily flammable solvents, corrosives, and toxins. The biologic materials include microbiological cultures, animal tissue and serum samples. Some experimental and clinical materials include human source tissue or fluid samples. We are subject to federal, state/provincial and local government regulation in the conduct of business, including regulations on employee safety and handling and disposal of hazardous and radioactive materials. Any new regulation or change to an existing regulation could require it to implement costly capital or operating improvements for which we have not budgeted. If we do not comply with these regulations, we may be subject to fines and other liabilities.
Risks Relating to Our Financial Results and Condition
Our future operating results are uncertain and likely to fluctuate.
Although we were profitable for the years 2000-2003, 2004 was impacted by a charge of $236.0 million for purchase of in-process research and development related to the Atrix acquisition, 2005 was impacted by a $410.5 million non-cash charge for impairment of goodwill and other intangible assets that resulted from the Atrix acquisition, and 2006 was impacted by a litigation settlement charge of $112.5 million related to ongoing patent litigation. Future operating performance and profitability are not certain. Our accumulated deficit at December 31, 2006 was approximately $ 603.3 million.
Our operating results may fluctuate from period to period for a number of reasons. A revenue shortfall or increase in operating expenses could arise from any number of factors, such as:

32


 

  1.   lower than expected revenues from sales of Visudyne or Eligard;
 
  2.   changes in pricing strategies or reimbursement levels for Visudyne or Eligard;
 
  3.   seasonal fluctuations, particularly in the third quarter due to decreased demand for Visudyne in the summer months;
 
  4.   high levels of marketing expenses for Visudyne or the launch of additional competitors to Visudyne or Eligard;
 
  5.   fluctuations in currency exchange rates;
 
  6.   unfavorable outcome of the German Eligard patent litigation commenced against QLT USA, Inc.’s German licensees by Takeda Chemical industries Ltd. and Takeda Pharma Gmbh;
 
  7.   unfavorable outcome in the litigation commenced by Massachusetts Eye and Ear Infirmary against QLT;
 
  8.   higher than expected operating expenses as a result of increased costs associated with the development or commercialization of Visudyne, Eligard, Aczone and our other products and candidates; and
 
  9.   increased operating expenses as a result of product, technology or other acquisitions or business combinations.
Future sales of Visudyne, Eligard and our other products may be less than expected.
Our prospects are dependent on the sales of Visudyne, Eligard and our other products. Our revenues to date have consisted largely of revenue from product sales of Visudyne or Eligard. If sales of Visudyne or Eligard, beyond levels that we anticipate, fail to occur it would have a material adverse effect on our business, financial condition and results of operations.
In addition, our revenues from Visudyne, Eligard and our other products licensed to third parties could vary significantly in future periods.
Our provision for income taxes and effective income tax rate may vary significantly and may adversely affect our results of operations and cash resources.
Significant judgement is required in determining our provision for income taxes. Various internal and external factors may have favorable or unfavorable effects on our future provision for income taxes and or effective income tax rate. These factors include but are not limited to changes in tax laws, regulations and/or rates, results of audits by tax authorities, changing interpretations of existing tax laws or regulations, changes in estimates of prior years’ items, future levels of R&D spending, and changes in overall levels of income before taxes. Furthermore, new accounting pronouncements or new interpretation of existing accounting pronouncements, such as those described in Note 3 to the Consolidated Financial Statements, can have a material impact on our effective income tax rate.
We may need additional capital in the future, and our prospects for obtaining it are uncertain.
Our business may not generate the cash necessary to fund our operations and anticipated growth. The amount required to fund additional operating expenses will also depend on other factors, including the status of competitive products, the success of our research and development programs, the extent and success of any collaborative research arrangements, any amounts we may be required to pay in connection with any ongoing litigation as a result of an adverse court decision or any settlement agreement that we may enter into, and the results of product, technology or other acquisitions or business combinations. We could seek additional funds in the future from a combination of sources, including product licensing, joint development and other financing arrangements. In addition, we may issue debt or equity securities if we determine that additional cash resources could be obtained under favorable conditions or if future development funding requirements cannot be satisfied with available cash resources. Additional capital may not be available on terms favorable to us, or at all. If adequate capital is unavailable, we may not be able to engage in desirable acquisition or in-licensing opportunities and may have to reduce substantially or eliminate expenditures for research, development, clinical testing, manufacturing and marketing for Visudyne, Eligard and our other products.
We have convertible debt outstanding, which, if not converted into equity, will require a significant amount of cash and may adversely affect our financial position and cash resources.

33


 

As of December 31, 2006, we had approximately $172.5 million of convertible debt bearing interest at the rate of 3% per annum and due in 2023. On each of September 15, 2008, 2013 and 2018, holders of the notes may require us to purchase all or a portion of their notes for cash at a purchase price equal to 100% of the principal amount of the notes, plus accrued and unpaid interest to, but excluding, that date. On the occurrence of certain events, such as a change in control or termination of trading, holders of the notes may require us to repurchase all or a portion of their notes for cash at a price equal to the principal amount plus accrued unpaid interest to, but excluding, the repurchase date. The notes also become immediately due and payable upon certain events of default by us. In the event that the holders of the convertible debt elect to require repayment of the debt instead of conversion to our common shares, our ability to make payments on and to refinance our indebtedness, including our convertible debt obligation, and to fund planned capital expenditures, R&D, as well as stock repurchases and expansion efforts will depend on our ability to generate cash in the future. This, to a certain extent, is subject to general economic, financial, competitive, legislative, regulatory and other factors that are and will remain beyond our control. Additionally, our indebtedness may increase our vulnerability to general adverse economic and industry conditions, require us to dedicate a substantial portion of our cash flow from operations to payments on our indebtedness, which would reduce the availability of our cash flow to fund working capital, capital expenditures, R&D, expansion efforts and other general corporate purposes, and limit our flexibility in planning for, or reacting to, changes in our business and the industry in which we operate.
The market price of our common shares is extremely volatile.
The stock prices of biopharmaceutical companies, including QLT, are extremely volatile, and it is likely that the market price of our common shares will continue to be highly volatile and investors in our common stock may experience a decrease in the value of their shares, including decreases unrelated to our operating performance or prospects.
Various provisions of our charter and our shareholder rights plan may have the effect of impeding a change in control that are beneficial to our shareholders.
With shareholder approval, we have adopted a shareholder rights plan that will be in effect until our annual general meeting in 2008. The general effect of the plan is to require anyone who seeks to acquire 20% or more of our outstanding common shares to make a bid complying with specific provisions included in the plan. In certain circumstances, holders of common shares may acquire additional shares of QLT (or those of the acquirer) at a 50% discount from the then-prevailing market price. The provisions of the plan could prevent or delay the acquisition of our company by means of a tender offer, a proxy contest or otherwise, making it more difficult for shareholders to receive any premium over the current market price that might be offered.
Our authorized preference share capital is available for issuance from time to time at the discretion of our board of directors, without shareholder approval. Our charter grants the board of directors the authority, subject to the corporate laws of British Columbia, to determine or alter the rights, preferences, privileges and restrictions granted to or imposed on any wholly unissued series of preference shares, including any dividend rate, voting rights, conversion privileges or redemption or liquidation rights. The rights of any future series of preference shares could have an adverse effect on the holders of our common shares by delaying or preventing a change of control, making removal of the present management more difficult or resulting in restrictions on the payment of dividends and other distributions to the holders of common shares.
Item 1B. UNRESOLVED STAFF COMMENTS
None.
Item 2. PROPERTIES
In Vancouver, British Columbia, Canada, we own and occupy a 160,000 square foot facility on the 2.3 acre site where our head office, certain research facilities and pilot manufacturing facility are located. We also own an additional 2.6 acres of land immediately adjacent to our head office facilities. At present, we have no plans to construct facilities on our adjacent site. As a result of reduced space requirements following the restructuring announced in the fourth quarter of 2006, in February 2007 we sublet approximately 33,000 square feet of that building to a third party, which lease has an initial four year term from April 1, 2007 to March 31, 2007. The tenant

34


 

has the right to terminate the lease after 3.5 years and, unless we notify the tenant that we desire the leased premises for our own use, the tenant has the option to renew the lease for up to two additional renewal terms of one year each.
In the U.S., we lease 43,000 square feet of office and research laboratory space located in Fort Collins, Colorado, pursuant to a lease that expires at the end of August, 2008, which may be renewed for two additional three year terms. As a result of our recent restructuring and the sale of our generic dermatology and dental businesses, our space requirement in Fort Collins has been reduced and we have sub-let a portion of our leased office and research space in Fort Collins to Tolmar, the purchaser of our generic dermatology and dental businesses.
We believe that our existing facilities are adequate to meet our needs for the foreseeable future.
Item 3. LEGAL PROCEEDINGS
We are subject to various legal proceedings and claims arising in the ordinary course of business. We cannot determine the ultimate liability with respect to such legal claims at this time.
(a) Eligard Patent Litigation
United States Patent Litigation
In 2003, plaintiffs TAP Pharmaceutical Products, Inc., Takeda Chemical Industries Ltd. and Wako Pure Chemical Industries, Ltd. filed suit against QLT USA, Inc. and co-defendant Sanofi-Synthelabo, Inc. in the U.S. federal court in the Northern District of Illinois Eastern Division (Case No. 1:03-CV-7822). TAP and its co-plaintiffs alleged that QLT USA and Sanofi-Synthelabo willfully infringed U.S. Patent No. 4,728,721 (the “‘721 patent”) by the manufacture and sale in the United States of the Eligard® product line and sought injunctive relief, damages, and an award of attorneys’ fees and costs against QLT USA and Sanofi-Synthelabo (the “TAP Litigation”).
On February 9, 2007, QLT USA, Inc. entered into a Settlement, Release and Patent License to settle the litigation captioned “TAP Pharmaceutical Products Inc., Takeda Chemical Industries, Ltd. and Wako Pure Chemical Industries, Ltd. v. Atrix Laboratories, Inc. and Sanofi-Synthelabo Inc.”, No. 03-C-7822, in the United States District Court for the Northern District of Illinois and the appeal pending therefrom in the United States Court of Appeals for the Federal Circuit. QLT USA, Sanofi-Synthelabo, Takeda Chemical Industries, Ltd. (“Takeda”), Wako Pure Chemical Industries, Ltd. (“Wako”), TAP Pharmaceutical Products Inc. (“TAP”) and Abbot Laboratories, Ltd. (“Abbot”) were parties to the settlement agreement. The settlement resolved that litigation initiated by TAP and its co-plaintiffs regarding U.S. patent no. 4,728,721.
Under the terms of the settlement agreement, and without admitting liability, QLT USA paid TAP $112.5 million and Sanofi-Synthelabo paid TAP $45.0 million, for an aggregate settlement amount of $157.5 million. The settlement agreement provides that TAP and its co-plaintiffs will release their claims made in the United States litigation against QLT USA and Sanofi-Synthelabo and each of TAP, Takeda, Wako and Abbott will grant QLT USA a transferable, non-exclusive, perpetual, royalty-free license under any of their past and future patents to make, use and sell QLT USA’s currently-marketed Eligard® products in the United States and Canada. The District Court and the Court of Appeals entered orders dismissing the respective litigation on February 15, 2007 and February 12, 2007, respectively.
In connection with the settlement agreement, on February 9, 2007, QLT USA and Sanofi-Synthelabo entered into an amended and restated Contribution Agreement to provide for, among other things, the dollar amount each party has agreed to contribute under the settlement agreement.
As a result of this settlement, we recorded a charge of US$112.5 million in our consolidated 2006 results. As of December 31, 2006, before payment of the settlement amount, our consolidated total cash, short-term investments, long-term investments and escrowed funds was approximately $378 million.

35


 

Germany Patent Litigation
On June 1, 2004, QLT USA’s Eligard marketing licensee for Eligard, MediGene AG, filed an action in the Federal Patent Court, Munich, Germany, seeking nullification of the European counterpart to the ‘721 patent, European Patent 0 202 065 (the “’065 patent”). The ‘065 patent expired on May 6, 2006.
On June 21, 2004, Takeda Chemical Industries Ltd., Wako Pure Chemical Industries, Ltd. and Takeda Pharma GmbH sought a provisional injunction in the Regional Court Hamburg, Germany, alleging that the marketing of Eligard by MediGene and its licensee Yamanouchi (now Astellas) in Germany violated the ‘065 patent. The Court denied that request.
On June 28, 2004, the Takeda companies and Wako filed a complaint in the Regional Court Düsseldorf, Germany, against MediGene and Yamanouchi, alleging infringement of the ‘065 patent.
In April 2005, in the suit initiated by MediGene, the Federal Patent Court ruled that all of the patent claims asserted by the Takeda companies and Wako in their subsequent infringement suit are null and void in Germany for lack of novelty and lack of inventive step. Takeda and Wako have appealed that decision. The Regional Court Düsseldorf has stayed the infringement action brought by Takeda and Wako in view of the Federal Patent Court’s decision. The German lawsuits relating to the ‘065 patent were not resolved by the settlement agreement reached in connection with the ‘721 lawsuit in the United States.
Under agreements QLT USA entered into with MediGene and Yamanouchi, QLT USA has provided certain indemnities to MediGene and Yamanouchi including indemnities covering certain losses relating to infringement of a third party’s proprietary rights on and subject to the terms of that agreement.
(b) Patent Litigation with MEEI
The First MEEI Lawsuit
In April 2000, Massachusetts Eye and Ear Infirmary (“MEEI”) filed a civil suit against QLT Inc. in the United States District Court (the “Court”) for the District of Massachusetts seeking to establish exclusive rights for MEEI as the owner of certain inventions relating to the use of verteporfin (the active pharmaceutical ingredient in Visudyne®) as the photoactive agent in the treatment of certain eye diseases including AMD.
In 2002, we moved for summary judgement against MEEI on all eight counts of MEEI’s complaint in Civil Action No. 00-10783-JLT. The Court granted our motion, dismissing all of MEEI’s claims. With respect to our counterclaim requesting correction of inventorship of U.S. Patent No. 5,789,349 (the "'349 patent”) to add an additional Massachusetts General Hospital (“MGH”) inventor, the Court stayed the claim pending the outcome of the trial described below.
MEEI appealed the decision of the Court to the U.S. Court of Appeals for the First Circuit. In a decision dated June 15, 2005, the Court of Appeals upheld the dismissal of five of MEEI’s eight claims and remanded to the district court for further proceedings concerning three of MEEI’s claims (unjust enrichment, unfair trade practices and misappropriation of trade secrets). In February, 2006 we filed a Petition for Writ of Certiorari in the United States Supreme Court asserting that MEEI’s claim for unjust enrichment is preempted by federal patent law. The Court of Appeals stayed its remand to the district court pending the resolution of our Petition by the Supreme Court. In May 2006, the Supreme Court denied our Petition, and MEEI’s three remaining claims were then remanded to the district court for further proceedings.
On November 6, 2006, a federal jury found QLT liable under Massachusetts state law for unjust enrichment and unfair trade practices and determined that we should pay to MEEI a royalty of 3.01% on net sales of Visudyne worldwide. It remains for the court to determine whether this relates to future sales, or past and future sales of Visudyne. The trial judge will now consider post-trial motions including whether the decision of the jury is of an advisory nature only or whether the judge will make his determination of liability and damages, if any. From the time Visudyne was launched in 2000 to December 31, 2006, net sales of Visudyne have totaled approximately $2.3 billion worldwide. The jury determined that the unfair trade practices were not committed knowingly or willfully and therefore declined to award enhanced damages. Any award may include interest at court imposed rates and

36


 

MEEI’s attorneys’ fees. We have filed post-trial motions addressing the effect of the jury’s verdict and to continue to vigorously pursue the defense of this case. It is uncertain when final judgment will be entered.
The Second MEEI Lawsuit
In May 2001 the United States Patent Office issued United States Patent No. 6,225,303 (the “’303 Patent”) to MEEI. The ‘303 Patent is derived from the same patent family as the Patent in issue in the first suit, the ‘349 patent, and claims a method of treating unwanted choroidal neovasculature in a shortened treatment time using verteporfin (the active pharmaceutical ingredient in Visudyne®). The patent application which led to the issuance of the ‘303 patent was filed and prosecuted by attorneys for MEEI and, in contrast to the ‘349 patent, named only MEEI researchers as inventors.
In May 2001, MEEI filed suit against us and Novartis Ophthalmics, Inc. in the United States District Court for the District of Massachusetts alleging infringement of the ‘303 Patent (Civil Action No. 01-10747-EFH). The suit seeks damages and injunctive relief for patent infringement. We denied the complaint and raised a number of affirmative defenses, including incorrect inventorship, and asserted counterclaims against MEEI and the two MEEI researchers who are named as inventors on the ‘303 patent. In addition, MGH intervened in the case requesting correction of inventorship on the ‘303 Patent to add three MGH scientists and one QLT scientist as joint inventors of the claimed inventions.
In 2004, we and MGH moved to correct inventorship on the ‘303 Patent. In January 2005, the Court granted partial summary judgement ordering that the ‘303 Patent be corrected to add QLT’s scientist as a joint inventor. Because the Court’s partial ruling made QLT a co-owner of the patent, the Court dismissed MEEI’s complaint for infringement. MEEI appealed that decision to the Court of Appeals for the Federal Circuit. In early October, 2006, the Court of Appeals for the Federal Circuit overturned that summary judgement on the basis that there were issues of fact that remain to be determined. The case has been remanded to the district court.
The ‘349 patent is co-owned by QLT, MGH and MEEI. QLT entered into an exclusive license with MGH for its rights under the ‘349 patent in return for a royalty equal to 0.5% of net sales of Visudyne in the United States and Canada. Under the license agreement with MGH, if QLT concludes a license agreement with MEEI for rights under the ‘349 patent and continuation patents which includes payment of royalties and other compensation to MEEI that are more favorable than are contained in the license agreement with MGH, then as of the effective date of such more favorable royalties or compensation to MEEI, the license agreement with MGH shall be revised to the same rate as paid under the agreement with MEEI.
(c) Effect of the German Eligard Patent Litigation and MEEI Litigation
The final outcome of the German Eligard patent litigation and MEEI litigation is not presently determinable or estimable and accordingly, no amounts have been accrued. There can be no assurance that the matters will finally be resolved in favor of QLT USA’s German licensees of Eligard or in our favor. If the German Eligard patent litigation is not resolved favorably, QLT USA’s German licensees could be found liable for damages and those licensees may attempt to assert a claim against QLT USA for indemnification of all or part of such damages. If the MEEI litigation is not resolved favorably, QLT could be liable for damages. While we cannot estimate the potential damages in the German Eligard patent litigation and MEEI litigation, or what level of indemnification by QLT USA, if any, will be required in connection with the German Eligard patent litigation under the agreements with its German licensees, MediGene and Yamanouchi (now Astellas), the amount of damages and indemnification could be substantial, which could have a material adverse impact on our financial condition. Alternatively, the German Eligard patent litigation and/or MEEI litigation could be resolved favorably or could be settled. An outcome could materially affect the market price of our shares, either positively or negatively. We will continue to aggressively pursue the German Eligard patent litigation and MEEI litigation defenses, and potential settlement discussions.
Item 4. SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS
No matters were submitted to a vote of our shareholders during the fourth quarter of the year ended December 31, 2006.

37


 

PART II
Item 5. MARKET FOR THE REGISTRANT’S COMMON SHARES, RELATED SHAREHOLDER MATTERS AND ISSUER
            PURCHASES OF EQUITY SECURITIES
Common Share Information
Our common stock is traded in Canada on the Toronto Stock Exchange under the symbol “QLT” and in the U.S. on The NASDAQ Stock Market under the symbol “QLTI”. The following table sets out, for the periods indicated, the high and low closing sales prices and trading volumes of the common shares, as reported by the Toronto Stock Exchange and The NASDAQ Stock Market.
                                                 
    The Toronto Stock Exchange   The NASDAQ Stock Market
    High   Low   Volume   High   Low   Volume
    (CAD$)   (CAD$)           (U.S.$)   (U.S.$)        
2006
                                               
 
                                               
Fourth Quarter
  $ 10.35     $ 8.62       12,196,874     $ 8.98     $ 7.69       55,168,839  
Third Quarter
    8.86       7.10       7,124,433       7.92       6.28       45,308,444  
Second Quarter
    9.37       7.53       8,951,607       8.31       6.77       51,772,917  
First Quarter
    8.99       6.84       11,896,512       7.82       5.95       98,016,067  
 
                                               
2005
                                               
 
                                               
Fourth Quarter
  $ 9.20     $ 7.03       28,212,418     $ 7.92     $ 6.05       74,122,811  
Third Quarter
    13.55       8.15       19,319,201       11.12       6.96       83,556,511  
Second Quarter
    15.55       11.87       26,225,580       12.67       9.47       71,776,758  
First Quarter
    21.04       15.02       23,604,803       17.19       12.37       71,802,369  
The last reported sale price of the common shares on The Toronto Stock Exchange and on The NASDAQ Stock Market on February 26, 2007 was CAD $10.46 and U.S. $9.08, respectively.
As of February 15, 2007, there were 2,100 registered holders of our common shares, 1,946 of whom were residents of the U.S. Of the total 75,254,215 common shares outstanding, the portion held by registered holders resident in the U.S. was 40,950,899 or 54.42%.

38


 

Share Price Performance Graph
The graph below compares cumulative total shareholder return on the common shares of QLT for the last five fiscal years with the total cumulative return of the S&P/TSX Composite Index and the NASDAQ Biotechnology Index over the same period.
(LINE GRAPH)
                                                 
    Dec. 31,
2001
    Dec. 31,
2002
    Dec. 31,
2003
    Dec. 31,
2004
    Dec. 30,
2005
    Dec. 29,
2006
QLT Total Return
    100.00       33.09       60.49       47.48       18.44       24.37  
S&P/TSX Composite Index
    100.00       86.03       106.93       120.27       146.61       167.89  
NASDAQ Biotechnology Index
    100.00       54.15       64.86       63.82       63.50       64.28  
The graph above assumes CAD$100 invested on December 31, 2001 in common shares of QLT and in each index converted, where applicable, to Canadian dollars at the Bank of Canada close rate in effect on each date. The share price shown above for the common shares is historical and not indicative of future price performance.
The forgoing graph and chart shall not be deemed to be incorporated by reference by any general statement incorporating by reference this Report into any filing under the Securities Act or under the Exchange Act, except to the extent we specifically incorporate this information by reference, and shall not otherwise be deemed filed under those Acts.
Dividend Policy
The Company has not declared or paid any dividends on its common shares since inception. The Company does not anticipate paying dividends in the foreseeable future.
Exchange Controls and Other Limitations Affecting Holders of Common Shares
There is no law, governmental decree or regulation in Canada that restricts the export or import of capital, or which would affect the remittance of dividends or other payments by the Company to non-resident holders of common shares in the Company, other than withholding tax requirements.
There is no limitation imposed by Canadian law or the charter or other constituent documents of the Company on the right of non-residents to hold or vote common shares in the Company, other than those imposed by the Investment Canada Act (Canada) (the “Investment Act”).

39


 

The Investment Act requires each individual, government or agency thereof, corporation, partnership, trust or joint venture that is not a “Canadian” as defined in the Investment Act (a “non-Canadian”) who commences a new business activity in Canada or acquires control of an existing Canadian business, where the establishment or acquisition of control is not a reviewable transaction, to file a notification with Industry Canada. The Investment Act generally prohibits implementation of a reviewable transaction by a non-Canadian unless after review the minister responsible for the Investment Act is satisfied that the investment is likely to be of net benefit to Canada. An investment in common shares of the Company by a non-Canadian would be reviewable under the Investment Act if it were an investment to acquire control of the Company and the value of the assets of the Company was $5 million or more. Higher limits apply for acquisitions by or from World Trade Organization, or WTO, member country investors.
The acquisition of a majority of the voting interests of an entity or of a majority of the undivided ownership interests in the voting shares of an entity that is a corporation is deemed to be acquisition of control of that entity. The acquisition of less than a majority but one-third or more of the voting shares of a corporation or of an equivalent undivided ownership interest in the voting shares of the corporation is presumed to be acquisition of control of that corporation unless it can be established that, on the acquisition, the corporation is not controlled in fact by the acquirer through the ownership of voting shares. The acquisition of less than one-third of the voting shares of a corporation or of an equivalent undivided ownership interest in the voting shares of the corporation is deemed not to be acquisition of control of that corporation. Certain transactions in relation to common shares in the Company would be exempt from review from the Investment Act, including:
  (a)   acquisition of common shares by a person in the ordinary course of that person’s business as a trader or dealer in securities;
 
  (b)   acquisition of control of the Company in connection with the realization of security granted for a loan or other financial assistance and not for any purpose related to the provisions of the Investment Act; and
 
  (c)   acquisition of control of the Company by reason of an amalgamation, merger, consolidation or corporate reorganization following which the ultimate direct or indirect control in fact of the Company, through the ownership of voting interests, remains unchanged.
The Investment Act was amended with the Act to Implement the Agreement Establishing the World Trade Organization, or WTO, to provide for special review thresholds for WTO member country investors. Under the Investment Act, as amended, an investment in common shares of the Company by a non-Canadian who is a WTO investor (as defined in the Investment Act) would be reviewable only if it were an investment to acquire control of our Company and the value of the assets of our Company was equal to or greater than a specified amount (the “Review Threshold”), which increases in stages. The Review Threshold was CAD$ 237 million in 2004, CAD$ 250 million in 2005 and is CAD$ 265 million in 2006. This amount is subject to an annual adjustment on the basis of a prescribed formula in the Investment Act to reflect inflation and real growth within Canada.
Certain Canadian and U.S. Federal Income Tax Information for U.S. Residents
The following is a summary of certain Canadian and U.S. federal income tax considerations applicable to holders of common shares of our Company. These tax considerations are stated in brief and general terms and are based on Canadian and U.S. law currently in effect. There are other potentially significant Canadian and U.S. federal income tax considerations and provincial, state and local income tax considerations with respect to ownership and disposition of the common shares which are not discussed herein. The tax considerations relative to ownership and disposition of the common shares may vary from shareholder to shareholder depending on the shareholder’s particular status. Accordingly, shareholders and prospective shareholders are encouraged to consult with their tax advisors regarding tax considerations, which may apply to the particular situation.

40


 

Canadian Federal Tax Information
Dividends paid on the common shares held by non-residents of Canada will generally be subject to Canadian withholding tax at the rate of 25%. The Canada-U.S. Income Tax Convention (1980) (the “Convention”) provides that the withholding rate on dividends paid to U.S. residents on the common shares is generally 15%.
Gains on sales or other dispositions of the common shares of our Company by a U.S. resident generally are not subject to Canadian income tax, unless the shareholder realizes the gains in connection with a business carried on in Canada with respect to such shares. A gain realized upon the disposition of the common shares by a U.S. resident that is otherwise subject to Canadian tax may be exempt from Canadian tax under the Convention.
Where the common shares are disposed of by way of an acquisition of such common shares by our Company, other than a purchase in the open market in the manner in which common shares normally would be purchased by any member of the public in the open market, the amount paid by our Company in excess of the paid-up capital of such common shares will be treated as a dividend and will be subject to non-resident withholding tax as described above.
U.S. Federal Tax Information
Distributions with respect to our common shares generally will be taxable as dividends to the extent of our Company’s earnings and profits, determined under U.S. tax principles, subject to the same preferential rate that applies to long-term capital gain (currently, 15% for individual Holders). Under current law, for taxable years beginning after December 31, 2010, distributions will be taxed at ordinary rates without the benefit of such preferential rates.
Corporate U.S. Holders generally will not be allowed a deduction for dividends received in respect of distributions on our common shares. Dividends will be treated as income from sources outside the U.S., but generally will be “passive income,” or in the case of a financial services entity, “financial services income” (and, for taxable years beginning after December 31, 2006, as “general category income”) for U.S. foreign tax credit purposes.
Special rules apply to U.S. Holders that hold stock in a “passive foreign investment company” (“PFIC”). A foreign corporation generally will be a PFIC for any taxable year in which either (i) 75% or more of its gross income is passive income or (ii) 50% or more of the average value of its assets consist of assets that produce, or that are held for the production of, passive income. For this purpose, passive income generally includes, among other things, interest, dividends, rents, royalties, gains from the sale of property that gives rise to dividends, interests, rents and royalties and gains from certain commodities transactions.
We believe that our Company was not a PFIC in 2006. However, there can be no assurance that our Company will not be considered a PFIC in a future taxable year, because status under the PFIC rules is based in part on factors not entirely within the Company’s control (such as market capitalization).
We believe that our Company was a PFIC in one or more taxable years prior to 2000. Accordingly, a U.S. Holder whose common shares were held at any time during a taxable year in which our Company was a PFIC may be subject to increased tax liability upon the sale, exchange or other disposition of shares of our common shares or upon the receipt of certain distributions. These adverse tax consequences will not apply, however, if a U.S. Holder timely filed and maintained (and in certain cases, continue to maintain) a qualified electing fund (“QEF”) election to be taxed annually on the holder’s pro rata portion of our Company’s earnings and profits.
We intend to comply with all record-keeping, reporting and other requirements so that U.S. Holders, who must continue to maintain a QEF election to avoid increased tax liability with respect to our common shares, may do so. However, if meeting those record-keeping and reporting requirements becomes onerous, we may decide, in our sole discretion, that such compliance is impractical and will so notify U.S. Holders. Until such time, U.S. Holders that desire to maintain a QEF election may contact our Investment Relations group for the PFIC Annual Information Statement, which may be used to complete their annual QEF election filings.

41


 

Item 6. SELECTED FINANCIAL DATA
Annual Financial Data
                                         
Year Ended December 31,   2006(5)   2005(4)   2004(2)(3)   2003   2002
 
(In thousands of U.S. dollars except per share information)        
 
                                       
CONSOLIDATED STATEMENT OF OPERATIONS DATA        
 
Total revenues
  $ 175,090     $ 229,837     $ 184,755     $ 146,750     $ 110,513  
Research and development expenses
    56,428       63,330       48,698       44,905       42,252  
(Loss) income from continuing operations
    (83,415 )     (313,484 )     (163,204 )     44,817       13,595  
(Loss) income before extraordinary gain
    (101,605 )     (325,412 )     (178,226 )     44,817       13,595  
Net (loss) income
    (101,605 )     (325,412 )     (165,709 )     44,817       13,595  
Basic net (loss) income per common share:
                                       
Continuing operations
    (0.99 )     (3.38 )     (2.23 )     0.65       0.20  
Discontinued operations
    (0.22 )     (0.13 )     (0.20 )            
Extraordinary gain(3)
                0.17              
 
Net (loss) income
    (1.20 )     (3.51 )     (2.26 )     0.65       0.20  
 
Diluted net (loss) income per common share:
                                       
Continuing operations
    (0.99 )     (3.38 )     (2.23 )     0.59       0.20  
Discontinued operations
    (0.22 )     (0.13 )     (0.20 )            
Extraordinary gain(3)
                0.17              
 
Net (loss) income
    (1.20 )     (3.51 )     (2.26 )     0.59       0.20  
 
 
                                       
CONSOLIDATED BALANCE SHEET DATA        
 
Cash, cash equivalents and short-term investment securities
  $ 374,216     $ 465,615     $ 379,852     $ 495,430     $ 207,935  
Working capital
    323,511       514,713       465,826       556,733       260,127  
Total assets
    639,106       776,494       1,116,249       634,722       345,841  
Long term debt
    172,500       172,500       172,500       172,500        
Total shareholders’ equity
    303,214       526,111       856,779       433,371       313,545  
 
     For all years presented there were no cash dividends per common share.
Quarterly Financial Data (1)
Set out below is selected consolidated financial information for each of the fiscal quarters of 2006 and 2005.
                                 
Three Months Ended   December 31     September 30     June 30     March 31  
 
(In thousands of U.S. dollars except per share information)        
 
                               
2006 (5)
                               
 
Total revenues
  $ 38,636     $ 38,246     $ 47,796     $ 50,412  
Gross Profit
    28,643       27,780       36,245       40,231  
Research and development expenses
    12,724       13,564       15,767       14,373  
Net (loss) income from continuing operations
    (110,505 )     6,195       8,240       12,654  
Net (loss) income
    (117,476 )     (3,746 )     7,484       12,133  
Basic net (loss) income per common share
                               
Continuing operations
    (1.47 )     (0.07 )     0.09       0.14  
Discontinued operations
    (0.09 )     (0.12 )     (0.01 )     (0.01 )
Net (loss) income
    (1.56 )     (0.04 )     0.08       0.13  
Diluted net (loss) income per common share
                               
Continuing operations
    (1.47 )     (0.07 )     0.09       0.14  
Discontinued operations
    (0.09 )     (0.12 )     (0.01 )     (0.01 )
Net (loss) income
    (1.56 )     (0.04 )     0.08       0.13  
 
                               
2005(4)
                               
 
Total revenues
  $ 47,386     $ 61,130     $ 59,627     $ 61,695  
Gross Profit
    37,561       48,236       49,821       48,165  

42


 

                                 
Three Months Ended   December 31     September 30     June 30     March 31  
 
Research and development expenses
    16,300       15,701       17,348       13,991  
Net (loss) income from continuing operations
    (362,829 )     14,290       18,160       16,896  
Net (loss) income
    (370,393 )     12,899       16,826       15,256  
Basic net (loss) income per common share
                               
Continuing operations
    (3.96 )     0.15       0.20       0.18  
Discontinued operations
    (0.08 )     (0.02 )     (0.01 )     (0.02 )
Net (loss) income
    (4.04 )     0.14       0.18       0.16  
Diluted net (loss) income per common share
                               
Continuing operations
    (3.96 )     0.15       0.20       0.18  
Discontinued operations
    (0.08 )     (0.02 )     (0.01 )     (0.02 )
Net (loss) income
    (4.04 )     0.14       0.18       0.16  
 
 
(1)   The basic and diluted income (loss) per share are determined separately for each quarter. Consequently, the sum of the quarterly amounts may differ from the annual amounts disclosed in the consolidated financial statements as a result of using different weighted average numbers of shares outstanding.
 
(2)   On March 31, 2004, we acquired all the outstanding shares of Kinetek Pharmaceuticals, Inc., or Kinetek, a privately held biopharmaceutical company based in Vancouver, British Columbia that focused on discovery and development of new targets and therapies, for $2.4 million. The extraordinary gain in fiscal 2004 of $12.5 million resulting from this acquisition related to the estimated fair value of net assets acquired, including the recognition of certain tax assets, in excess of the total consideration paid by us.
 
(3)   On November 19, 2004, we completed our acquisition of Atrix Laboratories, Inc., or Atrix, for $870 million. The impact of this acquisition on 2004 operations includes: total revenues of $5.0 million, a $236.0 million charge for purchased in-process research and development, and amortization of acquired intangibles of $0.9 million.
 
(4)   During the fourth quarter of 2005, events and circumstances indicated impairment of goodwill and intangible assets acquired in connection with our acquisition of Atrix in November 2004. As a result, we recorded a non-cash charge of $410.5 million to reduce the carrying value of our goodwill to $104.0 million and our intangible assets to $6.9 million.
 
(5)   On February 9, 2007, QLT USA and Sanofi-Synthelabo entered into a Settlement, Release and Patent License to settle the TAP Litigation, and without admitting liability, QLT USA paid $112.5 million and Sanofi-Synthelabo paid $45.0 million, for an aggregate settlement amount of $157.5 million. As a result of this settlement, we recorded a charge of $112.5 million in our results for 2006. (See Item 3 — Legal Proceedings and Note 23 to “Notes to the Consolidated Financial Statements”).

43


 

Item 7. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
The following information should be read in conjunction with the accompanying 2006 consolidated financial statements and notes thereto, which are prepared in accordance with generally accepted accounting principles, or GAAP, in the United States of America, or U.S. All of the following amounts are expressed in U.S. dollars unless otherwise indicated.
FORWARD-LOOKING STATEMENTS
This Report contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995 and “forward looking information” within the meaning of the Canadian securities legislation which are based on our current expectations and projections. Words such as “anticipate”, “project”, “expect”, “forecast”, “outlook”, “plan”, “intend”, estimate”, “should”, “may”, “assume”, “continue”, and variations of such words or similar expressions are intended to identify our forward-looking statements. Forward looking statements include, but are not limited to, those in which we state:
    anticipated levels of future sales of our products;
 
    anticipated future operating results;
 
    our expectations as to the outcome of the patent related litigation commenced by Massachusetts Eye and Ear Infirmary against us;
 
    our expectations as to the outcome of the German Eligard patent litigation commenced against QLT USA, Inc.’s German licensees by Takeda Chemical industries Ltd. and Takeda Pharma Gmbh;
 
    the anticipated timing and progress of clinical trials;
 
    the anticipated timing of regulatory submissions for our products;
 
    the anticipated timing for, receipt of and our ability to maintain regulatory approvals for our products;
 
    the anticipated timing for, receipt of and our ability to maintain reimbursement approvals for our products in development; and
 
    our expectation as to our eligibility for certain tax benefits resulting from new tax legislation in effect in the Province of British Columbia.
We caution that actual outcomes and results may differ materially from those expressed in our forward-looking statements because such statements are predictions only and they are subject to a number of important risks factors and uncertainties. Risk factors and uncertainties could cause actual results to differ from what is expressed or implied by our forward-looking statements. Although we believe that the assumptions underlying the forward-looking statements contained herein are reasonable, any of the assumptions could be inaccurate, and therefore such statements included in this Report may not prove to be accurate. In light of the significant uncertainties inherent in the forward-looking statements included herein, the inclusion of such information should not be regarded as a representation by us or any other person that the results or conditions described in such statements or our objectives and plans will be achieved. These statements, like all statements in this Report, speak only as of the date of this report, unless an earlier date is indicated, and, except as required by law and the rules and regulations of the SEC and Canadian regulatory authorities, we undertake no obligation to update or revise the statements.
OVERVIEW
We are a global biopharmaceutical company dedicated to the discovery, development and commercialization of innovative therapies. Our research and development efforts are focused on pharmaceutical products in the fields of ophthalmology and dermatology. In addition, we utilize two unique technology platforms, photodynamic therapy and Atrigel®, to create products such as Visudyne® and Eligard®.
QLT was formed in 1981 under the laws of the Province of British Columbia, Canada. In November 2004, we acquired Atrix Laboratories, Inc., (now QLT USA, Inc. or “QLT USA”) a Fort Collins, Colorado based biopharmaceutical company focused on advanced drug delivery. With our acquisition of Atrix in 2004, we expanded and diversified our consolidated portfolio of approved products, products in development or under regulatory review, and proprietary technologies. (For product revenues, see our Consolidated Financial Statements — Note 15).

44


 

Our first commercial product was in the field of photodynamic therapy, or PDT, which uses photosensitizers (light activated drugs) in the treatment of disease. Our lead commercial product, Visudyne, utilizes PDT to treat the eye disease known as wet age related macular degeneration, or wet AMD, the leading cause of blindness in people over the age of 55 in North America and Europe.
Visudyne is commercially available in more than 75 countries, including the U.S., Canada, Japan and the European Union countries, for the treatment of a form of wet AMD known as predominantly classic subfoveal choroidal neovascularization, or CNV, and in over 50 countries for the form of wet AMD known as occult subfoveal CNV. Visudyne is reimbursed in the U.S. by the Centers for Medicare & Medicaid Services for certain patients with the occult and minimally classic forms of wet AMD. It is also approved in more than 60 countries, including the U.S., Canada and the European Union countries, for the treatment of subfoveal CNV due to pathologic myopia (severe near-sightedness). In some countries, including the U.S. and Canada, Visudyne is also approved for presumed ocular histoplasmosis or other macular diseases. Visudyne was co-developed by QLT and Novartis Pharma AG of Switzerland (“Novartis Ophthalmics”) and is manufactured by QLT and sold by Novartis Ophthalmics under the terms of a co-development, manufacturing and commercialization agreement with Novartis Ophthalmics
In addition to our lead commercial product Visudyne, we market (through commercial licensees) the Eligard line of products for the treatment of prostate cancer. The Eligard product line includes four different commercial formulations of our Atrigel® technology combined with leuprolide acetate for the treatment of prostate cancer. The U.S. Food and Drug Administration, or FDA, has approved all four products: Eligard 7.5-mg (one-month), Eligard 22.5-mg (three-month), Eligard 30.0-mg (four-month) and Eligard 45.0-mg (six-month). The Eligard 7.5-mg and Eligard 22.5-mg products are also approved in a number of other countries, including 25 European countries, Canada, Australia, New Zealand, India and a number of Latin American countries. In addition to the U.S., Eligard 30-mg (four-month) is approved in Canada, Australia, New Zealand and India while Eligard 45.0-mg (six-month) is approved in Germany, Canada, Australia and India.
Our most advanced proprietary dermatology product, Aczone™, was approved by the FDA in July 2005 and by Health Canada in June 2006. Although Aczone is approved in the U.S and Canada, it is not yet marketed. Based on a post-approval commitment requested by the FDA, we conducted a Phase IV clinical trial of Aczone™ in more than 50 patients with G6PD deficiency and communicated the positive outcome of this study in November 2006. We intend to submit a label revision supplement to the FDA during the second quarter of 2007. A decision with respect to the commercialization of Aczone is pending the outcome of this submission to the FDA to remove the restriction currently on the approved label for the product.
Our efforts to increase our portfolio of products are ongoing. We carry out research and pre-clinical projects in our core therapeutic areas of ophthalmology and dermatology. We also conduct research and development work on product candidates using the Atrigel drug delivery system in a number of other therapeutic areas that we are currently considering divesting or out-licensing at the appropriate time and from which we can potentially derive royalty and other revenue upon commercialization.
To focus our business on the research and development of proprietary products in our core therapeutic areas, in December 2006, the generic dermatology business, dental business and the manufacturing facility of QLT USA, in Fort Collins, Colorado, were sold to Tolmar.
RECENT DEVELOPMENT
On February 9, 2007, our subsidiary, QLT USA, Inc., and Sanofi-Synthelabo entered into a Settlement, Release and Patent License agreement with TAP Pharmaceutical Products Inc. and its co-plaintiffs related to patent litigation initiated by TAP and its co-plaintiffs in 2003. Under the terms of the settlement agreement, and without admitting liability, QLT USA paid $112.5 million and Sanofi-Synthelabo paid $45.0 million, for an aggregate settlement amount of $157.5 million. As a result of this settlement, we recorded a charge of $112.5 million in our 2006 results. (See Item 3 — Legal Proceedings and Note 23 “Consolidated Financial Statements”).
CRITICAL ACCOUNTING POLICIES AND ESTIMATES
In preparing our consolidated financial statements, we are required to make certain estimates, judgements and assumptions that we believe are reasonable based upon the information available. These estimates and assumptions affect the reported amounts of assets and liabilities at the date of the financial statements and the reported amounts

45


 

of revenues and expenses during the periods presented. Significant estimates are used for, but not limited to, stock-based compensation, provisions for non-completion of inventory, assessment of the recoverability of long-lived assets, assessment of impairment of goodwill, accruals for contract manufacturing and research and development agreements, allocation of costs to manufacturing under a standard costing system, allocation of overhead expenses to research and development, determination of fair value of assets and liabilities acquired in the purchase business combinations, determination of fair value of assets held for sale, and provisions for taxes and contingencies. The significant accounting policies which we believe are the most critical to aid in fully understanding and evaluating our reported financial results include those which follow:
Reporting Currency and Foreign Currency Translation
We use the U.S. dollar as our reporting currency, while the Canadian dollar is the functional currency for QLT Inc., and the U.S. dollar is the functional currency for our U.S. subsidiaries. Our consolidated financial statements are translated into U.S. dollars using the current rate method. Assets and liabilities are translated at the rate of exchange prevailing at the balance sheet date. Shareholders’ equity is translated at the applicable historical rates. Revenues and expenses are translated at a weighted average rate of exchange for the respective years. Translation gains and losses from the application of the U.S. dollar as the reporting currency are included as part of the cumulative foreign currency translation adjustment, which is reported as a component of shareholders’ equity under accumulated other comprehensive income (loss). There are no significant estimates involved in applying the current rate method. As of December 31, 2006, our accumulated other comprehensive income totalled $83.5 million.
Revenue Recognition
Net Product Revenue
Our net product revenues are primarily derived from sales of Visudyne® and Eligard®.
With respect to Visudyne, under the terms of our PDT Product Development, Manufacturing and Distribution Agreement with Novartis Ophthalmics of Switzerland we are responsible for Visudyne manufacturing and product supply, and Novartis Ophthalmics is responsible for marketing and distribution of Visudyne. Our agreement with Novartis Ophthalmics provides that the calculation of total revenue for the sale of Visudyne be composed of three components: (1) an advance on the cost of inventory sold to Novartis Ophthalmics, (2) an amount equal to 50% of Novartis Ophthalmics’ net proceeds from Visudyne sales to end-customers (determined according to a contractually agreed definition), and (3) the reimbursement of other specified costs incurred and paid for by us. We recognize revenue from the sale of Visudyne when persuasive evidence of an arrangement exists, delivery to Novartis Ophthalmics has occurred, the end selling price of Visudyne is fixed or determinable, and collectibility is reasonably assured. Under the calculation of revenue noted above, this occurs when Novartis Ophthalmics has sold Visudyne to its end customers. Our revenue from Visudyne will fluctuate dependent upon Novartis Ophthalmics’ ability to market and distribute Visudyne to end customers.
We record product revenue from Visudyne based on the final net proceeds reconciliation provided by Novartis Ophthalmics at the end of each reporting period. The net proceeds reconciliation is based on actual sales of Visudyne less actual marketing, distribution, inventory, and royalty costs. This reconciliation is provided by Novartis Ophthalmics on a timely basis based upon mutually agreed upon dates. We evaluate the accuracy and completeness of the information by holding regular discussions with Novartis Ophthalmics, comparing to historical results as well as comparing to our internal forecasts. Furthermore, we conduct periodic audits of selected records of Novartis Ophthalmics and/or its affiliates to ensure that revenue and expenses are recorded accurately. No material adjustments have resulted from these audits.
With respect to Eligard, under the terms of the license agreements with our commercial licensees, we are responsible for the manufacture of Eligard and receive from our commercial licensees an agreed upon sales price upon shipment to them which may be more or less than our costs to manufacture Eligard. We also earn royalties from certain commercial licensees based upon their sales of Eligard products to end customers, which royalties are included in net royalty revenue. We recognize net revenue from product sales when persuasive evidence of an arrangement exists, product is shipped and title is transferred to our commercial licensees, collectibility is reasonably assured and the price is fixed or determinable. Our net product revenue from Eligard will fluctuate dependent upon our ability to deliver Eligard products to our commercial licensees. Our Eligard commercial licensees are responsible for all products after shipment from our facility. Under this calculation of revenue, we recognize net product revenue from Eligard at the time of shipment to our commercial licensees.

46


 

We do not offer rebates or discounts in the normal course of business and have not experienced any material product returns; accordingly, we do not provide an allowance for rebates, discounts, and returns.
Net Royalties
We recognize net royalties when product is shipped by certain of our commercial licensees to end customers based on royalty rates specified in our agreements with them. Generally, royalties are based on estimated net product sales (gross sales less discounts, allowances and other items) and calculated based on information supplied to us by our commercial licensees.
Contract Research and Development
Contract research and development revenues consist of non-refundable research and development funding under agreements with third parties with whom we have research or development relationships or licenses. Contract research and development funding generally compensates us for discovery, preclinical and clinical expenses related to the collaborative development programs for certain products and product candidates, and is recognized as revenue at the time research and development activities are performed under the terms of those agreements. For fixed price contracts, we recognize contract research and development revenue over the term of the agreement consistent with the pattern of work performed. Amounts received under those agreements for work actually performed are non-refundable even if the research and development efforts performed by us do not eventually result in a commercial product. Contract research and development revenues earned in excess of payments received are classified as contract research and development receivables and payments received in advance of revenue recognition are recorded as deferred revenue.
Licensing and milestones
We have licensing agreements that generally provide for non-refundable license fees and/or milestone payments. The licensing agreements typically require a non-refundable license fee and allow licensees to sell our proprietary products in a defined territory for a defined period. A milestone payment is a payment made by a licensee to us upon achievement of a pre-determined event, as defined in the applicable agreement. Non-refundable license fees and milestone payments are initially reported as deferred revenue. They are recognized as revenue over the remaining contractual term or as covered by patent protection, whichever is earlier, using the straight-line method or until the agreement is terminated. No milestone revenue is recognized until we have completed the required milestone-related services as set forth in licensing agreements.
Cost of Sales
Visudyne cost of sales, consisting of expenses related to the production of bulk Visudyne and royalty expense on Visudyne sales, are charged against earnings in the period that Novartis Ophthalmics sells to end customers. Cost of sales related to the production of various Eligard products are charged against earnings in the period of the related product sale to our commercial licensees. We utilize a standard costing system, which includes a reasonable allocation of overhead expenses, to account for inventory and cost of sales, with adjustments being made periodically to reflect current conditions. Our standard costs are estimated based on management’s best estimate of annual production volumes and material costs. Overhead expenses comprise direct and indirect support activities related to the manufacture of bulk Visudyne and various Eligard products and involve costs associated with activities such as quality inspection, quality assurance, supply chain management, safety and regulatory. There are three areas within our inventory costing system that require significant management judgment and estimates: (a) annual production volume, (b) overhead allocation, and (c) provision for non-completion of product inventory. These three areas are described below:
(a) We estimate our production volume at the beginning of the year in order to arrive at a per unit allocation of fixed costs. Our estimate of production volume is based on our forecast of product sales and is updated periodically.
(b) We estimate our overhead expenses in the beginning of the year in order to arrive at a per unit allocation of overhead. Our estimate of overhead expenses is based on historical experience and the projected production volume. We update our estimate on a periodic basis based on the latest information. Overhead expenses are allocated to inventory at various stages of the manufacturing process under a standard costing system, and

47


 

eventually to cost of sales as the related products are sold to our commercial licensees or in the case of Visudyne, by Novartis Ophthalmics to third parties.
(c) We record a provision for the non-completion of product inventory based on our history of batch completion to provide for the potential failure of inventory batches to pass quality inspection. The provision is calculated at each stage of the manufacturing process. We estimate our non-completion rate based on past production and adjust our provision based on actual production volume. A batch failure may utilize a significant portion of the provision as a single completed batch currently costs up to $1.2 million, depending on the product and the stage of production.
While we believe our standard costs are reliable, actual production costs and volume changes may impact inventory, cost of sales, and the absorption of production overheads. We had previously provided a reserve for obsolescence of our Eligard and generic dermatology inventory and component materials based on our periodic evaluation of potential obsolete inventory and our history of inventory obsolescence. In December 2006, our subsidiary sold our generic dermatology and dental businesses and the manufacturing facility in Fort Collins, Colorado, that produces both Eligard and generic dermatology products to Tolmar and entered into a supply agreement with Tolmar for the supply of Eligard products. As a result, we reduced our provision for obsolescence as it primarily relates to raw materials that are now managed by Tolmar.
Stock-Based Compensation
In the past, we accounted for our stock-based compensation under the intrinsic value method in accordance with the provisions of Accounting Principles Board (APB) Opinion No. 25, Accounting for Stock Issued to Employees, and provided pro forma disclosures of net income and net income per share.
In December 2004, the Financial Accounting Standards Board, or FASB, issued SFAS 123 Revised, Share-Based Payment, or SFAS 123R. The statement eliminates the alternative to account for stock-based compensation using APB 25 and requires such transactions be recognized as compensation expense in the statement of earnings based on their fair values on the date of the grant, with the compensation expense recognized over the period in which a grantee is required to provide service in exchange for the stock award. We have adopted this statement effective January 1, 2006 using a modified prospective application as defined in SFAS 123R. As such, the compensation expense recognition provisions are applicable to new awards and to any awards modified, repurchased or cancelled after the adoption date. Additionally, for any unvested awards outstanding at the adoption date, we recognize compensation expense over the remaining vesting period. Estimates of fair value are determined using the Black-Scholes option pricing model. The use of this model requires certain assumptions regarding the volatility, term, risk free interest rate and forfeiture experienced by the holder. SFAS 123R also requires the benefits of tax deductions in excess of recognized compensation cost to be reported as a financing cash flow, rather than as an operating cash flow as previously required. We are unable to utilize the tax benefits until we establish a history of profitability at QLT USA.
For the year ended December 31, 2006, stock based compensation of $4.2 million was expensed as follows: $2.4 million to research and development costs, $1.3 million to selling, general and administrative costs, $0.4 million to discontinued operations and a negligible amount to cost of sales. The assumptions used for options granted during 2006 included a volatility factor of 44.5%, a 3.0 year term until exercise, and a 4.1% risk free interest rate.
Research and Development
Research and development, or R&D, costs are expensed as incurred and consist of direct and indirect expenditures, including a reasonable allocation of overhead expenses, associated with our various research and development programs. Overhead expenses comprise general and administrative support provided to the research and development programs and involve costs associated with support activities such as facility maintenance, utilities, office services, information technology, legal, accounting and human resources. Significant management judgment is required in the selection of an appropriate methodology for the allocation of overhead expenses. Our methodology for the allocation of overhead expenses utilizes the composition of our workforce as the basis for our allocation. Specifically, we determine the proportion of our workforce that is dedicated to R&D activities and allocate to our R&D expense the equivalent proportion of overhead expenses. We consider this method the most reasonable method of allocation based on the nature of our business and workforce. Changes in the composition of our workforce and the types of support activities are factors that can influence our allocation of overhead expenses. Costs related to the acquisition of development rights for which no alternative use exists are classified as research and development and

48


 

expensed as incurred. Patent application, filing and defense costs are also expensed as incurred. R&D costs also include funding provided to collaborative partners for joint R&D programs.
Income Taxes
Income taxes are reported using the asset and liability method, whereby deferred tax assets and liabilities are recognized for the future tax consequences attributable to: (i) differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases, and (ii) operating loss and tax credit carry forwards using applicable enacted tax rates. An increase or decrease in these tax rates will increase or decrease the carrying value of future net tax assets resulting in an increase or decrease to net income. Income tax credits are included as part of the provision for income taxes. Significant estimates are required in determining our provision for income taxes. Some of these estimates are based on interpretations of existing tax laws or regulations. Various internal and external factors may have favorable or unfavorable effects on our future effective tax rate. These factors include, but are not limited to, changes in tax laws, regulations and/or rates, changing interpretations of existing tax laws or regulations, changes in estimates of prior years’ items, results of tax audits by tax authorities, future levels of research and development spending, and changes in overall levels of pre-tax earnings. The realization of our deferred tax assets is primarily dependent on generating sufficient taxable income prior to expiration of any loss carry forward balance. A valuation allowance is provided when it is more likely than not that a deferred tax asset may not be realized. (See Note 18 — Income Taxes in “Notes to the Consolidated Financial Statements”.)
Assets Held for Sale and Discontinued Operations
We consider assets to be held for sale when management approves and commits to a formal plan to actively market the assets for sale. Upon designation as held for sale, the carrying value of the assets are recorded at the lower of their carrying value or their estimated fair value, less costs to sell. We cease to record depreciation or amortization expense at that time. Our assets held for sale included certain non-core assets, particularly the generic dermatology business, dental business and related manufacturing facility of QLT USA. In December 2006, we completed the sale of these assets and recorded a loss on disposal, net of tax, of $8.0 million. This amount was included in our loss from discontinued operations. The results of operations for businesses that are classified as held for sale are excluded from continuing operations and reported as discontinued operations for the current and prior periods. Additionally, segment information does not include the results of businesses classified as discontinued operations.
Legal Proceedings
We are involved in a number of legal proceedings, the outcomes of which are not within our complete control and may not be known for prolonged periods of time. In these legal proceedings, the claimants seek damages, as well as other relief, which, if granted, could require significant expenditures. We record a liability in the consolidated financial statements for these actions when a loss is known or considered probable and the amount can be reasonably estimated. If the loss is not probable or cannot reasonably be estimated, no liability is recorded in the consolidated financial statements.
On February 9, 2007, QLT USA and Sanofi-Synthelabo entered into a Settlement, Release and Patent License to settle the TAP litigation in the United States and, without admitting liability, QLT USA paid $112.5 million and Sanofi-Synthelabo paid $45.0 million, for an aggregate settlement amount of $157.5 million. As a result of this settlement, we recorded a charge of $112.5 million in 2006.
As of December 31, 2006, except for the liability accrued in relation to the settlement with TAP, no reserve has been established related to legal proceedings. (See Item 3 - Legal Proceedings and Note 23 — Contingencies — in “Notes to the Consolidated Financial Statements.”)
Long-Lived and Intangible Assets
We incur costs to purchase and occasionally construct property, plant and equipment. The treatment of costs to purchase or construct these assets depends on the nature of the costs and the stage of construction. Costs incurred in the initial design and evaluation phase, such as the cost of performing feasibility studies and evaluating alternatives

49


 

are charged to expense. Costs incurred in the committed project planning and design phase, and in the construction and installation phase, are capitalized as part of the cost of the asset. We stop capitalizing costs when an asset is substantially complete and ready for its intended use. We depreciate plant and equipment using the straight-line method over their estimated economic lives, which range from 3-40 years. Determining the economic lives of plant and equipment requires us to make significant judgements that can materially impact our operating results.
We periodically evaluate our long-lived assets for potential impairment under SFAS 144, Accounting for the Impairment or Disposal of Long-lived Assets. We perform these evaluations whenever events or changes in circumstances suggest that the carrying amount of an asset or group of assets is not recoverable. If impairment recognition criteria in SFAS 144 have been met, we charge impairments of the long-lived assets to operations.
In accounting for acquisitions, we allocate the purchase price to the fair value of the acquired tangible and intangible assets, including in-process research and development, or IPR&D. We generally determine the value of acquired intangible assets and IPR&D using a discounted cash flow model, which requires us to make assumptions and estimates about, among other things: the time and investment that is required to develop products and technologies; our ability to develop and commercialize products before our competitors develop and commercialize products for the same indications; the amount of revenue to be derived from the products; and appropriate discount rates to use in the analysis. Use of different estimates and judgements could yield materially different results in our analysis, and could result in materially different asset values and IPR&D charges.
During the first quarter of 2006, we initiated an active plan to divest our non-core assets, including the generic dermatology and dental businesses and related manufacturing facility of QLT USA, and reclassified these assets, including acquired intangible assets, as assets held for sale for both current and prior periods. As a result, we ceased recording depreciation and amortization expenses in relation to these assets. Assets held for sale were recorded at the lower of their carrying value or their estimated fair value less costs to sell. During the third quarter of 2006, we recorded an impairment charge of $8.6 million as events and circumstances indicated an impairment to our assets held for sale. The determination of the fair value of assets held for sale was based on future discounted cash flows and requires significant judgements and estimates. In December 2006, we completed the sale of the generic dermatology and dental businesses and related manufacturing facility of QLT USA to Tolmar.
Impairment of Goodwill
In accordance with Statement of Financial Accounting Standard, or SFAS 142, Goodwill and Other Intangibles, we are required to perform impairment tests annually or whenever events or changes in circumstances suggest that the carrying value of an asset may not be recoverable. We made assumptions and estimates regarding product development, market conditions and cash flows in determining the valuation of goodwill and intangibles, all of which related to our acquisition of Atrix (now QLT USA). In December 2006, we completed the sale of the generic dermatology and dental businesses and related manufacturing facility of QLT USA. In accordance with SFAS 142, goodwill associated with the disposed businesses was included in the disposal and the remaining goodwill was tested for impairment. We did not identify any potential impairment as the fair value of our reporting unit exceeded its carrying amount. Our estimates of fair value were based upon factors such as projected future revenue, probability of success of our products in development, and other uncertain elements requiring significant judgements. While we use available information to prepare our estimates and to perform impairment evaluations, actual results in the future could differ significantly. Impairment tests in future periods may result in impairment charges which could materially impact our future reported results.
Recently Issued and Recently Adopted Accounting Standards
In February 2006, the FASB issued SFAS 155, “Accounting for Certain Hybrid Financial Instruments - an amendment of FASB statement 133 and 140 (“SFAS 155”). This Statement simplifies accounting for certain hybrid financial statements by permitting fair value remeasurements for any hybrid financial instrument that contains an embedded derivative that would otherwise require bifurcation, and eliminates the restriction on the passive derivative instruments that a qualifying special - purpose entity (SPE) may hold. We believe the adoption of SFAS 155 will not have a material impact on our results of operations.
In July 2006, the FASB issued FIN 48 “Accounting for Uncertainty in Income Taxes — an interpretation of FASB Statement No. 109”. This interpretation provides guidance on the financial statement recognition and measurement of a tax position taken or expected to be taken in a tax return. FIN 48 also provides guidance on derecognition, classification, interest and penalties, accounting in interim periods, disclosures, and transition. FIN 48 is effective

50


 

for fiscal years beginning after December 15, 2006. We are currently evaluating the impact of this standard on our Consolidated Financial Statements.
In September 2006, the FASB issued SFAS No. 157 “Fair Value Measurements” (“SFAS No. 157”) which defines fair value, establishes a framework for measuring fair value in generally accepted accounting principles, and expands disclosures about fair value measurements. This statement does not require any new fair value measurements and is effective for fiscal periods beginning after November 15, 2007. We are currently evaluating the impact of this standard on our Consolidated Financial Statements.
In February 2007, the FASB issued SFAS No. 159 “The Fair Value Option for Financial Assets and Financial Liabilities — including an amendment of FASB Statement No. 115” (“SFAS No. 159”) which permits entities to choose to measure many financial instruments and certain other items at fair value. This statement is effective for fiscal periods beginning after November 15, 2007. We are currently evaluating the impact of this standard on our Consolidated Financial Statements.
COMPARISON OF YEARS ENDED DECEMBER 31, 2006 AND 2005
For the year ended December 31, 2006, we recorded a net loss of $101.6 million, or $1.20 per common share. These results compare to a net loss of $ $325.4 million, or $3.51 per common share, for the year ended December 31, 2005. Detail discussion and analysis of our results of operations are as follows:
Revenues
Net Product Revenue
Net product revenue was determined as follows:
                 
    For the year ended
    December 31,
(In thousands of U.S. dollars)   2006   2005
 
Visudyne® sales by Novartis Ophthalmics
  $ 353,759     $ 483,762  
Less: Marketing and distribution costs(1)
    (132,669 )     (142,244 )
Less: Inventory costs(2)
    (18,275 )     (24,060 )
Less: Royalties to third parties(3)
    (7,545 )     (10,699 )
 
 
  $ 195,270     $ 306,759  
 
 
               
QLT’s 50% share of Novartis Ophthalmics’ net proceeds from Visudyne sales
  $ 97,635     $ 153,379  
Add: Advance on inventory costs from Novartis Ophthalmics(4)
    15,063       18,932  
Add: Royalties reimbursed to QLT(5)
    7,622       10,431  
Add: Other costs reimbursed to QLT(6)
    9,046       4,496  
 
Revenue from Visudyne® sales
  $ 129,366     $ 187,238  
 
               
Net product revenue from Eligard®
    22,494       16,808  
 
 
  $ 151,860     $ 204,046  
 
(1)   “Less: Marketing and distribution costs”
 
    This represents Novartis Ophthalmics’ cost of marketing, promoting, and distributing Visudyne, as well as certain specified costs incurred and paid for by QLT, determined in accordance with the PDT Product Development, Manufacturing, and Distribution Agreement between QLT and Novartis Ophthalmics. The costs incurred by Novartis Ophthalmics are related to its sales force, advertising expenses, marketing, and certain administrative overhead costs. The costs incurred by us include marketing support, legal and administrative expenses that we incur in support of Visudyne sales.

51


 

(2)   “Less: Inventory costs”
 
    This represents Novartis Ophthalmics’ cost of goods sold related to Visudyne. It includes the cost of bulk Visudyne we ship to Novartis Ophthalmics, plus Novartis Ophthalmics’ packaging and labeling costs, freight and custom duties.
 
(3)   “Less: Royalties to third parties”
 
    This represents the royalty expenses we incur and charge to Novartis Ophthalmics pursuant to the PDT Product Development, Manufacturing and Distribution Agreement between QLT and Novartis Ophthalmics. The amounts are calculated by us based on specified royalty rates from existing license agreements with our licensors of certain Visudyne patent rights.
 
(4)   “Add: Advance on inventory costs from Novartis Ophthalmics”
 
    This represents the amount that Novartis Ophthalmics advances to us for shipments of bulk Visudyne. The price of the Visudyne shipments is determined based on the existing agreement between QLT and Novartis Ophthalmics and represents our actual costs of producing Visudyne.
 
(5)   “Add: Royalties reimbursed to QLT”
 
    This is related to item (3) above and represents the amounts we receive from Novartis Ophthalmics in reimbursement for the actual royalty expenses we owe to third party licensors.
 
(6)   “Add: Other costs reimbursed to QLT”
 
    This represents reimbursement by Novartis Ophthalmics to us of our portion of the Marketing and distribution costs described in (1) above. This expense includes marketing support, legal and administrative expenses that we incur in support of Visudyne sales.
For the year ended December 31, 2006, revenue from Visudyne of $129.4 million decreased by $57.9 million or 31%, over the year ended December 31, 2005. The decrease was primarily due to a 27% decline in Visudyne sales as a result of decreased end user demand, particularly in the United States due to competing therapies. In 2006, approximately 20% of total Visudyne sales by Novartis Ophthalmics were in the U.S., compared to approximately 38% in 2005. Overall the ratio of our share of revenue on final sales compared to Visudyne sales was 27.6% for the year ended December 31, 2006, down from 31.7% in the prior year. Marketing and distribution costs decreased to $132.7 million for the year ended December 31, 2006, compared to $142.2 million in the prior year.
For the year ended December 31, 2006, net product revenue from Eligard of $22.5 million increased by $5.7 million (or 34%) over the prior year primarily due to launches of Eligard in additional countries in Europe and strong performance in Canada.
Net Royalties
For the year ended December 31, 2006, royalty revenue of $21.1 million was $5.3 million (or 33%) higher compared to the same period in 2005. The increase was due to additional Eligard launches in Europe, growth in Canada and higher sales in the U.S.
Contract Research and Development Revenue
We received non-refundable research and development funding from our commercial licensees, which was recorded as contract research and development revenue. For the year ended December 31, 2006, contract revenue totalled $1.2 million, down 88% compared to the same period in 2005. The decrease was primarily due to (i) the decline in research and development funding from Novartis Ophthalmics as our level of research and development activities for Visudyne programs fell below that of Novartis Ophthalmics, and (ii) the termination in mid-2005 of the Collaboration, Licensing and Supply agreement previously entered into with Astellas Ophthalmics US LLC to develop Aczone.

52


 

Costs and Expenses
Cost of Sales
For the year ended December 31, 2006, cost of sales decreased 8% to $42.2 million compared to $46.1 million for the same period in 2005. The decrease was due to lower sales of Visudyne, partially offset by higher shipments of Eligard to our commercial licensees. Cost of sales related to Visudyne decreased from $31.0 million to $22.9 million in the year ended December 31, 2006 compared to the same period in 2005. Cost of sales related to Eligard increased from $15.0 million to $19.3 million in the year ended December 31, 2006 compared to the same period in 2005.
Research and Development
Research and development, or R&D, expenditures decreased 11% to $56.4 million for the year ended December 31, 2006 compared to $63.3 million in the same period in 2005. The decrease was primarily due to reduced spending on Lemuteporfin and completion of the Visudyne in Occult study, partly offset by higher spending on Ocular research, stock compensation of $2.4 million, and in-licensing fees of $1.9 million for the year ended December 31, 2006.
The magnitude of future R&D expenses is highly variable and depends on many factors over which we have limited visibility and control. Numerous events can happen to an R&D project prior to it reaching any particular milestone which can significantly affect future spending and activities related to the project. These events include:
  changes in the regulatory environment
  introduction of competing treatments
  unexpected safety issues
  patent maintenance and enforcement issues
  changes in the commercial marketplace
  difficulties in enrolling patients
  delays in study progression
  inability to develop cost effective manufacturing methods that comply with regulatory standards
  uncertainties related to collaborative partners
  environmental risks
  other factors that we described in the Risk Factors section
R&D expenditures by therapeutic area were as follows:
                         
(In thousands of U.S. dollars)   2006     2005     2004  
 
Ocular
  $ 18,539     $ 18,215     $ 20,659  
Dermatology
    15,769       11,410       7,926  
Urology and Oncology
    7,500       23,436       17,905  
Others (including Atrigel programs not in the above therapeutic areas)
    14,620       9,769       2,208  
     
 
  $ 56,428     $ 63,330     $ 48,698  
     
Status of significant products in development is as follows:
         
Product/Indication   Location(s)   Status
 
Octreotide-Atrigel® — three-month
       
 
       
Carcinoid Syndrome
  U.S. and Canada   Phase IIa PK study planned to begin enrolment in 2007

53


 

         
Product/Indication   Location(s)   Status
 
GHRP -1- Atrigel® — one-month
       
 
       
Malnutrition in end-stage-renal-disease patients undergoing hemodialysis
  U.S.   Plan to complete Phase IIa study in 2007
 
       
Risperidone- Atrigel® — one-month
       
 
       
Schizophrenia
  U.S.   Plan to complete the IND-enabling program by end of 2007
 
       
Eligardâ 7.5-mg one-month
       
 
       
Prostate Cancer
  Japan   Application for marketing approval withdrawn. Currently assessing future development for this product in Japan.
Description of significant development programs are as follows:
(i) Expansion of Visudyne® Therapy
We are continuing efforts to improve the effectiveness of Visudyne therapy by exploring combination therapies and the effect of lower light doses (for example through reduced rate of fluence) administered during the PDT process.
Novartis Ophthalmics and QLT have initiated a company-sponsored study, known as VERITAS, comparing the safety and efficacy of Visudyne in combination with triamcinolone to Visudyne in combination with Macugen. That study completed enrollment and preliminary results are expected to be available in 2007.
In addition, in view of the importance of understanding the clinical significance of the use of Visudyne in combination with other therapies for the treatment of wet AMD, we are supporting a number of investigator-sponsored studies (“ISS”) which are designed to evaluate the potential of such Visudyne combination therapies. The focus of these studies has evolved with emerging clinical data from other therapies. Initially, these studies focused on evaluating the combination of Visudyne with triamcinolone (a steroid). The enrolment of two large ISS’ evaluating the combination of Visudyne and triamcinolone was completed. The one year results from both of those ISS’ are also expected to be available during 2007.
This evolution in the focus from combination of Visudyne with triamcinolone to combinations of Visudyne with anti-VEGF drugs or to triple therapy using Visudyne with a steroid and anti-VEGF drug reflects the evolution in medical practice. Thus, another ISS, which was initiated by the National Eye Institute (NEI) at the National Institute of Health (NIH) and supported by us under a Collaborative Research Agreement, started with the intent of assessing the potential benefit of combining Visudyne with triamcinolone (steroid), and is now being amended to include the study of Visudyne in combination with both a steroid and an anti-VEGF agent.
In addition, we are now supporting additional ISS’, which are evaluating different combinations of Visudyne with an anti-VEGF drug (VEGF stands for vascular endothelial growth factor) either as bi-therapy (Visudyne, plus an anti-VEGF) or triple therapy (Visudyne, plus two other drugs, an anti-VEGF and a steroid). We anticipate that 6-month results of the first ISS that has completed enrollment will be presented in the first half of 2007. Furthermore, we have initiated a patient registry to consolidate and study retrospective data obtained by retina specialists who have already used Visudyne as part of bi- or triple therapy. Based on the results of the ISS’ and available data, we are planning to initiate one or more company sponsored studies to investigate the use of Visudyne in combination with anti-VEGF agents and steroids.
Furthermore, certain of the ongoing ISS’ are also investigating the potential benefit of reduced fluence, or low light levels, on the efficacy and safety of Visudyne.

54


 

(ii) Eligard® 3.75-mg one-month Product
QLT USA was developing Eligard in Japan through a licensee, Sosei, for the treatment of prostate cancer. Sosei previously submitted the application for marketing approval of the Eligard 3.75 mg one-month formulation in Japan. After interaction with the Japanese Regulatory Authorities, they decided to withdraw the Eligard 3.75 mg one-month dossier from the Generic Division. As a result Sosei has notified us that it intends to terminate the license agreement for Eligard in Japan. We are currently assessing our future development plans for Eligard in Japan.
(iii) Aczone™
Aczone is under development for the treatment of Rosacea, a chronic skin disorder that most often affects the central face including also the nose, forehead, cheeks and chin. We initiated a Phase II study in November 2005 and 12-week follow-up results were obtained in the third quarter 2006. In the overall population, the results showed that Aczone was no better than vehicle in reducing the signs and symptoms of papulopustular rosacea. However, in patients with more severe signs and symptoms, the study analysis showed an advantage of Aczone over the vehicle control. A decision on whether to proceed with a Phase III program using Aczone in Rosacea for this group diagnosed with more severe rosacea is on hold until after we get a decision from the FDA to remove the label requirement for blood testing for all patients treated with Aczone.
(iv) Octreotide Atrigel®- three-month Product
Acromegaly
We have developed a formulation of octreotide in the Atrigel delivery system for the treatment of the symptoms of acromegaly. Acromegaly is a chronic disease of middle-aged persons characterized by elongation and enlargement of bones of the extremities and certain head bones, especially the frontal bone and jaws. In the first quarter of 2006, we filed an IND for this study but in May 2006 announced that we would delay the initiation of the Phase IIa Atrigel/octreotide program in acromegaly patients. This decision was made in cooperation with the U.S. Food and Drug Administration (FDA) following adverse event findings that occurred in an ongoing primate toxicology study designed to support repeated injections in patients. The FDA has required that we submit, and that the FDA be satisfied with, the final data from the ongoing toxicology study prior to initiating the 16-patient Phase IIa clinical program in acromegaly. We expect to submit the complete results of the toxicology study in the second quarter of 2007.
Carcinoid Syndrome
We have developed a formulation of octreotide in the Atrigel delivery system for the treatment of carcinoid syndrome. Carcinoid syndrome refers to the group of symptoms that occur in patients secondary to carcinoid tumors. This syndrome is characterized in particular by hot red flushing of the face, as well as severe and debilitating diarrhea. The carcinoid tumors occur primarily in the appendix, ileum, rectum, or bronchi. We intend to submit to the FDA a Phase II PK protocol in carcinoid syndrome patients in the second quarter of 2007 at the same time we submit the toxicology study results related to both the acromegaly and carcinoid syndrome programs.
Our current plan is to accelerate the development of Octreotide in Carcinoid syndrome ahead of any development program in acromegaly.
(v) GHRP-1-Atrigel® one-month Product
We have developed a formulation of Growth Hormone Releasing Peptide-1, or GHRP-1, in the Atrigel delivery system for the treatment of malnutrition in end-stage renal disease patients on hemodialysis. Malnutrition is common in maintenance dialysis patients and leads to poor dialysis outcome. We initiated a phase IIa clinical trial in 2006 with the first patient treated in late 2006. The results of this study are expected during 2007.

55


 

(vi) Risperidone Atrigel®- three-month Product
We have developed a formulation of Risperidone in the Atrigel delivery system for the treatment of schizophrenia. This IND-enabling program was initiated at the end of 2006 and is expected to be completed before the end of 2007.
Schizophrenia is a serious mental disorder that can cause significant disability and chronic problems. Approximately one percent of the population develops schizophrenia during their lifetime.
Selling, General and Administrative Expenses
For the year ended December 31, 2006, selling, general and administrative, or SG&A, increased 84% to $42.2 million, in comparison to $23.0 million for the year ended December 31, 2005. The increase was primarily due to higher legal fees. SG&A expense in 2006 included $17.5 million of legal fees related to the TAP litigation, and $1.3 million of stock compensation expense.
Amortization of Intangibles
As a result of the impairment charge to our intangible assets in 2005, no intangible assets remained on our balance sheet in 2006. Therefore, no amortization of intangibles was recorded in 2006. Intangible assets related to the generic dermatology business were included in assets held for sale during 2006 until sold in December 2006.
Litigation Settlement
On February 9, 2007, QLT USA, and Sanofi-Synthelabo entered into a Settlement, Release and Patent License to settle the TAP Litigation, and without admitting liability, QLT USA paid $112.5 million and Sanofi-Synthelabo paid $45.0 million, for an aggregate settlement amount of $157.5 million. As a result of this settlement, we recorded a charge of $112.5 million in 2006. (See Item 3 — Legal Proceedings and Note 23 to “Notes to the Consolidated Financial Statements.”)
Impairment of Goodwill and other Intangible Assets
In accordance with SFAS 142, Goodwill and Other Intangibles, we are required to perform impairment tests annually or whenever events or changes in circumstances suggest that the carrying value of an asset may not be recoverable. We look for the existence of facts and circumstances, either internal or external, which indicate that the carrying value of the assets may not be recovered.
During 2006, we did not identify any potential impairment of goodwill as the fair value of our reporting unit exceeded its carrying amount. Impairment of intangible assets related to our generic dermatology business was included in loss from discontinued operations (see Discontinued Operations below).
During the fourth quarter of 2005, events and circumstances indicated impairment of goodwill and intangible assets acquired in connection with our acquisition of Atrix (now QLT USA, Inc.) in November 2004. Indicators of impairment in the fourth quarter of 2005 included: lower projection for future Eligard sales based on lower than expected sales of Eligard in 2005; recent adverse court decisions in the ongoing patent infringement litigation related to Eligard; lower projection for future Aczone revenue based on new market research; our decision to seek partners for future Atrigel programs; and revised forecasts for Atrigel products in development. We measured the impairment loss based on the amount by which the carrying value of the assets exceeded their fair value. Our measurement of fair value was based on a blend of analyses which included future discounted cash flows, comparison with companies of similar industry and/or size, consideration of the recent price of our common shares, and other qualitative factors. Based on our analysis, in the fourth quarter of 2005, we recorded a charge of $410.5 million to reduce the carrying value of our goodwill to $104.0 million and our intangible assets to $6.9 million. Of the total impairment charge, $9.4 million was allocated to discontinued operations as it related to the generic dermatology and dental businesses.
Impairment of plant and equipment
In accordance with SFAS 144, Accounting for the Impairment or Disposal of Long-lived Assets, we periodically evaluate our long-lived assets for potential impairment. We perform these evaluations whenever events or changes in circumstances suggest that the carrying amount of an asset or group of assets is not recoverable. During the fourth

56


 

quarter of 2005, events and circumstances indicated impairment of our Pilot Manufacturing Facility and as a result we recorded an impairment charge of $7.0 million. The primary indicator of impairment was a reduction in the projected production at this facility. We measured the impairment loss based on the amount by which the carrying value of the assets exceeded their fair value. Our measurement of fair value was based on future discounted cash flows.
Restructuring
In the first quarter of 2005, we restructured our operations as a result of our acquisition of Atrix, now QLT USA. We provided over 50 affected employees with severance and support to assist with outplacement. As a result, we recorded $3.1 million of restructuring charges related to severance and termination costs.
In December 2005, we restructured our operations in order to concentrate our resources on key product development programs and business initiatives. We provided approximately 100 affected employees with severance and support to assist with outplacement and recorded $5.0 million of restructuring charges. We expect to complete final activities associated with this restructuring by early 2007.
On October 26, 2006, as a result of declining Visudyne sales and other factors, we restructured our operations in order to reduce our overall cost basis going forward. We have provided or will be providing approximately 80 affected employees with severance and support to assist with outplacement. We recorded $3.0 million of restructuring charge in the fourth quarter of 2006. We expect to record additional restructuring charges of approximately $1.5 — $2.0 million in 2007 as we complete final activities associated with this restructuring. Annual savings as a result of this restructuring are expected to be approximately $6.0 million.
Investment and Other Income
Net Foreign Exchange Gains (Losses)
Net foreign exchange (losses) gains comprise (losses) gains from the impact of foreign exchange fluctuation on our cash and cash equivalents, short-term investments, derivative financial instruments, foreign currency receivables, foreign currency payables and U.S. dollar denominated long-term debt. For the year ended December 31, 2006, we recorded net foreign exchange losses of 3.7 million versus net foreign exchange gains of $4.2 million in 2005. (See “Liquidity and Capital Resources – Interest and Foreign Exchange Rates”)
Details of our net foreign exchange gains (losses) were as follows:
                 
    For the year ended   For the year ended
(In thousands of U.S. dollars)   December 31, 2006   December 31, 2005
 
Cash and cash equivalents and short-term investments
  $ 733     $ (5,636 )
U.S. dollar long-term debt
    (562 )     5,857  
Foreign exchange contracts
    (4,606 )     7,401  
Foreign currency receivables and payables
    729       (3,470 )
     
Net foreign exchange (losses) gains
  $ (3,706 )   $ 4,152  
     
Interest Income
For the year ended December 31, 2006, interest income increased 55% to $20.5 million compared to $13.2 million for the same period in 2005. Higher interest income in 2006 was due to increase in yields on short-term investments which more than offset the reduction in cash due to our share buy-back programs.
Interest Expense
Interest expense comprised interest accrued on the 3% convertible senior notes and amortization of the related deferred financing expenses. For the year ended December 31, 2006 interest expense remained relatively flat at $6.6 million compared to $6.4 million in 2005.

57


 

Other Gains
In August 2006, we sold the non-U.S. rights of our BEMA technology for an upfront payment of $1.0 million and future considerations. In June 2006, we received payment from Axcan Pharma, Inc., or Axcan, of CAD $2.5 million (USD $2.2 million) representing the last milestone payment owed to us from Axcan related to the sale of our Photofrin business to them in 2000.
Discontinued Operations
In December 2006, QLT USA completed the sale of its generic dermatology and dental businesses and related manufacturing facility located in Fort Collins, Colorado to Tolmar a private pharmaceutical company. The purchase price was $21.0 million and has been paid in full, subject to the release from escrow in early 2008 of a customary 10% holdback (which has been included in restricted cash). We recognized a loss, net of tax, of $8.0 million related to this transaction. The assets sold included $17.1 million of fixed assets, $4.9 million of intangible assets, $3.0 million of inventory and $5.3 million of goodwill allocated in accordance with SFAS 142, Goodwill and Other Intangibles. The gross proceeds of $21.0 million and the related loss exclude $1.0 million of contingent consideration payable based on future commercial orders for Aczone being produced by Tolmar in the Fort Collins manufacturing facility. The divestiture of these assets is consistent with our strategy of concentrating our resources on the research and development of proprietary products in our core therapeutic areas. Approximately 140 employees have been or will be transitioned to the purchaser as part of the divestiture of this business. Eligard will continue to be manufactured at the Fort Collins manufacturing facility under the terms of a supply agreement between QLT USA and Tolmar.
In accordance with SFAS No. 144, “Accounting for the Impairment or Disposal of Long-lived Assets”, the results of operations and the loss on disposal of the generic dermatology and dental businesses had been excluded from continuing operations and reported as discontinued operations for the current and prior periods. Furthermore, the assets included as part of this divestiture had been reclassified as held for sale in the Consolidated Balance Sheet for prior periods. During the third quarter of 2006, we recorded a write-down of $8.6 million to our assets held for sale as a result of the failure to receive regulatory approval for a late stage generic dermatology product and a launch delay for another product. For the year ended December 31, 2006, we recorded a loss from discontinued operations, net of income taxes, of $18.2 million compared to a loss of $11.9 million for the same period in 2005, due to the loss recorded on disposal, impairment and other charges related to the failure to receive approval for a late stage product offset by increased sales of generic dermatology products and the cessation of depreciation and amortization on assets held for sale.
Income taxes
The provision for income taxes was $9.0 million for the year ended December 31, 2006, compared to a recovery of $7.2 million in 2005. The provision for income taxes for 2006 was largely the result of our Canadian operations being profitable. The recovery of income taxes for 2005 was the result of the impairment of intangible assets. (See Note 18 — Income Taxes in “Notes to the Consolidated Financial Statements”.)
The net deferred tax asset of $18.5 million was largely the result of capital loss carryforwards, provincial tax credits, research and development credits as well as other temporary differences. The net deferred tax liability of $5.5 million was largely a result of unrealized foreign exchange gains on our convertible debt.
As of December 31, 2006, we had a valuation allowance against specifically identified tax assets. The valuation allowance is reviewed periodically and if management’s assessment of the “more likely than not” criterion for accounting purposes changes, the valuation allowance is adjusted accordingly (See Note 18 in “Notes to the Consolidated Financial Statements”).
COMPARISON OF YEARS ENDED DECEMBER 31, 2005 AND 2004
For the year ended December 31, 2005, we recorded a net loss of $325.4 million, or $3.51 per common share. These results compare to a net loss of $165.7 million, or $2.26 per common share, for the year ended December 31, 2004. During 2005, we recorded a $410.5 million charge for impairment of goodwill and other intangible assets, $8.0 million for restructuring charges; $7.0 million for impairment of plant and equipment; $6.9 million for amortization

58


 

of in-process research and development from our acquisition of Atrix Laboratories, Inc.(QLT USA); and $2.9 million of separation costs related to the departure of the former President and Chief Executive Officer.
Revenues
Net Product Revenue
Net product revenue was determined as follows:
                 
    For the year     For the year  
    ended     ended  
    December 31,     December 31,  
(In thousands of U.S. dollars)   2005     2004  
 
Visudyne® sales by Novartis Ophthalmics
  $ 483,762     $ 448,277  
Less: Marketing and distribution costs(1)
    (142,244 )     (133,730 )
Less: Inventory costs(2)
    (24,060 )     (25,789 )
Less: Royalties to third parties(3)
    (10,699 )     (10,074 )
     
 
  $ 306,759     $ 278,684  
     
 
               
QLT’s 50% share of Novartis Ophthalmics’ net proceeds from Visudyne sales
  $ 153,379     $ 139,342  
Add: Advance on inventory costs from Novartis Ophthalmics(4)
    18,932       21,791  
Add: Royalties reimbursed to QLT(5)
    10,431       10,074  
Add: Other costs reimbursed to QLT(6)
    4,496       6,250  
     
Revenue from Visudyne® sales
  $ 187,238     $ 177,457  
 
               
Net product revenue from Eligard® and other products (effective November 20, 2004)
    16,808       931  
     
 
  $ 204,046     $ 178,388  
     
(1)   “Less: Marketing and distribution costs”
 
    This represents Novartis Ophthalmics’ cost of marketing, promoting, and distributing Visudyne, as well as certain specified costs incurred and paid for by QLT, determined in accordance with the PDT Product Development, Manufacturing, and Distribution Agreement between QLT and Novartis Ophthalmics. The costs incurred by Novartis Ophthalmics are related to its sales force, advertising expenses, marketing, and certain administrative overhead costs. The costs incurred by us include marketing support, legal and administrative expenses that we incur in support of Visudyne sales.
 
(2)   “Less: Inventory costs”
 
    This represents Novartis Ophthalmics’ cost of goods sold related to Visudyne. It includes the cost of bulk Visudyne we ship to Novartis Ophthalmics, plus Novartis Ophthalmics’ packaging and labelling costs, freight and custom duties.
 
(3)   “Less: Royalties to third parties”
 
    This represents the royalty expenses we incur and charge to Novartis Ophthalmics pursuant to the PDT Product Development, Manufacturing and Distribution Agreement between QLT and Novartis Ophthalmics. The amounts are calculated by us based on specified royalty rates from existing license agreements with our licensors of certain Visudyne patent rights.

59


 

(4)   “Add: Advance on inventory costs from Novartis Ophthalmics”
 
    This represents the amount that Novartis Ophthalmics advances to us for shipments of bulk Visudyne. The price of the Visudyne shipments is determined based on the existing agreement between QLT and Novartis Ophthalmics and represents our actual costs of producing Visudyne.
 
(5)   “Add: Royalties reimbursed to QLT”
 
    This is related to item (3) above and represents the amounts we receive from Novartis Ophthalmics in reimbursement for the actual royalty expenses we owe to third party licensors.
 
(6)   “Add: Other costs reimbursed to QLT”
 
    This represents reimbursement by Novartis Ophthalmics to us of our portion of the Marketing and distribution costs described in (1) above. This expense includes marketing support, legal and administrative expenses that we incur in support of Visudyne sales.
For the year ended December 31, 2005, net product revenue increased $30.7 million, or 17%, over the year ended December 31, 2004. Net product revenue from Eligard® and other products increased from $1.8 million in 2004, to $22.8 million in 2005 due to the full year impact of the Atrix acquisition. The revenue from Visudyne sales of $187.2 million in 2005 increased by $9.8 million, or 6%, over the year ended December 31, 2004. The increase was primarily due to an 8% increase in Visudyne sales, which resulted from growth in Europe and Japan, partially offset by a decrease in the USA. In 2005, approximately 38% of total Visudyne sales by Novartis Ophthalmics were in the U.S., compared to approximately 47% in 2004. Overall, the ratio of our share of revenue on final sales compared to Visudyne sales was 31.7% in 2005, up from 31.1% in the prior year. Marketing and distribution costs rose to $142.2 million for the year, compared to $133.7 million in 2004, due primarily to increases in sales force, general marketing and advertising and promotion expenses.
Net Royalties
As a result of our acquisition of Atrix (now QLT USA) at the end of 2004, we had $19.9 million of net royalties related to Eligard and other QLT USA products for the year ended December 31, 2005, compared to $2.3 million in the prior year. The increase related to the full year impact of the Atrix acquisition in 2005 in comparison to the prior year.
Contract Research and Development Revenue
We received non-refundable research and development funding from Sanofi-Synthelabo, Novartis Ophthalmics, Astellas US LLC and other licensees, which was recorded as contract research and development revenue. For the year ended December 31, 2005, contract research and development revenue increased by $6.8 million to $11.3 million. The increase was due to additional recoveries received from programs resulting from the acquisition of Atrix at the end of 2004.
Costs and Expenses
Cost of Sales
For the year ended December 31, 2005, cost of sales increased 53% to $51.2 million compared to $33.4 million for the year ended December 31, 2004. Cost of sales related to revenue from Visudyne remained relatively flat at $31.0 million in 2005, in comparison to $31.5 million in 2004, as a result of lower Visudyne manufacturing costs. Cost of sales in 2005 also includes $20.2 million related to revenue from Eligard and other products acquired in our acquisition of Atrix.
Research and Development
Research and development, or R&D, expenditures increased 49% to $74.6 million for the year ended December 31, 2005, in comparison to $50.1 million in 2004. The increase was primarily due to R&D expenses for Eligard, Aczone, Octreotide and other projects related to the Atrix acquisition.

60


 

Selling, General and Administrative Expenses
For the year ended December 31, 2005, selling, general and administrative, or SG&A, increased 34% to $23.5 million, in comparison to $17.5 million for the year ended December 31, 2004. The increase was related to additional SG&A expenses from the acquisition of Atrix and costs of $2.9 million related to the departure of the former President and Chief Executive Officer.
Depreciation Expense
Depreciation expense related to the depreciation of property, plant, and equipment. For the year ended December 31, 2005, depreciation expense increased 118% to $8.1 million in comparison to the year ended December 31, 2004. The increase in depreciation was a result of the addition of property, plant, and equipment from the Atrix acquisition.
Amortization of Intangibles
Amortization of intangibles for the years ended December 31, 2005 and 2004 of $6.9 million and $0.9 million is related to the developed technology and trademark intangibles acquired in our acquisition of Atrix on November 19, 2004. The estimated fair value of the trademark relates to the Eligard trademark and the estimated fair value of developed technology relates to existing FDA-approved products (certain Eligard, dermatology and dental products). Developed technology and trademark intangibles are being amortized over their expected useful lives of 16 to 17 years, respectively.
Impairment of Goodwill and other Intangible Assets
In accordance with SFAS 142, Goodwill and Other Intangibles, we are required to perform impairment tests annually or whenever events or changes in circumstances suggest that the carrying value of an asset may not be recoverable. We look for the existence of facts and circumstances, either internal or external, which indicate that the carrying value of the assets may not be recovered.
During the fourth quarter of 2005, events and circumstances indicated impairment of goodwill and intangible assets acquired in connection with our acquisition of Atrix in November 2004.
Indicators of impairment in the fourth quarter of 2005 included: lower projection for future Eligard sales based on lower than expected sales of Eligard in 2005; recent adverse court decisions in the ongoing patent infringement litigation related to Eligard; lower projection for future Aczone revenue based on new market research; our decision to seek partners for future Atrigel programs; and revised forecasts for Atrigel products in development.
We measured the impairment loss based on the amount by which the carrying value of the assets exceeded their fair value. Our measurement of fair value was based on a blend of analyses which included future discounted cash flows, comparison with companies of similar industry and/or size, consideration of the recent price of our common shares, and other qualitative factors. Based on our analysis, in the fourth quarter of 2005 we recorded a charge of $410.5 million to reduce the carrying value of our goodwill to $104.0 million and our intangible assets to $6.9 million.
Impairment of plant and equipment
In accordance with SFAS 144, Accounting for the Impairment or Disposal of Long-lived Assets, we periodically evaluate our long-lived assets for potential impairment. We perform these evaluations whenever events or changes in circumstances suggest that the carrying amount of an asset or group of assets is not recoverable. During the fourth quarter of 2005, events and circumstances indicated impairment of our Pilot Manufacturing Facility and as a result we recorded an impairment charge of $7.0 million. The primary indicator of impairment was a reduction in the projected production at this facility. We measured the impairment loss based on the amount by which the carrying value of the assets exceeded their fair value. Our measurement of fair value was based on future discounted cash flows.
In-process Research and Development
The in-process research and development, or IPR&D, charge of $236.0 million in 2004 was related to our acquisition of Atrix. We calculated the charge for IPR&D by determining the fair value of the existing products as

61


 

well as the technology that was currently under development, using the income approach. We did not have any acquisition-related IPR&D charges in 2005.
Restructuring
During the quarter ended March 31, 2005, we restructured our operations as a result of our acquisition of Atrix. We provided over 50 affected employees with severance and support to assist with outplacement. As a result, we recorded $3.1 million of restructuring charges related to severance and termination costs.
At the end of 2005, we restructured our operations in order to concentrate our resources on key product development programs and business initiatives. We provided approximately 100 affected employees with severance and support to assist with outplacement. As a result, we recorded $5.0 million of restructuring charges in the fourth quarter of 2005.
Investment and Other Income
Net Foreign Exchange Gains (Losses)
Net foreign exchange gains comprise gains from the impact of foreign exchange fluctuation on our cash and cash equivalents, short-term investments, derivative financial instruments, foreign currency receivables, foreign currency payables and U.S. dollar denominated long term debt. For the year ended December 31, 2005, we recorded net foreign exchange gains of $4.2 million versus net foreign exchange gains of $0.8 million in 2004. (See “Liquidity and Capital Resources – Interest and Foreign Exchange Rates”)
Details of our net foreign exchange gains (losses) were as follows:
                 
    For the year ended   For the year ended
(In thousands of U.S. dollars)   December 31, 2005   December 31, 2004
 
Cash and cash equivalents and short-term investments
  $ (5,636 )   $ (11,751 )
U.S. dollar long-term debt
    5,857       13,258  
Foreign exchange contracts
    7,401       905  
Foreign currency receivables and payables
    (3,470 )     (1,575 )
     
Net foreign exchange gains (losses)
  $ 4,152     $ 837  
     
Interest Income
For the year ended December 31, 2005, interest income increased 30% to $13.2 million compared to $10.1 million for the same period in 2004. The increase in yields on short-term investments and increase in cash generated from operations offset the reduction in cash due to cash payments related to the acquisition of Atrix in November 2004.
Interest Expense
Interest expense comprised interest accrued on the 3% convertible senior notes issued on August 15, 2003 and amortization of deferred financing expenses related to this placement. For the year ended December 31, 2005 interest expense remained relatively flat at $6.4 million compared to $6.3 million in 2004.
Other Gains
The prior year “other gain” of $1.9 million related to a payment received in September 2004 from Axcan Pharma, Inc. for a milestone payment resulting from the approval in Europe of Photofrin® for Barrett’s esophagus.
Extraordinary Gain
On March 31, 2004, we acquired all the outstanding shares of Kinetek Pharmaceuticals, Inc., or Kinetek, a privately held biopharmaceutical company based in Vancouver, British Columbia, which focused on discovery and development of new therapies. The extraordinary gain of $12.5 million recorded in 2004 resulting from this acquisition related to the estimated fair value of net assets acquired, including the recognition of certain tax assets, in

62


 

excess of the total consideration paid by us. On July 1, 2004, Kinetek was amalgamated with QLT and ceased to exist as a separate legal entity.
Income taxes
The recovery of income taxes was $7.2 million for the year ended December 31, 2005, compared to a provision of $29.5 million in 2004. The recovery for income taxes for 2005 was significantly impacted by the impairment of intangible assets. (See Note 18 — Income Taxes in “Notes to the Consolidated Financial Statements”.)
The net deferred tax asset of $10.1 million was largely the result of capital loss carryforwards, research and development credits as well as other temporary differences. The net deferred tax liability of $9.8 million was largely a result of unrealized foreign exchange gains on our convertible debt and remaining tangible and intangible depreciable assets in connection with the acquisition of Atrix in 2004.
As of December 31, 2005, we had a valuation allowance against specifically identified tax assets. The valuation allowance is reviewed periodically and if management’s assessment of the “more likely than not” criterion for accounting purposes changes, the valuation allowance is adjusted accordingly (See Note 18 in “Notes to the Consolidated Financial Statements”).
OUTLOOK FOR 2007
The statements and information contained in this section are forward-looking. See the “Special Note Regarding Forward-looking Statements”.
Lucentis, an anti-VEGF product by Genentech and Novartis Ophthalmics for the treatment of patients with wet age-related macular degeneration, received FDA approval in the United States in July 2006, and received European Union approval in January 2007. Based on this and current trends in Visudyne sales, we are projecting a decline in Visudyne sales in 2007 over those achieved in 2006 as Visudyne continues to face significant competitive pressure.
LIQUIDITY AND CAPITAL RESOURCES
We have financed operations, product development and capital expenditures primarily through proceeds from our commercial operations, public and private sales of equity securities, private placement of convertible senior notes, licensing and collaborative funding arrangements with strategic partners, and interest income.
The primary drivers of our operating cash flows during 2006 were cash receipts from product revenues and royalties, and cash payments related to the following: income tax payment, R&D activities, SG&A expenses, severances and related expenses associated with restructuring activities, legal expenses related to various legal proceedings, raw materials purchases, contract manufacturing fees for the manufacture of Visudyne, manufacturing costs related to the production of Eligard, interest expense related to our convertible notes, and investments in trading securities.
For the year ended December 31, 2006, we consumed $42.8 million of cash in operations compared to $95.5 million generated from operations for the same period in 2005. Investments in trading securities of $58.4 million, lower cash receipts from Visudyne sales and contract research and development of $67.5 million, higher income tax instalments of $33.1 million, higher foreign exchange contract payments of $4.1 million, were offset by higher cash receipts from Eligard and generic dermatology product sales, royalties, and licensing and milestone payments of $2.5 million, lower operating and inventory related expenditures of $12.8 million, other gains of $3.2 million representing the last milestone payment owed to us from Axcan Pharma Inc. related to the sale of our Photofrin business and the upfront payment from the sale of the non-U.S. rights of our BEMA technology, and higher interest income of $7.3 million.
During the year ended December 31, 2006, proceeds from the sale of our generic dermatology and dental business and related manufacturing facility and a decrease in short term investments accounted for the most significant cash flows provided by investing activities offset by capital expenditures and an increase in restricted cash of $3.9 million. We used $6.5 million for the purchase of property, plant and equipment.

63


 

For the year ended December 31, 2006, our cash flows used in financing activities consisted primarily of common shares repurchased, net of share repurchase costs, for $129.4 million offset by cash receipts of $0.8 million from stock option exercises.
Interest and Foreign Exchange Rates
We are exposed to market risk related to changes in interest and foreign currency exchange rates, each of which could adversely affect the value of our current assets and liabilities. At December 31, 2006, we had an investment portfolio consisting of fixed interest rate securities with an average remaining maturity of approximately 24 days and auction rate securities with an average remaining period to reset of approximately 17 days. If market interest rates were to increase immediately and uniformly by a hundred basis points from levels as at December 31, 2006, the fair value of the portfolio would decline by an immaterial amount due to the short remaining maturity period.
At December 31, 2006, we had $378.1 million in cash, cash equivalents, short-term investments and restricted cash, and $172.5 million of debt. To offset the foreign exchange impact of our $172.5 million U.S. dollar-denominated debt, we held at least the equivalent amount in U.S. dollar denominated cash, cash equivalents and short-term investments such that if the U.S. dollar were to decrease in value by 10% against the Canadian dollar, the decline in fair value of our U.S. dollar-denominated cash, cash equivalents and short-term investments would be approximately offset by the decline in the fair value of our $172.5 million U.S. dollar denominated long-term debt, resulting in an immaterial amount of unrealized foreign currency translation loss. As the functional currency of our U.S. subsidiaries is the U.S. dollar, the U.S. dollar-denominated cash, cash equivalents and short-term investments holdings of our U.S. subsidiaries do not result in foreign currency gains or losses in operations.
We enter into foreign exchange contracts to manage exposures to currency rate fluctuations related to our expected future net income and cash flows. The net unrealized gains (losses) in respect of such foreign currency contracts for 2006, were approximately $(1.2) million respectively, and were included as part of the net foreign exchange losses in our results of operations.
At December 31, 2006, we have outstanding forward foreign currency contracts as noted below.
                         
    Maturity Period   Quantity (millions)   Average Price
 
U.S. / Canadian dollar option-dated forward contracts to sell USD
    2007     USD 1.0   1.34014 per USD
 
                       
Swiss franc / Canadian dollar option-dated forward contract to sell CHF
    2007     CHF 29.7   0.90587 per CHF
 

64


 

Contractual Obligations
During August of 2003, we completed a Rule 144A private placement of $172.5 million aggregate principal amount of convertible senior notes due 2023. The notes bear interest at 3% per annum, payable semi-annually beginning March 15, 2004. The convertible senior notes are convertible at the option of the holders into common shares at the conversion rates referred to below only in the following circumstances: (i) if our common share price, calculated over a specified period, has exceeded 120% of the effective conversion price of the convertible senior notes; (ii) if the trading price of the convertible senior notes over a specified period has fallen below 95% of the amount equal to our then prevailing common share price times the applicable conversion rate provided that no notes may be converted pursuant to this condition after September 15, 2018, if, on any trading day during the specified period, the closing sale price of our common shares is greater than the conversion price in effect during such trading day and less than or equal to 120% of such conversion price; (iii) if the convertible senior notes are called for redemption; or (iv) if specified corporate transactions were to occur. The notes are convertible into our common shares, at an initial conversion rate of 56.1892 shares per $1,000 principal amount of notes, which represents a conversion price of approximately $17.80 per share.
On or after September 15, 2008, we may at our option redeem the notes, in whole or in part, for cash at a redemption price equal to 100% of the principal amount of the notes to be redeemed, plus any accrued and unpaid interest to, but excluding, the redemption date. We also have the option to redeem for cash all, but not less than all, of the notes at 100% of their principal amount, plus any accrued and unpaid interest to, but excluding, the redemption date, in the event of certain changes to Canadian withholding tax requirements. On each of September 15, 2008, 2013 and 2018, holders of the notes may require us to purchase all or a portion of their notes for cash at a purchase price equal to 100% of the principal amount of the notes, plus accrued and unpaid interest to, but excluding, that date. On the occurrence of certain events, such as a change in control or termination of trading, holders of the notes may require us to repurchase all or a portion of their notes for cash at a price equal to the principal amount plus accrued unpaid interest to, but excluding, the repurchase date. The notes also become immediately due and payable upon certain events of default by us. The notes are senior unsecured obligations and rank equally with all of our future senior unsecured indebtedness. The notes are effectively subordinated to all of our future secured indebtedness and all existing and future liabilities of our subsidiaries, including trade payables.
In the normal course of business, we enter into product supply agreements with contract manufacturers that contain commitments which expire at various dates through 2009 as well as other purchase commitments related to daily operations. In addition, we have entered into operating lease agreements related to office equipment and office space. The minimum annual commitments related to these agreements and our long-term debt are as follows:
                                         
(In thousands of U.S. dollars)           Payments due by period        
 
Contractual Obligations   Total   Less than 1 year   1-3 years   3-5 years   More than 5 years
 
Long-Term Debt:1
                                       
Principal
  $ 172,500     $     $ 172,500     $     $  
Interest
    8,819       5,175       3,644              
 
                                       
Operating Leases 2
    1,563       576       648       339        
 
                                       
Purchase Obligations 3
    43,648       29,413       14,235              
 
Total
  $ 226,530     $ 35,164     $ 191,027     $ 339     $  
 
1.   Long-term debt relates to the $172.5 million aggregate principal amount of 3% convertible senior notes described above. The amounts in the table above include interest and principal payable to 2008 assuming holders of the notes redeem on the earliest permitted redemption date of September 15, 2008. If redemption does not occur until the due date in 2023, total interest payable will be $86.4 million.
 
2.   Operating leases comprise our long-term leases of photocopiers, office space and postage meters.
 
3.   Purchase obligations comprise minimum purchase requirements of our product supply agreements with contract manufacturers ($41.2 million) and other outstanding purchase commitments related to the normal course of business ($2.4 million).

65


 

Off-Balance Sheet Arrangements
In the course of our business, we regularly provide indemnities with respect to certain matters, including product liability, patent infringement, contractual breaches and misrepresentations, and other indemnities to third parties under the clinical trial, license, service, manufacturing, supply, distribution and other agreements that we enter into in the normal course of our business.
Except as described above and the contractual arrangements described in the Contractual Obligations section, we do not have any other arrangements that create risk for QLT and are not recognized in our consolidated balance sheet.
General
In February 2007, we paid $112.5 million towards litigation settlement (see Item 3. Legal Proceedings). Our remaining cash resources and working capital, plus our cash generating capabilities, is sufficient, in our opinion, to fund ongoing product development programs and other operating and capital requirements, including the in-licensing or acquisition of products and technologies for the reasonably foreseeable future. The nature and form of any future in-licensing or acquisition may have a material impact on our financial position and results of operations. Depending on the overall structure of current and future strategic alliances, we may have additional capital requirements related to the further development, marketing and distribution of existing or future products.
Our working capital and capital requirements will depend upon numerous factors, including: the status of competitors; the outcome of legal proceedings (see Item 3. Legal Proceedings and Item 1. Business — Risk Factors); the progress of our preclinical and clinical testing; fluctuating or increasing manufacturing requirements and R&D programs; the timing and cost of obtaining regulatory approvals; the levels of resources that we devote to the development of manufacturing, marketing and support capabilities; technological advances; the cost of filing, prosecuting and enforcing our patent claims and other intellectual property rights; and our ability to establish collaborative arrangements with other organizations.
We may require additional capital in the future to fund any damage awards resulting from legal proceedings against us, clinical and product development costs for certain product applications or other technology opportunities, and strategic acquisitions of products, product candidates, technologies or other businesses. Accordingly, we may seek funding from a combination of sources, including product licensing, joint development and new collaborative arrangements, additional equity or debt financing or from other sources. No assurance can be given that additional funding will be available or, if available, on terms acceptable to us. If adequate capital is not available, our business could be materially and adversely affected.
FACTORS AFFECTING OUR BUSINESS AND PROSPECTS
There are many factors that affect our business and the results of our operations, some of which are beyond our control. These factors include:
    the failure of acquisitions to achieve anticipated results,
 
    competitive factors that may limit our ability to market our products,
 
    insufficient cash flow that could affect our debt financing and create refinancing risk,
 
    failure to generate sufficient revenue, which could impair our debt service payments,
 
    the failure to succeed with new products,
 
    our inability to obtain and enforce patents to protect our property rights,
 
    our dependence on contract manufacturers,
 
    potential liability for environmental contamination, which could result in substantial costs,
 
    our failure to successfully address competition for our products,
 
    adverse outcome in ongoing litigation,
 
    our dependence on third parties to market our products,
 
    efforts of governmental authorities and third party payors to limit or reduce reimbursement for our products,
 
    the inability to successfully develop and launch replacements for products that lose patent protection,
 
    impact of product liability claims,
 
    impact of regulatory approvals on the marketing of products, and
 
    failure to achieve projected development goals within anticipated timeframes.
MATERIAL DIFFERENCES IN OUR CONSOLIDATED FINANCIAL STATEMENTS BETWEEN U.S. GAAP AND CANADIAN GAAP
Our Consolidated Financial Statements have been prepared in accordance with U.S. GAAP on a basis consistent for all periods presented. Certain adjustments would be required for our U.S. GAAP financial statements to conform to Canadian GAAP. (See Note 24 in “Notes to the Consolidated Financial Statements”.)
Under Canadian GAAP, in 2006 our net loss would increase by $19.0 million to a loss of $(120.6) million; in 2005 our net loss would increase by $155.4 million to a loss of $(480.8) million; and in 2004 our net loss would decrease by $216.0 to become net income of $50.3 million.
The principal differences under Canadian GAAP as opposed to U.S.GAAP in 2006 were the additional allocation of goodwill and generic dermatology in-process research and development (net of tax) to loss from discontinued operations of $10.0 million, additional amortization expense of $4.5 million related to in-process research and development, imputed interest on convertible debt of $8.0 million as a result of bifurcation, offset by the reversal of the charge related to the acquisition of certain license and option rights of $1.8 million (net of amortization), reduction in unrealized foreign exchange loss of $1.3 million related to our convertible debt, and tax recovery of $0.3 million related to the aforementioned adjustments.
The principal differences under Canadian GAAP as opposed to U.S.GAAP in 2005 were the additional impairment charge of $184.4 million related to goodwill and intangible assets ($9.4 million included in loss from discontinued operations), additional amortization expense of $13.9 million

66


 

related to in-process research and development ($0.8 million included in loss from discontinued operations), imputed interest on convertible debt of $7.4 million as a result of bifurcation, stock-based compensation of $7.2 million ($0.1 million included in loss from discontinued operations), and tax effect of $57.2 million related to the aforementioned adjustments ($3.9 million included in loss from discontinued operations).
In 2004 the principal differences in our net income under Canadian GAAP as oppose to net loss under U.S. GAAP were the reversal of the $236.0 million write-off of in process research and development acquired in our acquisition of Atrix ($14.0 million included in loss from discontinued operations), offset by stock compensation of $11.2 million, imputed interest on convertible debt of $7.1 million as a result of bifurcation, additional amortization expense of $1.6 million related to in-process research and development ($0.1 million included in loss from discontinued operations), reduction in unrealized foreign exchange gain of $1.4 million related to our convertible debt, and tax effect of $1.3 million related to the aforementioned adjustments.
Net (loss) income per common share under Canadian GAAP would have been $(1.43), $(5.19) and $0.69 in 2006, 2005, and 2004, respectively.
Differences to reported values contained in our consolidated balance sheet and consolidated statements of cash flows under U.S. GAAP and Canadian GAAP result from the differences discussed above.

67


 

Item 7A. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
See “Management’s Discussion and Analysis of Financial Condition and Results of Operations - Liquidity and Capital Resources”.
Item 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA
Management’s Report on Internal Control over Financial Reporting
Our management is responsible for establishing and maintaining adequate internal control over financial reporting, as such term is defined in the U.S. Securities Exchange Act of 1934, Rules 13a-15(f). Under the supervision and with the participation of our management, including our principal executive officer and principal financial officer, we conducted an evaluation of the effectiveness of our internal control over financial reporting based on the framework in Internal Control — Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission.
Based on our evaluation under the framework in Internal Control — Integrated Framework, our management concluded that our internal control over financial reporting was effective as of December 31, 2006.
Our management’s assessment of the effectiveness of our internal control over financial reporting as of December 31, 2006 has been audited by Deloitte & Touche LLP, the independent registered chartered accountants that audited our December 31, 2006 consolidated annual financial statements, as stated in their report which is included herein.

68


 

REPORT OF INDEPENDENT REGISTERED CHARTERED ACCOUNTANTS
To the Board of Directors and Shareholders of
QLT Inc.
We have audited management’s assessment, included in the accompanying Management’s Report on Internal Control over Financial Reporting, that QLT Inc. and subsidiaries (the “Company”) maintained effective internal control over financial reporting as of December 31, 2006, based on criteria established in Internal Control—Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission. The Company’s management is responsible for maintaining effective internal control over financial reporting and for its assessment of the effectiveness of internal control over financial reporting. Our responsibility is to express an opinion on management’s assessment and an opinion on the effectiveness of the Company’s internal control over financial reporting based on our audit.
We conducted our audit in accordance with the standards of the Public Company Accounting Oversight Board (United States). Those standards require that we plan and perform the audit to obtain reasonable assurance about whether effective internal control over financial reporting was maintained in all material respects. Our audit included obtaining an understanding of internal control over financial reporting, evaluating management’s assessment, testing and evaluating the design and operating effectiveness of internal control, and performing such other procedures as we considered necessary in the circumstances. We believe that our audit provides a reasonable basis for our opinions.
A company’s internal control over financial reporting is a process designed by, or under the supervision of, the company’s principal executive and principal financial officers, or persons performing similar functions, and effected by the company’s board of directors, management, and other personnel to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles. A company’s internal control over financial reporting includes those policies and procedures that (1) pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of the assets of the company; (2) provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with generally accepted accounting principles, and that receipts and expenditures of the company are being made only in accordance with authorizations of management and directors of the company; and (3) provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use, or disposition of the company’s assets that could have a material effect on the financial statements.
Because of the inherent limitations of internal control over financial reporting, including the possibility of collusion or improper management override of controls, material misstatements due to error or fraud may not be prevented or detected on a timely basis. Also, projections of any evaluation of the effectiveness of the internal control over financial reporting to future periods are subject to the risk that the controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate.
In our opinion, management’s assessment that the Company maintained effective internal control over financial reporting as of December 31, 2006, is fairly stated, in all material respects, based on the criteria established in Internal Control—Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission. Also in our opinion, the Company maintained, in all material respects, effective internal control over financial reporting as of December 31, 2006, based on the criteria established in Internal Control—Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission.
We have also audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States), the consolidated financial statements and financial statement schedule as of and for the year ended December 31, 2006 of the Company and our report dated February 26, 2007 expressed an unqualified opinion on those financial statements and financial statement schedule and included an explanatory paragraph relating to the adoption of Statement of Financial Accounting Standard No. 123(R) — “Share Based Payment”.
/s/ DELOITTE & TOUCHE LLP
Independent Registered Chartered Accountants
Vancouver, Canada
February 26, 2007

69


 

REPORT OF INDEPENDENT REGISTERED CHARTERED ACCOUNTANTS
To the Board of Directors and Shareholders of
QLT INC.
We have audited the accompanying consolidated balance sheets of QLT Inc. and subsidiaries (“the Company”) as of December 31, 2006 and 2005 and the related consolidated statements of operations, cash flows and changes in shareholders’ equity for each of the three years in the period ended December 31, 2006. Our audits also included the financial statement schedule listed in the Index at Item 15. These financial statements and financial statement schedule are the responsibility of the Company’s management. Our responsibility is to express an opinion on these financial statements and financial statements schedule based on our audits.
We conducted our audits in accordance with the standards of the Public Company Accounting Oversight Board (United States). Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement. An audit includes examining, on a test basis, evidence supporting the amounts and disclosures in the financial statements. An audit also includes assessing the accounting principles used and significant estimates made by management, as well as evaluating the overall financial statement presentation. We believe that our audits provide a reasonable basis for our opinion.
In our opinion, such consolidated financial statements present fairly, in all material respects, the financial position of QLT Inc. and subsidiaries as of December 31, 2006 and 2005, and the results of their operations and their cash flows for each of the three years in the period ended December 31, 2006, in conformity with accounting principles generally accepted in the United States of America. Also, in our opinion, such financial statement schedule, when considered in relation to the basic consolidated financial statements taken as a whole, presents fairly, in all material respects the information set forth therein.
As discussed in Notes 3 and 14 to the consolidated financial statements, the company changed its method of accounting for stock-based compensation during the year ended December 31, 2006 as a result of adopting Statement of Financial Accounting Standards No. 123(R), “Share-Based Payment”.
We have also audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States), the effectiveness of the Company’s internal control over financial reporting as of December 31, 2006, based on the criteria established in Internal Control—Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission and our report dated February 26, 2007 expressed an unqualified opinion on management’s assessment of the effectiveness of the Company’s internal control over financial reporting and an unqualified opinion on the effectiveness of the Company’s internal control over financial reporting.
/s/ DELOITTE & TOUCHE LLP
Independent Registered Chartered Accountants
Vancouver, Canada
February 26, 2007

70


 

CONSOLIDATED BALANCE SHEETS
                 
As at December 31,   2006     2005  
 
(In thousands of U.S. dollars)                
ASSETS
               
Current assets
               
Cash and cash equivalents
  $ 299,053     $ 345,799  
Short-term investment securities
    75,163       119,816  
Restricted cash
    3,916        
Accounts receivable (Note 4)
    38,872       43,986  
Income taxes receivable
    4,049        
Inventories (Note 5)
    34,268       46,239  
Current portion of deferred income tax assets (Note 18)
    8,657       2,480  
Other (Note 6)
    14,031       20,728  
 
 
    478,009       579,048  
 
               
Property, plant and equipment (Note 7)
    50,497       52,797  
Assets held for sale
          29,626  
Deferred income tax assets (Note 18)
    9,838       7,593  
Goodwill (Note 9)
    98,641       103,958  
Other long-term assets (Note 10)
    2,121       3,472  
 
 
  $ 639,106     $ 776,494  
 
LIABILITIES
               
Current liabilities
               
Accounts payable
  $ 15,255     $ 14,519  
Income taxes payable
    29       17,253  
Accrued restructuring charge (Note 17)
    2,383       5,205  
Accrued liabilities (Note 11)
    125,805       17,901  
Deferred revenue
    11,508       9,457  
 
 
    154,980       64,335  
 
               
Deferred income tax liabilities (Note 18)
    5,483       9,800  
Deferred revenue
    2,929       3,748  
Long-term debt (Note 13)
    172,500       172,500  
 
 
    335,892       250,383  
 
COMMITMENTS AND GUARANTEES (NOTE 21)
               
CONTINGENCIES (NOTE 23)
               
 
               
SHAREHOLDERS’ EQUITY
               
Share capital (Note 14)
               
Authorized
               
500,000,000 common shares without par value
               
5,000,000 first preference shares without par value, issuable in series
               
Issued and outstanding
               
Common shares
    708,206       861,676  
December 31, 2006 –75,188,980 shares
               
December 31, 2005 –91,184,681 shares
               
Additional paid in capital
    114,724       66,565  
Accumulated deficit
    (603,251 )     (501,645 )
Accumulated other comprehensive income
    83,535       99,515  
 
 
    303,214       526,111  
 
 
  $ 639,106     $ 776,494  
 
See the accompanying “Notes to the Consolidated Financial Statements”.

71


 

CONSOLIDATED STATEMENTS OF OPERATIONS
                         
Year ended December 31,   2006     2005     2004  
 
(In thousands of U.S. dollars except per share information)           (note 19)     (note 19)  
Revenues
                       
Net product revenue (Note 15)
  $ 151,860     $ 204,046     $ 178,388  
Net royalties
    21,099       15,816       2,338  
Contract research and development (Note 16)
    1,155       9,251       4,029  
Licensing and milestones
    976       724        
 
 
    175,090       229,837       184,755  
 
 
                       
Costs and expenses
                       
Cost of sales
    42,191       46,056       33,157  
Research and development
    56,428       63,330       48,698  
Selling, general and administrative
    42,228       22,975       16,921  
Depreciation
    6,255       6,768       3,552  
Amortization of intangibles
          6,334       695  
Litigation settlement (Note 23)
    112,500              
Impairment of goodwill and other intangible assets
          401,085        
Impairment of plant and equipment
          6,955        
Purchase of in-process research and development
                222,000  
Restructuring charge (Note 17)
    2,828       8,042        
 
 
    262,430       561,545       325,024  
 
 
                       
Operating loss
    (87,340 )     (331,708 )     (140,269 )
 
                       
Investment and other income (loss)
                       
Net foreign exchange (loss) gains
    (3,706 )     4,152       837  
Interest income
    20,488       13,203       10,136  
Interest expense
    (6,595 )     (6,357 )     (6,261 )
Other gains
    2,773       49       1,905  
 
 
                       
Loss before income taxes
    (74,380 )     (320,661 )     (133,652 )
 
                       
(Provision for) recovery of income taxes (Note 18)
    (9,035 )     7,177       (29,552 )
 
 
                       
Loss from continuing operations
  $ (83,415 )   $ (313,484 )   $ (163,204 )
 
 
                       
Loss from discontinued operations, net of income tax (Note 19)
    (18,190 )     (11,928 )     (15,022 )
 
 
Loss before extraordinary gain
    (101,605 )     (325,412 )     (178,226 )
 
 
                       
Extraordinary gain (Note 8)
                12,517  
 
 
Net loss
  $ (101,605 )   $ (325,412 )   $ (165,709 )
 
 
                       
Basic net loss per common share
                       
Continuing operations
  $ (0.99 )   $ (3.38 )   $ (2.23 )
Discontinued operations
    (0.22 )     (0.13 )     (0.20 )
Extraordinary gain
                0.17  
 
Net loss
  $ (1.20 )   $ (3.51 )   $ (2.26 )
 
 
Diluted net (loss) income per common share
                       
Continuing operations
  $ (0.99 )   $ (3.38 )   $ (2.23 )
Discontinued operations
    (0.22 )     (0.13 )     (0.20 )
Extraordinary gain
                0.17  
 
Net loss
  $ (1.20 )   $ (3.51 )   $ (2.26 )
 
 
                       
Weighted average number of common shares outstanding (thousands)
                       
Basic
    84,596       92,637       73,240  
Diluted
    84,596       92,637       73,240  
 
See the accompanying “Notes to the Consolidated Financial Statements”.

72


 

CONSOLIDATED STATEMENTS OF CASH FLOWS
                         
Year ended December 31,   2006     2005     2004  
 
(In thousands of U.S. dollars)                        
Cash flows (used in) provided by operating activities
                       
Net (loss) income
  $ (101,605 )   $ (325,412 )   $ (165,709 )
Adjustments to reconcile net income to net cash from operating activities
                       
Impairment of goodwill and other intangible assets
          410,534        
Impairment of plant and equipment
          6,955        
Write-down of assets held for sale
    8,592              
In-process research and development
                236,000  
Amortization of intangibles
    78       6,915       852  
Depreciation
    7,087       8,088       3,715  
Write-down of fixed assets, investments and deposit
    1,013              
Write-down of inventory
    2,584              
Amortization of deferred financing expenses
    1,218       1,139       1,053  
Share-based compensation
    4,284              
Unrealized foreign exchange gains
    (9,503 )     (6,919 )     (12,396 )
Interest earned on restricted cash
    (41 )            
Extraordinary gain
                (12,517 )
Deferred income taxes
    (10,471 )     (36,189 )     19,612  
Loss on disposal of assets held for sale
    8,001              
Changes in non-cash operating assets and liabilities
                       
Purchase of trading securities
    (58,357 )            
Accounts receivable
    7,137       12,963       (9,382 )
Inventories
    6,573       275       749  
Other current assets
    6,351       (5,761 )     7,219  
Accounts payable
    (476 )     2,661       749  
Income tax (receivable) payable
    (21,694 )     16,190       (67 )
Accrued restructuring charge
    (2,836 )     5,134        
Other accrued liabilities
    107,837       (11,697 )     162  
Deferred revenue
    1,396       10,582       (4,845 )
 
 
    (42,832 )     95,458       65,195  
 
 
                       
Cash (used in) provided by investing activities
                       
Short-term investment securities
    112,834       (5,970 )     211,093  
Restricted cash
    (3,875 )            
Purchase of property, plant and equipment
    (6,546 )     (7,726 )     (11,657 )
Proceeds on disposal of property and equipment
    20,728              
Purchase of Atrix Laboratories, Inc., net of cash acquired
          (1,012 )     (301,145 )
Purchase of Kinetek Pharmaceuticals, Inc., net of cash acquired
                (2,316 )
 
 
    123,141       (14,708 )     (104,025 )
 
 
                       
Cash (used in) provided by financing activities
                       
Common shares repurchased
    (129,433 )     (27,754 )      
Deferred financing expenses
                (123 )
Issuance of common shares
    817       12,879       15,205  
 
 
    (128,616 )     (14,875 )     15,082  
 
 
                       
Effect of exchange rate changes on cash and cash equivalents
    1,561       2,837       38,427  
 
 
 
                       
Net (decrease) increase in cash and cash equivalents
    (46,746 )     68,712       14,679  
Cash and cash equivalents, beginning of year
    345,799       277,087       262,408  
 
 
                       
Cash and cash equivalents, end of year
  $ 299,053     $ 345,799     $ 277,087  
 
Supplementary cash flow information:
                       
 
Interest paid
  $ 5,792     $ 5,830     $ 6,035  
Income taxes paid
    40,235       7,119       11,342  
 
Non-cash investing and financing activities:
1.   On November 19, 2004, in connection with the acquisition of Atrix Laboratories, Inc. (now QLT USA Inc.) we issued 22,283,826 common shares valued at $436.1 million, assumed 6,106,961 options valued at $77.7 million, and a warrant to purchase 1,000,000 common shares of QLT valued at $16.2 million.
See the accompanying “Notes to the Consolidated Financial Statements”.

73


 

CONSOLIDATED STATEMENT OF CHANGES IN SHAREHOLDERS’ EQUITY
                                                         
                            Accumulated                        
                    Additional     Other                     Total  
    Common Shares     Paid-in     Comprehensive     Accumulated     Comprehensive     Shareholders’  
    Shares     Amount     Capital     Income (Loss)     Deficit     Income (Loss)     Equity  
 
(All amounts except share and per share information are expressed in thousands of U.S. dollars)  
Balance at December 31, 2003
    68,892,027     $ 395,627     $     $ 45,828     $ (8,084 )         $ 433,371  
Shares issued for the acquisition of Atrix Laboratories, Inc.
    22,283,826       436,094                               436,094  
Assumption of stock options and warrant on the acquisition of Atrix Laboratories, Inc.
                93,896                         93,896  
Exercise of stock options at prices ranging from CAD $12.10 to CAD $34.75 per share and U.S.$5.29 to U.S.$14.23 per share
    845,719       16,777       (1,703 )                       15,074  
 
Other comprehensive loss:
                                                       
Cumulative translation adjustment from application of U.S. dollar reporting
                      44,168           $ 44,168       44,168  
Unrealized (loss) on available for sale securities
                      (114 )           (114 )     (114 )
Net loss
                            (165,709 )     (165,709 )     (165,709 )
 
                                                     
 
Comprehensive loss
                                $ (121,655 )      
 
Balance at December 31, 2004
    92,021,572     $ 848,498     $ 92,193     $ 89,882     $ (173,794 )         $ 856,779  
Exercise of stock options at prices ranging from CAD$12.10 to CAD $13.35 per share and U.S. $2.63 - U.S. $16.22 per share
    1,304,509       25,068       (15,593 )                       9,475  
Exercise of warrant at U.S. $3.39 per share
    1,000,000       19,594       (16,204 )                       3,390  
 
Common share repurchase
    (3,141,400 )     (31,484 )     6,169             (2,439 )           (27,754 )
 
Other comprehensive loss:
                                                       
Cumulative translation adjustment from application of U.S. dollar reporting
                      9,792           $ 9,792       9,792  
 
Unrealized (loss) on available for sale securities
                      (159 )           (159 )     (159 )
 
Net loss
                            (325,412 )     (325,412 )     (325,412 )
 
                                                     
 
Comprehensive loss
                                $ (315,779 )      
 
Balance at December 31, 2005
    91,184,681     $ 861,676     $ 66,565     $ 99,515 (1)   $ (501,645 )         $ 526,111  
Exercise of stock options at prices ranging from CAD $7.79 to CAD $9.22 per share and U.S. $2.89 - U.S. $8.64 per share
    127,299       2,387       (1,574 )                       813  
Stock-based compensation
                4,586                         4,586  
Common share repurchase
    (16,123,000 )     (155,857 )     45,147                         (110,710 )
 
Other comprehensive loss:
                                                       
Cumulative translation adjustment from application of U.S. dollar reporting
                      (16,187 )         $ (16,187 )     (16,187 )
Unrealized gain on available for sale securities
                      207             207       207  
Net Income
                            (101,605 )     (101,605 )     (101,605 )
 
                                                     
 
Comprehensive loss
                                $ (117,585 )          
 
Balance at December 31, 2006
    75,188,980     $ 708,206     $ 114,724     $ 83,535 (1)   $ (603,251 )         $ 303,214  
 
(1)   At December 31, 2006, our accumulated other comprehensive income are related almost entirely to cumulative translation adjustments from the application of U.S. dollar reporting with an insignificant amount due to unrealized loss on available for sale securities.

74


 

NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
We are a global biopharmaceutical company dedicated to the discovery, development and commercialization of innovative therapies in the fields of ophthalmology and dermatology.
1. BASIS OF PRESENTATION
These consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the state of Delaware in the United States of America. All amounts herein are expressed in U.S. dollars unless otherwise noted.
In December 2006, we completed the sale of certain non-core assets, including the generic dermatology business, dental business and the related manufacturing facility owned by QLT USA in Fort Collins, Colorado. In accordance with SFAS No. 144 Accounting for the Impairment or Disposal of Long-lived Assets, the results of operations of the generic dermatology and dental businesses for the current and prior periods have been reported as discontinued operations, and the assets included as part of this divestiture have been reclassified as held for sale in the 2005 balance sheet. (See Note 19 — “Discontinued Operations.”)
2. PRINCIPLES OF CONSOLIDATION
These consolidated financial statements include the accounts of QLT Inc. and its subsidiaries, all of which are wholly owned. The principal subsidiaries included in our consolidated financial statements are QLT USA, Inc. and QLT Therapeutics, Inc., both of whom are incorporated in the state of Delaware in the United States of America. All significant intercompany transactions have been eliminated.
3. SIGNIFICANT ACCOUNTING POLICIES
Use of Estimates
The preparation of financial statements in conformity with generally accepted accounting principles requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the financial statements, and the reported amounts of revenue and expenses during the reporting periods presented. Significant estimates are used for, but not limited to, provisions for non-completion of inventory, provision for obsolete inventory, allowance for doubtful accounts, assessment of the recoverability of long-lived assets, assessment of impairment of goodwill, accruals for contract manufacturing and research and development agreements, accruals for compensation expenses, allocation of costs to manufacturing under a standard costing system, allocation of overhead expenses to research and development, determination of fair value of assets and liabilities acquired in purchase business combinations, stock-based compensation, and provisions for taxes and contingencies. Actual results may differ from estimates made by management.
Reporting Currency and Foreign Currency Translation
We use the U.S. dollar as our reporting currency, while the Canadian dollar is the functional currency for QLT Inc. and the U.S. dollar is the functional currency for our U.S. subsidiaries. Our consolidated financial statements are translated into U.S. dollars using the current rate method. Assets and liabilities are translated at the rate of exchange prevailing at the balance sheet date. Shareholders’ equity is translated at the applicable historical rates. Revenues and expenses are translated at a weighted average rate of exchange for the respective years. Translation gains and losses from the application of the U.S. dollar as the reporting currency are included as part of the cumulative foreign currency translation adjustment, which is reported as a component of shareholders’ equity under accumulated other comprehensive income (loss).
Segmented Information

We operate in one industry segment, which is the business of developing, manufacturing, and commercialization of therapeutics for human health care. Our chief operating decision makers review our operating results on an aggregate basis and manage our operations as a single operating segment. Our segment information does not include the results of businesses classified as discontinued operations.

75


 

Cash, Cash Equivalents and Short-term Investment Securities
Cash equivalents include highly liquid investments with insignificant interest rate risk and original maturities of three months or less at the date of purchase. Short-term investment securities consist of the following: (a) investment-grade interest bearing instruments with maturities between three months and one year at the date of purchase; and (b) auction rate securities with auction reset periods less than 12 months. We have designated certain of our short term investment securities as trading securities and included any related unrealized gains or losses in earnings. We report available-for-sale investments, if any, at fair value as of each balance sheet date and include any unrealized holding gains and losses in shareholders’ equity.
Inventories
Raw materials and supplies inventories are carried at the lower of actual cost and net realizable value. Finished goods and work-in-process inventories are carried at the lower of weighted average cost and net realizable value. We record a provision for non-completion of product inventory to provide for potential failure of inventory batches in production to pass quality inspection. The provision is calculated at each stage of the manufacturing process. We estimate our non-completion rate based on past production and adjust our provision quarterly based on actual production volume and actual non-completion experience. Inventory that is obsolete or expired is written down to its market value if lower than cost.
Investments
Investments in shares of other companies are classified as available-for-sale investments, and are carried at fair value at each balance sheet date. Unrealized gains and losses on these investments are recorded in accumulated other comprehensive income as a separate component of shareholders’ equity, unless the declines in market values are judged to be other than temporary in which case the losses are recognized in income in the period.
Long-lived and Intangible Assets
We incur costs to purchase and occasionally construct property, plant and equipment. The treatment of costs to purchase or construct these assets depends on the nature of the costs and the stage of construction. Costs incurred in the initial design and evaluation phase, such as the cost of performing feasibility studies and evaluating alternatives are charged to expense. Costs incurred in the committed project planning and design phase, and in the construction and installation phase, are capitalized as part of the cost of the asset. We stop capitalizing costs when an asset is substantially complete and ready for its intended use. We depreciate plant and equipment using the straight-line method over their estimated economic lives, which range from 3-40 years. Determining the economic lives of plant and equipment requires us to make significant judgements that can materially impact our operating results.
We periodically evaluate our long-lived assets for potential impairment under SFAS 144, Accounting for the Impairment or Disposal of Long-lived Assets. We perform these evaluations whenever events or changes in circumstances suggest that the carrying amount of an asset or group of assets is not recoverable. If impairment recognition criteria in SFAS 144 have been met, we charge impairments of the long-lived assets to operations.
In accounting for acquisitions, we allocate the purchase price to the fair value of the acquired tangible and intangible assets, including in-process research and development, or IPR&D. We generally determine the value of acquired intangible assets and IPR&D using a discounted cash flow model, which requires us to make assumptions and estimates about, among other things: the time and investment that is required to develop products and technologies; our ability to develop and commercialize products before our competitors develop and commercialize products for the same indications; the amount of revenue to be derived from the products; and appropriate discount rates to use in the analysis. Use of different estimates and judgments could yield materially different results in our analysis, and could result in materially different asset values and IPR&D charges.
During the first quarter of 2006, we initiated an active plan to divest our non-core assets, including the generic dermatology and dental businesses and related manufacturing facility of QLT USA, and reclassified these assets, including acquired intangible assets, as assets held for sale for both current and prior periods. Assets held for sale were recorded at the lower of their carrying value or their estimated fair value less costs to sell. During the third quarter of 2006, we recorded an impairment charge of $8.6 million as events and circumstances indicated impairment to our assets held for sale. The determination of the fair value of assets held for sale was based on future discounted cash flows and required significant judgements and estimates. In December 2006, we completed the sale of the generic dermatology and dental businesses and related manufacturing facility of QLT USA. (See Note 19 — “Discontinued Operations”.)

76


 

Goodwill Impairment
In accordance with Statement of Financial Accounting Standard (“SFAS”) 142, Goodwill and Other Intangibles, we are required to perform impairment tests annually or whenever events or changes in circumstances suggest that the carrying value of an asset may not be recoverable. We made assumptions and estimates regarding product development, market conditions and cash flows in determining the valuation of goodwill and intangibles, all of which related to our acquisition of Atrix (now QLT USA).
In December 2006, we completed the sale of the generic dermatology and dental businesses and related manufacturing facility of QLT USA. In accordance with SFAS 142, goodwill associated with the disposed businesses was included in the disposal and the remaining goodwill was tested for impairment. We did not identify any potential impairment as the fair value of our reporting unit exceeded its carrying amount.
During the fourth quarter of 2005, we conducted impairment tests and recorded a $410.5 million non-cash charge for impairment of goodwill and other intangible assets acquired in connection with our acquisition of Atrix in November 2004. Of the total impairment charge, $9.4 million was included in discontinued operations. (See Note 9 — “Goodwill and Intangible Assets”.)
Our estimates of fair value were based upon factors such as projected future revenue, probability of success of our products in development, and other uncertain elements requiring significant judgments. While we use available information to prepare our estimates and to perform impairment evaluations, actual results in the future could differ significantly. Impairment tests in future periods may result in impairment charges which could materially impact our future reported results.
Property, Plant and Equipment
During the first quarter of 2003, we reviewed our intended use of property and equipment and adopted the straight-line method for all newly acquired property and equipment beginning in 2003. We retain the declining balance method for all property and equipment acquired by our Canadian operations prior to 2003.
Property and equipment are recorded at cost and amortized as follows:
                     
    Method   Rates       Method   Years
Buildings
  Declining balance   4%    or   Straight-line   25 or 40 
Office furnishings, fixtures and other
  Declining balance   20%    or   Straight-line  
Research and commercial manufacturing equipment and computer operating system
  Declining balance   20%    or   Straight-line   3-5 
Computer hardware
  Declining balance   30%    or   Straight-line   3-5 
Revenue Recognition
Net Product Revenues
Our net product revenues are primarily derived from sales of Visudyne® and Eligard®.
With respect to Visudyne, under the terms of the PDT Product Development, Manufacturing and Distribution Agreement with Novartis Ophthalmics, a division of Novartis Pharma AG, we are responsible for Visudyne manufacturing and product supply, and Novartis Ophthalmics is responsible for marketing and distribution of Visudyne. Our agreement with Novartis Ophthalmics provides that the calculation of total revenue for the sale of Visudyne be composed of three components: (1) an advance on the cost of inventory sold to Novartis Ophthalmics, (2) an amount equal to 50% of Novartis Ophthalmics’ net proceeds from Visudyne sales to end-customers (determined according to a contractually agreed definition), and (3) the reimbursement of other specified costs incurred and paid for by us. We recognize revenue from the sale of Visudyne when persuasive evidence of an arrangement exists, delivery to Novartis Ophthalmics has occurred, the end selling price of Visudyne is fixed or determinable, and collectibility is reasonably assured. Under the calculation of revenue noted above, this occurs when Novartis Ophthalmics has sold Visudyne to its end customers. Our revenue from Visudyne will fluctuate dependent upon Novartis Ophthalmics’ ability to market and distribute Visudyne to end customers.
With respect to Eligard, under the terms of the license agreements with our commercial licensees, we are responsible for the supply of Eligard and receive from our commercial licensees an agreed upon sales price upon shipment to

77


 

them. We also earn royalties from certain commercial licensees based upon their sales of Eligard products to end customers, which royalties are included in net royalty revenue. We recognize net revenue from product sales when persuasive evidence of an arrangement exists, product is shipped and title is transferred to our commercial licensees, collectibility is reasonably assured and the price is fixed or determinable. Our net product revenue from Eligard will fluctuate dependent upon our ability to deliver Eligard products to our commercial licensees. Our Eligard commercial licensees are responsible for all products after shipment from our facility. Under this calculation of revenue, we recognize net product revenue from Eligard at the time of shipment to our commercial licensees.
We do not offer rebates or discounts in the normal course of business and have not experienced any material product returns; accordingly, we have not provided an allowance for rebates, discounts, and returns.
Net Royalties
We recognize net royalties when product is shipped by certain of our commercial licensees to end customers based on royalty rates specified in our agreements with them. Generally, royalties are based on estimated net product sales (gross sales less discounts, allowances and other items) and calculated based on information supplied to us by our commercial licensees.
Contract Research and Development
Contract research and development revenues consist of non-refundable research and development funding under agreements with third parties with whom we have research or development relationships or licenses. Contract research and development funding generally compensates us for discovery, preclinical and clinical expenses related to the collaborative development programs for certain products and product candidates, and is recognized as revenue at the time research and development activities are performed under the terms of those agreements. For fixed price contracts, we recognize contract research and development revenue over the term of the agreement consistent with the pattern of work performed. Amounts received under those agreements for work actually performed are non-refundable even if the research and development efforts performed by us do not eventually result in a commercial product. Contract research and development revenues earned in excess of payments received are classified as contract research and development receivables and payments received in advance of revenue recognition are recorded as deferred revenue. (See Note 4 – “Accounts Receivable” and Note 16 – “Contract Research and Development”).
Licensing and Milestones
We have licensing agreements that generally provide for non-refundable license fees and/or milestone payments. The licensing agreements typically require a non-refundable license fee and allow licensees to sell our proprietary products in a defined territory for a defined period. A milestone payment is a payment made by a licensee to us upon achievement of a pre-determined event, as defined in the applicable agreement. Non-refundable license fees and milestone payments are initially reported as deferred revenue. They are recognized as revenue over the remaining contractual term or as covered by patent protection, whichever is earlier, using the straight-line method or until the agreement is terminated. No milestone revenue is recognized until we have completed the required milestone-related services as set forth in licensing agreements.
Cost of Sales
Visudyne cost of sales, consisting of expenses related to the production of bulk Visudyne and royalty expense on Visudyne sales, are charged against earnings in the period that Novartis Ophthalmics sells to end customers. Cost of sales related to the production of various Eligard products are charged against earnings in the period of the related product sale to our commercial licensees. We utilize a standard costing system, which includes a reasonable allocation of overhead expenses, to account for inventory and cost of sales, with adjustments being made periodically to reflect current conditions. Our standard costs are estimated based on management’s best estimate of annual production volumes and material costs. Overhead expenses comprise direct and indirect support activities related to the manufacture of bulk Visudyne and various Eligard products and involve costs associated with activities such as quality inspection, quality assurance, supply chain management, safety and regulatory. Overhead expenses are allocated to inventory at various stages of the manufacturing process under a standard costing system, and eventually to cost of sales as the related products are sold to our commercial licensees or in the case of Visudyne, by Novartis Ophthalmics to third parties. We record a provision for the non-completion of product inventory based on our history of batch completion. The provision is calculated at each stage of the manufacturing process. We had previously provided a reserve for obsolescence of our Eligard and generic dermatology inventory

78


 

and component materials based on our periodic evaluation of potential obsolete inventory and our history of inventory obsolescence. In December 2006, we sold our generic dermatology business and the manufacturing facility in Fort Collins, Colorado, that produces both Eligard and generic dermatology products to Tolmar and entered into a supply agreement with Tolmar for the supply of Eligard products. As a result, we reduced our provision for obsolescence.
Stock-Based Compensation
On January 1, 2006, we adopted SFAS 123 Revised, Share-Based Payment, (“SFAS 123R”) using the modified prospective method. This statement eliminated the alternative to account for stock-based compensation using the intrinsic value method in accordance with the provisions of Accounting Principles Board (APB) Opinion No. 25, Accounting for Stock Issued to Employees. SFAS 123R requires such transactions be recognized as compensation expense in the statement of earnings based on their fair values on the date of the grant, with the compensation expense recognized over the period in which a grantee is required to provide service in exchange for the stock award. Compensation expense recognition provisions are applicable to new awards and to any awards modified, repurchased or cancelled after the adoption date. Additionally, for any unvested awards outstanding at the adoption date, we recognize compensation expense over the remaining service period using the compensation cost calculated for pro forma disclosure purposes under Statement of Financial Accounting Standard 123, Accounting for Stock-Based Payment, or SFAS123. As stock-based compensation expense recognized in the statement of income for the three and twelve month periods ended December 31, 2006 is based on awards ultimately expected to vest, it has been reduced for estimated forfeitures. SFAS 123R requires forfeitures to be estimated at the time of grant and revised, if necessary, in subsequent periods if actual forfeitures differ from those estimates. Previously, in the pro forma information required under SFAS 123, we accounted for forfeitures as they occurred. Under the modified prospective application, prior periods are not revised for comparative purposes.
Impact of the Adoption of SFAS 123R
During 2006, we recorded stock-based compensation expense for awards granted prior to, but not yet vested, as of January 1, 2006, as if the fair value method required for pro forma disclosure under SFAS 123 was in effect for expense recognition purposes, adjusted for estimated forfeitures. For stock-based awards granted after January 1, 2006, we have recognized compensation expense based on the estimated grant date fair value method using the Black-Scholes valuation model, adjusted for estimated forfeitures. When estimating forfeitures, we consider voluntary termination behaviors as well as trends of actual option forfeitures.
The Black-Scholes option pricing model was developed for use in estimating the value of traded options that have no vesting restrictions and are fully transferable. In addition, option pricing models require the input of highly subjective assumptions including the expected stock price volatility. We determine expected volatility and expected life of our stock options based upon historical and other economic data trended into future years. The risk-free interest rate assumption is based upon observed interest rates appropriate for the terms of our stock options.
The weighted average grant date fair value of stock options granted in the twelve months ended December 31, 2006 was CAD $3.00 and U.S. $2.93 whereas the grant date fair value of stock options granted in the twelve months ended December 31, 2005 was CAD $3.82 and U.S. $3.40. The grant date fair value of stock options granted in the twelve months ended December 31, 2004 was CAD $11.70. No U.S. dollar stock options were granted in 2004. We use the following weighted average assumptions:
                         
    2006     2005     2004  
 
Annualized volatility
    44.5 %     47.1 %     55.9 %
Risk-free interest rate
    4.1 %     3.5 %     2.9 %
Expected life (years)
    3.0       2.5       2.5  
Dividends
    0.0       0.0       0.0  

79


 

The impact on our results of operations of recording stock-based compensation for the twelve-month period ended December 31, 2006 was as follows:
         
(In thousands of U.S. dollars, except share information)   Twelve months ended
(Unaudited)   December 31, 2006
 
Cost of sales
  $ 55  
Research and development
    2,447  
Selling, general and administrative
    1,315  
Restructuring
    112  
Discontinued operations
    354  
 
Share based compensation expense before income taxes
    4,283  
Related income tax benefits
     
 
Share based compensation, net of income taxes
  $ 4,283  
 
 
       
Net share based compensation, per common share:
       
Basic
  $ 0.05  
 
 
       
Diluted
  $ 0.05  
In March 2005, our Board of Directors approved a Directors’ Deferred Share Unit Plan (the “DDSU Plan”) for non-employee directors. Under the DDSU Plan, at the discretion of the Board of Directors, non-employee directors can receive all or a percentage of their equity-based compensation in the form of deferred share units (“DSU’s”), each of which has a value equal to the closing price of QLT’s common shares on the Toronto Stock Exchange on the date of grant. A vested DSU is convertible into cash only (no shares are issued), and is automatically converted after the non-employee director ceases to be a member of the Board unless the director is removed from the Board for just cause. The DSU’s vest in equal amounts over 36 months beginning on the first day of the first month after the grant date. The value of a vested DSU, when converted to cash, is equivalent to the closing price of a QLT common share on the date the conversion takes place. The obligations for future settlement of DSU’s are accrued as compensation expense as the DSU’s vest and each reporting period obligations are revalued for changes in the market value of QLT’s common shares. For the year ended December 31, 2006, we recognized $0.4 million (2005 — $0.1 million) of compensation expense related to DSU’s in our operating results. At December 31, 2006, total unrecognized compensation costs related to unvested DSU’s granted prior to that date was $0.7 million, which is expected to be recognized over a period of 35 months with a weighted average period of 24 months. For the year ending December 31, 2006, no DSU’s were converted to cash.
Pro forma Information for Periods Prior to the Adoption of SFAS 123R
Prior to adopting the provisions of SFAS 123R, we accounted for our stock-based compensation under the intrinsic value method in accordance with the provisions of Accounting Principles Board (APB) Opinion No. 25, Accounting for Stock Issued to Employees, and provided the pro forma disclosures of net income and net income per share. Previously reported amounts have not been restated for the adoption of SFAS 123R.
The following pro forma financial information presents the net income per common share had we recognized stock-based compensation using a fair value based accounting method:

80


 

                 
(In thousands of U.S. dollars except per share information)   2005   2004
 
Net (loss) income as reported
  $ (325,412 )   $ (165,709 )
Less: Additional stock-based compensation expense under the fair value method
    (7,171 )     (11,229 )
 
Pro forma
  $ (332,583 )   $ (176,938 )
 
Basic net (loss) income per common share
               
As reported
  $ (3.51 )   $ (2.26 )
Pro forma
    (3.59 )     (2.42 )
 
Diluted net (loss) income per share
               
As reported
  $ (3.51 )   $ (2.26 )
Pro forma
    (3.59 )     (2.42 )
 
Research and Development
Research and development costs are expensed as incurred and consist of direct and indirect expenditures, including a reasonable allocation of overhead expenses, associated with our various research and development programs. Overhead expenses comprise general and administrative support provided to the research and development programs and involve costs associated with support activities such as facility maintenance, utilities, office services, information technology, legal, accounting and human resources. Patent application, filing and defense costs are expensed as incurred. Research and development costs also include funding provided to third parties for joint research and development programs.
Income Taxes
Income taxes are reported using the asset and liability method, whereby deferred tax assets and liabilities are recognized for the future tax consequences attributable to: (i) differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases, and (ii) operating loss and tax credit carry forwards using applicable enacted tax rates. An increase or decrease in these tax rates will increase or decrease the carrying value of future net tax assets resulting in an increase or decrease to net income. Income tax credits, such as investment tax credits, are included as part of the provision for income taxes. The realization of our deferred tax assets is primarily dependent on generating sufficient taxable income prior to expiration of any loss carry forward balance. A valuation allowance is provided when it is more likely than not that a deferred tax asset may not be realized. (See Note 18 — Income Taxes)
Derivative Financial Instruments
We enter into foreign exchange contracts to manage exposure to currency rate fluctuations related to our expected future net earnings and cash flows. We do not engage in speculative trading of derivative financial instruments. The foreign exchange contracts are not designated as hedging instruments, and as a result all foreign exchange contracts are marked to market and the resulting gains and losses are recorded in the statement of income in each reporting period. Details of foreign exchange contracts outstanding at December 31, 2006 are described in Note 20 — “Financial Instruments and Concentration of Credit Risk”.
Assets Held for Sale and Discontinued Operations
We consider assets to be held for sale when management approves and commits to a formal plan to actively market the assets for sale. Upon designation as held for sale, the carrying value of the assets are recorded at the lower of their carrying value or their estimated fair value, less costs to sell. We cease to record depreciation or amortization expense at that time. Our assets held for sale included certain non-core assets, particularly the generic dermatology business, dental business and related manufacturing facility of QLT USA Fort Collins, Colorado. In December 2006, we completed the sale of these assets and recorded a loss on disposal, net of tax, of $8.0 million. This amount was included in our loss from discontinued operations. The results of operations for businesses that are classified as held for sale are excluded from continuing operations and reported as discontinued operations for the current and prior periods. Additionally, segment information does not include the results of businesses classified as discontinued operations.
Legal Proceedings
We are involved in a number of legal actions, the outcomes of which are not within our complete control and may not be known for prolonged periods of time. In these legal actions, the claimants seek damages, as well as other

81


 

relief, which, if granted, could require significant expenditures. We record a liability in the consolidated financial statements for these actions when a loss is known or considered probable and the amount can be reasonably estimated. If the loss is not probable or cannot reasonably be estimated, a liability is not recorded in the consolidated financial statements. On February 9, 2007, QLT USA, Inc., entered into a Settlement, Release and Patent License to settle the litigation initiated by TAP Pharmaceutical Products Inc. (or TAP) and its co-plaintiffs in 2003. Under the terms of the settlement agreement, and without admitting liability, QLT USA paid TAP $112.5 million and Sanofi-Synthelabo paid TAP $45.0 million, for an aggregate settlement amount of $157.5 million. As a result of this settlement, we recorded a charge of $112.5 million in our consolidated 2006 results. Details of our potentially material legal proceedings are described in Note 23 — Contingencies. As of December 31, 2006, except for the liability accrued in relation to the settlement with TAP, no reserve has been established related to legal proceedings.
Net (Loss) Income Per Common Share
Basic net (loss) income per common share is computed using the weighted average number of common shares outstanding during the period. Diluted net (loss) income per common share is computed in accordance with the treasury stock method and “if converted” method, as applicable, which uses the weighted average number of common shares outstanding during the period and also includes the dilutive effect of potentially issuable common stock from outstanding stock options, warrants and convertible debt. In addition, the related interest and amortization of deferred financing fees on convertible debt, when dilutive, (net of tax) are added back to income, since these would not be paid or incurred if the convertible senior notes were converted into common shares.
The following table sets out the computation of basic and diluted net income per common share:
                         
(In thousands of U.S. dollars, except per share data)   2006   2005   2004
 
Numerator:
                       
Loss from continuing operations
  $ (83,415 )   $ (313,484 )   $ (163,204 )
Loss from discontinued operations, net of tax
    (18,190 )     (11,928 )     (15,022 )
Extraordinary gain
                12,517  
     
Net loss
  $ (101,605 )   $ (325,412 )   $ (165,709 )
Effect of dilutive securities:
                       
Convertible senior notes — interest expense
                 
     
Adjusted loss
  $ (101,605 )   $ (325,412 )   $ (165,709 )
     
Denominator: (thousands)
                       
Weighted average common shares outstanding
    84,596       92,637       73,240  
Effect of dilutive securities:
                       
Stock options
                 
Convertible senior notes
                 
     
Diluted potential common shares
                 
     
Diluted weighted average common shares outstanding
    84,596       92,637       73,240  
     
 
                       
Basic net loss per common share:
                       
Continuing operations
  $ (0.99 )   $ (3.38 )   $ (2.23 )
Discontinued operations
    (0.22 )     (0.13 )     (0.20 )
Extraordinary gain
                0.17  
     
Net loss
  $ (1.20 )   $ (3.51 )   $ (2.26 )
     
 
                       
Diluted net loss per common share:
                       
Continuing operations
  $ (0.99 )   $ (3.38 )   $ (2.23 )
Discontinued operations
    (0.22 )     (0.13 )     (0.20 )
Extraordinary gain
                0.17  
     
Net loss
  $ (1.20 )   $ (3.51 )   $ (2.26 )
     
Excluded from the calculation of diluted net income per common share for all years presented were 9,692,637 shares related to the conversion of the $172.5 million 3% convertible senior notes because their effect was anti-dilutive. Also excluded from the calculation of diluted net income per common share for the year ended December 31, 2006 were 6,978,577 shares (in 2005 — 9,647,224 shares, in 2004 — 12,401,263 shares) related to stock options because their effect was anti-dilutive.

82


 

Recently Issued Accounting Standards
In February 2006, the FASB issued SFAS 155, “Accounting for Certain Hybrid Financial Instruments - an amendment of FASB statement 133 and 140 (“SFAS 155”). This Statement simplifies accounting for certain hybrid financial statements by permitting fair value remeasurements for any hybrid financial instrument that contains an embedded derivative that would otherwise require bifurcation, and eliminates the restriction on the passive derivative instruments that a qualifying special - purpose entity (SPE) may hold. SFAS 155 is effective for all financial instruments acquired or issued in the first fiscal year beginning after Sept. 15, 2006. We believe the adoption of SFAS 155 will not have a material impact on our results of operations.
In July 2006, the FASB issued FIN 48 “Accounting for Uncertainty in Income Taxes — an interpretation of FASB Statement No. 109”. This interpretation provides guidance on the financial statement recognition and measurement of a tax position taken or expected to be taken in a tax return. FIN 48 also provides guidance on derecognition, classification, interest and penalties, accounting in interim periods, disclosures, and transition. FIN 48 is effective for fiscal years beginning after December 15, 2006. We are currently evaluating the impact of this standard on our Consolidated Financial Statements.
In September 2006, the FASB issued SFAS No. 157 “Fair Value Measurements” (“SFAS No. 157”) which defines fair value, establishes a framework for measuring fair value in generally accepted accounting principles, and expands disclosures about fair value measurements. This statement does not require any new fair value measurements and is effective for fiscal periods beginning after November 15, 2007. We are currently evaluating the impact of this standard on our Consolidated Financial Statements.
In February 2007, the FASB issued SFAS No. 159 “The Fair Value Option for Financial Assets and Financial Liabilities — including an amendment of FASB Statement No. 115” (“SFAS No. 159”) which permits entities to choose to measure many financial instruments and certain other items at fair value. This statement is effective for fiscal periods beginning after November 15, 2007. We are currently evaluating the impact of this standard on our Consolidated Financial Statements.
4. ACCOUNTS RECEIVABLE
                 
(In thousands of U.S. dollars)   2006     2005  
 
Visudyne®
  $ 24,542     $ 34,188  
Royalties
    8,769       5,358  
Contract research and development
    641       1,176  
Eligard® product shipments
    2,611       1,859  
Trade and other
    2,434       2,078  
Allowance for doubtful accounts
    (125 )     (673 )
 
 
  $ 38,872     $ 43,986  
 
Accounts receivable – Visudyne represents amounts due from Novartis Ophthalmics and consists of our 50% share of Novartis Ophthalmics’ net proceeds from Visudyne sales, amounts due from the sale of bulk Visudyne to Novartis Ophthalmics and reimbursement of specified royalty and other costs. The allowance for doubtful accounts has been provided for specifically identified accounts.

83


 

5. INVENTORIES
                 
(In thousands of U.S. dollars)   2006     2005  
 
Raw materials and supplies
  $ 10,723     $ 22,046  
Work-in-process
    27,981       29,083  
Finished goods
    676       390  
Reserve for obsolete inventory
          (1,452 )
Provision for non-completion of product inventory
    (5,112 )     (3,828 )
 
 
  $ 34,268     $ 46,239  
 
We record a provision for non-completion of product inventory to provide for the potential failure of inventory batches in production to pass quality inspection. During the year ended December 31, 2006, we incurred charges against the provision for non-completion of $1.1 million (2005 — $0.8 million).
6. OTHER CURRENT ASSETS
                 
(In thousands of U.S. dollars)   2006     2005  
 
Inventory in transit held by Novartis Ophthalmics
  $ 10,677     $ 10,725  
Foreign exchange contracts
          5,015  
Prepaid expenses and other
    3,354       4,988  
 
 
  $ 14,031     $ 20,728  
 
Inventory in transit comprises finished goods that have been shipped to and are held by Novartis Ophthalmics. Under the terms of our collaborative agreement, upon delivery of inventory to Novartis Ophthalmics, we are entitled to an advance equal to our cost of inventory. The inventory in transit is also included in deferred revenue at cost, and will be recognized as revenue in the period of the related product sale and delivery by Novartis Ophthalmics to third parties, where collection is reasonably assured.
Foreign exchange contracts consist of unrealized amounts arising from recording foreign currency derivative financial instruments at market. (See Note 11 — “Accrued Liabilities”)
7. PROPERTY, PLANT AND EQUIPMENT
                         
    2006  
            Accumulated     Net  
(In thousands of U.S. dollars)   Cost     Depreciation     Book Value  
 
Buildings
  $ 30,663     $ 7,036     $ 23,627  
Office furnishings, fixtures, and other
    7,959       5,102       2,857  
Research equipment
    13,902       8,704       5,198  
Commercial manufacturing equipment
    11,658       4,506       7,152  
Computer hardware and operating system
    19,119       13,611       5,508  
Land
    6,155             6,155  
 
 
  $ 89,456     $ 38,959     $ 50,497  
 

84


 

                         
    2005  
            Accumulated     Net  
(In thousands of U.S. dollars)   Cost     Depreciation     Book Value  
 
Buildings
  $ 35,287     $ 6,667     $ 28,620  
Office furnishings, fixtures, and other
    5,027       3,758       1,269  
Research equipment
    11,458       7,741       3,717  
Commercial manufacturing equipment
    8,475       3,222       5,253  
Computer hardware and operating system
    19,227       11,468       7,759  
Land
    6,179             6,179  
 
 
  $ 85,653     $ 32,856     $ 52,797  
 
In accordance with SFAS 144, Accounting for the Impairment or Disposal of Long-lived Assets, we periodically evaluate our long-lived assets for potential impairment. We perform these evaluations whenever events or changes in circumstances suggest that the carrying amount of an asset or group of assets is not recoverable. During the fourth quarter of 2005, events and circumstances indicated impairment of our Pilot Manufacturing Facility and as a result we recorded an impairment charge of $7.0 million. The primary indicator of impairment was a reduction in the projected production of this facility. We measured the impairment loss based on the amount by which the carrying value of the assets exceeded their fair value. Our measurement of fair value was based on future discounted cash flows.
8. BUSINESS COMBINATIONS
Acquisition of Atrix Laboratories, Inc.
On November 19, 2004, we completed our acquisition of Atrix, a biopharmaceutical company focused on advanced drug delivery. Upon completion of the acquisition, each outstanding share of Atrix common stock was converted into the right to receive one QLT Inc. common share and $14.61 in cash. In addition, each option to purchase Atrix common stock that was outstanding at the closing of the acquisition was assumed by us. The results of operations of Atrix were included in the consolidated statement of operations since the acquisition date, and the related assets and liabilities were recorded based upon their respective fair values at the date of acquisition.
The aggregate consideration for the acquisition of Atrix was $870.5 million, which included $325.6 million in cash, acquisition related expenditures of $15.0 million, and the issuance of 22.3 million common shares of QLT Inc., as set out more fully below. In connection with the acquisition, we also assumed all of the outstanding options and warrants to purchase Atrix common shares and exchanged them for options to purchase our common shares. The total consideration paid for Atrix, including acquisition costs, was allocated based on management’s assessment as to the estimated fair values on the acquisition date. The purchase price and final allocation of the purchase price to the fair value of the acquired tangible and intangible assets and liabilities is as follows:

85


 

         
(In thousands of U.S. dollars)        
Purchase Price
       
Cash paid for shares tendered
  $ 325,567  
Issuance of 22,283,826 QLT Inc. common shares
    436,094  
Assumption of options to purchase 6,106,961 QLT Inc. common shares
    77,655  
Assumption of a warrant to purchase 1,000,000 QLT Inc. common shares
    16,204  
Acquisition costs
    14,957  
 
     
Total purchase price
  $ 870,477  
 
     
 
       
Fair Value of Tangible and Intangible Assets Acquired and Liabilities Assumed
       
Cash and cash equivalents
  $ 30,121  
Short-term investments
    80,519  
Other current assets
    31,175  
Property, plant and equipment
    26,372  
Goodwill
    409,586  
In-process research and development
    236,000  
Intangibles
    109,129  
Current liabilities
    (8,920 )
Deferred income tax liability
    (43,505 )
 
     
Net assets
  $ 870,477  
 
     
The purchase price was allocated to the tangible and intangible assets acquired and liabilities assumed based on their estimated fair values at the date of acquisition. The excess of the purchase price over the estimated fair values of the assets acquired and liabilities assumed amounted to $409.6 million which was allocated to goodwill.
We issued 22.3 million common shares to Atrix’s shareholders. These shares were valued at $436.1 million based on the average of the closing price of QLT Inc. common shares for the period two business days before through two business days after June 14, 2004, the announcement date of the acquisition. The options and warrants to purchase QLT shares were valued at $77.7 million and $16.2 million, respectively, using the Black-Scholes option pricing model. Assumptions used for this valuation are:
                         
    Volatility   Risk-free Interest Rate   Expected Life (years)
     
Options
    60 %     3.38 %     4.0  
Warrants
    40 %     2.36 %     0.4  
In connection with our acquisition of Atrix, we acquired IPR&D related to five projects: advanced formulations of Eligard for prostate cancer, Aczone for acne, Octreotide for symptoms associated with carcinoid tumors, CP-533,536 for bone growth, and generic dermatology products. As of the acquisition date, these projects had not reached technological feasibility and did not have an alternative future use. Accordingly, we allocated to IPR&D, and charged to expense in our consolidated statements of operations for the year ended December 31, 2004, $236.0 million, representing the portion of the purchase price attributable to these projects.
The amount allocated to acquired intangible assets comprises trademarks of $8.0 million and developed technology of $100.8 million. The estimated fair value of trademarks relate to the Eligard trademark and the estimated fair value of developed technology relate to existing FDA-approved products comprising Eligard, certain dermatology products and dental products. The estimated fair values for both were determined based on a discounted forecast of the estimated net future cash flows to be generated from the trademark and developed technology. The estimated fair value of the trademark and developed technology are being amortized on a straight-line basis over 17 and 16 years, respectively, which are the estimated periods over which cash flows will be generated.

86


 

Acquisition of Kinetek Pharmaceuticals, Inc.
On March 31, 2004, we acquired all the outstanding shares of Kinetek Pharmaceuticals, Inc., or Kinetek, a privately held biopharmaceutical company based in Vancouver, British Columbia that focused on discovery and development of new targets and therapies. The results of operations of Kinetek were included in the consolidated statement of operations since the acquisition date, and the related assets and liabilities were recorded based upon their respective fair values at the date of acquisition. We paid an aggregate cash purchase price of $2.4 million, which included acquisition related expenditures of $0.1 million. The extraordinary gain of $12.5 million resulting from this acquisition related to the estimated fair value of net assets acquired, including the recognition of certain tax assets, in excess of the total consideration paid by us. On July 1, 2004, Kinetek was amalgamated with QLT and ceased to exist as a separate legal entity.
9. GOODWILL AND INTANGIBLE ASSETS
As discussed in Note 3 — Significant Accounting Policies, we perform regular reviews to determine if the carrying values of our goodwill and purchased intangible assets may be impaired. We look for the existence of facts and circumstances, either internal or external, which indicate that the carrying value of the assets may not be recovered.
During 2006, we did not identify any potential impairment of goodwill as the fair value of our reporting unit exceeded its carrying amount. Impairment of intangible assets related to our generic dermatology business was included in loss from discontinued operations.
During the fourth quarter of 2005, events and circumstances indicated impairment of goodwill and intangible assets acquired in connection with our acquisition of Atrix Laboratories, Inc. (Note 8). Indicators of impairment in the fourth quarter of 2005 included: lower projection for future Eligard sales based on lower than expected sales of Eligard in 2005; recent adverse court decisions in the ongoing litigations related to Eligard; lower projection for future Aczone revenue based on new market research; our decision to seek partners for future Atrigel programs; and revised forecasts for Atrigel products in development. We measured the impairment loss based on the amount by which the carrying value of the assets exceeded their fair value. Our measurement of fair value was based on a blend of analyses which includes future discounted cash flows, comparison with companies of similar industry and/or size, consideration of the recent price of our common shares, and other qualitative factors. Based on our analysis, in the fourth quarter of 2005 we recorded a charge of $410.5 million to reduce the carrying value of our goodwill to $104.0 million and our intangible assets to $6.9 million.
Intangible assets and goodwill are detailed as follows:

87


 

                                 
            Developed        
(In thousands of U.S. dollars)   Goodwill   Technology   Trademark   Total
 
Cost
  $ 409,586     $ 111,600     $ 8,000     $ 529,186  
 
                               
Accumulated amortization
          (562 )     (53 )     (615 )
 
 
                               
January 1, 2005
    409,586       111,038       7,947       528,571  
 
                               
Amortization
          (6,682 )     (471 )     (7,153 )
 
                               
Impairment losses
    (305,628 )     (97,430 )     (7,476 )     (410,534 )
 
 
                               
Balance as of December 31, 2005
    103,958       6,926             110,884  
 
                               
Amortization
          (78 )           (78 )
 
                               
Allocation to loss from discontinued operations
    (5,317 )     (6,848 )           (12,165 )
 
 
                               
Balance as of December 31, 2006
  $ 98,641     $     $     $ 98,641  
 
Our developed technology at the end of 2005 consisted of dermatology products that were approved by the FDA at the time of the acquisition in November 2004. Developed technology was amortized on a straight-line basis over its estimated useful life of 16 years until it was classified as held for sale during the first quarter of 2006. Total accumulated amortization recorded for developed technology and trademark is $7,322 and $524, respectively.
10. OTHER LONG-TERM ASSETS
                 
(In thousands of U.S. dollars)   2006     2005  
 
Deferred financing expenses
  $ 1,922     $ 3,117  
Other
    199       355  
 
 
  $ 2,121     $ 3,472  
 
Deferred financing expenses represent debt issue costs related to the convertible senior notes, net of amortization. Deferred financing expenses are being amortized over five years commencing August 2003.
11. ACCRUED LIABILITIES
                 
(In thousands of U.S. dollars)   2006     2005  
 
Royalties
  $ 1,723     $ 2,654  
Compensation
    4,683       5,432  
Separation costs
    1,107       2,540  
Foreign exchange contracts
    2,011       2,172  
Atrix acquisition costs
    147       154  
Interest
    1,936       1,740  
Litigation settlement (Note 23)
    112,500        
Other
    1,698       3,209  
 
 
  $ 125,805     $ 17,901  
 

88


 

12. CREDIT AND FOREIGN EXCHANGE FACILITIES
We have one credit facility and two foreign exchange facilities with three financial institutions for the sole purpose of entering into foreign exchange contracts.
The credit facility is secured by money market instruments equivalent to our credit limit of CAD $26.0 million that we deposited with the financial institution. We cannot draw on this credit facility as it serves as a pledge against our outstanding derivative contracts. As a result, interest charges are not applicable.
The two foreign exchange facilities have similar terms and allow us to enter into a maximum $550.0 million of forward foreign exchange contracts for terms up to 15 months, or in the case of spot foreign exchange transactions, a maximum limit of $95.0 million. These foreign exchange facilities are secured by money market instruments equivalent to our contingent credit exposure for the period in which any foreign exchange transactions are outstanding. At December 31, 2006, money market instruments totalling $3.5 million were pledged as security for these foreign exchange facilities. Interest charges, at the financial institutions’ prime rate plus 2%, are only applicable if we are in default with regards to the foreign exchange contracts.
13. LONG TERM DEBT
In August 2003, we completed a private placement of $172.5 million aggregate principal amount of convertible senior notes due in 2023. The notes bear interest at 3% per annum, payable semi-annually beginning March 15, 2004.
The notes are convertible at the option of the holders into common shares at the conversion rates referred to below only in the following circumstances: (i) if our common share price, calculated over a specified period, has exceeded 120% of the effective conversion price of the convertible senior notes; (ii) if the trading price of the convertible senior notes over a specified period has fallen below 95% of the amount equal to our then prevailing common share price times the applicable conversion rate; (iii) if, subject to certain exceptions, the convertible senior notes are called for redemption; or (iv) if specified corporate transactions were to occur. The notes are convertible into common shares of QLT, at an initial conversion rate of 56.1892 shares per $1,000 principal amount of notes, which represents a conversion price of approximately $17.80 per share.
We have the right to redeem the convertible senior notes for cash at any time on or after September 15, 2008. We also had the option to redeem for cash all, but not less than all, of the notes at 100% of their principal amount, plus any accrued and unpaid interest to, but excluding, the redemption date, in the event of certain changes to Canadian withholding tax requirements. Holders of the convertible senior notes have the right to require us to redeem these notes, for cash, at their issue price plus accrued interest on September 15 in each of 2008, 2013, and 2018. On the occurrence of certain events, such as a change in control or termination of trading, holders of the notes may require us to repurchase all or a portion of their notes for cash at a price equal to the principal amount plus accrued unpaid interest to, but excluding, the repurchase date. The notes also become immediately due and payable upon certain events of default by us.
The notes are senior unsecured obligations and rank equally with all of our future senior unsecured indebtedness. The notes are effectively subordinated to all of our future secured indebtedness and all existing and future liabilities of our subsidiaries, including trade payables.
14. SHARE CAPITAL
  (a)   Authorized Shares
 
      There were no changes to the authorized share capital of QLT during the three-year period ended December 31, 2006.
 
  (b)   Share Buy-Back Program

89


 

      On April 28, 2005, we announced a share buy-back program pursuant to which we could purchase up to $50.0 million of our common shares over a two-year period. In December 2005 we increased the amount that could be purchased to $100.0 million of our common shares over a two-year period ending May 2007. The share purchases were made as a normal course issuer bid and were effected in the open market through the facilities of The Toronto Stock Exchange and the NASDAQ Stock Market, and in accordance with all regulatory requirements. Cumulative purchases under this program since May 2005 were 6,264,400 common shares at an average price of $8.20, for a total cost of $51.3 million. On July 27, 2006, we terminated this normal course issuer bid as a result of our decision to proceed with an offer to purchase up to 13 million common shares in a modified “Dutch Auction” tender offer. Under this “Dutch Auction” tender offer, shareholders were invited to tender all or a portion of their shares at a price per share that was not less than US$7.00 and not greater than US$8.00. Based on the number of shares tendered and the prices specified by the tendering shareholders, we determined the lowest price per share within the range that allowed us to buy 13 million shares properly tendered. The tender offer commenced on August 3, 2006 and expired on September 8, 2006. As a result of this tender offer, we accepted for purchase and cancellation 13 million common shares at a price of $8.00 per share, totalling $104 million. These shares represented approximately 14.7% of the shares outstanding as of September 8, 2006. Our total outstanding common shares on December 31, 2006 were 75,188,980 shares.
 
      In repurchasing our common shares under the normal course issuer bid described above, the prices we paid for the shares we repurchased were different than our carrying value for these shares. We had previously recorded this difference between purchase price and carrying value in the accumulated deficit section of our shareholders’ equity. We have made adjustments to prior periods to record the amounts representing the excess of carrying value over the purchase price of the shares as additional paid-in capital. As a result, our December 31, 2005 additional paid-in capital increased by $6.2 million and correspondingly, our accumulated deficit increased by $6.2 million. This adjustment had no impact on previously reported results of operations or cash flows and was not material to the balance sheet.
 
  (c)   Shareholder Protection Rights Plan
 
      Effective March 17, 2002 we adopted a Shareholder Rights Plan, which was then amended and restated effective April 8, 2005 (the “Rights Plan”), and approved, as amended, by the shareholders of QLT at the 2005 Annual General Meeting of QLT. The Rights Plan will remain in effect until the 2008 annual meeting of shareholders. Under the Rights Plan, holders of common shares are entitled to one share purchase right for each common share held. Generally, if any person or group makes a take-over bid, other than a bid permitted under the Rights Plan (a “Permitted Bid”) or acquires beneficial ownership of 20% or more of our outstanding common shares without complying with the Rights Plan, the Rights Plan will entitle the holders of share purchase rights to purchase, in effect, common shares of QLT at 50% of the prevailing market price. A take-over bid for QLT can avoid the dilutive effects of the share purchase rights, and therefore become a Permitted Bid, if it complies with provisions of the Rights Plan.
 
  (d)   Warrant
 
      As part of our acquisition of Atrix, on November 19, 2004 we assumed an outstanding warrant entitling the holder to purchase up to 1,000,000 of our common shares at a net exercise price of $3.39 per share. The warrant was exercised in full into 1,000,000 of our common shares in January 2005.
 
  (e)   Stock Options
 
      We currently maintain four equity compensation plans which provide for the issuance of common shares to employees, officers and directors, all of which have been approved by the shareholders, namely the 1998 Incentive Stock Option Plan, the 2000 Incentive Stock Option Plan, the 1987 Atrix Performance Stock Option Plan and the 2000 Atrix Performance Stock Option Plan. We also maintain one equity compensation plan, the Non-Qualified Atrix Stock Option Plan which provides for the issuance of common shares to certain outside consultants. The Non-Qualified Atrix Stock Option Plan was not approved by shareholders of Atrix Laboratories, Inc. (“Atrix”), but the details of this Plan was included in the Joint Proxy Statement prospectus mailed to shareholders of QLT and Atrix on or about October 18, 2004 and was the subject of the approval granted by our shareholders in connection with our acquisition of Atrix.

90


 

      As of February 28, 2007, no QLT securities remain available for issuance under the 1998 Stock Option Plan or the 1987 Atrix Performance Stock Option Plan, however, both of these plans remain in effect for so long as options previously granted under these plans remain outstanding.
 
      Details of the manner in which those options formerly granted by Atrix were assumed by QLT were included in the Joint Proxy Statement prospectus mailed to shareholder of QLT and Atrix on or about October 18, 2004 and were the subject of the approval granted by our shareholders in connection with our acquisition of Atrix.
 
      None of these plans have been amended in the last fiscal year and there are no entitlements previously granted under any of these plans that remain subject to ratification by security holders. No financial assistance is provided by us to the participants under these plans to facilitate the exercise of options.
 
      Exercise Price
 
      Pursuant to the terms of each of our plans, the exercise price of options granted will be determined by the Compensation Committee, but will in no event be less than the fair market value of our common shares immediately preceding the grant. As such, the exercise price for options granted under all our plans is the closing price on the TSX (for Canadian employees) or NASDAQ (for U.S. employees) immediately preceding the grant.
 
      Exercise Period
 
      Although the plans provide discretion to the Compensation Committee or QLT’s board to have an exercise period of up to 10 years, all options granted under the 1998 Incentive Stock Option Plan and the 2000 Incentive Stock Option Plan have an exercise period of 5 years. Under 1987 Atrix Performance Stock Option Plan, the 2000 Atrix Performance Stock Option Plan and the Non-Qualified Atrix Stock Option Plan, Atrix previously provided a 10 year exercise period to optionees. However, since our acquisition of Atrix on November 19, 2004, all options granted under the 2000 Atrix Performance Stock Option Plan have been given a 5 year exercise period. No options have been granted under the 1987 Atrix Performance Stock Option Plan or the Non-Qualified Atrix Stock Option Plan since the acquisition.
 
      Vesting
 
      Under the 1998 Incentive Stock Option Plan and the 2000 Incentive Stock Option Plan vesting of options granted under such plans occurs monthly over 36 months, subject to such altered vesting schedules as the Compensation Committee or QLT’s board may determine. For senior managers, executive officers and Directors, 50% of any unvested options vest on the termination of employment without cause, and 100% of unvested options vest on the occurrence of a change of control.
 
      All options granted under the 1987 Atrix Performance Stock Option Plan, the 2000 Atrix Performance Stock Option Plan and the Non-Qualified Atrix Stock Option Plan prior to our acquisition of Atrix became 100% vested as a condition of the transaction. In addition, any non-qualified options that were issued prior to the acquisition were amended immediately following the closing so that such options are exercisable until the earlier of: (i) one year following the date of termination of the option holder’s position, if the option holder is terminated other than for cause within 12 months of the acquisition; and (ii) the expiration of the option term. Since the acquisition of Atrix, options granted under the 2000 Atrix Performance Stock Option Plan have vested monthly over 36 months.
 
      Below is a summary of certain of the key terms of each of the equity compensation plans that we currently maintain:
  (i)   1998 Incentive Stock Option Plan, or 1998 Plan
 
      Share Reserve. The number of Common Shares which may be reserved for issuance pursuant to options granted under the 1998 Incentive Stock Option Plan shall not exceed, in the aggregate, 5,000,000. The number of common shares reserved for issuance to any one person under this plan shall not, in the aggregate, exceed five percent of QLT’s issued and outstanding common shares (on a

91


 

      non-diluted basis). At December 31, 2006, options to purchase an aggregate total of 79,750 common shares were outstanding under the 1998 Plan and exercisable in the future at CAD $12.10 per common share.
 
      Administration. The Compensation Committee administers the 1998 Incentive Stock Option Plan.
 
      Eligibility. The Directors, officers, and employees of QLT or our affiliated companies, who in the opinion of the Compensation Committee, are important for our growth and success and whose participation in this plan will, in the opinion of the executive compensation committee, accomplish the purposes of this plan, are eligible to participate under the 1998 Incentive Stock Option Plan.
 
      Grant and Exercise of Options. Subject to the terms of the 1998 Incentive Stock Option Plan, the Compensation Committee may grant to any eligible person one or more options as it deems appropriate. The Compensation Committee may also impose such limitations or conditions on the exercise or vesting of any option as it deems appropriate.
 
      Each option shall terminate on the 90th day after the date on which the optionee ceases to be an eligible person, provided that if such optionee ceases to be an eligible person by reason of the death of such optionee, all or any of the common shares then covered by such option may be purchased by the legal representative of such optionee, or by the person or persons to whom the right of such optionee under the option agreement entered into with such optionee have passed by will or by operation of the laws of devolution or distribution and descent, until the earlier of (i) the date that is twelve months after the date of the death of such optionee, and (ii) the expiry date of such option as set out in the respective option agreement.
 
      Transferability. No option granted under this plan may be transferred or assigned except by will or by operation of the laws of devolution or distribution and descent or pursuant to a qualified domestic relations order, as defined by the Internal Revenue Code of 1986 and may be exercised only by an optionee during his or her lifetime.
 
      Amendments or Termination. Our Compensation Committee has the right at any time to suspend, amend or terminate the 1998 Incentive Stock Option Plan subject to certain exceptions.
 
  (ii)   2000 Incentive Stock Option Plan, or 2000 Plan
 
      Share Reserve. We have reserved an aggregate of 7,000,000 common shares for issuance under the 2000 Incentive Stock Option Plan. Common shares with respect to options that are not exercised in full, will be available for grant under subsequent options under this plan. In addition, the number of common shares reserved for issuance to any one person shall not, in the aggregate, exceed five percent of the issued and outstanding common shares (on a non-diluted basis). The Committee will not grant options to a Director who is not an employee or executive of QLT where such grant will result in those Directors who are not employees or executives of QLT and who hold options under this plan, holding, in the aggregate, more than 0.25% of the issued and outstanding common shares (on a non-diluted basis). At December 31, 2006, options to purchase an aggregate total of 3,986,272 common shares were outstanding under the 2000 Plan and exercisable in the future at prices ranging between CAD $7.79 and CAD $32.85 per common share.
 
      Administration. The Compensation Committee administers the 2000 Incentive Stock Option Plan.
 
      Eligibility. The Directors, officers, employees and consultants of QLT or our affiliated companies, who is or will be, in the opinion of the Compensation Committee, important for our growth and success and whose participation in this 2000 Incentive Stock Option 2000 Incentive Stock Option Plan will, in the opinion of the Compensation Committee, accomplish the purposes of this 2000 Incentive Stock Option Plan, are eligible to participate in the 2000 Incentive Stock Option Plan.
 
      Grant and Exercise of Options. Subject to the terms of the 2000 Incentive Stock Option Plan, the Compensation Committee may grant to any eligible person one or more options as it deems appropriate. The Compensation Committee may also impose such limitations or conditions on the exercise or vesting of any option as it deems appropriate.

92


 

      An option will expire automatically on the earlier of (i) the date on which such option is exercised in respect of all of the common shares that may be purchased under this 2000 Incentive Stock Option Plan, and (ii) the date fixed by the Compensation Committee as the expiry date of such option, which date will not be more than ten years from the date of grant.
 
      If an optionee’s status as an eligible person terminates as a result of retirement or ceases to be a consultant by normal termination of the consulting agreement or ceases to be a Director of QLT, and if such optionee has worked on behalf of QLT for at least 20 years or is at least 60 years of age and has worked continuously for at least five years, all options of such optionee will become immediately vested and will be exerciseable until the expiry of the options. In all other cases, all options will become immediately vested and will be exercisable for a period of the earlier of 90 days and the expiry of the options. If the optionee’s status as an eligible person is terminated for cause, the option shall terminate immediately. If an optionee’s status as an eligible person is terminated as a result of disability, the option will expire 12 months after the date of termination, or on such other date determined by the Compensation Committee and specified in the option agreement. In the event that the optionee dies before otherwise ceasing to be an eligible person, or before the expiration of the option following such a termination, the option will expire 12 months after the date of death, or on such other date determined by the Compensation Committee and specified in the option agreement. Notwithstanding the foregoing, except as expressly permitted by our Compensation Committee, all stock options will cease to vest as at the date upon which the optionee ceases to be eligible to participate in this plan.
 
      Transferability. No option may be transferred or assigned except by will or by operation of the laws of devolution or distribution and descent or pursuant to a qualified domestic relations order, as defined by the U.S. Internal Revenue Code of 1986 and may be exercised only by an optionee during his or her lifetime.
 
      Amendments or Termination. Our Compensation Committee has the right at any time to suspend, amend or terminate the 2000 Incentive Stock Option Plan, but will not have the right to (i) affect in a manner that is adverse or prejudicial to, or that impairs, the benefits and rights of any optionee under any option previously granted without the consent of such optionee; (ii) decrease the number of common shares that may be issued pursuant to any option granted under this plan without the consent of such optionee; (iii) increase the option exercise price without the consent of the optionee; and (iv) grant any option if this plan has been suspended.
 
  (iii)   1987 Atrix Performance Stock Option Plan, or 1987 Atrix Plan
 
      Share Reserve. Prior to our acquisition of Atrix on November 19, 2004, an aggregate of 2,500,000 common shares of Atrix Laboratories, Inc. had been reserved for issuance under the 1987 Atrix Performance Stock Option Plan. Upon the expiration or termination of an option which has not been exercised in full, the number of common shares reserved for issuance under that option which have not been issued will become available for issue for the purpose of additional options which may be granted under this plan. Upon acquisition, we assumed the remaining options outstanding and issuable under the 1987 Atrix Performance Stock Option Plan which, after converting, provide for the issuance of up to 267,937 common shares of QLT Inc. At December 31, 2006, options to purchase an aggregate total of 79,899 common shares were outstanding under the 1987 Atrix Plan and exercisable in the future at prices ranging between U.S. $2.89 and U.S. $9.98 per common share.
 
      Administration. The Compensation Committee administers the 1987 Atrix Performance Stock Option Plan.
 
      Eligibility. The Directors, officers, and key employees of Atrix or of any subsidiary companies, who, in the opinion of the Compensation Committee, contribute materially to the profitability and success of Atrix are eligible to participate in this plan.
 
      Grant and Exercise of Options. Subject to the terms of the 1987 Atrix Performance Stock Option Plan, the Compensation Committee may grant to any eligible person one or more options as it deems

93


 

      appropriate. The Compensation Committee may also impose such limitations or conditions on the exercise or vesting of any option as it deems appropriate.
 
      If an employee ceases to be an employee of the Company for any reason, other than by reason of death or disability, then all options held by such employee which are not exercisable when the employee ceases to be an employee shall terminate. All options which are exercisable when the employee ceases to be an employee must be exercised prior to the earlier of (i) the expiration date of the options or (ii) the date occurring 3 months after the date on which the employee ceases to be an employee.
If an employee dies while in the employ of Atrix or during the 3 month post-termination exercise period, the legal representative of such employee may exercise such option prior to the earlier of (i) the expiration date of the options, or (ii) the date occurring 12 months after the date of death. Such options shall terminate if they are not exercised during such period.
 
      If the employment of an employee terminates by reason of the employee’s disability while such employee is entitled to exercise an option, such option must be exercised prior to the earlier of (i) the expiration date of the options or (ii) the date occurring 12 months after the date of the employee’s disability. Such options shall terminate if they are not exercised during such period.
 
      Transferability. No option may be transferred or assigned except by will or by operation of the laws of descent and distribution and may be exercised only by an optionee during his or her lifetime.
 
      Amendments or Termination. The Board of Directors has the right at any time to suspend, amend or terminate the 1987 Atrix Performance Stock Option Plan. No amendment to the plan will be made without shareholder approval that will (i) increase the total number of common shares reserved for options under the plan, (ii) reduce the exercise price of any option granted under this plan below the fair market value at the time of grant, (iii) modify the provisions of the plan pertaining to eligibility, or (iv) materially increase the benefits accruing to participants under this plan.
 
  (iv)   2000 Atrix Performance Stock Option Plan, or 2000 Atrix Plan
 
      Share Reserve. Prior to the our acquisition of Atrix on November 19, 2004, an aggregate of 4,750,000 common shares of Atrix Laboratories, Inc. had been reserved for issuance under the 2000 Atrix Performance Stock Option Plan. Shares covered by an option grant which is forfeited or cancelled, expires or is settled in cash, shall be deemed not to have been issued for purposes of determining the maximum aggregate number of shares which may be issued under this plan. The maximum number of common shares with respect to which options may be granted to any one person in any fiscal year of Atrix shall be 400,000 shares. Where an optionee commences the provision of continuous service, the optionee may be granted options for up to an additional 300,000 shares which shall not count against the 400,000 limit. Upon acquisition, the Company assumed the remaining options outstanding and issuable under the 2000 Atrix Performance Stock Option Plan which, after converting, provide for the issuance of up to 6,794,636 common shares of QLT Inc. At December 31, 2006, options to purchase an aggregate total of 2,920,257 common shares were outstanding under the 2000 Atrix Plan and exercisable at prices ranging between U.S. $4.90 and U.S. $17.82 per common share.
 
      Administration. The Compensation Committee administers the plan.
 
      Eligibility. Awards other than incentive stock options as defined in Section 422 of the Internal Revenue Code, may be granted to employees, Directors and consultants. Incentive stock options as defined in Section 422 of the Internal Revenue Code may be granted only to employees of Atrix, parent or a subsidiary.
 
      Grant and Exercise of Options. The Compensation Committee may grant to any eligible person one or more options as it deems appropriate and may also impose such limitations or conditions on the exercise or vesting of any option as it deems appropriate.
 
      An option will expire automatically on the earlier of (i) the date on which such option is exercised in respect of all of the common shares that may be purchased under this plan, and (ii) the date fixed by the Compensation Committee as the expiry date of such option, which date will not be more than ten

94


 

      years from the date of grant (or five years for an option granted to an optionee that owns shares representing more than 10% of the voting power of all classes of shares of Atrix or any parent or subsidiary).
 
      Transferability. No incentive stock option may be sold, pledged, assigned, hypothecated, transferred, or disposed of in any manner other than by will or by the laws of descent or distribution and may be exercised only by an optionee during his or her lifetime. Other awards may be transferred by gift or through a domestic relations order to member of the grantee’s immediate family to the extent provided for in the stock option agreement or determined and to the extent determined by the Compensation Committee.
 
      Amendments or Termination. Our Compensation Committee has the right at any time to suspend, amend or terminate the 2000 Atrix Performance Stock Option Plan. No options may be granted during any suspension of this plan, or after termination of this plan. Any amendment, suspension or termination shall not affect options already granted, and such awards shall remain in full force and effect as if the plan had not been amended, suspended or terminated, unless mutually agreed otherwise, which agreement must be in writing and signed by the optionee and Atrix.
 
  (v)   Non-Qualified Atrix Stock Option Plan, or Non-Qualified Atrix Plan
 
      Share Reserve. Prior to our acquisition of Atrix on November 19, 2004, an aggregate of 150,000 common shares of Atrix Laboratories, Inc. had been reserved for issuance under the Non-Qualified Atrix Stock Option Plan. Options under the Non-Qualified Atrix Plan are granted to outside consultants. Upon acquisition, the Company assumed the remaining options outstanding and issuable under the Non-Qualified Atrix Plan which, after converting, provide for issuance of up to 207,543 common shares of QLT Inc. At December 31, 2006, there were no options to purchase common shares outstanding under the Non-Qualified Atrix Plan.
 
      Administration. The Compensation Committee of our board of Directors administers the Non-Qualified Atrix Stock Option Plan.
 
      Eligibility. The board, upon recommendation of the Compensation Committee, may grant options to any consultant, independent contractor and any other designated persons who are not employees, which the Compensation Committee in its discretion shall designate.
 
      Grant and Exercise of Options. The Compensation Committee may grant to any eligible person one or more options as it deems appropriate. The Compensation Committee may also impose such limitations or conditions on the exercise or vesting of any option as it deems appropriate. Options granted at different times under this plan need not contain similar provisions.
 
      In the event of any termination of the consulting or other agreement between an optionee and Atrix, all options which had not been exercised as of the date of such termination will immediately expire. In the event that an optionee dies while retained by Atrix and without having fully exercised his options, the executors or administrators, or legatees or heirs of his estate shall have the right to exercise such options to the extent that such deceased optionee was entitled to exercise the options on the date of death. In no event shall the options be exercisable more than two years from the date of death.
 
      Transferability. Options shall not be transferable other than by will or by the laws of descent and distribution, and during an optionee’s lifetime shall be exercisable only by such optionee.
 
      Amendments or Termination. Our Compensation Committee has the right at any time terminate, amend or revise the Non-Qualified Atrix Stock Option Plan. The Compensation Committee may not, without the consent of the holder of an option, alter or impair any option previously granted under this plan.

95


 

Stock option activity with respect to our 1998 Plan and 2000 Plan is presented below:
                         
            Exercise Price   Aggregate intrinsic
(In Canadian dollars)   Number of Options   Per Share Range   value (in millions)
 
Outstanding at December 31, 2003
    7,236,624     $ 12.10 - 108.60          
 
                       
Granted
    950,200       21.04 -   32.85          
Exercised
    (709,696 )     12.10 -   34.75          
Cancelled
    (1,046,730 )     12.10 - 108.60          
 
 
                       
Outstanding at December 31, 2004
    6,430,398     $ 12.10 - 108.60          
 
                       
Granted
    1,447,450       7.79 -   20.75          
Exercised
    (16,944 )     12.10 -   13.35          
Cancelled
    (2,391,054 )     9.84 - 108.60          
 
 
                       
Outstanding at December 31, 2005
    5,469,850     $ 7.79 - 108.60          
 
                       
Granted
    1,846,968       7.79 -   10.35          
Exercised
    (2,153 )     7.79 -     9.22          
Cancelled
    (3,248,643 )     7.79 - 108.60          
 
 
                       
Outstanding at December 31, 2006
    4,066,022     $ 7.79 -   32.85     $ 3.0  
 
                       
Exerciseable at December 31, 2006
                  $ 0.9  
 
The weighted average exercise price of outstanding options under the 1998 Plan and 2000 Plan as at December 31, 2006, December 31, 2005 and December 31, 2004 are CAD $13.87, CAD $25.28, and CAD $47.64, respectively.
Stock option activity with respect to all other Company option plans is presented below:
                         
            Exercise Price   Aggregate intrinsic
(In U.S. dollars)   Number of Options   Per Share Range   value (in millions)
 
Options assumed at November 19, 2004
    6,106,888     $ 2.63 -   17.82          
 
Granted
                   
Exercised
    (136,023 )     5.29 -   14.23          
Cancelled
                   
 
Outstanding at December 31, 2004
    5,970,865     $ 2.63 -   17.82          
 
                       
Granted
    505,875       6.54 -   12.37          
Exercised
    (1,287,565 )     2.63 -   16.22          
Cancelled
    (1,011,801 )     2.70 -   17.82          
 
 
                       
Outstanding at December 31, 2005
    4,177,374     $ 2.89 -   17.82          
 
                       
Granted
    322,085       7.27 -     8.62          
Exercised
    (125,146 )     2.89 -     8.64          
Cancelled
    (1,374,157 )     5.06 -   17.82          
 
 
                       
Outstanding at December 31, 2006
    3,000,156     $ 2.89 -   17.82     $ 0.6  
 
                       
Exerciseable at December 31, 2006
                  $ 0.4  
 
The weighted average exercise price of outstanding options under all other plans as at December 31, 2006, December 31, 2005 and December 31, 2004 was U.S. $12.31, U.S. $12.60 and U.S. $11.65, respectively.

96


 

Additional information relating to stock options outstanding under the 1998 Plan and the 2000 Plan as of December 31, 2006, is presented below:
                                         
(In Canadian dollars) Options Outstanding   Options Exercisable
                    Weighted            
                    Average            
            Weighted   Remaining           Weighted
    Number of   Average   Contractual   Number of   Average Exercise
Price Range   Options   Exercise Price   Life (Years)   Options   Price
 
Under $12.50
    2,409,785     $ 8.72       4.15       681,190     $ 8.78  
$12.51 - $17.50
    843,816       14.44       2.34       656,531       14.28  
$17.51 - $30.00
    354,751       23.14       0.60       346,808       23.19  
$30.01 - $37.50
    457,670       32.76       2.22       417,875       32.77  
 
 
    4,066,022     $ 13.87               2,102,404          
 
 
Options exercisable under the immediately above noted option Plans as at December 31, 2005 and December 31, 2004 were 4,045,408 and 5,226,578 respectively.
 
Additional information relating to stock options outstanding under all other Company options plans as of December 31, 2006, is presented below:
                                         
(In U.S. dollars)   Options Outstanding   Options Exercisable
                    Weighted            
                    Average            
            Weighted   Remaining           Weighted
    Number of   Average   Contractual   Number of   Average Exercise
Price Range   Options   Exercise Price   Life (Years)   Options   Price
 
Under $7.50
    250,374     $ 6.27       3.90       147,460     $ 5.80  
$7.51 - $10.00
    685,068       8.63       4.88       537,394       8.67  
$10.01 - $12.50
    744,791       11.76       5.15       685,198       11.70  
$12.51 - $16.00
    364,865       13.92       5.94       364,865       13.92  
$16.01 - $17.82
    955,058       16.33       7.44       955,058       16.33  
 
 
    3,000,156     $ 12.31               2,689,975          
 
Options exercisable under the immediately above noted option Plans as at December 31, 2005 and December 31, 2004 were 3,771,394 and 5,970,865 respectively.
The number of options issued and outstanding under all plans at any time is limited to 15% of the number of our issued and outstanding common shares. As of December 31, 2006, the number of options issued and outstanding under all plans was 9.4% of the issued and outstanding common shares.
At December 31, 2006, total unrecognized estimated compensation cost related to non-vested stock options granted prior to that date was $6.5 million, which is expected to be recognized over 36 months with a weighted-average period of 2.1 years. The total share-based compensation cost of stock options capitalized as part of inventory was $0.3 million during the year ended December 31, 2006. The total intrinsic value of the stock options exercised during the year ended December 31, 2006 was $0.2 million. For the year ended December 31, 2006, we recorded cash received from the exercise of stock options of $0.8 million and there were no related tax benefits recognized during this period. Upon option exercise, we issue new shares of stock.

97


 

15. NET PRODUCT REVENUE
Net product revenue was determined as follows:
                         
(In thousands of U.S. dollars)   2006   2005   2004
 
Visudyne® sales by Novartis Ophthalmics
  $ 353,759     $ 483,762     $ 448,277  
Less: Marketing and distribution costs
    (132,669 )     (142,244 )     (133,730 )
Less: Inventory costs
    (18,275 )     (24,060 )     (25,789 )
Less: Royalties to third parties
    (7,545 )     (10,699 )     (10,074 )
 
 
  $ 195,270     $ 306,759     $ 278,684  
 
 
                       
QLT’s 50% share of Novartis Ophthalmics’ net proceeds from Visudyne sales
  $ 97,635     $ 153,379     $ 139,342  
Add: Advance on inventory costs from Novartis Ophthalmics
    15,063       18,932       21,791  
Add: Royalties reimbursed to QLT
    7,622       10,431       10,074  
Add: Other costs reimbursed to QLT
    9,046       4,496       6,250  
 
Revenue from Visudyne® sales
  $ 129,366     $ 187,238     $ 177,457  
 
Net product revenue from Eligard®
    22,494       16,808       931  
 
 
  $ 151,860     $ 204,046     $ 178,388  
 
For the year ended December 31, 2006, approximately 20% (2005 – 38%, 2004 – 47%) of total Visudyne sales were in the U.S., with Europe and other markets responsible for the remaining 80% (2004 – 62%, 2003 – 53%).
16. CONTRACT RESEARCH AND DEVELOPMENT
We received non-refundable research and development funding from our strategic partners, which was recorded as contract research and development revenue. Details of our contract research and development revenue were as follows:
                         
(In thousands of U.S. dollars)   2006   2005   2004
 
Visudyne® ocular programs
  $     $ 3,685     $ 3,633  
Aczoneprograms
          2,716        
Eligard® programs
    202       1,177        
Others
    953       1,673       396  
     
Contract research and development revenue
  $ 1,155     $ 9,251     $ 4,029  
     
17. RESTRUCTURING CHARGES
In the first quarter of 2005, we restructured our operations as a result of our acquisition of Atrix. We provided over 50 affected employees with severance and support to assist with outplacement (“First Restructuring”). As a result, we recorded $3.1 million of restructuring charges in 2005 related to severance and termination costs.
In December 2005, we restructured our operations in order to concentrate our resources on key product development programs and business initiatives (“Second Restructuring”). We provided approximately 100 affected employees with severance and support to assist with outplacement and recorded $5.0 million of restructuring charges. During the third quarter of 2006, we adjusted our restructuring accruals by an inconsequential amount to reflect current estimates related to this restructuring plan. We expect to complete final activities associated with this restructuring by early 2007.

98


 

On October 26, 2006, as a result of declining Visudyne sales, we announced plans to restructure our operations in order to reduce our overall cost structure going forward (“Third Restructuring”). We have provided or will be providing approximately 80 affected employees with severance and support to assist with outplacement. We recorded $3.0 million of restructuring charge in the fourth quarter of 2006. We expect to record additional restructuring charges in 2007 as we complete final activities associated with this restructuring. We anticipate paying most amounts by the end of 2007.
The details of our restructurings are as follows:
Severance and termination benefits accrued
                                 
    First   Second   Third    
(In thousands of U. S. dollars)   Restructuring   Restructuring   Restructuring   Total
 
Balance at December 31, 2005
  $ 227     $ 4,499     $     $ 4,726  
Restructuring charge
                2,879       2,879  
Adjustments
    (20 )     (240 )           (260 )
Cash payments
    (207 )     (3,573 )     (1,365 )     (5,145 )
 
Balance at December 31, 2006
  $     $ 686     $ 1,514     $ 2,200  
 
Other related expenses accrued
                                 
    First   Second   Third    
(In thousands of U. S. dollars)   Restructuring   Restructuring   Restructuring   Total
 
Balance at December 31, 2005
  $     $ 479     $     $ 479  
Restructuring charge
                164       164  
Adjustments
          45             45  
Cash payments
          (425 )     (80 )     (505 )
 
Balance at December 31, 2006
  $     $ 99     $ 84     $ 183  
 
Combined Total
                                 
    First   Second   Third    
(In thousands of U. S. dollars)   Restructuring   Restructuring   Restructuring   Total
 
Balance at December 31, 2005
  $ 227     $ 4,978     $     $ 5,205  
Restructuring charge
                3,043       3,043  
Adjustments
    (20 )     (195 )           (215 )
Cash payments
    (207 )     (3,998 )     (1,445 )     (5,650 )
 
Balance at December 31, 2006
  $     $ 785     $ 1,598     $ 2,383  
 

99


 

18. INCOME TAXES
Income (loss) before income taxes, discontinued operations and extraordinary gain was as follows:
                         
(In thousands of U.S. dollars)   2006   2005   2004
 
Canada
  $ 44,782     $ 88,421     $ 88,230  
United States and other
    (119,162 )     (409,082 )     (221,882 )
 
Loss before income taxes, discontinued operations and extraordinary gain
  $ (74,380 )   $ (320,661 )   $ (133,652 )
 
The components of the provision for income taxes were as follows:
                         
(In thousands of U.S. dollars)   2006   2005   2004
 
Canada
  $ 9,130     $ 27,661     $ 30,051  
United States and other
    (95 )     (34,838 )     (499 )
 
Provision for (recovery of) income taxes
  $ 9,035     $ (7,177 )   $ 29,552  
 
                         
(In thousands of U.S. dollars)   2006   2005   2004
 
Provision for current and deferred income taxes
  $ (35,295 )   $ (9,903 )   $ 28,669  
Increase in valuation allowance
    44,330       2,726       883  
 
Provision for (recovery of) income taxes
  $ 9,035     $ (7,177 )   $ 29,552  
 
                         
(In thousands of U.S. dollars)   2006   2005   2004
 
Current income taxes
  $ 19,427     $ 30,439     $ 9,346  
Deferred income taxes
    (10,392 )     (37,616 )     20,206  
 
Provision for (recovery of) income taxes
  $ 9,035     $ (7,177 )   $ 29,552  
 

100


 

Differences between our statutory income tax rates and our effective income tax rates applied to the pre-tax income consisted of the following:
                         
(In thousands of U.S. dollars)   2006   2005   2004
 
Loss before income taxes
  $ (74,380 )   $ (320,661 )   $ (121,135 )
Extraordinary gain
                (12,517 )
 
Loss before income taxes, discontinued operations and extraordinary gain
  $ (74,380 )   $ (320,661 )   $ (133,652 )
Canadian statutory tax rates
    34.12 %     34.86 %     35.62 %
 
Expected income tax (recovery) provision
  $ (25,378 )   $ (111,782 )   $ (47,607 )
Charge for goodwill impairment
          113,265        
Purchased in-process research and development
                82,264  
Increase in valuation allowance
    44,330       2,726       480  
Provincial tax credits on patent sourced income
    (4,582 )            
Foreign tax rate differences
    (3,498 )     (8,984 )     (3,186 )
Investment tax credits
    (1,685 )     (2,261 )     (2,378 )
Recovery of prior year taxes
    (1,576 )            
Stock Options
    1,318              
Future tax rate reductions
    481              
Deferred gain on sale of Photofrin®
                (341 )
Permanent differences and other
    (375 )     (141 )     320  
 
Provision for (recovery of) income taxes
  $ 9,035     $ (7,177 )   $ 29,552  
 
The tax effects of temporary differences that give rise to significant components of the deferred income tax assets and deferred income tax liabilities are presented below:

101


 

                 
(In thousands of U.S. dollars)   2006   2005
 
Deferred tax assets
               
Net operating loss carryforwards
  $ 51,563     $ 48,515  
Litigation settlement
    41,868        
Research & development tax credit carryforwards
    9,518       7,261  
Capital loss carryforwards
    6,302       6,450  
Depreciable and amortizable assets
    6,960       3,455  
Provincial tax credits on patent sourced income
    4,469        
Provision for non-completion of product inventory
    1,651       706  
Deferred Revenue
    1,457       1,776  
Unpaid employee compensation
    511       44  
Other temporary differences
    886       637  
 
Total gross deferred income tax assets
  $ 125,185     $ 68,844  
Less: valuation allowance
    (106,690 )     (58,771 )
 
Total deferred income tax assets
  $ 18,495     $ 10,073  
Less: current portion
    (8,657 )     (2,480 )
 
Net long-term portion of deferred income tax assets
  $ 9,838     $ 7,593  
 
               
Deferred tax liabilities
               
Deferred tax liability associated with the tangible and intangible assets acquired in the acquisition of Atrix
  $ (89 )   $ (3,834 )
Unrealized foreign exchange gains
    (5,394 )     (5,532 )
Other temporary differences
          (434 )
 
Total deferred income tax liabilities
  $ (5,483 )   $ (9,800 )
 
 
               
Net deferred income tax (liabilities) assets
  $ 13,012     $ 273  
 
In 2006, a valuation allowance continues to be applied to our non-capital loss and research and development credit carryforwards to offset these respective deferred tax assets in recognition of the uncertainty that such tax benefits will be realized. There may be limitations on the utilization of our accumulated net operating losses and Federal and State tax credit carryforwards as a result of changes in control that have occurred. The bulk of our valuation allowance relates to the litigation settlement, acquired losses and U.S. post-acquisition losses.
At December 31, 2006, we had approximately $137.8 million of total operating loss carryforwards with approximately $129.8 million relating to our U.S. subsidiary and $8.0 million relating to other foreign losses. The loss carryforwards expire at various dates through 2026. We also had approximately $9.5 million of research and development credits available for carryforward of which approximately $5.6 million were generated by our U.S. subsidiary. The research and development credit carryforwards expire at various dates through 2026. We also had approximately $34.4 million of capital loss carryforwards of which approximately $32.2 million carryforward indefinitely and the remaining $2.2 million related to our U.S. subsidiary expire at various dates through 2010. The deferred tax benefit of these loss carryforwards and research and development credits is ultimately subject to final determination by taxation authorities. The increase in the deferred income tax asset associated with depreciable and amortizable assets is primarily a result of the recognition of the component of prior years deferred income tax associated with the depreciable and amortizable assets that were sold as part of the divestiture of our generic

102


 

dermatology and dental businesses and related manufacturing facility (See Note 19 in “Notes to the Consolidated Financial Statements”). The provincial tax credits on patent source income of approximately $4.5 million are a result of new tax legislation in the province of British Columbia which became effective January 1, 2006. The new legislation results in a reduction of our Canadian corporate provincial income tax that is attributed to income derived from certain patents. The deferred tax asset of $41.9 million arose under the terms of the settlement agreement (See Note 23 in “Notes to the Consolidated Financial Statements”) between Sanofi-Synthelabo and TAP Pharmaceutical Products Inc. and its co-plaintiffs.
As part of the 2004 purchase price accounting for the acquisition of Atrix, some of the intangible and tangible assets were required to be written-up by virtue of generally accepted accounting principles that were applicable to the acquisition. The accounting write-up resulted in a deferred income tax liability associated with property, plant and equipment, trademarks, and developed technology that were amortized over a period of 5, 16, and 17 years, respectively, and an inventory write-up that is recognized in cost of sales as the related products are sold. The reduction in the deferred tax liability is largely a result of the sale of the intangible assets associated with the divestiture of our generic dermatology and dental businesses and related manufacturing facility (See Note 19 in “Notes to the Consolidated Financial Statements”).
The increase in our valuation allowance in 2006 was largely the result of the litigation settlement, accumulated U.S. tax losses and tax credits that we cannot benefit. The valuation allowance is reviewed periodically and if the assessment of the “more likely than not” criterion changes, the valuation allowance is adjusted accordingly.
In 2005, the combined Canadian Federal and Provincial statutory income tax rate was reduced on a pro-rata basis from 35.62% to 34.12%, yielding an annual statutory rate of 34.86% in 2005 and 34.12% in 2006.
19. DISCONTINUED OPERATIONS
In December 2006, QLT USA completed the sale of its generic dermatology and dental businesses and related manufacturing facility located in Fort Collins, Colorado to Tolmar Inc., a private pharmaceutical company. The purchase price was $21.0 million and was paid in full, subject to the release from escrow in early 2008 of a 10% holdback. We recognized a loss, net of tax, of $8.0 million related to this transaction. The assets sold included $17.1 million of fixed assets, $4.9 million of intangible assets, $3.0 million of inventory and $5.3 million of goodwill allocated in accordance with SFAS 142, Goodwill and Other Intangibles. The gross proceeds of $21.0 million and the related loss exclude $1.0 million of contingent consideration payable based on future commercial orders for Aczone, if Aczone is being produced by Tolmar Inc. in the Fort Collins manufacturing facility. The loss also excludes any other final purchase price adjustments related to working capital that may be made in the future and are currently under review. The divestiture of these assets is consistent with our strategy of concentrating our resources on the research and development of proprietary products in our core therapeutic areas. Approximately 140 employees have been or will be transitioned to the purchaser as part of the divestiture of this business. Eligard will continue to be manufactured at the Fort Collins manufacturing facility under the terms of a supply agreement between QLT USA and Tolmar.
In accordance with SFAS No. 144, “Accounting for the Impairment or Disposal of Long-lived Assets”, the results of operations and the loss on disposal of the generic dermatology and dental businesses had been excluded from continuing operations and reported as discontinued operations for the current and prior periods. Furthermore, the assets included as part of this divestiture had been reclassified as held for sale in the Consolidated Balance Sheet for prior periods. During the third quarter of 2006, we recorded a write-down of $8.6 million to our assets held for sale as a result of the failure to receive regulatory approval for a late stage generic dermatology product and a launch delay for another product. For the year ended December 31, 2006, we recorded a loss from discontinued operations, net of income taxes, of $18.2 million compared to a loss of $11.9 million for the same period in 2005, due to the loss recorded on disposal, impairment and other charges related to the failure to receive approval for a late stage product offset by increased sales of generic dermatology products and the cessation of depreciation and amortization on assets held for sale.
The significant components of our results from discontinued operations, net of income taxes, for 2006, 2005 and 2004 are as follows:

103


 

                         
(In thousands of U.S. dollars)   2006     2005     2004  
 
Net revenue
  $ 15,077     $ 12,136     $ 1,317  
 
 
                       
Write-down of assets held for sale
  $ (8,592 )            
 
 
                       
Pretax losses
  $ (11,322 )   $ (16,157 )   $ (15,126 )
Income taxes
    1,093       4,229       104  
 
 
    (10,229 )     (11,928 )     (15,022 )
 
                       
Loss on disposal
  $ (10,488 )            
Income tax on disposal
    2,527              
 
Net loss from discontinued operations
  $ (18,190 )   $ (11,928 )   $ (15,022 )
 
20. FINANCIAL INSTRUMENTS AND CONCENTRATION OF CREDIT RISK
As at December 31, 2006 and December 31, 2005, the carrying amounts for our cash and cash equivalents, short-term investment securities, restricted cash, accounts receivable, and accounts payable approximated fair value due to the short-term maturity of these financial instruments. In 2006, we designated a portion of our short-term investments as trading securities. As at December 31, 2006, $1.8 million of unrealized gains related to outstanding trading securities were included in earnings. Our long-term debt comprises $172.5 million aggregate principal amount of convertible senior notes which had a fair value of $161.2 million as of December 31, 2006 as published by an independent financial markets information provider. These notes are not listed on any securities exchange or included in any automated quotation system. The published value may not be reliable as the amounts cannot be independently verified and not all trades are reflected.
With respect to the concentration of credit risk, our accounts receivable, as at December 31, 2006 and December 31, 2005, are comprised primarily of amounts owing from Novartis Pharma AG.
We purchased goods and services primarily in Canadian (“CAD”) and U.S. dollars (“USD”), and earned most of our revenues in Euros (“EUR”) and USD. We entered into foreign exchange contracts to manage exposure to currency rate fluctuations related to our expected future net income (primarily in EUR and USD) and cash flows (in USD and Swiss francs (“CHF”)). We are exposed to credit risk in the event of non-performance by counterparties in connection with these foreign exchange contracts. We mitigate this risk by transacting with a diverse group of financially sound counterparties and, accordingly, do not anticipate loss for non-performance. Foreign exchange risk is also managed by satisfying foreign denominated expenditures with cash flows or assets denominated in the same currency. The net unrealized loss in respect of such foreign currency contracts, as at December 31, 2006, was approximately $1.2 million, which was included in our results of operations. At December 31, 2006, we had outstanding forward foreign currency contracts as noted below.
                 
    Maturity Period   Quantity (millions)   Average Price
 
U.S. / Canadian dollar option-dated forward contracts to sell USD
    2007     USD 1.0   1.34014 per USD
Swiss franc / Canadian dollar option-dated forward contract to sell CHF
    2007     CHF 29.7   0.90587 per CHF
 
21. COMMITMENTS AND GUARANTEES
In the normal course of business, we enter into product supply agreements with contract manufacturers, which expire at various dates to 2009 and total $41.2 million, as well as other purchase commitments related to daily operations. In addition, we have entered into operating lease agreements related to office equipment and office

104


 

space. Estimated operating lease payments are $0.6 million in 2007, $0.4 million in 2008, and $0.2 million in 2009. The minimum annual commitment related to these agreements payable over the next five years is as follows:
         
(In thousands of U.S. dollars)        
Year ending December 31,
       
2007
  $ 29,989  
2008
    13,713  
2009
    1,171  
2010
    194  
2011
    145  
In the course of our business, we regularly provide indemnities with respect to certain matters, including product liability, patent infringement, contractual breaches and misrepresentations, and other indemnities to third parties under the clinical trial, license, service, manufacturing, supply, distribution and other agreements that we enter into in the normal course of our business. As at December 31, 2006, no amount has been accrued related to indemnities.
22. SEGMENTED INFORMATION
We operate in one industry segment, which is the business of developing, manufacturing, and commercializing therapeutics for human health care. Our chief operating decision makers review our operating results on an aggregate basis and manage our operations as a single operating segment. Our segment information does not include the results of businesses classified as discontinued operations.
Details of our revenues by category are as follows:
Revenues
                         
(In thousands of U.S. dollars)   2006     2005     2004  
 
Visudyne®
  $ 129,366     $ 187,238     $ 177,457  
Eligard®
    42,324       31,588       3,270  
Other
    1,269       1,036        
Contract research and development
    1,155       9,251       4,028  
Licensing and Milestones
    976       724        
 
 
  $ 175,090     $ 229,837     $ 184,755  
 

105


 

Details of our revenues and property, plant and equipment by geographic segments are as follows:
Revenues1
                         
(In thousands of U.S. dollars)   2006     2005     2004  
 
U.S.
  $ 54,776     $ 102,967     $ 99,356  
Europe
    83,321       87,852       65,800  
Canada
    17,438       16,171       10,149  
Other
    19,555       22,847       9,450  
 
 
  $ 175,090     $ 229,837     $ 184,755  
 
Property, plant and equipment
                 
(In thousands of U.S. dollars)   2006     2005  
 
Canada
  $ 45,634     $ 48,379  
U.S.
    4,863       4,418  
 
 
  $ 50,497     $ 52,797  
 
(1)  Revenues are attributable to a geographic segment based on the location of: (a) the customer, for net revenue and royalties; and (b) the head office of the collaborative partner, in the case of revenues from contract research and development and collaborative arrangements.
23. CONTINGENCIES
(a) Eligard Patent Litigation
United States Patent Litigation
In 2003, plaintiffs TAP Pharmaceutical Products, Inc., Takeda Chemical Industries Ltd. and Wako Pure Chemical Industries, Ltd. filed suit against QLT USA, Inc. and co-defendant Sanofi-Synthelabo, Inc. in the U.S. federal court in the Northern District of Illinois Eastern Division (Case No. 1:03-CV-7822). TAP and its co-plaintiffs alleged that QLT USA and Sanofi-Synthelabo willfully infringed U.S. Patent No. 4,728,721 (the “‘721 patent”) by the manufacture and sale in the United States of the Eligard® product line and sought injunctive relief, damages, and an award of attorneys’ fees and costs against QLT USA and Sanofi-Synthelabo (the “TAP Litigation”).
On February 9, 2007, QLT USA, Inc. entered into a Settlement, Release and Patent License to settle the litigation captioned “TAP Pharmaceutical Products Inc., Takeda Chemical Industries, Ltd. and Wako Pure Chemical Industries, Ltd. v. Atrix Laboratories, Inc. and Sanofi-Synthelabo Inc.”, No. 03-C-7822, in the United States District Court for the Northern District of Illinois and the appeal pending therefrom in the United States Court of Appeals for the Federal Circuit. QLT USA, Sanofi-Synthelabo, Takeda Chemical Industries, Ltd. (“Takeda”), Wako Pure Chemical Industries, Ltd. (“Wako”), TAP Pharmaceutical Products Inc. (“TAP”) and Abbot Laboratories, Ltd. (“Abbot”) were parties to the settlement agreement. The settlement resolved that litigation initiated by TAP and its co-plaintiffs regarding U.S. patent no. 4,728,721.
Under the terms of the settlement agreement, and without admitting liability, QLT USA paid TAP $112.5 million and Sanofi-Synthelabo paid TAP $45.0 million, for an aggregate settlement amount of $157.5 million. The settlement agreement provides that TAP and its co-plaintiffs will release their claims made in the United States litigation against QLT USA and Sanofi-Synthelabo and each of TAP, Takeda, Wako and Abbott will grant QLT USA a transferable, non-exclusive, perpetual, royalty-free license under any of their past and future patents to make, use and sell QLT USA’s currently-marketed Eligard® products in the United States and Canada. The District Court

106


 

and the Court of Appeals entered orders dismissing the respective litigation on February 15, 2007 and February 12, 2007, respectively.
In connection with the settlement agreement, on February 9, 2007, QLT USA and Sanofi-Synthelabo entered into an amended and restated Contribution Agreement to provide for, among other things, the dollar amount each party has agreed to contribute under the settlement agreement.
As a result of this settlement, we will record a charge of US$112.5 million in our consolidated 2006 results. As of December 31, 2006, before payment of the settlement amount, our consolidated total cash, short-term investments, long-term investments and escrowed funds was approximately $378 million.
Germany Patent Litigation
On June 1, 2004, QLT USA’s Eligard marketing licensee for Eligard, MediGene AG, filed an action in the Federal Patent Court, Munich, Germany, seeking nullification of the European counterpart to the ‘721 patent, European Patent 0 202 065 (the “’065 patent”). The ‘065 patent expired on May 6, 2006.
On June 21, 2004, Takeda Chemical Industries Ltd., Wako Pure Chemical Industries, Ltd. and Takeda Pharma GmbH sought a provisional injunction in the Regional Court Hamburg, Germany, alleging that the marketing of Eligard by MediGene and its licensee Yamanouchi (now Astellas) in Germany violated the ‘065 patent. The Court denied that request.
On June 28, 2004, the Takeda companies and Wako filed a complaint in the Regional Court Düsseldorf, Germany, against MediGene and Yamanouchi, alleging infringement of the ‘065 patent.
In April 2005, in the suit initiated by MediGene, the Federal Patent Court ruled that all of the patent claims asserted by the Takeda companies and Wako in their subsequent infringement suit are null and void in Germany for lack of novelty and lack of inventive step. Takeda and Wako have appealed that decision. The Regional Court Düsseldorf has stayed the infringement action brought by Takeda and Wako in view of the Federal Patent Court’s decision. The German lawsuits relating to the ‘065 patent were not resolved by the settlement agreement reached in connection with the ‘721 lawsuit in the United States.
Under agreements QLT USA entered into with MediGene and Yamanouchi, QLT USA has provided certain indemnities to MediGene and Yamanouchi including indemnities covering certain losses relating to infringement of a third party’s proprietary rights on and subject to the terms of that agreement.
(b) Patent Litigation with MEEI
The First MEEI Lawsuit
In April 2000, Massachusetts Eye and Ear Infirmary (“MEEI”) filed a civil suit against QLT Inc. in the United States District Court (the “Court”) for the District of Massachusetts seeking to establish exclusive rights for MEEI as the owner of certain inventions relating to the use of verteporfin (the active pharmaceutical ingredient in Visudyne®) as the photoactive agent in the treatment of certain eye diseases including AMD.
In 2002, we moved for summary judgement against MEEI on all eight counts of MEEI’s complaint in Civil Action No. 00-10783-JLT. The Court granted our motion, dismissing all of MEEI’s claims. With respect to our counterclaim requesting correction of inventorship of U.S. Patent No. 5,789,349 (the "‘349 patent”) to add an additional Massachusetts General Hospital (“MGH”) inventor, the Court stayed the claim pending the outcome of the trial described below.
MEEI appealed the decision of the Court to the U.S. Court of Appeals for the First Circuit. In a decision dated June 15, 2005, the Court of Appeals upheld the dismissal of five of MEEI’s eight claims and remanded to the district court for further proceedings concerning three of MEEI’s claims (unjust enrichment, unfair trade practices and misappropriation of trade secrets). In February 2006, we filed a Petition for Writ of Certiorari in the United States Supreme Court asserting that MEEI’s claim for unjust enrichment is preempted by federal patent law. The Court of Appeals stayed its remand to the district court pending the resolution of our Petition by the Supreme Court. In May

107


 

2006, the Supreme Court denied our Petition, and MEEI’s three remaining claims were then remanded to the district court for further proceedings.
On November 6, 2006, a federal jury found QLT liable under Massachusetts state law for unjust enrichment and unfair trade practices and determined that we should pay to MEEI a royalty of 3.01% on net sales of Visudyne worldwide. It remains for the court to determine whether this relates to future sales, or past and future sales of Visudyne. The trial judge will now consider post-trial motions including whether the decision of the jury is of an advisory nature only or whether the judge will make his determination of liability and damages, if any. From the time Visudyne was launched in 2000 to December 31, 2006, net sales of Visudyne have totaled approximately $2.3 billion worldwide. The jury determined that the unfair trade practices were not committed knowingly or willfully and therefore declined to award enhanced damages. Any award may include interest at court imposed rates and MEEI’s attorneys’ fees. We have filed post-trial motions addressing the effect of the jury’s verdict and to continue to vigorously pursue the defense of this case. It is uncertain when final judgment will be entered.
The Second MEEI Lawsuit
In May 2001 the United States Patent Office issued United States Patent No. 6,225,303 (the “’303 Patent”) to MEEI. The ‘303 Patent is derived from the same patent family as the Patent in issue in the first suit, the ‘349 patent, and claims a method of treating unwanted choroidal neovasculature in a shortened treatment time using verteporfin (the active pharmaceutical ingredient in Visudyne®). The patent application which led to the issuance of the ‘303 patent was filed and prosecuted by attorneys for MEEI and, in contrast to the ’349 patent, named only MEEI researchers as inventors.
In May 2001, MEEI filed suit against us and Novartis Ophthalmics, Inc. in the United States District Court for the District of Massachusetts alleging infringement of the ‘303 Patent (Civil Action No. 01-10747-EFH). The suit seeks damages and injunctive relief for patent infringement. We denied the complaint raised a number of affirmative defenses, including incorrect inventorship, and asserted counterclaims against MEEI and the two MEEI researchers who are named as inventors on the ‘303 patent. In addition, MGH intervened in the case requesting correction of inventorship on the ‘303 Patent to add three MGH scientists and one QLT scientist as joint inventors of the claimed inventions.
In 2004, we and MGH moved to correct inventorship on the ‘303 Patent. In January 2005, the Court granted partial summary judgement ordering that the ‘303 Patent be corrected to add QLT’s scientist as a joint inventor. Because the Court’s partial ruling made QLT a co-owner of the patent, the Court dismissed MEEI’s complaint for infringement. MEEI appealed that decision to the Court of Appeals for the Federal Circuit. In early October, 2006, the Court of Appeals for the Federal Circuit overturned that summary judgement on the basis that there were issues of fact that remain to be determined. The case has been remanded to the district court.
The ‘349 patent is co-owned by QLT, MGH and MEEI. QLT entered into an exclusive license with MGH for its rights under the ‘349 patent in return for a royalty equal to 0.5% of net sales of Visudyne in the United States and Canada. Under the license agreement with MGH, if QLT concludes a license agreement with MEEI for rights under the ‘349 patent and continuation patents which includes payment of royalties and other compensation to MEEI that are more favorable than are contained in the license agreement with MGH, then as of the effective date of such more favorable royalties or compensation to MEEI, the license agreement with MGH shall be revised to the same rate as paid under the agreement with MEEI.
(c) Effect of the German Eligard Patent Litigation and MEEI Litigation
The final outcome of the German Eligard patent litigation and MEEI litigation is not presently determinable or estimable and accordingly, no amounts have been accrued. There can be no assurance that the matters will finally be resolved in favor of QLT USA’s German licensees of Eligard or in our favor. If the German Eligard patent litigation is not resolved favorably, QLT USA’s German licensees could be found liable for damages and those licensees may attempt to assert a claim against QLT USA for indemnification of all or part of such damages. If the MEEI litigation is not resolved favorably, QLT could be liable for damages. While we cannot estimate the potential damages in the German Eligard patent litigation and MEEI litigation, or what level of indemnification by QLT USA, if any, will be required in connection with the German Eligard patent litigation under the agreements with its German licensees, MediGene and Yamanouchi (now Astellas), the amount of damages and indemnification could be substantial, which could have a material adverse impact on our financial condition. Alternatively, the German Eligard patent litigation and/or MEEI litigation could be resolved favorably or could be settled. An outcome could materially affect the market price of our shares, either positively or negatively. We will continue to aggressively pursue the defense of the German Eligard patent litigation and MEEI litigation, and potential settlement discussions.

108


 

24. RECONCILIATION FROM U.S. GAAP TO CANADIAN GAAP
Canadian securities regulations allow issuers that are required to file reports with the United States Securities & Exchange Commission, or SEC, upon meeting certain conditions, to satisfy their Canadian continuous disclosure obligations by using financial statements prepared in accordance with U.S. GAAP. Accordingly, for annual and interim periods in fiscal 2005 and 2006, we will include in the notes to our consolidated financial statements a reconciliation highlighting the material differences between our financial statements prepared in accordance with U.S. GAAP as compared to financial statements prepared in accordance with accounting principles generally accepted in Canada (“Canadian GAAP”). Subsequent to 2006, no further interim reconciliation will be required under current Canadian securities regulations. Prior to 2005, we prepared annual and interim financial statements (with accompanying notes) and Management’s Discussion and Analysis - Canadian Supplement in accordance with Canadian GAAP, all of which were presented as a separate report and filed with the relevant Canadian securities regulators in compliance with our Canadian continuous disclosure obligations.
Our annual consolidated financial statements have been prepared in accordance with U.S. GAAP and the accounting rules and regulations of the SEC which differ in certain material respects from those principles and practices that we would have followed had our consolidated financial statements been prepared in accordance with Canadian GAAP. The following is a reconciliation of our net (loss) income as reported under U.S. GAAP and our net (loss) income reported in accordance with Canadian GAAP for the years ended December 31, 2006, 2005, and 2004.

109


 

                         
Years ended December 31,   2006   2005   2004
 
(In thousands of U.S. dollars, except per share amounts)                        
 
Net loss, U.S. GAAP
  $ (101,605 )   $ (325,412 )   $ (165,709 )
Stock-based compensation charge (a)
          (7,071 )     (11,233 )
Purchase of in-process research and development (b)
                222,000  
Amortization of in-process research and development (b)
    (4,457 )     (13,059 )     (1,486 )
FIT recovery on amortization of in-process research and development (b)
    1,694       4,962       566  
Imputed interest on convertible debt (c)
    (8,018 )     (7,437 )     (7,073 )
Unrealized foreign exchange gain (loss) on convertible debt (c)
    1,303       292       (1,387 )
License and option fees (d)
    1,910              
Amortization of license and option fees (d)
    (76 )            
Goodwill impairment charge (e)
          (174,963 )      
(Provision for) recovery of income taxes on above items (b), (f)
    (1,420 )     48,308       655  
(Loss) income from discontinued operations, net of income taxes (l)
    (9,968 )     (6,469 )     13,941  
     
Net (loss) income, Canadian GAAP
  $ (120,637 )   $ (480,849 )   $ 50,274  
     
 
                       
Basic net (loss) income per common share, Canadian GAAP
                       
(Loss) income before discontinued operations and extraordinary gain
  $ (1.09 )   $ (4.99 )   $ 0.53  
Discontinued operations
    (0.33 )     (0.20 )     (0.01 )
Extraordinary gain
                0.17  
     
Net (loss) income
  $ (1.43 )   $ (5.19 )   $ 0.69  
 
                       
Diluted net income per common share, Canadian GAAP
                       
(Loss) income before discontinued operations and extraordinary gain
  $ (1.09 )   $ (4.99 )   $ 0.52  
Discontinued operations
    (0.33 )     (0.20 )     (0.01 )
Extraordinary gain
                0.17  
     
Net (loss) income
  $ (1.43 )   $ (5.19 )   $ 0.68  
 
                       
Weighted average number of common shares outstanding (in thousands)
                       
Basic
    84,596       92,637       73,240  
Diluted
    84,596       92,637       73,771  
The following is a reconciliation of our balance sheet information as reported in U.S. GAAP and our balance sheet information computed in accordance with Canadian GAAP as of December 31, 2006 and December 31, 2005.

110


 

                 
As at December 31,  
2006
 
2005
(In thousands of United States dollars)                
Total assets under U.S. GAAP
  $ 639,107     $ 776,494  
Short-term investments (g)
          137  
Future income tax assets (f)
    (1,166 )      
Intangibles, net (b), (d)
    69,641       83,880  
Goodwill (b), (e)
    40,067       41,923  
Other long-term assets (g)
    14       313  
 
Total assets under Canadian GAAP
  $ 747,663     $ 902,747  
 
 
               
Total liabilities under U.S. GAAP
    335,893       250,383  
Future income tax liabilities (b), (f)
    24,845       31,289  
Long-term debt (c)
    (11,258 )     (17,848 )
 
Total liabilities under Canadian GAAP
  $ 349,480     $ 263,824  
 
 
               
Total shareholders’ equity under U.S. GAAP
  $ 303,214     $ 526,111  
Common shares (a), (h), (i)
    (2,434 )     (2,434 )
Contributed surplus (a)
    58,938       59,000  
Equity component of convertible debt (c)
    33,500       33,500  
(Deficit) Retained earnings (j)
    (739 )     16,758  
Cumulative translation adjustment (g), (k)
    5,704       5,988  
 
Total shareholder’s equity under Canadian GAAP
  $ 398,183     $ 638,923  
 
(a)   Effective January 1, 2004, we adopted the fair value method of accounting for all employee and non-employee stock-based compensation for Canadian GAAP purposes on a retroactive basis, without restatement of prior periods. Compensation expense is recorded for stock options issued to employees using the fair value method. Under U.S. GAAP, we adopted SFAS 123R for stock options granted to employees and directors on January 1, 2006, using the modified prospective method, resulting in no material difference between U.S. GAAP and Canadian GAAP for the year ended December 31, 2006.
 
(b)   Under Canadian GAAP, acquired in-process research and development (“IPR&D”) projects are recorded as an intangible asset and amortized over their useful life. On November 19, 2004, we acquired IPR&D of $236.0 million through the acquisition of Atrix Laboratories, Inc. Accordingly, this amount was capitalized for Canadian GAAP purposes and is being amortized using the straight-line method over its useful life of seventeen years. As a result of book-tax basis differences attributable to IPR&D, an additional deferred tax liability of $89.7 million was recorded. During the year ended December 31, 2006, the future income tax liability was adjusted by $1.7 million for Canadian GAAP purposes to reflect the reduction in the temporary difference due to the amortization of the IPR&D. Under U.S. GAAP, IPR&D is expensed at time of acquisition. As a result of the impairment charge during 2005, amortization of IPR&D was lower for the year ended December 31, 2006. In addition, the future income tax liability was reduced by $91.8 million under Canadian GAAP ($39.9 million under U.S. GAAP). See note (e) for further discussion on the impairment charge.
 
(c)   In 2003, we completed a private placement of $172.5 million aggregate principal amount of convertible senior notes. Under Canadian GAAP, an amount of $33.5 million, representing the estimated value of the right of conversion, was allocated to the shareholders’ equity as the equity component of the convertible debt. Furthermore, with bifurcation, accretion expense is recorded as interest expense under Canadian GAAP. Under U.S. GAAP, bifurcation of debt is not required. In addition, foreign exchange gains/losses are calculated for the full face value of the debt under U.S. GAAP, and calculated only on the liability component under Canadian GAAP.
 
(d)   During the year ended December 31, 2006, we acquired certain license and option rights. Under U.S. GAAP, technology licenses and options may not have alternative future uses and were therefore expensed as research

111


 

    and development costs. Under Canadian GAAP, the license and option rights were capitalized as intangibles and are amortized over their useful lives of 17 — 18 years.
 
(e)   As a result of our 2005 impairment tests for goodwill and other intangibles we recorded, under U.S. and Canadian GAAP, non-cash impairment charges of $410.5 million and $594.9 million, respectively. The charge reduced the Canadian GAAP carrying amount of goodwill to $145.9 million. Under U.S. GAAP, as explained in (b) above, we expensed IPR&D at the time of acquisition which had the effect of lowering the carrying value of the assets we acquired from Atrix as compared to Canadian GAAP. Under Canadian GAAP, as explained in (b) above, we capitalized IPR&D at the time of acquisition, which increased the carrying value of the assets we acquired from Atrix as compared to US GAAP. With the higher carrying value, impairment of goodwill and other intangibles was higher under Canadian GAAP than under US GAAP. There was no impairment in 2006.
 
(f)   The differences between Canadian GAAP and U.S. GAAP assets and liabilities resulted in different deferred tax assets and deferred tax liabilities under the respective GAAP’s. Furthermore, investment tax credits are calculated using different formulas for Canadian and U.S. GAAP purposes due to different forecasted earnings under the respective GAAP’s. Under U.S. GAAP, the benefits of investment tax credits are recorded as part of the tax provision. Under Canadian GAAP, such tax credits are classified against the expenditure to which they relate, which is research and development.
 
(g)   We hold certain investments which under Canadian GAAP are recorded at historical costs adjusted for permanent impairment. Under U.S. GAAP they are recorded as available-for-sale securities. Such securities are required to be marked to market, with unrealized holding gains and losses recorded in other comprehensive income.
 
(h)   Under Canadian GAAP, beneficial conversion features attached to certain historical preferred shares were not included in share capital. Under U.S. GAAP, in prior years, a beneficial conversion feature attached to certain preferred shares was accreted as a return to the preferred shareholders. This resulted in an increase in the stated amount of historical share capital.
 
(i)   In 2000 and 2001, we accelerated the vesting of certain employee stock options as part of their severance. Under U.S. GAAP we recorded compensation expense and additional paid in capital in shareholders’ equity equal to the intrinsic value of the options and under Canadian GAAP there was no charge recorded.
 
(j)   Certain adjustments to retained earnings are required to account for the accumulated historical differences between Canadian GAAP and U.S. GAAP as discussed in the other parts of this note.
 
(k)   The cumulative translation adjustment resulting from the translation of our Canadian functional currency financial statements into U.S. dollar for reporting purposes differs between Canadian GAAP and U.S. GAAP due to the difference in the value of our assets and liabilities under the respective GAAP’s.
 
(l)   Under Canadian GAAP, acquired in-process research and development (“IPR&D”) projects are recorded as an intangible asset and amortized over their useful life. Generic dermatology IPR&D projects were sold as part of the QLT USA sale of its generic dermatology and dental businesses and related manufacturing facility. As a result, we included $8.0 million of generic dermatology IPR&D, net of tax, in our loss from discontinued operations. Due to the difference in carrying value of goodwill under Canadian GAAP (refer to note (e) above), we allocated an additional $1.9 million of goodwill to loss from discontinued operations.
 
(m)   Recent accounting policy developments include the following:
(i) Comprehensive Income
Commencing with our 2007 fiscal year, the new recommendations of the Canadian Institute of Chartered Accountants (“CICA”) for accounting for comprehensive income (CICA Handbook Section 1530), for the recognition and measurement of financial instruments (CICA Handbook Section 3855) and for hedges (CICA Handbook Section 3865) will apply. The transitional rules for these sections require implementation at the beginning of a fiscal year; and we have not implemented these sections in our 2006 fiscal year. The concept of comprehensive income for purposes of Canadian GAAP will be to include changes in shareholders’ equity arising from unrealized changes in the values of financial instruments.
(ii) Non-Monetary Transactions
The new recommendation of CICA Handbook Section 3831 is applicable commencing in fiscal 2006. The amended recommendations will result in non-monetary transactions normally being measured at fair values, and at carrying values when certain criteria are met. The adoption of CICA Handbook Section 3831 did not have a material impact on our results of operations.

112


 

Item 9. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE
     None.
Item 9A. CONTROLS AND PROCEDURES
Disclosure Controls and Procedures
The Company maintains a set of disclosure controls and procedures designed to ensure that information required to be disclosed in filings made pursuant to the Securities Exchange Act of 1934 is recorded, processed, summarized and reported within the time periods specified and in accordance with the Securities and Exchange Commission’s rules and forms and is accumulated and communicated to management, including the Chief Executive Officer and Chief Financial Officer. The Company’s principal executive and financial officers have evaluated the Company’s disclosure controls and procedures as of the end of the period covered by this report and concluded that the Company’s disclosure controls and procedures were effective.
It should be noted that the design of any system of controls is based in part upon certain assumptions about the likelihood of future events, and there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions, regardless of how remote. However, our Chief Executive Officer and Chief Financial Officer have concluded that our disclosure controls and procedures are effective under circumstances where our disclosure controls and procedures should reasonably be expected to operate effectively.
Management’s Report on Internal Control over Financial Reporting
Our management is responsible for establishing and maintaining adequate internal controls over financial reporting, as that term is defined in Exchange Act Rule 13a-15(f). Management’s report on our internal controls over financial reporting is included at Item 8 of this Annual Report.
No change was made to our internal controls over financial reporting during the fiscal quarter ended December 31, 2006 that has materially affected, or is reasonably likely to materially affect, such internal controls over financial reporting.
Item 9B. OTHER INFORMATION
     None

113


 

PART III
The Information required by Items 10 through 14 of Part III of this Annual Report on Form 10-K are incorporated by reference from the proxy statement for use in connection with the Company’s Annual Meeting of Shareholders to be held on May 17, 2007.
Item 10. DIRECTORS AND EXECUTIVE OFFICERS OF THE REGISTRANT
The information required for this Item is incorporated by reference from the information set forth under the headings “Director Nomination Process,” “Audited Consolidated Financial Statements and Additional Information,” “Audit and Risk Committee,” “Section 16(a) Beneficial Ownership Reporting Compliance,” “Corporate Code of Ethics and Code of Exemplary Conduct,” “Election of Directors” and “Information Concerning Board Committees” in our definitive proxy statement for our annual meeting of shareholders to be held on May 17, 2007.
We have a code of ethics and code of exemplary conduct for senior financial officers that applies to our principal executive officer, all senior financial managers, including the principal financial and accounting officer, our treasurer and controller, our Vice President of investor relations, internal legal counsel, our corporate secretary, and all other company officers. We also have a code of business conduct and ethics that applies to all of our employees. Information regarding our codes is available on our website at www.qltinc.com, and is incorporated by reference to the information set forth under the heading "Corporate Code of Ethics and Code of Exemplary Conduct" in our definitive proxy statement for our annual meeting of shareholders to be held on May 17, 2007. We intend to satisfy the disclosure requirements under Item 10 of Form 8-K regarding any amendment to, or a waiver from, a provision of our codes by posting such amendment or waiver on our website.
Item 11. EXECUTIVE COMPENSATION
The information required for this Item is incorporated by reference from the information set forth under the headings “Compensation of Non-Employee Directors,” “Equity-Based Compensation,” “Compensation Committee Interlocks and Insider Participation,” “Report of the Executive Compensation Committee,” “Executive Compensation,” “Summary Compensation Table,” “Grants of Plan Based Awards,” “Outstanding Equity Awards at Fiscal Year End,” “Option Exercises and Stock Vested,” “Potential Payments Upon Termination or Change-in-Control,” “Option Grants in Last Fiscal Year” and “Aggregated Option Exercises in Last Fiscal Year and Fiscal Year-End Option Values” in our definitive proxy statement for our annual meeting of shareholders to be held on May 17, 2007.
Item 12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT
Equity Compensation Plan Information
The following table sets out information regarding our common stock that may be issued upon the exercise of options, warrants and other rights granted to employees, consultants or directors under all of our existing equity compensation plans, as of December 31, 2006:
                         
    (a)   (b)   (c)
                    Number of securities
    Number of           remaining available
    Securities to be           for issuance under
    issued upon exercise   Weighted average   equity compensation
    of outstanding   exercise price of   plans (excluding
    options, warrants   outstanding options,   securities reflected
PLAN CATEGORY   and rights   warrants and rights   in column (a))
 
Equity compensation plans approved by security holders
    4,066,022 (1)   CAD $13.87     2,675,542  
Equity compensation plans approved by security holders
    3,000,156 (1)   USD $12.31     2,481,213  
Equity compensation plans not approved by security holders(2)
                 
 
Total
    7,066,178               5,156,755  
 

114


 

 
(1)   We currently maintain four equity compensation plans that have been approved by shareholders which provide for the issuance of common stock to employees, officers and directors. These four equity compensation plans are designated as the 1998 Incentive Stock Option Plan, the 2000 Incentive Stock Option Plan, the 1987 Atrix Performance Stock Option Plan and the 2000 Atrix Performance Stock Option Plan. No further Company securities remain available for issuance under either the 1998 Stock Option Plan or the 1987 Atrix Performance Stock Option Plan, however, both Plans remain in effect for so long as options previously granted under these Plans remain outstanding.
 
(2)   We currently maintain one equity compensation plan that has not been approved by shareholders which provides for the issuance of common stock to certain outside consultants of the Company. This plan has been designated as the Non-Qualified Atrix Stock Option Plan. The Compensation Committee sets the option price and exercise terms granted under the Non-Qualified Atrix Stock Option Plan. The exercise price of all options granted under the Non-Qualified Atrix Stock Option Plan has been the closing market price at the time of the grant.
Other information required for this Item is incorporated by reference from the proxy statement for use in connection with the annual meeting of shareholders to be held on May 17, 2007.
Item 13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS
The information required for this Item is incorporated by reference from the information set forth under the headings “Indebtedness of Directors, Executive Officers and Senior Officers,” “Potential Payments Upon Termination or Change-In-Control,” “Interest of Certain Persons in Material Transactions” and “Information Concerning Board Committees” in our definitive proxy statement for use in connection with the annual meeting of shareholders to be held on May 17, 2007.
Item 14. PRINCIPAL ACCOUNTANTS’ FEES AND SERVICES
The information required for this Item is incorporated by reference from the information set forth under the heading “Appointment of Independent Auditors” in our definitive proxy statement for use in connection with the annual meeting of shareholders to be held on May 17, 2007.

115


 

PART IV
Item 15. EXHIBITS AND FINANCIAL STATEMENT SCHEDULES
Financial Statements
  (i)   The following financial statement documents are included as part of Item 8 to this Form 10-K.
Report of Independent Registered Chartered Accountants
Consolidated Balance Sheets
Consolidated Statements of Operations
Consolidated Statements of Cash Flows
Consolidated Statements of Changes in Shareholders’ Equity
Notes to the Consolidated Financial Statements
  (ii)   Schedules required by Article 12 of Regulation S-X:
Except for Schedule II – Valuation and Qualifying Accounts, all other schedules have been omitted because they are not applicable or not required, or because the required information is included in the consolidated financial statements or notes thereto.
Schedule II — Valuation and Qualifying Accounts for the Years ended December 31, 2006, 2005 and 2004.
Provision for non-completion of product inventory
(In thousands of U.S. dollars)
                                 
            Additions charged        
    Balance at   to costs and   Write-offs, and   Balance at end
Year   beginning of year   expenses   provision reduction   of year
 
2006
  $ 3,828     $ 2,738     $ 1,454     $ 5,112  
2005
    1,457       3,137       766       3,828  
2004
          3,655       2,198       1,457  
Reserve for inventory obsolescence
(In thousands of U.S. dollars)
                                 
            Additions charged        
    Balance at   to costs and   Write-offs, and   Balance at end
Year   beginning of year   expenses   provision reduction   of year
 
2006
  $ 1,452     $ 1,924     $ 3,376     $  
2005
          2,306       854       1,452  
2004
                       
Allowance for doubtful accounts
(In thousands of U.S. dollars)
                                 
            Additions charged        
    Balance at   to costs and   Write-offs, and   Balance at end
Year   beginning of year   expenses   provision reduction   of year
 
2006
  $ 673     $ 62     $ 610     $ 125  
2005
          683       10       673  
2004
                       
Deferred tax asset valuation allowance
(In thousands of U.S. dollars)
                                 
            Additions charged        
    Balance at   to costs and   Write-offs, and   Balance at end
Year   beginning of year   expenses   provision reduction   of year
 
2006
  $ 58,771     $ 49,731     $ 1,812     $ 106,690  
2005
    54,113       6,710       2,052       58,771  
2004
    1,654       52,843       384       54,113  

116


 

Exhibits Index
The exhibits listed below are filed as part of this Report. References under the caption “Location” to exhibits or other filings indicate that the exhibit or other filing has been filed, that the indexed exhibit and the exhibit referred to are the same and that the exhibit referred to is incorporated by reference. Management contracts and compensatory plans or arrangements filed as exhibits to this Report are identified by an asterisk. The Commission file number for our Exchange Act filings referenced below is 1-10524.
         
Exhibit   Description   Location
2.1
  Asset Purchase Agreement, dated December 20, 2006, by and among Tolmar, Inc., Dillford Company S.A. and QLT USA, Inc. (1)   Filed herewith
 
       
3.0
  Articles   Exhibit 3.2 to the Company’s Current Report on Form 8-K dated May 25, 2005 and filed with the Commission on June 1, 2005.
 
       
4.1
  Shareholder Rights Plan Agreement, as amended and restated, dated as of April 8, 2005, between QLT Inc. and ComputerShare Trust Company of Canada.   Exhibit 41 to the Company’s Current Report on Form 8-K dated April 8, 2005 and filed with the Commission on April 13, 2005.
 
       
4.2
  Registration Rights Agreement, as amended and restated, dated as of December 17, 2004 by and between QLT Inc., Elan International Services, Ltd., and Elan Pharmaceutical Investments III, Ltd.   Exhibit 4.2 to the Company’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2005.
 
       
10.1
  Agreement, dated April 8, 1982, between Dr. Julia Levy, Quadra Logic Technologies Inc. and the University of British Columbia.   Exhibit to the Company’s Registration Statement on Form F-1 (File No. 33-31222) filed with the Commission on September 25, 1989.
 
       
10.2
  Agreement, dated January 15, 1988, between Dr. David Dolphin, Quadra Logic Technologies Inc. and the University of British Columbia.   Exhibit to the Company’s Annual Report on Form 20-F for the year ended December 31, 1988.
 
       
10.3
  Royalty Adjustment and Stock Option Agreement dated August 10, 1989, between Quadra Logic Technologies Inc. and Dr. David Dolphin.   Exhibit to the Company’s Amendment No. 1 to the Registration Statement on Form F-1 dated November 6, 1989.
 
       
10.4
  Royalty Agreement, dated December 15, 1987, between Quadra Logic Technologies Inc. and Dr. David Dolphin.   Exhibit to the Company’s Amendment No. 1 to the Registration Statement on Form F-1 dated November 6, 1989.
 
       
10.5
  1998 QLT Incentive Stock Option Plan.   Exhibit 10.68 to the Company’s Annual Report on Form 10-K for the year ended December 31, 1998.
 
       
10.6*
  2000 QLT Incentive Stock Option Plan (as amended in 2002); (formerly numbered 10.70).   Exhibit to the Company’s Registration Statement on Form S-8 filed with the Commission on September 20, 2002.
 
       
10.7*
  Employment Agreement dated December 18, 2001 between QLT Inc. and Paul J. Hastings.   Exhibit 10.77 to the Company’s Annual Report on Form 10-K for the year ended December 31, 2002.
 
       
10.8*
  Employment Agreement dated May 19, 2000 between QLT Inc. and Alain Curaudeau.   Exhibit 10.80 to the Company’s Annual Report on Form 10-K for the year ended December 31, 2002.
 
       
10.9
  POT Development, Manufacturing and Distribution Agreement, dated July 1, 1994, between Quadra Logic Technologies Inc. and CIBA Vision AG, Hettlingen (now Novartis   Exhibit to the Company’s Annual Report on Form 10-K for the year ended December 31, 1995.

117


 

         
Exhibit   Description   Location
 
  Ophthalmics, a division of Novartis Pharma AG).    
 
       
10.10
  BPD-MA Verteporfin Supply Agreement, dated March 12, 1999 between QLT PhotoTherapeutics Inc. and Parkedale Pharmaceuticals, Inc. (1)   Exhibit 10.54 to the Company’s Annual Report on Form 10-K for the year ended December 31, 1998.
 
       
10.11
  BPD-MA Presome Supply Agreement, dated February 26, 1998, between QLT PhotoTherapeutics Inc. and Nippon Fine Chemical Co., Ltd. (1)   Exhibit 10.55 to the Company’s Annual Report on Form 10-K for the year ended December 31, 1998.
 
       
10.12
  BPD-MA Supply Agreement, dated December 11, 1998, between QLT PhotoTherapeutics Inc. and Raylo Chemicals Limited. (1)   Exhibit 10.56 to the Company’s Annual Report on Form 10-K for the year ended December 31, 1998.
 
       
10.13
  License Agreement, dated December 8, 1998, between QLT PhotoTherapeutics Inc. and The General Hospital Corporation. (1)   Exhibit 10.63 to the Company’s Annual Report on Form 10-K for the year ended December 31, 1998.
 
       
10.14
  Amending Agreement to PDT Product Development, Manufacturing and Distribution Agreement dated as of July 23, 2001 between Novartis Ophthalmics AG and QLT Inc. (1)   Exhibit 10.74 to the Company’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2002.
 
       
10.15
  Amending Agreement to PDT Product Development, Manufacturing and Distribution Agreement entered into July 22, 2003 between Novartis Ophthalmics AG (now Novartis Ophthalmics, a division of Novartis Pharma AG) and QLT Inc.   Exhibit 10.77 to the Company’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2003.
 
       
10.16
  Agreement and Plan of Merger by and among QLT Inc, Aspen Acquisition Corp. and Atrix Laboratories, Inc. dated as of June 14, 2004.   Annex A to the Company’s Joint Proxy Statement/Prospectus on Form S-4 dated October 14, 2004.
 
       
10.17
  License and Royalty Agreement, dated as of August 8, 2000 between Atrix Laboratories, Inc. and Pfizer Inc.   Exhibit 99.3 to Atrix Laboratories, Inc.’s Current Report on Form 8-K dated August 8, 2000 and filed with the Commission on September 7, 2000.
 
       
10.18
  Collaboration, Development and Supply Agreement dated as of August 28, 2000 between Atrix Laboratories, Inc. and Sandoz, Inc. (formerly Geneva Pharmaceuticals, Inc.)   Exhibit 10.13 to Atrix Laboratories, Inc.’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2000.
 
       
10.19
  Collaboration, License and Supply Agreement dated as of December 8, 2000 between Atrix Laboratories, Inc. and Sanofi-Synthelabo Inc. as amended through February 15, 2007. (1)   Filed herewith.
 
       
10.20
  Collaboration, License and Supply Agreement, dated as of April 4, 2001, between Atrix Laboratories, Inc. and MediGene as amended through May 17, 2006. (1)   Filed herewith.
 
       
10.21*
  Separation Letter Agreement with Michael J. Doty.   Exhibit 10.1 to the Company’s Current Report on Form 8-K dated April 15, 2005 and filed with the Commission on April 21, 2005.
 
       
10.22*
  QLT Inc. 2005 Cash Incentive Plan.   Exhibit 10.01 to the Company’s Current Report on Form 8-K dated May 10, 2005 and filed with

118


 

         
Exhibit   Description   Location
 
      the Commission on May 16, 2005.
 
       
10.23*
  Deferred Share Unit Plan For Non-Employee Directors.   Exhibit 10.32 to the Company’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2005.
 
       
10.24*
  Change Of Control Letter Agreement between QLT Inc. and Cameron Nelson.   Exhibit 10.34 to the Company’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2005.
 
       
10.25*
  Letter Agreement dated September 23, 2005 between QLT Inc. and Paul J. Hastings.   Exhibit 10.1 to the Company’s Current Report on Form 8-K dated September 23, 2005 and filed with the Commission on September 26, 2005.
 
       
10.26*
  Employment Agreement dated September 26, 2005 between QLT Inc. and Robert L. Butchofsky.   Exhibit 10.35 to the Company’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2005.
 
       
10.27*
  Change of control letter agreement dated September 26, 2005 for Robert L. Butchofsky.   Exhibit 10.36 to the Company’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2005.
 
       
10.28*
  Employment Agreement dated November 8, 2005 between QLT Inc. and Cameron Nelson.   Exhibit 10.37 to the Company’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2005.
 
       
10.29*
  Consultancy Agreement, dated December 7, 2005, between QLT Inc. and Dr. Mohammad Azab.   Exhibit 10.40 to the Company’s Annual Report on Form 10-K for the year ended December 31, 2005.
 
       
10.30*
  Employment Agreement dated December 9, 2005 between QLT USA, Inc. and Michael R. Duncan.   Exhibit 10.41 to the Company’s Annual Report on Form 10-K for the year ended December 31, 2005.
 
       
10.31*
  Change of Control Letter Agreement dated December 9, 2005 between QLT USA, Inc. and Michael R. Duncan.   Exhibit 10.42 to the Company’s Annual Report on Form 10-K for the year ended December 31, 2005.
 
       
10.32*
  Form of Stock Option Agreement for stock option grants to senior employees and executive officers.   Exhibit 10.43 to the Company’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2006.
 
       
10.33*
  Employment Agreement dated May 31, 2006 between QLT Inc. and Peter J. O’Callaghan.   Exhibit 10.44 to the Company’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2006.
 
       
10.34*
  Change of Control Agreement dated May 31, 2006 between QLT Inc. and Peter J. O’Callaghan.   Exhibit 10.45 to the Company’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2006.
 
       
10.35
  Settlement, Release and Patent License dated February 9, 2007 by and among Takeda Pharmaceutical Company Limited, Wako Pure Chemical Industries, Ltd., TAP Pharmaceutical Products Inc., Abbott Laboratories, Limited – Laboratories Abbott, Limitee, QLT USA, Inc., and Sanofi-Synthelabo, Inc.   Filed herewith.

119


 

         
Exhibit   Description   Location
10.36
  Eligard® Manufacturing and Supply Agreement, dated December 22, 2006, between Tolmar, Inc. and QLT USA, Inc. (1)   Filed herewith.
 
       
10.37
  Amended and Restated Contribution Agreement, dated February 9, 2007, between Sanofi-Synthelabo, Inc. and QLT USA, Inc. (1)   Filed herewith.
 
       
11
  Statement re: computation of per share earnings.   Filed herewith.
 
       
21
  Subsidiaries of QLT Inc.   Filed herewith.
 
       
23
  Consent of Deloitte & Touche LLP.   Filed herewith.
 
       
31.1
  Certification pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002: Robert L. Butchofsky, President and Chief Executive Officer.   Filed herewith.
 
       
31.2
  Certification pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002: Cameron R. Nelson, Vice President, Finance, and Chief Financial Officer.   Filed herewith.
 
       
32.1
  Certification pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002: Robert L. Butchofsky, President and Chief Executive Officer.   Filed herewith.
 
       
32.2
  Certification pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002: Cameron R. Nelson, Vice President, Finance, and Chief Financial Officer.   Filed herewith.
 
Notes:
*   Denotes executive compensation plans or arrangements.
(1)   Certain portions of this exhibit have been omitted and filed separately with the Commission pursuant to a grant of confidential treatment under Rule 24b-2 promulgated under the Securities Exchange Act of 1934, as amended.

120


 

SIGNATURES
     Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the Registrant has duly caused this Report to be signed on its behalf by the undersigned, thereunto duly authorized.
     Dated: February 28, 2007
         
    QLT INC.
 
       
 
  By:   /s/ Robert L. Butchofsky
 
       
 
      Robert L. Butchofsky, President and Chief Executive Officer
 
      (Principal Executive Officer)
 
       
 
  By:   /s/ Cameron R. Nelson
 
       
 
      Cameron R. Nelson, Vice President, Finance and Chief Financial Officer
 
      (Principal Financial and Accounting Officer)

121


 

POWER OF ATTORNEY
KNOW ALL PERSONS BY THESE PRESENTS:
That the undersigned officers and directors of QLT Inc. do hereby constitute and appoint Robert L. Butchofsky and Cameron R. Nelson, and each of them, the lawful attorney and agent or attorneys and agents with power and authority to do any and all acts and things and to execute all instruments which said attorneys and agents, or either of them, determine may be necessary or advisable or required to enable QLT Inc. to comply with the Securities Exchange Act of 1934, as amended, and any rules or regulations or requirements of the Securities and Exchange Commission in connection with this Form 10-K Annual Report. Without limiting the generality of the foregoing power and authority, the powers granted include the power and authority to sign the names of the undersigned officers and directors in the capacities indicated below to this Form 10-K or amendments or supplements thereto, and each of the undersigned hereby ratifies and confirms all that said attorneys and agents or either of them, shall do or cause to be done by virtue hereof. This Power of Attorney may be signed in several counterparts.
IN WITNESS WHEREOF, each of the undersigned has executed this Power of Attorney on behalf of the Registrant and in the capacities and on the dates indicated.
         
Signatures   Title   Date
 
/s/ Robert L. Butchofsky
  President, Chief Executive Officer and Director
(Principal Executive Officer)
  February 28, 2007
       
Robert L. Butchofsky
     
 
       
/s/ Cameron R. Nelson
  Vice President, Finance and Chief Financial Officer
(Principal Financial and Accounting Officer)
  February 28, 2007
       
Cameron R. Nelson
     
 
       
/s/ E. Duff Scott
  Director   February 28, 2007
         
E. Duff Scott
       
 
       
/s/ Bruce L.A. Carter
  Director   February 28, 2007
         
Bruce L.A. Carter
       
 
       
/s/ C. Boyd Clarke
  Chairman of the Board of Directors and Director   February 28, 2007
       
C. Boyd Clarke
     
 
       
/s/ Peter A. Crossgrove
  Director   February 28, 2007
         
Peter A. Crossgrove
       
 
       
/s/ Ronald D. Henriksen
  Director   February 28, 2007
         
Ronald D. Henriksen
       
 
       
/s/ Ian J. Massey
  Director   February 28, 2007
         
Ian J. Massey
       
 
       
/s/ Alan C. Mendelson
  Director   February 28, 2007
         
Alan C. Mendelson
       
 
       
/s/ Richard R. Vietor
  Director   February 28, 2007
         
Richard R. Vietor
       
 
       
/s/ Jack L. Wood
  Director   February 28, 2007
         
Jack L. Wood
       

122

EX-2.1 2 o34971exv2w1.txt ASSET PURCHASE AGREEMENT DATED DECEMBER 20, 2006 EXHIBIT 2.1 CONFIDENTIAL TREATMENT REQUESTED BY QLT INC. ASSET PURCHASE AGREEMENT AMONG QLT USA, INC., AND TOLMAR, INC. AND DILLFORD COMPANY S.A. TABLE OF CONTENTS
PAGE ----------------- ARTICLE I DEFINITIONS.......................................................... 1 Section 1.01 Definitions...................................................... 1 ARTICLE II SALE AND PURCHASE OF ASSETS.......................................... 12 Section 2.01 Sale and Purchase................................................ 12 Section 2.02 Excluded Assets.................................................. 13 Section 2.03 Assumed Liabilities.............................................. 13 Section 2.04 Purchase Price................................................... 14 Section 2.05 Adjustments to Purchase Price.................................... 15 Section 2.06 Determination of Adjustments..................................... 16 Section 2.07 Transfer Taxes; Prorations....................................... 17 Section 2.08 Allocation of Purchase Price..................................... 17 Section 2.09 Assignment and Assumption........................................ 17 ARTICLE III THE CLOSING.......................................................... 18 Section 3.01 Time and Place of Closing........................................ 18 Section 3.02 Deliveries by Seller............................................. 18 Section 3.03 Deliveries by Buyer.............................................. 20 Section 3.04 Deliveries by the Parties........................................ 20 Section 3.05 Further Assurances............................................... 20 ARTICLE IV REPRESENTATIONS AND WARRANTIES OF SELLER............................. 21 Section 4.01 Organization and Qualification................................... 21 Section 4.02 Authority........................................................ 21 Section 4.03 No Conflicts; Required Consents.................................. 22 Section 4.04 Financial Statements............................................. 22 Section 4.05 Absence of Changes............................................... 22 Section 4.06 Seller Contracts................................................. 23 Section 4.07 Title; Sufficiency; Condition of Assets.......................... 24 Section 4.08 Real Property.................................................... 24 Section 4.09 Intellectual Property............................................ 25 Section 4.10 Regulatory Compliance............................................ 28 Section 4.11 Suppliers........................................................ 29
-i- TABLE OF CONTENTS (continued)
PAGE ----------------- Section 4.12 Employees........................................................ 30 Section 4.13 Employee Benefit Plans........................................... 30 Section 4.14 Compliance with Legal Requirements; Governmental Approvals....... 30 Section 4.15 Litigation....................................................... 31 Section 4.16 Environmental Matters............................................ 31 Section 4.17 Taxes............................................................ 32 Section 4.18 Brokers.......................................................... 32 Section 4.19 Transactions with Affiliates..................................... 32 Section 4.20 Solvency......................................................... 33 Section 4.21 Inventory........................................................ 33 Section 4.22 Seller's Marketing Efforts....................................... 33 ARTICLE V REPRESENTATIONS AND WARRANTIES OF BUYER.............................. 34 Section 5.01 Organization and Good Standing................................... 34 Section 5.02 Authority........................................................ 34 Section 5.03 No Conflicts; Required Consents.................................. 34 Section 5.04 Financial Capacity............................................... 35 Section 5.05 Brokers.......................................................... 35 Section 5.06 Debarment........................................................ 35 Section 5.07 Title Commitments................................................ 35 Section 5.08 Purchase in Good Faith........................................... 35 ARTICLE VI ADDITIONAL COVENANTS................................................. 36 Section 6.01 Transactions and Conduct of Business Pending the Closing......... 36 Section 6.02 Employee Matters................................................. 37 Section 6.03 401(k) Plan...................................................... 38 Section 6.04 Access to Information............................................ 39 Section 6.05 Notice of Certain Events......................................... 39 ARTICLE VII ADDITIONAL AGREEMENTS................................................ 40 Section 7.01 Confidentiality.................................................. 40 Section 7.02 Use of Proceeds.................................................. 41
-ii- TABLE OF CONTENTS (continued)
PAGE ----------------- Section 7.03 No Shop and Non-Solicitation..................................... 41 Section 7.04 COBRA............................................................ 41 ARTICLE VIII TERMINATION OF AGREEMENT............................................. 42 Section 8.01 Grounds for Termination.......................................... 42 Section 8.02 Effect of Termination............................................ 42 ARTICLE IX INDEMNIFICATION...................................................... 42 Section 9.01 Survival of Representations and Warranties....................... 42 Section 9.02 Indemnification by Seller........................................ 42 Section 9.03 Indemnification by Buyer......................................... 43 Section 9.04 Environmental Indemnification.................................... 43 Section 9.05 Procedures for Indemnification; Buyer's Security Interest in Escrow Amount.................................................... 44 Section 9.06 Limitations on Indemnification................................... 46 Section 9.07 Damages Limitations.............................................. 47 Section 9.08 Specific Performance............................................. 47 Section 9.09 Exclusive Remedy................................................. 47 Section 9.10 Characterization of Indemnification Payment...................... 48 Section 9.11 No Other Representation.......................................... 48 ARTICLE X MISCELLANEOUS........................................................ 48 Section 10.01 Amendments and Waivers........................................... 48 Section 10.02 Notices.......................................................... 48 Section 10.03 Applicable Law................................................... 49 Section 10.04 Exhibits and Schedules........................................... 50 Section 10.05 Assignments; Successors and Assigns.............................. 50 Section 10.06 No Third-Party Beneficiaries..................................... 50 Section 10.07 Counterparts..................................................... 50 Section 10.08 Severability..................................................... 50 Section 10.09 Entire Agreement................................................. 50 Section 10.10 Interpretation................................................... 50 Section 10.11 Construction..................................................... 51
-iii- TABLE OF CONTENTS (continued)
PAGE ----------------- Section 10.12 Expenses of the Parties.......................................... 51 Section 10.13 Jurisdiction; Service of Process................................. 51 Section 10.14 Waiver of Jury Trial............................................. 51 Section 10.15 Recovery of Fees by Prevailing Party............................. 52 Section 10.16 Seller Disclosure Schedule....................................... 52 Section 10.17 Time of the Essence.............................................. 52 Exhibits Form of Aczone(R) Manufacturing and Supply Agreement............................. Exhibit A Form of Assignment and Assumption Agreement...................................... Exhibit B Form of Atrigel(R) Manufacturing and Supply Agreement............................ Exhibit C Form of Eligard(R) Manufacturing and Supply Agreement............................ Exhibit D Form of Escrow Agreement......................................................... Exhibit E Form of Governmental Approval Assignments........................................ Exhibit F Form of Guarantee Agreement...................................................... Exhibit G Form of Deed of Trust and Fixture Filing......................................... Exhibit H Form of Non-Competition Agreement................................................ Exhibit I Form of Pledge Agreement......................................................... Exhibit J Form of Promissory Note.......................................................... Exhibit K Form of Security Agreement....................................................... Exhibit L Form of Transition Service Agreement............................................. Exhibit M Form of Pre-Closing Certificate.................................................. Exhibit 2.06(a) Form of General Assignment and Bill of Sale...................................... Exhibit 3.02(a) Form of Patent Assignment........................................................ Exhibit 3.02(b)-1 Form of Trademark Assignment..................................................... Exhibit 3.02(b)-2 Form of Special Warranty Deed.................................................... Exhibit 3.02(c) Form of FIRPTA Affidavit......................................................... Exhibit 3.02(h) Form of Opinion.................................................................. Exhibit 3.02(k) Form of Press Release............................................................ Exhibit 7.01(c) Seller Disclosure Schedules Dental Products.................................................................. Schedule 2.01(b) Deposits and Advances............................................................ Schedule 2.01(c) Generic Dermatology Products..................................................... Schedule 2.01(d) Governmental Approvals........................................................... Schedule 2.01(e) Transferred Inventory............................................................ Schedule 2.01(g) Owned and leased Vehicles........................................................ Schedule 2.01(h) Personal Property (including all Tools, Machinery and Equipment)................. Schedule 2.01(i) Personal Property Leases......................................................... Schedule 2.01(j)
-iv- TABLE OF CONTENTS (continued)
PAGE ----------------- Real Property.................................................................... Schedule 2.01(k) Seller Contracts/Key Contracts................................................... Schedule 2.01(l) Seller Intellectual Property..................................................... Schedule 2.01(m) Excluded Assets.................................................................. Schedule 2.02(e) Excluded Liabilities............................................................. Schedule 2.03 Allocation of Purchase Price..................................................... Schedule 2.08 Seller's Required Consents....................................................... Schedule 4.03 Pro Forma Income Statement....................................................... Schedule 4.04 Absence of Changes............................................................... Schedule 4.05 Additional Assets to be Purchased by Buyer....................................... Schedule 4.07 Regulatory Compliance............................................................ Schedule 4.10 Suppliers........................................................................ Schedule 4.11 List of Current Employees........................................................ Schedule 4.12(a) Employee Legal Issues............................................................ Schedule 4.12(b) Claims by Employees.............................................................. Schedule 4.12(c) Employee Benefit Plans........................................................... Schedule 4.13 Environmental Matters............................................................ Schedule 4.16 Transactions with Affiliates..................................................... Schedule 4.19 Seller's Transactions and Conduct of Business.................................... Schedule 6.01 List of Key Employees............................................................ Schedule 6.02(a) Employee Benefit Plans for Transferred Employees................................. Schedule 6.02(c) 401(k) Plan Participation for Transferred Employees.............................. Schedule 6.03(a)
-v- ASSET PURCHASE AGREEMENT THIS ASSET PURCHASE AGREEMENT is made as of December 20, 2006 (the "Effective Date"), by and among Tolmar, Inc., a Delaware corporation ("Buyer") and a newly formed wholly-owned subsidiary of Dillford Company S.A., a Uruguayan sociedad anonima ("Parent"), Parent and QLT USA, Inc., a Delaware corporation ("Seller"). Buyer, Parent and Seller are sometimes referred to herein individually as a "Party" and collectively as the "Parties." RECITALS WHEREAS, Seller is engaged in the business of, among other things, developing and manufacturing topical generic dermatology products pursuant to the Sandoz Agreement and dental products for distribution in the United States, Canada and certain other countries; and WHEREAS, Seller owns and operates an approximately 60,000 square foot manufacturing facility located in Fort Collins, Colorado, at which Seller manufactures the topical generic dermatology products and dental products, as well as other pharmaceutical products; and WHEREAS, Buyer desires to purchase from Seller, and Seller desires to sell to Buyer; substantially all of the assets, properties, rights and claims related to the topical generic dermatology business, the Dental Business and the Manufacturing Facility on the terms and conditions set forth herein; NOW, THEREFORE, in consideration of the foregoing recitals and the mutual representations, warranties, covenants and promises contained herein, the adequacy and sufficiency of which are hereby acknowledged, the Parties hereto agree as follows: AGREEMENT ARTICLE I DEFINITIONS Section 1.01 DEFINITIONS. (a) The following terms shall have the following meanings for the purposes of this Agreement: "Aczone(R) Manufacturing and Supply Agreement" means that certain manufacturing and supply agreement between Seller and Buyer in the form attached hereto as Exhibit A, which the Parties intend to be an entirely independent, separate and severable agreement from this Agreement. "Affiliate" means, with respect to any specified Person, (a) any other Person that, directly or indirectly, owns or controls, is under common ownership or control with, or is owned or controlled by, such specified Person, (b) any other Person that is a director, officer or partner or is, directly or indirectly, the beneficial owner of ten percent (10%) or more of any class of equity securities of the specified Person or a Person described in clause (a) of this paragraph, or (c) another Person of which the specified Person is a director, officer or partner or is, directly or indirectly, the beneficial owner of ten percent (10%) or more of any class of equity securities. "Agreement" means this Asset Purchase Agreement (including the Seller Disclosure Schedule and all other schedules and exhibits attached hereto), as amended from time to time. "Assignment and Assumption Agreement" means the assignment and assumption agreement covering all of the Assumed Liabilities in the form attached hereto as Exhibit B. "Atrigel(R) Manufacturing and Supply Agreement" means that certain manufacturing and supply agreement between Seller and Buyer in the form attached hereto as Exhibit C, which the Parties intend to be an entirely independent, separate and severable agreement from this Agreement. "Books and Records" means all books, files, papers, agreements, correspondence, databases, information systems, programs, software, documents and records relating to the Purchased Assets or the Assumed Liabilities, primarily used in the Business, on whatever medium; but excluding batch records and similar manufacturing records that Seller is required to maintain under applicable Legal Requirements and those relating to the Excluded Assets. "Business" means the Generic Dermatology Business, the Dental Business and the Manufacturing Business, but excluding the Excluded Assets. "Business Day" means any day other than (a) a Saturday or a Sunday or (b) a day on which commercial banks located in Denver, Colorado are generally closed for business. "Closing" means the consummation of the Transaction. "Code" means the United States Internal Revenue Code of 1986, as amended. "Consent" means any approval, consent, ratification, permission, waiver or authorization (including any Governmental Approval). "Contract" means any agreement, contract, consensual obligation, promise, understanding, arrangement, commitment or undertaking of any nature (whether written or oral and whether express or implied). "Conveyance Document" means any and all deeds, bills of sale, assignments and other good and sufficient instruments of transfer, conveyance and assignment to effect or evidence the sale, conveyance, assignment, transfer, and delivery of the Purchased Assets to Buyer and to vest in Buyer title to the Purchased Assets in accordance with the terms of this Agreement. "Copyrights" means all registered and unregistered copyrights, including such rights in and to all works of authorship and all other rights of a similar nature corresponding thereto throughout the world, whether published or unpublished, including associated rights to prepare, -2- reproduce, perform, make derivative works of, display and distribute copyrighted works and copies, compilations and derivative works thereof. "Damages" means and includes any loss, damage, injury, Liability, claim, demand, settlement, judgment, award, fine, penalty, Tax, fee (including all reasonable legal fees, accounting fees, expert fees or advisory fees), charge, cost (including any cost of investigation) or expense of any nature. "Dental Business" means all of Seller's right, title, interest and obligations to develop, manufacture and sell the Dental Products, together with all Contracts and Governmental Approvals for or relating primarily to such Dental Products. "Dental Products" means those products as listed on Schedule 2.01(b). "Deposits and Advances" means performance and other bonds, security and other deposits, advance payments, prepaid credits and deferred charges primarily used in or primarily related to the Business, all of which are listed on Schedule 2.01(c). "Earn-Out Event" means the receipt by Buyer of a firm purchase order from Seller or Seller's licensee or sublicensee to manufacture the Aczone product in a quantity equal to [**] or more of the sales forecasted (by Seller or Seller's licensee) for the twelve month period immediately following the commercial launch of the Aczone product in the United States of America, pursuant to and in accordance with the terms of the Aczone(R) Manufacturing and Supply Agreement at any time after the Effective Date and prior to [**]. "Eligard(R) Manufacturing and Supply Agreement" means that certain manufacturing and supply agreement between Seller and Buyer in the form attached hereto as Exhibit D, which the Parties intend to be an entirely independent, separate and severable agreement from this Agreement. "Encumbrance" means any lien, pledge, hypothecation, charge, mortgage, security interest, encumbrance, trust, claim, preference, right of possession, lease, tenancy, license, encroachment, covenant, Order, option, right of first refusal, preemptive right, exception, reservation, limitation or impairment. "Entity" means any corporation (including any non-profit corporation), general partnership, limited partnership, limited liability partnership, joint venture, estate, trust or company (including any limited liability company or joint stock company). "Environmental Laws" means all federal, state and local statutes, regulations, orders, and applicable rules of common law relating to pollution or protection of the environment, including, without limitation, those relating to Releases or threatened Releases of Hazardous Materials or otherwise relating to the presence, production, generation, manufacture, processing, disposal, distribution, labeling, testing, control, cleanup, use, treatment, storage, transport or handling of Hazardous Materials. - ---------- ** Confidential Treatment Requested. -3- "Environmental Permits" means any permit, approval, identification, number, license and other authorization required under any applicable Environmental Laws. "ERISA" means the Employee Retirement Income Security Act of 1974, as amended. "Escrow Agreement" means the escrow and security agreement between Buyer, Seller and the Escrow Agent in the form attached hereto as Exhibit E. "Excluded Transferred Inventory" means (a) all raw materials, work in process and finished goods related to the Excluded Assets, wherever located and whether held by Seller or third parties, which inventory shall remain the property of Seller, but, to the extent located at the Manufacturing Facility, shall remain located at the Manufacturing Facility for the benefit of Seller as more specifically described in the Manufacturing and Supply Agreements, (b) all inventory for Calcipotriene, and (c) all inventory for Fluticasone with a Net Book Value in excess of [**]. "GAAP" means United States generally accepted accounting principles in effect on the date on which they are to be applied pursuant to this Agreement, applied consistently throughout the relevant periods. "Generic Dermatology Business" means all of Seller's right, title, interest and obligations to develop and manufacture the Generic Dermatology Products pursuant to, and as more specifically set forth in, the Sandoz Agreement, together with all Contracts and Governmental Approvals for or relating primarily to the Generic Dermatology Products. "Generic Dermatology Products" means those products listed on Schedule 2.01(d). "Governmental Approval" means any: (a) permit, license, certificate, concession, approval, consent, ratification, permission, clearance, confirmation, exemption, waiver or authorization issued, granted, given or otherwise made available by or under the authority of any Governmental Authority or pursuant to any Legal Requirement; or (b) right under any Contract with any Governmental Authority. "Governmental Approval Assignments" means those assignments necessary to transfer the Governmental Approvals in the form attached hereto as Exhibit F. "Governmental Authority" means the: (a) government of the United States or any state, commonwealth, territory, county, municipality, district or other jurisdiction of any nature; (b) federal, state, local, municipal or other government; (c) governmental or quasi governmental authority of any nature (including any governmental division, subdivision, department, agency, bureau, branch, office, commission, council, board, instrumentality, officer, official, representative, organization, unit, body or Entity and any court or other tribunal); or (d) individual, Entity or body exercising, or entitled to exercise, any executive, legislative, judicial, administrative, regulatory, police, military or taxing or arbitral authority or power of any nature. - ---------- ** Confidential Treatment Requested. -4- "Guarantee Agreement" means that certain guarantee agreement in the form attached hereto as Exhibit G between Parent and Seller under which Parent shall irrevocably and unconditionally guarantee Buyer's obligations under the Promissory Note and Security Agreement. "Hazardous Materials" means all substances defined as Hazardous Substances, Pollutants or Contaminants in the National Oil and Hazardous Substances Pollution Contingency Plan, 40 C.F.R. Section 300.5, any petroleum, hydrocarbons, petroleum products and any components, fractions, or derivatives thereof, and any other substance, chemical, waste or material that is otherwise regulated under any Environmental Law, including any that were used or generated in the Manufacturing Business during the Pre-Closing Period. "Independent Accounting Firm" means any big "four" accounting firm that does not currently represent a Party or another independent accounting firm of international reputation mutually acceptable to Buyer and Seller. "Intellectual Property Rights" means any or all rights in and to intellectual property and analogous intangible property rights, including, without limitation, (a) Patents, Trade Secrets, Copyrights, and Trademarks, (b) any rights similar, corresponding or equivalent to any of the foregoing anywhere in the world, and (c) all rights thereunder (including the right to enforcement for past infringements thereof), remedies related there to (including remedies relating to past infringements thereof), and rights to protection of interests therein under the laws of all jurisdictions. "IRS" means the Internal Revenue Service. "Key Contract" means those Seller Contracts designated as key contracts on Schedule 2.01(l). "Knowledge" or a similar statement qualifying a statement by the Seller's knowledge means, when capitalized, actual knowledge of Michael R. Duncan, David R. Speights, Sean F. Moriarty, Joe Winslow, Judy Goldberg or James Munro, after reasonable investigation in the Ordinary Course of their respective duties. "Legal Requirement" means any federal, state, local, municipal or other law, statute, constitution, ordinance, code, Order, edict, decree, proclamation, treaty, convention, rule, regulation, permit, ruling, directive, pronouncement, requirement (licensing or otherwise), specification, determination or decision that is, has been enacted, adopted, passed, approved, promulgated, made, implemented or otherwise put into effect by or under the authority of any Governmental Authority. "Liability" means any debt, obligation, duty or liability of any nature, including without limitation, a contingent debt or liability, regardless of whether such debt, obligation, duty or liability would be required to be disclosed on a balance sheet prepared in accordance with GAAP and regardless of whether such debt, obligation, duty or liability is immediately due and payable. -5- "Manufacturing and Supply Agreements" means the Eligard(R) Manufacturing and Supply Agreement, the Atrigel(R) Manufacturing and Supply Agreement and the Aczone(R) Manufacturing and Supply Agreement. "Manufacturing Business" means Seller's manufacture of the products comprising the Generic Dermatology Business, the Dental Business and other pharmaceutical products at the Manufacturing Facility. "Manufacturing Facility" means the manufacturing facility located in Fort Collins, Colorado comprised of approximately 60,000 sq. ft situated on approximately eight (8) acres of land owned by Seller. "Material Adverse Effect" means any circumstance, change, development or event that has had, or is reasonably likely to have, a material adverse effect on the business, assets, condition (financial or otherwise), operations or results of operations of the Business taken as a whole, other than with respect to any matters which, directly or indirectly, relate to or result from (a) public or industry knowledge relating to the Transaction, (b) changes in GAAP or regulatory accounting requirements, (c) changes generally adversely affecting the United States economy or the generic pharmaceutical industry, or (d) war, acts of terrorism or the outbreak of hostilities. "Mortgage" means that certain deed of trust and fixture filing in the form attached hereto as Exhibit H. "Net Book Value" means the net book value of an asset calculated in accordance with GAAP. "No Shop Period" means that period of time commencing on the Effective Date and ending on the Closing Date. "Non-Competition Agreement" means that certain non-competition agreement between Seller and Buyer in the form attached hereto as Exhibit I. "Order" means any temporary, preliminary or permanent order, judgment, injunction, edict, decree, ruling, pronouncement, determination, decision, verdict, stipulation, subpoena, writ or award that is or has been issued, made, entered, rendered or otherwise put into effect by or under the authority of any Governmental Authority. "Ordinary Course of Business" or "Ordinary Course" means occurrences in the ordinary course of the Business, consistent with past practices (other than as a result of a violation of Law or breach of contract). "Owned and Leased Vehicles" means all vehicles owned by Seller and all rights in vehicle leases to which Seller is a party, in either case that are primarily used in the Business, all of which are listed on Schedule 2.01(h). "Patents" means all United States and foreign patents and utility models and applications therefor (including all reissues, divisions, re-examinations, renewals, extensions, provisionals, continuations and continuations-in-part thereof), and all equivalent or similar rights anywhere in -6- the world in inventions and discoveries, including, without limitation, invention disclosures related to the Business or any Purchased Assets or Assumed Liabilities and generated in connection with the Business, all as set forth on Schedule 2.01(m). "Permitted Encumbrance" means each of the following Encumbrances: (a) liens for taxes, assessments and governmental charges that are not due and payable as of the Closing Date or are being contested in good faith; (b) pledges or deposits made in the Ordinary Course of Business, for which an adjustment is set forth on Exhibit 2.06(a); (c) liens of mechanics, materialmen, warehousemen or other like liens securing obligations incurred in the Ordinary Course of Business that are not due and payable as of the Closing Date or are being contested in good faith; (d) similar liens and encumbrances which are incurred in the Ordinary Course of Business and which do not in the aggregate materially detract from the value of any Purchased Asset or materially impair the use thereof in the operation of the Business; (e) zoning laws and ordinances and similar Legal Requirements regulating the use or occupancy of any parcel of Real Property or the activities conducted thereon that are imposed by any Governmental Authority having jurisdiction over such Real Property; (f) rights reserved to any Governmental Authority to regulate the affected property; and (g) as to any parcel of Real Property, any easements, rights-of-way, servitudes, permits, restrictions and minor imperfections or irregularities in title which are reflected in the public records and which do not individually or in the aggregate interfere with the right or ability to own, use, occupy or operate the Real Property or to convey good, marketable and indefeasible title to such Real Property. "Person" means any individual, Entity or Governmental Authority. "Personal Property" means personal property, office furnishings, supplies, tools, machinery, equipment and other tangible personal property primarily used in the Business and located at the Manufacturing Facility, including the Personal Property listed on Schedule 2.01(i). "Personal Property Leases" means rights in leases of Personal Property to which Seller is a party or by which any of the Personal Property is bound, all of which are listed on Schedule 2.01(j). "Pledge Agreement" means that stock pledge agreement between Parent and Seller in the form attached hereto as Exhibit J. "Post-Closing Period" means any taxable period beginning after the close of business on the Closing Date or, in the case of any tax period which includes any time before and after the close of business on the Closing Date, the portion of such period beginning after the close of business on the Closing Date. "Pre-Closing Period" means any taxable period ending at or before the close of business on the Closing Date or, in the case of any taxable period which includes any time before and after the close of business on the Closing Date, the portion of such period at or before the close of business on the Closing Date. "Proceeding" means any action, suit, litigation, arbitration, proceeding (including any civil, criminal, administrative, investigative or appellate proceeding), prosecution, contest, hearing, inquiry, inquest, audit, examination or investigation that is or has been commenced, -7- brought, conducted or heard at law or in equity or before any Governmental Authority or any arbitrator or arbitration panel. "Promissory Note" means that certain secured promissory note, in the form attached hereto as Exhibit K, in the aggregate principal amount of Eight Million Four Hundred Thousand Dollars ($8,400,000). "QLT USA Products" means the products to be manufactured by Buyer for Seller under the Manufacturing and Supply Agreements, including all know-how, Patents, regulatory approvals and other assets related thereto. "Real Property" means that certain parcel of land located in Fort Collins, Colorado, in the County of Larimer, State of Colorado, consisting of approximately eight (8) acres as more particularly described on Schedule 2.01(k), together with all easements and interests appurtenant thereto including, but not limited to, any streets or other public ways adjacent to the Real Property and any appurtenant development rights or water or mineral rights. "Real Property Improvements" means all improvements located on the Real Property, including the Manufacturing Facility. "Real Property Lease" means rights in real estate leases primarily used in the Business to which Seller is a party. "Receivables" means all accounts and notes receivable, checks and negotiable instruments payable to Seller arising out of or relating to the Business. "Release" means any release, spill, emission, discharge, leaking, pumping, pouring, dumping, injection, deposit, disposal, dispersal, leaching or migration of Hazardous Materials. "Representatives" means officers, directors, employees, attorneys, accountants, advisors and agents of a Party. "Sandoz Agreement" means, collectively, that certain Collaboration, License and Supply Agreement between Seller, and Sandoz Inc. (formerly know as Geneva Pharmaceuticals, Inc.) dated August 28, 2000, as subsequently amended by Amendment No. 1 to Collaboration, License and Supply Agreement dated July 17, 2003, as subsequently amended by Amendment No. 2 to Collaboration, License and Supply Agreement dated November 11, 2004, including QLT USA's rights under that certain Common Interest Agreement, dated June 27, 2006, between QLT USA and Sandoz Inc. "Security Agreement" means that certain security agreement between Buyer and Seller in the form attached hereto as Exhibit L. "Security Documents" means the Promissory Note, the Security Agreement, the Pledge Agreement, the Guarantee and the Mortgage. "Seller Assigned Intellectual Property" means all Seller Intellectual Property owned by Seller and exclusively related to the Business, the Purchased Assets, or the Assumed Liabilities. -8- "Seller Assigned Intellectual Property Contracts" means all Seller Intellectual Property Contracts under which Seller has acquired or been granted, or granted or conveyed, any license, permission or other right to utilize any Seller Intellectual Property exclusively related to the Business, the Purchased Assets, or the Assumed Liabilities. "Seller Contracts" means collectively all Contracts and rights under any and all Contracts to which Seller is a party or is subject or by which Seller is bound solely in connection with the Business or to which the Business is subject, all of which are listed on Schedule 2.01(l). "Seller Intellectual Property" means all Intellectual Property Rights necessary for the Business as presently conducted, including, without limitation, as applicable, the manufacture, use, sale and other enjoyment of the Seller Products and the use of the Purchased Assets as currently utilized in the Business, but excluding software licenses for generally available software used in the Business that either requires consent, license or payment of a fee to assign. "Seller Intellectual Property Contract" means any Contract under which Seller has acquired or been granted, or is granted or conveyed, any license, permission or other right to utilize any Seller Intellectual Property. "Seller Licensed Intellectual Property" means all Seller Intellectual Property not exclusively related to the Business, the Purchased Assets, or the Assumed Liabilities. "Seller Products" means the Generic Dermatology Products and the Dental Products. "Tax" or "Taxes" means (a) any net income, alternative or add-on minimum tax, gross income, gross receipts, sales, use, ad valorem, value added, transfer, franchise, profits, license, withholding, payroll, employment, excise, severance, stamp, occupation, premium, property, environmental or windfall profit tax, custom, duty or other tax, governmental fee or other like assessment or charge of any kind whatsoever, together with any interest, penalty, addition-to-tax or additional amount imposed by any Governmental Authority (domestic or foreign) responsible for the imposition of any such tax, (b) any Liability of Seller for the payment of any amount of the type described in clause (a) above as a result of being a member of an affiliated, consolidated, combined or unitary group, and (c) any Liability of Seller for the payment of any amount as a result of being party to any tax sharing agreement or with respect to the payment of any amounts of the type described in clauses (a) or (b) above as a result of any express or implied obligation to indemnify any other Person. "Tax Authority" means Governmental Authority responsible for the imposition, assessment or collection of any Tax. "Tax Return" means any return, statement, declaration, notice, certificate or other document that is or has been filed with or submitted to, or required to be filed with or submitted to, any Governmental Authority in connection with the determination, assessment, collection or payment of any Tax or in connection with the administration, implementation or enforcement of or compliance with any Legal Requirement related to any Tax. "Trade Secrets" means all trade secrets and other rights in know-how and confidential or proprietary information under applicable law throughout the world, including, without limitation -9- (financial, business, processing, manufacturing or marketing information, new developments, inventions, processes, and ideas), and all other proprietary information, in all such cases, that provide Seller with advantages over competitors who do not know or use it, as well as any and all documentation thereof (including all related lists, papers, blueprints, drawings or descriptions or identities of compositions, formulae, diaries, notebooks, specifications, designs, methods of manufacture and methods of processing, software, technical information, and compilations) and all associated claims and rights related thereto (excluding, for the avoidance of doubt, rights subject to issued or published Patents, Copyrights in published works, and Trademarks). "Trademarks" means any and all registered and unregistered trademarks, service marks, and general intangibles of a similar nature (including, without limitation, all logos, trade names, corporate names, trade dress, slogans, and product names), as well as all Internet domain names and addresses and general-use e-mail addresses, and all goodwill associated therewith throughout the world. "Transaction" or "Transactions" means, collectively, the transactions contemplated by this Agreement. "Transaction Documents" means this Agreement, all Exhibits and attachments thereto, and all other agreements, certificates, instruments, documents and writings delivered by Parent, Buyer and/or Seller in connection with the Transaction. "Transfer Taxes" means all federal, state, local or foreign sales, use, transfer, real property transfer, mortgage recording, stamp duty, value-added or similar Taxes that may be imposed in connection with the transfer of Purchased Assets or assumption of Assumed Liabilities, together with any interest, additions to Tax or penalties with respect thereto and any interest in respect of such additions to Tax or penalties. "Transferred Inventory" means all inventory of Seller Products and all raw materials, work in process and finished goods primarily used in the Business (other than the Excluded Transferred Inventory), wherever located and whether held by Seller or third parties, all of which is listed on Schedule 2.01(g) (which Schedule 2.01(g) describes such Transferred Inventory in reasonable detail and includes the following information with respect to each item of Transferred Inventory: inventory date, book value, item number and description, type, unit of measure, unit cost, stock room location, total quantity, total cost, manufacturing date, and expiration date), but excluding the Excluded Transferred Inventory. "Transition Services Agreement" means that certain transition services agreement between Buyer and Seller in the form attached hereto as Exhibit M. (b) Each of the following terms is defined in the section set forth opposite such term below: Assumed Liabilities Section 2.03 Bankruptcy Code Section 5.07(e) Biologic Section 4.10(a) Burrill Section 4.18 Buyer Preamble
-10- Buyer Damages Section 9.02 Buyer Defined Contribution Plan Section 6.03(a) Buyer Welfare Benefit Plans Section 6.02(d) Buyer's Basket Section 9.06(b)(i) Buyer's Indemnification Cap Section 9.06(b)(ii) Claim Notice Section 9.05(a)(i)(A) Closing Date Section 3.01 COBRA Qualified Beneficiaries Section 7.04 Drug Section 4.10(a) Effective Date Preamble Employees Section 4.12(a) Escrow Section 2.04(b) Escrow Agent Section 2.04(b) Escrow Amount Section 2.04(b) Escrow Payment Section 2.04(b) Escrow Percentage Section 2.04(b) Excluded Assets Section 2.02 Excluded Liabilities Section 2.03 FDA Section 4.14 FDCA Section 4.14 General Assignment and Bill of Sale Section 3.02(a) Indemnitee Section 9.05(a)(i) Indemnitor Section 9.05(a)(i) Initial Payment Section 2.04(a)(i) Notice Period Section 9.05(a)(i)(B) Parent Preamble Parties Preamble Party Preamble Permits Section 4.14 Post-Closing Certificate Section 2.06(b) Pre-Closing Certificate Section 2.06(a) Pro Forma Income Statement Section 4.04 Purchase Price Section 2.04(a) Purchased Assets Section 2.01 Required Consents Section 4.03 Restricted Asset Section 2.09(a) Seller Preamble Seller Damages Section 9.03 Seller Disclosure Schedule ARTICLE IV Seller Plans Section 4.13 Seller Registered Intellectual Property Rights Section 4.09(a) Seller's Basket Section 9.06(a)(i) Seller's Indemnification Cap Section 9.06(a)(ii) Survival Date Section 9.01 Third Party Acquisition Section 6.03 Title Commitments Section 5.07
-11- Title Company Section 5.07 Title Policies Section 3.02(l) Transferred Employee Section 6.02(a)
ARTICLE II SALE AND PURCHASE OF ASSETS Section 2.01 SALE AND PURCHASE. Subject to the terms and conditions set forth in this Agreement, at the Closing, Seller shall sell, transfer, convey, assign and deliver to Buyer, and Buyer shall purchase from Seller, all of Seller's right, title and interest in the assets, properties, goodwill and rights of Seller primarily used in the Business, other than the Excluded Assets (collectively, the "Purchased Assets"), including the following: (a) the Books and Records; (b) the Dental Products; (c) the Deposits and Advances; (d) the Generic Dermatology Products; (e) the Governmental Approvals (and pending applications therefor) necessary to conduct the Business, all of which are listed on Schedule 2.01(e); (f) the Real Property Improvements; (g) the Transferred Inventory; (h) the Owned and Leased Vehicles; (i) the Personal Property; (j) the Personal Property Leases; (k) the Real Property; (l) the Seller Contracts and Seller Assigned Intellectual Property Contracts; (m) the Seller Assigned Intellectual Property; (n) all goodwill generated by or associated with the Business; and (o) all other assets, properties, rights and claims (excluding Intellectual Property Rights not otherwise included in subsections (a) through (n) above) primarily used in the Business, including, without limitation, all pending claims under any insurance policy of Seller to the extent such claims relate to damage to any Purchased Asset, to any Assumed Liability, or to the Business. -12- Section 2.02 EXCLUDED ASSETS. Notwithstanding the provisions of Section 2.01, the Purchased Assets shall not include the following (collectively, the "Excluded Assets"): (a) cash, cash equivalents, marketable securities and Receivables; (b) any intercompany or intracompany receivable cash balances between Seller and any of its Affiliates or between any of its Affiliates; (c) corporate seals, certificates of incorporation, minute books, stock transfer records, or other records related to the corporate organization of Seller; (d) the Seller Plans and contracts of insurance for employee group medical, dental and life insurance plans and all insurance policies and rights and claims thereunder; (e) the assets listed on Schedule 2.02(e); (f) subject to Section 2.01(o), all insurance policies and rights and claims thereunder; (g) all personnel records (but at the Closing Seller shall deliver to Buyer copies of all such excluded records relating to the Transferred Employees, other than any employee medical or other records that Seller is prohibited from disclosing to Seller under applicable Legal Requirements) and other records, including batch records and similar manufacturing records that Seller is required to maintain in its possession under applicable Legal Requirements (but at the Closing Seller shall deliver to Buyer copies of all such batch records and similar manufacturing records relating to the Purchased Assets or the Assumed Liabilities, primarily used in the Business, other than any such records that Seller is prohibited from disclosing to Seller under applicable Legal Requirements); (h) all rights of Seller under the Transaction Documents; (i) the Excluded Transferred Inventory; and (j) all assets, of whatever nature, not primarily used in the Business, including, without limitation, the QLT USA Products and all polymer manufacturing equipment, contracts to purchase raw materials, license, distribution and contract manufacturing agreements for or related to the QLT USA Products. For the avoidance of doubt, all assets not specifically set forth on the Schedules referenced in Section 2.01 of this Agreement shall be deemed Excluded Assets. Section 2.03 ASSUMED LIABILITIES. Subject to the terms and conditions of this Agreement, at the Closing, Seller shall assign, and Buyer shall assume, the Assumed Liabilities. For the purposes of this Agreement, the "Assumed Liabilities" shall mean only the following Liabilities of Seller, and in any event shall not include any Excluded Liabilities: (a) all accrued Liabilities of the Business for which Buyer receives a credit under Section 2.05, (b) those obligations and Liabilities attributable to periods after Closing under the Seller Contracts and Governmental Approvals (and pending applications therefor) that are included in the Purchased -13- Assets, (c) other obligations and Liabilities of Seller only to the extent that there shall be an adjustment in favor of Buyer with respect thereto pursuant to Section 2.05, (d) all obligations and liabilities arising out of Buyer's ownership of the Purchased Assets or operation of the Business after Closing, and (e) all Liabilities arising after the Closing attributable to the Transferred Employees. Except only for Assumed Liabilities, Buyer does not assume, and shall not have any responsibility for, any liabilities or obligations of Seller, including but not limited to Liabilities or obligations associated with Excluded Assets (collectively, the "Excluded Liabilities"). Without limiting the generality of the foregoing, Buyer does not assume, and shall not have any responsibility for, any Liabilities or obligations of Seller arising from or relating to any of the Excluded Liabilities set forth on Schedule 2.03. Section 2.04 PURCHASE PRICE. (a) Subject to the terms of this Agreement, as full consideration for the sale, transfer, conveyance, assignment and delivery of the Purchased Assets and the execution and delivery of the Transaction Documents by Seller to Buyer, Buyer shall pay to Seller Twenty-Two Million Dollars ($22,000,000), as such sum may be adjusted pursuant to the provisions of this Agreement (the "Purchase Price"). The Purchase Price, plus or minus prorations and other adjustments pursuant to this Agreement, shall be paid to Seller as follows: (i) on the Effective Date, Buyer shall deposit with the Escrow Agent a sum equal to Twelve Million Six Hundred Thousand Dollars ($12,600,000) (the "Initial Payment"), in immediately available U.S. funds. On the Closing Date the Initial Payment, less the Escrow Percentage (which shall be remain deposited with the Escrow Agent as described in Section 2.04(b)) shall be delivered to Seller and credited against the Purchase Price, and all interest accrued on the Initial Payment while deposited with the Escrow Agent shall be delivered to Buyer; (ii) no later than February 28, 2007, Buyer shall pay to Seller Four Million Two Hundred Thousand Dollars ($4,200,000), less the Escrow Percentage (which shall be deposited with the Escrow Agent as described in Section 2.04(b)), by wire transfer of immediately available U.S. funds, provided that Buyer may elect to prepay such amount at any time, in whole or in part, without premium or penalty; (iii) no later than March 31, 2007, Buyer shall pay to Seller Four Million Two Hundred Thousand Dollars ($4,200,000), less the Escrow Percentage (which shall be deposited with the Escrow Agent as described in Section 2.04(b)), by wire transfer of immediately available U.S. funds, provided that Buyer may elect to prepay such amount at any time, in whole or in part, without premium or penalty; and (iv) within ten (10) Business Days following the occurrence of the Earn-Out Event, Buyer shall pay to Seller One Million Dollars ($1,000,000) by wire transfer of immediately available U.S. funds; provided, however, that if the -14- Earn-Out Event does not occur, then Buyer shall have no obligation to make such payment to Seller and the Purchase Price shall be reduced accordingly. (b) Without limiting the generality of Sections 2.04(a)(i) through (iii), as security for the indemnification obligations of Seller under this Agreement, concurrently with any payment made pursuant to Sections 2.04(a)(i) through (iii) Buyer shall deliver by wire transfer of immediately available U.S. funds to SunTrust Bank, a Georgia banking corporation, as escrow agent (the "Escrow Agent"), and Escrow Agent shall retain, ten percent (10%) (the "Escrow Percentage") of each such payment of Purchase Price payable by Buyer under Sections 2.04(a)(i) through (iii) (each an "Escrow Payment"). The Escrow Payments shall be held in escrow (the "Escrow") in accordance with the terms of the Escrow Agreement. For the avoidance of doubt, at any time on or after the Closing Date the aggregate Escrow Payments (collectively, the "Escrow Amount") held in escrow shall not exceed ten percent (10%) of the aggregate Purchase Price that would have been paid to Seller, absent the Escrow Payments. (c) SECURITY FOR SUBSEQUENT PAYMENTS. As security for Buyer's obligations to make the payments set forth in Sections 2.04(a)(ii) through (iii), at the Closing Buyer shall execute and deliver the Promissory Note, the Security Agreement, the Mortgage, the Pledge Agreement and the Guarantee Agreement. Upon Seller's receipt of the payment set forth in Section 2.04(a)(iii), Seller shall promptly (and in any event within three (3) Business Days) take all necessary and appropriate action to cause the Promissory Note, the Security Agreement, the Mortgage, the Pledge Agreement and the Guarantee Agreement to be terminated and any collateral secured thereby to be released. If Buyer provides Seller with at least five (5) Business Days notice before such payment is to be made, Seller shall cooperate with Buyer to provide that such terminations and releases shall occur substantially simultaneously with Seller's receipt of such payment. Section 2.05 ADJUSTMENTS TO PURCHASE PRICE. The Purchase Price shall be subject to adjustment as follows: (a) The Purchase Price shall be adjusted on a pro rata basis as of the Closing Date for all prepaid expenses (to the extent such prepayments may accrue to Buyer's benefit), accrued expenses and Liabilities (including but not limited to real and personal property Taxes), and prepaid income and deposits, all as determined in accordance with Seller's past accounting treatment thereof, consistently applied, and to reflect the principle that all expenses and income attributable to the Business for the Pre-Closing Period are for the account of Seller, and all expenses and income attributable to the Business for the Post-Closing Period are for the account of Buyer. (b) There shall be credited to the account of Seller and become the property of Buyer (but only to the extent that Buyer is entitled to the benefit or value thereof after Closing), deposits relating to the Business that are held by third parties as of the Closing Date for the account of Seller or as security for Seller's performance of its obligations (other than with respect to Excluded Assets and any other deposits the full benefit of which will not be available to Buyer following the Closing), including deposits on leases and deposits for utilities. -15- (c) The Purchase Price shall be adjusted, upward or downward, to reflect the amount by which the Net Book Value of the Transferred Inventory delivered to Buyer on the Closing Date is greater or less than [**]. (d) There shall be credited to the account of Buyer, [**] of the Transfer Taxes paid by Buyer on behalf of Seller in accordance with Section 2.07(a). Section 2.06 DETERMINATION OF ADJUSTMENTS. Preliminary and final adjustments to the Purchase Price shall be determined as follows: (a) On the Effective Date, Seller shall deliver to Buyer a report substantially in the form attached hereto as Exhibit 2.06(a) (the "Pre-Closing Certificate"), certified as to completeness and accuracy by Seller, showing in detail the preliminary determination of the adjustments referred to in Section 2.05, if any, calculated as of the Closing Date, and any documents substantiating the adjustments proposed in the Pre-Closing Certificate. (b) Within thirty (30) days after Closing, Seller shall deliver to Buyer a report (the "Post-Closing Certificate"), certified by Seller in the same manner as the Pre-Closing Certificate, showing in detail the final determination of all adjustments which were not calculated as of the Closing Date and containing any corrections to the Pre-Closing Certificate, together with any documents substantiating the adjustments proposed in the Post-Closing Certificate. Buyer shall provide Seller with reasonable access to all records which Buyer has in its possession and which are necessary for Seller to prepare the Post-Closing Certificate. (c) Within thirty (30) days after receipt of the Post-Closing Certificate, Buyer shall give Seller written notice of Buyer's objections, if any, to the Post-Closing Certificate. If Buyer makes any such objection, the Parties shall endeavor to resolve Buyer's objections within thirty (30) days after Seller's receipt thereof. If Buyer and Seller are unable to resolve such objections within such thirty (30)-day period, Seller and Buyer shall cause the Independent Accounting Firm to resolve any remaining disputed amounts within one hundred twenty (120) days after the Closing Date. The determination of the Independent Accounting Firm shall be conclusive and binding upon Seller and Buyer, and Seller and Buyer shall bear equally the fees and expenses payable to the Independent Accounting Firm in connection with such determination. Within (i) ninety (90) days after the Closing Date, if Buyer does not timely object to the Post-Closing Certificate, or if it does so but its objections are resolved within the thirty (30)-day period provided above, or (ii) otherwise, within ten (10) Business Days after Buyer's objections are resolved as provided above; Buyer shall pay to Seller, or Seller shall pay to Buyer, as applicable, the amount by which the Purchase Price as finally determined is more or less, respectively, than the amount of the Purchase Price as estimated in the Pre-Closing Certificate. - ---------- ** Confidential Treatment Requested. -16- Section 2.07 TRANSFER TAXES; PRORATIONS. (a) Notwithstanding any Legal Requirements to the contrary, each of Buyer and Seller shall be responsible for [**] of any and all Transfer Taxes when due, and Buyer shall, at its own expense, file all necessary Tax Returns and other documentation with respect to all such Transfer Taxes. Buyer shall pay the full amount of such Transfer Taxes and the Purchase Price shall be adjusted to reflect Buyer's payment of Seller's portion of such Transfer Tax. (b) Seller shall be responsible for and shall pay any Taxes arising or resulting from or in connection with the conduct of the Business or the ownership of the Purchased Assets attributable to the Pre-Closing Period. Buyer shall be responsible for and shall pay any Taxes arising or resulting from or in connection with the conduct of the Business or the ownership of the Purchased Assets attributable to the Post-Closing Period. (c) All real property, personal property, ad valorem or other similar Taxes (not including income Taxes) levied with respect to the Purchased Assets or the Business for a taxable period which includes (but does not end on) the Closing Date shall be apportioned between Buyer and Seller based on the number of days included in such period through but excluding the Closing Date and the number of days included in such period on and after the Closing Date. Section 2.08 ALLOCATION OF PURCHASE PRICE. The Parties agree to allocate the Purchase Price among the Purchased Assets as specified on Schedule 2.08. The allocation of the Purchase Price set forth on Schedule 2.08 is intended to comply with the requirements of Section 1060 of the Code. The Parties agree that: (a) such allocation was determined in an arm's length negotiation and that none of the Parties shall take a position on any Tax Return (including IRS Form 8594), before any Tax Authority or in any Proceeding that is in any way inconsistent with such allocation without the written consent of the other Party or unless specifically required pursuant to a determination by an applicable Tax Authority; (b) they shall cooperate with each other in connection with the preparation, execution and filing of all Tax Returns related to such allocation; and (c) they shall promptly advise each other regarding the existence of any tax audit, controversy or litigation related to such allocation. Section 2.09 ASSIGNMENT AND ASSUMPTION. (a) Notwithstanding anything herein to the contrary, if an attempted sale, assignment, transfer or delivery of any Purchased Asset would be ineffective without the Consent of any third party, or if such an act would violate the rights of any third party in such Purchased Asset or otherwise affect adversely the rights of Buyer in such Purchased Asset, and the applicable Consent has not been obtained on or prior to the Closing Date, - ---------- ** Confidential Treatment Requested. -17- this Agreement shall not constitute an actual or attempted sale, assignment, transfer or delivery of such Purchased Asset (each, a "Restricted Asset"). Unless and until any such Consent is obtained, such Restricted Asset shall not constitute a Purchased Asset and any associated Liability shall not constitute an Assumed Liability for any purpose hereunder except to the extent provided in Section 2.09(c). (b) In any such case, Seller shall use commercially reasonable efforts to obtain, as soon as practicable, such Consent. Buyer shall cooperate reasonably with Seller in obtaining such Consents, provided, that Buyer shall not be required to pay any cash consideration therefor or give or allow to remain in effect any guaranty, letter of credit, performance bond or other financial assurance. As soon as such Consent is obtained, Seller shall sell, transfer, convey, assign and deliver to Buyer, for no additional consideration, all of Seller's right, title and interest in such Restricted Asset, and such Restricted Asset shall constitute a Purchased Asset and all associated Liabilities shall constitute Assumed Liabilities for all purposes hereunder. (c) Until such Consent shall have been obtained, Seller shall at its expense effect an alternate arrangement, in the form of a license, sublease, operating agreement or other arrangement, in any case reasonably satisfactory to Buyer, which results in Buyer receiving all the benefits and bearing all the ordinary course costs, Liabilities and other obligations with respect to each Restricted Asset, from the Closing Date until such time as such Consent is obtained, that Buyer would have received and borne, respectively, if such Restricted Asset had constituted a Purchased Asset as of the Closing. ARTICLE III THE CLOSING Section 3.01 TIME AND PLACE OF CLOSING. The Closing shall occur at the offices of Morrison & Foerster LLP, 370 Seventeenth Street, Suite 5200, Denver, Colorado 80202, at 10:00 a.m., local time, on December 22, 2006 or such other date and time as is mutually agreed to by the Parties (the "Closing Date"). Section 3.02 DELIVERIES BY SELLER. On the Effective Date, Seller shall deliver the following items (duly executed by Seller and notarized as appropriate) to the Escrow Agent for delivery to Buyer at the Closing, all of which shall be in form and substance reasonably acceptable to Buyer: (a) General Assignment and Bill of Sale covering all of the applicable Purchased Assets, substantially in the form attached hereto as Exhibit 3.02(a) (the "General Assignment and Bill of Sale"); (b) any and all documents necessary to properly assign, and to properly record the assignment, to Buyer of all of Seller's right, title and interest in and to the Seller Assigned Intellectual Property in the United States in the forms attached hereto as Exhibit 3.02(b)-1 and 3.02(b)-2; -18- (c) a special warranty deed conveying the Real Property free and clear of all Encumbrances other than the Permitted Encumbrances in the form attached hereto as Exhibit 3.02(c); (d) the Governmental Approval Assignments; (e) such other specific instruments of sale, transfer, conveyance and assignment as Buyer may request; (f) assignments of all Personal Property Leases; (g) vehicle titles and assignments sufficient to transfer title to the Owned and Leased Vehicles; (h) an affidavit of Seller, under penalty of perjury, that Seller is not a "foreign person" (as defined in the Foreign Investment in Real Property Tax Act and applicable regulations) and that Buyer is not required to withhold any portion of the consideration payable under this Agreement under the provisions of such Act, in the form attached as Exhibit 3.02(h); (i) the Required Consents for the Key Contracts and such other Seller Contracts that have been obtained by Seller, duly executed by the applicable third party, in form and substance reasonably satisfactory to Buyer; (j) with respect to any financing statements filed against any of the Purchased Assets, UCC-3 termination statements; (k) an opinion, dated as of the Closing Date, from Morrison & Foerster LLP, Seller's legal counsel, substantially in the form attached hereto as Exhibit 3.02(k); (l) the irrevocable written commitment of the Title Company to deliver to Buyer an ALTA 1992 standard form owner's policies of title insurance, insuring a fee or leasehold interest, as applicable, in each parcel of the Real Property, all premiums and charges for which shall have been paid by Seller (the "Title Policies"), the premiums for additional endorsements or extended coverage, to the extent requested by Buyer shall be paid by Buyer; (m) a certificate of Seller's Secretary certifying as to: (i) the certificate of incorporation and bylaws of Seller as in effect as of the Effective Date, (ii) resolutions of Seller's stockholders and its board of directors authorizing the execution, delivery and performance of this Agreement and of all other Transaction Documents, and (iii) the incumbency of Seller's officers executing this Agreement and all other Transaction Documents; and (n) a certificate from the Secretary of State of Colorado and Delaware as to Seller's good standing. -19- Section 3.03 DELIVERIES BY BUYER. On the Effective Date, Buyer shall deliver the following items (duly executed by Buyer and notarized as appropriate) to the Escrow Agent for delivery to Seller at the Closing, all of which shall be in a form and substance reasonably acceptable to Seller: (a) the Initial Payment; (b) a certificate of Buyer's Secretary certifying as to, as applicable: (i) the certificate of incorporation and bylaws of Buyer as in effect as of the Effective Date, (ii) resolutions of Buyer's and Parent's stockholders, if applicable, and board of directors authorizing the execution, delivery and performance of this Agreement and of all other Transaction Documents, and (iii) the incumbency of Buyer's and Parent's officers executing this Agreement and all other Transaction Documents; (c) the Non-Competition Agreement; and (d) the Promissory Note and the Mortgage. Section 3.04 DELIVERIES BY THE PARTIES. On the Effective Date, Parent, Buyer and Seller, as applicable, shall deliver the following items (duly executed by the applicable Party and notarized, as appropriate) to the Escrow Agent for delivery to the applicable Party at Closing: (a) the Assignment and Assumption Agreement; (b) each of the Manufacturing and Supply Agreements; (c) the Transition Services Agreement; (d) the Escrow Agreement; (e) the Security Agreement, the Pledge Agreement and the Guarantee Agreement; and (f) such other certificates, instruments or documents required pursuant to the provisions of this Agreement or otherwise necessary or appropriate to transfer the Purchased Assets or assume the Assumed Liabilities in accordance with the terms hereof and consummate the Transaction. Section 3.05 FURTHER ASSURANCES. Subject to the terms and conditions hereof, each Party hereto shall use its reasonable best efforts to take all action required of it to fulfill its obligations under the terms of this Agreement and to facilitate the consummation of the Transaction. In furtherance thereof, Seller agrees to deliver or provide to Buyer on or immediately following the Closing Date: (a) all files relating to FDA drug or device applications, including all approvals and pending approvals, and all FDA site approvals, in each case relating to any Purchased Asset; -20- (b) the Books and Records, as mutually agreed to by Buyer and Seller, including, without limitation, as described in the definition of "Books and Records"; (c) copies of all personnel records and other records that Seller is retaining in its possession as required by applicable Legal Requirements relating to the Transferred Employees, other than any medical or other records of the Transferred Employees that Seller is prohibited from disclosing to Buyer pursuant to applicable Legal Requirements; and (d) such assistance to Buyer as is reasonably necessary to record the Seller Assigned Intellectual Property and Seller Assigned Intellectual Property Contracts, whether inside or outside the United States. ARTICLE IV REPRESENTATIONS AND WARRANTIES OF SELLER Except as set forth in the corresponding schedule of the disclosure schedule of Seller delivered to Buyer concurrently with the execution and delivery of this Agreement (the "Seller Disclosure Schedule") (provided, that if any fact or item disclosed in any schedule of the Seller Disclosure Schedule shall be relevant to any other section of this Agreement, then such fact or item shall be deemed to be disclosed with respect to such other section of this Agreement, but only to the extent to which it is readily apparent on its face that such fact or item is so relevant), Seller hereby represents and warrants to Buyer that, as of the Effective Date and as of the Closing Date: Section 4.01 ORGANIZATION AND QUALIFICATION. Seller is a corporation duly organized, validly existing and in good standing under the laws of the jurisdiction of its incorporation, and has all requisite power and authority to own, lease and operate its properties and to carry on its business as presently conducted. Seller is duly qualified or licensed as a foreign corporation to conduct business and is in good standing in each jurisdiction where the character of the properties owned, leased or operated by it or the nature of its business makes such qualification or licensing necessary, except where the failure to be so duly qualified or licensed and in good standing, individually or in the aggregate, would not have a Material Adverse Effect. Section 4.02 AUTHORITY. Seller has all corporate power and authority to execute and deliver this Agreement and the other Transaction Documents to which Seller is a party, to perform its obligations hereunder and thereunder, and to consummate the Transaction. The execution and delivery of this Agreement and the other Transaction Documents to which Seller is a party and the consummation by Seller of the Transaction have been duly and validly authorized by all corporate action and no other corporate proceeding on the part of Seller is necessary to authorize this Agreement and the other Transaction Documents or to consummate the Transaction. This Agreement has been, and at Closing the other Transaction Documents to which Seller is a party will be duly and validly executed and delivered by Seller and assuming the due authorization, execution and delivery by Buyer, this Agreement constitutes, and at Closing the other Transaction Documents to which Seller is a party will constitute, the legal, valid and binding obligation of Seller, enforceable against Seller in accordance with their -21- respective terms, except as may be limited by bankruptcy, insolvency, reorganization, moratorium and other similar laws and equitable principles related to or limiting creditors' rights generally and by the availability of equitable remedies and defenses. Section 4.03 NO CONFLICTS; REQUIRED CONSENTS. No Consents other than those set forth in Schedule 4.03 (the "Required Consents") are required with respect to Seller's execution and delivery of this Agreement, the other Transaction Documents, and the consummation of the Transaction. The execution, delivery and performance of this Agreement and the other Transaction Documents by Seller do not and will not, with or without notice or lapse of time (a) conflict with or violate Seller's Certificate of Incorporation or bylaws; (b) conflict with or violate any Legal Requirement applicable to Seller or by which any property or asset of Seller is bound or affected, except where the existence of such conflict or violation would not, individually or in the aggregate, have a Material Adverse Effect; (c) assuming the Consents listed in Schedule 4.03 are obtained, result in any breach of or constitute a default under, or give to others any right of termination, amendment, acceleration or cancellation of, or result in the creation of any Encumbrance on, any Purchased Asset; (d) violate or conflict with any other material restriction of any kind or character to which Seller is subject, except where the existence of violation or conflict would not, individually or in the aggregate, have a Material Adverse Effect; or (e) require Seller to obtain any Consent of, or make or deliver any filing or notice to, a Governmental Authority. Section 4.04 FINANCIAL STATEMENTS. Seller has delivered to Buyer an unaudited pro forma income statement of the Business for the nine (9) months ended September 30, 2006 (the "Pro Forma Income Statement"), a copy of which is set forth on Schedule 4.04. The Pro Forma Income Statement was prepared in good faith, upon reasonable estimates and reflects the best currently available judgments of Seller's management, after giving effect to the terms of the Transaction, as to those historical revenues and operating expenses directly attributable to the Business, based on Seller's accounting books and records and internal accounting practices, as more specifically described in the notes accompanying the Pro Forma Income Statement (including the adjustments, assumptions and qualifications set forth therein). Section 4.05 ABSENCE OF CHANGES. Other than as disclosed on Schedule 4.05, since September 30, 2006: (a) Seller has conducted the Business in the Ordinary Course of Business; (b) no event or circumstance has occurred that has had or is reasonably likely to have a Material Adverse Effect; (c) Seller has not taken any action, agreed to take any action, or omitted to take any action that would constitute a breach of Section 6.01 if such action or omission were taken between the Effective Date and the Closing Date; (d) Seller has not made any capital expenditure (or series of related capital expenditures) with respect to the Business other than in the Ordinary Course of Business; (e) Seller has not transferred, assigned, or granted any license or sublicense of any rights under or with respect to any Seller Intellectual Property; -22- (f) Seller has not experienced any damage, destruction, or loss (whether or not covered by insurance) to the Business; (g) Seller has not adopted, amended, modified, or terminated any Seller Plan; (h) Seller has not entered into any employment contract or collective bargaining agreement, written or oral, or modified the terms of any existing such contract or agreement, in each case that would apply to any of the Transferred Employees; (i) Seller has not granted any increase in the base compensation of any of the Transferred Employees outside the Ordinary Course of Business; (j) Seller has not made any other change in employment terms for any of the Transferred Employees outside the Ordinary Course of Business; and (k) Seller has not committed to do any of the foregoing. Section 4.06 SELLER CONTRACTS. (a) Schedule 2.01(l) provides a true and complete list of each Seller Contract. Seller has provided Buyer with true and accurate copies of all Seller Contracts. The rights acquired under each Seller Contract will be exercisable and enforceable by Buyer on and after the Closing to the same extent as by Seller prior to the Closing. (b) Each Seller Contract is valid and binding on Seller subject to applicable bankruptcy, insolvency and similar laws affecting creditors' rights generally and to general principles of equity (regardless of whether enforceability is considered in a Proceeding at law or in equity) and, to the Knowledge of Seller, each other party thereto, and is in full force and effect, except with respect to those Seller Contracts, other than Key Contracts, as would not be reasonably likely to have a Material Adverse Effect. Seller has not received any written notice from any other party to any Seller Contract, and otherwise has no Knowledge, that such third party intends to terminate, not renew, or challenge the validity or enforceability of any Seller Contract, except for such terminations, non-renewals or challenges related to Seller Contracts, other than Key Contracts, as would not be reasonably likely to have a Material Adverse Effect. Seller is not and, to the Knowledge of Seller, no other party thereto, is in violation of or in default under (nor does there exist any condition which upon the passage of time or the giving of notice or both would cause such a violation of or default under) any Seller Contract to which it is a party or by which it or any of its properties or assets is bound, except for violations or defaults to Seller Contracts, other than Key Contracts, that individually or in the aggregate are not reasonably likely to have a Material Adverse Effect. True and complete copies of each written Seller Contract and true and complete written summaries of each oral Seller Contract (including all amendments, supplements, modifications and waivers thereof) have been made available or provided to Buyer by Seller. (c) The Seller Contracts, taken as a whole, constitute all of the Contracts necessary to enable Seller to conduct the Business as presently conducted. -23- (d) Seller has not granted a written power of attorney to any Person, which power of attorney authorizes such Person to take any action on behalf of Seller that would result in a valid and binding obligation on Seller with respect to the Purchased Assets or the Business, except for the implicit authority of officers of a Delaware corporation to act on behalf of a corporation and as set forth in Seller's organizational documents or resolutions of its board of directors. Section 4.07 TITLE; SUFFICIENCY; CONDITION OF ASSETS. (a) Except as set forth in Schedule 4.07, Seller has good and valid title to all of the Purchased Assets, free and clear of any Encumbrances except the Permitted Encumbrances or the licenses and grants to other Persons included in a Seller Intellectual Property Contract. None of the Permitted Encumbrances could reasonably be expected to materially impair the continued use and operation of the Purchased Assets with respect to the Business as presently conducted. No Purchased Asset is subject to any preemptive right, right of first refusal or other right or restriction. (b) Except as set forth in Schedule 4.07, the sale, transfer and assignment of the Purchased Assets as contemplated by this Agreement will give Buyer possession of all the assets, taken as a whole, required to operate the Business as presently conducted. To the Knowledge of Seller, there are no facts or conditions affecting the Purchased Assets, which could, individually or in the aggregate, interfere in any material respect with Buyer's ability to use, own, occupy or operate the Purchased Assets after the Closing as presently used, owned, occupied or operated by Seller. (c) The Purchased Assets are free from defects, ordinary wear and tear excepted, have been maintained in accordance with normal industry practice, are in good operating condition and repair, ordinary wear and tear excepted, and are suitable and adequate for the purposes for which such assets are currently used or being held for use. Section 4.08 REAL PROPERTY. Seller hereby makes the following representations and warranties to Buyer with respect to the Real Property and Personal Property contained therein, each of which shall be deemed to be independently material and relied upon by Buyer: (a) Seller has delivered to Buyer true and complete copies of all existing title insurance policies, title reports, surveys, environmental reports, in Seller's possession or control, if any, with respect to the Real Property. The Seller is not a party to any Real Property Lease with respect to the Business. (b) Seller has no Knowledge of: (i) any violation of any applicable Legal Requirement requiring any work, repairs, construction, alteration or installation on or in connection with the Real Property; (ii) any commenced public improvement affecting the Real Property which may result in special assessments or otherwise affect the Real Property; (iii) any structural, mechanical, electrical, heating, cooling or plumbing defect of material significance in any of the Real Property; (iv) any uncured notice of any unsatisfactory condition concerning any of the Real Property from any insurance company or mortgagee; or (v) any planned, pending or contemplated condemnation, -24- eminent domain, or similar action or proceeding with respect to the Real Property or any part thereof. (c) There are no material actions, suits, proceedings, litigation, arbitration, administrative hearings, attachments or executions, pending or, to the Knowledge of Seller, threatened against Seller relating to the Real Property. (d) To the Knowledge of Seller, the Real Property is in material compliance with the Americans with Disabilities Act of 1990, as amended. (e) There have been no bankruptcy or dissolution proceedings involving Seller during the time Seller has had any interest in the Real Property. Section 4.09 INTELLECTUAL PROPERTY. (a) Schedule 2.01(m) sets forth a true and complete list of all Seller Intellectual Property either owned by Seller or subject to a registration or application for registration in Seller's name (the "Seller Registered Intellectual Property Rights"), specifying as to each, as applicable: (i) the nature of such Seller Intellectual Property; (ii) the owner of such Seller Intellectual Property and the nature of the rights held by Seller in and to the Seller Intellectual Property; (iii) in the case of Seller Registered Intellectual Property Rights, the jurisdictions by or in which such Intellectual Property Rights have been issued or registered or in which an application for such issuance or registration has been filed, including the respective registration or application numbers and dates of issuance, registration or filing; and (iv) in the case of Seller Registered Intellectual Property Rights, a description of each filing, payment, and action that must be made or taken on or before the date that is one hundred twenty (120) days after the Effective Date in order to maintain any applications and registrations for any such Seller Intellectual Property Rights. Seller has provided Buyer with true and complete copies of all applications, registrations, correspondence and other material documents filed, or existing and to be filed, with the applicable Governmental Authority with respect to the Seller Registered Intellectual Property Rights. (b) Schedule 2.01(l) sets forth a true and complete list of all Seller Intellectual Property Contracts, including, without limitation, all Seller Assigned Intellectual Property Contracts, specifying as to each, (i) the parties to the Seller Intellectual Property Contract, and (ii) whether the Seller Intellectual Property Contract is a Seller Assigned Intellectual Property Contract, other than (A) agreements commonly generated in the Ordinary Course of Business (including, except as otherwise required by this Section 4.09, -25- software licenses for generally available software, employee assignment agreements, nondisclosure agreements, consulting agreements, material transfer agreements, service agreements, clinical trial agreements and evaluation agreements) and except as set forth in Schedule 4.07, and (B) Seller Intellectual Property Contracts that are not material to the Business taken as a whole. Schedule 2.01(l) sets forth, as of the date hereof, all Seller Intellectual Property Contracts (excluding those Contracts excluded from the previous sentence in (A) and (B) above) under which Seller is obligated to make any payments of amounts in excess of [**] (in any form, including royalties, milestones and other contingent payments) to third parties for use of any Seller Intellectual Property with respect to the commercialization of any of Seller Products. The Seller Intellectual Property Contracts provide Seller with all licenses, permissions and other rights to utilize any Intellectual Property Rights owned by any Person other than Seller necessary for the conduct of the Business as currently conducted (including, without limitation, as applicable, all Intellectual Property Rights necessary for the manufacture, use, sale and other enjoyment of the Seller Products and the use or enjoyment of the Purchased Assets as presently utilized in the Business), except for those licenses, permission and other rights provided for under subsections (A) and (B) of the first sentence of this paragraph (b). The Seller Assigned Intellectual Property Contracts provide Seller with all licenses, permissions and other rights to utilize any Intellectual Property Rights owned by any Person other than Seller necessary for and used exclusively by Seller in the conduct the Business as currently conducted (including, without limitation, as applicable, all Intellectual Property Rights necessary for the manufacture, use, sale and other enjoyment of the Seller Products and the use or enjoyment of the Purchased Assets as presently utilized in the Business), except for those licenses, permission and other rights provided for under subsections (A) and (B) of the first sentence of this paragraph (b). All Seller Assigned Intellectual Property Contracts will be enforceable by Buyer on and after the Closing to the same extent as by Seller prior to the Closing. (c) The Seller Assigned Intellectual Property, the Seller Licensed Intellectual Property and the Intellectual Property Rights acquired by or granted to Seller under the Seller Assigned Intellectual Property Contracts constitute all Seller Intellectual Property. The rights granted to Buyer under the Atrigel(R) Manufacturing and Supply Agreement together with the Purchased Assets convey to Buyer all Seller Licensed Intellectual Property necessary to use, make and sell Seller Products. The Seller Intellectual Property constitutes all Intellectual Property Rights necessary to conduct the Business as presently conducted (including, without limitation, as applicable, all Intellectual Property Rights necessary for the manufacture, use, sale, and other enjoyment of the Seller Products and the Purchased Assets as presently utilized in the Business), other than software licenses for generally available software and except as set forth in Schedule 4.07. Except for the Seller Intellectual Property acquired by or granted to Seller under the Seller Intellectual Property Contracts disclosed in Schedule 2.01(l), and other than the Contracts described under subsections (A) and (B) of the first sentence of Section 4.09(b) above, Seller is the sole and exclusive owner of all right, title and interest in and to the Seller Intellectual Property free and clear of all Encumbrances other than Permitted Encumbrances and other than any rights granted by Seller to any third party described below. Following the - ---------- ** Confidential Treatment Requested. -26- Closing, all Seller Intellectual Property will be either (i) owned by Buyer as Seller Assigned Intellectual Property free and clear of all Encumbrances other than Permitted Encumbrances and without the need to seek the approval or consent (except for the Required Consents) of any Person or the need to make payments to any Person other than as set forth in this Agreement, or (ii) licensed or conveyed to Buyer pursuant to a Seller Assigned Intellectual Property Contract or the Atrigel(R) Manufacturing and Supply Agreement free and clear of all Encumbrances, other than Permitted Encumbrances and without the need to seek the approval or consent (other than the Required Consents) of any Person or the need to make payments to any Person other than as set forth in this Agreement, subject in the case of both (i) and (ii) to any rights granted or conveyed by Seller to any third party under the Seller Assigned Intellectual Property Contract disclosed in Schedule 2.01(l), the Atrigel(R) Manufacturing and Supply Agreement, or under a license to use such information for evaluation purposes provided pursuant to confidentiality and nondisclosure agreements or material transfer agreements entered into in the Ordinary Course of Business. (d) All of the Seller Intellectual Property owned or registered in Seller's name and, to the Seller's Knowledge, all other Seller Intellectual Property, is valid, subsisting and enforceable. Seller and, to Seller's Knowledge, no other Person, has received any notice, claim or allegation (in all such cases in writing) that the Seller Intellectual Property owned by Seller is invalid or unenforceable. There are no actions, suits, proceedings or claims pending or, to the Knowledge of Seller, threatened in writing with regard to the ownership, licensing or infringement of any Seller Intellectual Property. (e) To the Seller's Knowledge, the Seller Intellectual Property owned by Seller (i) has not been infringed or misappropriated by any Person, and (ii) is not being infringed or misappropriated by any Person. Seller has not threatened in writing or initiated any claim, action or Proceeding against any Person alleging that any action of the Person infringes or misappropriates any Seller Intellectual Property. (f) To Seller's Knowledge, the Seller Products, Purchased Assets, and the operation of the Business of Seller as presently conducted (including the manufacture, use or sale of Seller Products and the Purchased Assets as presently utilized in the Business) are not currently infringing on any Intellectual Property Rights of any Person. Except as set forth on Schedule 2.03, there are no actions, suits, proceedings or claims pending or, to the Knowledge of Seller, threatened in writing, claiming that Seller has infringed or misappropriated, or is infringing or misappropriating, any Intellectual Property Rights of any Person in connection with the Business. Other than pursuant to a license to use such information for evaluation purposes provided pursuant to nondisclosure agreements or material transfer agreements entered into in the Ordinary Course of Business, and other than as set forth in the agreements identified in Schedule 2.01(l) and the Atrigel(R) Manufacturing and Supply Agreement, there is no contractual restriction on the use of any Seller Intellectual Property owned by Seller and, to Seller's Knowledge any other Seller Intellectual Property. (g) Except as disclosed on Schedule 2.01(m), the Patents included in the Seller Registered Intellectual Property Rights are pending or issued and have not been -27- abandoned, and have been prosecuted in the ordinary course. All Patents and Trademarks listed in Schedule 2.01(m), owned by Seller that are material to the conduct of the Business have been duly registered and/or applied for with each appropriate Governmental Authority in the jurisdiction(s) indicated in Schedule 2.01(m), all necessary affidavits of continuing use have been timely filed, and all necessary maintenance fees have been timely paid to continue all such rights in effect except with respect to abandoned applications, Patents or Trademarks in the ordinary course of prosecution and maintenance. None of the Patents listed in Schedule 2.01(m) included in the Seller Registered Intellectual Property Rights has been declared invalid, in whole or in part, by any Governmental Authority. There are no ongoing or, to the Knowledge of Seller, threatened in writing, interferences, oppositions, reissues, reexaminations or other similar proceedings involving any of the Patents or Trademarks listed in Schedule 2.01(m) and owned by Seller in the United States Patent and Trademark Office or in any foreign patent office or similar administrative agency. Section 4.10 REGULATORY COMPLIANCE. (a) As to each Seller Product subject to the FDCA and the FDA regulations promulgated thereunder or similar Legal Requirements in any foreign jurisdiction that are developed, manufactured, tested, distributed, labeled, stored and/or marketed by Seller (each such Seller Product, a "Biologic" or a "Drug", as the case may be), each such Biologic or Drug is being developed, manufactured, tested, distributed, labeled, stored and/or marketed by Seller and, to the Knowledge of Seller, marketed, by each other Person developing, manufacturing, testing, distributing, labeling, storing and/or marketing such Drug on behalf of Seller, in material compliance with all applicable FDA, state and foreign Legal Requirements, including investigational device exemptions, new drug applications, biological license applications or abbreviated new drug applications to test, manufacture or market a new Biologic or a new Drug, good manufacturing and quality systems requirements, labeling, advertising, record keeping, filing of reports and security. As of the date hereof, Seller has not received and, to the Knowledge of Seller, none of its licensees have received, any notice or other communication from the FDA or any other Governmental Authority (i) contesting the investigational or premarket clearance or approval of, the manufacturing or testing of, the uses of or the labeling, storage, or promotion of any Seller Products or (ii) otherwise alleging any violation applicable to any Biologic or Drug by Seller of any Legal Requirement. (b) No Biologic or Drug is under consideration for or has been recalled, withdrawn, suspended, or discontinued (other than for commercial or other business reasons) or required a field notification, field alert, or field correction by Seller in the United States or outside the United States (whether voluntarily or otherwise). Except as set forth in Schedule 4.10, no proceedings in the United States or outside of the United States (whether completed or pending) seeking the recall, withdrawal, suspension, seizure or discontinuance of any Biologic or Drug are pending or, to the Knowledge of Seller, threatened against Seller with respect to any of the Seller Products or any of the QLT USA Products, or to the Knowledge of Seller, any licensee of any Biologic or Drug, nor have any such proceedings been pending at any time in the five (5) year period prior to the date hereof. Except as set forth in Schedule 4.10, to the Knowledge of Seller, there -28- are no facts, circumstances or conditions that would reasonably be expected to form the basis for any audit, investigation, suit, claim, action (legal or regulatory) or Proceeding (legal or regulatory) with respect to a recall, withdrawal, suspension, seizure or discontinuance, or a change in the marketing classification or labeling of any Drug or Biologic or with respect to any of the Seller Products or any of the QLT USA Products. True and complete copies of all material data of Seller with respect to the safety or efficacy of the Seller Products have been provided to or made available in the data room to Buyer. (c) All reports, documents, claims, notices, or approvals required to be filed, obtained, maintained, or furnished to any Governmental Authority for each Seller Product have been so filed, obtained, maintained or furnished, and all such reports, documents, claims and notices were true and complete in all material respects on the date filed (or were corrected in or supplemented by a subsequent filing). As to each Biologic or Drug for which a premarket approval application, biological license application, new drug application, premarket clearance or approval, investigational new drug application, abbreviated new drug application, investigational device exemption other state or foreign regulatory application has been submitted, approved or cleared, Seller is in material compliance with all Legal Requirements including 21 U.S.C. Sections 360c and 355 or 21 C.F.R. Parts 800, 312, 314, 600 or 601 et seq., respectively, and other applicable Legal Requirements and all terms and conditions of such applications. (d) No article of any Biologic or Drug manufactured and/or distributed by Seller is (i) adulterated within the meaning of 21 U.S.C. Section 351 (or similar Legal Requirements); (ii) misbranded within the meaning of 21 U.S.C. Section 352 (or similar Legal Requirements); or (iii) a product that is in violation of 21 U.S.C. Section 355, Section 360c or 42 U.S.C. Section 262 (or similar Legal Requirements). (e) Except as set forth in Schedule 4.10, Seller has not received any notice that the FDA or any other Governmental Authority has (i) commenced or, to the Knowledge of Seller, threatened to initiate, any action to withdraw its approval or request the recall of any Seller Product or any QLT USA Product; (ii) commenced, or, to the Knowledge of Seller, threatened to initiate, any action to enjoin production of any Seller Product or any QLT USA Product; or (iii) commenced or, to the Knowledge of Seller, threatened to initiate, any action to enjoin the production of any Seller Product or any QLT USA Product produced at any facility, including the Manufacturing Facility, where any Biologic or Drug is manufactured, tested or packaged. Section 4.11 SUPPLIERS. Except as set forth in Schedule 4.11, during the past twelve (12) months, there has not been any material adverse change in the business relationship of Seller with any supplier of active pharmaceutical ingredients to Seller or with any clinical research organization providing services to Seller. Schedule 2.01(l) sets forth a true and complete list of all sole source suppliers of goods or services to the Business with respect to which practical alternative sources of supply are not available on comparable terms and conditions. -29- Section 4.12 EMPLOYEES. (a) Schedule 4.12(a) contains a true and complete list of all current officers and employees engaged in the Business (the "Employees") and all contracts or commitments pertaining to terms of employment, compensation, bonuses, profit sharing, commissions, incentives, loans or loan guarantees, severance pay or benefits, which are currently in effect, with any current Employee or consultant engaged in the Business, and true and complete copies of all such contracts, agreements, plans, arrangements and understandings have been delivered or made available to Buyer. (b) Except to the extent provided in Schedule 4.12(b), Seller is in compliance in all material respects with the Legal Requirements respecting employment and employment practices, terms and conditions of employment, wages and hours and occupational safety for Employees, and has not received notice of, and is not engaged in, any unfair labor practice. (c) Except to the extent provided in Schedule 4.12(c), there are no claims, grievances or arbitration proceedings, workers' compensation proceedings, labor disputes, governmental investigations or administrative proceedings of any kind pending or, to the Knowledge of Seller, threatened against or relating to the Employees or employment practices, or operations as they pertain to conditions of employment for Employees, nor is Seller subject to any Order arising from any such matter. (d) No labor, collective bargaining, union or similar agreement is currently in existence or is being negotiated by Seller, and no union or labor organization has been certified or recognized as the representative of any employees of Seller or, to the Knowledge of Seller, is seeking such certification or recognition or is attempting to organize any of the employees of Seller. Section 4.13 EMPLOYEE BENEFIT PLANS. Schedule 4.13 lists, as of the Effective Date, all employment, consulting and severance agreements, pension, profit sharing and retirement plans and all bonus and other employee benefit or fringe benefit plans, including, without limitation, "employee benefit plans" as such term is defined under Section 3(3) of ERISA, maintained or with respect to which contributions are made by Seller or with respect to which Seller has any Liability with respect to the Employees (the "Seller Plans"). Section 4.14 COMPLIANCE WITH LEGAL REQUIREMENTS; GOVERNMENTAL APPROVALS. Without limiting the provisions of Section 4.10, Seller is in compliance with all Legal Requirements and rules and regulations of any Governmental Authority applicable to the Purchased Assets and the Business except for failures to be in compliance that, individually or in the aggregate, have not had, and would not reasonably be expected to have, a Material Adverse Effect. Without limiting the provisions of Section 4.10, Seller has in full force and effect all approvals, authorizations, certificates, filings, consents, clearances, franchises, licenses, notices and permits of or with all Governmental Authorities (collectively, "Permits"), including all Permits under the Federal Food, Drug and Cosmetic Act of 1938, as amended (the "FDCA"), and the regulations of the Federal Food and Drug Administration (the "FDA") promulgated thereunder, necessary for it to own, lease or operate the Purchased Assets and the Business and -30- to carry on the Business and operations as presently conducted, except where the failure to have such Permits individually or in the aggregate has not had and would not reasonably be expected to have a Material Adverse Effect. There has occurred no default under, or violation of, any such Permit, except for any such default or violation that individually or in the aggregate has not had and would not reasonably be expected to have a Material Adverse Effect. Section 4.15 LITIGATION. Except for the litigation described in Schedule 2.03, there is no Proceeding pending or, to the Knowledge of Seller, threatened, or any judgment outstanding, involving or affecting all or any part of the Business or the Purchased Assets. Section 4.16 ENVIRONMENTAL MATTERS. (a) Seller (i) is in compliance with all, and is not subject to any Liability, in each case with respect to any, applicable Environmental Laws; (ii) holds or has applied for all Environmental Permits necessary to conduct its current operations with respect to the Business, and in the case of each such Environmental Permit that Seller has applied for, (A) such Environmental Permit is listed on Schedule 4.16, (B) Seller reasonably expects that such Environmental Permit will be issued in a timely manner either to Buyer, or to Seller and promptly thereafter will be assigned by Seller to Buyer, and (C) pending Seller's receipt of such Environmental Permit, Seller's failure to hold such Environmental Permit will not have an adverse effect on the Business or any of the Purchased Assets, (iii) is in material compliance with its Environmental Permits, and (iv) no event has occurred and no condition exists, that would constitute or result in a violation by Seller of, or a failure on the part of Seller to comply with the terms of, any Environmental Law or any Environmental Permit in any material respect. (b) Since January 1, 2001, Seller has not received any written allegation, notice, demand, letter, claim or request for information from any Governmental Authority or any other Person alleging that Seller has been, is or may be in violation of, or liable under, any Environmental Law or any Environmental Permit. (c) Since January 1, 2001, Seller (i) has not entered into or agreed to any consent decree, agreement, Contract or order, nor is Seller subject to any judgment, decree or judicial or administrative order relating to compliance with Environmental Laws, Environmental Permits or the investigation, sampling, monitoring, treatment, remediation, removal or cleanup of Hazardous Materials and no investigation, litigation or other claim, action, suit or proceeding is pending or, to the Knowledge of Seller, threatened with respect thereto; and (ii) is not an indemnifying party in connection with any investigation, litigation or other claim, action, suit or proceeding threatened or asserted by any third-party indemnified party for any Liability under any Environmental Law or relating to any Hazardous Materials. (d) None of the Real Property owned or leased by the Business is listed or, to the Knowledge of Seller, proposed for listing on the "National Priorities List" under CERCLA, nor has there has been any Release or threatened Release of Hazardous Materials on, under or from such Real Property. -31- (e) There have been no Hazardous Materials generated by the Business that have been disposed of by Seller, or to its Knowledge, any third party, or come to rest at any site that has been listed or, to the Knowledge of Seller, proposed for listing on the "National Priorities List" under CERCLA, as updated through the date hereof, or any similar state or foreign list of sites requiring investigation or cleanup. (f) Seller has made available or provided the Buyer with copies of all reports and related documentation regarding any actual or alleged violation of Environmental Laws or Environmental Permits in connection with, or Releases of Hazardous Materials at, under or from, the Real Property or the Manufacturing Facility, and all such reports are listed on Schedule 4.16. Section 4.17 TAXES. (a) Seller has timely filed all Tax Returns that it was required to file, and when filed such Tax Returns were true, correct and complete in all material respects. All Taxes owed by Seller have been paid in full on a timely basis, and no other Taxes relating to the Business are payable by Seller with respect to any period ending prior to the date of this Agreement. There are no liens for Taxes on any Purchased Asset, other than liens for Taxes not yet due and payable. (b) No audit of any Tax Return relating to the Business is currently pending or, to the Knowledge of Seller, threatened. Seller is not currently is the beneficiary of any extension of time within which to file any Tax Return. No claim has ever been made by any Governmental Authority in a jurisdiction where Seller does not file Tax Returns relating to the Business that it is or may be subject to taxation by that jurisdiction. (c) Seller is a "United States person" within the meaning of Section 7701(a)(30) of the Code. (d) Seller has not waived any statute of limitations in respect of Taxes or agreed to any extension of time with respect to a Tax assessment or deficiency within the last three (3) years. Section 4.18 BROKERS. No broker, finder or investment banker is entitled to any brokerage, finder's or other fee or commission in connection with the Transaction based upon arrangements made by or on behalf of Seller, except for the fee arrangement between Burrill & Company ("Burrill") and Seller. Seller shall be responsible for, and shall indemnify Buyer in connection with, such fee arrangement. Section 4.19 TRANSACTIONS WITH AFFILIATES. Except as disclosed in Schedule 4.19, there are no existing contracts, transactions, indebtedness or other arrangements, or any related series thereof, between Seller, on the one hand, and any of the directors, officers or other Affiliates of Seller, on the other hand, related to the Business. -32- Section 4.20 SOLVENCY. (a) The Purchase Price represents reasonably equivalent value for the Purchased Assets; (b) Seller is acting in good faith and has no reason to believe that Buyer is purchasing the Purchased Assets other than in good faith; (c) Seller is not entering into the Transaction with the intent to hinder, delay or defraud any Person to which it is or may become indebted; (d) Seller (i) is not currently a debtor or alleged debtor in a case filed under the United States Bankruptcy Code, Title 11 U.S.C., (ii) is not the subject of a receivership proceeding under any state law, (iii) is not a party in any case providing for a collective remedy among Seller's creditors generally, (iv) is not the subject of a present threat by another person or entity to commence any of the foregoing proceedings against Seller, and (v) has no present intention to commence any such proceeding on its own behalf; (e) As of the Effective Date, Seller is, and as of the Closing Date and immediately after the Closing Seller will be, not "insolvent," as that term is defined in the text and interpretive case law of the United States Bankruptcy Code, Title 11 U.S.C., as amended (the "Bankruptcy Code"), subject to certain material assumptions by Seller regarding the reasonable amount or validity of any contingent Liabilities; and (f) As of the Closing Date, Seller is, and immediately after the Closing Seller will be, able to pay its Liabilities as they mature, subject to certain material assumptions by Seller regarding the reasonable amount or validity of any contingent Liabilities. Section 4.21 INVENTORY. Schedule 2.01(g) is correct and complete in all material respects as of the Effective Date. Section 4.22 SELLER'S MARKETING EFFORTS. The Transaction and this Agreement constitute the culmination of Seller's commercially reasonable efforts to expose the Business and the Purchased Assets to the applicable market and promote a sale of the Business and the Purchased Assets on terms that represent reasonably equivalent value for the Purchased Assets. In order to sell the Business and the Purchased Assets, Seller retained Burrill, a life science merchant bank with experience in the marketing and selling of businesses and assets similar or reasonably comparable to the Business and the Purchased Assets, respectively, as an independent consultant to identify and approach parties that might potentially be interested in purchasing the Business and the Purchased Assets. Burrill prepared and distributed a memorandum to certain of such parties concerning the Business and the Purchased Assets and otherwise marketed the Business and the Purchased Assets in a manner Seller believes was reasonably sufficient to expose the Purchased Assets to potential purchasers. During the marketing period, several entities other than Buyer expressed to Seller and Burrill such entities' interest in potentially purchasing the Business and the Purchased Assets, and several entities other than Buyer toured the Manufacturing Facility and investigated the Business and the Purchased Assets as prospective purchasers. Ultimately, Seller, in consultation with Burrill, determined that the -33- terms of purchase offered by Buyer and set forth in this Agreement represented, based on all the facts and circumstances, the terms most economically favorable to Seller for the purchase of the Business and the Purchased Assets resulting from Seller's marketing efforts. ARTICLE V REPRESENTATIONS AND WARRANTIES OF BUYER Buyer represents and warrants to Seller that, as of the date of this Agreement and as of the Closing Date: Section 5.01 ORGANIZATION AND GOOD STANDING. Buyer is a corporation and Parent is a sociedad anonima, each duly organized, validly existing and in good standing under the laws of its jurisdiction of organization, and has all requisite power and authority to own, lease and operate its properties and to carry on its business as presently conducted. Buyer is duly qualified or licensed as a foreign corporation to conduct business and is in good standing in each jurisdiction where the character of the properties owned, leased or operated by it or the nature of its business makes such qualification or licensing necessary, except where the failure to be so duly qualified or licensed and in good standing would not have a Material Adverse Effect. Section 5.02 AUTHORITY. Each of Buyer and Parent has all necessary power and authority to execute and deliver this Agreement and the other Transaction Documents to which it is a party, to perform its obligations hereunder and thereunder, and to consummate the Transaction. The execution and delivery of this Agreement and the other Transaction Documents and the consummation by Buyer and Parent of the Transaction have been duly and validly authorized by all requisite action and no other corporate proceeding on the part of Buyer or Parent is necessary to authorize this Agreement and the other Transaction Documents or to consummate the Transaction. This Agreement has been, and at Closing the other Transaction Documents to which Buyer or Parent is a party will be, duly and validly executed and delivered by Buyer and Parent, as applicable. This Agreement constitutes, and at Closing the other Transaction Documents will constitute, the legal, valid and binding obligation of Buyer and Parent, as applicable, enforceable against each of them in accordance with their respective terms, except as may be limited by bankruptcy, insolvency, reorganization, moratorium and other similar laws and equitable principles related to or limiting creditors' rights generally and by the availability of equitable remedies and defenses. Section 5.03 NO CONFLICTS; REQUIRED CONSENTS. No Consents are required with respect to Buyer's and Parent's execution and delivery of this Agreement, the other Transaction Documents, and the consummation of the Transaction. The execution, delivery and performance of this Agreement and the other Transaction Documents by Buyer and Parent do not and will not, with or without notice or lapse of time, (a) conflict with or violate such Party's certificate of incorporation or bylaws or equivalent organizational documents; (b) conflict with or violate any Legal Requirement applicable to Buyer or Parent or by which any property or asset of Buyer or Parent is bound or affected, except -34- where the existence of such conflict or violation would not, individually or in the aggregate, have a Material Adverse Effect; (c) result in any breach of or constitute a default under, or give to others any right of termination, amendment, acceleration or cancellation of, or result in the creation of any Encumbrance on any property or asset of Buyer or Parent pursuant to, any note, bond, mortgage, indenture, contract, agreement, lease, license, permit, franchise or other instrument or obligation, except where the existence of such breach, default or right or the creation of such Encumbrance would not, individually or in the aggregate, have a Material Adverse Effect; (d) violate or conflict with any other material restriction of any kind or character to which Buyer or Parent is subject, except where the existence of violation or conflict would not, individually or in the aggregate, have a Material Adverse Effect; or (e) require Buyer or Parent to obtain any Consent of, or make or deliver any filing or notice to, a Governmental Authority. Section 5.04 FINANCIAL CAPACITY. At the Closing, Buyer shall have sufficient funds, or shall have procured adequate financing, upon terms satisfactory to Seller, to enable Buyer to pay the Purchase Price, to perform all of its obligations hereunder and to otherwise operate the Business following the Closing Date. Section 5.05 BROKERS. No broker, finder or investment banker is entitled to any brokerage, finder's or other fee or commission in connection with the Transaction based upon arrangements made by or on behalf of Buyer or Parent. Section 5.06 DEBARMENT. None of the entities, laboratories or clinical sites of Buyer, Parent or their Affiliates and no employee, representative, agent, assistant or associate of Buyer, Parent or their Affiliates, have been debarred pursuant to the Federal Food Drug and Cosmetic Act. Section 5.07 TITLE COMMITMENTS. Seller has provided to Buyer, at Seller's cost, commitments of title insurance (the "Title Commitments") issued by a nationally-recognized title insurance company (the "Title Company"), and photocopies of all recorded items described as exceptions therein, committing to insure fee title or leasehold title, respectively, in each parcel of the Real Property owned or leased by Seller, in Buyer by ALTA Form 1992 owner's policies of title insurance. Buyer has reviewed such Title Commitments and has noted no Encumbrance to any parcel of Real Property which, in the determination of Buyer, is not a Permitted Encumbrance. Section 5.08 PURCHASE IN GOOD FAITH. Buyer is purchasing the Purchased Assets in good faith and is not entering into the Transaction with the intent to hinder, delay or defraud any Person to which the Business is or may become indebted. -35- ARTICLE VI ADDITIONAL COVENANTS Section 6.01 TRANSACTIONS AND CONDUCT OF BUSINESS PENDING THE CLOSING. From the Effective Date until the Closing Date, Seller represents, warrants and covenants that Seller shall conduct the Business in the Ordinary Course and will use its commercially reasonable efforts to preserve intact the Business organization and relationships with third parties and to keep available the services of the Employees. Without limiting the generality of the foregoing, from the Effective Date until the Closing Date, and except as disclosed in Schedule 6.01, Seller will not do or propose to do any of the following with respect to, or which could reasonably be expected to have a Material Adverse Effect on, the Business or the Purchased Assets, without the prior written consent of Buyer: (a) enter into any Contract, commitment or transaction related to the Business not in the Ordinary Course; (b) terminate any Employees, other than in the Ordinary Course; (c) amend, accelerate, terminate, cancel, or otherwise modify the terms of any Seller Contract or Governmental Approval; (d) transfer to any Person or Entity any rights to the Seller Intellectual Property; (e) sell, lease, license, transfer, assign, or otherwise dispose of any of, or cancel, compromise, waive, or release any right or claim (or series of related rights and claims) included in, the Purchased Assets; (f) commence a Proceeding related to the Business other than for the routine collection of bills; (g) increase the salaries or wage rates of any Transferred Employees or amend any health care benefit plans, programs or policies relating to the Transferred Employees or enter into any employment contract or collective bargaining agreement, written or oral, or modify the terms of any such contract or agreement with respect to the Transferred Employees; (h) revalue any of the Purchased Assets, including writing down the value of the Transferred Inventory other than in the Ordinary Course of Business and consistent with past practice; (i) make or change any material tax election or adopt or change any material tax accounting method related to the Business, other than in the Ordinary Course of Business; (j) fail to pay or otherwise satisfy its monetary obligations as they become due, except such as are being contested in good faith; -36- (k) take any action or fail to take any action that would cause a Material Adverse Effect; (l) impose or permit to exist any Encumbrance other than a Permitted Encumbrance upon any of the Purchased Assets; or (m) enter into any contract or agree, in writing or otherwise, to take any of the actions described above in this Section 6.01, or any action that would make any of its representations or warranties contained in this Agreement untrue or incorrect in any material respect or prevent it from performing or cause it not to perform its covenants hereunder. Section 6.02 EMPLOYEE MATTERS. (a) Buyer shall assume the employment agreements, in the form provided to Buyer, of Michael R. Duncan and [**], and each of such employees shall receive credit for the years of service at Seller (and its predecessor Atrix Laboratories, Inc.) for purposes of determining any severance benefits payable to such employees in the event of any subsequent termination of employment. On the Effective Date, Buyer shall offer employment to all employees employed by Seller as of December 31, 2006 whose employment and responsibilities relate primarily to the Business, with such offers remaining open until January 1, 2007 (except with respect to any employees that cease to be employed between the making of such offer and January 1, 2007) and being conditioned upon the actual occurrence of the Closing (each a "Transferred Employee"). A current list of such employees is set forth on Schedule 4.12(a). The terms of Buyer's offer letter shall provide that upon commencement of employment with Buyer upon the date indicated in their respective offer letters, such employee shall be deemed to have resigned as an employee of Seller. Buyer shall use its commercially reasonable efforts to offer to each such employee a position similar to his or her position immediately prior to the Closing Date at either the same or higher base pay and at the same location at which such employee was employed immediately prior to the Closing Date. Employees who are on short-term disability leave, authorized leave of absence or military service as of the Closing Date shall be offered employment to the same extent, if any, as Seller would be required to offer employment in accordance with applicable Legal Requirements. Notwithstanding the provisions of Section 6.02(a), as of the Effective Date Buyer has offered employment to those Transferred Employees set forth on Schedule 6.02(a), and such Transferred Employees have accepted Buyer's offer of employment (which offer, other than the date thereof, shall otherwise conform with the provisions of Section 6.02(a)), with such exceptions as Buyer considers, in its reasonable discretion, shall not impair or interfere with the operation of the Business after the Closing. (b) Transferred Employees shall be employees at will and nothing expressed or implied in this Agreement (except as set forth in this Section 6.02(b)) will obligate the Buyer to provide continued employment to any Transferred Employee for any specified - ---------- ** Confidential Treatment Requested. -37- period of time following the Closing Date; provided, however, that so long as the Promissory Note remains outstanding Buyer shall not terminate any Transferred Employee other than "for cause." For purposes of this subsection (b), "for cause" shall mean any Transferred Employee's gross negligence, willful misconduct, material non-performance of such employee's duties or conviction of a felony or crime of moral turpitude. Buyer will be the sole judge of the number, identity and qualifications of employees necessary for the conduct of its business operations and reserves the right to take any personnel action it deems necessary or appropriate with respect to Transferred Employees. (c) For the period from January 1, 2007 to the first anniversary of the Closing Date, or such earlier date on which any Transferred Employee's employment is terminated (except with respect to any benefits payable upon or after termination of employment), Buyer shall provide salary, healthcare and 401(k) plan benefits (all of which are set forth on Schedule 6.02(c)) that are substantially similar to, and no less favorable in the aggregate than those provided to such Transferred Employees immediately prior to the Closing Date. (d) With respect to the welfare benefit plans, programs and arrangements maintained, sponsored or contributed to by Buyer ("Buyer Welfare Benefit Plans") in which a Transferred Employee may be eligible to participate on or after January 1, 2007, Buyer shall, to the extent permitted by applicable Legal Requirements (i) permit Transferred Employees to participate in the Buyer Welfare Benefit Plans commencing January 1, 2007, or such later date as such Transferred Employee commences employment with Buyer, and shall use its commercially reasonable efforts to cause its insurance carrier to waive all waiting periods and all limitations as to preexisting and at-work conditions, if any, with respect to participation and coverage requirements applicable to each Transferred Employee under any Buyer Welfare Benefit Plan to the same extent waived under a comparable plan in which such Transferred Employees participated immediately prior to the Closing Date; and (ii) make commercially reasonable efforts to cause any eligible expenses incurred by any Transferred Employee and his or her covered dependents to be taken into account under the Buyer Welfare Benefit Plans for purposes of satisfying all deductible, coinsurance and maximum out-of-pocket requirements applicable to such Transferred Employee and his or her dependents as if such amounts had been paid in accordance with the Buyer Welfare Benefit Plans. (e) Nothing in this Section 6.02, expressed or implied, shall be construed (i) to prevent Buyer from terminating or modifying to any extent or in any respect any benefit plan that Buyer may establish or maintain; provided that appropriate provision is made to comply with the provisions of this Section 6.02 or (ii) except as set forth in Section 6.03(c), to create any third-party beneficiary rights in any Transferred Employee or otherwise give such employees any rights whatsoever under this Agreement. Section 6.03 401(K) PLAN. (a) Except as set forth in Schedule 6.03(a), as of 5:00 p.m., Mountain Standard Time on December 31, 2006, each Transferred Employee who is a participant in -38- the Seller 401(k) Savings and Retirement Plan shall become fully vested in his account balance in the Seller 401(k) Savings and Retirement Plan. Buyer agrees to establish a defined contribution employee pension benefit plan that is qualified under Section 401(a) of the Code (the "Buyer Defined Contribution Plan"), effective no later than January 1, 2007. Transferred Employees shall receive credit for years of service at Seller for purposes of determining the right to receive matching contributions under the Buyer Defined Contribution Plan on terms substantially similar to those provided in the Seller 401(k) Savings and Retirement Plan. Upon receipt of a letter from the administrator of the Seller 401(k) Savings and Retirement Plan that complies with Treas. Regs. Section 1.401(a)(31)-1, Q&A 14(c), Example 2, the Buyer Defined Contribution Plan will accept rollovers of balances in the Seller 401(k) Savings and Retirement Plan, including the rollover of any outstanding participant loan balances held in the Seller 401(k) Savings and Retirement Plan. (b) Before the expiration of the remedial amendment period that applies under Code Section 401(b) to the Buyer Defined Contribution Plan for determination of its initial qualification under Code Section 401(a), Buyer shall apply for a determination by the IRS to the effect that the Buyer Defined Contribution Plan satisfies the requirements for qualification under Section 401(a) of the Code, and Buyer shall take all reasonable actions to ensure continued qualification of the Buyer Defined Contribution Plan under Section 401(a) of the Code. (c) Notwithstanding any other provision of this Agreement, the provisions of this Section 6.03 may be enforced by the Seller or by any Transferred Employee as a third-party beneficiary of this Agreement. Section 6.04 ACCESS TO INFORMATION. Seller will (a) upon reasonable notice give Buyer and its Representatives reasonable access, during normal business hours and in a manner so as not to interfere with the normal business operations of Seller, to the offices, properties, books and records of Seller related to the Business, including without limitation all records and documents of Seller regarding the title, physical condition, development, and operation of the Real Property; and (b) furnish to Buyer and its Representatives such financial and operating data and other information relating to the Business as such Persons may reasonably request, including without limitation copies of all soil, geological, hydrological and other engineering reports, inspections, environmental reports, and site plans and zoning and platting documents that Seller has in its possession concerning the Real Property; provided, however, that, prior to the expiration or termination of any waiting period required by any Governmental Authority or other similar Legal Requirement applicable to the Transaction, Buyer and its Representatives shall only be permitted such reasonable access which, in Seller's reasonable discretion, after consultation with its outside counsel, is appropriate during such review process and provided, further, that in no event shall Seller be obligated to provide any access or information if Seller determines in good faith after consultation with its outside counsel that providing such access or information may violate any applicable Legal Requirement or cause Seller to breach a confidentiality obligation to which it is bound or jeopardize any recognized privilege available to Seller. No information or knowledge obtained in any investigation pursuant to this Section 6.04 shall affect or be deemed to modify any representation or warranty contained in this Agreement. -39- Section 6.05 NOTICE OF CERTAIN EVENTS. During the period between the Effective Date and the Closing, Seller shall give prompt notice to Buyer, and Buyer shall give prompt notice to Seller, of any failure of Seller or Buyer, as the case may be, to comply with or satisfy any covenant or agreement to be complied with or satisfied by it under this Agreement (provided that the delivery of any such notice shall not limit or otherwise affect any remedies available to the Party receiving such notice). ARTICLE VII ADDITIONAL AGREEMENTS Section 7.01 CONFIDENTIALITY. (a) Any non-public information that Buyer or Parent may obtain from Seller in connection with this Agreement with respect to the Business, Seller or any of its Affiliates shall be deemed confidential and, unless and until Closing shall occur, neither Buyer nor Parent shall disclose any such information to any third party (other than its Representatives whose knowledge thereof is necessary or advisable in order to facilitate the consummation of the Transaction) or use such information to the detriment of Seller; provided that (i) Buyer and Parent may use and disclose any such information once it has been publicly disclosed (other than by Buyer or Parent or any of their respective Representatives in breach of its obligations under this Section 7.01(a)) or which rightfully has come into the possession of Buyer or Parent (other than from Seller or any of its Representatives); and (ii) to the extent that Buyer or Parent may become compelled by any Legal Requirement to disclose any of such information, Buyer or Parent may disclose such information if it shall have used all reasonable efforts, and shall have afforded Seller the opportunity, to obtain an appropriate protective order, or other satisfactory assurance of confidential treatment, for the information compelled to be disclosed. In the event of termination of this Agreement, Buyer and Parent shall use all reasonable efforts to cause to be delivered to Seller, and retain no copies of, any documents, work papers and other materials obtained by Buyer or Parent or on its behalf from Seller or any of its Affiliates or Representatives, whether so obtained before or after the execution hereof. (b) Any non-public information that Seller shall obtain from Buyer or Parent in connection with this Agreement with respect to Buyer or any of its Affiliates, or with respect to any of the Purchased Assets, any of the Assumed Liabilities, or the Business, shall be deemed confidential, and Seller shall not disclose such information to any third party or use such information to the detriment of Buyer or Parent or the Business; provided, that (i) Seller may use and disclose any such information once it has been publicly disclosed (other than by Seller or any of its Representatives in breach of its obligations under this Section 7.01(b)) or which rightfully has come into the possession of Seller (other than from Buyer or Parent or any of their respective Representatives); and (ii) to the extent that Seller may become compelled by any Legal Requirement to disclose any of such information, Seller may disclose such information if it shall have used all reasonable efforts, and shall have afforded Buyer and Parent the opportunity, to obtain an appropriate protective order, or other satisfactory assurance of confidential treatment, for the information compelled to be disclosed. In the event of termination of this Agreement, -40- Seller shall use all reasonable efforts to cause to be delivered to Buyer or its Affiliates, and retain no copies of, any documents, work papers, and other materials obtained by Seller or on its behalf from Buyer or Parent or any of their respective Affiliates or Representatives, whether so obtained before or after the execution hereof. (c) Except as otherwise set forth herein, the Parties acknowledge that the Transaction is of a confidential nature and shall not be disclosed prior to the Closing except to Representatives whose knowledge thereof is necessary or advisable in order to facilitate the consummation of the Transaction, or as required by any Legal Requirement. Buyer and Parent acknowledge that Seller intends to issue a press release upon the execution of this Agreement, and Seller agrees to provide a copy of such press release, in the form attached hereto as Exhibit 7.01(c), to Buyer. Seller and Buyer shall consult with and cooperate with the other with respect to any oral or written statements to the Employees concerning this Agreement and the Transaction. Buyer shall make only those press releases or other public disclosures as are required by applicable Legal Requirements. Section 7.02 USE OF PROCEEDS. Seller covenants and agrees (a) to retain [**] of the Purchase Price it receives from Buyer, and (b) not to declare or pay any dividend or make any other distribution of any of the Purchase Price to QLT Inc. or any of its Affiliates, until such time as the litigation specifically identified in Schedule 2.03 is finally resolved without further possibility of appeal. Section 7.03 NO SHOP AND NON-SOLICITATION. Seller agrees that it will not during the No Shop Period directly or indirectly, through any Affiliate or Representative, seek or solicit, initiate, entertain or encourage any proposals or offers from any Person relating to the acquisition, in one or a series of related transactions, of the Business (a "Third Party Acquisition"); nor will Seller participate in any discussions or negotiations regarding, or furnish to any Person any information with respect to, or otherwise cooperate with, facilitate or encourage any effort or attempt by any Person to do or seek any Third Party Acquisition (it being understood that an acknowledgement only of an unsolicited inquiry by Seller to an inquiring Person advising such Person of Seller's obligations hereunder shall not be deemed a discussion or negotiation in violation of the provisions of this Section 7.03), and if Seller receives any such unsolicited inquiry it shall promptly, and in no event later than the next Business Day, inform Buyer thereof, but Seller shall not otherwise be required to identify such third party or disclose the terms or conditions of such inquiry. Upon commencement of the No Shop Period, Seller shall immediately cease and cause to be terminated all such contacts or negotiations with any Person as to any Third Party Acquisition. Section 7.04 COBRA. Seller covenants and agrees that Seller shall provide COBRA for all employees who do not become Transferred Employees and who are COBRA Qualified Beneficiaries existing as of the Closing. For purposes of this Section 7.04, "COBRA Qualified Beneficiaries" shall mean any person entitled to benefits under Code Section 4980B or ERISA Section 601 et al. - ---------- ** Confidential Treatment Requested. -41- ARTICLE VIII TERMINATION OF AGREEMENT. Section 8.01 GROUNDS FOR TERMINATION. At any time prior to the Closing, this Agreement may be terminated (a) upon the mutual written consent of Buyer and Seller and (b) Buyer may terminate this Agreement if any Required Consent that has been obtained with respect to any Key Contract is rescinded or withdrawn prior to the Closing. Section 8.02 EFFECT OF TERMINATION. If this Agreement is terminated in accordance with Section 8.01, all obligations of the Parties hereunder shall terminate, except for the obligations set forth in this Article VIII and the provisions of Sections 7.01, 10.02, 10.03, 10.06 and 10.08 through 10.15; provided, that such termination shall not release either Party from any Liability that has already accrued as of the effective date of such termination, and shall not constitute a waiver or release of, or otherwise be deemed to prejudice or adversely affect, any rights, remedies or claims, whether for damages or otherwise, which a Party may have hereunder, at law, equity or otherwise or which may arise out of or in connection with such termination. ARTICLE IX INDEMNIFICATION Section 9.01 SURVIVAL OF REPRESENTATIONS AND WARRANTIES. All representations and warranties of Seller or Buyer in this Agreement or any Conveyance Document shall survive the Closing until February 28, 2008 (the "Survival Date"); provided, that any claim for indemnification based upon a breach of any such representation or warranty and asserted prior to the Survival Date by written notice in accordance with Section 9.05 shall survive until final resolution of such claim; and provided further, that the representations and warranties set forth in Section 4.17 shall survive until the expiration of the applicable statute of limitations period with respect to such matters. Section 9.02 INDEMNIFICATION BY SELLER. Subject to the limitations set forth in this Article IX, Seller shall indemnify, defend and hold harmless Buyer and its Representatives from and against any and all Damages, whether or not involving a third party claim, including reasonable attorneys' fees (collectively, "Buyer Damages"), arising out of, relating to or resulting from: (a) any breach of a representation or warranty of Seller contained in this Agreement or any Conveyance Document; (b) any breach of a covenant of Seller contained in this Agreement or in any Conveyance Document; (c) any claim made by a Transferred Employee against Buyer solely relating to Seller's use or possession of such Transferred Employee's personnel records or similar information retained by Seller, but not to the extent such claim relates to the delivery of -42- copies of any such records by Seller to Buyer pursuant to this Agreement or the use by Buyer of such records; or (d) any Excluded Asset or Excluded Liability. Section 9.03 INDEMNIFICATION BY BUYER. Subject to the limitations set forth in this Article IX, Buyer shall indemnify, defend and hold harmless Seller and its Representatives from and against any and all Damages, whether or not involving a third party claim, including reasonable attorneys' fees (collectively, "Seller Damages"), arising out of, relating to or resulting from: (a) any breach of a representation or warranty of Buyer contained in this Agreement or in any Security Document or the Non-Competition Agreement; (b) any breach of a covenant of Buyer or Parent contained in this Agreement or in any Security Document or the Non-Competition Agreement; (c) any claim made by a Transferred Employee relating to Buyer's or Parent's use or possession of such Transferred Employee's personnel records or similar information obtained from Seller at the request of Buyer or Parent; or (d) any Assumed Liability. Section 9.04 ENVIRONMENTAL INDEMNIFICATION. In addition to the other indemnification provisions in this Article IX: (a) Seller shall indemnify, defend and hold harmless Buyer from and against any and all Damages arising out of, relating to or resulting from the actual or alleged presence, Release or threatened Release of Hazardous Materials, and the actual or alleged violation of any Environmental Law or Environmental Permit (including costs of cleanup, containment or other remediation) with respect or relating to the Real Property or the Manufacturing Facility, but only to the extent such violation, Release, threatened Release or presence is shown by Buyer, by a preponderance of evidence, to have originated during the Pre-Closing Period. A Release during the Pre-Closing Period, that continues or that continued during the Post-Closing Period, shall be deemed to have originated during the Pre-Closing Period, but only to the extent such Release is shown by Buyer, by a preponderance of evidence, to have originated during the Pre-Closing Period. (b) Subject to the last sentence of Section 9.04(a), Buyer shall indemnify, defend and hold harmless Seller from and against any and all Damages arising out of, relating to or resulting from the actual or alleged presence, Release or threatened Release of Hazardous Materials, and the actual or alleged violation of any Environmental Law or Environmental Permit (including costs of cleanup, containment or other remediation) with respect or relating to the Real Property or the Manufacturing Facility, but only to the extent such violation, release or presence is not shown by Buyer, by a preponderance of evidence, to have originated during the Pre-Closing Period. -43- Section 9.05 PROCEDURES FOR INDEMNIFICATION; BUYER'S SECURITY INTEREST IN ESCROW AMOUNT. (a) Claims for Indemnification. All claims for indemnification under this Article IX shall be asserted and resolved as follows: (i) In the event that any claim or demand for which any Party (the "Indemnitor") would be liable under this Article IX to any other Party (the "Indemnitee") hereunder is asserted against or sought to be collected by a third party: (A) the Indemnitee shall promptly notify the Indemnitor of such claim or demand specifying the nature of such claim or demand and the amount or the estimated amount thereof to the extent then reasonably practicable (which estimate shall not be conclusive of the final amount of such claim or demand) (the "Claim Notice"); provided, however, that the failure of the Indemnitee to give notice as provided herein shall not relieve an Indemnitor of its obligations under this Article IX, except to the extent the Indemnitor is actually prejudiced thereby; (B) the Indemnitor shall have thirty (30) days from its receipt of the Claim Notice (the "Notice Period") to notify the Indemnitee (x) whether the Indemnitor disputes its liability to the Indemnitee hereunder with respect to such claim or demand, and (y) if it does not dispute such liability, whether it desires, at its sole cost and expense, to defend the Indemnitee against such claim or demand; provided, however, that the Indemnitee is hereby authorized prior to and during the Notice Period to file any motion, answer or other pleading which it reasonably deems necessary or appropriate to protect its interests; (C) if the Indemnitor notifies the Indemnitee within the Notice Period that the Indemnitor does not dispute such liability and desires to defend against such claim or demand, then except as hereinafter provided, the Indemnitor shall have the right to defend by appropriate proceedings, provided that the Indemnitor shall not settle any such claim without the prior written consent of the Indemnitee, unless any such settlement involves only the payment of money and provides for the delivery of a full release of any liability to the Indemnitee. The Indemnitee shall make available to the Indemnitor, at the Indemnitor's expense, any documents and materials in its possession or control that may be necessary or useful to such defense; (D) if the Indemnitor notifies the Indemnitee within the Notice Period and if the Indemnitee desires to participate in, but not control, any such defense or settlement it may do so at its sole cost and expense. Notwithstanding the foregoing, the Indemnitor shall not be entitled to assume the defense of any third party claim (and shall be liable for the fees -44- and expenses of counsel incurred by the Indemnitee in defending such third party claim) if (i) the third party claim seeks an order, injunction or other equitable relief or relief for other than money damages against the Indemnitee which the Indemnitee reasonably determines, after conferring with its outside counsel, cannot be separated from any related claim for money damages or (ii) if (A) the Indemnitor has failed after a reasonable period of time to assume such defense and to employ counsel, or (B) as evidenced by the opinion of counsel, different defenses would be available to the Indemnitee in such action such that a conflict of interest exists that makes control by the Indemnitor not advisable. In such an event, the Indemnitee shall be entitled to, with respect to clause (i), assume the defense of the portion relating to claims involving an injunction or other equitable relief or for relief other than money damages and, with respect to clause (ii), assume the defense of the entire proceeding; and (E) if the Indemnitor disputes the Indemnitor's liability with respect to such claim or demand within the Notice Period, then the amount of any such claim or demand, or, if the same be contested by the Indemnitor or by the Indemnitee, then that portion thereof as to which such defense is unsuccessful, as well as any associated obligations and expenses, shall be conclusively deemed to be a liability of the Indemnitor (subject, if the Indemnitor has timely disputed liability, to a determination that the disputed liability is covered by these indemnification provisions). (b) In the event the Indemnitee has a claim against the Indemnitor under this Article IX that does not involve a claim or demand being asserted against or sought to be collected from it by a third party, the Indemnitee shall promptly send a Claim Notice with respect to such claim to the Indemnitor. If the Indemnitor does not notify the Indemnitee within the Notice Period that it disputes such claim, the amount of such claim shall be conclusively deemed a liability of the Indemnitor hereunder. (c) Buyer shall submit any claim for indemnification under this Article IX in accordance with the provisions of the Escrow Agreement; provided, however, that in the event Buyer Damages are in excess of the Escrow Amount, but less than Seller's Indemnification Cap, upon notice to Seller specifying in reasonable detail the basis therefore, Buyer may set off any amount to which it may be entitled under this Article IX against amounts otherwise payable under the Promissory Note; provided that Buyer must give notice of such a claim for such amount under and in accordance with the terms of the Escrow Agreement. To secure Buyer's right to recover upon Seller's indemnification obligations under this Agreement, pursuant to and as more fully set forth in the Escrow Agreement, Seller shall grant to Buyer a first-priority lien and security interest upon the Escrow Amount. Seller and the Escrow Agent shall authorize, cooperate and assist with and otherwise take all actions reasonably necessary to perfect Buyer's liens and security interests in the Escrow Amount, including the filing of any financing statements deemed necessary by Buyer under any provisions of the Uniform Commercial Code applicable to Buyer, Seller or the Escrow, all as deemed necessary by Buyer and acceptable to Buyer in Buyer's reasonable discretion. -45- Section 9.06 LIMITATIONS ON INDEMNIFICATION. (a) Limitations on Seller's Obligation to Indemnify Buyer. Notwithstanding anything herein to the contrary, Seller shall not be obligated to indemnify Buyer under this Article IX: (i) unless the aggregate of all Buyer Damages exceeds [**] ("Seller's Basket"), in which case the Buyer shall be entitled to recover all Buyer Damages in excess of Seller's Basket; or (ii) to the extent that the aggregate of all Buyer Damages exceeds [**] ("Seller's Indemnification Cap"); provided, that Seller's Indemnification Cap and Seller's Basket shall not apply to any Seller indemnification obligation arising out of, relating to or resulting from (x) fraud, intentional misrepresentation or willful misconduct by Seller; (y) from a breach of Sections 4.01, 4.02, 4.17 or 4.18, or (z) arising out of, relating to or resulting under Sections 9.02(b) and 9.02(d). (b) Limitations on Buyer's Obligation to Indemnify Seller. Notwithstanding anything herein to the contrary, Buyer shall not be obligated to indemnify Seller under this Article IX: (i) unless the aggregate of all Seller Damages exceeds [**] ("Buyer's Basket"), in which case the Seller shall be entitled to recover all Seller Damages in excess of Buyer's Basket; or (ii) to the extent that the aggregate of all Seller Damages exceeds [**] ("Buyer's Indemnification Cap"); provided, that the Buyer's Indemnification Cap and Buyer's Basket shall not apply to any Buyer indemnification obligation arising out of, relating to or resulting from (x) fraud, intentional misrepresentation or willful misconduct by Buyer; (y) from a breach of Sections 5.01, 5.02 or 5.05, or (z) arising out of, relating to or resulting under Sections 9.03(b) and 9.03(d). (c) Indemnification Payment Net of Insurance. Any payment made by Seller pursuant to Section 9.02, on the one hand, or by Buyer pursuant to Section 9.03, on the other hand, pursuant to this Article IX in respect of any claim (i) shall be net of any insurance proceeds realized by and paid to the indemnified party in respect of such claim; and (ii) shall be (A) reduced by an amount equal to any Tax benefits attributable to such claim; and (B) increased by an amount equal to any Taxes attributable to the receipt of such payment, but only to the extent that such Tax benefits are actually realized, or such Taxes are actually paid, as the case may be, by Seller or by Buyer or by any consolidated, combined or unitary group of which such Party is a member. The indemnified party shall use its reasonable efforts to make insurance claims relating to any claim for which it is - ---------- ** Confidential Treatment Requested. -46- seeking indemnification pursuant to this Article IX, provided that the indemnified party shall not be obligated to make such an insurance claim if the indemnified party in its reasonable judgment believes that the cost of pursuing such an insurance claim together with any corresponding increase in insurance premiums or other chargebacks to the indemnified party, as the case may be, would exceed the value of the claim for which the indemnified party is seeking indemnification. Section 9.07 DAMAGES LIMITATIONS. Notwithstanding any other provision hereof, in no event shall Seller be liable or obligated to indemnify Buyer from and against any consequential, indirect or special damages, including, without limitation, lost profits, business interruption and loss of business opportunities or goodwill. This exclusion of any such consequential, indirect or special damages shall apply whether the action in which recovery of damages is sought is based on contract, tort, (including sole, concurrent or other negligence or strict liability), statute or otherwise. To the extent permitted by applicable Legal Requirements, any statutory remedies that are inconsistent with this Section 9.07 are waived. Section 9.08 SPECIFIC PERFORMANCE. Each Party acknowledges and agrees that the Business is unique and recognizes and affirms that in the event that the Transaction does not close (other than due to the termination of this Agreement pursuant to and in accordance with the provisions of Section 8.01), or in the event that any provision of Article VII is not performed in accordance with its specific terms or otherwise is breached, that the non-breaching Party would be damaged irreparably, that money damages would be inadequate and that the non-breaching Party would have no adequate remedy at law, so that the non-breaching Party shall have the right, in addition to any other rights and remedies existing in its favor, to enforce its rights and the other Parties' obligations hereunder not only by action for damages but also by action for specific performance, injunctive, and/or other equitable relief to cause the Transaction to close as contemplated by and in accordance with the terms of this Agreement and to enforce specifically the terms and provisions of Article VII. Section 9.09 EXCLUSIVE REMEDY. Except for claims involving fraud or willful misconduct, for equitable relief or a breach of this Article IX, the indemnification remedies provided in this Article IX shall be the exclusive remedies available to the Parties and their respective Affiliates following the Closing with respect to (a) any claims for any inaccuracy or breach of any representation or warranty made by the Parties contained in this Agreement or in any of the certificates or Conveyance Documents furnished by any Party pursuant to this Agreement; or (b) any non-compliance with or breach of or default in the performance of any of the covenants or agreements contained in this Agreement, and the Parties shall not be entitled to a rescission of this Agreement or to any further indemnification or other rights or claims of any nature whatsoever in respect thereof, all of which the Parties hereto hereby waive; provided, however, that the remedies provided in this Article IX with respect to the Security Documents, the Non-Competition Agreement and the Manufacturing and Supply Agreements, if any, shall be cumulative and shall not preclude any Party from asserting any other right, or seeking any other remedies, against any other Party which it may have under such documents. Section 9.10 CHARACTERIZATION OF INDEMNIFICATION PAYMENT. Any payment made after the Closing pursuant to indemnification obligations arising under this Agreement shall be treated -47- as an adjustment to the Purchase Price for all purposes, including federal, state and local Tax and financial accounting purposes. Section 9.11 NO OTHER REPRESENTATION. Each of Buyer and Parent acknowledges and agrees (a) that, except for the representations and warranties contained in Article IV or Section 6.01, none of Seller or its Affiliates nor any of their respective directors, officers, employees, subsidiaries, controlling persons, agents or Representatives, makes or has made any representation or warranty, either express or implied, as to the accuracy or completeness of any information relating to Seller provided or otherwise made available prior to the Closing (including in management presentations and including any projections, forecast or forward-looking information) to Buyer or Parent, each of its shareholders, Affiliates, lenders, holders of its indebtedness or any of their respective directors, officers, employees, Affiliates, controlling persons, agents or Representatives; and (b) that, to the fullest extent permitted by any Legal Requirement, Seller and its Affiliates and their respective directors, officers, employees, subsidiaries, controlling persons, agents or Representatives shall not have any Liability to Buyer or Parent, each of its shareholders, Affiliates, lenders, holders of its indebtedness or any of their respective directors, officers, employees, Affiliates, controlling persons, agents or Representatives based upon any information provided or made available prior to the Closing to Buyer or Parent or such shareholder, Affiliate, lender, holder of its indebtedness, director, officer, employee, Affiliate, controlling person, agent or representative thereof on any basis (including in contract or tort), except (i) with respect to the representations and warranties set forth in Article IV or Section 6.01 and subject to the limitations and restrictions contained in this Agreement; and (ii) with respect to claims for or in the nature of fraud. ARTICLE X MISCELLANEOUS Section 10.01 AMENDMENTS AND WAIVERS. This Agreement may not be amended, supplemented or modified, except by an agreement in writing signed by each of the Parties. Either Party may waive compliance by the other Parties with any term or provision of this Agreement; provided, that such waiver shall not operate as a waiver of, or estoppel with respect to, any other or subsequent failure. No waiver shall be effective unless it is in writing and is signed by the Party asserted to have granted such waiver. Section 10.02 NOTICES. All notices, requests, demands and other communications required or permitted under this Agreement shall be in writing and shall be deemed to have been duly given, made and received (a) when delivered personally or by telecopy; (b) one (1) Business Day, if in the United States and three (3) Business Days if outside the United States following the day when deposited with a reputable, established overnight courier service for delivery to the intended addressee; or (c) three (3) Business Days following the day when deposited with the United States Postal Service as first class, registered or certified mail, postage prepaid and addressed as set forth below: -48- If to Buyer or Parent: Tolmar, Inc. 701 Centre Avenue Fort Collins, Colorado 80526 Attention: Chief Executive Officer Telephone No.: (970) 212-4990 Facsimile No.: (970) 494-0241 With a copy, which shall not Tolmar, Inc. constitute notice, given in the manner Av. Cabildo 86 prescribed above, to: 5 floor (1426) Capital Federal Buenos Aires, Argentina Attention: Secretary Telephone No.: +(54)-11-4776-7197 Facsimile No.: +(54)-11-4899-2828 With a copy, which shall not Holme Roberts & Owen LLP constitute notice, given in the manner 1700 Lincoln Street, Suite 4100 prescribed above, to: Denver, Colorado 80203 Attention: Troy R. Braegger, Esq. Telephone No.: (303) 866-0454 Facsimile No.: (303) 866-0200 If to Seller: QLT USA, Inc. 2579 Midpoint Drive Fort Collins, Colorado 80525 Attention: President Telephone No.: (970) 482-5868 Facsimile No.: (970) 482-9735 With a copy, which shall not Morrison & Foerster LLP constitute notice, given in the manner 5200 Republic Plaza prescribed above, to: 370 Seventeenth Street Denver, CO 80202 Attention: Warren L. Troupe, Esq. Telephone No.: (303) 592-1500 Facsimile No.: (303) 592-1510 Either Party may alter its notice address by notifying the other Parties of such change of address in conformity with the provisions of this Section 10.02. Section 10.03 APPLICABLE LAW. This Agreement is to be construed in accordance with and governed by the internal laws of the State of Colorado, without giving effect to any choice of law rule that would cause the application of the laws of any jurisdiction other than the internal laws of the State of Colorado to the rights and duties of the Parties. -49- Section 10.04 EXHIBITS AND SCHEDULES. All Exhibits and Schedules attached hereto are hereby incorporated by reference into, and made a part of, this Agreement. Section 10.05 ASSIGNMENTS; SUCCESSORS AND ASSIGNS. Neither this Agreement nor any rights or obligations hereunder may be assigned or otherwise transferred by any Party without the prior written consent of the other Parties. Any purported assignment or other disposition by a Party, except as permitted herein, shall be null and void. For purposes of this Section 10.05, the terms "assign" and "assignment" shall be deemed to include (a) a merger in which a Party is not the surviving entity; (b) a consolidation or division of a Party; (c) a sale of all or substantially all of the assets of a Party; or (d) a change of control resulting from a sale or repurchase of shares or similar transaction involving a Party. Subject to the foregoing, this Agreement shall be binding upon and shall inure to the benefit of the Parties and their respective successors and permitted assigns. Section 10.06 NO THIRD-PARTY BENEFICIARIES. Except as provided in Section 6.03(c) of this Agreement, the terms and provisions of this Agreement are intended solely for the benefit of each Party and their respective successors and permitted assigns, and the Parties do not intend to confer third-party beneficiary rights upon any other Person. Section 10.07 COUNTERPARTS. This Agreement may be executed (including, without limitation, by facsimile signature) in one or more counterparts, with the same effect as if the Parties had signed the same document. Each counterpart so executed shall be deemed to be an original, and all such counterparts shall be construed together and shall constitute one agreement. Section 10.08 SEVERABILITY. If any provision of this Agreement, or the application of any such provision to any Person or set of circumstances, shall be determined to be invalid, unlawful, void or unenforceable to any extent, the remainder of this Agreement, and the application of such provision to Persons or circumstances other than those as to which it is determined to be invalid, unlawful, void or unenforceable, shall not be impaired or otherwise affected and shall continue to be valid and enforceable to the fullest extent permitted by law. Section 10.09 ENTIRE AGREEMENT. This Agreement, together with the Transaction Documents referred to herein, contains the entire understanding between the Parties with respect to the subject matter hereof and supersedes all prior and contemporaneous agreements and understandings, inducements or conditions, express or implied, oral or written, between the Parties. The Parties intend that this Agreement, together with the Transaction Documents referred to above, be the several, complete and exclusive embodiment of their agreement, and that any evidence, oral or written, of a prior or contemporaneous agreement that alters or modifies this Agreement shall not be admissible in any Proceeding concerning this Agreement. The express terms hereof control and supersede any course of performance and/or usage of the trade inconsistent with any of the terms hereof. Section 10.10 INTERPRETATION. Unless otherwise indicated herein, with respect to any reference made in this Agreement to a Section (or Article, Subsection, Paragraph, Subparagraph or Clause), Exhibit or Schedule, such reference shall be to a section (or article, subsection, paragraph, subparagraph or clause) of, or an exhibit or schedule to, this Agreement. The table of contents and any article, section, subsection, paragraph or subparagraph headings contained in -50- this Agreement are for reference purposes only and shall not affect in any way the meaning or interpretation of this Agreement. Whenever the words "include," "includes" or "including" are used in this Agreement, they shall be deemed, as the context indicates, to be followed by the words "but (is/are) not limited to." Words used herein, regardless of the number and gender specifically used, shall be deemed and construed to include any other number, singular or plural, and any other gender, masculine, feminine or neuter, as the context indicates is appropriate. Where specific language is used to clarify or illustrate by example a general statement contained herein, such specific language shall not be deemed to modify, limit or restrict the construction of the general statement which is being clarified or illustrated. Section 10.11 CONSTRUCTION. The construction of this Agreement shall not take into consideration the Party who drafted or whose representative drafted any portion of this Agreement, and no canon of construction shall be applied that resolves ambiguities against the drafter of a document. Each Party acknowledges that: (a) it has read this Agreement; (b) it has been represented in the preparation, negotiation and execution of this Agreement by legal counsel of its own choice or has voluntarily declined to seek such counsel; and (c) it understands the terms and consequences of this Agreement and is fully aware of the legal and binding effect of this Agreement. Section 10.12 EXPENSES OF THE PARTIES. Subject to provisions contained herein relating to recovery of fees in connection with legal actions or proceedings, each Party shall bear the expenses incurred by such Party in connection with the negotiation and execution of this Agreement and the consummation of the Transaction, including, but not limited to, all legal, accounting, financial, advisory, consulting and all other fees and expenses of third parties incurred by a Party in connection with the negotiation and effectuation of the terms and conditions of this Agreement and the Transaction contemplated hereby, shall be the obligation of the respective Party incurring such fees and expenses. Section 10.13 JURISDICTION; SERVICE OF PROCESS. Any Proceeding seeking to enforce any provision of, or based on any right arising out of, this Agreement may be brought against any of the Parties only in the courts of the State of Colorado, City and County of Denver, or, if it has or can acquire the necessary jurisdiction, in the United States District Court for the District of Colorado. Each of the Parties hereby waives, and agrees not to assert, as a defense in any action, suit or proceeding for the interpretation or enforcement of this Agreement, that it is not subject thereto or that such action, suit or proceeding may not be brought or is not maintainable in said courts or that the venue thereof may not be appropriate or that this Agreement may not be enforced in or by such courts and the Parties hereto irrevocably agree that all shall be heard and determined in such a Colorado State or federal court. Process in any Proceeding referred to in the preceding sentence may be served on either Party anywhere in the world. Section 10.14 WAIVER OF JURY TRIAL. THE PARTIES HEREBY EXPRESSLY WAIVE THE RIGHT TO A TRIAL BY JURY IN ANY ACTION OR PROCEEDING BROUGHT BY OR AGAINST EITHER OF THEM RELATING TO THIS AGREEMENT. THE PARTIES ACKNOWLEDGE THAT THIS AGREEMENT INVOLVES COMPLEX TRANSACTIONS AND THAT DISPUTES HEREUNDER WILL BE MORE QUICKLY AND ECONOMICALLY RESOLVED BY AN EXPERIENCED AND EXPERT DECISION MAKER. ACCORDINGLY, THE PARTIES AGREE, BASED ON THE ADVICE OF THEIR -51- COUNSEL, THAT ANY DISPUTE HEREUNDER BE RESOLVED BY A JUDGE APPLYING APPLICABLE LAW. Section 10.15 RECOVERY OF FEES BY PREVAILING PARTY. If any legal action, including, without limitation, an action for arbitration or injunctive relief, is brought relating to this Agreement or the breach or alleged breach hereof, the prevailing Party in any final judgment or arbitration award, or the non-dismissing Party in the event of a voluntary dismissal by the Party instituting the action, shall be entitled to the full amount of all reasonable expenses, including all court costs, arbitration fees and actual attorneys' fees paid or incurred in good faith. Section 10.16 SELLER DISCLOSURE SCHEDULE. The Seller Disclosure Schedule is hereby incorporated into this Agreement to the same extent as though fully set forth herein. Section 10.17 TIME OF THE ESSENCE. With regard to all dates and time periods set forth or referred to in this Agreement, time is of the essence. [SIGNATURES FOLLOW ON A SEPARATE PAGE] -52- IN WITNESS WHEREOF, each of the Parties has caused this Agreement to be executed and delivered on its behalf by their respective officers thereunto duly authorized all as of the Effective Date. "Buyer" Tolmar, Inc. By: /s/ Patricio Martin Rodriguez ------------------------------------ Name: Patricio Martin Rodriguez Title: Vice President "Seller" QLT USA, INC. By: /s/ Sean F. Moriarty ------------------------------------ Name: Sean F. Moriarty Title: President "Parent" DILLFORD COMPANY S.A. By: /s/ Jorge Ramos Manso ------------------------------------ Name: Jorge Ramos Manso Title: Attorney-in-Fact
EX-10.19 3 o34971exv10w19.txt COLLABORATION, LICENSE & SUPPLY AGREEMENT 12-8-00 EXHIBIT 10.19 CONFIDENTIAL TREATMENT REQUESTED BY QLT INC. COLLABORATION, LICENSE AND SUPPLY AGREEMENT BETWEEN ATRIX LABORATORIES, INC. AND SANOFI-SYNTHELABO INC. TABLE OF CONTENTS
SECTION PAGE NO. - ------- -------- Article I DEFINITIONS........................................................... 1 Article II COLLABORATION........................................................ 8 Section 2.01. Objectives..................................................... 8 Section 2.02. Development Program............................................ 8 Section 2.03. Atrix Obligations.............................................. 9 Section 2.04. Sanofi-Synthelabo Obligations.................................. 9 Section 2.05. Availability of Resources; Cooperation......................... 9 Article III LICENSE............................................................. 10 Section 3.01. License Fee.................................................... 10 Section 3.02. License Terms.................................................. 10 Section 3.03. Marks.......................................................... 11 Article IV ROYALTY AND MILESTONE PAYMENTS....................................... 11 Section 4.01. Research and Development Expenses.............................. 11 Section 4.02. Royalty Payments............................................... 11 Section 4.03. Milestone Payments............................................. 11 Section 4.04. Additional Milestone Payments.................................. 11 Section 4.05. Reports........................................................ 11 Article V NEW PRODUCT........................................................... 13 Section 5.01. New Product.................................................... 13 Section 5.02. Right of First Negotiation..................................... 13 Article VI COMMERCIALIZATION.................................................... 14 Section 6.01. Promotion And Marketing Obligations............................ 14 Article VII MANUFACTURE AND SUPPLY.............................................. 16 Section 7.01. Agreement to Supply Product.................................... 16 Section 7.02. Quality Assurance.............................................. 16 Section 7.03. Atrix's Duties................................................. 17 Section 7.04. Compliance with Applicable Laws................................ 18 Section 7.05. Second Manufacturing Source.................................... 18 Section 7.06. Failure to Supply.............................................. 18 Section 7.07. Allocation..................................................... 19 Article VIII PURCHASE AND SALE.................................................. 19 Section 8.01. Purchase Price and Payment..................................... 19 Section 8.02. Adjustment to Purchase Price/Audit............................. 20 Section 8.03. Labeling....................................................... 21 Section 8.04. Purchase Forms................................................. 21 Section 8.05. Confirmation................................................... 21
Section 8.06. Delivery....................................................... 21 Section 8.07. Forecasts and Orders........................................... 21 Section 8.08. Demonstration Samples.......................................... 23 Article IX WARRANTY, REJECTION AND INSPECTIONS.................................. 23 Section 9.01. Atrix Warranty................................................. 23 Section 9.02. Rejection of Product for Failure to Conform to Specifications.. 23 Section 9.03. Sanofi-Synthelabo Inspections.................................. 24 Article X REGULATORY COMPLIANCE................................................. 24 Section 10.01. Marketing Authorization Holder................................. 24 Section 10.02. Maintenance Of Marketing Authorizations........................ 24 Section 10.03. Interaction with Competent Authorities......................... 24 Section 10.04. Adverse Drug Event Reporting and Phase IV Surveillance......... 25 Section 10.05. Post - First Commercial Sale Testing And Reporting............. 26 Section 10.06. Assistance..................................................... 26 Section 10.07. Compliance..................................................... 26 Article XI PATENTS AND TRADEMARKS............................................... 27 Section 11.01. Maintenance of Patents or Marks................................ 27 Section 11.02. Cooperation.................................................... 27 Section 11.03. Atrix to Prosecute Infringement................................ 27 Section 11.04. Infringement Claimed by Third Parties.......................... 28 Article XII CONFIDENTIALITY..................................................... 28 Section 12.01. Confidentiality................................................ 28 Section 12.02. Disclosure of Agreement........................................ 28 Article XIII ATRIX'S OPTION TO MARKET THE PRODUCT UNDER CERTAIN CIRCUMSTANCES... 29 Section 13.01. Co-Marketing Rights............................................ 29 Article XIV REPRESENTATIONS AND WARRANTIES...................................... 29 Section 14.01. Corporate Power................................................ 29 Section 14.02. Due Authorization.............................................. 29 Section 14.03. Binding Obligation............................................. 29 Section 14.04. Ownership of Atrigel(R) Patent Rights.......................... 30 Section 14.05. Patent Proceedings............................................. 30 Section 14.06. Legal Proceedings.............................................. 30 Section 14.07. Atrix's Manufacturing Facility................................. 30 Section 14.08. Limitation on Warranties....................................... 30 Section 14.09. Limitation of Liability........................................ 30 Article XV INDEMNIFICATION...................................................... 31 Section 15.01. Sanofi-Synthelabo Indemnified by Atrix......................... 31 Section 15.02. Atrix Indemnified by Sanofi-Synthelabo......................... 31 Section 15.03. Prompt Notice Required......................................... 31 Section 15.04. Indemnitor May Settle.......................................... 31 Article XVI COVENANTS........................................................... 32 Section 16.01. Covenant Not To Launch Competitive Product..................... 32 Section 16.02. Limitation To The Territory.................................... 33
ii Section 16.03. Access to Books and Records.................................... 33 Section 16.04. A&S Spending Levels............................................ 33 Section 16.05. Marketing Expenses............................................. 34 Section 16.06. Compliance..................................................... 34 Section 16.07. Protection of the Marks........................................ 34 Section 16.08. Launch Quantities.............................................. 34 Section 16.09. Further Actions................................................ 34 Article XVII PRODUCT RECALL..................................................... 35 Section 17.01. Product Recalls or Withdrawal.................................. 35 Section 17.02. Recall Costs................................................... 35 Section 17.03. Notification Of Complaints..................................... 36 Section 17.04. Notification Of Threatened Action.............................. 36 Article XVIII INSURANCE......................................................... 36 Section 18.01. Insurance...................................................... 36 Article XIX TERM; DEFAULT AND TERMINATION....................................... 37 Section 19.01. Term........................................................... 37 Section 19.02. Termination by Either Party.................................... 37 Section 19.03. Termination by Either Party for Cause.......................... 37 Section 19.04. Termination by Atrix........................................... 37 Section 19.05. Termination by Sanofi-Synthelabo............................... 38 Section 19.06. Remedies....................................................... 38 Section 19.07. Effect of Termination.......................................... 38 Article XX MISCELLANEOUS........................................................ 41 Section 20.01. No-Solicitation................................................ 41 Section 20.02. Commercially Reasonable Efforts................................ 41 Section 20.03. Assignment..................................................... 41 Section 20.04. Force Majeure.................................................. 41 Section 20.05. Governing Law.................................................. 42 Section 20.06. Waiver......................................................... 42 Section 20.07. Severability................................................... 42 Section 20.08. Notices........................................................ 42 Section 20.09. Independent Contractors........................................ 43 Section 20.10. Rules of Construction.......................................... 43 Section 20.11. Publicity...................................................... 43 Section 20.12. Entire Agreement; Amendment.................................... 43 Section 20.13. Headings....................................................... 44 Section 20.14. Counterparts................................................... 44 Exhibit A - Atrigel(R) Patent Rights............................................ A-1 Exhibit B - Form of Certificate of Compliance................................... B-1 Exhibit C - Specifications...................................................... C-1 Exhibit D - Form of Stock Purchase Agreement.................................... D-1 Exhibit E - Development Program................................................. E-1 Exhibit F - Sanofi-Synthelabo's SOP............................................. F-1 Exhibit G - Six Month Product Development Program............................... G-1
iii COLLABORATION, LICENSE AND SUPPLY AGREEMENT This Collaboration, License and Supply Agreement (the "Agreement") is made as of December 8, 2000 by and between Atrix Laboratories, Inc., a Delaware corporation having offices at 2579 Midpoint Drive, Fort Collins, CO, 80525-4417 ("Atrix"), and Sanofi-Synthelabo Inc. a Delaware corporation having offices at 90 Park Avenue, New York, NY, 10016 ("Sanofi-Synthelabo"). Atrix and Sanofi-Synthelabo are sometimes referred to collectively herein as the "Parties" or singly as a "Party." RECITALS WHEREAS, Atrix possesses proprietary drug delivery systems including "Atrigel(R)" and has substantial experience and expertise in the discovery, design and development of products based on these proprietary drug delivery systems for medical, dental and veterinary applications; WHEREAS, Sanofi-Synthelabo possesses substantial resources and expertise in the development, commercialization and marketing of pharmaceutical products; WHEREAS, Atrix wishes to grant to Sanofi-Synthelabo, and Sanofi-Synthelabo wishes to obtain from Atrix, an exclusive license under Atrix's Atrigel(R) Technology to market, advertise, promote, distribute, offer for sale, sell and import the Product in the Territory for use in the Field on the terms and subject to the conditions set forth herein; and WHEREAS, Sanofi-Synthelabo wishes Atrix to manufacture and Atrix desires to manufacture each of the Product to be sold in the Territory by Sanofi-Synthelabo. NOW, THEREFORE, in consideration of the foregoing recitals and the mutual covenants and agreements contained herein, the Parties hereto, intending to be legally bound, do hereby agree as follows: AGREEMENT ARTICLE I DEFINITIONS The following terms as used in this Agreement shall, unless the context clearly indicates to the contrary, have the meaning set forth below: "Acceptance for Filing" means Atrix's receipt of a letter issued by the FDA indicating acceptance for filing of an NDA pursuant to 21 CFR Section 314.101. "ADE" has the meaning set forth in Section 10.04. "Affiliate" means an individual, trust, business trust, joint venture, partnership, corporation, association or any other entity which owns, is owned by or is under common ownership with, a Party. For the purposes of this definition, the term "owns" (including, with 1 correlative meanings, the terms "owned by" and "under common ownership with") as used with respect to any Party, shall mean the possession (directly or indirectly) of more than 50% of the outstanding voting securities of a corporation or comparable equity interest in any other type of entity. "Applicable Laws" means all applicable laws, rules, regulations and guidelines within or without the Territory that may apply to the development, marketing, manufacturing, packaging or sale of the Product in the Territory or the performance of either Party's obligations under this Agreement including laws, regulations and guidelines governing the import, export, development, marketing, distribution and sale of the Product in the Territory, to the extent applicable and relevant, and including all cGMP or Good Clinical Practices standards or guidelines promulgated by the FDA or the Competent Authorities and including trade association guidelines, where applicable, as well as United States' export control laws and the United States' Foreign Corrupt Practices Act. "Approval Letter" means a letter issued by the FDA indicating approval of a product, as defined in 21 CFR Section 314.105, or a similar letter issued by a Competent Authority in any other country in the Territory. "A&S" means Sanofi-Synthelabo's advertising and selling expenditures incurred in and associated with the promotional support of the Product, including the creation, development and acquisition of advertising and selling materials, including, but not limited to, expenditures for samples, detailing materials, journal advertising, in-office waiting room materials, educational programs, including Web-site programs for physicians and patients, convention booths, direct mail, consumer support, third party support, managed care programs, post-marketing Phase IV studies to support existing indications, market research, market surveys, market analysis and the training and costs of the pharmaceutical detail force, the medical therapeutic liaisons and the telesales staff used with regard to support of the Product. The costs of warehousing and physical distribution, post-marketing Phase IV studies to support new indications, and discounts given to managed care organizations shall not be considered to be A&S expenses for purposes of this Agreement. "Atrigel(R)" means Atrix's proprietary drug delivery system consisting of flowable compositions (e.g., solutions, gels, pastes and putties) of biodegradable polymers and biocompatible solvents. "Atrigel(R) Know-How" means all Know-How related to Atrix's proprietary Atrigel(R) drug delivery system as of the Effective Date, which is not covered by the Atrigel(R) Patent Rights, but is necessary or useful to develop, manufacture and commercialize the Product in the Territory for use in the Field, and which is under the Control of Atrix as of the Effective Date. "Atrigel(R) Patent Rights" means all Patent Rights related to Atrix's proprietary Atrigel(R) drug delivery system as of the Effective Date and at any time during the Term of this Agreement, which are necessary or appropriate to develop, manufacture and commercialize the Product in the Territory for use in the Field, which are under the Control of Atrix as of the Effective Date and Improvements thereto developed during the Term. The Atrigel(R) Patent Rights as of the Effective Date are set forth on Exhibit A. 2 "Atrigel(R) Technology" means the Atrigel(R) Patent Rights and the Atrigel(R) Know-How. "Atrix Manufacturing Cost" means the actual cost of the Manufacture by Atrix of the Product under a Manufacturing Process, including the related quality assurance and quality control activities as required by Applicable Laws (other than the costs set forth in Section 2.03), which actual cost shall be comprised of the cost of goods produced as determined in accordance with GAAP, and shall include direct labor, direct material, including raw materials and packaging materials, and the allocable portion of the manufacturing overhead of Atrix directly attributable to the Manufacture of the Product. The allocable portion of the manufacturing overhead shall be determined by taking the total facility cost for the period, less an adjustment for idle capacity, and allocating the remaining facility cost by labor usage to each of the products produced in the facility during the period. For example: If the facility cost for the period was $1,000,000 and it was operating at 80% capacity, the allocable facility cost would be $800,000. If the Product represented 30% of labor usage during the period, the allocable portion of the manufacturing overhead directly attributable to the Manufacture of the Product would be $240,000. Atrix Manufacturing Cost shall exclude selling, general and administrative, research and development, and interest expenses and any and all debt service payments of Atrix. For a period of twelve (12) months from the date of First Commercial Sale of each Product the Atrix Manufacturing Cost for each Product will be set as follows (the "Twelve Month Cost"): One Month Product - [**] Three Month Product - [**] Four Month Product - [**] "Certificate of Compliance" means the certificate of compliance in the form attached hereto as Exhibit B. "cGMP" means current good manufacturing practices as defined in 21 CFR Section 110 et seq. "CMC" means chemistry manufacturing and controls. "Collaboration" means the activities of the Parties carried out in performance of, and the relationship between the Parties established by, this Agreement. "Competent Authorities" means collectively the governmental entities in each country in the Territory responsible for the regulation of medicinal products intended for human use. "Competitive Product" means any leuteinizing hormone releasing hormone (LHRH) or derivative or analog thereof, whether agonist or antagonist, whether naturally-occurring or synthetic, used for the treatment of prostate cancer, endometriosis or uterine fibroids. "Confidential Information" means any confidential information of a Party relating to any use, process, method, compound, research project, work in process, future development, scientific, engineering, manufacturing, marketing, business plan, financial or personnel matter relating to the disclosing Party, its present or future products, sales, suppliers, customers, - ---------- ** Confidential Treatment Requested. 3 employees, investors or business, whether in oral, written, graphic or electronic form. Confidential Information shall not include any information which the receiving Party can prove by competent evidence: is now, or hereafter becomes, through no act or failure to act on the part of the receiving Party, generally known or available; is known by the receiving Party at the time of receiving such information, as evidenced by its written records maintained in the ordinary course of business; is hereafter furnished to the receiving Party by a Third Party, as a matter of right and without restriction on disclosure; is independently developed by the receiving Party, as evidenced by its written records, without knowledge of, and without the aid, application or use of, the disclosing Party's Confidential Information; or is the subject of a written permission to disclose provided by the disclosing Party. "Consumer Price Index" means the Consumer Price Index for all Urban Consumers (Consumer Prices - All Urban Consumers, 1982-84 = 100) as published by the Bureau of Labor Statistics of the Department of Labor of the United States Department of Commerce. "Control" means the possession of the ability to grant a license or sublicense as provided for herein without violating the terms of any agreement or other arrangement with any Third Party. "Demonstration Samples" means Units, absent leuprolide acetate, used to demonstrate the manner in which the Product is prepared and used, and labeled "demonstration samples, for demonstration purposes only, not for human use." "Development Program" has the meaning set forth in Section 2.02. "Effective Date" means 3:00 p.m., Eastern Standard Time on the third business day after any waiting period (and any extension thereof) and/or approvals applicable to the consummation of the Agreement under the HSR Act shall have expired, been terminated or obtained, as applicable. "FDA" means the United States Food and Drug Administration. "Field" means the primary indication for the palliative treatment of prostate cancer and the secondary indication for the treatment of endometriosis and uterine fibroids. "First Commercial Sale" means (i) with respect to a country in the Territory, the first sale for use, consumption or resale of each Product by Sanofi-Synthelabo in such country and (ii) with respect to the Territory, the First Commercial Sale in any country within the Territory. A sale to an Affiliate shall not constitute a First Commercial Sale unless the Affiliate is the end user of the Product. 4 "Four Month Product" means the formulation comprised of leuprolide acetate in an Atrigel(R) delivery system that provides for the sustained release of leuprolide acetate over a period of about one hundred and twenty (120) days and not less than one hundred and twelve (112) days with a primary indication for the palliative treatment of prostate cancer. "GAAP" means United States generally accepted accounting principles consistently applied on a basis consistent throughout the periods indicated and consistent with each other. "Good Clinical Practices" means good clinical practices as defined in 21 CFR Section 50 et seq. and Section 312 et seq. "Governmental Approval" means all permits, licenses and authorizations, including but not limited to, Marketing Authorization and Pricing and Reimbursement Approvals required by the FDA or any other Competent Authority as a prerequisite to the manufacturing, packaging, marketing and selling of the Product or the Units; excluding, however, import permits. "HSR Act" means the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended. "Improvements" means any and all developments, inventions or discoveries in the Field relating to the Atrigel(R) Technology developed, or acquired by Atrix at any time during the Term and shall include, but not be limited to, developments intended to enhance the safety and/or efficacy of the Product. "Know-How" means all know-how, trade secrets, inventions, data, processes, techniques, procedures, compositions, devices, methods, formulas, protocols and information, whether or not patentable, which are not generally publicly known, including, without limitation, all chemical, biochemical, toxicological, and scientific research information. "Launch Quantity" means a quantity of Product adequate to meet the requirements set forth for the first six (6) months in the initial forecast to be provided by Sanofi-Synthelabo to Atrix as provided in Section 8.07. "Manufacture" or "Manufacturing Process" means the storage, handling, production, processing and packaging of a Product or a Demonstration Sample, in accordance with this Agreement. "Marketing Authorization" means all necessary and appropriate regulatory approvals, excluding Pricing and Reimbursement Approvals, where applicable, to put the Product on the market in a particular country in the Territory. "Marks" means "Atrigel(R)" or "Leuprogel(TM)" or any additional trademarks selected by the Parties pursuant to Section 6.01(b) in either case, alone or accompanied by any logo or design and any foreign language equivalents in sound or meaning, whether registered or not. "NDA" means a New Drug Application, and all amendments and supplements thereto, filed or to be filed, with the FDA seeking authorization and approval to manufacture, package, ship and sell a product as more fully defined in 21 CFR Section 314.5 et seq. 5 "Net Sales" means the [**] Components of Net Sales shall be determined in the ordinary course of business in accordance with historical practice and using the accrual method of accounting in accordance with GAAP. In the event Sanofi-Synthelabo transfers Product to a Third Party in a bona fide arm's length transaction, for consideration, in whole or in part, other than cash or to a Third Party in other than a bona fide arm's length transaction, the Net Sales price for such Product shall be deemed to be the standard invoice price then being invoiced by Sanofi-Synthelabo in an arms length transaction with similar customers. In the event that Sanofi-Synthelabo includes one or more Product as part of a bundle of products, Sanofi-Synthelabo agrees not to offer or sell any such Product as a loss leader (i.e. sold at less than the invoice price at which any such Product is sold when not part of a bundle of products) in determining the price of the bundled products. "Net Selling Price" means with respect to a given time period and for a given country, Net Sales with respect to such country divided by the number of Units sold in such country during such time period. "New Product" means a product consisting of a combination of leuprolide acetate in the Atrigel(R) delivery system (other than the Product and substantially differentiable from the Product on the basis of leuprolide acetate concentration or duration of action). "One Month Product" means the formulation comprised of leuprolide acetate in an Atrigel(R) delivery system that provides for the sustained release of leuprolide acetate over a period of about thirty (30) days and not less than twenty-eight (28) days with a primary indication for the palliative treatment of prostate cancer. "Packaging Specifications" means the packaging and labeling specifications for the Unit, as may be mutually determined by Atrix and Sanofi-Synthelabo, from time to time. "Patent Rights" means all rights under patents and patent applications, and any and all patents issuing therefrom (including utility, model and design patents and certificates of invention), together with any and all substitutions, extensions (including supplemental protection certificates), registrations, confirmations, reissues, divisionals, continuations, continuations-in-part, re-examinations, renewals and foreign counterparts of the foregoing, and all improvements, supplements, modifications or additions. "Pricing and Reimbursement Approvals" means any pricing and reimbursement approvals which must be obtained before placing the Product on the market in any country in the Territory in which such approval is required. "Prime Rate of Interest" means the prime rate of interest published from time to time in the Wall Street Journal as the prime rate; provided, however that if the Wall Street Journal does not publish the Prime Rate of Interest, then the term "Prime Rate of Interest" shall mean the rate - ---------- ** Confidential Treatment Requested. 6 of interest publicly announced by Bank of America, N.A., as its Prime Rate, Base Rate, Reference Rate or the equivalent of such rate, whether or not such bank makes loans to customers at, above, or below said rate. "Product" means collectively the One Month Product, the Three Month Product, the Four Month Product, and the Six Month Product (should the Parties agree to develop it) supplied in Unit packages or any formulation of leuprolide acetate, in any concentration, in the Atrigel(R) delivery system for the palliative treatment of prostate cancer. "Royalty" means the royalty to be paid by Sanofi-Synthelabo to Atrix as set forth in Section 4.02. "Royalty Term" means the period of time commencing on the First Commercial Sale of the Product in any country in the Territory and ending on the expiration of the last to expire of the Atrigel(R) Patent Rights covering the Product in such country. "Shipment" means each individual group of Product received by Sanofi-Synthelabo from Atrix. "Six Month Product" means the formulation comprised of leuprolide acetate in an Atrigel(R) delivery system that provides for the sustained release of leuprolide acetate over a period of about one hundred and eighty (180) days and not less than one hundred and sixty eight (168) days with a primary indication for the palliative treatment of prostate cancer. "Specifications" means the specifications for the Product attached hereto as Exhibit C, and as may be amended from time to time by the Parties. "Stock Purchase Agreement" means that certain Stock Purchase Agreement dated as of the same date as this Agreement between Atrix and Sanofi-Synthelabo attached hereto as Exhibit D. "Term" has the meaning set forth in Section 19.01. "Territory" means the United States and Canada. "Third Party" means any entity other than: (a) Atrix, (b) Sanofi-Synthelabo or (c) an Affiliate of Atrix or Sanofi-Synthelabo. "Three Month Product" means the formulation comprised of leuprolide acetate in an Atrigel(R) delivery system that provides for the sustained release of leuprolide acetate over a period of about ninety (90) days and not less than eighty-four (84) days with a primary indication for the palliative treatment of prostate cancer. "Unit" means the Product packaged in a two-part system consisting of (a) one syringe of Atrigel(R) delivery system and a needle in a moisture proof pouch and sterilized by gamma irradiation; (b) one syringe containing sufficient leuprolide acetate for a One Month Product, Three Month Product, Four Month Product or Six Month Product, aseptically filled and lyophilized in the syringe, and packaged in a moisture-proof pouch; (c) instructions for use, as 7 such trade or sample package may be changed or reformulated by Atrix and Sanofi-Synthelabo from time to time; and (d) a commercial trade or sample package. "United States" means the United States of America, its territories and possessions, including the Commonwealth of Puerto Rico. ARTICLE II COLLABORATION Section 2.01. OBJECTIVES. Pursuant to the Development Program, Atrix shall conduct research and development activities using the Atrigel(R) Technology to develop a Product for the palliative treatment of prostate cancer. During the Term, Atrix will have primary responsibility for the activities described in Section 2.03 and Sanofi-Synthelabo will have primary responsibility for the activities described in Section 2.04. Section 2.02. DEVELOPMENT PROGRAM. (a) Development Program. Atrix shall utilize the Atrigel(R) Technology to conduct research and development of the One Month Product, the Three Month Product and the Four Month Product, pursuant to a written, development program to which Atrix and Sanofi-Synthelabo have given their prior written approval (the "Development Program"), a copy of which is attached hereto as Exhibit E. (b) Six Month Product. If Sanofi-Synthelabo elects to have Atrix develop the Six Month Product in accordance with Exhibit G, Sanofi-Synthelabo shall be solely responsible for all costs and expenses incurred (i) in developing the Six Month Product; and (ii) in obtaining the Marketing Authorizations for the Six Month Product (collectively the "Six Month Cost"). Sanofi-Synthelabo shall pay such Six Month Cost within thirty (30) days of receipt of each invoice from Atrix for such Six Month Cost. If Sanofi-Synthelabo in good faith disputes the amount of any such invoice for the Six Month Cost, then Sanofi-Synthelabo shall notify Atrix that it in good faith disputes the amount of any such invoice for the Six Month Cost and any such dispute shall be resolved by the Parties within thirty (30) days from the date of receipt of the disputed invoice; provided however if the dispute cannot be resolved to the mutual satisfaction of the Parties within such thirty (30) day period then either Party may request that the dispute be submitted to the Chief Executive Officers of Atrix and Sanofi-Synthelabo, respectively, for joint resolution. If the dispute is not jointly resolved by the Parties' respective Chief Executive Officers within ten (10) days from submission to the Parties' respective Chief Executive Officers, then Atrix shall be entitled to pursue any and all remedies at law available to it. In no event will the dispute resolution period exceed a maximum of forty (40) days unless otherwise agreed to in writing by the Parties. Further, Sanofi-Synthelabo may in its discretion determine to pay any such disputed amount and in the event amounts are finally determined not to be due by Sanofi-Synthelabo, Atrix shall repay, with interest paid at a rate equal to the Prime Rate of Interest, such excess amounts determined not to be due. (c) License for Six Month Product. Upon satisfaction of the provisions of Section 2.02(b) above, Sanofi-Synthelabo shall be deemed to have an exclusive license to 8 the Six Month Product on the same basis, terms and conditions set forth in this Agreement for the license for each other Product except that notwithstanding the foregoing, [**] shall be credited against the additional Six Month Product Milestone as set forth in Section 4.04 of this Agreement and [**], if any, shall be credited against amounts owed by Sanofi-Synthelabo to Atrix as set forth in Section 4.04(ii). Audit of Six Month Cost. Sanofi-Synthelabo shall have the right to cause an independent, certified public accountant reasonably acceptable to Atrix to audit those records of Atrix relating to the calculation of the Six Month Cost for the sole purpose of verifying the Six Month Cost. Such audits may be exercised during normal business hours nor more than once in a twelve (12) month period upon at least ten (10) days prior written notice. Section 2.03. ATRIX OBLIGATIONS. Pursuant to the time table established for its doing so in the Development Program, Atrix will, at its own expense, except as provided in Section 2.02, be responsible for (a) validation, formulation and development of the Product, (b) animal toxicology studies required for commercial launch of the Product, (c) scale-up, initial and on-going stability studies in primary closure package system(s), (d) supporting commercialization of the final formulation of the Product in accordance with the Development Program, and (e) except as provided in Section 2.02, Atrix shall also secure any and all Governmental Approvals and Marketing Authorizations. Except as otherwise provided in this Agreement, Atrix shall own and maintain all Governmental Approvals and related information and shall disclose all such information to Sanofi-Synthelabo, as soon as possible; provided, however, that information related to Atrigel(R) Technology shall be subject to the confidentiality provisions of this Agreement in Article XII, below. Section 2.04. SANOFI-SYNTHELABO OBLIGATIONS. Sanofi-Synthelabo, at its own expense, will be responsible for (a) all market research related to the Product; and (b) commercialization of the Product (including all sales and marketing activities related to the Product). Sanofi-Synthelabo will obtain import permits and pay all duties, fees, tariffs and similar obligations required to market the Product in each country in the Territory. Section 2.05. AVAILABILITY OF RESOURCES; COOPERATION. Each Party shall maintain laboratories, offices and/or other facilities reasonably necessary to carry out the activities to be performed by such Party pursuant to the Development Program. Upon reasonable advance notice, each Party agrees to make its employees and non-employee consultants reasonably available at their respective places of employment to consult with the other Party on issues arising in connection with any request from any regulatory agency, including, without limitation, regulatory, scientific, technical and clinical testing issues. - ---------- ** Confidential Treatment Requested. 9 ARTICLE III LICENSE Section 3.01. LICENSE FEE. In partial consideration for the License granted under Section 3.02(a), Sanofi-Synthelabo shall pay to Atrix an initial one-time non-refundable license fee equal to Eight Million Dollars ($8,000,000) on the Effective Date by wire transfer of immediately available funds to an account to be designated by Atrix to Sanofi-Synthelabo prior to the Effective Date. On the Effective Date, Sanofi-Synthelabo shall also purchase from Atrix Fifteen Million Dollars ($15,000,000) of Atrix's common stock, as provided in the Stock Purchase Agreement. Section 3.02. LICENSE TERMS. The terms and conditions of the exclusive license (the "License") granted by Atrix to Sanofi-Synthelabo shall be as follows: (a) License Grant. Atrix hereby grants to Sanofi-Synthelabo an exclusive license under the Atrigel(R) Technology to market, advertise, promote, distribute, offer for sale, sell and import the Product in the Territory for use in the Field subject to the terms and conditions herein. This exclusive license can only be transferred by Sanofi-Synthelabo on the basis set forth in Section 20.03 of this Agreement, below. (b) License Termination. (i) If Sanofi-Synthelabo has not undertaken commercially reasonable efforts to begin distribution and marketing of the One Month Product, the Three Month Product, the Four Month Product and/or the Six Month Product, if applicable, in the United States within ninety (90) days following receipt of written notice from Atrix that Governmental Approval has been received for each respective Product for the United States and provided that Atrix has available Launch Quantities of the respective Product, then the following shall occur with respect to each Product not launched within such ninety (90) days: (i) Atrix shall have the right to grant a license to a Third Party, to market, advertise, promote, distribute, offer for sale, sell or import the One Month Product, the Three Month Product, the Four Month Product and/or the Six Month Product, if applicable, respectively, in the United States and (ii) the license granted to Sanofi-Synthelabo pursuant to Sections 3.02(a) and 3.03 shall automatically terminate with respect to the applicable Product in the United States and the United States shall no longer be included in the Territory for such Product. (ii) The Parties will negotiate in good faith the launch date in Canada for each Product taking into account market conditions in Canada and the United States and any reimbursement issues, as they relate to each Product, in Canada. If the Parties cannot in good faith agree on a launch date in Canada for each Product the matter shall be submitted to the Advisory Board for resolution. 10 Section 3.03. MARKS. Subject to the terms and conditions of this Agreement, Atrix hereby grants to Sanofi-Synthelabo an exclusive in the Field, royalty-free right to use the Marks in connection with the marketing, advertising, promotion, distribution and sale of the Product. ARTICLE IV ROYALTY AND MILESTONE PAYMENTS Section 4.01. RESEARCH AND DEVELOPMENT EXPENSES. Except as set forth in Section 2.02, Atrix shall, at its sole expense, be responsible for all research and development expenses pertaining to the Product. Section 4.02. ROYALTY PAYMENTS. Sanofi-Synthelabo shall pay to Atrix a royalty consisting of [**] for a period equal to the Royalty Term for each Product in each country in the Territory. All royalty payments due to Atrix under this Agreement shall be paid within thirty (30) days of the end of each calendar quarter, unless otherwise specifically provided herein. Section 4.03. MILESTONE PAYMENTS. Sanofi-Synthelabo shall pay to Atrix, as licensing fees, the following milestone payments within thirty (30) days after Atrix gives notice to Sanofi-Synthelabo of the occurrence of the specified milestone event: (i) [**] (ii) [**] (iii) [**] (iv) [**] (v) [**] (vi) [**] Section 4.04. ADDITIONAL MILESTONE PAYMENTS. Should the Parties agree to develop the Six Month Product, Sanofi-Synthelabo shall pay to Atrix, as licensing fees, the following milestone payments within thirty (30) days after Atrix gives notice to Sanofi-Synthelabo of the occurrence of the specified milestone event: (i) [**] (ii) [**] provided however, [**] shall be credited against [**] and [**], if any, shall be credited against amounts owed by Sanofi-Synthelabo to Atrix as set forth in Section 4.04(ii). Section 4.05. REPORTS. - ---------- ** Confidential Treatment Requested. 11 (a) Reports. Sanofi-Synthelabo shall furnish to Atrix a quarterly written report showing in reasonably specific detail, on a Product by Product and country by country basis, (a) the calculation of Net Sales; (b) royalties payable in United States' Dollars, if any, which shall have accrued hereunder based upon Net Sales; (c) withholding taxes, if any, required by law to be deducted with respect to such sales; (d) the dates of the First Commercial Sales of any Product in any country in the Territory during the reporting period; and (e) the exchange rates used to determine the amount of United States' Dollars (the "Royalty Statement"). Reports shall be due as soon as possible, but in any event no later than thirty (30) days following the close of each calendar quarter. (b) Exchange Rate; Manner and Place of Payment. All payments hereunder shall be payable in United States dollars. With respect to each quarter, for countries other than the United States, whenever conversion of payments from any foreign currency shall be required, such conversion shall be made at the rate of exchange reported in The Wall Street Journal on the last business day of the applicable calendar quarter. All payments owed under this Agreement shall be made by wire transfer to a bank account designated by Atrix, unless otherwise specified in writing by Atrix. (c) Late Payments. In the event that any payment, including contingent payments, due hereunder is not made when due, each such payment shall accrue interest from the date due at the rate of one and one half percent (1.50%) per month; provided, however, that in no event shall such rate exceed the maximum legal annual interest rate. The payment of such interest shall not limit Atrix from exercising any other rights it may have under this Agreement as a consequence of the lateness of any payment. (d) Records and Audits. During the Term and for a period of two (2) years thereafter or as otherwise required in order for Atrix to comply with Applicable Law, Sanofi-Synthelabo shall keep complete and accurate records in sufficient detail to permit Atrix to confirm the completeness and accuracy of: (i) the information presented in each Royalty Statement and all payments due hereunder; (ii) the calculation of A&S and (iii) the calculation of Net Sales. Sanofi-Synthelabo shall permit Atrix to inspect those records of Sanofi-Synthelabo (including but not limited to financial records) that relate to Net Sales, Royalty Statements and A&S for the sole purpose of verifying the completeness and accuracy of the Royalty Statements, the calculation of the Net Selling Price and Net Sales and the calculation of A&S. Such inspection shall be at Atrix's expense and shall be subject to reasonable advance notice to Sanofi-Synthelabo, during Sanofi-Synthelabo's usual business hours. Further, Atrix shall have the right to cause an independent, certified public accountant reasonably acceptable to Sanofi-Synthelabo to audit such records to confirm royalty payments and A&S expenditures for the Product for the preceding year. Such audits may be exercised during normal business hours no more than once in any twelve (12) month period upon at least ten (10) days prior written notice by Atrix to Sanofi-Synthelabo. If such accounting firm concludes that such payments were underpaid, Sanofi-Synthelabo shall pay Atrix the amount of any such underpayments, plus interest at a rate equal to the Prime Rate of Interest, within thirty (30) days of the date Atrix delivers to Sanofi-Synthelabo such accounting firm's report so concluding that such payments were underpaid. If such accounting firm concludes that such payments were overpaid, Atrix shall pay to Sanofi-Synthelabo the amount of any 12 such overpayments, without interest, within thirty (30) days of the date Atrix delivers to Sanofi-Synthelabo such accounting firm's report so concluding that such payments were overpaid. Atrix shall bear the full cost of such audit unless such audit discloses an underpayment by more than five percent (5%) of the amount due under this Agreement. In such case, Sanofi-Synthelabo shall bear the full cost of such audit. (e) Taxes. All taxes levied on account of the payments accruing to Atrix under this Agreement shall be paid by Atrix for its own account, including taxes levied thereon as income to Atrix. If provision is made in law or regulation for withholding, such tax shall be deducted from the payment made by Sanofi-Synthelabo, paid to the proper taxing authority and a receipt of payment of the tax secured and promptly delivered to Atrix. Each Party agrees to assist the other Party in claiming exemption from such deductions or withholdings under any double taxation or similar agreement or treaty from time to time in force. (f) Prohibited Payments. Notwithstanding any other provision of this Agreement, if Sanofi-Synthelabo is prevented from paying any payments by virtue of the statutes, laws, codes or governmental regulations of the country from which the payment is to be made, then such payment may be paid by depositing funds in the currency in which it accrued to Atrix's account in a bank acceptable to Atrix in the country whose currency is involved. ARTICLE V NEW PRODUCT Section 5.01. NEW PRODUCT. Subject to Sanofi-Synthelabo's right of first negotiation under Section 5.02 below, Atrix may or, at Sanofi-Synthelabo's request, will seek to develop and have the FDA approve a New Product. Section 5.02. RIGHT OF FIRST NEGOTIATION. For a period of thirty (30) days following the receipt of notice from (i) Atrix of its intention to develop a New Product or (ii) Sanofi-Synthelabo of its intention to have Atrix develop a New Product, Sanofi-Synthelabo shall have the first right to negotiate binding material terms for a definitive license agreement for the New Product. In the event (a) Sanofi-Synthelabo does not determine within such thirty (30) day period to pursue a license for the New Product, (b) the Parties are unable to reach agreement on binding material terms of such a license within such thirty (30) day period, or (c) if the Parties have reached agreement on binding material terms of such a license within such thirty (30) day period, but are unable to enter into a definitive agreement within ninety (90) days following the written notice from Atrix, Atrix shall have no further obligation to Sanofi-Synthelabo under this Section 5.02. If Sanofi-Synthelabo and Atrix cannot agree to the terms of such license, then Atrix may enter into an agreement with a Third Party, provided that the terms of the agreement are no less favorable to Atrix, in any material respect (individually or in the aggregate), than those last proposed in writing by Sanofi-Synthelabo. The rights of Sanofi-Synthelabo under this Section 5.02 shall only apply to those countries for which Sanofi-Synthelabo retains a license under Sections 3.02 and 3.03 as of the date of Atrix's written notice that the FDA has approved a New Product. 13 ARTICLE VI COMMERCIALIZATION Section 6.01. PROMOTION AND MARKETING OBLIGATIONS. (a) Marketing Efforts. Sanofi-Synthelabo agrees to use commercially reasonable efforts to promote the sale, marketing and distribution of the Product in the Territory, consistent with accepted business practices devoting the same level of efforts as it devotes to its own products of comparable market potential. "Comparable market potential" shall be fairly determined by Sanofi-Synthelabo in good faith and shall be based upon market size, price, competition and general marketing parameters. Each Party shall promptly advise the other Party of any issues that materially and adversely affect its ability to market the Product in the Territory. In such event, senior executives of Sanofi-Synthelabo and Atrix shall meet and in good faith discuss what actions should be taken in light of such issues. (b) Trademarks. Sanofi-Synthelabo shall be the exclusive licensee of the Marks in the Territory for use in connection with the promotion, marketing and sale of the Product, which trademarks shall remain the sole property of Atrix. If either Sanofi-Synthelabo or Atrix desires that the Product subsequently be sold under a different name, or if any Competent Authority requires that Product be sold under a different name, the following provisions shall apply: (i) the different name (the "New Trademark") must be acceptable to Atrix, (ii) the New Trademark must be legally obtainable by Atrix in each jurisdiction where the New Trademark is sought, (iii) the New Trademark must be acceptable to the Competent Authority in each jurisdiction where a variation making the change to the applicable Marketing Authorization is sought, (iv) all costs (including reasonable attorneys' fees) for obtaining any change to a Marketing Authorization and for obtaining the right to use the New Trademark in each jurisdiction will be paid by (A) Sanofi-Synthelabo if Sanofi-Synthelabo requested the New Trademark, (B) Atrix if Atrix requested the New Trademark, and (C) one-half by Sanofi-Synthelabo and one-half by Atrix if a Competent Authority required the New Trademark, and (v) any New Trademarks obtained or authorized shall be owned by and be the sole property of Atrix; provided, however that any New Trademark requested by Sanofi-Synthelabo, and all costs for which are paid by Sanofi-Synthelabo, shall be owned by and be the sole property of Sanofi-Synthelabo. (c) Packaging. Atrix shall package and label the Product, the Units and the Demonstration Samples in compliance with the Packaging Specifications and Applicable Laws. Atrix, in consultation with Sanofi-Synthelabo, shall be responsible for assuring that such packaging and labeling conform with all Applicable Laws, if any, of the FDA for export of the Product and the Demonstration Samples to the countries in the Territory other than the United States and that the Units comply with the Packaging Specifications. Atrix, in consultation with Sanofi-Synthelabo, shall also be responsible for assuring that packaging and labeling comply with all Applicable Laws where such Product is to be distributed for sale. All additional incremental costs resulting from changes to the Packaging Specifications made at the request of Sanofi-Synthelabo that are not required 14 to export the Product to countries in the Territory on a country by country basis under Applicable Laws shall be borne by Sanofi-Synthelabo. (d) Proposed Pricing Of Product. Within thirty (30) days of Atrix's receipt of the Marketing Authorization in each country in the Territory, Sanofi-Synthelabo shall provide the Advisory Board (as defined below) with a detailed copy of the expected selling price schedule of the Units in such country in the Territory (including any (i) prompt payment or other trade or quantity discounts which Sanofi-Synthelabo expects to offer and (ii) commission rates or rebates which Sanofi-Synthelabo expects to offer to distributors and agents). (e) Marketing Plans And Reports. Thirty (30) days prior to the expected date of First Commercial Sale in any country in the Territory and at the beginning of each calendar year thereafter, Sanofi-Synthelabo shall submit to the Advisory Board in writing the annual marketing, sales and distribution plan for each such country detailing Sanofi-Synthelabo and its Affiliates' proposed marketing, sales and distribution strategy and tactics for the sale and distribution of Product during such calendar year, or portion thereof. In addition, Sanofi-Synthelabo shall submit to the Advisory Board copies of any market research reports relating to Product sales and Product competition which Sanofi-Synthelabo or its Affiliates commission or otherwise obtain to the extent permissible by the agency preparing the report. To the extent the foregoing information is contained in plans or reports which contain information about other products or markets, Sanofi-Synthelabo may submit to the Advisory Board only those excerpts from such plans or reports which relate to the Product and Product competition. (f) Advisory Board. The Parties agree to form an advisory board (the "Advisory Board") comprised of three (3) representatives from each of Sanofi-Synthelabo and Atrix. An officer of each Party shall serve as the co-chairmen of the Advisory Board. Except as set forth in Section 13.01, the Advisory Board will meet on a quarterly basis and at such time will be consulted by Sanofi-Synthelabo on all major decisions in the marketing of the Product in each country in the Territory, but Sanofi-Synthelabo, alone, will be responsible for making the final decisions on all sales, marketing, promotion and distribution issues, regardless of the action or inaction of the Advisory Board, including, without limitation, the following areas as they relate to the sales, marketing, promotion and distribution of the Product: (i) Product positioning in the marketplace; (ii) quantity of direct selling efforts, including the number of sales details to be made; (iii) extent and degree of non-personal selling and promotional efforts; (iv) quantity and content of workshops and medical symposia; (v) design and implementation of a Phase IV clinical study program to support the Product; 15 (vi) design and implementation of a consumer awareness program; (vii) selection of physicians for a medical advisory board and speakers bureau; (viii) planning for international regulatory submissions; (ix) dispute resolution regarding sales, marketing and promotional activities related to the Product; and (x) internet presence. (g) Co-Promotional Activities of Atrix. Beginning in month twenty-four (24) following the launch of the first of any Product on a country-by-country basis within the Territory, Atrix shall have the right, [**] to participate in the sales, marketing and promotion of the Product. If Atrix so elects, Atrix will provide additional field sales representatives (the "Atrix Sales Force") and/or funding to augment the sales, marketing and promotional activities of the Product by Sanofi-Synthelabo as the Parties may agree. [**]. ARTICLE VII MANUFACTURE AND SUPPLY Section 7.01. AGREEMENT TO SUPPLY PRODUCT. Subject to the terms hereof, Sanofi-Synthelabo agrees to purchase exclusively from Atrix, and Atrix agrees to Manufacture for, and sell exclusively to Sanofi-Synthelabo during the Term of this Agreement, Sanofi-Synthelabo's total requirements for the Product and the Demonstration Samples in the Territory on the terms and conditions set forth herein. Subject to Sanofi-Synthelabo's prior written approval, such approval not to be unreasonably withheld, conditioned or delayed by Sanofi-Synthelabo, Atrix may subcontract any part of the Manufacturing Process for the Product and the Demonstration Samples to a Third Party provided: (a) the Product, the Demonstration Samples and the facilities continue to meet the requirements as defined in this Agreement and (b) Atrix has obtained all required Governmental Approvals. If subcontracting is initiated by Atrix, for any Manufacturing Process, Atrix will bear the cost of validation and necessary stability work, as well as any other directly related costs. Section 7.02. QUALITY ASSURANCE. Atrix shall Manufacture the Product in accordance with the Specifications. Atrix shall consult with Sanofi-Synthelabo as to any proposed changes in the Specifications, manufacturing processes, or in Atrix's quality assurance procedures which might render Atrix unable to supply Product in accordance with the terms of this Agreement, prior to making those changes, and obtain Sanofi-Synthelabo's prior, written consent thereto, which consent will not be unreasonably withheld, conditioned or delayed by Sanofi-Synthelabo. Atrix shall immediately notify Sanofi-Synthelabo in writing - ---------- ** Confidential Treatment Requested. 16 of any changes required by a Competent Authority in the Specifications or Atrix's quality assurance procedures that would render Atrix unable to supply the Product and/or Demonstration Samples in accordance with the terms of this Agreement. The Parties agree to develop and execute an appropriate action plan in such situation. Section 7.03. ATRIX'S DUTIES. Atrix agrees to Manufacture the Product in accordance with the Specifications, applicable cGMP and NDA requirements and to furnish to Sanofi-Synthelabo with every shipment a written certificate of analysis and Certificate of Compliance that confirms conformity of the Product to the Specifications and cGMP. The Product may be subjected to testing by Sanofi-Synthelabo at its designated facility in order to verify conformance of the Product with the Specifications. In addition, Atrix shall: (a) Provide Sanofi-Synthelabo with a copy of the written sampling and testing procedures used by Atrix to confirm conformity of the Product to the Specifications; (b) Retain a sample of each batch of Product and, upon request, make it available to Sanofi-Synthelabo for inspection. The retained sample shall be sufficient in size to allow Sanofi-Synthelabo and Atrix to perform tests to determine whether or not the Product conforms to the Specifications. The retained sample shall be kept under the same conditions as those under which the Product is stored at Sanofi-Synthelabo's facilities; (c) Maintain records to ensure Atrix's ability to perform a complete lot history via lot tracing of the Product; and (d) Keep on file all manufacturing records and analytical results pertaining to the manufacture of each batch of Product for a period expiring not earlier than two (2) years after the expiration date of the last lot of Sanofi-Synthelabo's Product manufactured with that batch of Product. Atrix shall make all such records available to Sanofi-Synthelabo upon request. (e) Consult closely on an ongoing basis with the Advisory Board on all aspects of the manufacturing and development of the Product, including the use of any subcontractors to perform part of the Manufacturing Process, the obtaining of any and all required Governmental Approval(s) for the Manufacture of the Product and the obtaining of any and all required Marketing Authorizations to permit the marketing, sale and distribution of the Product in the Territory. In this regard, Atrix will provide monthly reports to the Advisory Board on the status of the Manufacture and development of the Product including, without limitation, to the extent applicable, all current information on: (i) any material issues, problems or developments with regard to (x) any subcontractors being utilized to perform part of the Manufacture of the Product, or (y) any customer service issues; (ii) the current status of all pending applications seeking any Governmental Approval(s) or Marketing Authorization(s) for the Product from any Competent Authority; and (iii) as to the status or progress of obtaining any patent rights pertaining to any aspect of the Product. (f) Provide to Sanofi-Synthelabo within twenty-four (24) hours of receipt by Atrix, complete copies of any and all inspection reports pertaining to the Manufacture 17 and development of the Product which Atrix receives from any Competent Authority, or which is obtained by Atrix from any third party agency, and promptly provide to Sanofi-Synthelabo any such report which is internally produced by Atrix's staff or that of any of its Affiliates. (g) Provide Sanofi-Synthelabo with complete access to all existing and hereafter produced: (i) batch records of the Product; (ii) quality inspection reports of the Product, whether internally or externally generated; (iii) any and all investigation reports of the Product, whether internally or externally generated; and (iv) packaging records pertaining to the Product; and (h) Provide Sanofi-Synthelabo with notice within twenty-four (24) hours of notification of any scheduled inspection by any Competent Authority of Atrix's facilities, books or records, or of the facilities, books or records of any subcontractor being utilized by Atrix to perform any portion or all of the Manufacture or development of the Product. Atrix shall inform such Competent Authority that Sanofi-Synthelabo may desire to be present at such inspection; provided that Sanofi-Synthelabo's right to be present is subject to approval by such Competent Authority and subject to Sanofi-Synthelabo being available at the time and date established by such Competent Authority. Atrix shall use reasonable efforts to secure a time and date for such inspection that is reasonably acceptable to Sanofi-Synthelabo; provided however that Atrix alone has the right to make the final decision on all such matters. Section 7.04. COMPLIANCE WITH APPLICABLE LAWS. Sanofi-Synthelabo and Atrix (if Atrix has exercised its co-promotion and/or co-marketing rights pursuant to Sections 6.01(g) and 13.01, respectively, of this Agreement) shall be responsible for compliance with Applicable Laws relating to the promotion, marketing, sale and distribution of the Product, Units and the Demonstration Samples, as applicable. Atrix shall be responsible for compliance with Applicable Laws relating to the Manufacture, design and production of the Product and the Demonstration Samples, as applicable, and with cGMP relating to the Manufacture and testing of the Product. Section 7.05. SECOND MANUFACTURING SOURCE. Atrix, at its own cost and expense, shall validate, qualify and obtain all Governmental Approvals for a Third Party as a second source (the "Second Source") to Manufacture the Product. Atrix will file a supplement to the NDA for each Product with the FDA no later than six (6) months after the NDA for each Product is approved to seek FDA approval for such Second Source to Manufacture each such Product. After such filing, Atrix shall use reasonable efforts to obtain final FDA approval for such Second Source to Manufacture each such Product including modifying the NDA supplement if required by the FDA. Upon prior written notice to Atrix, Sanofi-Synthelabo shall have the right to inspect and audit the Second Source's facilities used to Manufacture the Product to confirm that such facilities are in compliance with Applicable Laws and the Governmental Approvals. Atrix, at its sole cost and expense, may have a representative(s) accompany Sanofi-Synthelabo's representative(s) on any such inspection or audit. Section 7.06. FAILURE TO SUPPLY. Atrix shall immediately notify Sanofi-Synthelabo if Atrix is unable to fill any order placed by Sanofi-Synthelabo pursuant to Section 8.07. If Atrix is unable to cure such failure within thirty (30) days after such notice, Atrix shall, upon such 18 failure, make arrangements with the Second Source to Manufacture and sell to Atrix the Product until such time as Atrix is again able to Manufacture the Product; provided, however, any consequent incremental costs which result by reason of the use of the Second Source under this Section 7.06 shall be the sole cost and liability of Atrix. Subject to the following paragraph, if Atrix is unable (including due to reasons of Force Majeure) to supply Product to Sanofi-Synthelabo for a period of ninety (90) days or more or if Atrix notifies Sanofi-Synthelabo that Atrix will be unable to perform under this Section 7.06 (or that the Second Source will be unable to perform under Section 7.05), Atrix hereby grants to Sanofi-Synthelabo a nonexclusive, royalty-free license under the Atrigel(R) Technology and any other relevant technology necessary to make or have made the Product, for use solely for sale or distribution in the Territory and solely until such time as Atrix is again able to Manufacture the Product at which time Atrix will regain its exclusive right to Manufacture and supply the Product to Sanofi-Synthelabo. Sanofi-Synthelabo may grant sublicenses under the foregoing license with the consent of Atrix, such consent not to be unreasonably withheld. At the request of Sanofi-Synthelabo, Atrix shall provide reasonable technical assistance in connection with the transfer of manufacturing described in this Section. Notwithstanding the foregoing, Atrix shall not be deemed to be unable to fill any order placed by Sanofi-Synthelabo as follows: (a) if Atrix's inability to fill any order arises as a result of [**] increase in Sanofi-Synthelabo's order over Sanofi-Synthelabo's prior forecast; or (b) in the event that Atrix must purchase additional equipment or construct a new facility in order to expand its capacity in order to meet purchase orders hereunder, Atrix will be deemed to have satisfied this paragraph by placing a purchase order for such equipment or signing a contract for such construction within sixty (60) days of Atrix's receipt of Sanofi-Synthelabo's purchase order showing firm quantities in excess of Atrix's capacity; provided that Atrix diligently pursues and completes within a reasonable time thereafter such purchase or construction. Section 7.07. ALLOCATION. If Atrix exercises its rights to co-market under Article XIII and if Atrix is unable to supply all of the requirements of the Product, and quantities ordered by Sanofi-Synthelabo in accordance with Section 8.07, then Atrix shall allocate the resources available to it so that Sanofi-Synthelabo receives at least its proportional share of available supplies as determined based on reasonable forecasts (taking into consideration past sales and sales performance against forecast) of Sanofi-Synthelabo and Atrix. ARTICLE VIII PURCHASE AND SALE Section 8.01. PURCHASE PRICE AND PAYMENT. Atrix shall sell, and Sanofi-Synthelabo shall purchase, each Product at a price equal to the Atrix Manufacturing Cost, including any adjustments pursuant to Section 8.02 (the "Purchase Price"). Atrix shall invoice Sanofi-Synthelabo monthly for all Product and Demonstration Samples shipped by Atrix to Sanofi-Synthelabo and payment shall be due thirty (30) days from receipt of the invoice. - ---------- ** Confidential Treatment Requested. 19 Section 8.02. ADJUSTMENT TO PURCHASE PRICE/AUDIT. (a) The Atrix Manufacturing Cost will be adjusted on a Product by Product basis annually commencing with the first day of the first calendar month twelve (12) months from the date of the First Commercial Sale of each Product (the "Adjusted Atrix Manufacturing Cost"). [**]: (i) if Sanofi-Synthelabo in good faith disputes the amount of the Adjusted Atrix Manufacturing Cost, then Sanofi-Synthelabo shall notify Atrix of a good faith dispute and such dispute shall be resolved by the Parties within thirty (30) days from the date of notice of the Adjusted Atrix Manufacturing Cost; provided however if the dispute cannot be resolved to the mutual satisfaction of the Parties within such thirty (30) day period then either Party may request that the dispute be submitted to the Chief Executive Officers of Atrix and Sanofi-Synthelabo, respectively, for joint resolution. If the dispute is not jointly resolved by the Parties' respective Chief Executive Officers within ten (10) days from submission to the Parties' respective Chief Executive Officers then Atrix shall be entitled to pursue any and all remedies at law available to it. In no event will the dispute resolution period exceed a maximum of forty (40) days unless otherwise agreed in writing by the Parties; and (ii) Sanofi-Synthelabo shall pay for Product ordered during the dispute period at the Purchase Price in effect prior to Atrix's notice of an adjustment of the Atrix Manufacturing Cost. If upon resolution of any dispute the Purchase Price is greater than the Purchase Price paid by Sanofi-Synthelabo during the dispute period, Atrix will invoice Sanofi-Synthelabo for the difference and Sanofi-Synthelabo shall pay the same promptly upon receipt of such invoice. (b) If at any time following twelve (12) months from the date of the First Commercial Sale of each Product, on a Product by Product basis, the Atrix Manufacturing Cost is in excess of the Twelve Month Cost then Sanofi-Synthelabo may request that the Parties meet to review and discuss the Atrix Manufacturing Cost. [**] Notwithstanding the foregoing, in the event that increases [**] result in an increased Atrix Manufacturing Cost which becomes, in Sanofi-Synthelabo's sole judgment to be commercially non-viable, Sanofi-Synthelabo may terminate this Agreement pursuant to Section 19.05. (c) Commencing twelve (12) months from the date of First Commercial Sale of each Product Sanofi-Synthelabo shall have the right to cause an independent, certified public accountant reasonably acceptable to Atrix to audit those records of Atrix relating to the calculation of the Atrix Manufacturing Cost for the sole purpose of verifying the Atrix Manufacturing Cost. Such audits may be exercised during normal business hours nor more than once in a twelve (12) month period upon at least ten (10) days prior written notice. - ---------- ** Confidential Treatment Requested. 20 Section 8.03. LABELING. (a) After execution of this Agreement, Sanofi-Synthelabo shall have the right to review and comment upon any proposed changes to the labeling for the Product and to participate in discussions with the Competent Authorities concerning any labeling change. Notwithstanding the above, Atrix shall have the authority to make the final decision with regard to any labeling revisions. (b) Both Parties will approve all artwork developed for inclusion in the Product packaging, including carton labels, package inserts, etc., which approval will not be unreasonably withheld, conditioned or delayed by either Party. If Sanofi-Synthelabo wishes to institute changes in labeling artwork, both Parties will develop a mutually acceptable implementation schedule. Neither Party shall alter, change or in any way modify the artwork, which has previously been approved, for any reason, without prior written authorization from the other Party which authorization shall not be unreasonably withheld, conditioned or delayed by either Party, provided that such approved artwork shall conform to all Applicable Laws. Section 8.04. PURCHASE FORMS. Purchase orders, purchase order releases, confirmations, acceptances and similar documents submitted by a Party in conducting the activities contemplated under this Agreement are for administrative purposes only and shall not add to or modify the terms of the Agreement. To the extent of any conflict or inconsistency between this Agreement and any such document, the terms of this Agreement shall govern. Section 8.05. CONFIRMATION. Atrix shall confirm each purchase order within ten (10) business days from the date of receipt of a purchase order and shall supply the Product within a maximum of sixty (60) days from the date of acceptance of a purchase order, or later if so specified in the purchase order. Failure of Atrix to confirm any purchase order shall not relieve Atrix of its obligation to supply Product ordered by Sanofi-Synthelabo in conformity with this Agreement. Section 8.06. DELIVERY. Delivery terms for Product and Demonstration Samples shall be FOB Atrix's manufacturing facility at Fort Collins, Colorado. Atrix shall ship Product and Demonstration Samples in accordance with Sanofi-Synthelabo's purchase order form or as otherwise directed by Sanofi-Synthelabo in writing. Title to any Product or Demonstration Samples purchased by Sanofi-Synthelabo shall pass to Sanofi-Synthelabo upon the earlier of (i) a common carrier accepting possession or control of such Product or Demonstration Samples, as applicable, or (ii) passage of such Product or Demonstration Samples, as applicable, from the loading dock of Atrix's facilities to Sanofi-Synthelabo or its agent. Section 8.07. FORECASTS AND ORDERS. (a)Not later than six (6) months following submission of the NDA or other applicable regulatory filing on a country by country basis, Sanofi-Synthelabo will provide Atrix with a twelve (12) month forecast of Sanofi-Synthelabo's requirement of Product on a Product by Product basis, including Demonstration Samples, on a country by country basis as follows: (i) For the first twelve (12) months of the forecast, the forecasts shall be provided quarterly, no less than forty-five (45) days prior to the beginning of each 21 quarter. Said requirements will be based on standard production planning parameters including but not limited to sales forecasts, sales demand forecasts, promotional forecasts, inventory requirements, and the like. The first two (2) quarters of the twelve (12) month forecast will be stated in monthly requirements. The second two (2) quarters of the twelve (12) month forecast will be total requirement by stock keeping unit and will be stated as quarterly requirements. The first three (3) months of the twelve (12) month forecast will be firm orders to purchase. The second three (3) months will be allowed to be flexed from the previous forecast by plus or minus twenty-five percent (25%) per month until fixed by the subsequent forecast; provided that the aggregate adjustment from the quantity set forth in the previous forecast for such three (3) month period shall not exceed fifty percent (50%) in aggregate during that three (3) month period. The last two (2) quarters' total quantities will be an estimate and not binding. (ii) After the first twelve (12) months Sanofi-Synthelabo will provide to Atrix a rolling twelve (12) month forecast with the first three (3) months of the rolling twelve (12) month forecast a firm order to purchase. Each order in the rolling twelve (12) month forecast shall be provided monthly, no less than twenty (20) days prior to the beginning of each month. All orders will be for full batch quantities. (b) It is understood that Atrix will not maintain Product or Demonstration Sample inventory in excess of the forecast, but will produce Product or Demonstration Sample upon receipt of that portion of Sanofi-Synthelabo's forecasts that constitute firm orders to purchase. The above periods whether fixed or flexible will be adjusted based upon existing lead times at time of start up. (c) Sanofi-Synthelabo agrees to purchase a sufficient amount of Product to enable Sanofi-Synthelabo to carry sufficient inventory to allow for fluctuations in sales demand so as to allow Atrix reasonable lead time to meet increased demand. Atrix will use commercially reasonable efforts to meet any increase in demand in excess of the allowed adjustment, but will not be obligated to do so; provided, however, notwithstanding anything to the contrary in this Section 8.07, Atrix shall be obligated to [**]. All forecasts will be made by Sanofi-Synthelabo to Atrix in good faith based upon standard commercial parameters. From time to time after the Effective Date, the Parties shall consider whether, in light of market demand, manufacturing capacity, inventory levels and other pertinent factors, to revise the schedule for delivery of forecasts and, if appropriate, negotiate in good faith to revise such schedule. (d) The Launch Quantity of the Product when delivered to the common carrier shall not have an expiration date of less than fifteen (15) months from the date of such delivery, provided (a) Product other than the Launch Quantity shall not have an expiration date of less than twenty four (24) months once real time stability data is - ---------- ** Confidential Treatment Requested. 22 submitted by Atrix to the FDA, and/or (b) as the Parties may otherwise agree in writing on a case by case basis. Section 8.08. DEMONSTRATION SAMPLES. Pursuant to the provisions of Section 8.07 above, Atrix shall supply to Sanofi-Synthelabo such quantities of Demonstration Samples as Sanofi-Synthelabo may reasonably request to be used solely for training purposes (and not for sale), and not for human use, for so long as Sanofi-Synthelabo retains a License pursuant to Sections 3.02 and 3.03 in the specific country in the Territory. Demonstration Samples shall be sold by Atrix to Sanofi-Synthelabo at the Atrix Manufacturing Cost for such Demonstration Samples. Sanofi-Synthelabo shall not use the Demonstration Samples for any purpose other than as set forth in this Section 8.08. ARTICLE IX WARRANTY, REJECTION AND INSPECTIONS Section 9.01. ATRIX WARRANTY. Atrix represents and warrants to Sanofi-Synthelabo that (i) the Product delivered pursuant to this Agreement shall comply with the Specifications; (ii) is not adulterated or misbranded under Applicable Laws; and (iii) at the time of Manufacture and delivery to Sanofi-Synthelabo the Product will be, and is, free from any defects, liens and encumbrances and Sanofi-Synthelabo shall receive good and marketable title to the Product. EXCEPT AS OTHERWISE SET FORTH HEREIN, ATRIX MAKES NO OTHER WARRANTIES OF ANY OTHER KIND, INCLUDING BUT NOT LIMITED TO ANY WARRANTY OF MERCHANTABILITY OR FITNESS OF THE PRODUCT AND DEMONSTRATION SAMPLES FOR ANY PURPOSE, AND ATRIX EXPRESSLY DISCLAIMS ANY SUCH OTHER WARRANTIES WITH RESPECT TO THE PRODUCT AND DEMONSTRATION SAMPLES, EITHER EXPRESSED OR IMPLIED. Section 9.02. REJECTION OF PRODUCT FOR FAILURE TO CONFORM TO SPECIFICATIONS. Sanofi-Synthelabo shall have thirty (30) days after the receipt of any Shipment to determine conformity of the Shipment to the Specifications and/or Applicable Laws. If testing of such Shipment shows a failure of the Shipment to meet the Specifications and/or Applicable Laws, Sanofi-Synthelabo may return the entire Shipment, or any portion thereof, to Atrix at Atrix's expense within a reasonable time following the above described testing, provided that notice of non-conformity is received by Atrix from Sanofi-Synthelabo within forty (40) days of Sanofi-Synthelabo's receipt of said Shipment. Atrix shall have the option to provide to Sanofi-Synthelabo, within thirty (30) days after such notice is received by it, Product that meets the Specifications and Applicable Laws or to promptly provide Sanofi-Synthelabo with full credit for the Purchase Price paid by Sanofi-Synthelabo for the returned Product. In either case the cost of freight and handling to return or replace the goods shall be at the expense of Atrix. If Sanofi-Synthelabo does not notify Atrix of the non-conformity of the Product within forty (40) days of receipt of said Shipment, the Product shall be deemed to meet the Specifications, the Packaging Specifications and Applicable Laws. Notwithstanding anything in this Agreement to the contrary, the Parties may agree to a return of the Product or an adjustment in the Purchase Price in the event of any failure or defect in the Product. Should there be a discrepancy between Sanofi-Synthelabo's test results and the results of testing performed by Atrix, such discrepancies shall be finally resolved by testing performed by an independent Third Party mutually agreed upon by Sanofi-Synthelabo and Atrix. 23 The costs of such testing shall be borne by the Party against whom the discrepancy is resolved. In the event Product has been previously returned to Atrix and an independent Third Party determines that the Product meets the Specifications, Sanofi-Synthelabo shall be responsible for all costs associated with the return. Section 9.03. SANOFI-SYNTHELABO INSPECTIONS. Atrix shall upon reasonable (but not less than ten (10) days) prior written notice by Sanofi-Synthelabo and during normal business hours, allow Sanofi-Synthelabo and cause any sub-contractors and the Second Source to allow Sanofi-Synthelabo, to inspect and audit Atrix's facilities, the facilities of Atrix's sub-contractors and the facilities of the Second Source used to Manufacture the Product and the Demonstration Samples, twice annually, to confirm that the facilities and the equipment, personnel and operating and testing procedures used by Atrix, Atrix's subcontractor(s) and the Second Source in the Manufacture, testing, storage and distribution of the Product are in compliance with Applicable Laws and the Governmental Approvals; provided that such inspection does not interfere with Atrix's, Atrix's sub-contractor(s)' and the Second Source's normal operations or cause Atrix, Atrix's sub-contractor(s) and the Second Source to violate or be in breach of any confidentiality agreements with any Third Party. ARTICLE X REGULATORY COMPLIANCE Section 10.01. MARKETING AUTHORIZATION HOLDER. Unless otherwise required by Applicable Laws, Atrix shall be the holder of all Marketing Authorizations for each country in the Territory; provided, however, that Sanofi-Synthelabo shall hold the Canadian Marketing Authorization. Atrix will own and maintain the Marketing Authorizations (other than the Canadian Marketing Authorization which shall be the responsibility of Sanofi-Synthelabo) during the term of this Agreement. Each Party agrees that neither it nor its Affiliates will do anything to adversely affect a Marketing Authorization. Section 10.02. MAINTENANCE OF MARKETING AUTHORIZATIONS. Atrix agrees to maintain the Marketing Authorizations throughout the term of this Agreement, including obtaining any variations or renewals thereof, and Sanofi-Synthelabo agrees to reimburse Atrix for [**] of all of Atrix's out-of-pocket expenses incurred in connection with maintaining the Marketing Authorizations within thirty (30) days after Atrix submits its invoice and appropriate documentation to Sanofi-Synthelabo for [**] of such expenses. Section 10.03. INTERACTION WITH COMPETENT AUTHORITIES. (a) After execution of this Agreement, each Party shall provide to the other Party a copy of any significant correspondence regarding the Product in the Territory that it submits to or receives from Competent Authorities, within ten (10) days of submission or receipt, as the case may be. Within five (5) days after receipt of an Approval Letter for the Product in the Territory, Atrix will notify the appropriate Competent Authorities in - ---------- ** Confidential Treatment Requested. 24 writing that Sanofi-Synthelabo will be the contact for all communications with the Competent Authorities concerning the Product in the Territory, except for those issues relating to CMC. (b) Within five (5) days after Atrix notifies Sanofi-Synthelabo of receipt by Atrix of an Approval Letter for the Product in the Territory, Sanofi-Synthelabo will notify the appropriate Competent Authorities in writing that Sanofi-Synthelabo is accepting the transfer from Atrix described in Section 10.03(a), and assuming responsibility for all communications with the Competent Authorities concerning the Product in the Territory, except for those issues relating to CMC. Sanofi-Synthelabo shall provide Atrix with a copy of any significant correspondence regarding the Product that it submits to or receives from the Competent Authorities, within ten (10) days prior to the date of submission or within ten (10) days from receipt, as the case may be. Section 10.04. ADVERSE DRUG EVENT REPORTING AND PHASE IV SURVEILLANCE. (a) Each Party shall advise the other Party, by telephone or facsimile, within twenty-four (24) hours after a Party becomes aware of any potentially serious or unexpected adverse event (including adverse drug experiences, as defined in 21 C.F.R. Section 314.80 or other applicable Regulations) (an "ADE") involving the Product or the Demonstration Samples. Such advising Party shall provide the other Party with a written report delivered by confirmed facsimile of any adverse reaction, stating the full facts known to such Party, including but not limited to customer name, address, telephone number, batch, lot and serial numbers, and other information as required by Applicable Laws. For so long as Sanofi-Synthelabo has an exclusive license to market, promote and sell the Product in the Territory for use in the Field, Sanofi-Synthelabo shall have full responsibility for (i) monitoring such adverse reactions; and (ii) data collection activities that occur between Sanofi-Synthelabo and the patient or medical professional, as appropriate, including any follow-up inquiries which Sanofi-Synthelabo deems necessary or appropriate. Sanofi-Synthelabo shall make any necessary reports to the Competent Authorities, with a complete copy provided to Atrix at the same time the report is made by Sanofi-Synthelabo to the Competent Authorities. If Atrix exercises its right to co-market as set forth in Section 13.01 then upon the occurrence of an ADE the Parties shall promptly meet, in person or by telephone, as appropriate, to discuss and determine how to mutually handle and resolve any issues relating to or arising from any such ADE. (b) In the event either Party requires information regarding adverse drug events with respect to reports required to be filed by it in order to comply with Applicable Laws, including obligations to report ADEs to the Competent Authorities, each Party agrees to provide such information to the other on a timely basis. (c) The Parties agree to follow Sanofi-Synthelabo's standard operating procedure for reporting and identifying adverse drug reactions (the "SOP") a copy of which is attached hereto as Exhibit F. In the event the SOP is modified or amended during the term of this Agreement, Sanofi-Synthelabo shall provide Atrix with copies of any such modification or amendment to the SOP for Atrix's prior approval, which will 25 not be unreasonably withheld, conditioned or delayed, at least five (5) business days prior to such amendment taking effect. Sanofi-Synthelabo shall designate a qualified person under Applicable Laws to be responsible for ADE reporting in each country in the Territory. In the event Atrix requires information regarding adverse drug events with respect to reports required to be filed by Atrix in order to comply with Applicable Laws, Sanofi-Synthelabo agrees to provide such information to Atrix on a basis sufficient to allow Atrix to timely comply with Applicable Laws. (d) If the report of an ADE causes a Competent Authority to request labeling revision as a result of an ADE or that a Phase IV surveillance program be conducted, then the Parties shall promptly enter into discussions and shall mutually agree on all of the material terms and conditions of such labeling revision or Phase IV surveillance program; provided, however the costs of such labeling revision or Phase IV surveillance program shall be borne [**]. Atrix shall have the authority to make the final decision with regard to any labeling revisions. Atrix agrees that should Applicable Laws require that any such interim data and results from such Phase IV surveillance programs be prepared in written form, Atrix shall comply with such requirements and provide all such information in writing to Sanofi-Synthelabo and the Competent Authorities in accordance with Applicable Laws. Atrix further agrees that Sanofi-Synthelabo shall have the right to incorporate, refer to and cross-reference such results and underlying data in any regulatory filing or any other filing or requirement Sanofi-Synthelabo is required to undertake with respect to the Product. Section 10.05. POST - FIRST COMMERCIAL SALE TESTING AND REPORTING. If, after the date of First Commercial Sale in any country in the Territory, adverse events or other issues arise with respect to the safety or efficacy of the Product which jeopardizes the Product's performance or are deemed by the Parties to potentially limit its approved indications, the Parties shall consult with each other with respect to such events or other issues. If the Parties determine that the situation requires clinical testing after First Commercial Sale in any country in the Territory, modifications to any Marketing Authorization or other communication with any Competent Authority or entity, Atrix shall design and the Parties shall implement any such testing, modifications or communication as shall be agreed upon by the Parties, and the costs shall be borne [**]. Section 10.06. ASSISTANCE. Each Party shall provide reasonable assistance to the other at the other's request, in connection with their obligations pursuant to this Article X, subject to reimbursement of all of its out-of-pocket costs by the requesting Party. Section 10.07. COMPLIANCE. Sanofi-Synthelabo and Atrix shall comply with all Applicable Laws within the Territory as set forth in this Agreement, including the provision of information by Sanofi-Synthelabo and Atrix to each other necessary for Atrix and Sanofi-Synthelabo to comply with any applicable reporting requirements. Each Party shall promptly notify the other Party of any comments, responses or notices received from, or inspections by, the FDA, or other applicable Competent Authorities, which relate to or may impact the Product - ---------- ** Confidential Treatment Requested. 26 or the Manufacture of the Product or the sales and marketing of the Product, and shall promptly inform the other Party of any responses to such comments, responses, notices or inspections and the resolution of any issue raised by the FDA or other Competent Authorities. ARTICLE XI PATENTS AND TRADEMARKS Section 11.01. MAINTENANCE OF PATENTS OR MARKS. Atrix shall, at Atrix's expense, maintain and protect the Atrigel(R) Patent Rights and the Marks in all countries in the Territory; provided however, that upon written request by Atrix, Sanofi-Synthelabo shall, at no cost or expense to Sanofi-Synthelabo, provide such assistance as may be necessary to enable Atrix to comply with the administrative formalities necessary to maintain any Atrigel(R) Patent Rights or the Marks. Section 11.02. COOPERATION. Sanofi-Synthelabo shall make available to Atrix or its authorized attorneys, agents or representatives, its employees, agents or consultants necessary or appropriate to enable Atrix to file, prosecute and maintain patent applications for a period of time sufficient for Atrix to obtain the assistance it needs from such personnel. Where appropriate, Sanofi-Synthelabo shall sign or cause to have signed all documents relating to said patent or patent applications at no charge to Atrix. Section 11.03. ATRIX TO PROSECUTE INFRINGEMENT. During the Term, each Party shall give prompt notice to the other of any Third Party act which may infringe the Atrigel(R) Patent Rights or the Marks and shall cooperate with each other to terminate such infringement without litigation. Atrix shall, at its sole expense, prosecute the judicial or administrative proceedings against such Third Party infringement. Sanofi-Synthelabo shall provide such assistance and cooperation to Atrix as may be necessary to successfully prosecute any action against Third Party infringement at Atrix's expense and may deduct the expenses thereof from any amounts payable to Atrix under this Agreement. In the event Atrix fails to institute proceedings against any Third Party infringement of the Atrigel(R) Patent Rights and/or the Marks within ninety (90) days after notice given by either Party to the other of said Third Party infringement, Sanofi-Synthelabo may take such action as it deems appropriate, including without limitation, the filing of a lawsuit against such Third Party. In such event Atrix will provide such assistance and cooperation to Sanofi-Synthelabo as may be necessary, at Sanofi-Synthelabo's expense, and Sanofi-Synthelabo may deduct all costs and expenses of such actions against any amount payable to Atrix under this Agreement and retain all amounts awarded in such action. Sanofi-Synthelabo may settle any such claim so long as the terms of such settlement do not impair Atrix's rights hereunder or Atrix's rights in the Atrigel(R) Technology. In the event that either Party fails to terminate any Third Party infringement as a consequence of a final determination by a court of competent jurisdiction that all or any portion of the patent claims covering the Product are invalid or unenforceable, then if such infringement results in a Third Party selling a product that competes with the Product, then Sanofi-Synthelabo's obligation to pay royalties provided for in this Agreement in respect of Net Sales of the Product in the affected country in the Territory shall be reduced by the percentage by which sales of the Product by Sanofi-Synthelabo in the affected country in the Territory decrease as a result of the Third Party's sales of the competing product in the affected country in the Territory. 27 Section 11.04. INFRINGEMENT CLAIMED BY THIRD PARTIES. In the event a Third Party commences, or threatens to commence, a judicial or administrative proceeding against a Party to this Agreement and such proceeding pertains to a patent or Mark, the Party against whom such proceeding is threatened or commenced shall give prompt notice to the other Party. Atrix shall, at its sole cost and expense, defend any and all such claims or proceedings and shall indemnify and hold harmless Sanofi-Synthelabo from any and all liabilities, costs and expenses, including, without limitation, attorneys' fees, incurred with respect to any such claim or proceeding and Sanofi-Synthelabo shall provide such assistance and cooperation to Atrix as may be necessary to successfully defend any such claim or proceeding. ARTICLE XII CONFIDENTIALITY Section 12.01. CONFIDENTIALITY. During the Term and for a period of [**] thereafter, each Party shall maintain all Confidential Information of the other Party as confidential and shall not disclose any such Confidential Information to any Third Party or use any such Confidential Information for any purpose, except (a) as expressly authorized by this Agreement, (b) as required by law, rule, regulation or court order (provided that the disclosing Party shall first notify the other Party and shall use commercially reasonable efforts to obtain confidential treatment of any such information required to be disclosed), or (c) to its Affiliates, employees, agents, consultants and other representatives to accomplish the purposes of this Agreement, so long as such persons are under an obligation of confidentiality no less stringent than as set forth herein. Each Party may use such Confidential Information only to the extent required to accomplish the purposes of this Agreement. Each Party shall use at least the same standard of care as it uses to protect its own Confidential Information to ensure that its Affiliates, employees, agents, consultants and other representatives do not disclose or make any unauthorized use of the other Party's Confidential Information. Each Party shall promptly notify the other Party upon discovery of any unauthorized use or disclosure of the other Party's Confidential Information. Section 12.02. DISCLOSURE OF AGREEMENT. Neither Party shall release to any Third Party or publish in any way any non-public information with respect to the terms of this Agreement without the prior written consent of the other Party, which consent shall not be unreasonably withheld, except for the disclosure by a Party of the terms of this Agreement to lenders, investment bankers and other financial institutions of its choice solely for purposes of financing the business operations of such Party; provided such Party uses reasonable efforts to obtain a signed confidentiality agreement with any such financial institution with respect to such information on terms substantially similar to those contained in this Article XII and except as provided in Section 20.11. Nothing contained in this paragraph shall prohibit either Party from filing this Agreement as required by the rules and regulations of the Securities and Exchange Commission, national securities exchanges or the Nasdaq Stock Market; provided the disclosing Party discloses only the minimum information required to be disclosed in order to comply with such requirements, including requesting confidential treatment of this Agreement (after consultation with the other Party) and filing this Agreement in redacted form. - ---------- ** Confidential Treatment Requested. 28 ARTICLE XIII ATRIX'S OPTION TO MARKET THE PRODUCT UNDER CERTAIN CIRCUMSTANCES Section 13.01. CO-MARKETING RIGHTS. If Sanofi-Synthelabo should fail to achieve, through no fault of Atrix, at least a [**], then, and in such event only, Atrix shall have the right and option, exercisable in its sole discretion, by written notice to that effect delivered by Atrix to Sanofi-Synthelabo within sixty (60) days after said event occurs, to co-market the Product in the United States, either by itself, using a Third Party or in conjunction with a Third Party. If Atrix exercises its right to co-market the Product in the United States the following shall occur: (i) Sanofi-Synthelabo shall grant Atrix an exclusive sublicense of its rights under this Agreement (and no other Sanofi-Synthelabo proprietary or intellectual property rights) with the right to sub-license, to market, advertise, promote, distribute, offer for sale, sell and import the Product in the United States; (ii) Atrix will be solely responsible for its expenses related to marketing the Product in the United States and Atrix will retain all revenues from Product that it sells in the United States; (iii) Atrix and/or its sublicensee shall only be entitled to market one additional brand of the Product and Atrix and/or its sublicensee shall market the Product using a different trademark than the Mark and (iv) the Advisory Board will be deemed to be automatically dissolved as of the date Atrix exercises its right to co-market the Product. ARTICLE XIV REPRESENTATIONS AND WARRANTIES Section 14.01. CORPORATE POWER. As of the date of this Agreement and as of the Effective Date, each Party hereby represents and warrants that such Party is duly organized and validly existing under the laws of the state of its incorporation and has full power and authority to enter into this Agreement and the transactions contemplated hereby and to carry out the provisions hereof. Section 14.02. DUE AUTHORIZATION. As of the date of this Agreement and as of the Effective Date, each Party hereby represents and warrants that such Party is duly authorized to execute and deliver this Agreement and to perform its obligations hereunder. Section 14.03. BINDING OBLIGATION. As of the date of this Agreement and as of the Effective Date, each Party hereby represents and warrants that this Agreement is a legal and valid obligation binding upon it and is enforceable in accordance with its terms, except that the enforcement of the rights and remedies created hereby is subject to bankruptcy, insolvency, reorganization and similar laws of general application affecting the rights and remedies of creditors and that the availability of the remedy of specific performance or of injunctive relief is subject to the discretion of the court before which any proceeding therefor may be brought. As of the date of this Agreement and as of the Effective Date, the execution, delivery and performance of this Agreement by such Party does not conflict with any - ---------- ** Confidential Treatment Requested. 29 agreement, instrument or understanding, oral or written, to which it is a party or by which it may be bound, nor violate any law or regulation of any court, governmental body or administrative or other agency having authority over it. Section 14.04. OWNERSHIP OF ATRIGEL(R) PATENT RIGHTS. As of the date of this Agreement and as of the Effective Date, Atrix represents and warrants that (a) it is the sole owner of all right, title and interest in and to the Atrigel(R) Patent Rights and the Marks, (b) it has not granted any license under the Atrigel(R) Patent Rights or the Marks for any Product in the Territory for use in the Field to any Third Party and is under no obligation to grant any such license, except to Sanofi-Synthelabo, and (c) there are no outstanding liens, encumbrances, agreements or understanding of any kind, either written, oral or implied, regarding either the Atrigel(R) Patent Rights or the Marks which are inconsistent or in conflict with this Agreement. Section 14.05. PATENT PROCEEDINGS. As of the date of this Agreement and as of the Effective Date, Atrix represents and warrants that, to the best of its knowledge, (a) no patent or patent application within the Atrigel(R) Patent Rights is the subject of any pending interference, opposition, cancellation or other protest proceeding, and (b) the Atrigel(R) Technology does not infringe the published intellectual property rights of any Third Party. Section 14.06. LEGAL PROCEEDINGS. As of the date of this Agreement and as the Effective Date, each Party hereby represents and warrants to the other Party that there is no action, suit or proceeding pending against or affecting, or, to the knowledge of either Party, threatened against or affecting that Party, or any of its assets, before any court or arbitrator or any governmental body, agency or official that would, if decided against either Party, have a material adverse impact on the business, properties, assets, liabilities or financial condition of that Party (that are not already reflected in that Party's respective financial statements) and which would have a material adverse effect on that Party's ability to consummate the transactions contemplated by this Agreement. Section 14.07. ATRIX'S MANUFACTURING FACILITY. As of the date of this Agreement and as of the Effective Date, Atrix represents and warrants to Sanofi-Synthelabo that Atrix's manufacturing facility is capable of manufacturing [**]. Section 14.08. LIMITATION ON WARRANTIES. Except as expressly set forth in this Agreement, nothing herein shall be construed as a representation or warranty by Atrix to Sanofi-Synthelabo that the Atrigel(R) Technology is not infringed by any Third Party, or that the practice of such rights does not infringe any published intellectual property rights of any Third Party. Neither Party makes any warranties, express or implied, concerning the success of the Development Program or the commercial utility of the Product. Section 14.09. LIMITATION OF LIABILITY. NEITHER PARTY SHALL BE ENTITLED TO RECOVER FROM THE OTHER PARTY ANY SPECIAL OR PUNITIVE DAMAGES IN CONNECTION WITH THIS AGREEMENT OR ANY LICENSE GRANTED HEREUNDER. - ---------- ** Confidential Treatment Requested. 30 ARTICLE XV INDEMNIFICATION Section 15.01. SANOFI-SYNTHELABO INDEMNIFIED BY ATRIX. Atrix shall indemnify and hold Sanofi-Synthelabo, its Affiliates, and their respective employees, directors and officers, harmless from and against any liabilities or obligations, damages, losses, claims, encumbrances, costs or expenses (including attorneys' fees) (any or all of the foregoing herein referred to as "Loss") insofar as a Loss or actions in respect thereof, whether existing or occurring prior to, on or subsequent to the Effective Date, arises out of or is based upon (a) any misrepresentation (or alleged misrepresentation) or breach (or alleged breach) of any of the warranties, covenants or agreements made by Atrix in this Agreement; (b) the manufacturing of any Product or Demonstration Samples; (c) any claims that the Product (as a result of the use of Atrigel(R) Technology therein) or its Manufacture (as a result of the use of Atrigel(R) Technology therein), use or sale infringes the patent, trademark or proprietary right of a Third Party or (d) if Atrix exercises its rights to co-market the Product under Article XIII, Atrix's, or its sublicensee's, marketing, sale, distribution or promotion of the Product. Section 15.02. ATRIX INDEMNIFIED BY SANOFI-SYNTHELABO. Sanofi-Synthelabo shall indemnify and hold Atrix, its Affiliates, and their respective employees, directors and officers, harmless from and against any Loss insofar as such Loss or actions in respect thereof occurs subsequent to the Effective Date, whether existing or occurring prior to, on or subsequent to the date hereof, arises out of or is based upon (a) any misrepresentation (or alleged misrepresentation) or breach (or alleged breach) of any of the warranties, covenants or agreements made by Sanofi-Synthelabo in this Agreement; (b) Sanofi-Synthelabo's use of the Marks or the Marketing Authorizations in the marketing, sale, distribution or promotion of the Product or the Demonstration Samples; (c) Sanofi-Synthelabo's marketing, sale, distribution or promotion of the Product or the Demonstration Samples or (d) the use of Sanofi-Synthelabo's name and trademark in the packaging and labeling of the Product and in the marketing, sale, distribution or promotion of the Product or the Demonstration Samples. Section 15.03. PROMPT NOTICE REQUIRED. No claim for indemnification hereunder shall be valid unless notice of the matter which may give rise to such claim is given in writing by the indemnitee (the "Indemnitee") to the persons against whom indemnification may be sought (the "Indemnitor") as soon as reasonably practicable after such Indemnitee becomes aware of such claim, provided that the failure to notify the Indemnitor shall not relieve it from any liability which it may have to the Indemnitee otherwise than under this Article XV. Such notice shall state that the Indemnitor is required to indemnify the Indemnitee for a Loss and shall specify the amount of Loss and relevant details thereof. The Indemnitor shall notify Indemnitee no later than sixty (60) days from such notice of its intention to assume the defense of any such claim. In the event the Indemnitor fails to give such notice within that time the Indemnitor shall no longer be entitled to assume such defense. Section 15.04. INDEMNITOR MAY SETTLE. The Indemnitor shall at its expense, have the right to settle and defend, through counsel reasonably satisfactory to the Indemnitee, any action which may be brought in connection with all matters for which indemnification is available. In such event the Indemnitee of the Loss in question and any successor thereto shall permit the Indemnitor full and free access to its books and records and otherwise fully cooperate with the 31 Indemnitor in connection with such action; provided that this Indemnitee shall have the right fully to participate in such defense at its own expense. The defense by the Indemnitor of any such actions shall not be deemed a waiver by the Indemnitor of its right to assert a claim with respect to the responsibility of the Indemnitor with respect to the Loss in question. The Indemnitor shall have the right to settle or compromise any claim against the Indemnitee without the consent of the Indemnitee provided that the terms thereof: (a) provide for the unconditional release of the Indemnitee; (b) require the payment of compensatory monetary damages by Indemnitor only; and (c) expressly state that neither the fact of settlement nor the settlement agreement shall constitute, or be construed or interpreted as, an admission by the Indemnitee of any issue, fact, allegation or any other aspect of the claim being settled. No Indemnitee shall pay or voluntarily permit the determination of any liability which is subject to any such action while the Indemnitor is negotiating the settlement thereof or contesting the matter, except with the prior written consent of the Indemnitor, which consent shall not be unreasonably withheld or delayed. If the Indemnitor fails to give Indemnitee notice of its intention to defend any such action as provided herein, the Indemnitee involved shall have the right to assume the defense thereof with counsel of its choice, at the Indemnitor's expense, and defend, settle or otherwise dispose of such action. With respect to any such action which the Indemnitor shall fail to promptly defend, the Indemnitor shall not thereafter question the liability of the Indemnitor hereunder to the Indemnitee for any Loss (including counsel fees and other expenses of defense). ARTICLE XVI COVENANTS Section 16.01. COVENANT NOT TO LAUNCH COMPETITIVE PRODUCT. (a) Sanofi-Synthelabo hereby covenants and shall cause its Affiliates to agree not to out-license, commercialize, market, sell, distribute or have marketed, have sold or have distributed any Competitive Product in any country in the Territory in which Sanofi-Synthelabo retains a license granted by Atrix under Article III during the Term. Notwithstanding the foregoing, if Sanofi-Synthelabo or any Affiliate acquires an entity or all or substantially all of the assets of an entity and such entity distributes a Competitive Product or such assets include a Competitive Product, Sanofi-Synthelabo or such Affiliate shall have one hundred and eighty (180) days in which to divest itself of such Competitive Product or to otherwise cease marketing, sales and distribution of such Competitive Product, and Sanofi-Synthelabo shall not be in breach of this Section 16.01 if it or the Affiliate, as the case may be, so divests or ceases marketing, sales and distribution within such one hundred and eighty (180) day period; (b) All of the covenants in this Section 16.01 shall be construed as an agreement independent of any other provision in this Agreement, and the existence of any claim or cause of action of either Party, its designee or its Affiliates against the other Party, whether predicated on this Agreement or otherwise, shall not constitute a defense to an action by the Party who is not in breach of this Section 16.01 to enforce such covenants against the other Party; 32 (c) The Parties hereby agree that the covenants set forth in this Section 16.01 are a material and substantial part of the transactions contemplated by this Agreement; and (d) Because of the difficulty of measuring economic losses to Atrix as a result of a breach of the restrictive covenants set forth in this Section 16.01, and because of the immediate and irreparable damage that would be caused to Atrix for which monetary damages would not be a sufficient remedy, the Parties agree that Atrix will be entitled to seek specific performance, temporary and permanent injunctive relief, and such other equitable remedies to which it may then be entitled against Sanofi-Synthelabo. This Section 16.01 shall not limit any other legal or equitable remedies that Atrix may have against Sanofi-Synthelabo for violation of the restrictions of this Section 16.01. The Parties agree that Atrix shall have the right to seek relief for any violation or threatened violation of this Section 16.01 by Sanofi-Synthelabo from any court of competent jurisdiction in any jurisdiction authorized to grant the relief necessary to prohibit the violation or threatened violation of this Section 16.01. This Section shall apply with equal force to Sanofi-Synthelabo's Affiliates, if any of them is the holder of the Marketing Authorization at the time the violation or threatened violation of this Section 16.01 takes place. Section 16.02. LIMITATION TO THE TERRITORY. Sanofi-Synthelabo covenants and agrees that it will not, nor shall it permit its Affiliates, without the prior written authorization of Atrix to: (i) promote or actively solicit sale of the Product or advertise the Product, outside of the Territory; (ii) purchase or cause to be purchased Product which Sanofi-Synthelabo has represented, directly or indirectly, as being for the purpose of sale in a specific country in the Territory for sale in any other country in the Territory; (iii) contact any of Atrix's suppliers or vendors of the Product or components relating to the Product; (iv) contact the Competent Authorities or other entity about the Product, except as required by Applicable Laws or as may be necessary or appropriate to carry out its obligations hereunder; and (v) knowingly sell or distribute for resale the Product purchased hereunder to a Third Party who intends to sell outside of the Territory. Section 16.03. ACCESS TO BOOKS AND RECORDS. Sanofi-Synthelabo covenants and agrees that it shall permit Atrix, at Atrix's expense and during normal business hours, to exercise the inspection rights granted to Atrix by Sanofi-Synthelabo under Section 4.05(d). Section 16.04. A&S SPENDING LEVELS. Sanofi-Synthelabo covenants and agrees that during the first [**] following the first commercial shipment of the Product [**], Sanofi-Synthelabo's annual A&S spending levels in each country in the Territory, on a country by country basis, shall be at least [**], not to exceed [**] in the aggregate. Sanofi-Synthelabo further covenants and agrees that after such [**] Period, Sanofi-Synthelabo shall maintain annual A&S spending levels [**]. - ---------- ** Confidential Treatment Requested. 33 Section 16.05. MARKETING EXPENSES. Sanofi-Synthelabo covenants and agrees that except as provided in Section 6.01(g), Sanofi-Synthelabo shall be solely responsible for the cost and implementation of all marketing, sales, promotional and related activities concerning the marketing, sale and promotion of the Product. Section 16.06. COMPLIANCE. Sanofi-Synthelabo covenants and agrees that it will assume all responsibility for selling and distributing the Product and the Demonstration Samples, as applicable, including obtaining all necessary permits and licenses, and any other requirements relating to the import, sale and distribution of the Product and the Demonstration Samples, as applicable, imposed by Applicable Law, other than Governmental Approvals and Marketing Authorizations, and Sanofi-Synthelabo shall comply with all Applicable Laws affecting the use, possession, distribution, advertising and all forms of promotion in connection with the sale and distribution of the Product and the Demonstration Samples in the Territory. Section 16.07. PROTECTION OF THE MARKS. Sanofi-Synthelabo covenants and agrees that neither Sanofi-Synthelabo nor its Affiliates shall publish, employ nor cooperate in the publication of, any misleading or deceptive advertising material with regard to Atrix or the Marks. Section 16.08. LAUNCH QUANTITIES. Each Party covenants and agrees to the other as follows: (a) that Atrix will provide Launch Quantity of the Product; (b) that Sanofi-Synthelabo will timely provide to Atrix its forecast of Sanofi-Synthelabo's requirement of Product, on a Product by Product basis, including Demonstration Samples, in order to enable Atrix to timely provide Launch Quantity of the Product to Sanofi-Synthelabo. Section 16.09. FURTHER ACTIONS. Upon the terms and subject to the conditions hereof, each of the Parties hereto shall use its commercially reasonable efforts to (i) take, or cause to be taken, all appropriate action and do, or cause to be done, all things necessary, proper or advisable under Applicable Law or otherwise to consummate and make effective the transactions contemplated by this Agreement, (ii) obtain from Competent Authorities any consents, licenses, permits, waivers, approvals, authorizations or orders required to be obtained or made by the Parties in connection with the authorization, execution and delivery of this Agreement and the consummation of the transactions contemplated by this Agreement and (iii) make all necessary filings, and thereafter make any other required submissions, with respect to this transaction under (A) the Securities Exchange Act of 1934, as amended and the Securities Act of 1933, as amended, and the rules and regulations thereunder and any other applicable federal or state securities laws, (B) the HSR Act, and any other antitrust regulations and (C) any other Applicable Law. The Parties hereto shall cooperate with each other in connection with the making of all such filings, including by providing copies of all such documents to the other Party's counsel (subject to appropriate confidentiality restrictions) prior to filing and, if requested, by accepting all reasonable additions, deletions or changes suggested in connection therewith. Without limiting the generality of the foregoing, each Party shall take or omit to take such action as the other Party shall reasonably request to cause the Parties to obtain any material Governmental Approvals and/or the expiration of applicable waiting periods, provided that the 34 foregoing shall not obligate either Party to take or to omit to take any action (including, without limitation, the expenditure of funds or any holding separate and agreeing to sell or otherwise dispose of assets, categories of assets or businesses) as in the good faith opinion of such Party, would cause a material adverse effect on a Party. ARTICLE XVII PRODUCT RECALL Section 17.01. PRODUCT RECALLS OR WITHDRAWAL. If at any time or from time to time any Competent Authority of any country in the Territory requests either Party to recall the Product or if a voluntary recall is contemplated (a "Recall"), the Party to whom such request is made or the Party contemplating such Recall, as the case may be, shall immediately notify the other Party. Neither Party shall carry out a voluntary Recall without the prior written approval of the other Party which approval shall not be unreasonably withheld, conditioned or delayed by either Party. Any Recall shall be carried out by Sanofi-Synthelabo in as expeditious a manner as reasonably possible to preserve the goodwill and reputation of the Product and the goodwill and reputation of the Parties. Sanofi-Synthelabo shall in all events be responsible for conducting any Recalls, market withdrawals or corrections with respect to the Product. Sanofi-Synthelabo shall maintain records of all sales and distribution of Product and customers sufficient to adequately administer a Recall, market withdrawal or correction for the period required by Applicable Law. Section 17.02. RECALL COSTS. Sanofi-Synthelabo shall be responsible for conducting any Recall and the cost and expense of a Recall shall be allocated as follows: (a) if such Recall is a voluntary Recall or shall be due to tampering or other cause, other than a manufacturer's defect, but not due to the negligence or misconduct of the Parties, or the breach by a Party of its warranties or obligations hereunder, then Sanofi-Synthelabo and Atrix shall [**] of the costs and expenses incurred by Sanofi-Synthelabo in connection with such Recall, including, without limitation, all product credits and returns, freight and shipping costs and product disposal expenses. In such event, Atrix agrees to pay Sanofi-Synthelabo within ten (10) days after its receipt from Sanofi-Synthelabo of any invoice(s) assessing Atrix [**] of these said costs, as listed above; (b) if such Recall shall be due to manufacturer's defect or the negligence or the breach by Atrix of its warranties or obligations hereunder or the misconduct of Atrix, all such costs and expenses shall be borne and paid solely by Atrix and Atrix will reimburse Sanofi-Synthelabo for any such costs and expenses paid by Sanofi-Synthelabo within ten (10) days of receipt of an invoice for such costs and expenses from Sanofi-Synthelabo, and if not so paid Sanofi-Synthelabo shall have the right to offset such amounts against amounts otherwise due by Sanofi-Synthelabo to Atrix hereunder; and - ---------- ** Confidential Treatment Requested. 35 (c) if such Recall is due to the negligence or the breach by Sanofi-Synthelabo of its warranties or obligations hereunder or the misconduct of Sanofi-Synthelabo, all such costs and expenses shall be borne and paid solely by Sanofi-Synthelabo and Sanofi-Synthelabo will reimburse Atrix for any such costs and expenses paid by Atrix within thirty (30) days of receipt of an invoice and appropriate documentation for such costs and expenses from Atrix. Section 17.03. NOTIFICATION OF COMPLAINTS. Each Party agrees that throughout the Term of this Agreement, and with respect to all Product or Demonstration Samples supplied and purchased under this Agreement, after the termination of this Agreement, it will (i) notify the other Party immediately of all available information concerning any complaint product defect reports, and similar notices received by either Party with respect to the Product or Demonstration Samples, whether or not determined to be attributable to the Product or Demonstration Samples and (ii) with respect to an ADE, comply with the provisions of Section 10.04. Sanofi-Synthelabo, in consultation with Atrix, shall define and implement regulatory compliance procedures, including, without limitation, action plans and an SOP for product defect reporting and will handle all product complaints in the Territory. In connection with any such product complaint Atrix shall cooperate as reasonably requested by Sanofi-Synthelabo including performing any testing and follow-up investigations mutually agreed upon by the Parties. Section 17.04. NOTIFICATION OF THREATENED ACTION. Throughout the duration of this Agreement and with respect to all Product supplied and purchased under this Agreement, after the termination of this Agreement, each Party shall immediately notify the other Party of any information it receives regarding any threatened or pending action, inspection or communication by or from a concerned Competent Authority which may affect the safety or efficacy claims of the Product or the continued marketing of the Product. Upon receipt of such information, the Parties shall consult with each other in an effort to arrive at a mutually acceptable procedure for taking appropriate action. ARTICLE XVIII INSURANCE Section 18.01. INSURANCE. Each Party shall, at its sole cost and expense, obtain and keep in force comprehensive general liability insurance, including any applicable self-insurance coverage, with bodily injury, death and property damage limits of Five Million and 00/100 Dollars ($5,000,000.00) per occurrence and Five Million and 00/100 Dollars ($5,000,000.00) in the aggregate, including contractual liability and product liability coverage. At such time, each Party shall furnish the other with a certificate of insurance signed by an authorized representative of such Party's insurance underwriter evidencing the insurance coverage required by this Agreement, showing that the other Party has been listed as an additional party insured on such policy, and providing for at least thirty (30) days prior written notice to the other Party of any cancellation, termination or reduction of such insurance coverage. 36 ARTICLE XIX TERM; DEFAULT AND TERMINATION Section 19.01. TERM. This Agreement shall commence as of the Effective Date and shall expire on a country-by-country basis on the expiration of the last applicable Atrigel(R) Patent Right, or any other patents obtained by Atrix with regard to the Product, in such country (the "Term"). Section 19.02. TERMINATION BY EITHER PARTY. This Agreement may be terminated and the other agreements contemplated hereunder may be terminated at any time prior to the Effective Date as follows: (a) by mutual written consent duly authorized by the boards of directors of each of Atrix and Sanofi-Synthelabo; (b) by either Atrix or Sanofi-Synthelabo, if the Effective Date shall not have occurred on or before February 28, 2001 solely as a result of the failure of the waiting period to have expired or the failure to obtain termination or approval under the HSR Act; provided further that the right to terminate shall not be available to any Party whose failure to fulfill its obligations hereunder shall have been the cause of, or shall have resulted in, the failure of the Agreement to be consummated by the applicable date. Section 19.03. TERMINATION BY EITHER PARTY FOR CAUSE. Either Party may terminate this Agreement prior to the expiration of the Term upon the occurrence of any of the following: (a) Upon or after the cessation of operations of the other Party or the bankruptcy, insolvency, dissolution or winding up of the other Party (other than dissolution or winding up for the purposes or reconstruction or amalgamation); or (b) Upon or after the breach of any material provision of this Agreement by the other Party if the breaching Party has not cured such breach within sixty (60) days after written notice thereof by the non-breaching Party. Section 19.04. TERMINATION BY ATRIX. Atrix may terminate this Agreement prior to the expiration of the Term with respect to any country in the Territory upon the occurrence of any of the following: (a) Upon the failure by Sanofi-Synthelabo to pay for fifteen (15) days from receipt of notice thereof from Atrix, a copy of which shall be sent to both Sanofi-Synthelabo's Chief Financial Officer and General Counsel pursuant to the terms of Section 20.08,: (i) any royalty payment, or portion thereof, pursuant to Section 4.02; (ii) any milestone payments, or portion thereof, pursuant to Section 4.03 or Section 4.04; or (iii) the Purchase Price due to Atrix under Section 8.01 of this Agreement; provided, however, that this subsection (a) shall not apply to any royalty payment, or portion thereof, pursuant to Section 4.02, which is the subject of a good faith dispute (a "Disputed Amount") between Sanofi-Synthelabo and Atrix. Further, Sanofi-Synthelabo shall pay interest on any Disputed Amount at a rate equal to the Prime Rate of Interest to 37 begin accruing on a daily basis from the date such payment was due and continuing until such payment is received by Atrix. Any Disputed Amount shall be resolved by the Parties within ninety (90) days from the date Sanofi-Synthelabo notifies Atrix of a good faith dispute; provided however if the dispute cannot be resolved to the mutual satisfaction of the Parties within such ninety (90) day period then either Party may request that the dispute be submitted to the Chief Executive Officers of Atrix and Sanofi-Synthelabo, respectively, for joint resolution. If the dispute is not jointly resolved by the Parties' respective Chief Executive Officers within ten (10) days from submission to the Parties' respective Chief Executive Officers then Atrix shall be entitled to pursue any and all remedies at law available to it. In no event will the dispute resolution period exceed a maximum of one hundred (100) days unless otherwise agreed in writing by the Parties. Further, Sanofi-Synthelabo may in its discretion determine to pay any such Disputed Amount and in the event amounts are finally determined not to be due by Sanofi-Synthelabo, Atrix shall repay, without interest, such excess amounts determined not to be due; or (b) Upon the occurrence of any material misrepresentation or omission in any report required to be delivered by Sanofi-Synthelabo to Atrix by Section 4.05(a), which misrepresentation or omission is caused by Sanofi-Synthelabo's willful misconduct, gross negligence or bad faith. Section 19.05. TERMINATION BY SANOFI-SYNTHELABO. Sanofi-Synthelabo may terminate this Agreement prior to the expiration of the Term with respect to any country in the Territory upon an increase in the Atrix Manufacturing Cost over the Twelve Month Cost and the failure of Sanofi-Synthelabo and Atrix to reach mutual agreement on the Purchase Price of the Product. Section 19.06. REMEDIES. All of the non-breaching Party's remedies shall be cumulative, and the exercise of one remedy hereunder by the non-defaulting Party shall not be deemed to be an election of remedies. Section 19.07. EFFECT OF TERMINATION. (a) In the event of termination of this Agreement pursuant to Section 19.02, this Agreement shall forthwith become void, there shall be no liability under this Agreement on the part of Atrix or Sanofi-Synthelabo or any of their respective Affiliates, employees, directors and officers, and all rights and obligations of each Party hereto shall cease; provided, however, that nothing herein shall relieve any Party from liability for the willful breach of any of its representations, warranties, covenants or agreements set forth in this Agreement. (b) Subject to Section 19.07(d), upon termination of this Agreement by Atrix pursuant to Sections 19.03 or 19.04, (i) Sanofi-Synthelabo shall have no right to practice within the Atrigel(R) Patent Rights or use any of the Atrigel(R) Technology, (ii) all rights, title or interest in, or other incidents of ownership under, the Atrigel(R) Technology and the Marks shall revert to and become the sole property of Atrix, and (iii) Sanofi-Synthelabo shall reimburse Atrix for costs and expenses reasonably incurred or committed to by Atrix and for which Sanofi-Synthelabo is otherwise obligated to reimburse Atrix pursuant to this Agreement in connection with the activities performed 38 by Atrix in accordance with the Development Program prior to the effective date of such termination. (c) Upon termination of this Agreement by Sanofi-Synthelabo pursuant to Section 19.03, the licenses granted under Sections 3.02 and 3.03 shall remain in effect so long as Sanofi-Synthelabo has not breached its obligations to Atrix under this Agreement as of the date of such termination. (d) Upon termination by Atrix under Sections 19.03 or 19.04 or by Sanofi-Synthelabo under Section 19.05, the following shall occur: (i) All applicable licenses granted to Sanofi-Synthelabo shall terminate immediately, including the rights granted to Sanofi-Synthelabo pursuant to Sections 3.02 and 3.03, and Sanofi-Synthelabo shall have no further rights to the Product subject to Sanofi-Synthelabo's option to sell off existing inventory of Product and distribute existing inventory of Demonstration Samples for six (6) months after the termination date under subsection (iii) hereof, and Sanofi-Synthelabo shall not, either directly or indirectly, use or permit the use of the same or of the documentation relating to the Product, except to sell off existing inventory under subsection (ii) hereof; (ii) Sanofi-Synthelabo, at its option, may sell off any existing inventory of Product and utilize the Demonstration Samples during a period not to exceed six (6) months following such termination. If Sanofi-Synthelabo chooses this option, Sanofi-Synthelabo shall: (A) within thirty (30) days of issuance of a notice of termination by any Party, notify Atrix that it intends to sell off existing inventory of Product and utilize the Demonstration Samples as provided in this Agreement; (B) continue to comply with its payment obligations to Atrix under Article IV; (C) continue to sell off existing inventory of Product and utilize the Demonstration Samples for six (6) months after the notice of termination but at the expiration of the six (6) months, at Atrix's election, either (1) sell all existing inventory of Product and Demonstration Samples to Atrix or (2) destroy all remaining inventory of Product and Demonstration Samples in accordance with Applicable Law, providing Atrix with proof of destruction in writing sufficient to comply with Applicable Laws; provided that in either case, Atrix shall pay to Sanofi-Synthelabo, the full amount of the actual cost paid by Sanofi-Synthelabo to Atrix for such remaining inventory of Product and Demonstration Samples. If Sanofi-Synthelabo sells any inventory of Product or Demonstration Samples to Atrix pursuant to this subsection, it shall warrant that such inventory of Product and Demonstration Samples has 39 been stored in compliance with all Applicable Laws, has not been adulterated and has otherwise been maintained according to the requirements of Applicable Laws and Marketing Authorizations; (D) if Sanofi-Synthelabo notifies Atrix that Sanofi-Synthelabo does not intend to sell off any existing inventory of Product and utilize the Demonstration Samples, Sanofi-Synthelabo shall, at Atrix's election, either (1) sell all existing inventory of Product and Demonstration Samples to Atrix or (2) destroy all remaining inventory of Product and Demonstration Samples in accordance with Applicable Law, providing Atrix with proof of destruction in writing sufficient to comply with Applicable Laws; provided that in either case, Atrix shall pay to Sanofi-Synthelabo, the full amount of the actual cost paid by Sanofi-Synthelabo to Atrix, for such remaining inventory of Product and Demonstration Samples. If Sanofi-Synthelabo sells any inventory of Product or Demonstration Samples to Atrix pursuant to this subsection, it shall warrant that such inventory of Product and Demonstration Samples has been stored in compliance with all Applicable Laws, has not been adulterated and has otherwise been maintained according to requirements of Applicable Laws and Competent Authorities; and (E) any sales of Product or Demonstration Samples made by Sanofi-Synthelabo to Atrix pursuant to this Section 19.07 shall be made by Sanofi-Synthelabo within thirty (30) days of the end of the time period specified by Section 19.07(d)(ii) and shall be shipped to Atrix appropriately packaged and stored. All transportation costs in connection with such sale, including without limitation, insurance, freight and duties, shall be shared equally by Sanofi-Synthelabo and Atrix. Amounts owed by Atrix to Sanofi-Synthelabo pursuant to this Section 19.07(d) for the Product or Demonstration Samples shall be paid by Atrix within ten (10) days after receipt by Atrix of an appropriately detailed invoice from Sanofi-Synthelabo for the amount so owing to it by Atrix under this subsection. (e) Expiration or termination of this Agreement shall not relieve the Parties of any obligation accruing prior to such expiration or termination. Except as set forth below or elsewhere in this Agreement, the obligations and rights of the Parties under Sections 11.04, 14.07, 14.08 and Articles XII, XV, XVII and XX shall survive expiration or termination of this Agreement; provided that in the case of Section 4.05(d), such rights and obligations shall survive for only one (1) year after termination or expiration. (f) Within thirty (30) days following the expiration or termination of this Agreement, each Party shall return to the other Party, or destroy, upon the written request of the other Party, any and all Confidential Information of the other Party in its possession and upon a Party's request, such destruction (or delivery) shall be confirmed in writing to such Party by a responsible officer of the other Party. 40 ARTICLE XX MISCELLANEOUS Section 20.01. NO-SOLICITATION. During the Term of this Agreement, neither Party nor its Affiliates (collectively, the "Initiating Group") shall, directly or through its representatives, solicit for employment or hire any officer, director, employee or consultant of the other Party or its subsidiaries or controlled Affiliates (collectively, the "Other Group") with whom the Initiating Group has contact in connection with, or who otherwise is known by the Initiating Group to participate in, the transactions contemplated by this Agreement. The Initiating Group shall not be precluded from hiring any such person who has been terminated by the Other Group prior to commencement of employment discussions between such person and the Initiating Group or its representatives. "Solicitation" shall not include any generalized public advertisement or any other solicitation by the Initiating Group or its representatives that is not specifically directed toward any such employee of the Other Group or toward any group of such employees of the Other Group. Section 20.02. COMMERCIALLY REASONABLE EFFORTS. Each Party shall use commercially reasonable efforts to perform its responsibilities under this Agreement. As used herein, the term "commercially reasonable efforts" means, unless the Parties agree otherwise, those efforts consistent with the exercise of prudent scientific and business judgment, as applied to other products of similar scientific and commercial potential within the relevant product lines of the Parties. Section 20.03. ASSIGNMENT. Except as expressly provided hereunder, neither this Agreement nor any rights or obligations hereunder may be assigned or otherwise transferred by either Party without the prior written consent of the other Party (which consent shall not be unreasonably withheld); provided, however, that either Party may assign this Agreement and its rights and obligations hereunder without the other Party's consent (a) in connection with the transfer or sale of all or substantially all of the business of such Party to which this Agreement relates to another Party, whether by merger, sale of stock, sale of assets or otherwise, or (b) to any Affiliate. Notwithstanding the foregoing, any such assignment to an Affiliate shall not relieve the assigning Party of its responsibilities for performance of its obligations under this Agreement. The rights and obligations of the Parties under this Agreement shall be binding upon and inure to the benefit of the successors and permitted assigns of the Parties. Any assignment not in accordance with this Agreement shall be void. Section 20.04. FORCE MAJEURE. Neither Party shall be held liable or responsible to the other Party nor be deemed to have defaulted under or breached this Agreement for failure or delay in fulfilling or performing any term of this Agreement when such failure or delay is caused by or results from causes beyond the reasonable control of the affected Party, including, but not limited to, fire, floods, embargoes, war, acts of war (whether war be declared or not), insurrections, riots, civil commotions, strikes, lockouts or other labor disturbances, acts of God or acts, omissions or delays in acting by any governmental authority or the other Party, or for any other reason which is completely beyond the control of the Party (collectively a "Force Majeure"); provided that the Party whose performance is delayed or prevented shall continue to use good faith diligent efforts to mitigate, avoid or end such delay or failure in performance as soon as practicable. 41 Section 20.05. GOVERNING LAW. This Agreement shall be governed by, and construed and enforced in accordance with, the laws of the State of New York, except that no conflict of laws provision shall be applied to make the laws of any other jurisdiction applicable to this Agreement. Section 20.06. WAIVER. Except as specifically provided for herein, the waiver from time to time by either of the parties of any of their rights or their failure to exercise any remedy shall not operate or be construed as a continuing waiver of same or of any other of such Party's rights or remedies provided in this Agreement. Section 20.07. SEVERABILITY. In case any provision of this Agreement shall be invalid, illegal or unenforceable, the validity, legality and enforceability of the remaining provisions shall not in any way be affected or impaired thereby. Section 20.08. NOTICES. All notices, requests and other communications to any party hereunder shall be in writing and shall be deemed to have been given if delivered personally, mailed by certified mail (return receipt requested) or sent by cable, telegram or recognized overnight delivery service to the parties at the following addresses or at such other addresses as, specified by the parties by like notice: IF TO ATRIX: Atrix Laboratories, Inc. 2579 Midpoint Drive Fort Collins, CO 80525 Attn: Charles P. Cox, Ph.D., M.B.A. Vice President, New Business Development Telephone: (970) 482-5868 Facsimile: (970) 482-9735 COPIES TO: Morrison & Foerster LLP 5200 Republic Plaza 370 17th Street Denver, Colorado 80202-5638 Attn: Warren L. Troupe, Esq. Telephone: (303) 592-2255 Facsimile: (303) 592-1510 IF TO SANOFI-SYNTHELABO: Sanofi-Synthelabo Inc. 90 Park Avenue New York, NY 10016 Attn: Gregory Irace Vice President and Chief Financial Officer Telephone: (212) 551-4000 Facsimile: (212) 551-4905 42 COPIES TO: Sanofi-Synthelabo Inc. 90 Park Avenue New York, NY 10016 Attn: John Spinmato Senior Vice President and General Counsel Telephone: (212) 551-4306 Facsimile: (212) 551-4919 Notice so given shall be deemed given and received (i) if by mail on the fourth (4th) day after posting; (ii) by cable, telegram, telex of personal delivery on the date of actual transmission or (as the case may be) personal or other delivery; and (iii) if by overnight courier, on the next business day following the day such notice is delivered to the courier service. Section 20.09. INDEPENDENT CONTRACTORS. It is expressly agreed that Atrix and Sanofi-Synthelabo shall be independent contractors and that the relationship between the two Parties shall not constitute a partnership or agency of any kind. Neither Atrix nor Sanofi-Synthelabo shall have the authority to make any statements, representations or commitments of any kind, or to take any action, which shall be binding on the other Party, without the prior written consent of the other Party. Section 20.10. RULES OF CONSTRUCTION. The Parties hereto agree that they have been represented by counsel during the negotiation and execution of this Agreement and, therefore, waive the application of any law, regulation, holding or rule of construction providing that ambiguities in an agreement or other document will be construed against the Party drafting such agreement or document. Whenever the context hereof shall so require, the singular shall include the plural, the male gender shall include the female gender and neuter, and vice versa. Section 20.11. PUBLICITY. Sanofi-Synthelabo and Atrix shall consult with each other before issuing any press release with respect to this Agreement or the transactions contemplated hereby and neither shall issue any such press release or make any such public statement without the prior consent of the other, which consent shall not be unreasonably withheld; provided, however, (a) that a Party may, without the prior consent of the other Party, issue such press release or make such public statement as may upon the advice of counsel be required by law or the rules and regulations of the NASDAQ or any stock exchange, or (b) if it has used reasonable efforts to consult with the other Party prior thereto, (such consent shall be deemed to have been given if the recipient of the press release or public statement fails to respond to the other Party within forty-eight (48) hours after the recipient's receipt of such press release or public statement). No such consent of the other Party shall be required to release information which has previously been made public. Section 20.12. ENTIRE AGREEMENT; AMENDMENT. This Agreement (including the Exhibits attached hereto) sets forth all of the covenants, promises, agreements, warranties, representations, conditions and understandings between the parties hereto with respect to the subject matter hereof and supersedes and terminates all prior agreements and understandings between the Parties. There are no covenants, promises, agreements, warranties, representations conditions or understandings, either oral or written, between the parties other than as set forth herein. No subsequent alteration, amendment, change or addition to this Agreement shall be 43 binding upon the Parties hereto unless reduced to writing and signed by the respective authorized officers of the Parties. Section 20.13. HEADINGS. The captions contained in this Agreement are not a part of this Agreement, but are merely guides or labels to assist in locating and reading the several articles hereof. Section 20.14. COUNTERPARTS. This Agreement may be executed in two or more counterparts, each of which shall be deemed an original, but all of which together shall constitute one and the same instrument. [Remainder of Page Intentionally Left Blank] 44 IN WITNESS WHEREOF, the Parties hereto have caused this Agreement to be executed in duplicate by their duly authorized officers as of the date and year first above written. ATRIX LABORATORIES, INC., SANOFI-SYNTHELABO INC. a Delaware corporation a Delaware corporation By: /s/ David R. Bethune By: /s/ Ed Proctor ----------------------------------- ---------------------------------- Name: David R. Bethune Name: Ed Proctor Title: Chairman and Chief Executive Title: President & CEO Officer By: /s/ Gregory Irace ---------------------------------- Name: Gregory Irace Title: Vice President and Chief Financial Officer 45 EXHIBIT A ATRIGEL(R) PATENT RIGHTS [**] - ---------- ** Confidential Treatment Requested. A-1 EXHIBIT B FORM OF CERTIFICATE OF COMPLIANCE Issue Date: _______________________ CERTIFICATE OF COMPLIANCE FOR ______________________________________________________________ CUSTOMER _________________________________________________________ LOT NUMBER _______________________________________________________ FILL DATE ______________________ PREP/EX DATE ____________________ DOSAGE ___________________________________________________________ QUANTITY OF RELEASABLE VIALS _____________________________________ The batch production record for this product has been reviewed for accuracy, completeness, and compliance with established written standard procedures and in accordance with cGMP requirements. Any deviations/abnormal occurrences from the aforementioned requirements have been appropriately documented, reviewed, and approved. Reviewed By: ___________________________________ Batch Record Auditor Date: ___________________ Approved By: ______________________________________________________________ Acting Supervisor Manager, Documentation Date: ___________________ cc: All Customers B-1 EXHIBIT C SPECIFICATIONS (see attached) [**] - ---------- ** Confidential Treatment Requested. C-1 EXHIBIT D STOCK PURCHASE AGREEMENT (see Exhibit 99.2 of Form 8-K filed with SEC on February 23, 2001 by Atrix Laboratories, Inc.) D-1 EXHIBIT E DEVELOPMENT PROGRAM (see attached) [**] - ---------- ** Confidential Treatment Requested. E-1 EXHIBIT F SANOFI-SYNTHELABO'S SOP (see attached) [**] - ---------- ** Confidential Treatment Requested. F-1 EXHIBIT G SIX MONTH PRODUCT DEVELOPMENT PROGRAM (see attached) [**] - ---------- ** Confidential Treatment Requested. G-1 CONFIDENTIAL TREATMENT REQUESTED BY QLT INC. FIRST AMENDMENT TO AGREEMENT This First Amendment to Collaboration, License and Supply agreement (this "First Amendment"), is made by and between Atrix Laboratories, Inc., a Delaware corporation having offices at 2579 Midpoint Drive, Fort Collins, CO, 80525-4417 ("Atrix"), and Sanofi-Synthelabo Inc., a Delaware corporation having offices at 90 Park Avenue, New York, NY, 10016 ("Sanofi-Synthelabo") as of this 21st day of December, 2001. Atrix and Sanofi-Synthelabo are sometimes referred to collectively herein as the "Parties" or singly as a "Party." WHEREAS, the Parties entered into that certain Collaboration, License and Supply Agreement dated as of December 8, 2000 (the "Agreement"); and WHEREAS, pursuant to Sections 2.02(b) and 4.04 of the Agreement, Sanofi-Synthelabo desires to engage Atrix to proceed with the development of the Six Month Product pursuant to the terms set forth in the Agreement as amended by this First Amendment. NOW, THEREFORE, in consideration of the mutual covenants and agreements set forth in the Agreement and as hereinafter set forth, and other good and valuable consideration, the receipt and sufficiency of which is hereby acknowledged, the Parties agree as follows: 1. Section 2.02(b) of the Agreement is hereby amended in its entirety to read as follows: "(b) Six Month Product. Sanofi-Synthelabo elects to have Atrix develop the Six Month Product in accordance with Exhibits G and H. Sanofi-Synthelabo shall be [**] incurred (A) in developing the Six Month Product; and (B) in obtaining the Marketing Authorizations for the Six Month Product (collectively, the "Six Month Cost"), up to the budgeted amount set forth in Exhibit H (the "Budgeted Six Month Cost"), plus [**] Sanofi-Synthelabo shall pay such Six Month Cost within [**] of receipt of each invoice from Atrix for such Six Month Cost. In the event that the Six Month Cost exceeds the Budgeted Six Month Cost by more than [**], Sanofi-Synthelabo shall reimburse Atrix for [**] of the amount in excess of [**] of the Budgeted Six Month Cost. For example, the budgeted Six Month Cost is [**] and if the actual Six Month Cost is [**], then Sanofi-Synthelabo would reimburse Atrix for an aggregate amount equal to [**] plus [**] of the Six Month Cost in [**] of the Budgeted Six Month Cost [**]. Notwithstanding anything to the contrary contained in the Agreement, the sum of the Six Month Cost and all amounts actually paid or owed by Sanofi-Synthelabo (and not creditable) under its milestone obligations set forth in Section 4.04 shall not exceed [**]. - ---------- ** Confidential Treatment Requested. 1 If Sanofi-Synthelabo in good faith disputes the amount of any such invoice for the Six Month Cost, then Sanofi-Synthelabo shall notify Atrix that it in good faith disputes the amount of any such invoice for the Six Month Cost and any such dispute shall be resolved by the Parties within thirty (30) days from the date of receipt of the disputed invoice; provided, however, if the dispute cannot be resolved to the mutual satisfaction of the Parties within such thirty (30) days period then either Party may request that the dispute be submitted to the Chief Executive Officers of Atrix and Sanofi-Synthelabo, respectively, for joint resolution. If the dispute is not jointly resolved by the Parties' respective Chief Executive Officers within ten (10) days from submission to the Parties' respective Chief Executive Officers, then Atrix shall be entitled to pursue any and all remedies at law available to it. In no event will the dispute resolution period exceed a maximum of forty (40) days unless otherwise agreed to in writing by the Parties. Further, Sanofi-Synthelabo may in its discretion determine to pay any such disputed amount and in the event amounts are finally determined not to be due by Sanofi-Synthelabo, Atrix shall repay, with interest paid at a rate equal to the Prime Rate of Interest, such excess amounts determined not to be due." 2. A new Section 2.02(c) of the Agreement is hereby added to the Agreement to read as follows, with current Sections 2.02(c) and 2.02(d) renumbered as Sections 2.02(d) and 2.02(e), respectively: "(c) Reduction in Six Month Product Milestones. If the NDA for the Six Month Product has not been filed: (i) within [**] of the target date set forth in Exhibit H (the "NDA Target Date"), and such delay was not caused by a Force Majeure or the actions or inactions of Sanofi-Synthelabo, the milestone payments otherwise payable by Sanofi-Synthelabo to Atrix under Section 4.04 shall be reduced by [**]; or (ii) within [**] of the NDA Target Date, and such delay was not caused by a Force Majeure or the actions or inactions of Sanofi-Synthelabo, the milestone payments otherwise payable by Sanofi-Synthelabo to Atrix under Section 4.04 shall be reduced by an aggregate amount of [**] (for example, the Six Month Product Milestone payable under Section 4.04(i) would be reduced to [**]; or (iii) within [**] of the NDA Target Date, and such delay was not caused by a Force Majeure or the actions or inactions of Sanofi-Synthelabo, or if the Six Month Cost exceeds the budgeted Six Month Cost by [**] or more (provided, such increase in the Six Month Cost was not caused by a Force Majeure or the actions or inactions of Sanofi-Synthelabo), Sanofi-Synthelabo may, at its sole discretion, terminate its obligations with respect to development of the Six Month Product, including, but not limited to, any payment obligations therefore; provided, however, Sanofi-Synthelabo shall be responsible for those Six Month Costs incurred by Atrix prior to the date Atrix receives notice from Sanofi-Synthelabo that it has elected to terminate its obligations with respect - ---------- ** Confidential Treatment Requested. 2 to the Six Month Product under this Section 2.02(c)(iii), including any non-cancelable costs incurred or to be incurred by Atrix, but only to the extent provided in Section 2.02(b) of the Agreement." 3. New Section 2.02(d) of the Agreement (formerly Section 2.02(c)) is hereby amended in its entirety to read as follows: "(d) License for Six Month Product. Upon satisfaction of the provisions of Section 2.02(b) above, Sanofi-Synthelabo shall be deemed to have an exclusive license to the Six Month Product on the same basis, terms and conditions set forth in this Agreement for the license for each other Product. Notwithstanding the foregoing: (i) (A) [**] of the Six Month Cost up to [**] of the Budgeted Six Month Cost shall be credited against the Six Month Product Milestone payable to Atrix under Section 4.04(i) of this Agreement and (B) the balance of [**] of the Six Month Cost up to [**] of the Budgeted Six Month Cost, if any, shall be credited against amounts owed by Sanofi-Synthelabo to Atrix under Section 4.04(ii); and (ii) (A) [**] of the Six Month Cost in excess of [**] of the Budgeted Six Month Cost, if any, shall be credited against the Six Month Product Milestone payable under Section 4.04(i) and (B) [**] of the Six Month Cost in excess of [**] of the Budgeted Six Month Cost, if any, shall be credited against amounts owed by Sanofi-Synthelabo to Atrix under Section 404(ii)." 4. The last paragraph of Section 4.04 of the Agreement, which begins with the words "provided, however" is hereby amended in its entirety to read as follows: "provided, however, that the milestone payments payable under this Section 4.04 shall be subject to the terms and provisions of sections 2.02(c) and (d) of this Agreement." 5. A new Exhibit H is hereby added to the Agreement in the form attached to this First Amendment. The Parties acknowledge and agree that Exhibits G and H are based on the current knowledge and understanding of the Parties as to the development work required to commercialize the Six Month Product and that such Exhibits are subject to reasonable modification at any time due to actions or inactions taken by the FDA. The Parties further acknowledge and agree that such actions or inactions by the FDA could result in delays or increase the costs to develop the Six Month Product, and that any such actions by the FDA shall constitute a Force Majeure event under the Agreement. 6. This First Amendment and all rights hereunder may not be assigned or transferred by either Party without the prior written consent of each of the Parties hereto. 7. All capitalized terms used and not otherwise defined herein shall have the same meanings as set forth in the Agreement. - ---------- ** Confidential Treatment Requested. 3 8. Except as expressly modified by the terms hereof, the terms and provisions of the Agreement shall remain in full force and effect as originally written. 9. Signatures on this First Amendment may be communicated by facsimile transmission and shall be binding upon the Parties transmitting the same by facsimile transmission. If executed in counterparts, this First Amendment will be as effective as if simultaneously executed. 4 IN WITNESS WHEREOF, the Parties hereto have caused this First Amendment to be duly executed by their respective authorized officers as of the day and year first above written. ATRIX LABORATORIES, INC. By: /s/ Charles P. Cox ---------------------------------- Name: Charles P. Cox, Ph.D., M.B.A. Title: Senior Vice President Corporate Development SANOFI-SYNTHELABO INC. By: /s/ John M. Spinnato ---------------------------------- Name: John M. Spinnato Title: Senior Vice President, Legal, and General Counsel, Secretary By: /s/ Stacey Brady ---------------------------------- Name: Stacey Brady Title: Director, Financial Control 5 EXHIBIT H SIX MONTH PRODUCT EXPENSES AND TIMING [**] - ---------- ** Confidential Treatment Requested. CONFIDENTIAL TREATMENT REQUESTED BY QLT INC. SECOND AMENDMENT TO AGREEMENT This Second Amendment to Collaboration, License and Supply Agreement (this "Second Amendment"), is made by and between Atrix Laboratories, Inc., a Delaware corporation having offices at 2579 Midpoint Drive, Fort Collins, CO, 80525-4417 ("Atrix"), Sanofi-Synthelabo Inc., a Delaware corporation having offices at 90 Park Avenue, New York, NY, 10016 ("Sanofi-Synthelabo") as of this 7th day of March, 2002. Atrix and Sanofi-Synthelabo are sometimes referred to collectively herein as the "Parties" or singly as a "Party." WHEREAS, the Parties entered into that certain Collaboration, License and Supply Agreement dated as of December 8, 2000, as subsequently amended by that certain First Amendment to Collaboration, License and Supply Agreement dated December 21, 2001 (collectively, the "Agreement"); and WHEREAS, the Parties desire to further amend the Agreement as set forth herein. NOW, THEREFORE, in consideration of the mutual covenants and agreements set forth in the Agreement and as hereinafter set forth, and other good and valuable consideration, the receipt and sufficiency of which is hereby acknowledged, the Parties agree as follows: 1. The definition of "Marks" as set forth in Article I of the Agreement is hereby amended in its entirety to read as follows and all references to the "Marks" in the Agreement are hereby amended to refer to the "Atrix Mark," unless otherwise set forth in this Second Amendment: "Atrix Mark" means "Atrigel(R)" or any additional trademarks selected by the Parties pursuant to Section 6.01(b) other than "Eligard(TM)" in either case, alone or accompanied by any logo or design and any foreign language equivalents in sound or meaning, whether registered or not." 2. A new definition is hereby added to the Agreement after the definition "Royalty Term" in Article I to read as follows: "Sanofi-Synthelabo Mark" means "Eligard(TM)", accompanied by any logo or design and any foreign language equivalents in sound or meaning, whether registered or not." 3. Section 3.03 of the Agreement is hereby amended in its entirety to read as follows: "Section 3.03. ATRIX MARK. Subject to the terms and conditions of this Agreement, Atrix hereby grants to Sanofi-Synthelabo an exclusive in the Field, royalty-free right to use the Atrix Mark in the Territory in connection with the marketing, advertising, promotion, 1 distribution and sale of the Product. The Atrix Mark shall remain the sole property of Atrix." 4. Section 6.01(b) of the Agreement is hereby amended in its entirety to read as follows: "(b) Trademarks. The Parties agree that the Product will be marketed under the Sanofi-Synthelabo Mark in the Territory. If either Sanofi-Synthelabo or Atrix desires that the Product subsequently be sold under a different name other than "Eligard(TM)", or if any Competent Authority requires that Product be sold under a different name other than "Eligard(TM)", the following provisions shall apply: (i) the different name (the "New Trademark") must be acceptable to Atrix, (ii) the New Trademark must be legally obtainable by Atrix in each jurisdiction where the New Trademark is sought, (iii) the New Trademark must be acceptable to the Competent Authority in each jurisdiction where a variation making the change to the applicable Marketing Authorization is sought, (iv) all costs (including reasonable attorneys' fees) for obtaining any change to a Marketing Authorization and for obtaining the right to use the New Trademark in each jurisdiction will be paid by [**], and (v) any New Trademarks obtained or authorized shall be owned by and be the sole property of Atrix; provided, however that any New Trademark requested by Sanofi-Synthelabo, and all costs for which are paid by Sanofi-Synthelabo, shall be owned by and be the sole property of Sanofi-Synthelabo." 5. Section 8.03(b) of the Agreement is hereby amended in its entirety to read as follows: "(b) Both Parties will approve all artwork developed for inclusion in the Product packaging, including carton labels, package inserts, etc., which approval will not be unreasonably withheld, conditioned or delayed by either Party. The Parties acknowledge and agree that the Atrix Mark will appear on the syringe A label, the syringe A pouch label, the outer pouch and carton of each Unit. In addition, the carton of each Unit will contain the statement "Atrigel(R) is a registered trademark of Atrix Laboratories, Inc." If Sanofi-Synthelabo wishes to institute changes in labeling artwork, both Parties will develop a mutually acceptable implementation schedule. Neither Party shall alter, change or in any way modify the artwork, which has previously been approved, for any reason, without prior written authorization from the other Party which authorization shall not be unreasonably withheld, conditioned or delayed by either Party, provided that such approved artwork shall conform to all Applicable Laws." 6. Clause (iii) of Section 13.01 of the Agreement is hereby amended by replacing the term "Mark" with the term "Sanofi-Synthelabo Mark." 7. Section 15.02(d) of the Agreement is hereby amended in its entirety to read as follows: "(d) the use of Sanofi-Synthelabo's name and trademark and the Sanofi-Synthelabo Mark in the packaging and labeling of the Product and in the marketing, sale, distribution or promotion of the Product or the Demonstration Samples." - ---------- ** Confidential Treatment Requested. 2 8. Section 19.07(e) of the Agreement is hereby amended in its entirety to read as follows: "(e) Expiration or termination of this Agreement shall not relieve the Parties of any obligation accruing prior to such expiration or termination. Except as set forth below or elsewhere in this Agreement, the obligations and rights of the Parties under Sections 11.04, 14.08, 14.09 and Articles XII, XV, XVII and XX shall survive expiration or termination of this Agreement; provided that in the case of Section 4.05(d), such rights and obligations shall survive for only one (1) year after termination or expiration." 9. The first sentence of Section 10.03(a) of the Agreement is hereby amended in its entirety to read as follows: "After execution of this Agreement, each Party shall provide to the other Party a copy of any significant correspondence regarding the Product in the Territory that it submits to or receives from the Competent Authorities, within ten (10) days prior to the date of submission or within five (5) days from the date of receipt, as the case may be." 10. The last sentence of Section 10.03(b) of the Agreement is hereby amended in its entirety to read as follows: "Sanofi-Synthelabo shall provide Atrix with a copy of any significant correspondence regarding the Product that it submits to or receives from the Competent Authorities, within ten (10) days prior to the date of submission or within five (5) days from the date of receipt, as the case may be." 11. This Second Amendment and all rights hereunder may not be assigned or transferred by either Party without the prior written consent of each of the Parties hereto. 12. All capitalized terms used and not otherwise defined herein shall have the same meanings as set forth in the Agreement. 13. Except as expressly modified by the terms hereof, the terms and provisions of the Agreement shall remain in full force and effect as originally written. 14. Signatures on this Second Amendment may be communicated by facsimile transmission and shall be binding upon the Parties transmitting the same by facsimile transmission. If executed in counterparts, this Second Amendment will be as effective as if simultaneously executed. 3 IN WITNESS WHEREOF, the Parties hereto have caused this Second Amendment to be duly executed by their respective authorized officers as of the day and year first above written. ATRIX LABORATORIES, INC. By /s/ Charles P. Cox ----------------------------------- Name: Charles P. Cox, Ph.D., M.B.A. Title: Senior Vice President Corporate Development SANOFI-SYNTHELABO INC. By /s/ John M. Spinnato ----------------------------------- Name: John M. Spinnato Title: Senior Vice President General Counsel and Secretary By /s/ Gregory Irace ----------------------------------- Name: Gregory Irace Title: Vice President and Chief Financial Officer 4 CONFIDENTIAL TREATMENT REQUESTED BY QLT INC. [ATRIX LETTERHEAD] August 22, 2003 Sanofi-Synthelabo Inc. 90 Park Avenue New York, NY 10016 Attn: Christophe Bianchi We refer to the Collaboration, License and Supply Agreement, dated as of December 8, 2000, by and between Atrix Laboratories, Inc., a Delaware corporation ("Atrix"), and Sanofi-Synthelabo Inc. a Delaware corporation ("Sanofi-Synthelabo"), as subsequently amended on each of December 21, 2001 and March 7, 2002 (collectively, the "Agreement"). The parties hereto have mutually agreed to further amend the Agreement as follows: 1. Section 4.02 of the Agreement is hereby amended in its entirety to read as follows: Section 4.02 ROYALTY PAYMENTS. (a) Royalty Payments. Except as set forth in Section 4.02 (b), Sanofi-Synthelabo shall pay to Atrix a royalty consisting of [**]on a country-by-country and Product-by-Product basis for a period equal to the Royalty Term for each Product in each country in the Territory. (i) Royalty [**] (i) Royalty [**]. (b) Due Dates. All royalty payments due to Atrix under this Agreement shall be paid within thirty (30) days of the end of each calendar quarter, unless otherwise specifically provided herein. Except for the modification to Section 4.02, this letter agreement does not amend, modify or supplement the Agreement in any way. Notwithstanding any provision of this Amendment, nothing herein constitutes or may be deemed to constitute a representation, warranty or covenant on the part of Sanofi-Synthelabo that it will achieve any particular level of Net Sales in any calendar year. - ---------- ** Confidential Treatment Requested. 1 Sincerely yours, ATRIX LABORATORIES, INC. By: /s/ Sean Moriarty ---------------------------------- Name: Sean Moriarty Title: Vice President, Business Development and Counsel Accepted and Agreed this __ day of August, 2003 SANOFI-SYNTHELABO INC. By: /s/ Christer Odqvist ---------------------------------- Name: Christer Odqvist Title: Vice President, Strategy & Business Operations By: /s/ Gregory Irace ---------------------------------- Name: Gregory Irace Title: Senior Vice President & CFO 2 CONFIDENTIAL TREATMENT REQUESTED BY QLT INC. FOURTH AMENDMENT TO AGREEMENT This Fourth Amendment to the Collaboration, License and Supply Agreement (this "AMENDING AGREEMENT"), is entered into as of the 1st day of March, 2005 between QLT USA, Inc. (formerly Atrix Laboratories, Inc.), a Delaware corporation having offices at 2579 Midpoint Drive, Fort Collins, Colorado, 80525-4417 ("QLT USA"), and Sanofi-Synthelabo Inc., a Delaware corporation having offices at 90 Park Avenue, New York, NY, 10016 ("SANOFI-SYNTHELABO"). WHEREAS: A. QLT USA and Sanofi-Synthelabo entered into a Collaboration, License and Supply Agreement dated as of December 8, 2000, as subsequently amended (collectively, the "COLLABORATION AGREEMENT"); B. As a result of the acquisition of Aventis SA by Sanofi-Synthelabo SA, Aventis Pharma Inc., a Canadian corporation ("SA CANADA"), became an Affiliate of Sanofi-Synthelabo; C. SA Canada markets products under the brand name [**] in the formulations and for the indications as described in Exhibit A to this Amending Agreement; D. Section 16.01 of the Collaboration Agreement contains certain restrictions with respect to the outlicensing, commercialization, marketing, sale or distribution by Sanofi-Synthelabo and its Affiliates of Competitive Products; and E. QLT USA and Sanofi-Synthelabo wish to amend the Collaboration Agreement regarding the sale of [**] by Sanofi-Synthelabo or any of its Affiliates in Canada in exchange for [**] made by Sanofi-Synthelabo to QLT USA, all in accordance with the terms and conditions set forth in this Amending Agreement. NOW THEREFORE, in consideration of the mutual covenants and agreements set forth in the Collaboration Agreement and as hereinafter set forth, and other good and valuable consideration, the receipt and sufficiency of which is hereby acknowledged, the Parties agree as follows: 1. ARTICLE I - NEW DEFINITIONS. The following defined terms shall be added to Article I of the Collaboration Agreement: "SA CANADA" means Aventis Pharma Inc." [**] [**] - ---------- ** Confidential Treatment Requested. 1 "[**]" means [**]. Components of the [**]." [**] 2. SECTION 4.06. A new Section 4.06 of the Collaboration Agreement shall be added as follows: "Sanofi-Synthelabo shall [**] as follows: (a) [**] of the [**] that are made between [**]; (b) [**] of the [**] that are made between [**]; (c) [**] of the [**] that are made between [**]; and (d) [**] of the [**] that are made on or after [**]. (e) All [**] pursuant to this Section 4.06 shall [**], unless otherwise specifically provided herein." 3. SECTION 4.05. All references in Section 4.05(a) of the Collaboration Agreement to "Products" shall be replaced by the words [**]. In addition, all reporting obligations of Sanofi-Synthelabo and audit and other rights of QLT USA set forth in Section 4.05(d) of the Collaboration Agreement shall also apply with respect to the records of Sanofi-Synthelabo and its Affiliates (including SA Canada) that relate to the [**] and statements of the [**] prepared in connection with the [**], irrespective of whether sales are made by Sanofi-Synthelabo and/or its Affiliates. 4. SECTION 6.01. The following shall be added to the end of Section 6.01 of the Collaboration Agreement: "For greater certainty, provided that Sanofi-Synthelabo complies with its obligations under Section 16.01(e)(ii) to (iv), then the mere fact that Sanofi-Synthelabo continues to sell (including through any of its Affiliates) the [**] in Canada shall not give rise to a breach of this Section 6.01." 5. SECTION 11.03. The final two sentences in Section 11.03 of the Collaboration Agreement are hereby replaced with the following sentences: "In the event that either party fails to terminate any Third Party infringement as a consequence of a final determination by a court of competent jurisdiction that all or any portion of the patent claims covering the Product are invalid or unenforceable, then if such infringement results in a Third Party selling a product that competes with the Product, then Sanofi-Synthelabo's obligation to make [**] provided for in this Agreement in the affected country in the Territory shall be reduced by the percentage by which sales of the Product by Sanofi-Synthelabo or its Affiliates in the affected country in the - ---------- ** Confidential Treatment Requested. 2 Territory decrease as a result of the Third Party's sales of the competing product in the affected country in the Territory." 6. SECTION 16.01. Section 16.01 of the Collaboration Agreement is hereby amended by adding the following as a new Section 16.01(e): "(e) (i) Effective as of [**], the restrictions in Section 16.01(a) of this Agreement do not apply to the out-licensing, commercialization, marketing, sale or distribution in Canada by Sanofi-Synthelabo or its Affiliates of [**]. For greater certainty, nothing in this Section 16.01(e) alters or limits the restrictions set out in Section 16.01(a) with respect to the outlicensing, commercialization, marketing, sale and distribution of [**] in the United States, which restriction shall continue; (ii) Sanofi-Synthelabo shall, and shall cause its Affiliates, including SA Canada to use "reasonable commercial efforts" to [**]. (iii) Neither Sanofi-Synthelabo nor any of its Affiliates will license or sublicense its rights to the [**] in Canada to a Third Party without the prior written consent of QLT USA, which consent will not be unreasonably withheld or delayed. To the extent that Sanofi-Synthelabo or any of its Affiliates licenses or sublicenses rights to the [**] in Canada to a Third Party, any sales of the [**] in Canada made by such Third Party shall be deemed to be included in the definition of the [**] and will be subject to the corresponding [**] and audit and inspection rights set forth herein." (iv) Following the date of this Amending Agreement, Sanofi-Synthelabo and its Affiliates, agents, licensees or sublicensees shall not actively promote and market the [**]: (a)QLT USA shall have the right to request, not more than once during any such year, that Sanofi-Synthelabo provide QLT USA with a report setting forth in reasonable detail the purchases in Canadian dollars of the [**], if any, made either directly or indirectly (including through distributors or wholesalers) to [**]. Where Sanofi-Synthelabo or its Affiliates does not know the amount of [**] made indirectly to [**], Sanofi-Synthelabo shall have the option of relying on information obtained from a reputable third-party market intelligence firm in order to complete the foregoing report, (b) [**]. (c)QLT USA shall have same rights as set out in Section 4.05(d) of this Agreement to inspect and audit the records of Sanofi-Synthelabo or its Affiliates, if any, that relate to any report furnished by Sanofi-Synthelabo pursuant to 16(e)(iv) solely to determine the completeness and accuracy of such report. The notice, costs and results of such audit shall be determined as if it were an audit being conducted in accordance with Section 4.05(d) of this Agreement." - ---------- ** Confidential Treatment Requested. 3 7. REFERENCES TO ATRIX TO QLT USA. Effective the date hereof, all references in the Collaboration Agreement to "Atrix" and "Atrix Laboratories, Inc." shall be deemed to be references to "QLT USA" and "QLT USA, Inc." 8. ASSIGNMENT OF RIGHTS; TERMINATION OF AMENDING AGREEMENT. Prior to [**]. Sanofi-Synthelabo agrees to provide QLT USA with 30 days' prior written notice of any such sale, transfer or assignment. Upon the completion of such transaction, except for such rights and obligations as accrued prior to the date of termination of this Amending Agreement, this Amending Agreement shall terminate and be of no further force or effect. 9. TERMINATION. (a) QLT USA may terminate this Amending Agreement prior to the expiration of the Term upon the occurrence of any of the following: (i) [**]. (ii) Upon the occurrence of any material misrepresentation or omission in any report required to be delivered by Sanofi-Synthelabo to QLT USA by paragraph 3 of this Amending Agreement, which misrepresentation or omission is caused by Sanofi-Synthelabo's willful misconduct, gross negligence or bad faith. (b) Either party may terminate this Amending Agreement prior to the expiration of the Term upon or after the breach of any material provision of this Amending Agreement by the other Party if the breaching Party has not cured such breach within sixty (60) days after written notice thereof by the non-breaching Party. 10. ASSIGNMENT. This Amending Agreement and all rights hereunder may not be assigned or transferred by either Party except in accordance with the terms of Section 20.03 of the Collaboration Agreement. 11. CAPITALIZED TERMS. All capitalized terms used in this Amending Agreement and not otherwise defined herein shall have the same meanings as set forth in the Collaboration Agreement. 12. TERMS OF COLLABORATION AGREEMENT. Except as expressly modified by the terms of this Amending Agreement, the terms and provisions of the Collaboration Agreement (as previously amended) shall remain in full force and effect as originally written. 13. COUNTERPARTS. This Agreement may be executed in one or more counterparts, and by the different Parties hereto in separate counterparts, each of which when executed shall be deemed to be an original but all of which taken together shall constitute one and the same agreement. - ---------- ** Confidential Treatment Requested. 4 IN WITNESS WHEREOF, the Parties hereto have caused this Amending Agreement to be duly executed by their respective authorized officers as of the day and year first above written. QLT USA, INC. By: /s/ Michael R. Duncan --------------------------------- Michael R. Duncan President SANOFI-SYNTHELABO INC. By: /s/ Gregory Irace --------------------------------- Name: Gregory Irace Title: Senior Vice President & Chief Financial Officer By: /s/ Timothy Rothwell --------------------------------- Name: Timothy Rothwell Title: President & CEO 5 EXHIBIT A [**] - ---------- ** Confidential Treatment Requested. CONFIDENTIAL TREATMENT REQUESTED BY QLT INC. -------------------------------------------- AMENDMENT TO AGREEMENT This Amendment to the Collaboration, License and Supply Agreement (this "AMENDING AGREEMENT") is entered into as of this 15th day of February (the "EFFECTIVE DATE") between QLT USA, Inc. (formerly Atrix Laboratories, Inc.), a Delaware corporation having offices at 2579 Midpoint Drive, Fort Collins, Colorado, 80525-4417 ("QLT USA"), and Sanofi-Synthelabo Inc., a Delaware corporation having offices at 55 Corporate Boulevard, Bridgewater, NJ 08807 ("SANOFI-SYNTHELABO"). WHEREAS, QLT USA and Sanofi-Synthelabo have previously entered into a Collaboration, License and Supply Agreement dated as of December 8, 2000, as subsequently amended (collectively, the "COLLABORATION AGREEMENT"); and WHEREAS, QLT USA and Sanofi-Synthelabo have entered into that certain Amended and Restated Contribution Agreement dated February 9, 2007 (the "CONTRIBUTION Agreement"), under which the parties agreed that this Amending Agreement shall automatically become effective upon the payment by Sanofi-Synthelabo of the Sanofi-Synthelabo Contribution in accordance with the terms of the Settlement Agreement (as such terms are defined in the Contribution Agreement). NOW THEREFORE, in consideration of the mutual covenants and agreements set forth in the Contribution Agreement and as hereinafter set forth, and other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties agree as follows: 1. The Collaboration Agreement is hereby amended as follows: (a) Section 6.01(g) and Article XIII of the Collaboration Agreement are deleted in their entirety, any previous exercise of co-marketing rights by QLT USA is null and void as of the Effective Date; (b) Section 4.06(d) of the Collaboration Agreement is deleted in its entirety and Section 4.06(c) of the Collaboration Agreement is amended and restated in its entirety as follows: "(c) [**]Net Sales that are made on or after [**] (c) Sanofi-Synthelabo transferred all of its rights and obligations under the Collaboration Agreement to its Affiliate, Sanofi-Aventis U.S. LLC, in accordance with Section 20.03 of the Agreement. All references in the Collaboration Agreement to "Sanofi-Synthelabo" and "Sanofi-Synthelabo Inc." shall be deemed to be references to "Sanofi-Aventis U.S." and "Sanofi-Aventis U.S. LLC," respectively. Notwithstanding the foregoing, such assignment shall not relieve Sanofi-Synthelabo of its responsibilities for performance of its obligations under the Collaboration Agreement. - -------- ** Confidential Treatment Requested. (d) Section 20.03 is amended to include the following: "Notwithstanding any other provision of this Agreement, Sanofi-Synthelabo may assign or transfer this Agreement or its rights or obligations hereunder (collectively the "Rights"), whether in the aggregate or on a country-by-country basis, without the prior written consent of QLT USA but on at least thirty (30) days prior notice; provided, however, that Sanofi-Synthelabo may not assign or transfer any Rights without the prior written consent of QLT USA to: [**]or (b) to a Third Party [**]. If, during the term of this Agreement, Sanofi-Synthelabo wishes to assign or transfer all or a portion of the Rights to a Third Party, Sanofi-Synthelabo will first offer such Rights to QLT USA. QLT USA will have [**] following the date Sanofi-Synthelabo first presents QLT USA with such offer to decide whether to purchase such Rights from Sanofi-Synthelabo. Should QLT USA desire to purchase such Rights, QLT USA will provide Sanofi-Synthelabo with written notice thereof within said [**] and the parties shall thereupon negotiate in good faith exclusively with each other for a period not to [**] after the date QLT USA gives the requisite notice to Sanofi-Synthelabo. Should Sanofi-Synthelabo and QLT USA not enter into an agreement for the purchase of such Rights during the negotiation period, Sanofi-Synthelabo shall be [**]. In the event Sanofi-Synthelabo does not enter into a definitive agreement with a Third Party within [**] following the termination of such negotiation period, if any, with QLT USA has ended, the provisions of this Section shall apply again, and Sanofi-Synthelabo, prior to selling such Rights, must first offer such rights to QLT USA. Any agreement transferring the Rights in violation of this Section 20.3 shall be null and void ab initio. Sanofi-Synthelabo shall provide QLT USA with an unredacted copy of the executed agreement between Sanofi-Synthelabo and any such Third Party promptly upon execution of the same. Notwithstanding the foregoing, any assignment or transfer of a portion (rather than all) of such Rights shall not alter the rights and obligations of Sanofi-Synthelabo under the Collaboration Agreement with respect to the Rights it has not assigned. [**] 2. This Amending Agreement and all rights hereunder may not be assigned or transferred by either Party except in accordance with the terms of Section 20.03 of the Collaboration Agreement, as herein amended. 3. All capitalized terms used in this Amending Agreement and not otherwise defined herein shall have the same meanings as set forth in the Collaboration Agreement. 4. Except as expressly modified by the terms of this Amending Agreement, the terms and provisions of the Collaboration Agreement (as previously amended) shall remain in full force and effect as originally written. 5. This Amending Agreement may be executed in one or more counterparts, and by the different Parties hereto in separate counterparts, each of which when executed shall be deemed to be an original but all of which taken together shall constitute one and the same agreement. - -------- ** Confidential Treatment Requested. IN WITNESS WHEREOF, the Parties hereto have caused this Amending Agreement to be duly executed by their respective authorized officers as of the day and year first above written. QLT USA, INC. By: /s/ Sean F. Moriarty ------------------------- Sean F. Moriarty President SANOFI-SYNTHELABO INC. By: /s/ John M. Spinnato ------------------------ John M. Spinnato Vice President and General Counsel By: /s/ Laurent Gilhodes -------------------- Laurent Gilhodes Vice President and Controller SANOFI-AVENTIS U.S. LLC By: /s/ John M. Spinnato ------------------------ John M. Spinnato Vice President and General Counsel By: /s/ Laurent Gilhodes -------------------------- Laurent Gilhodes Vice President and Controller
EX-10.20 4 o34971exv10w20.txt COLLABORATION, LICENSE & SUPPLY AGREEMENT 4-4-01 EXHIBIT 10.20 CONFIDENTIAL TREATMENT REQUESTED BY QLT INC. COLLABORATION, LICENSE AND SUPPLY AGREEMENT BETWEEN ATRIX LABORATORIES, INC. AND MEDIGENE AKTIENGESELLSCHAFT TABLE OF CONTENTS
SECTION PAGE NO. - ------- -------- ARTICLE I DEFINITIONS................................................ 1 ARTICLE II COLLABORATION............................................. 9 Section 2.01. Objectives......................................... 9 Section 2.02. Prostate Cancer Development Program................ 9 Section 2.03. Commercialization.................................. 11 Section 2.04. Availability of Resources; Cooperation............. 11 ARTICLE III LICENSE.................................................. 11 Section 3.01. License Fee........................................ 11 Section 3.02. License Terms...................................... 11 Section 3.03. Marks.............................................. 13 Section 3.04. Ownership of Intellectual Property................. 13 ARTICLE IV ROYALTY AND MILESTONE PAYMENTS............................ 13 Section 4.01. Research and Development Expenses.................. 13 Section 4.02. Royalty Payments................................... 13 Section 4.03. Milestone Payments................................. 14 Section 4.04. Sales Milestone Payment............................ 14 Section 4.05. Reports............................................ 14 ARTICLE V NEW PRODUCT................................................ 16 Section 5.01. New Product........................................ 16 Section 5.02. Right of First Negotiation......................... 16 ARTICLE VI COMMERCIALIZATION......................................... 17 Section 6.01. Promotion And Marketing Obligations................ 17 ARTICLE VII MANUFACTURE AND SUPPLY................................... 20 Section 7.01. Agreement to Supply Product........................ 20 Section 7.02. Quality Assurance.................................. 20 Section 7.03. Atrix's Duties..................................... 20 Section 7.04. Compliance with Applicable Laws.................... 22 Section 7.05. Second Manufacturing Source........................ 22 Section 7.06. Failure to Supply.................................. 22 Section 7.07. Allocation......................................... 23 ARTICLE VIII PURCHASE AND SALE....................................... 23 Section 8.01. Purchase Price and Payment......................... 23 Section 8.02. Adjustment to Purchase Price/Audit................. 24 Section 8.03. Labeling and Artwork............................... 25 Section 8.04. Purchase Forms..................................... 26 Section 8.05. Confirmation....................................... 26 Section 8.06. Delivery........................................... 26 Section 8.07. Forecasts and Orders............................... 26 Section 8.08. Demonstration Samples.............................. 28 ARTICLE IX WARRANTY, REJECTION AND INSPECTIONS....................... 28 Section 9.01. Atrix Warranty..................................... 28
Section 9.02. Rejection of Product for Failure to Conform to Specifications..................................... 28 Section 9.03. MediGene Inspections............................... 29 ARTICLE X REGULATORY COMPLIANCE...................................... 30 Section 10.01. Marketing Authorization Holder..................... 30 Section 10.02. Maintenance Of Marketing Authorizations............ 30 Section 10.03. Interaction with Competent Authorities............. 30 Section 10.04. Adverse Drug Event Reporting and Phase IV Surveillance....................................... 30 Section 10.05. Commercial Sale Testing And Reporting.............. 31 Section 10.06. Assistance......................................... 32 Section 10.07. Compliance......................................... 32 ARTICLE XI PATENTS AND TRADEMARKS.................................... 32 Section 11.01. Maintenance of Patents or Marks.................... 32 Section 11.02. Prosecution of Infringement........................ 33 Section 11.03. Infringement Claimed by Third Parties.............. 34 ARTICLE XII CONFIDENTIALITY.......................................... 34 Section 12.01. Confidentiality.................................... 34 Section 12.02. Disclosure of Agreement............................ 35 ARTICLE XIII ATRIX'S OPTION TO MARKET THE PRODUCT UNDER CERTAIN CIRCUMSTANCES...................................... 35 Section 13.01. Co-Marketing Rights................................ 35 ARTICLE XIV REPRESENTATIONS AND WARRANTIES........................... 36 Section 14.01. Corporate Power.................................... 36 Section 14.02. Due Authorization.................................. 36 Section 14.03. Binding Obligation................................. 36 Section 14.04. Ownership of Atrigel(R) Patent Rights.............. 36 Section 14.05. Patent Proceedings................................. 36 Section 14.06. Legal Proceedings.................................. 37 Section 14.07. Compliance With Applicable Laws.................... 37 Section 14.08. Limitation on Warranties........................... 37 Section 14.09. Limitation of Liability............................ 37 ARTICLE XV INDEMNIFICATION........................................... 37 Section 15.01. MediGene Indemnified by Atrix...................... 37 Section 15.02. Atrix Indemnified by MediGene...................... 38 Section 15.03. Prompt Notice Required............................. 38 Section 15.04. Indemnitor May Settle.............................. 38 ARTICLE XVI COVENANTS................................................ 39 Section 16.01. Covenant Not To Launch Competitive Product......... 39 Section 16.02. Limitation To The Territory........................ 39 Section 16.03. Access to Books and Records........................ 40 Section 16.04. A&S Spending Levels................................ 40 Section 16.05. Marketing Expenses................................. 40 Section 16.06. Compliance......................................... 40 Section 16.07. Reports............................................ 40 Section 16.08. Protection of the Marks............................ 41 Section 16.09. Launch Quantities.................................. 41 Section 16.10. Further Actions.................................... 41
ii Section 16.11. Equitable Relief................................... 41 ARTICLE XVII PRODUCT RECALL.......................................... 42 Section 17.01. Product Recalls or Withdrawal...................... 42 Section 17.02. Recall Costs....................................... 42 Section 17.03. Notification Of Complaints......................... 43 Section 17.04. Notification Of Threatened Action.................. 43 ARTICLE XVIII INSURANCE.............................................. 43 Section 18.01. Insurance.......................................... 43 ARTICLE XIX TERM; DEFAULT AND TERMINATION............................ 44 Section 19.01. Term............................................... 44 Section 19.02. Termination by Either Party for Cause.............. 44 Section 19.03. Termination by Atrix............................... 44 Section 19.04. Termination by MediGene............................ 45 Section 19.05. Remedies........................................... 45 Section 19.06. Effect of Termination.............................. 45 Section 19.07. License Following Expiration....................... 45 ARTICLE XX MISCELLANEOUS............................................. 47 Section 20.01. No-Solicitation.................................... 48 Section 20.02. Commercially Reasonable Efforts.................... 48 Section 20.03. Assignment......................................... 48 Section 20.04. Force Majeure...................................... 48 Section 20.05. Governing Law...................................... 49 Section 20.06. Waiver............................................. 49 Section 20.07. Severability....................................... 49 Section 20.08. Notices............................................ 49 Section 20.09. Independent Contractors............................ 50 Section 20.10. Rules of Construction.............................. 50 Section 20.11. Publicity.......................................... 50 Section 20.12. Entire Agreement; Amendment........................ 52 Section 20.13. Headings........................................... 53 Section 20.14. Counterparts....................................... 53 Exhibit A - Atrigel(R) Patent Rights................................. A-1 Exhibit B - Form of Certificate of Compliance........................ B-1 Exhibit C - [**]..................................................... C-1 Exhibit D - Form of Stock Purchase Agreement......................... D-1 Exhibit E - [**]..................................................... E-1 Exhibit F - MediGene's SOP........................................... F-1 Exhibit G - Drug Delivery Competitors................................ G-1
- ---------- ** Confidential Treatment Requested. iii COLLABORATION, LICENSE AND SUPPLY AGREEMENT This Collaboration, License and Supply Agreement (the "Agreement") is made as of April 4, 2001(the "Effective Date") by and between Atrix Laboratories, Inc., a Delaware corporation having offices at 2579 Midpoint Drive, Fort Collins, CO, 80525-4417 ("Atrix"), and MediGene Aktiengesellschaft, a German corporation having offices at Lochhamer Strasse 11, Planegg/Martinsried, Germany ("MediGene"). Atrix and MediGene are sometimes referred to collectively herein as the "Parties" or singly as a "Party." RECITALS WHEREAS, Atrix possesses proprietary drug delivery systems including "Atrigel(R)" and has substantial experience and expertise in the discovery, design and development of products based on these proprietary drug delivery systems for medical, dental and veterinary applications; WHEREAS, MediGene possesses substantial resources and expertise in the research and development of pharmaceutical products and intends to invest substantial resources for the commercialization and marketing of pharmaceutical products under this Agreement; WHEREAS, Atrix wishes to grant to MediGene, and MediGene wishes to obtain from Atrix, an exclusive license under Atrix's Atrigel(R) Technology to market, advertise, promote, distribute, offer for sale, sell and import the Product in the Territory for use in the Field on the terms and subject to the conditions set forth herein; and WHEREAS, MediGene wishes Atrix to manufacture and Atrix desires to manufacture each of the Product to be sold in the Territory by MediGene. NOW, THEREFORE, in consideration of the foregoing recitals and the mutual covenants and agreements contained herein, the Parties hereto, intending to be legally bound, do hereby agree as follows: AGREEMENT ARTICLE I DEFINITIONS (a) The following terms as used in this Agreement shall have the meaning set forth below: "Acceptance for Filing" means MediGene's receipt of a letter issued by the EMEA or other Competent Authority indicating acceptance for filing of a regulatory dossier pursuant to Applicable Laws in the Territory. "Affiliate" means an individual, trust, business trust, joint venture, partnership, corporation, association or any other entity which owns, is owned by or is under common ownership with, a Party. For the purposes of this definition, the term "owns" (including, with correlative meanings, the terms "owned by" and "under common ownership with") as used with 1 respect to any Party, shall mean the possession (directly or indirectly) of more than 50% of the outstanding voting securities of a corporation or comparable equity interest in any other type of entity. "Applicable Laws" means all applicable laws, rules, regulations and guidelines that may apply to the development, marketing, manufacturing, packaging or sale of the Product in the Territory or the performance of either Party's obligations under this Agreement including laws, regulations and guidelines governing the import, export, development, marketing, distribution and sale of the Product in the Territory, to the extent applicable and relevant, and including all cGMP or Good Clinical Practices standards or guidelines promulgated by the FDA or the Competent Authorities and including trade association guidelines, where applicable, as well as United States' export control laws and the United States' Foreign Corrupt Practices Act. "A&S" means MediGene's advertising and selling expenditures incurred in and associated with the promotional support of the Product in the Territory, including the respective overhead allocation costs for supporting and warehousing the Product, physical and logistic distribution expenses, creation, development and acquisition of advertising and selling materials, including, but not limited to, expenditures for samples, detailing materials, journal advertising, in-office waiting room materials, educational programs, including Web-site programs for physicians and patients, convention booths, direct mail, consumer support, third party support, managed care programs, post-marketing Phase IV studies to support existing indications, market research, market surveys, market analysis and the training and costs of the pharmaceutical detail force, and the telesales staff used with regard to support of the Product. "Atrigel(R)" means Atrix's proprietary drug delivery system consisting of flowable compositions (e.g., solutions, gels, pastes and putties) of biodegradable polymers and biocompatible solvents. "Atrigel(R) Know-How" means all Know-How related to Atrix's proprietary Atrigel(R) drug delivery system and which is under the Control of Atrix as of the Effective Date, or is created during the term of this Agreement including, but not limited to, data and documentation of clinical trials and useful for clinical trials created outside the Territory as of the Effective Date and during the term of this Agreement, which is not covered by the Atrigel(R) Patent Rights, but is necessary or useful to develop, Manufacture and commercialize the Product in the Territory for use in the Field. "Atrigel(R) Patent Rights" means all Patent Rights related to Atrix's proprietary Atrigel(R) drug delivery system as of the Effective Date and at any time during the Term of this Agreement, which are necessary or appropriate to develop, Manufacture and commercialize the Product in the Territory for use in the Field, which are under the Control of Atrix as of the Effective Date and Improvements thereto developed during the Term. The Atrigel(R) Patent Rights as of the Effective Date are set forth on Exhibit A. "Atrigel(R) Technology" means the Atrigel(R) Patent Rights and the Atrigel(R) Know-How. "Atrix Manufacturing Cost" means the actual cost of the Manufacture by Atrix of the Product under a Manufacturing Process, including the related quality assurance and quality 2 control activities as required by Applicable Laws (other than the costs set forth in Section 2.03), which actual cost shall be comprised of the cost of goods produced as determined in accordance with GAAP, and shall include direct labor, direct material, including raw materials and packaging materials, and the allocable portion of the manufacturing overhead of Atrix directly attributable to the Manufacture of the Product. The allocable portion of the manufacturing overhead shall be determined by taking the total facility cost for the period, less an adjustment for idle capacity, and allocating the remaining facility cost by labor usage to each of the products produced in the facility during the period. For example: If the facility cost for the period was $1,000,000 and it was operating at 80% capacity, the allocable facility cost would be $800,000. If the Product represented 30% of labor usage during the period, the allocable portion of the manufacturing overhead directly attributable to the Manufacture of the Product would be $240,000. Atrix Manufacturing Cost shall exclude selling, general and administrative, research and development, and interest expenses and any and all debt service payments of Atrix. For a period of twelve (12) months from the date of First Commercial Sale of each Product the Atrix Manufacturing Cost for each Product will be set as follows for the [**] (the "Twelve Month Cost"): [**] Dosage Forms Cost: [**] One Month Product - [**] [**] Three Month Product - [**] [**] Four Month Product - [**] [**] Six Month Product - [**] [**] [**] Dosage Forms Cost: [**] One Month Product - [**] [**] Three Month Product - [**] [**] Four Month Product - [**] [**] Six Month Product - [**] [**] "Certificate of Compliance" means the certificate of compliance in the form attached hereto as Exhibit B. "cGMP" means current good manufacturing practices as defined in 21 CFR Section 110 et seq. "Collaboration" means the activities of the Parties carried out in performance of, and the relationship between the Parties established by, this Agreement. - ---------- ** Confidential Treatment Requested. 3 "Competent Authorities" means collectively the governmental entities in each country, or recognized regional authorities, in the Territory responsible for the regulation of medicinal products intended for human use. "Competitive Product" means any leuteinizing hormone releasing hormone (LHRH) or a structurally related derivative or structurally related analog thereof, whether agonist or antagonist, whether naturally-occurring or synthetic, used for the treatment of prostate cancer, endometriosis or uterine fibroids. "Confidential Information" means any confidential or proprietary information of a Party, whether in oral, written, graphic or electronic form, confirmed in writing and marked as confidential within thirty (30) days of the date of disclosure. Confidential Information shall not include any information which the receiving Party can prove by competent evidence: (a) is now, or hereafter becomes, through no act or failure to act on the part of the receiving Party, generally known or available; (b) is known by the receiving Party at the time of receiving such information, as evidenced by its written records maintained in the ordinary course of business; (c) is hereafter furnished to the receiving Party by a Third Party, as a matter of right and without restriction on disclosure; (d) is independently developed by the receiving Party, as evidenced by its written records, without knowledge of, and without the aid, application or use of, the disclosing Party's Confidential Information; or (e) is the subject of a written permission to disclose provided by the disclosing Party. "Consumer Price Index" means the Consumer Price Index for all Urban Consumers (Consumer Prices - All Urban Consumers, 1982-84 = 100) as published by the Bureau of Labor Statistics of the Department of Labor of the United States Department of Commerce. "Control" means the possession of the ability to grant a license or sublicense as provided for herein without violating the terms of any agreement or other arrangement with any Third Party. "Demonstration Samples" means Units, absent leuprolide acetate, used to demonstrate the manner in which the Product is prepared and used, and labeled "demonstration samples, for demonstration purposes only, not for human use." "EMEA" means the European Medicine Evaluation Agency. 4 [**] [**] [**] [**] [**] [**] "FDA" means the United States Food and Drug Administration. "Field" means the treatment of prostate cancer, endometriosis and uterine fibroids. "First Commercial Sale" means (i) with respect to a country in the Territory, the first sale for use, consumption or resale of each Product by MediGene in such country and (ii) with respect to the Territory, the First Commercial Sale in any country within the Territory. A sale to an Affiliate shall not constitute a First Commercial Sale unless the Affiliate is the end user of the Product. "GAAP" means United States generally accepted accounting principles consistently applied on a basis consistent throughout the periods indicated and consistent with each other. "Good Clinical Practices" means good clinical practices as defined in 21 CFR Section 50 et seq. and Section 312 et seq. "Governmental Approval" means all permits, licenses and authorizations, including but not limited to, import permits, Marketing Authorizations required by any Competent Authority as a prerequisite to the Manufacturing, packaging, marketing or selling of the Product or the Units. "Improvements" means any and all developments, inventions or discoveries in the Field relating to the Atrigel(R) Technology developed, or acquired by Atrix at any time during the Term and shall include, but not be limited to, developments intended to enhance the safety and/or efficacy of the Product. "Know-How" means all know-how, trade secrets, inventions, data, processes, techniques, procedures, compositions, devices, methods, formulas, protocols and information, whether or not patentable, which are not generally publicly known, including, without limitation, all chemical, biochemical, toxicological, and scientific research information, whether in written, graphic or video form or any other form or format. - ---------- ** Confidential Treatment Requested. 5 "Launch Quantity" means a quantity of Product adequate to meet the requirements set forth for the first six (6) months in the Initial Forecast. "Major Countries" or "Major Country" means individually or collectively, as the case may be, the countries of France, Germany, Italy, Spain and the United Kingdom. "Manufacture" or "Manufacturing Process" means the storage, handling, production, processing and packaging of a Product or a Demonstration Sample, in accordance with this Agreement and Applicable Laws. "Marketing Authorization" means all necessary and appropriate regulatory approvals, including but not limited to, variations thereto, and Pricing and Reimbursement Approvals where applicable, to put the Product on the market in a particular country in the Territory. "Marks" means "Atrigel(R)" or "Leuprogel(TM)" or any additional trademarks selected by Atrix in either case, alone or accompanied by any logo or design and any foreign language equivalents in figure, sound or meaning, whether registered or not. "NDA" means a New Drug Application, and all amendments and supplements thereto, filed or to be filed, with the FDA seeking authorization and approval to manufacture, package, ship and sell a product in the United States as more fully defined in 21 CFR Section 314.5 et seq. "Net Sales" means the [**] Components of Net Sales shall be determined in the ordinary course of business in accordance with historical practice and using the accrual method of accounting in accordance with GAAP. In the event MediGene transfers Product to a Third Party in a bona fide arm's length transaction, for consideration, in whole or in part, other than cash or to a Third Party in other than a bona fide arm's length transaction, the Net Sales price for such Product shall be deemed to be the standard invoice price then being invoiced by MediGene in an arms length transaction with similar customers. In the event that MediGene includes one or more Product as part of a bundle of products, MediGene agrees not to offer or sell any such Product as a loss leader (i.e. sold at less than the invoice price at which any such Product is sold when not part of a bundle of products) in determining the price of the bundled products. "Net Selling Price" means with respect to a given time period and for a given country on a product by product basis, Net Sales with respect to such country divided by the number of Units for the [**] sold in such country during such time period. "New Product" means a product containing a combination of leuprolide acetate in the Atrigel(R) delivery system (other than the Product) or any other product using any leuteinizing hormone releasing hormone (LHRH) or a structurally related derivative or structurally related - ---------- ** Confidential Treatment Requested. 6 analog thereof, whether agonist or antagonist, whether naturally-occurring or synthetic, for use in the Territory, outside of the Field. "Packaging Specifications" means the packaging specifications and the labeling specifications for the Unit, as mutually determined by Atrix and MediGene from time to time, and in compliance with Applicable Laws. "Patent Rights" means all rights under patents and patent applications, and any and all patents issuing therefrom (including utility, model and design patents and certificates of invention), together with any and all substitutions, extensions (including supplemental protection certificates), registrations, confirmations, reissues, divisionals, continuations, continuations-in-part, re-examinations, renewals and foreign counterparts of the foregoing, and all improvements, supplements, modifications or additions. "Phase IV" means, as applicable, a study or program designed to obtain additional safety or efficacy data, detect new uses for or abuses of a drug, or to determine effectiveness for labeled indications under conditions of widespread usage, which is commenced after regulatory approval of a Product. "Pricing and Reimbursement Approvals" means any pricing and reimbursement approvals which must be obtained before placing Product on the market in any country in the Territory in which such approval is required. "Prime Rate of Interest" means the prime rate of interest published from time to time in the Wall Street Journal as the prime rate; provided, however that if the Wall Street Journal does not publish the Prime Rate of Interest, then the term "Prime Rate of Interest" shall mean the rate of interest publicly announced by Bank of America, N.A., as its Prime Rate, Base Rate, Reference Rate or the equivalent of such rate, whether or not such bank makes loans to customers at, above, or below said rate. "Product" means individually and collectively the [**] supplied in Unit packages [**], supplied in Unit packages, for use in the Field. "Royalty" means the royalty to be paid by MediGene to Atrix as set forth in Section 4.02. "Royalty Term" means the period of time commencing on the First Commercial Sale of each Product in any country in the Territory and ending on the expiration of the last to expire of the Atrigel(R) Patent Rights covering each Product in such country. "Shipment" means each individual group of Product received by MediGene from Atrix. "Specifications" means the specifications for the Product as may be amended from time to time by the Parties and in compliance with Applicable Laws. The Specifications for the [**] are attached hereto as Exhibit C. - ---------- ** Confidential Treatment Requested. 7 "Stock Purchase Agreement" means that certain Stock Purchase Agreement dated as of the same date as this Agreement between Atrix and MediGene attached hereto as Exhibit D. "Territory" means Albania, Andorra, Armenia, Austria, Azerbaijan, Belarus, Belgium, Bosnia and Herzegovina, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Georgia, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Monaco, Netherlands, Norway, Poland, Portugal, Republic of Moldova, Romania, Russian Federation, Slovakia, Slovenia, Spain, Sweden, Switzerland, The former Yugoslav Republic of Macedonia, Turkey, Ukraine, United Kingdom and Yugoslavia. "Third Party" means any entity other than: (a) Atrix, (b) MediGene or (c) an Affiliate of Atrix or MediGene. "U.C.C." means the Uniform Commercial Code of Colorado. "Unit" means the Product, currently packaged in a two-part system containing (a) one syringe of Atrigel(R) delivery system and a needle in a moisture proof pouch and sterilized by gamma irradiation; (b) one syringe containing sufficient leuprolide acetate for a [**], aseptically filled and lyophilized in the syringe, and packaged in a moisture-proof pouch; (c) instructions for use; and (d) a commercial trade or sample package. The trade or sample package may be changed or reformulated by Atrix and MediGene from time to time and the term "Unit" shall refer to the Product in such changed or reformulated package. "United States" means the United States of America, its territories and possessions, including the Commonwealth of Puerto Rico. [**] [**] [**] [**] [**] (b) Each of the following terms is defined in the Section set forth opposite such term below: ADE............................................ Section 10.04(a) Adjusted Atrix Manufacturing Cost.............. Section 8.02(a) Advisory Board................................. Section 6.01(e)(i) Agreement...................................... Preamble Atrix.......................................... Preamble
- ---------- ** Confidential Treatment Requested. 8 Atrix Sales Force.............................. Section 6.01(f) Clinical Documentation......................... Section 2.02(c) Disputed Amount................................ Section 19.03(a) Documentation.................................. Section 8.02(b) Effective Date................................. Preamble [**] Force Majeure.................................. Section 20.04 Indemnitee..................................... Section 15.03 Indemnitor..................................... Section 15.03 Initial Forecast............................... Section 8.07(a) Initiating Group............................... Section 20.01 License........................................ Section 3.02 Licensed Territory............................. Section 16.02(b) Loss........................................... Section 15.01 MediGene....................................... Preamble [**] Other Group.................................... Section 20.01 Parties........................................ Preamble Party.......................................... Preamble Program Technology............................. Section 3.04(a) Purchase Price................................. Section 8.01 Recall......................................... Section 17.01 Results........................................ Section 2.02(c) Royalty Statement.............................. Section 3.04(a) Second Source.................................. Section 7.05 SOP............................................ Section 10.04(c) Term........................................... Section 19.01 [**] Twelve Month Cost.............................. See "Atrix Manufacturing Cost" [**]
ARTICLE II COLLABORATION Section 2.01. OBJECTIVES. Pursuant to the [**] Development Program [**], Atrix and MediGene shall conduct research and development activities using the Atrigel(R) Technology to develop Product for use in the Field. Section 2.02. PROSTATE CANCER DEVELOPMENT PROGRAM. (a) U.S. Product. Atrix shall utilize the Atrigel(R) Technology to conduct research and development of the [**] for the palliative treatment of prostate cancer for the U.S. - ---------- ** Confidential Treatment Requested. 9 market at its own cost and expense, pursuant to a written development program (the [**]), a copy of which is attached hereto as Exhibit E. [**] MediGene shall reimburse Atrix for all costs and expenses incurred by Atrix in supporting MediGene's registration of [**] for use in the Territory, promptly upon receipt of a reasonably detailed invoice setting forth such costs and expenses in accordance with a budget mutually agreed to by the Parties and approved by MediGene. (i) If additional clinical trials or additional tests are required by Competent Authorities to market [**] the Product in the Territory then the Parties shall discuss the design and budget of such clinical trials and tests and MediGene shall conduct and pay all costs and expenses associated with such clinical trials and tests. For the avoidance of any doubt, MediGene shall make the final determination as to the design of such clinical trials and tests; provided that MediGene will consider the effect of such designs on the marketing and sale of the Product outside the Territory. Atrix shall diligently assist and support MediGene in such clinical trials and tests and MediGene shall reimburse Atrix for all costs and expenses incurred by Atrix in supporting such clinical trials and tests promptly upon receipt of a reasonably detailed invoice setting forth such costs and expenses in accordance with the budget mutually agreed to by the Parties and approved by MediGene. Further, Atrix shall sell and supply to MediGene [**] necessary for such additional clinical trials and tests at Atrix's actual cost of goods, including overhead allocation but excluding any manufacturing profit. (ii) If Atrix's U.S. licensee elects not to fund the development, [**] in the field of endometriosis or uterine fibrosis and MediGene elects to fund the development of such Product for sale in the Territory, then the Parties shall discuss the design and budget of such development and MediGene shall conduct and pay all costs and expenses associated with the development of such Product with such indication in the Territory. For the avoidance of any doubt, MediGene shall make the final determination as to the design of such development program; provided that MediGene will consider the effect of such design on the marketing and sale of the Product outside the Territory. Atrix shall diligently assist and support MediGene in such development program and MediGene shall reimburse Atrix for all costs and expenses incurred by Atrix in supporting such development program, promptly upon receipt of a reasonably detailed invoice setting forth such costs and expenses in accordance with the budget mutually agreed to by the Parties and approved by MediGene. (b) [**] (c) Regulatory and Clinical Documents. Subject to Section 3.02, MediGene will own all documentation, including all notes, summaries and analyses related thereto, developed in connection with such clinical trials and regulatory submissions (the - ---------- ** Confidential Treatment Requested. 10 "Clinical Documentation") and the results of such clinical testing (the "Results"); provided that MediGene shall provide Atrix with copies of all the Clinical Documentation and the Results; and further provided, that MediGene shall provide Atrix with reasonable access to and full use of the Clinical Documentation and the Results. (d) Audit of [**] Costs. MediGene shall have the right to cause an independent, certified public accountant reasonably acceptable to Atrix to audit those records of Atrix relating to the calculation of those costs and expenses of Atrix for which MediGene is responsible for under this Section 2.02 for the sole purpose of verifying such costs and expenses. Such audits may be exercised during normal business hours no more than once in a twelve (12) month period upon at least ten (10) days prior written notice. Section 2.03. COMMERCIALIZATION. MediGene, at its own expense, will be responsible for (a) conducting all market research related to the Product; and (b) commercialization of the Product in the Territory (including all sales and marketing activities related to the Product). MediGene will obtain Governmental Approvals in the Territory and pay all duties, fees, tariffs and similar obligations required to market the Product in each country in the Territory. Section 2.04. AVAILABILITY OF RESOURCES; COOPERATION. Each Party shall maintain laboratories, offices and/or other facilities reasonably necessary to carry out the activities to be performed by such Party pursuant to the [**]. Upon reasonable advance notice, each Party agrees to make its employees and non-employee consultants reasonably available at their respective places of employment to consult with the other Party on issues arising in connection with any request from any regulatory agency, including, without limitation, regulatory, scientific, technical and clinical testing issues. ARTICLE III LICENSE Section 3.01. LICENSE FEE. In partial consideration for the License granted under Section 3.02(a), MediGene shall pay to Atrix an initial one-time non-refundable license fee equal to Two Million Dollars ($2,000,000) on the Effective Date by wire transfer of immediately available funds to an account to be designated by Atrix to MediGene prior to the Effective Date. On the Effective Date, MediGene shall also purchase from Atrix Four Million Dollars ($4,000,000) of Atrix's common stock, as provided in the Stock Purchase Agreement. Section 3.02. LICENSE TERMS. The terms and conditions of the exclusive license (the "License") granted by Atrix to MediGene shall be as follows: (a) License Grant. Subject to the terms of this Agreement, Atrix hereby grants to MediGene an exclusive license under the Atrigel(R) Technology to use, develop, market, advertise, promote, distribute, offer for sale, sell and import, but not Manufacture, the Product in the Territory for use in the Field, with a right to sublicense in accordance with - ---------- ** Confidential Treatment Requested. 11 this Section 3.02, and agrees to transfer the Atrigel(R) Know-How to MediGene, only to the extent necessary and sufficient for MediGene to exercise its rights and perform its obligations hereunder. This exclusive license can only be transferred by MediGene on the basis set forth in Section 20.03. (b) Right to Sublicense without Manufacturing. Subject to the terms of this Agreement, MediGene shall have the right to grant, under the license granted by Atrix to MediGene under Section 3.02(a) and without the prior written consent of Atrix, a sublicense to a Third Party. MediGene will provide a copy of any such sublicense to Atrix promptly upon the execution of the same. The right to sublicense granted under this Section 3.02(b) shall be subject to the terms and conditions of the license itself, and MediGene shall be responsible for and shall guarantee the performance by the sublicensee of such obligations. (c) [**] (d) License Termination. If MediGene has not undertaken commercially reasonable efforts to begin distribution and marketing of [**], if applicable, in (i) each Major Country within ninety (90) days following receipt of written notice by MediGene that Governmental Approval has been received for each respective Product for each Major Country and (ii) each other country in the Territory within one hundred and eighty (180) days following receipt of written notice by MediGene that Governmental Approval has been received for each respective Product for each other country in the Territory and provided that Atrix has available Launch Quantities of the respective Product, then the following shall occur with respect to each Product not so distributed and marketed: (A) in each Major Country within such ninety (90) days and (B) in each other country in the Territory within such one hundred and eighty (180) days: (1) Atrix shall have the right to grant a license to a Third Party, to market, advertise, promote, distribute, offer for sale, sell or import [**], if applicable, respectively, on a country-by-country basis in the Major Countries; provided that the terms of such licenses are no less favorable to Atrix, in any material respect, than those set forth in this Agreement (excluding milestone payments and subject to adjustments to the dollar amount of Net Sales at which a higher royalty rate becomes payable (to reflect the fact that the licensee under such license will not have the right to market and sell the Product in the entire Territory)), (2) the licenses granted to MediGene under this Agreement shall automatically terminate with respect to that specific Product in that specific country in the Territory and such country shall no longer be included in the Territory for such Product and (3) MediGene shall grant to Atrix an irrevocable, non-exclusive, royalty-free license, with the right to sublicense, to use the Clinical Documentation, the Results and the Marketing Authorizations and make any required filings with Competent Authorities, only to the extent necessary and sufficient for Atrix or its licensee to market the Product in such country; provided, however, such rights shall not include any license or other right to use MediGene's trademarks or tradedress. - ---------- ** Confidential Treatment Requested. 12 Section 3.03. MARKS. Subject to the terms and conditions of this Agreement, Atrix hereby grants to MediGene an exclusive, royalty-free right to use the Marks in the Territory in connection with the use, development, marketing, advertising, promotion, distribution and sale of the Product in the Field. Section 3.04. OWNERSHIP OF INTELLECTUAL PROPERTY. (a) All right, title and interest in and to any developments, inventions or discoveries made in connection with any leuteinizing hormone releasing hormone (LHRH) or a structurally related derivative or structurally related analog thereof, whether agonist or antagonist, whether naturally-occurring or synthetic, used for treatments outside the Field, which do not relate to the Atrigel(R) Technology or the Product, made or conceived only during and as a direct result of either Party's work in connection with this Agreement, shall be jointly owned by the Parties, including any patentable inventions (the "Program Technology). For the avoidance of doubt, MediGene shall have no right, title or interest in or to the Atrigel(R) Technology or the Marks, except as specifically set forth in this Agreement. (b) Atrix and MediGene each grants to the other a nonexclusive, irrevocable, worldwide, royalty-free, perpetual license, including the right to grant sublicenses to Affiliates, to make and use the Program Technology for all research purposes (consistent with the purpose and intent of this Agreement) other than the sale or manufacture for sale of products or processes; provided that if any Party desires to make, manufacture, use, market or sell any product based upon the Program Technology or desires to provide to a Third Party a sublicense to make, manufacture, use, market or sell any product based on the Program Technology, then such Party shall grant to the other Party a right of first negotiation under substantially the same terms and procedures as MediGene's right of first negotiation as set forth in Section 5.02 with respect to such product. ARTICLE IV ROYALTY AND MILESTONE PAYMENTS Section 4.01. RESEARCH AND DEVELOPMENT EXPENSES. Except as set forth in Section 2.02, Atrix shall, at its sole expense, be responsible for all research and development expenses pertaining to the Product. Section 4.02. ROYALTY PAYMENTS. MediGene shall pay to Atrix a royalty based on [**] for a period equal to the Royalty Term for each Product in each country in the Territory as follows: (I) [**] - ---------- ** Confidential Treatment Requested. 13 All royalty payments due to Atrix under this Agreement shall be paid within forty five (45) days of the end of each calendar quarter, unless otherwise specifically provided herein. Section 4.03. MILESTONE PAYMENTS. MediGene shall pay to Atrix, as licensing fees, the following milestone payments within thirty (30) days after Atrix gives notice to MediGene of the occurrence of the specified milestone event: (a) [**] (b) [**] (c) [**] (d) [**] (e) [**] and (f) [**] [**]. For the avoidance of doubt, the milestone payments referred to in this Section 4.03 shall be paid only once by MediGene. Section 4.04. SALES MILESTONE PAYMENT. MediGene shall pay to Atrix as a one-time payment the sum of [**]. For the avoidance of doubt, the milestone payment referred to in this Section 4.04 shall be paid only once by MediGene. Section 4.05. REPORTS. (a) Reports. MediGene shall furnish to Atrix a quarterly written report showing in reasonably specific detail, on a Product by Product and country by country basis, (a) the calculation of Net Sales; (b) royalties payable in United States' Dollars, if any, which shall have accrued hereunder based upon Net Sales; (c) withholding taxes, if any, required by law to be deducted with respect to such sales; (d) the dates of the First Commercial Sales of any Product in any country in the Territory during the reporting period; and (e) the exchange rates used to determine the amount of United States' Dollars (collectively, the "Royalty Statement"). Royalty Statements shall be due as soon as possible, but in any event no later than sixty (60) days following the close of each calendar quarter. (b) Exchange Rate; Manner and Place of Payment. All payments hereunder shall be payable in United States dollars. With respect to each quarter, whenever conversion of payments from any foreign currency shall be required, such conversion shall be made at the rate of exchange reported in The Wall Street Journal on the last business day of the applicable calendar quarter. All payments owed under this Agreement shall be made by - ---------- ** Confidential Treatment Requested. 14 wire transfer to a bank account designated by Atrix, unless otherwise specified in writing by Atrix. (c) Late Payments. In the event that any payment, including contingent payments, due hereunder is not made when due, each such payment shall accrue interest from the date due at Prime Rate of Interest. The payment of such interest shall not limit Atrix from exercising any other rights it may have under this Agreement as a consequence of the lateness of any payment. (d) Records and Audits. During the Term and for a period of two (2) years thereafter or as otherwise required in order for Atrix to comply with Applicable Law, MediGene shall keep complete and accurate records in sufficient detail to permit Atrix to confirm the completeness and accuracy of: (i) the information presented in each Royalty Statement and all payments due hereunder; (ii) the calculation of A&S and (iii) the calculation of Net Sales. MediGene shall permit an independent, certified public accountant reasonably acceptable to MediGene to audit and/or inspect those records of MediGene (including but not limited to financial records) that relate to Net Sales, Royalty Statements and A&S for the sole purpose of: (A) verifying the completeness and accuracy of the Royalty Statements; (B) verifying the calculation of the Net Selling Price, the calculation of Net Sales and the calculation of A&S and (C) to confirm Royalty payments and A&S expenditures for the Product for the previous year. Such inspection shall be conducted during MediGene's normal business hours, no more than once in any twelve (12) month period and upon at least ten (10) days prior written notice by Atrix to MediGene. If such accounting firm concludes that such payments were underpaid for the preceding year, MediGene shall pay Atrix the amount of any such underpayments for the preceding year, plus interest at a rate equal to the Prime Rate of Interest, within thirty (30) days of the date Atrix delivers to MediGene such accounting firm's report so concluding that such payments were underpaid for the preceding year. If such accounting firm concludes that such payments were overpaid for the preceding year, Atrix shall pay to MediGene the amount of any such overpayments for the preceding year, without interest, within thirty (30) days of the date Atrix delivers to MediGene such accounting firm's report so concluding that such payments were overpaid for the preceding year. Atrix shall bear the full cost of such audit unless such audit discloses an underpayment by more than five percent (5%) of the amount due for the preceding year. In such case, MediGene shall bear the full cost of such audit. (e) Taxes. All taxes levied on account of the payments accruing to Atrix under this Agreement shall be paid by Atrix for its own account, including taxes levied thereon as income to Atrix. If provision is made in law or regulation for withholding, such tax shall be deducted from the payment made by MediGene, paid to the proper taxing authority and a receipt of payment of the tax secured and promptly delivered to Atrix. Each Party agrees to assist the other Party in claiming exemption from such deductions or withholdings under any double taxation or similar agreement or treaty from time to time in force. (f) Prohibited Payments. Notwithstanding any other provision of this Agreement, if MediGene is prevented from paying any payments by virtue of the statutes, 15 laws, codes or governmental regulations of the country from which the payment is to be made, then such payment may be paid by depositing funds in the currency in which it accrued to Atrix's account in a bank acceptable to Atrix in the country whose currency is involved. ARTICLE V NEW PRODUCT Section 5.01. NEW PRODUCT. Subject to MediGene's right of first negotiation under Section 5.02 below, Atrix may or, at MediGene's request and at [**] will, seek to develop and have the EMEA or other Competent Authority approve a New Product. Section 5.02. RIGHT OF FIRST NEGOTIATION. For a period of thirty (30) days following the receipt of notice from (i) Atrix of its intention to develop a New Product or (ii) MediGene of its intention to have Atrix develop a New Product, MediGene shall have the first right to negotiate binding material terms for a definitive license agreement for the New Product. In the event (a) MediGene does not determine within such thirty (30) day period to pursue a license for the New Product, (b) the Parties are unable to reach agreement on binding material terms of such a license within such thirty (30) day period, or (c) if the Parties have reached agreement on binding material terms of such a license within such thirty (30) day period, but are unable to enter into a definitive agreement within ninety (90) days following the written notice from Atrix, which period may be extended upon the mutual agreement of the Parties, Atrix shall have no further obligation to MediGene under this Section 5.02. If MediGene and Atrix cannot agree to the terms of such license, then Atrix may enter into an agreement with a Third Party, provided that the terms of the agreement are no less favorable to Atrix, in any material respect (individually or in the aggregate), than those last proposed in writing by MediGene. The rights of MediGene under this Section 5.02 shall be limited to those countries in the Territory for which MediGene retains a license under Sections 3.02 and 3.03 as of the date written notice is received under this Section 5.02 by Atrix or MediGene, as applicable. If Atrix enters into an agreement with a Third Party under this Section 5.02, Atrix shall notify MediGene of this fact within four (4) weeks after the date the agreement is entered into. MediGene shall then have the right to appoint an appropriate independent person, reasonably acceptable to Atrix, having sufficient experience in licensing matters, which person shall execute a confidentiality agreement in such form as is reasonably satisfactory to Atrix, to examine the terms and conditions of such agreement to determine that the terms thereof are no less favorable to Atrix, in any material respect (individually or in the aggregate), than those last proposed in writing by MediGene. Such determination shall be made within six (6) weeks after the date Atrix provides notice to MediGene that it has entered into such an agreement with a Third Party. - ---------- ** Confidential Treatment Requested. 16 ARTICLE VI COMMERCIALIZATION Section 6.01. PROMOTION AND MARKETING OBLIGATIONS. (a) Marketing Efforts. MediGene agrees to use commercially reasonable efforts to promote the sale, marketing and distribution of the Product in the Territory, consistent with accepted business practices devoting the same level of efforts as it devotes to its own products of comparable market potential. "Comparable market potential" shall be fairly determined by MediGene in good faith and shall be based upon market size, price, competition and general marketing parameters. Each Party shall promptly advise the other Party of any issues that materially and adversely affect its ability to market the Product in the Territory. In such event, senior executives of MediGene and Atrix shall meet and in good faith discuss what actions should be taken in light of such issues. (b) Trademarks. Subject to the terms and conditions of this Agreement, MediGene shall have the right to use any trademark, logo, design and/or tradedress for the Product in the Territory, provided such trademark, logo, design and/or tradedress complies with Applicable Laws. (c) Packaging. Atrix shall package and label the Product, the Units and the Demonstration Samples in compliance with the Packaging Specifications and Applicable Laws. Atrix, in consultation with MediGene, shall be responsible for assuring that such packaging and labeling conform with all Applicable Laws, if any, of the FDA for export of the Product and the Demonstration Samples into the Territory and that the Units comply with the Packaging Specifications. Atrix, in consultation with MediGene, shall also be responsible for assuring that packaging and labeling comply with all Applicable Laws where such Product is to be distributed for sale in the Territory. All additional incremental costs resulting from changes to the Packaging Specifications made at the request of MediGene that are not required to export or import the Product to countries in the Territory on a country by country basis under Applicable Laws shall be borne by MediGene. (d) Marketing Plans And Reports. Sixty (60) days prior to the expected date of First Commercial Sale in any Major Country and at the beginning of each calendar year thereafter, MediGene shall submit to the Advisory Board in writing the annual marketing, sales and distribution plan for each Major Country detailing MediGene's and its Affiliates' proposed marketing, sales and distribution strategy and tactics for the sale and distribution of Product during such calendar year, or portion thereof, including the expected selling price schedules for each Product in each Major Country (including any (i) prompt payment or other trade or quantity discounts which MediGene expects to offer and (ii) commission rates or rebates which MediGene expects to offer to distributors and agents). In addition, upon the request of Atrix, MediGene shall submit to the Advisory Board copies of any market research reports relating to Product sales and Product competition which MediGene or its Affiliates commission or otherwise obtain to the extent permissible by the agency preparing the report. To the extent the foregoing 17 information is contained in plans or reports which contain information about other products or markets, MediGene may submit to the Advisory Board only those excerpts from such plans or reports which relate to the Product and Product competition. (e) Advisory Board. (i) Formation and Function. Promptly after the Effective Date, MediGene and Atrix will each appoint two (2) senior representatives to a committee (the "Advisory Board") that shall have oversight for any activity under this Agreement for the Territory. Atrix will select an individual to serve as chairman of the Advisory Board for the initial twelve (12) months. Thereafter, the chairmanship will rotate between a MediGene member and an Atrix member every twelve (12) months. Except as set forth in Section 13.01, the Advisory Board will be consulted by both Parties on all major decisions in the development and marketing of the Product in each country in the Territory, including, without limitation, in the following areas as they relate to the Product: (A) Product positioning in the marketplace; (B) quantity of direct selling efforts, including the number of sales details to be made; (C) extent and degree of non-personal selling and promotional efforts; (D) quantity and content of workshops and medical symposia; (E) design and implementation of a Phase IV clinical study program to support the Product; (F) design and implementation of a consumer awareness program; (G) selection of physicians for a medical advisory board and speakers bureau; (H) planning for international regulatory submissions; (I) dispute resolution regarding sales, marketing and promotional activities related to the Product; and (J) internet presence; (K) design and performance of other clinical studies in any country of the Territory. MediGene, alone, will be responsible for making the final decisions on the development and marketing of the Product (subject to the provisions of Section 2.02) regardless of the action or inaction of the Advisory Board. MediGene 18 agrees that in making such decisions and taking such actions that it will consider the effect of such decisions and actions on the marketing and sale of the Product outside the Territory. Notwithstanding the foregoing, for the avoidance of doubt, Atrix, alone, shall make the final decision on all matters concerning the Manufacture of the Product, except (a) Product labeling, as provided in Section 8.03, and (b) if MediGene exercises its Manufacturing rights, as provided in Sections 7.06 or 8.02(b). (ii) Meetings. The Advisory Board will meet every six (6) months and at such other times as a Party may request, alternating between Planegg/Martinsried, Germany and Fort Collins, Colorado and will otherwise communicate regularly by telephone, facsimile and/or video conference. The chairman of the Advisory Board shall prepare minutes of all meetings. Each Party recognizes the importance of the Advisory Board in the success of the Collaboration and will use diligent efforts to cause all of its representatives on the Advisory Board to attend all meetings of the Advisory Board. A Party may change any of its appointments to the Advisory Board at any time upon giving written notice to the other Party. (iii) Working Groups. The Advisory Board may establish appropriate working groups for the marketing and any other activities necessary for the development and marketing of the Product in the Territory. Each working group shall meet at least once every three (3) months and at such other times as a Party may request, alternating between Planegg/Martinsried, Germany and Fort Collins, Colorado and will otherwise communicate regularly by telephone, facsimile and/or video conference. All actions of a working group shall be by unanimous consent of its members and be reported to the Advisory Board in writing for approval by the Advisory Board. Any disputes or disagreements within a working group shall be resolved by the Advisory Board. (f) Co-Promotional Activities of Atrix. Beginning [**] following the launch of the first of any Product on a country-by-country basis within the Territory, Atrix shall have the right, [**] to participate in the sales, marketing and promotion of the Product. If Atrix so elects, [**] and MediGene will take all actions, including making any required filings with Competent Authorities, necessary to allow Atrix to use the applicable Marketing Authorizations in connection with Atrix's participation in such activities, as far as legally permissible. [**] Difficulties and differences arising from the co-promotional activities of Atrix, in particular the Atrix Sales Force, will be discussed within the Advisory Board. If these differences cannot be settled by the Advisory Board, MediGene is entitled to request that the Atrix Sales Force or individual members thereof are withdrawn. [**] - ---------- ** Confidential Treatment Requested. 19 ARTICLE VII MANUFACTURE AND SUPPLY Section 7.01. AGREEMENT TO SUPPLY PRODUCT. Subject to the terms hereof, MediGene agrees to purchase exclusively from Atrix, and Atrix agrees to Manufacture for, and sell exclusively to MediGene during the Term of this Agreement, MediGene's total requirements for the Product and the Demonstration Samples in the Territory on the terms and conditions set forth herein. Subject to MediGene's prior written approval, such approval not to be unreasonably withheld, conditioned or delayed by MediGene, Atrix may subcontract any part of the Manufacturing Process for the Product and the Demonstration Samples to a Third Party provided: (a) the Product, the Demonstration Samples and the facilities continue to meet the requirements as defined in this Agreement, (b) Atrix has obtained all required Governmental Approvals to subcontract any part of the Manufacturing Process for the Product to be sold in the Territory and (c) the Third Party has obtained all required Governmental Approvals for the Manufacturing Process for the Product to be sold in the Territory. If subcontracting is initiated by Atrix or requested by the Competent Authorities for any Manufacturing Process for Product to be sold in the Territory, Atrix will bear the cost of validation and necessary stability work, as well as any other directly related costs. Section 7.02. QUALITY ASSURANCE. Atrix shall Manufacture the Product in accordance with the Specifications. Atrix shall consult with MediGene as to any proposed changes in the Specifications, Manufacturing Process, or in Atrix's quality assurance procedures which might render Atrix unable to supply Product in accordance with the terms of this Agreement, prior to making those changes, and obtain MediGene's prior, written consent thereto, which consent will not be unreasonably withheld, conditioned or delayed by MediGene. Atrix shall immediately notify MediGene in writing of any changes required by a Competent Authority in the Specifications or Atrix's quality assurance procedures that would render Atrix unable to supply the Product and/or Demonstration Samples in accordance with the terms of this Agreement. The Parties agree to develop and execute an appropriate action plan in such situation. Any additional costs or expenses shall be shared between the Parties in such proportion as is equal to each Party's relative fault in causing such change or changes to occur; provided, however, that if the Parties cannot reach an agreement in good faith as to the relative fault of each Party or if neither Party is at fault, such additional costs and expenses shall be born equally by the Parties. Section 7.03. ATRIX'S DUTIES. Atrix covenants to Manufacture the Product in accordance with the Specifications and Applicable Laws, and to furnish to MediGene with every Shipment a written certificate of analysis and Certificate of Compliance that confirms conformity of the Product to the Specifications. The Product may be subjected to testing by MediGene at its designated facility in order to verify conformance of the Product with the Specifications. In addition, Atrix shall: (a) provide MediGene with a copy of the written sampling and testing procedures used by Atrix to confirm conformity of the Product to the Specifications; (b) retain a sample of each batch of Product for a period equal to (i) five (5) years or (ii) such period as required by Applicable Laws or the Competent Authorities. Upon 20 the written request of MediGene, Atrix shall make such samples available to MediGene for inspection. The retained sample shall be sufficient in size to allow MediGene and Atrix to perform tests to determine whether or not the Product conforms to the Specifications. The retained sample shall be kept under the same conditions as those under which the Product is stored at MediGene's facilities; (c) maintain records to ensure Atrix's ability to perform a complete lot history via lot tracing of the Product; (d) keep on file all manufacturing records and analytical results pertaining to the Manufacture of each batch of Product for a period equal to (i) five (5) years or (ii) such period as required by Applicable Laws or the Competent Authorities, with such period commencing on the expiration date of the last lot of the last batch of Product Manufactured and shipped to MediGene. Atrix shall make all such records available to MediGene upon request; (e) consult on an ongoing basis with the Advisory Board on all aspects of the manufacturing and development of the Product, including the use of any subcontractors to perform part of the Manufacturing Process and assist MediGene on an ongoing basis to obtain all necessary Marketing Authorizations, in accordance with Section 2.02; (f) provide to MediGene within twenty-four (24) hours of receipt by Atrix, complete copies of any and all inspection reports pertaining to the Manufacture and development of the Product which Atrix receives from any Competent Authority and the FDA, or which is obtained by Atrix from any Third Party agency, and promptly provide to MediGene any such report which is internally produced by Atrix's staff or that of any of its Affiliates; (g) provide MediGene with complete access to all existing and hereafter produced: (i) batch records of the Product; (ii) quality inspection reports of the Product, whether internally or externally generated; (iii) any and all investigation reports of the Product, whether internally or externally generated; and (iv) packaging records pertaining to the Product; and (h) provide MediGene with notice within forty-eight (48) hours of notification of any scheduled inspection by any Competent Authority of Atrix's facilities, books or records, or of the facilities, books or records of any subcontractor being utilized by Atrix to perform any portion or all of the Manufacture or development of the Product. Atrix shall inform such Competent Authority that MediGene may desire to be present at such inspection; provided that MediGene's right to be present is subject to approval by such Competent Authority and subject to MediGene being available at the time and date established by such Competent Authority. Atrix shall use reasonable efforts to secure a time and date for such inspection that is reasonably acceptable to MediGene; provided, however, that Atrix alone shall have the right to make the final decision on all such matters. 21 Section 7.04. COMPLIANCE WITH APPLICABLE LAWS. MediGene and Atrix (if Atrix has exercised its co-promotion and/or co-marketing rights pursuant to Sections 6.01(f) and 13.01, respectively, but only in connection with Atrix's activities thereunder) shall be responsible for compliance with Applicable Laws relating to the promotion, marketing, sale and distribution of the Product, Units and the Demonstration Samples, as applicable. Atrix shall be responsible for compliance with Applicable Laws relating to the Manufacture, design and production of the Product and the Demonstration Samples, as applicable, and with cGMP relating to the Manufacture and testing of the Product. Section 7.05. SECOND MANUFACTURING SOURCE. Atrix, at its own cost and expense, shall validate, qualify and obtain all Governmental Approvals for a Third Party as a second source (the "Second Source") to Manufacture and label the Product for sale in the Territory. No later than three (3) months after the Marketing Authorization for each Product is approved, Atrix shall take all necessary actions and provide all necessary information to enable MediGene to file a variation to the Marketing Authorization for each Product in the Territory with the Competent Authorities to request approval by such Competent Authorities for such Second Source to Manufacture each such Product for sale in the Territory. After such filing, MediGene, with the assistance of Atrix, shall use reasonable efforts to obtain final approval by the Competent Authorities for such Second Source to Manufacture each such Product including modifying the variation to the Marketing Authorization if required by a Competent Authority. Upon prior written notice to Atrix, MediGene shall have the right, at its sole cost and expense, to inspect and audit the Second Source's facilities used to Manufacture the Product to confirm that such facilities are in compliance with Applicable Laws and the Governmental Approvals. Atrix, at its sole cost and expense, may have a representative(s) accompany MediGene's representative(s) on any such inspection or audit. Section 7.06. FAILURE TO SUPPLY. (a) Atrix shall immediately notify MediGene if Atrix is unable to fill any order placed by MediGene pursuant to Section 8.07. If Atrix is unable to cure such failure within fifteen (15) business days after such notice, Atrix shall, within five (5) business days after the expiration of such cure period, make arrangements with the Second Source for the Second Source to take commercially reasonable steps to commence the Manufacture of the Product and to sell to Atrix the Product until such time as Atrix is again able to Manufacture the Product; provided, however, any consequent incremental costs which result by reason of the use of the Second Source under this Section 7.06(a) shall be the sole cost and liability of Atrix. (b) Subject to Section 7.06(c), if Atrix is unable (including due to reasons of Force Majeure) to supply Product to MediGene for a period of forty-five (45) business days or more or if Atrix notifies MediGene that Atrix and the Second Source will be unable to perform under Section 7.06(a), then upon such event, Atrix shall be deemed to have granted to MediGene and MediGene shall be deemed to have, without any further action by either Party, a non-exclusive royalty-free license under the Atrigel(R) Technology only to the extent necessary and sufficient to Manufacture the Product for sale or distribution in the Territory. At such time as Atrix or the Second Source is again able to Manufacture the Product, such license to MediGene will terminate and Atrix will 22 regain its exclusive right to Manufacture and supply the Product to MediGene, subject to the terms and conditions of the manufacturing agreement between MediGene and a Third Party manufacturer. Atrix, upon MediGene's written request, shall provide MediGene or any Third Party manufacturer chosen by MediGene within two (2) weeks of the date of such request with all Atrigel(R) Know-How related to the Manufacturing Process, but only to the extent necessary and sufficient to exercise its rights hereunder. Atrix shall also provide MediGene with any additional documentation and materials, at MediGene's expense, reasonably necessary to Manufacture the Product in the Territory in accordance with the license granted hereunder. If MediGene, enters into an agreement with a Third Party to Manufacture the Product, MediGene shall use commercially reasonable efforts to limit any such agreement to as short of period of time as commercially reasonable after giving effect to the period of time Atrix or the Second Source is expected to be unable to supply the Product. Any Third Party manufacturer shall execute confidentiality agreements with Atrix in form and substance reasonably satisfactory to Atrix. If necessary, Atrix will support the implementation of its Atrigel Know-How for the Manufacture of the Product by providing appropriate employees giving the required advice at the premises of MediGene or such Third Party. The cost for these employees will be borne by MediGene. Except as set forth in this Section 7.06(b), any additional costs and expenses reasonably incurred by MediGene shall be borne by Atrix. (c) Notwithstanding the foregoing, Atrix shall not be deemed to be unable to fill any order for Products placed by MediGene if Atrix's inability to fill any order for Products arises as a result of [**] increase in MediGene's order for Products over MediGene's prior firm forecast for each such Product. [**] Section 7.07. ALLOCATION. If Atrix exercises its rights to co-market under Article XIII and if Atrix is unable to supply all of the requirements of the Product, and quantities ordered by MediGene in accordance with Section 8.07, then Atrix shall allocate the resources available to it so that MediGene receives at least its proportional share of available supplies as determined based on reasonable forecasts (taking into consideration past sales and sales performance against forecast) of MediGene and Atrix. ARTICLE VIII PURCHASE AND SALE Section 8.01. PURCHASE PRICE AND PAYMENT. Atrix shall sell, and MediGene shall purchase, each Product at a price equal to the Atrix Manufacturing Cost for each such Product, including any adjustments pursuant to Section 8.02 (the "Purchase Price"). Atrix shall invoice MediGene monthly for all Product and Demonstration Samples shipped by Atrix to MediGene and payment shall be due thirty (30) days from receipt of the invoice. - ---------- ** Confidential Treatment Requested. 23 Section 8.02. ADJUSTMENT TO PURCHASE PRICE/AUDIT. (a) The Atrix Manufacturing Cost will be adjusted on a Product by Product and country by country basis annually commencing with the first day of the first calendar month twelve (12) months from the date of the First Commercial Sale of each Product (the "Adjusted Atrix Manufacturing Cost"). [**]: (i) if MediGene in good faith disputes the amount of the Adjusted Atrix Manufacturing Cost, then MediGene shall notify Atrix of this fact and such dispute shall be resolved by the Parties within thirty (30) days from the date of notice to MediGene of the Adjusted Atrix Manufacturing Cost. If such dispute cannot be resolved to the mutual satisfaction of the Parties within such thirty (30) day period then either Party may request that the dispute be submitted to the Chief Executive Officers of Atrix and MediGene, respectively, for joint resolution. If the dispute is not jointly resolved by the Parties' respective Chief Executive Officers within ten (10) days from submission to the Parties' respective Chief Executive Officers then Atrix shall be entitled to pursue any and all remedies at law available to it. In no event will the dispute resolution period exceed a maximum of forty (40) days unless otherwise agreed in writing by the Parties; and (ii) MediGene shall pay for Product ordered during the dispute period at the Purchase Price in effect prior to Atrix's notice of the Adjusted Atrix Manufacturing Cost. If upon resolution of any dispute the Purchase Price is greater than the Purchase Price paid by MediGene during the dispute period, Atrix will invoice MediGene for the difference and MediGene shall pay the same promptly upon receipt of such invoice. If upon resolution of any dispute the Purchase Price is lower than the Purchase Price paid by MediGene during the dispute period, Atrix will reimburse MediGene for the difference paid during the dispute period, [**]. (b) If at any time following twelve (12) months from the date of the First Commercial Sale of each Product, on a Product by Product basis, the Atrix Manufacturing Cost is in excess of the Twelve Month Cost then MediGene may request that the Parties meet to review and discuss the Atrix Manufacturing Cost. [**] Notwithstanding the foregoing, commencing twelve (12) months from the date of the First Commercial Sale of each Product, on a Product by Product basis, in the event that the total increase results in an increased Atrix Manufacturing Cost which becomes, in MediGene's sole judgment, commercially non-viable for a given Product in a given country in the Territory, MediGene shall have the right, in its sole discretion, to [**]: (i) [**]; (ii) [**]; and - ---------- ** Confidential Treatment Requested. 24 (iii) [**] (c) Commencing twelve (12) months from the date of First Commercial Sale of each Product MediGene shall have the right, at its sole cost and expense, to cause an independent, certified public accountant reasonably acceptable to Atrix to audit those records of Atrix relating to the calculation of the Atrix Manufacturing Cost and/or the Adjusted Atrix Manufacturing Cost for the sole purpose of verifying the Atrix Manufacturing Cost or the Adjusted Atrix Manufacturing Cost, respectively. Such audits may be exercised during normal business hours no more than once in a twelve (12) month period upon at least ten (10) days prior written notice. MediGene shall pay all of the costs of such audit unless such audit discloses an overstatement of the Atrix Manufacturing Cost or the Adjusted Atrix Manufacturing Cost by more than [**] of the amount claimed or stated as the Atrix Manufacturing Cost or the Adjusted Atrix Manufacturing Cost, respectively, for the preceding year. In such case, Atrix shall pay all of the costs of such audit. Section 8.03. LABELING AND ARTWORK. (a) After execution of this Agreement, Atrix shall have the right to review and comment upon any labeling and proposed changes to the labeling of the Product and to participate in discussions with the Competent Authorities concerning any labeling or proposed labeling change in accordance with Section 8.03(c). Notwithstanding the above, MediGene shall make the final decision with regard to any labeling or labeling revisions, provided that MediGene will consider, in making its decision, the effect such labeling or labeling revision will have on the marketing and sale of the Product outside the Territory. (b) MediGene will approve all artwork developed for inclusion in the Product packaging, including carton labels, package inserts, etc. If MediGene wishes to institute changes in labeling artwork, both Parties will develop a mutually acceptable implementation schedule. The actual cost of implementing such change will be at MediGene's sole cost and expense, including any materials made obsolete by MediGene's changes to the artwork. Atrix shall not alter, change or in any way modify the artwork, which has previously been approved, for any reason, without prior written authorization from MediGene, provided that such approved artwork shall conform to all Applicable Laws. Notwithstanding the foregoing, MediGene shall have the final say on any change in such artwork, provided that MediGene will consider, in making its decision, the effect any such change will have on the marketing and sale of the Product outside the Territory and provided further that such change is in compliance with all Applicable Laws in the Territory. (c) MediGene shall provide Atrix with notice within forty-eight (48) hours of notification of any scheduled meeting or conference with any Competent Authority with - ---------- ** Confidential Treatment Requested. 25 respect to any labeling or proposed labeling change. MediGene shall inform such Competent Authority that Atrix may desire to be present at such meeting or conference; provided that Atrix's right to be present is subject to approval by such Competent Authority and subject to Atrix being available at the time and date established by such Competent Authority. MediGene shall use reasonable efforts to secure a time and date for such meeting or conference that is reasonably acceptable to Atrix; provided, however, that MediGene alone has the right to make the final decision on all such matters. Section 8.04. PURCHASE FORMS. Purchase orders, purchase order releases, confirmations, acceptances and similar documents submitted by a Party in conducting the activities contemplated under this Agreement are for administrative purposes only and shall not add to or modify the terms of the Agreement. To the extent of any conflict or inconsistency between this Agreement and any such document, the terms of this Agreement shall govern. Section 8.05. CONFIRMATION. Atrix shall confirm each purchase order within five (5) business days from the date of receipt of a purchase order and shall supply the Product within a maximum of sixty (60) days from the date of acceptance of a purchase order, or later if so specified in the purchase order during the first twelve months after the First Commercial Sale of the Product. [**] Failure of Atrix to confirm any purchase order shall not relieve Atrix of its obligation to supply Product ordered by MediGene in conformity with this Agreement. Section 8.06. DELIVERY. Delivery terms for Product and Demonstration Samples shall be FOB Atrix's manufacturing facility at Fort Collins, Colorado, or FOB the Second Source's manufacturing facility. Atrix shall ship Product and Demonstration Samples in accordance with MediGene's purchase order form or as otherwise directed by MediGene in writing. Title to any Product or Demonstration Samples purchased by MediGene shall pass to MediGene upon the earlier of (i) a common carrier accepting possession or control of such Product or Demonstration Samples, as applicable, or (ii) passage of such Product or Demonstration Samples, as applicable, from the loading dock of Atrix's facilities or the loading dock of the Second Source's facilities, as applicable, to MediGene or its agent. Section 8.07. FORECASTS AND ORDERS. (a) Not later than six (6) months following submission of the NDA or other applicable regulatory filing on a country by country basis, MediGene will provide Atrix with a twelve (12) month forecast of MediGene's requirement of each Product, on a Product by Product basis, including Demonstration Samples, and on a country by country basis as follows (the "Initial Forecast"): (i) For the first twelve (12) months of the forecast for each Product, the forecasts shall be provided quarterly, no less than forty-five (45) days prior to the beginning of each quarter. Said requirements will be based on standard production planning parameters including but not limited to sales forecasts, sales demand forecasts, promotional forecasts, inventory requirements, and the like. - ---------- ** Confidential Treatment Requested. 26 The first two (2) quarters of the twelve (12) month forecast will be stated in monthly requirements. The second two (2) quarters of the twelve (12) month forecast will be total requirement by stock keeping unit and will be stated as quarterly requirements. The first three (3) months of the twelve (12) month forecast will be firm orders to purchase. The second three (3) months will be allowed to be flexed from the previous forecast by plus or minus [**] per month until fixed by the subsequent forecast; provided that the aggregate adjustment from the quantity set forth in the previous forecast for such three (3) month period shall not exceed [**] in aggregate during that three (3) month period. [**] (ii) After the first twelve (12) months MediGene will provide to Atrix a rolling twelve (12) month forecast for each Product with the first three (3) months of the rolling twelve (12) month forecast a firm order to purchase. Each order in the rolling twelve (12) month forecast shall be provided monthly, no less than twenty (20) days prior to the beginning of each month. All orders will be for full batch quantities. (b) It is understood that Atrix [**] will produce Product or Demonstration Sample upon receipt of that portion of MediGene's forecasts that constitute firm orders to purchase. The above periods whether fixed or flexible will be adjusted based upon existing lead times at time of start up. (c) MediGene agrees to purchase a sufficient amount of Product to enable MediGene to carry sufficient inventory to allow for fluctuations in sales demand so as to allow Atrix reasonable lead time to meet increased demand. Atrix will use commercially reasonable efforts to meet any increase in demand in excess of the allowed adjustment, but will not be obligated to do so; provided, however, notwithstanding anything to the contrary in this Section 8.07, Atrix shall be obligated to [**]. All forecasts will be made by MediGene to Atrix in good faith based upon standard commercial parameters. From time to time after the Effective Date, the Parties shall consider whether, in light of market demand, manufacturing capacity, inventory levels and other pertinent factors, to revise the schedule for delivery of forecasts and, if appropriate, negotiate in good faith to revise such schedule. (d) The Launch Quantity of the Product when delivered to the common carrier shall not have an expiration date of less than [**] from the date of such delivery, provided (a) Product other than the Launch Quantity shall not have an expiration date of less than [**] once real time stability data is submitted by Atrix to the respective Competent Authority, and/or (b) as the Parties may otherwise agree in writing on a case by case basis. (e) In the event MediGene does not receive a Marketing Authorization in a specified country in the Territory, but Atrix nevertheless has Manufactured the Launch - ---------- ** Confidential Treatment Requested. 27 Quantity of the Product for sale in such country in the Territory, the Atrix Manufacturing Cost attributable to the Manufacture of the Launch Quantity for sale in such country shall be borne equally by the Parties after deducting the cost of any Product which MediGene can sell in another country in the Territory and the cost of direct materials Atrix could otherwise use in the manufacture of other products. Section 8.08. DEMONSTRATION SAMPLES. Pursuant to the provisions of Section 8.07 above, Atrix shall supply to MediGene such quantities of Demonstration Samples as MediGene may reasonably request to be used solely for training purposes (and not for sale), and not for human use, for so long as MediGene retains a license pursuant to Sections 3.02 and 3.03 in the specific country in the Territory where the Demonstration Samples are to be used for training purposes. Demonstration Samples shall be sold by Atrix to MediGene at [**] for such Demonstration Samples. MediGene shall not use the Demonstration Samples for any purpose other than as set forth in this Section 8.08. ARTICLE IX WARRANTY, REJECTION AND INSPECTIONS Section 9.01. ATRIX WARRANTY. Atrix represents and warrants to MediGene that (i) the Product delivered pursuant to this Agreement shall comply with the Specifications at the date of delivery; (ii) the Product to be sold in the Territory is not adulterated or misbranded under Applicable Laws in the Territory at the date of delivery; (iii) at the time of Manufacture and delivery to MediGene the Product will be, and is, free from any defects, liens and encumbrances and MediGene shall receive good and marketable title to the Product, and (iv) at the date of Manufacture that Atrix has the right, and to the best of its knowledge each Second Source has the right, to Manufacture and label the Product, and (v) to its knowledge no restrictions for the import of the Product into the Territory exist at the time of Manufacture and delivery to MediGene. EXCEPT AS OTHERWISE SET FORTH HEREIN, ATRIX MAKES NO OTHER WARRANTIES OF ANY OTHER KIND, INCLUDING BUT NOT LIMITED TO ANY WARRANTY OF MERCHANTABILITY (AS DESCRIBED IN SECTION 4-2-314 OF THE U.C.C.) OR FITNESS OF THE PRODUCT AND DEMONSTRATION SAMPLES FOR ANY PURPOSE (AS DESCRIBED IN SECTION 4-2-315 OF THE U.C.C.), AND ATRIX EXPRESSLY DISCLAIMS ANY SUCH OTHER WARRANTIES WITH RESPECT TO THE PRODUCT AND DEMONSTRATION SAMPLES, EITHER EXPRESS OR IMPLIED. Section 9.02. REJECTION OF PRODUCT FOR FAILURE TO CONFORM TO SPECIFICATIONS. MediGene shall have forty-five (45) days after the receipt of any Shipment to determine conformity of the Shipment to the Specifications and/or Applicable Laws, except for hidden defects. A "hidden defect" shall mean a defect in the Product not discovered by MediGene during its testing of the Product in accordance with generally accepted industry - ---------- ** Confidential Treatment Requested. 28 testing procedures and which would not be a defect normally expected to be discovered in accordance with such testing. If testing of such Shipment shows a failure of the Shipment to meet the Specifications and/or Applicable Laws, MediGene may return the entire Shipment, or any portion thereof, to Atrix at Atrix's expense within a reasonable time following the above described testing, provided that notice of non-conformity is received by Atrix from MediGene within forty-five (45) days of MediGene's receipt of said Shipment except for hidden defects. MediGene shall have the right to request that Atrix provide to MediGene, within thirty (30) days after such notice is received by it, Product that meets the Specifications and Applicable Laws or to promptly provide MediGene with full credit for the Purchase Price paid by MediGene for the returned Product. In case of a hidden defect, MediGene shall have the right to request that Atrix provide to MediGene, within thirty (30) days after a notice concerning a hidden defect is received by it, Product that meets the Specifications and Applicable Laws or to promptly provide MediGene with full credit for the Purchase Price paid by MediGene for the returned Product. In either case the cost of freight and handling to return or replace the returned Product shall be at the expense of Atrix. If MediGene does not notify Atrix of the non-conformity of the Product within forty-five (45) days of receipt of said Shipment, the Product shall be deemed to meet the Specifications, the Packaging Specifications and Applicable Laws, except for hidden defects. Notwithstanding anything in this Agreement to the contrary, the Parties may agree to a return of the Product or an adjustment in the Purchase Price in the event of any failure or defect in the Product. Should there be a discrepancy between MediGene's test results and the results of testing performed by Atrix, such discrepancies shall be finally resolved by testing performed by an independent Third Party mutually agreed upon by MediGene and Atrix. The costs of such testing shall be borne by the Party against whom the discrepancy is resolved. In the event Product has been previously returned to Atrix and an independent Third Party determines that the Product meets the Specifications, MediGene shall be responsible for all costs associated with the return. Section 9.03. MEDIGENE INSPECTIONS. Atrix shall upon reasonable (but not less than five (5) business days) prior written notice by MediGene and during normal business hours, allow MediGene and cause any sub-contractors and the Second Source to allow MediGene, to inspect and audit Atrix's facilities, the facilities of Atrix's sub-contractors and the facilities of the Second Source used to Manufacture the Product and the Demonstration Samples, twice annually, to confirm that the facilities and the equipment, personnel and operating and testing procedures used by Atrix, Atrix's subcontractor(s) and the Second Source in the Manufacture, testing, storage and distribution of the Product are in compliance with Applicable Laws and the Governmental Approvals; provided that such inspection does not interfere with Atrix's, Atrix's sub-contractor(s)' and the Second Source's normal operations or cause Atrix, Atrix's sub-contractor(s) and the Second Source to violate or be in breach of any confidentiality agreements with any Third Party pertaining to other products. 29 ARTICLE X REGULATORY COMPLIANCE Section 10.01. MARKETING AUTHORIZATION HOLDER. Unless otherwise required by Applicable Laws and subject to the provisions of Sections 3.02 and 19.06(e), [**] shall be the holder of all Marketing Authorizations for each country in the Territory. [**] will own and maintain the Marketing Authorizations during the term of this Agreement. Each Party agrees that neither it nor its Affiliates and any sublicensee will do anything to adversely affect a Marketing Authorization. Section 10.02. MAINTENANCE OF MARKETING AUTHORIZATIONS. [**] agrees, at its sole cost and expense, to maintain the Marketing Authorizations throughout the Term of this Agreement, including obtaining any variations or renewals thereof. Section 10.03. INTERACTION WITH COMPETENT AUTHORITIES. (a) After execution of this Agreement, each Party shall provide to the other Party a copy of any significant correspondence regarding the Product in the Territory that it submits to or receives from Competent Authorities and/or the FDA, within ten (10) days of submission or receipt, as the case may be. (b) In addition to the requirements set forth in Section 2.02(c), MediGene shall provide Atrix with a copy of any significant correspondence regarding the Product that it submits to or receives from the Competent Authorities, within ten (10) days prior to the date of submission or within ten (10) days from receipt, as the case may be. Section 10.04. ADVERSE DRUG EVENT REPORTING AND PHASE IV SURVEILLANCE. (a) Each Party, including its permitted sublicensees, shall advise the other Party, by telephone or facsimile, immediately but in no event later than twenty-four (24) hours after a Party, or its sublicensees, becomes aware of any potentially serious or unexpected adverse event (including adverse drug experiences, as defined in Applicable Laws) (an "ADE") involving the Product or the Demonstration Samples. Such advising Party shall provide the other Party with a written report delivered by confirmed facsimile of any adverse reaction, stating the full facts known to such Party, including but not limited to customer name, address, telephone number, batch, lot and serial numbers, and other information as required by Applicable Laws. For so long as MediGene has an exclusive license to market, promote and sell the Product in any country in the Territory for use in the Field, MediGene shall have full responsibility for (i) monitoring such adverse reactions; and (ii) data collection activities that occur between MediGene and the patient or medical professional, as appropriate, including any follow-up inquiries which MediGene deems necessary or appropriate. - ---------- ** Confidential Treatment Requested. 30 If Atrix exercises its right to co-market as set forth in Section 13.01 then upon the occurrence of an ADE the Parties shall promptly meet, in person or by telephone, as appropriate, to discuss and determine how to mutually handle and resolve any issues relating to or arising from any such ADE. (b) In the event either Party requires information regarding adverse drug events with respect to reports required to be filed by it in order to comply with Applicable Laws, including obligations to report ADEs to the Competent Authorities, each Party agrees to provide such information to the other on a timely basis. (c) The Parties agree to follow MediGene's standard operating procedure for reporting and identifying adverse drug reactions (the "SOP") a copy of which is attached hereto as Exhibit F. In the event the SOP is modified or amended during the term of this Agreement, MediGene shall provide Atrix with copies of any such modification or amendment to the SOP for Atrix's prior approval, which will not be unreasonably withheld, conditioned or delayed, at least five (5) business days prior to such amendment taking effect. MediGene shall designate a qualified person under Applicable Laws to be responsible for ADE reporting in each country in the Territory. (d) If the report of an ADE causes a Competent Authority to request labeling revision as a result of an ADE or that a Phase IV surveillance program be conducted, then the Parties shall promptly enter into discussions and shall mutually agree on all of the material terms and conditions of such labeling revision or Phase IV surveillance program; provided, however the costs of such labeling revision or Phase IV surveillance program shall be borne [**]. MediGene shall have the authority to make the final decision with regard to any labeling revisions provided that MediGene will consider, in making its decision, the effect any such labeling revisions will have on the marketing and sale of the Product outside the Territory. MediGene agrees that should Applicable Laws require that any such interim data and results from such Phase IV surveillance programs be prepared in written form, MediGene shall comply with such requirements and provide all such information in writing to MediGene and the Competent Authorities in accordance with Applicable Laws. MediGene further agrees that Atrix shall have the right to incorporate, refer to and cross-reference such results and underlying data in any regulatory filing or any other filing or requirement Atrix is required to undertake with respect to the Product. Atrix agrees that MediGene shall have the right to incorporate, refer to and cross-reference such results and underlying data in any regulatory filing or any other filing or requirement MediGene is required to undertake with respect to the Product in the Territory Section 10.05. COMMERCIAL SALE TESTING AND REPORTING. If, after the date of First Commercial Sale in any country in the Territory, a Competent Authority requires additional testing, modification or communication related to approved indications of the Product, then the - ---------- ** Confidential Treatment Requested. 31 Parties shall design and MediGene shall implement any such testing, modification or communication as shall be mutually agreed upon by the Parties, and the costs shall be borne [**]. Section 10.06. ASSISTANCE. Each Party shall provide reasonable assistance to the other at the other's request, in connection with their obligations pursuant to this Article X, subject to reimbursement of all of its out-of-pocket costs by the requesting Party. Section 10.07. COMPLIANCE. MediGene and Atrix shall comply with all Applicable Laws within the Territory as set forth in this Agreement, including the provision of information by MediGene and Atrix to each other necessary for Atrix and MediGene to comply with any applicable reporting requirements. Each Party shall promptly notify the other Party of any comments, responses or notices received from, or inspections by, the FDA, or other applicable Competent Authorities, which relate to or may impact the Product or the Manufacture of the Product or the sales and marketing of the Product, and shall promptly inform the other Party of any responses to such comments, responses, notices or inspections and the resolution of any issue raised by the FDA or other Competent Authorities. ARTICLE XI PATENTS AND TRADEMARKS Section 11.01. MAINTENANCE OF PATENTS OR MARKS. (a) Atrix shall, at Atrix's expense and to the extent commercially reasonable, maintain and protect the Atrigel(R) Patent Rights and the Marks in all countries in the Territory; provided however, that upon written request by Atrix, MediGene shall, at no cost or expense to MediGene, provide such assistance as may be necessary to enable Atrix to comply with the administrative formalities necessary to maintain the Atrigel(R) Patent Rights and the Marks and to prosecute and obtain new patents related to the Atrigel(R) Technology. MediGene shall, at MediGene's expense, maintain and protect any trademark, logo, design and/or tradedress for the Product in those countries in the Territory for which MediGene retains a license pursuant to Section 3.02 and to the extent commercially reasonable, other than the Marks. (b) MediGene, to the extent commercially reasonable, shall maintain and protect the Program Technology in all countries in the Territory and Atrix, to the extent commercially reasonable, shall maintain and protect the Program Technology outside the Territory; provided however, that each Party shall provide such assistance as may be necessary to enable the other Party to comply with the administrative formalities necessary to maintain the Program Technology. In the event that a Party responsible for the filing, prosecution and maintenance of any patent application or patent within the Program Technology desires to abandon such patent application or patent, or if such Party later declines responsibility for such patent application or patent, such Party shall provide reasonable prior written notice to the other Party of its intention to abandon or - ---------- ** Confidential Treatment Requested. 32 decline responsibility, and the other Party shall have the right, but not the obligation, to prepare, file, prosecute, and maintain any such patent application or patent within the Program Technology. The Parties shall share equally the costs of filing, prosecuting and maintaining patents or patent applications within the Program Technology. In addition, each Party shall provide the other Party the opportunity to review, consult with and assist such Party in the preparation of filing, prosecuting and maintaining such patents and patent applications. Section 11.02. PROSECUTION OF INFRINGEMENT. (a) During the Term, each Party shall give prompt notice to the other of any Third Party act which may infringe the Atrigel(R) Patent Rights or the Marks in the Territory and shall cooperate with each other to terminate such infringement without litigation. Atrix shall, at its sole expense, prosecute the judicial or administrative proceedings against such Third Party infringement. MediGene shall provide such assistance and cooperation to Atrix as may be necessary to successfully prosecute any action against Third Party infringement at Atrix's expense and may deduct the expenses thereof from any amounts payable to Atrix under this Agreement. In the event Atrix fails to institute proceedings against any Third Party infringement of the Atrigel(R) Patent Rights and/or the Marks within forty-five (45) days after notice given by either Party to the other of said Third Party infringement, MediGene may take such action as it deems appropriate, including without limitation, the filing of a lawsuit against such Third Party. In such event Atrix will provide such assistance and cooperation to MediGene as may be necessary, at MediGene's expense, and MediGene may deduct all costs and expenses of such actions against any amount payable to Atrix under this Agreement and retain all amounts awarded in such action. (b) In the event any patent included in the Program Technology is infringed by a Third Party, the Party responsible for prosecution and maintenance of the applicable Program Technology under Section 11.01(b) shall have the right to bring and control such action or proceeding, using counsel reasonably acceptable to the Parties, and the other Party shall provide such assistance and cooperation to the Party bringing such action as may be necessary to successfully prosecute any action against such Third Party. The Parties shall share equally in the costs with respect thereto. In the event Atrix or MediGene, as the case may be, fails to institute proceedings against any Third Party infringement of the Program Technology within the earlier of (i) the time period required under Applicable Laws or (ii) forty-five (45) days after notice given by either Party to the other of said Third Party infringement, the other Party may take such action as it deems appropriate, including without limitation, the filing of a lawsuit against such Third Party. In such event Atrix or MediGene, as the case may be, will provide such assistance and cooperation to the other Party as may be necessary, at the other Party's expense, and such Party may deduct, in the case of MediGene, or add, in the case of Atrix, all costs and expenses of such actions against any amount payable to, in the case of MediGene, or receivable from, in the case of Atrix, the other Party under this Agreement and retain all amounts awarded in such action. 33 (c) Neither Atrix nor MediGene may settle an action or proceeding against an infringer related to the Program Technology, and MediGene may not settle an action or proceeding against an infringer related to Atrigel(R) Technology, with respect to an infringement without the written consent of the other Party. Such consent shall not be unreasonably withheld or delayed, but may be withheld if such settlement would materially and adversely affect the interest of such Party, including Atrix's rights hereunder or Atrix's rights in the Atrigel(R) Technology. Section 11.03. INFRINGEMENT CLAIMED BY THIRD PARTIES. In the event a Third Party commences, or threatens to commence, a judicial or administrative proceeding against a Party to this Agreement and such proceeding pertains to the Atrigel(R) Patent Rights or Marks, the Party against whom such proceeding is threatened or commenced shall give prompt notice to the other Party. Atrix shall, at its sole cost and expense, defend any and all such claims or proceedings and shall indemnify and hold harmless MediGene from any and all liabilities, costs and expenses, including, without limitation, attorneys' fees, incurred with respect to any such claim or proceeding and MediGene shall provide such assistance and cooperation to Atrix as may be necessary to successfully defend any such claim or proceeding. In the event a Third Party commences, or threatens to commence, a judicial or administrative proceeding against a Party to this Agreement and such proceeding pertains to the Program Technology, the Party responsible for prosecution and maintenance of the applicable Program Technology under Section 11.01(a) shall have the right to defend any and all such claims or proceeding, using counsel reasonably acceptable to the Parties, and the Parties shall share equally the costs with respect thereto; provided, however, if such Party elects not to defend such claim or fails to use commercially reasonable efforts to defend such claim, the other Party shall have the right to control the defense of such claims by counsel of its own choice at the cost of the Party who initially had the right to defend such claim. ARTICLE XII CONFIDENTIALITY Section 12.01. CONFIDENTIALITY. During the Term and for a period of [**] thereafter, each Party shall maintain all Confidential Information of the other Party as confidential and shall not disclose any such Confidential Information to any Third Party or use any such Confidential Information for any purpose, except (a) as expressly authorized by this Agreement, (b) as required by law, rule, regulation or court order (provided that the disclosing Party shall first notify the other Party and shall use commercially reasonable efforts to obtain confidential treatment of any such information required to be disclosed), or (c) to its Affiliates, employees, agents, consultants and other representatives to accomplish the purposes of this Agreement, so long as such persons are under an obligation of confidentiality no less stringent than as set forth herein. Each Party may use such Confidential Information only to the extent required to accomplish the purposes of this Agreement. Each Party shall use at least the same standard of care as it uses to protect its own Confidential Information to ensure that its Affiliates, employees, - ---------- ** Confidential Treatment Requested. 34 agents, consultants and other representatives do not disclose or make any unauthorized use of the other Party's Confidential Information. Each Party shall promptly notify the other Party upon discovery of any unauthorized use or disclosure of the other Party's Confidential Information. Section 12.02. DISCLOSURE OF AGREEMENT. Neither Party shall release to any Third Party or publish in any way any non-public information with respect to the terms of this Agreement without the prior written consent of the other Party, which consent shall not be unreasonably withheld, except for the disclosure by a Party of the terms of this Agreement to lenders, investment bankers and other financial institutions of its choice solely for purposes of financing the business operations of such Party; provided such Party uses reasonable efforts to obtain a signed confidentiality agreement with any such financial institution with respect to such information on terms substantially similar to those contained in this Article XII and except as provided in Section 20.11. Nothing contained in this paragraph shall prohibit either Party from filing this Agreement as required by the rules and regulations of the Securities and Exchange Commission, national securities exchanges (including those located in countries outside of the United States) or the Nasdaq Stock Market; provided the disclosing Party discloses only the minimum information required to be disclosed in order to comply with such requirements, including requesting confidential treatment of this Agreement (after consultation with the other Party) and filing this Agreement in redacted form. ARTICLE XIII ATRIX'S OPTION TO MARKET THE PRODUCT UNDER CERTAIN CIRCUMSTANCES Section 13.01. CO-MARKETING RIGHTS. Subject to Section 7.07, if MediGene should fail to achieve (through no fault of Atrix, including an act of Force Majeure with respect to Atrix) at least a [**], then, and only if either of such events occur, Atrix shall have the right and option, exercisable in its sole discretion, by written notice to that effect delivered by Atrix to MediGene within sixty (60) days after said event occurs, to co-market the Product in each such country in the Territory that did not obtain a [**], either by itself, using a Third Party or in conjunction with a Third Party. If Atrix exercises its right to co-market the Product in such country in the Territory the following shall occur, to the extent allowed by Applicable Laws: (i) MediGene shall grant Atrix an irrevocable, exclusive, royalty free license, except as against MediGene, with the right to sublicense, under the License granted to MediGene under Section 3.02 of this Agreement (and no other MediGene proprietary or intellectual property rights) to market, advertise, promote, distribute, offer for sale, sell and import the Product in such country in the Territory; (ii) MediGene shall grant to Atrix an irrevocable, non-exclusive, royalty-free license, with the right to sublicense, to use the Clinical Documentation, the Results and the Marketing Authorizations and make any required filings with the Competent Authorities, to the extent legally permissible, in connection with such activities; (iii) Atrix will be solely responsible for its expenses related to marketing the Product in such country in the Territory and Atrix will retain all revenues from Product that it or its sublicensees sell in such country in the Territory; (iv) - ---------- ** Confidential Treatment Requested. 35 Atrix and/or its sub-licensee shall only be entitled to market one additional brand of the Product and Atrix and/or its sub-licensee shall market the Product using a different mark than the Mark associated with the Product in that country in the Territory; (v) subject to and in compliance with all Applicable Laws, Atrix will use commercially reasonable efforts to restrict the sale of such Product by its sublicensee outside of said country in the Territory; and (vi) the Advisory Board will be deemed to be automatically dissolved as of the date Atrix exercises its right to co-market the Product. ARTICLE XIV REPRESENTATIONS AND WARRANTIES Section 14.01. CORPORATE POWER. As of the Effective Date, each Party hereby represents and warrants that such Party is duly organized and validly existing under the laws of the jurisdiction of its incorporation and has full power and authority to enter into this Agreement and the transactions contemplated hereby and to carry out the provisions hereof. Section 14.02. DUE AUTHORIZATION. As of the Effective Date, each Party hereby represents and warrants that such Party is duly authorized to execute and deliver this Agreement and to perform its obligations hereunder. Section 14.03. BINDING OBLIGATION. As of the Effective Date, each Party hereby represents and warrants that this Agreement is a legal and valid obligation binding upon it and is enforceable in accordance with its terms, except that the enforcement of the rights and remedies created hereby is subject to bankruptcy, insolvency, reorganization and similar laws of general application affecting the rights and remedies of creditors and that the availability of the remedy of specific performance or of injunctive relief is subject to the discretion of the court before which any proceeding therefor may be brought. As of the Effective Date, the execution, delivery and performance of this Agreement by such Party does not conflict with any agreement, instrument or understanding, oral or written, to which it is a party or by which it may be bound, nor violate any law or regulation of any court, governmental body or administrative or other agency having authority over it. Section 14.04. OWNERSHIP OF ATRIGEL(R) PATENT RIGHTS. As of the Effective Date, Atrix represents and warrants that (a) it is the sole owner of all right, title and interest in and to the Atrigel(R) Patent Rights and the Marks, (b) it has not granted any license under the Atrigel(R) Patent Rights or the Marks for any Product in the Territory for use in the Field to any Third Party and is under no obligation to grant any such license, except to MediGene, and (c) there are no outstanding liens, encumbrances, agreements or understanding of any kind, either written, oral or implied, regarding either the Atrigel(R) Patent Rights or the Marks which are inconsistent or in conflict with this Agreement. Section 14.05. PATENT PROCEEDINGS. As of the Effective Date, Atrix represents and warrants that, (a) no patent or patent application within the Atrigel(R) Patent Rights is the subject of any pending interference, opposition, cancellation or other protest proceeding, and (b) to the best of its knowledge, the Atrigel(R) Technology does not infringe the published intellectual property rights of any Third Party. 36 Section 14.06. LEGAL PROCEEDINGS. As of the Effective Date, each Party hereby represents and warrants to the other Party that there is no action, suit or proceeding pending against or affecting, or, to the knowledge of either Party, threatened against or affecting that Party, or any of its assets, before any court or arbitrator or any governmental body, agency or official that would, if decided against either Party, have a material adverse impact on the business, properties, assets, liabilities or financial condition of that Party (that are not already reflected in that Party's respective financial statements that, with respect to Atrix, have been filed with the Securities and Exchange Commission or, with respect to MediGene, have been disclosed to the relevant stock market supervisory authority and/or the public) and which would have a material adverse effect on that Party's ability to consummate the transactions contemplated by this Agreement. Section 14.07. COMPLIANCE WITH APPLICABLE LAWS. Atrix represents and warrants that it is in compliance with Applicable Laws with respect to the development and Manufacture of Product for clinical trials including, without limitation, that it owns or has access to manufacturing facilities approved by the FDA and available for the Manufacture of Product for clinical trials and that, as of the Effective Date, Atrix is not subject to any stop order from the FDA or any Competent Authority that would effect Atrix's ability to Manufacture the Product for clinical trials in the Territory. In addition, to its knowledge, Atrix is not aware of any fact or circumstance that would cause it to become subject to a stop order or which would prevent it from complying with Applicable Laws with respect to the development and Manufacture of Product intended for sale in the Territory at the time of First Commercial Sale. Section 14.08. LIMITATION ON WARRANTIES. Except as expressly set forth in this Agreement, nothing herein shall be construed as a representation or warranty by Atrix to MediGene that the Atrigel(R) Technology is not infringed by any Third Party, or that the practice of such rights does not infringe any published intellectual property rights of any Third Party. Neither Party makes any warranties, express or implied, concerning the success of the [**] Development Program [**], or the commercial utility of the Product. Section 14.09. LIMITATION OF LIABILITY. NEITHER PARTY SHALL BE ENTITLED TO RECOVER FROM THE OTHER PARTY ANY SPECIAL, EXEMPLARY OR PUNITIVE DAMAGES (AS SUCH TERMS ARE DEFINED IN BLACK'S LAW DICTIONARY, SIXTH EDITION) IN CONNECTION WITH THIS AGREEMENT OR ANY LICENSE GRANTED HEREUNDER. ARTICLE XV INDEMNIFICATION Section 15.01. MEDIGENE INDEMNIFIED BY ATRIX. Atrix shall indemnify and hold MediGene, its Affiliates, and their respective employees, directors and officers, harmless from and against any liabilities or obligations, damages, losses, claims, encumbrances, costs or - ---------- ** Confidential Treatment Requested. 37 expenses (including attorneys' fees) (any or all of the foregoing herein referred to as "Loss") insofar as a Loss or actions in respect thereof arises out of or is based upon (a) any misrepresentation (or alleged misrepresentation) or breach (or alleged breach) of any of the warranties, covenants or agreements made by Atrix in this Agreement; (b) the Manufacturing of any Product or Demonstration Samples (Manufactured by Atrix or the Second Source); (c) any claims that the Product (as a result of the use of Atrigel(R) Technology therein) or its Manufacture (as a result of the use of Atrigel(R) Technology therein), use or sale infringes the patent, trademark or proprietary right of a Third Party; (d) if Atrix exercises its rights to co-market the Product under Article XIII, Atrix's, or its sub-licensee's, marketing, sale, distribution or promotion of the Product or (e) the Atrix Sales Force, except to the extent such Loss arises out of, or results from, the negligence or actions of MediGene. Section 15.02. ATRIX INDEMNIFIED BY MEDIGENE. MediGene shall indemnify and hold Atrix, its Affiliates, and their respective employees, directors and officers, harmless from and against any Loss insofar as such Loss or actions in respect thereof occurs subsequent to the Effective Date arises out of or is based upon (a) any misrepresentation (or alleged misrepresentation) or breach (or alleged breach) of any of the warranties, covenants or agreements made by MediGene in this Agreement; (b) MediGene's or its sublicensee's use of the Marks or the Marketing Authorizations in the marketing, use, handling, storage, sale, distribution or promotion of the Product or the Demonstration Samples; (c) MediGene's or its sublicensee's marketing, use, handling, storage, sale, distribution or promotion of the Product or the Demonstration Samples; (d) the Manufacture of any Product or Demonstration Samples by MediGene or its sublicensee, which Loss was not the result of Atrix's breach of the terms and provisions of this Agreement; or (e) the use of MediGene's name and trademark in the packaging and labeling of the Product and in the marketing, sale, distribution or promotion of the Product or the Demonstration Samples. Section 15.03. PROMPT NOTICE REQUIRED. No claim for indemnification hereunder shall be valid unless notice of the matter which may give rise to such claim is given in writing by the indemnitee (the "Indemnitee") to the persons against whom indemnification may be sought (the "Indemnitor") as soon as reasonably practicable after such Indemnitee becomes aware of such claim, provided that the failure to notify the Indemnitor shall not relieve the Indemnitor from any liability except to the extent that such failure to notify actually adversely impacts the Indemnitor's ability to defend such claim. Such notice shall state that the Indemnitor is required to indemnify the Indemnitee for a Loss and shall specify the amount of Loss and relevant details thereof. The Indemnitor shall notify Indemnitee no later than sixty (60) days from such notice of its intention to assume the defense of any such claim. In the event the Indemnitor fails to give such notice within that time the Indemnitor shall no longer be entitled to assume such defense. Section 15.04. INDEMNITOR MAY SETTLE. The Indemnitor shall at its expense, have the right to settle and defend, through counsel reasonably satisfactory to the Indemnitee, any action which may be brought in connection with all matters for which indemnification is available. In such event the Indemnitee of the Loss in question and any successor thereto shall permit the Indemnitor full and free access to its books and records and otherwise fully cooperate with the Indemnitor in connection with such action; provided that this Indemnitee shall have the right fully to participate in such defense at its own expense. The defense by the Indemnitor of any such actions shall not be deemed a waiver by the Indemnitor of its right to assert a claim with 38 respect to the responsibility of the Indemnitor with respect to the Loss in question. The Indemnitor shall have the right to settle or compromise any claim against the Indemnitee without the consent of the Indemnitee provided that the terms thereof: (a) provide for the unconditional release of the Indemnitee; (b) require the payment of compensatory monetary damages by Indemnitor only; and (c) expressly state that neither the fact of settlement nor the settlement agreement shall constitute, or be construed or interpreted as, an admission by the Indemnitee of any issue, fact, allegation or any other aspect of the claim being settled. No Indemnitee shall pay or voluntarily permit the determination of any liability which is subject to any such action while the Indemnitor is negotiating the settlement thereof or contesting the matter, except with the prior written consent of the Indemnitor, which consent shall not be unreasonably withheld or delayed. If the Indemnitor fails to give Indemnitee notice of its intention to defend any such action as provided herein, the Indemnitee involved shall have the right to assume the defense thereof with counsel of its choice, at the Indemnitor's expense, and defend, settle or otherwise dispose of such action. With respect to any such action which the Indemnitor shall fail to promptly defend, the Indemnitor shall not thereafter question the liability of the Indemnitor hereunder to the Indemnitee for any Loss (including counsel fees and other expenses of defense). ARTICLE XVI COVENANTS Section 16.01. COVENANT NOT TO LAUNCH COMPETITIVE PRODUCT. MediGene hereby covenants and shall cause its Affiliates to agree not to out-license, commercialize, market, sell, distribute or have marketed, have sold or have distributed any Competitive Product in any country in the Territory in which MediGene retains a license granted by Atrix under Article III during the Term. Notwithstanding the foregoing, if MediGene or any Affiliate acquires an entity or all or substantially all of the assets of an entity and such entity distributes a Competitive Product or such assets include a Competitive Product, MediGene or such Affiliate shall have one hundred and eighty (180) days in which to divest itself of such Competitive Product or to otherwise cease marketing, sales and distribution of such Competitive Product, and MediGene shall not be in breach of this Section 16.01 if it or the Affiliate, as the case may be, so divests or ceases marketing, sales and distribution within such one hundred and eighty (180) day period; Section 16.02. LIMITATION TO THE TERRITORY. (a) MediGene covenants and agrees that it will not, nor shall it permit its Affiliates, without the prior written authorization of Atrix, to the extent allowed by Applicable Laws: (i) promote or actively solicit sale of the Product or advertise the Product, in any country where MediGene does not have a necessary Marketing Authorization or in any country that is not part of the Territory; (ii) purchase or cause to be purchased Product which MediGene has represented, directly or indirectly, as being for the purpose of sale in a specific country in the Territory for sale in any other country in the Territory; (iii) with regard to the Product, contact any of Atrix's suppliers or vendors of the Product or components relating to the Product, except as necessary to exercise its right to Manufacture the Product and to conduct audits, each as set forth in this Agreement; (iv) contact the FDA or Competent Authorities or other entity located outside the Territory about the Product, except as required by Applicable Laws or as may 39 be necessary or appropriate to exercise its Manufacturing rights or carry out its obligations as set forth in this Agreement; and (v) knowingly sell or distribute for resale the Product purchased hereunder to a Third Party who intends to sell such Product in a country where MediGene does not have a Marketing Authorization, if required, or in any country that is not part of the Territory. (b) To the extent Atrix exercises its rights to grant a license to a Third Party in accordance with Section 3.02(e), Atrix covenants and agrees that it will not, and shall use commercially reasonable efforts to ensure that such Third Party does not, without the prior written authorization of MediGene, to the extent allowed by Applicable Laws: (i) promote or actively solicit sale of the Product or advertise the Product, in any country where Atrix does not have the right to grant such license under Section 3.02(e) (the "Licensed Territory"); (ii) allow a Third Party to purchase or cause to be purchased Product which the Third Party has represented, directly or indirectly, as being for the purpose of sale in the Licensed Territory for sale in the Territory but outside the Licensed Territory; and (iii) knowingly sell or distribute for resale the Product to a Third Party who intends to sell such Product in the Territory but outside the Licensed Territory. Section 16.03. ACCESS TO BOOKS AND RECORDS. Each Party covenants and agrees that it shall permit the other Party, at the other Party's expense and during normal business hours, to exercise such Party's inspection rights as set forth in this Agreement. Section 16.04. A&S SPENDING LEVELS. MediGene covenants and agrees that during the first [**] months following the date of the First Commercial Sale of the Product in the Territory [**], MediGene's annual A&S spending levels in the Territory shall be at least [**] in the aggregate. MediGene further covenants and agrees that after such [**] Period, MediGene shall maintain annual A&S spending levels in the Territory [**]. Section 16.05. MARKETING EXPENSES. MediGene covenants and agrees that, except as otherwise specified in this Agreement, MediGene shall be solely responsible for the cost and implementation of all marketing, sales, promotional and related activities concerning the marketing, sale and promotion of the Product. Section 16.06. COMPLIANCE. MediGene covenants and agrees that, except as otherwise specified in this Agreement, it will assume all responsibility for selling and distributing the Product and the Demonstration Samples, as applicable, including obtaining all necessary Governmental Approvals, and any other requirements relating to the import, sale and distribution of the Product and the Demonstration Samples, as applicable, imposed by Applicable Law, and MediGene shall comply with all Applicable Laws affecting the use, possession, distribution, advertising and all forms of promotion in connection with the sale and distribution of the Product and the Demonstration Samples in the Territory. Section 16.07. REPORTS. MediGene covenants and agrees that, except as otherwise specified in this Agreement, MediGene shall have the obligation and responsibility for and shall - ---------- ** Confidential Treatment Requested. 40 make any and all necessary reports to the Competent Authorities, including but not limited to reports on an ADE, and shall provide Atrix with a complete copy of any such report simultaneously with the submission of the report to the Competent Authorities. Atrix covenants and agrees that it shall provide MediGene with a complete copy of any and all necessary reports simultaneously with the submission of such report to the Competent Authorities including the FDA. Section 16.08. PROTECTION OF THE MARKS. The Parties covenant and agree that neither Party nor their Affiliates shall publish, employ nor cooperate in the publication of, any misleading or deceptive advertising material with regard to the Parties, or the Marks or MediGene's trademarks for the Product. Section 16.09. LAUNCH QUANTITIES. Each Party covenants and agrees to the other as follows: (a) that Atrix will provide Launch Quantity of the Product; (b) that MediGene will timely provide to Atrix its forecast of MediGene's requirement of Product, on a Product by Product and country by country basis, including Demonstration Samples, in order to enable Atrix to timely provide Launch Quantity of the Product to MediGene. Section 16.10. FURTHER ACTIONS. Upon the terms and subject to the conditions hereof, each of the Parties hereto shall use its commercially reasonable efforts to (i) take, or cause to be taken, all appropriate action and do, or cause to be done, all things necessary, proper or advisable under Applicable Law or otherwise to consummate and make effective the transactions contemplated by this Agreement, (ii) obtain from Competent Authorities any consents, licenses, permits, waivers, approvals, authorizations or orders required to be obtained or made by the Parties in connection with the authorization, execution and delivery of this Agreement and the consummation of the transactions contemplated by this Agreement and (iii) make all necessary filings, and thereafter make any other required submissions, with respect to this transaction under (A) the Securities Exchange Act of 1934, as amended and the Securities Act of 1933, as amended, and the rules and regulations thereunder and any other applicable federal or state securities laws and (B) any other Applicable Law. The Parties hereto shall cooperate with each other in connection with the making of all such filings, including by providing copies of all such documents to the other Party's counsel (subject to appropriate confidentiality restrictions) prior to filing and, if requested, by accepting all reasonable additions, deletions or changes suggested in connection therewith. Without limiting the generality of the foregoing, each Party shall take or omit to take such action as the other Party shall reasonably request to cause the Parties to obtain any material Governmental Approvals and/or the expiration of applicable waiting periods, provided that the foregoing shall not obligate either Party to take or to omit to take any action (including, without limitation, the expenditure of funds or any holding separate and agreeing to sell or otherwise dispose of assets, categories of assets or businesses) as in the good faith opinion of such Party, would cause a material adverse effect on a Party. Section 16.11. EQUITABLE RELIEF. The Parties understand and agree that because of the difficulty of measuring economic losses to the non-breaching Party as a result of a breach of the 41 covenants set forth in this Article XVI, and because of the immediate and irreparable damage that may be caused to the non-breaching Party for which monetary damages would not be a sufficient remedy, the Parties agree that the non-breaching Party will be entitled to seek specific performance, temporary and permanent injunctive relief, and such other equitable remedies to which it may then be entitled against the breaching Party. This Article XVI shall not limit any other legal or equitable remedies that the non-breaching Party may have against the breaching Party for violation of the covenants set forth in this Article XVI. The Parties agree that the non-breaching Party shall have the right to seek relief for any violation or threatened violation of this Article XVI by the breaching Party from any court of competent jurisdiction in any jurisdiction authorized to grant the relief necessary to prohibit the violation or threatened violation of this Article XVI. This Article XVI shall apply with equal force to the breaching Party's Affiliates. ARTICLE XVII PRODUCT RECALL Section 17.01. PRODUCT RECALLS OR WITHDRAWAL. If at any time or from time to time any Competent Authority of any country requests a Party to recall the Product or if a voluntary recall of the Product is contemplated by either Party (collectively, a "Recall"), then the Party to whom such request is made or the Party contemplating such Recall, as the case may be, shall immediately notify the other Party. Neither Party shall carry out a voluntary Recall in the Territory without the prior written approval of the other Party, which approval shall not be unreasonably withheld, conditioned or delayed by either Party. Any Recall in the Territory shall be carried out by MediGene in as expeditious a manner as reasonably possible to preserve the goodwill and reputation of the Product and the goodwill and reputation of the Parties. MediGene shall in all events be responsible for conducting any Recall in the Territory, market withdrawals or corrections with respect to the Product in the Territory. MediGene shall maintain records of all sales and distribution of Product and customers sufficient to adequately administer a Recall, market withdrawal or correction for the period required by Applicable Law. Atrix shall be responsible, at its sole cost and expense, for conducting any Recall outside of the Territory and agrees to notify MediGene immediately if a Competent Authority outside of the Territory has requested a Recall or if Atrix is contemplating a voluntary Recall outside of the Territory; provided, however, that any such voluntary Recall shall be subject to Atrix's contractual obligations with Third Parties outside the Territory and, if Atrix is permitted to exercise discretion under such contractual obligations, Atrix shall consider the effect of such voluntary recall on the marketing and sale of the Product in the Territory. Section 17.02. RECALL COSTS. MediGene shall be responsible for conducting any Recall in the Territory and the cost and expense of a Recall shall be allocated as follows: (a) if such Recall is a voluntary Recall or shall be due to tampering or other cause, other than a manufacturer's defect, but not due to the negligence or misconduct of the Parties, or the breach by a Party of its warranties or obligations hereunder, then MediGene and Atrix shall [**] of the costs and expenses incurred by MediGene in - ---------- ** Confidential Treatment Requested. 42 connection with such Recall, including, without limitation, all product credits and returns, freight and shipping costs and product disposal expenses. In such event, Atrix agrees to pay MediGene within ten (10) days after its receipt from MediGene of any invoice(s) assessing Atrix [**] of these said costs, as listed above; (b) if such Recall shall be due to manufacturer's defect or the negligence or the breach by Atrix of its warranties or obligations hereunder or the misconduct of Atrix, all such costs and expenses shall be borne and paid solely by Atrix and Atrix will reimburse MediGene for any such costs and expenses paid by MediGene within ten (10) days of receipt of an invoice for such costs and expenses from MediGene, and if not so paid MediGene shall have the right to offset such amounts against amounts otherwise due by MediGene to Atrix hereunder; and (c) if such Recall is due to the negligence or the breach by MediGene of its warranties or obligations hereunder or the misconduct of MediGene, all such costs and expenses shall be borne and paid solely by MediGene and MediGene will reimburse Atrix for any such costs and expenses paid by Atrix within thirty (30) days of receipt of an invoice and appropriate documentation for such costs and expenses from Atrix. Section 17.03. NOTIFICATION OF COMPLAINTS. Each Party agrees that throughout the Term of this Agreement, and with respect to all Product or Demonstration Samples supplied and purchased under this Agreement, after the termination of this Agreement, it will (i) notify the other Party immediately of all available information concerning any complaint, product defect reports, and similar notices received by either Party with respect to the Product or Demonstration Samples, whether or not determined to be attributable to the Product or Demonstration Samples and (ii) with respect to an ADE, comply with the provisions of Section 10.04. MediGene, in consultation with Atrix, shall define and implement regulatory compliance procedures, including, without limitation, action plans and an SOP for product defect reporting and will handle all product complaints in the Territory. In connection with any such product complaint Atrix shall cooperate as reasonably requested by MediGene including performing any testing and follow-up investigations mutually agreed upon by the Parties. Section 17.04. NOTIFICATION OF THREATENED ACTION. Throughout the duration of this Agreement and with respect to all Product supplied and purchased under this Agreement, after the termination of this Agreement, each Party shall immediately notify the other Party of any information it receives regarding any threatened or pending action, inspection or communication by or from a concerned Competent Authority which may affect the safety or efficacy claims of the Product or the continued marketing of the Product. Upon receipt of such information, the Parties shall consult with each other in an effort to arrive at a mutually acceptable procedure for taking appropriate action. ARTICLE XVIII INSURANCE Section 18.01. INSURANCE. Each Party shall, at its sole cost and expense, obtain and keep in force sufficient comprehensive general liability insurance, including any applicable self- 43 insurance coverage, with bodily injury, death and property damage including contractual liability and product liability coverage. ARTICLE XIX TERM; DEFAULT AND TERMINATION Section 19.01. TERM. This Agreement shall commence as of the Effective Date and shall expire on a country-by-country basis on the expiration of the last applicable Atrigel(R) Patent Right, or any other patents obtained by Atrix with regard to the Product, in such country (the "Term"). Section 19.02. TERMINATION BY EITHER PARTY FOR CAUSE. Either Party may terminate this Agreement prior to the expiration of the Term upon the occurrence of any of the following: (a) Upon or after the cessation of operations of the other Party or the bankruptcy, insolvency, dissolution or winding up of the other Party (other than dissolution or winding up for the purposes or reconstruction or amalgamation); or (b) Upon or after the breach of any material provision of this Agreement by the other Party if the breaching Party has not cured such breach within sixty (60) days after written notice thereof by the non-breaching Party; provided, however, if any such breach relates solely to one or more Products, then the non-breaching Party may only terminate this Agreement to the extent it applies to such Product or Products and this Agreement shall remain in effect as it applies to all other Products. Section 19.03. TERMINATION BY ATRIX. Atrix may terminate this Agreement prior to the expiration of the Term with respect to any country in the Territory upon the occurrence of any of the following: (a) Upon the failure by MediGene to pay for fifteen (15) days from receipt of notice thereof from Atrix, pursuant to the terms of Section 20.08: (i) any Royalty payment, or portion thereof, pursuant to Section 4.02; (ii) any milestone payments, or portion thereof, pursuant to Section 4.03 or Section 4.04; or (iii) the Purchase Price due to Atrix under Section 8.01 of this Agreement; provided, however, that this subsection (a) shall not apply to any Royalty payment, or portion thereof, pursuant to Section 4.02, which is the subject of a good faith dispute (a "Disputed Amount") between MediGene and Atrix. Further, MediGene shall pay interest on any Disputed Amount at a rate equal to the Prime Rate of Interest to begin accruing on a daily basis from the date such payment was due and continuing until such payment is received by Atrix. Any Disputed Amount shall be resolved by the Parties within ninety (90) days from the date MediGene notifies Atrix of a good faith dispute; provided, however, if the Disputed Amount cannot be resolved to the mutual satisfaction of the Parties within such ninety (90) day period then either Party may request that the dispute be submitted to the Chief Executive Officers of Atrix and MediGene, respectively, for joint resolution. If the Disputed Amount is not jointly resolved by the Parties' respective Chief Executive Officers within ten (10) days from submission to the Parties' respective Chief Executive Officers then 44 Atrix shall be entitled to pursue any and all remedies at law available to it. In no event will the dispute resolution period exceed a maximum of one hundred (100) days unless otherwise agreed in writing by the Parties. Further, MediGene may in its discretion determine to pay any such Disputed Amount and in the event amounts are finally determined not to be due by MediGene, Atrix shall repay, without interest, such excess amounts determined not to be due; or (b) Upon the occurrence of any material misrepresentation or omission in any Royalty Statement, which misrepresentation or omission is caused by MediGene's willful misconduct, gross negligence or bad faith. Section 19.04. TERMINATION BY MEDIGENE. MediGene may terminate its license to the Product for a country in the Territory prior to the expiration of the Term in the event that MediGene determines in good faith that the Purchase Price for the Product is not commercially viable with respect to such country in the Territory in accordance with Section 8.02(b). Section 19.05. REMEDIES. All of the non-breaching Party's remedies shall be cumulative, and the exercise of one remedy hereunder by the non-defaulting Party shall not be deemed to be an election of remedies. These remedies shall include the non-breaching Party's right to sue for damages for such breach without terminating this Agreement. Section 19.06. EFFECT OF TERMINATION. (a) Subject to Section 19.06(d), upon termination of this Agreement by Atrix pursuant to Sections 19.02 or 19.03, (i) MediGene shall have no right to practice within the Atrigel(R) Patent Rights or use any of the Atrigel(R) Technology, (ii) all rights, title or interest in, or other incidents of ownership under, the Atrigel(R) Technology and the Marks shall revert to and become the sole property of Atrix, (iii) MediGene shall reimburse Atrix for costs and expenses reasonably incurred or committed to by Atrix prior to the effective date of such termination and for which MediGene is otherwise obligated to reimburse Atrix pursuant to this Agreement in connection with the activities performed by Atrix prior to the effective date of such termination consistent with the budget mutually agreed to by the Parties and approved by MediGene in accordance with Section 2.02, provided that Atrix shall use commercially reasonable efforts to minimize the such costs and expenses between the termination notice date and the date of termination, and (iv) MediGene shall grant to Atrix an irrevocable, non-exclusive, royalty-free license, with the right to sublicense, to the Clinical Documentation, the Results and the Marketing Authorizations and make any required filings with the Competent Authorities to the extent necessary and sufficient to market and sell the Product in the Territory. (b) Upon termination of this Agreement by MediGene pursuant to Section 19.02(a), MediGene shall receive an irrevocable, non-exclusive, royalty-free license, with the right to sublicense, to Manufacture, market, advertise, promote, distribute, offer for sale, sell and import the Product in the Territory. Upon termination of this Agreement by MediGene pursuant to Section 19.02(b), the following shall occur: (i) MediGene shall have no right to practice within the Atrigel(R) Patent Rights or use any of the Atrigel(R) 45 Technology, and (ii) all rights, title or interest in, or other incidents of ownership under, the Atrigel(R) Technology and the Marks shall revert to and become the sole property of Atrix. (c) Upon termination by Atrix under Sections 19.02 or 19.03 or by MediGene under Sections 19.02(b) or 19.04, the following shall occur: (i) Except as otherwise provided in this Agreement, all applicable licenses granted to MediGene shall terminate immediately, including the rights granted to MediGene pursuant to Sections 3.02 and 3.03, and MediGene shall have no further rights to the Product subject to MediGene's option to sell off existing inventory of Product and distribute existing inventory of Demonstration Samples for six (6) months after the termination date under subsection (ii) hereof, and MediGene shall not, either directly or indirectly, use or permit the use of the same or of the documentation relating to the Product, except to sell off existing inventory under subsection (ii) hereof; (ii) MediGene, at its option, may sell off any existing inventory of Product and utilize the Demonstration Samples during a period not to exceed six (6) months following such termination. If MediGene chooses this option, MediGene shall: (A) within thirty (30) days of issuance of a notice of termination by any Party, notify Atrix that it intends to sell off existing inventory of Product and utilize the Demonstration Samples as provided in this Agreement; (B) continue to comply with its payment obligations to Atrix under Article IV; (C) continue to sell off existing inventory of Product and utilize the Demonstration Samples for six (6) months after the notice of termination but at the expiration of the six (6) months, at Atrix's election, either (1) sell all existing inventory of Product and Demonstration Samples to Atrix or (2) destroy all remaining inventory of Product and Demonstration Samples in accordance with Applicable Law, providing Atrix with proof of destruction in writing sufficient to comply with Applicable Laws; provided that in either case, Atrix shall pay to MediGene, the full amount of the actual cost paid by MediGene to Atrix for such remaining inventory of Product and Demonstration Samples. If MediGene sells any inventory of Product or Demonstration Samples to Atrix pursuant to this subsection, it shall warrant that such inventory of Product and Demonstration Samples has been stored in compliance with all Applicable Laws, has not been adulterated and has otherwise been maintained according to the requirements of Applicable Laws and Marketing Authorizations; (D) if MediGene notifies Atrix that MediGene does not intend to sell off any existing inventory of Product and utilize the Demonstration Samples, MediGene shall, at Atrix's election, either (1) sell all existing 46 inventory of Product and Demonstration Samples to Atrix or (2) destroy all remaining inventory of Product and Demonstration Samples in accordance with Applicable Law, providing Atrix with proof of destruction in writing sufficient to comply with Applicable Laws; provided that in either case, Atrix shall pay to MediGene, the full amount of the actual cost paid by MediGene to Atrix, for such remaining inventory of Product and Demonstration Samples. If MediGene sells any inventory of Product or Demonstration Samples to Atrix pursuant to this subsection, it shall warrant that such inventory of Product and Demonstration Samples has been stored in compliance with all Applicable Laws, has not been adulterated and has otherwise been maintained according to requirements of Applicable Laws and Competent Authorities; and (E) any sales of Product or Demonstration Samples made by MediGene to Atrix pursuant to this Section 19.06 shall be made by MediGene within thirty (30) days of the end of the time period specified by Section 19.06(c)(ii) and shall be shipped to Atrix appropriately packaged and stored. All transportation costs in connection with such sale, including without limitation, insurance, freight and duties, shall be shared equally by MediGene and Atrix. Amounts owed by Atrix to MediGene pursuant to this Section 19.06(c) for the Product or Demonstration Samples shall be paid by Atrix within ten (10) days after receipt by Atrix of an appropriately detailed invoice from MediGene for the amount so owing to it by Atrix under this subsection. (d) Except as otherwise provided in this Agreement, expiration or termination of this Agreement shall not relieve the Parties of any obligation accruing prior to such expiration or termination. Except as set forth below or elsewhere in this Agreement, the obligations and rights of the Parties under Sections 3.04, 14.08, 14.09 and Articles XII, XV, XVII and XX and this Article IX shall survive expiration or termination of this Agreement. (e) Subject to the provision of Section 19.07, within thirty (30) days following the expiration or termination of this Agreement, each Party shall return to the other Party, or destroy, upon the written request of the other Party, any and all Confidential Information of the other Party in its possession and upon a Party's request, such destruction (or delivery) shall be confirmed in writing to such Party by a responsible officer of the other Party. Section 19.07. LICENSE FOLLOWING EXPIRATION. After expiration of the Royalty Term, and upon request by MediGene, Atrix shall continue to sell the Product to MediGene upon terms mutually agreeable to the Parties pursuant to a separate supply agreement to be negotiated in good faith between the Parties. 47 ARTICLE XX MISCELLANEOUS Section 20.01. NO-SOLICITATION. During the Term of this Agreement, neither Party nor its Affiliates (collectively, the "Initiating Group") shall, directly or through its representatives, solicit for employment or hire any officer, director or employee of the other Party or its subsidiaries or controlled Affiliates (collectively, the "Other Group") with whom the Initiating Group has contact in connection with, or who otherwise is known by the Initiating Group to participate in, the transactions contemplated by this Agreement. The Initiating Group shall not be precluded from hiring any such person who has been terminated by the Other Group prior to commencement of employment discussions between such person and the Initiating Group or its representatives. "Solicitation" shall not include any generalized public advertisement or any other solicitation by the Initiating Group or its representatives that is not specifically directed toward any such employee of the Other Group or toward any group of such employees of the Other Group. Section 20.02. COMMERCIALLY REASONABLE EFFORTS. Unless another standard is indicated in this Agreement, each Party shall use commercially reasonable efforts to perform its responsibilities under this Agreement. As used herein, the term "commercially reasonable efforts" means, unless the Parties agree otherwise, those efforts consistent with the exercise of prudent scientific and business judgment, as applied to other products of similar scientific and commercial potential within the relevant product lines of the Parties. Section 20.03. ASSIGNMENT. Except as expressly provided hereunder, neither this Agreement nor any rights or obligations hereunder may be assigned or otherwise transferred by either Party without the prior written consent of the other Party (which consent shall not be unreasonably withheld); provided, however, that either Party may assign this Agreement and its rights and obligations hereunder without the other Party's consent (a) in connection with the transfer or sale of all or substantially all of the business of such Party to which this Agreement relates to another Party, whether by merger, sale of stock, sale of assets or otherwise, or (b) to any Affiliate. Notwithstanding the foregoing, any such assignment to an Affiliate shall not relieve the assigning Party of its responsibilities for performance of its obligations under this Agreement. The rights and obligations of the Parties under this Agreement shall be binding upon and inure to the benefit of the successors and permitted assigns of the Parties. Any assignment not in accordance with this Agreement shall be void. Section 20.04. FORCE MAJEURE. Neither Party shall be held liable or responsible to the other Party nor be deemed to have defaulted under or breached this Agreement for failure or delay in fulfilling or performing any term of this Agreement when such failure or delay is caused by or results from causes beyond the reasonable control of the affected Party, including, but not limited to, fire, floods, embargoes, war, acts of war (whether war be declared or not), insurrections, riots, civil commotions, strikes, lockouts or other labor disturbances, acts of God or acts, omissions or delays in acting by any governmental authority or the other Party, or for any other reason which is completely beyond the control of the Party (collectively a "Force Majeure"); provided that the Party whose performance is delayed or prevented shall continue to 48 use good faith diligent efforts to mitigate, avoid or end such delay or failure in performance as soon as practicable. Section 20.05. GOVERNING LAW. This Agreement shall be governed by, and construed and enforced in accordance with, the laws of the State of Delaware, USA, except that no conflict of laws provision shall be applied to make the laws of any other jurisdiction applicable to this Agreement. Section 20.06. WAIVER. Except as specifically provided for herein, the waiver from time to time by either of the parties of any of their rights or their failure to exercise any remedy shall not operate or be construed as a continuing waiver of same or of any other of such Party's rights or remedies provided in this Agreement. Section 20.07. SEVERABILITY. In case any provision of this Agreement shall be invalid, illegal or unenforceable, the validity, legality and enforceability of the remaining provisions shall not in any way be affected or impaired thereby. Any provision of this Agreement held invalid or unenforceable in part or degree will remain in full force and effect to the extent not held invalid or unenforceable. Section 20.08. NOTICES. All notices, requests and other communications to any party hereunder shall be in writing and shall be deemed to have been given if delivered personally, mailed by certified mail (return receipt requested) or sent by cable, telegram or recognized overnight delivery service to the parties at the following addresses or at such other addresses as, specified by the parties by like notice: IF TO ATRIX: Atrix Laboratories, Inc. 2579 Midpoint Drive Fort Collins, CO 80525 Attn: Charles P. Cox, Ph.D., M.B.A. Vice President, New Business Development Telephone: (970) 482-5868 Facsimile: (970) 482-9735 COPIES TO: Morrison & Foerster LLP 5200 Republic Plaza 370 17th Street Denver, Colorado 80202-5638 Attn: Warren L. Troupe, Esq. Telephone: (303) 592-2255 Facsimile: (303) 592-1510 49 IF TO MEDIGENE: MediGene Aktiengesellschaft Lochhamer Strasse 11 D-82152 Planegg/Martinsried Germany Attn: Dr. Martin Poehlchen Vice President of Business Development Telephone: 011-49-89-8956-320 Facsimile: 011-49-89-8956-3220 Notice so given shall be deemed given and received (i) if by international mail on the seventh (7th) day after posting; (ii) by cable, telegram, telex or personal delivery on the date of actual transmission, with evidence of transmission acceptance, or (as the case may be) personal or other delivery; and (iii) if by international courier, on the fourth (4th) business day following the day such notice is delivered to the international courier service, or such earlier delivery date as may be confirmed to the sender by such courier service. Section 20.09. INDEPENDENT CONTRACTORS. It is expressly agreed that Atrix and MediGene shall be independent contractors and that the relationship between the two Parties shall not constitute a partnership or agency of any kind. Neither Atrix nor MediGene shall have the authority to make any statements, representations or commitments of any kind, or to take any action, which shall be binding on the other Party, without the prior written consent of the other Party. Section 20.10. RULES OF CONSTRUCTION. The Parties hereto agree that they have been represented by counsel during the negotiation and execution of this Agreement and, therefore, waive the application of any law, regulation, holding or rule of construction providing that ambiguities in an agreement or other document will be construed against the Party drafting such agreement or document. Whenever the context hereof shall so require, the singular shall include the plural, the male gender shall include the female gender and neuter, and vice versa. Section 20.11. PUBLICITY. MediGene and Atrix shall consult with each other before issuing any press release with respect to this Agreement or the transactions contemplated hereby and neither shall issue any such press release or make any such public statement without the prior consent of the other, which consent shall not be unreasonably withheld; provided, however, (a) that a Party may, without the prior consent of the other Party, issue such press release or make such public statement as may upon the advice of counsel be required by law or the rules and regulations of the Nasdaq or any other stock exchange, or (b) if it has used reasonable efforts to consult with the other Party prior thereto, (such consent shall be deemed to have been given if the recipient of the press release or public statement fails to respond to the other Party within forty-eight (48) hours after the recipient's receipt of such press release or public statement). No such consent of the other Party shall be required to release information which has previously been made public. Section 20.12. ENTIRE AGREEMENT; AMENDMENT. This Agreement (including the Exhibits attached hereto) sets forth all of the covenants, promises, agreements, warranties, representations, conditions and understandings between the parties hereto with respect to the subject matter hereof and supersedes and terminates all prior agreements and understandings 50 between the Parties. There are no covenants, promises, agreements, warranties, representations conditions or understandings, either oral or written, between the parties other than as set forth herein. No subsequent alteration, amendment, change or addition to this Agreement shall be binding upon the Parties hereto unless reduced to writing and signed by the respective authorized officers of the Parties. Section 20.13. HEADINGS. The captions contained in this Agreement are not a part of this Agreement, but are merely guides or labels to assist in locating and reading the several articles hereof. Section 20.14. COUNTERPARTS. This Agreement may be executed in two or more counterparts, each of which shall be deemed an original, but all of which together shall constitute one and the same instrument. IN WITNESS WHEREOF, the Parties hereto have caused this Agreement to be executed in duplicate by their duly authorized officers as of the Effective Date. ATRIX LABORATORIES, INC., MEDIGENE AKTIENGESELLSCHAFT a Delaware corporation a German corporation By: /s/ David R. Bethune By: /s/ Peter Heinrich --------------------------------- ------------------------------------ Name: David R. Bethune Name: Dr. Peter Heinrich Title: Chairman and Chief Executive Title: Vorstandsvorsitzender Officer 51 EXHIBIT A ATRIGEL(R) PATENT RIGHTS [**] - ---------- ** Confidential Treatment Requested. A-1 EXHIBIT B FORM OF CERTIFICATE OF COMPLIANCE Issue Date: ____________________ CERTIFICATE OF COMPLIANCE FOR ____________________________________________________________________________ CUSTOMER _______________________________________________________________________ LOT NUMBER ________________________________________________________________ FILL DATE ___________________________ PREP/EX DATE ___________________________ DOSAGE _________________________________________________________________________ QUANTITY OF RELEASABLE VIALS ___________________________________________________ The batch production record for this product has been reviewed for accuracy, completeness, and compliance with established written standard procedures and in accordance with cGMP requirements. Any deviations/abnormal occurrences from the aforementioned requirements have been appropriately documented, reviewed, and approved. Reviewed By: ---------------------------------------- Batch Record Auditor Date: ------------------------------- Approved By: ---------------------------------------- Acting Supervisor Manager, Documentation Date: ------------------------------- cc: All Customers B-1 EXHIBIT C [**] (see attached) - ---------- ** Confidential Treatment Requested. C-1 EXHIBIT D FORM OF STOCK PURCHASE AGREEMENT (See Exhibit 99.2 of Form 8-K filed with the SEC on June 19, 2001 by Atrix Laboratories, Inc.) D-2 EXHIBIT E [**] (see attached) - ---------- ** Confidential Treatment Requested. E-1 EXHIBIT F MEDIGENE'S SOP** (see attached) - ---------- ** Confidential Treatment Requested. F-1 EXHIBIT G DRUG DELIVERY COMPETITORS [**] - ---------- ** Confidential Treatment Requested. 1 CONFIDENTIAL TREATMENT REQUESTED BY QLT INC. I. AMENDMENT OF THE COLLABORATION, LICENSE AND SUPPLY AGREEMENT EFFECTIVE APRIL 4, 2001 (THE "AGREEMENT") BETWEEN ATRIX LABORATORIES, INC. ("ATRIX") AND MEDIGENE AKTIENGESELLSCHAFT ("MEDIGENE") CONCERNING AE EXCHANGE As provided by Section 20.12 of the Agreement, Atrix and MediGene with effect as of September 12, 2002 amend the Agreement as set out below: Section 10.04 of the Agreement as currently in effect is deleted and replaced by the following: "Section 10.04 ADVERSE EVENT REPORTING AND PHASE IV SURVEILLANCE. (a) In order to enable MediGene to meet its legal requirements regarding adverse event reporting, Atrix shall collect from all of its license partners other than MediGene having a license for the Product any safety information (the "Safety Information"). The term "Safety Information" shall be including, but not limited to (i) all serious adverse events (as defined by ICH E2A) ("SAE") known from all sources (spontaneous reporting, clinical studies, literature, regulatory authorities and compassionate use) and (ii) all non serious adverse reactions from spontaneous reporting and literature. Any such Safety Information shall be submitted to MediGene in the form developed by the Council for International Organizations of Medical Sciences standard ("CIOMS Form") by fax. The Parties will, by separate mutual written agreement, define further requirements for the data and information which shall be given by Atrix in the CIOMS Form. The Safety Information provided in the CIOMS Form shall be transmitted to MediGene (i) within [**] calendar days in case of SAE, and (ii) in all other cases not regarding any SAE, within [**] calendar days after first knowledge of the respective license partner about the Safety Information. All Safety Information to be sent to MediGene shall be sent attention to the pharmacovigilance officer of MediGene. MediGene shall have the right to ask Atrix for additional information about these reports. The queries will be sent to Atrix by e-mail or fax; Atrix shall answer within [**] calendar days. Atrix shall ensure, that the requested information or any other follow-up information will be included into the CIOMS Form by the respective license partner within [**] calendar days after first knowledge of the additional information by the respective license partner. In case license partners conduct clinical trials with regard to the Product, Atrix shall ensure that the respective license partner will without delay provide Atrix with lists containing non serious adverse events from the clinical studies every three months. Atrix will forward these lists to MediGene within reasonable time. In case Atrix exercises its rights to co-market the Product within the Territory pursuant to Section 13.01 of the Agreement, Atrix shall have the same responsibility as the other license - ---------- ** Confidential Treatment Requested. 1 partners to provide Safety Information, including lists on non serious adverse events from clinical studies with regard to the Product marketed by Atrix. If Atrix exercises its right to co-market as set forth in Section 13.01 then, upon the occurrence of any adverse event relevant for reporting as Safety Information according this provision (an "AE"), the Parties shall promptly meet in person or by telephone, as appropriate, to discuss and determine how to mutually handle and resolve any issues relating to or arising from any such AE. (b) In order to enable Atrix to meet its legal requirements regarding adverse event reporting, MediGene shall report to Atrix any Safety Information related to the use of the Product in the Territory and known to MediGene, including, but not limited to (i) all SAE known from all sources (spontaneous reporting, clinical studies, literature, regulatory authorities and compassionate use) and (ii) all non serious adverse reactions from spontaneous reporting. Any such Safety Information shall be submitted by MediGene to Atrix in a CIOMS Form by fax. The Safety Information provided in a CIOMS Form shall be transmitted to Atrix (i) in case of SAE within [**] calendar days, and (ii) in all other cases not regarding SAE, within [**] calendar days, after first knowledge about the Safety Information. All Safety Information to be sent to Atrix shall be sent attention to the pharmacovigilance officer of Atrix. Atrix will have the right to ask MediGene for additional information about these reports. The queries will be sent to MediGene by e-mail; MediGene will answer within [**] calendar days. MediGene shall ensure, that the requested information or any other follow-up information will be included into the CIOMS Form within [**] calendar days after first knowledge of the additional information. (c) If the report of an AE causes a Competent Authority to request labeling revision as a result of an AE or that a Phase IV surveillance program be conducted, then the Parties shall promptly enter into discussions and shall mutually agree on all of the material terms and conditions of such labeling revision or Phase IV surveillance program; provided, however the costs of such labeling revision or Phase IV surveillance program shall be borne [**] by MediGene and [**] by Atrix. MediGene shall have the authority to make the final decision with regard to any labeling revisions provided that MediGene will consider, in making its decision, the effect any such labeling revisions will have on the marketing and sale of the Product outside the Territory. MediGene agrees that should Applicable Laws require that any such interim data and results from such Phase IV surveillance programs be prepared in written form, MediGene shall comply with such requirements and provide all such information in writing to MediGene and the Competent Authorities in accordance with Applicable Laws. MediGene further agrees that Atrix shall have the right to incorporate, refer to and cross-reference such results and underlying data in any regulatory filing or any other filing or requirement Atrix is required to undertake with respect to the Product. Atrix agrees that MediGene shall have the right to incorporate, refer to and cross-reference such results and underlying data in any regulatory filing or any other filing or requirement MediGene is required to undertake with respect to the Product in the Territory." The Agreement remains otherwise unaltered. - ---------- ** Confidential Treatment Requested. 2 IN WITNESS WHEREOF, the parties have executed this amendment to the Agreement as of the date first above written. ATRIX LABORATORIES, INC. MEDIGENE AG a Delaware corporation a German corporation By: /s/ Charles P. Cox By: /s/ Peter Heinrich --------------------------------- ------------------------------------ Name: Charles P. Cox, Phd, MBA Name: Dr. Peter Heinrich Title: SVP, Corporate Development Title: CEO MEDIGENE AG a German corporation By: ------------------------------------ Name: ---------------------------------- Title: -------------------------------- 3 CONFIDENTIAL TREATMENT REQUESTED BY QLT INC. SECOND AMENDMENT TO COLLABORATION, LICENSE AND SUPPLY AGREEMENT This Second Amendment to Collaboration, License and Supply Agreement (this "Second Amendment"), is made by and between Atrix Laboratories, Inc., a Delaware corporation having offices at 2579 Midpoint Drive, Fort Collins, CO, 80525-4417 ("Atrix"), and MediGene AG, a German corporation having offices at Lochhamer Strasse 11, Planegg/Martinsried, Germany ("MediGene") as of this 22nd day of December, 2003. Atrix and MediGene are sometimes referred to collectively herein as the "Parties" or singly as a "Party." WHEREAS, the Parties entered into that certain Collaboration, License and Supply Agreement dated as of April 4, 2001, as subsequently amended by that certain First Amendment to Collaboration, License and Supply Agreement and Stock Purchase Agreement effective as of September 12, 2002 (collectively, the "Agreement"); and WHEREAS, MediGene intends to grant a sublicense under the Agreement to YAMANOUCHI U.K. Limited and to enter into a Distribution, Sublicense and Supply Agreement in connection therewith; and WHEREAS, the Parties therefore desire to further amend the Agreement as set forth herein. NOW, THEREFORE, in consideration of the mutual covenants and agreements set forth in the Agreement and as hereinafter set forth, and other good and valuable consideration, the receipt and sufficiency of which is hereby acknowledged, the Parties agree as follows: 1. The definition of each of "cGMP", "First Commercial Sale", "Governmental Approval", "Marketing Authorization", "Net Sales", "Royalty Term", and "Territory" in Article I of the Agreement is hereby deleted in its entirety and replaced with the following: "cGMP" means according to and in compliance with each of the highest standards contained within the Pharmaceutical Inspection Convention and those issued by the EFTA Secretariat Geneva and GMP requirements defined in the EC Rules Governing Medicinal Products in European Community Volume IV (as each of these may be supplemented, amended, updated, revised or replaced from time to time)." "First Commercial Sale" means (a) with respect to a country in the Territory, the first sale for use, consumption or resale of each Product by MediGene or YAMANOUCHI or its sublicensees in such country and (b) with respect to the Territory, the First Commercial Sale in any country within the Territory. A sale to an Affiliate shall not constitute a First Commercial Sale unless the Affiliate is the end user of the Product." "Governmental Approval(s) " means all permits, licenses and authorizations, including but not limited to, import permits, Marketing Authorizations, and Pricing and Reimbursement Approvals required by any Competent Authority as a prerequisite to the Manufacture, packaging, marketing or selling of the Product or the Units." 1 "Marketing Authorization" means all necessary and appropriate regulatory approvals, including but not limited to, variations thereto, to put the Product on the market in a particular country in the Territory." "Net Sales" means the [**]. Components of Net Sales shall be determined in the ordinary course of business in accordance with historical practice and using the accrual method of accounting in accordance with GAAP. In the event MediGene or its Affiliates or YAMANOUCHI or its Affiliates, subcontractors or sublicensees transfers Product to a Third Party in a bona fide arm's length transaction, for consideration, in whole or in part, other than cash or to a Third Party in other than a bona fide arm's length transaction, the Net Sales price for such Product shall be deemed to be the standard invoice price then being invoiced by MediGene or its Affiliates or YAMANOUCHI or its Affiliates, subcontractors or sublicensees in an arm's length transaction with similar customers. In the event that MediGene or its Affiliates or YAMANOUCHI or its Affiliates, subcontractors or sublicensees includes one or more Product as party of a bundle of products, MediGene agrees not to, and agrees to cause its Affiliates, YAMANOUCHI and YAMANOUCHI's Affiliates, subcontractors and sublicensees not to, offer or sell any such Product as a loss leader (i.e. sold at less than the invoice price at which any such Product is sold when not part of a bundle of products) in determining the price of the bundled products." "Royalty Term" means the period of time commencing on the First Commercial Sale of each Product in any country in the Territory and [**]." "Territory" means Albania, Andorra, Armenia, Austria, Azerbaijan, Belarus, Belgium, Bosnia and Herzegovina, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Georgia, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Monaco, Netherlands, Norway, Poland, Portugal, Republic of Moldova, Romania, Russian Federation, San Marino, Slovakia, Slovenia, Spain, Sweden, Switzerland, The former Yugoslav Republic of Macedonia, Turkey, Ukraine, United Kingdom, the Vatican City and Yugoslavia." 2. The following new definitions are hereby inserted into Article I of the Agreement in alphabetical order: "Financial Year" means the financial year being each twelve month period commencing on April 1 and ending on March 31." "Non-Major Country" or "Non-Major Countries" means individually or collectively, as the case may be, the countries in the Territory excluding the Major Countries." "[**] ""Valid Claim" means a claim of an issued, unexpired patent which has not been: (a) held invalid or unenforceable by a final decision of a court or governmental agency of competent jurisdiction within the Territory, which decision is unappealable or was not appealed within the time allowed, or - ---------- ** Confidential Treatment Requested. 2 (b) admitted in writing to be invalid or unenforceable by the holder(s) by disclaimer or otherwise provided that the holder(s) shall have thirty (30) days from notice by MediGene or its sublicensees of such admission and MediGene's reliance, or the sublicensees' reliance respectively, on this clause to remedy any effects caused by such admission." 3. The following is hereby inserted as new Section 2.03: "Section 2.03 [**]. 4. Section 2.03 of the Agreement, as existing prior to this Second Amendment, is hereby renumbered as Section 2.04, deleted in its entirety and replaced with the following: "Section 2.04. COMMERCIALIZATION. Subject to the terms and conditions of this Agreement, MediGene, at its own expense, will be responsible for (a) conducting all market research related to the Product; and (b) commercialization of the Product in the Territory (including all sales and marketing activities related to the Product). Subject to Section 3.02(d), MediGene or its sublicensees will obtain and maintain Governmental Approvals in the Territory and pay all duties, fees, tariffs and similar obligations required to market the Product in each country in the Territory, [**]. With respect to countries [**], MediGene shall use its commercially reasonable efforts to obtain and maintain Governmental Approvals for those Product(s) MediGene or its sublicensees elects to market in such countries. Subject to Section 2.02(a), Atrix shall, at MediGene's expense, provide MediGene and its sublicensees with commercially reasonable assistance in respect of MediGene's and such sublicensee's applications and maintenance of Governmental Approvals." 5. Section 2.04 of the Agreement is hereby renumbered as Section 2.05. 6. Section 3.02(d) of the Agreement is hereby deleted in its entirety and replaced with the following: "[**]". (i) With respect to countries that are part of the [**], MediGene shall be [**]. MediGene shall keep Atrix informed of all material activities regarding the launch, approval and Marketing of Product in such countries, notably of all applications for Marketing Authorizations, and of its intent to start Marketing and Distribution in such countries in order to allow Atrix sufficient time to reasonably comply with its obligations in respect of supply of Product under this Agreement. (ii) With respect to a country (A) that is part of [**], and (B) in which a Marketing Authorization is needed for launch of Product(s) but a Pricing and Reimbursement Approval is not reasonably required for the successful and financially sound launch as set out in Exhibit H (which Exhibit may be amended upon notice by MediGene if there is a change in Applicable Law), Section 3.02(d)(iv) shall apply, whereby the relevant date for - ---------- ** Confidential Treatment Requested. 3 the calculation of time in (iv) below ("Trigger") shall be [**]. (iii) With respect to a country (A) that is part of the Territory [**], and (B) in which both a Marketing Authorization is needed and a Pricing and Reimbursement Approval is reasonably required for the successful and financially sound launch of Product(s) as set out in Exhibit H (which Exhibit may be amended upon notice by MediGene if there is a charge in Applicable Law), the following shall apply: (I) No later than [**] after notice of grant of the Marketing Authorization and the Pricing and Reimbursement Approval in a country is received by MediGene, MediGene shall in its sole discretion decide whether to launch (the "Positive Launch Decision") or not to launch (the "Negative Launch Decision") such Product in such country (the Positive Launch Decision and the Negative Launch Decision hereinafter individually also being referred to as the "Launch Decision"), and shall notify Atrix in writing of such Launch Decision. If Atrix has not received a written notification of a Negative Launch Decision with respect to a Product for a specific country within [**] after notice of grant of both the Marketing Authorization and the Pricing and Reimbursement Approval in such country is received by MediGene, MediGene shall be deemed to have notified Atrix of a Positive Launch Decision with regard to such Product and such country on the business day immediately following expiry of such [**] period. MediGene shall make any Launch Decision by assessing, in good faith, the case for or against launching the respective Product in the respective country, such assessment taking into account the following: [**]. Where a Negative Launch Decision has been notified to Atrix MediGene shall provide Atrix within [**] of the expiry of the [**], and subject to obligations of confidentiality reasonably acceptable to MediGene, copies of all relevant information and documents on which the Negative Launch Decision was made. (II) In case of a Negative Launch Decision Atrix shall be entitled to request that such Negative Launch Decision be assessed by an independent expert Third Party appointed by MediGene and acceptable to Atrix (the "Independent Assessor"), such request to be made in writing delivered to MediGene no later than [**] after receipt of the respective Negative Launch Decision by Atrix. The Independent Assessor shall assess the Negative Launch Decision of MediGene within reasonable time and shall promptly and simultaneously notify Atrix and MediGene of the result in writing of this assessment. The Independent Assessor shall assess the Negative Launch Decision impartially having regard to and considering the criteria referred to above under Section 3.02(d)(iii)(I). (III) If the Independent Assessor determines that the Negative Launch Decision of MediGene is on balance correct, or if Atrix does not exercise its right to request an assessment of the Negative Launch Decision by an Independent Assessor within [**] after receipt of the Launch Decision by Atrix, then MediGene shall no longer be obliged, but shall remain exclusively entitled, to launch the respective Product in the respective country. - ---------- ** Confidential Treatment Requested. 4 (IV) In case of a Positive Launch Decision, Section 3.02(d)(iv) shall apply, whereby the relevant date for the calculation of time in (iv) below ("Trigger") shall be the date the Positive Launch Decision is either made or deemed to be made by MediGene. (V) If the Independent Assessor notifies MediGene of his determination that the Negative Launch Decision of MediGene is not correct, Section 3.02(d)(iv) shall apply, whereby the relevant date for the calculation of time in (iv) below ("Trigger") shall be the date of [**]. (iv) If MediGene has not undertaken commercially reasonable efforts to begin Distribution and Marketing of the Product (A) in a Major Country within [**] following the Trigger, as defined above, for the Product in that Major Country and (B) in a Non-Major Country within [**] following the Trigger, as defined above, for the Product for that Non-Major Country; provided that in each case of (A) and (B) above Atrix and MediGene have available and have delivered (and YAMANOUCHI having ordered) Launch Quantities of the Product, then, and at any time such event occurs, and upon each such occurrence, the following shall occur with respect to that Product not so distributed and marketed, in that Major Country within such [**] or, as the case may be, in that Non-Major Country within such [**]: (I) Atrix shall have the right upon [**] written notice to MediGene to terminate the Agreement with respect to that Product in that specific country and, upon such termination, such country shall no longer be included in the Territory for such Product, and (II) Atrix shall have the right to grant a license to a Third Party to market and distribute that Product in such country, provided that the terms of such license are no more favorable to the Third Party, in any material respect, than those set forth in this Agreement, and subject to adjustments to reflect the fact that the licensee under such licenses will not have the right to market and distribute the Product in the entire Territory; and (III) MediGene shall, or shall procure that YAMANOUCHI and its sublicensees will: (1) promptly transfer to Atrix the Marketing Authorizations, and other Governmental Approvals where applicable, relating to such Product in such country and (2) make any mandatory filings with Competent Authorities in respect thereof, and (3) grant to Atrix an irrevocable, non-exclusive, royalty-free license, with the right to sublicense, to use any Clinical Documentation to the extent necessary and sufficient for Atrix, its Affiliates and sublicensees to use the Governmental Approvals and to market and distribute such Product in such country. (v) For the avoidance of doubt, notwithstanding the foregoing, MediGene shall in no event be entitled to unreasonably refrain from or delay any submission for any Marketing Authorization or Pricing and Reimbursement Approval for the Product(s). (vi) The rights and obligations under this Section 3.02(d) shall be cumulative with the other rights and obligations under this Agreement and shal1 not apply with respect to any - ---------- ** Confidential Treatment Requested. 5 country [**]." 7. The following is hereby added to the Agreement as new Section 3.02(e): "(e) Sublicense to YAMANOUCHI. It is agreed that MediGene may grant a sublicense under the Atrigel(R) Technology and the Atrix Marks to YAMANOUCHI U.K. Limited ("YAMANOUCHI") in accordance with a Distribution, Sublicense and Supply Agreement substantially in the form attached hereto as Exhibit I (the "Sublicense"). Neither Party shall be entitled to terminate this Agreement under Section 19.02(b) due to the other Party's failure to comply with the terms of this Agreement if such failure is caused by a conflict between the terms and conditions of the Sublicense and this Agreement that makes it impossible for such Party to perform its obligations under this Agreement (the "Conflict"); provided that notwithstanding the foregoing, a Party's right to terminate this Agreement pursuant to its terms and conditions if the other Party does not comply with its financial obligations under this Agreement shall not be excluded or otherwise affected by this provision. In the event that after the date of execution of the Sublicense a Party determines that there is a Conflict, such Party shall provide written notice of such occurrence to the other Party and the Parties will attempt to negotiate in good faith an amendment to this Agreement so that no such Conflict exists. If such amendment is not executed within thirty (30) days following a Party's receipt of such notice the Parties will have all of their respective rights and obligations under this Agreement, except for the right to terminate this Agreement pursuant to Section 19.02(b); provided that notwithstanding the foregoing, a Party's right to terminate this Agreement pursuant to its terms and conditions if the other Party does not comply with its financial obligations under this Agreement shall not be excluded or otherwise affected by this provision. 8. Section 3.03 of the Agreement is hereby renumbered as Section 3.03(a) and the following is hereby added as a new Section 3.03(b): "(b) Without the prior written consent of Atrix, MediGene shall market and distribute the Products in the Territory under the Atrix Marks. Notwithstanding the foregoing, MediGene shall be entitled, without the consent of Atrix, to market and distribute the Product under a YAMANOUCHI Trade Mark rather than an Atrix Mark if an objection to the use of an Atrix Mark has been lawfully raised by (i) a Competent Authority in the Territory; or (ii) a Third Party with enforceable trade mark rights having seniority to those of the Atrix Marks." 9. Section 3.04(b) of the Agreement is hereby deleted in its entirety and the following are hereby added as Sections 3.04(b), 3.04(c), 3.04(d) and 3.04(e): "(b) All right, title and interest in and to any developments, inventions or discoveries made in connection with any leuteinizing hormone releasing hormone (LHRH) or a structurally related derivative or structurally related analog thereof, whether agonist or antagonist, whether naturally-occurring or synthetic, used for treatments outside the Field, which do not relate to the Atrigel(R) Technology or the Product, but are specifically only made during and as a direct result of either MediGene's or YAMANOUCHl's or other sublicensee's work in connection with this - ---------- ** Confidential Treatment Requested. 6 Agreement, shall be jointly owned by Atrix, MediGene, and YAMANOUCHI or the applicable sublicensee, including any patentable inventions (the "Program Technology"). (c) Subject to Section 3.04(e), each of Atrix and MediGene grant to the other and to YAMANOUCHI, and MediGene shall procure that YAMANOUCHI and any other sublicensee, grants to Atrix a non-exclusive, irrevocable, worldwide, royalty-free, perpetual license, including the right to grant sublicenses to Affiliates, to make and use the Program Technology for all research purposes (consistent with the purpose and intent of this Agreement) other than the sale or manufacture for sale of products or processes; provided that if any Party desires to provide a Third Party a sublicense to manufacture, use, market or sell any product based on the Program Technology, then such Party shall grant to the other Party a right of first negotiation according to Section 3.04(d) with respect to such product. (d) For a period of thirty (30) days following the receipt of notice from any Party (the "Notifying Party") of its intention to grant a sublicense as set out in Section 3.04(c), the other Party(ies) (the "Notified Party") shall have the first right to negotiate binding material terms for a definitive license agreement for such a product. In the event (i) the Notified Party does not determine within such thirty (30) day period to pursue a license for such a product, or (ii) the Parties are unable to reach agreement on binding material terms of such a license within such thirty (30) day period, or (iii) if the Parties have reached agreement on binding material terms of such a license within such thirty (30) day period, but are unable to enter into a definitive agreement within ninety (90) days following the written notice from the Notifying Party, which period may be extended upon the mutual agreement of the Parties, the Notifying Party shall have no further obligation to the Notified Party under this Section 3.04(d. If the Parties cannot agree to the terms of such license, then the Notifying Party may enter into an agreement with a Third Party, provided that the terms of the agreement are no more favorable to the Notifying Party, in any material respect (individually or in the aggregate), than those last proposed in writing by the Notified Party. The rights of Notified Party under this Section 3.04(d) shall be limited to those countries in the Territory for which Notified Party retains a license under this Agreement as of the date written notice is received under this Section 3.04(d) by either Party, as applicable. If Notifying Party enters into an agreement with a Third Party under this Section 3.04(d), Notifying Party shall notify Notified Party of this fact within four (4) weeks after the date the agreement is entered into. Notified Party shall then have the right to appoint an appropriate independent person, reasonably acceptable to Notifying Party, having sufficient experience in licensing matters, which person shall execute a confidentiality agreement in such form as is reasonably satisfactory to Notifying Party, to examine the terms and conditions of such agreement to determine that the terms thereof are no more favorable to Notifying Party, in any material respect (individually or in the aggregate), than those last proposed in writing by Notified Party. Such determination shall be made within six (6) weeks after the date Notifying Party provides notice to Notified Party that it has entered into such an agreement with a Third Party. In the event the terms are more favorable to Notifying Party then the Notifying Party shall terminate the Third Party license immediately. (e) Any developments, inventions or discoveries made in connection with any leutenizing hormone releasing hormone ("LHRH") or a structurally related derivative or structurally related analog thereof, whether agonist or antagonist, whether naturally-occurring or synthetic, used for treatments outside the Field, which do not relate to the Atrigel@ Technology or the Product, but which were made during and as a direct result of either MediGene's or Atrix's work in 7 connection with the License ("Head-License Technology") shall be jointly owned by Atrix, MediGene and YAMANOUCHI and will be subject to the obligations of Sections 3.04, 11.01(c) and 11.02(b) as if it were included in the definition of Program Technology and in respect of Sections 3.04, 11.0l(c) and 11.02(b), subject to that certain Tripartite Agreement between Atrix, MediGene and YAMANOUCHI dated as of the effective date of the Sublicense. (i) The definition of Party and Parties in this Section 3.04 shall include, where appropriate, Atrix, MediGene and YAMANOUCHI or other applicable sublicensee. (ii) Notified Party as defined under Section 3.04(d) shall be capable of being both singular and plural." 10. Section 4.03 of the Agreement is hereby deleted in its entirety and replaced with the following: "Section 4.03. MILESTONE PAYMENTS. MediGene shall pay to Atrix, as licensing fees, the following milestone payments within thirty (30) days after Atrix gives notice to MediGene of the occurrence of the specified milestone event: (a) [**]; (b) [**]; (c) [**]; (d) [**]; (e) [**]; and (f) [**]. (g) [**]. (h) For the avoidance of doubt, the milestone payments referred to in this Section 4.03 (a) to (g) shall be paid only once by MediGene." 11. Sections 6.01(a) and 6.01(c) are hereby deleted in their entirety and replaced with the following: "(a) MediGene agrees to use, and to procure that YAMANOUCHI or any other sublicensees will use, commercially reasonable efforts to promote the sale, marketing and distribution of the Product in the Territory, consistent with accepted business practices devoting the same level of efforts as it devotes to its own products of comparable market potential. "Comparable market potential" shall be fairly determined by MediGene in good faith and shall be based upon market size, price, present and future competition and general marketing parameters. Each Party shall promptly advise the other Party, and MediGene will ensure that YAMANOUCHI or any other sublicensees shall promptly advise the Parties, of any issues that materially and adversely affect - ---------- ** Confidential Treatment Requested. 8 its ability to market the Product in the Territory. In such event, senior executives of MediGene, YAMANOUCHI or any other sublicensees and Atrix shall meet and in good faith discuss what actions should be taken in light of such issues. (c) MediGene shall have the right to designate all packaging design and/or trade dress for the marketing and distribution of the Product in the Territory. Such packaging design and/or trade dress shall (i) for all Products name MediGene, or its sublicensees if requested by MediGene, as the holder of the Marketing Authorization, and shall (ii) be in compliance with the Packaging Specifications and all Applicable Laws, and shall (iii) be subject to prior approval by Atrix, such approval not being unreasonably withheld or delayed. Atrix shall package and label the Product, the Units and the Demonstration Samples in compliance with the Packaging Specifications and Applicable Laws. Atrix, in consultation with MediGene, shall be responsible for assuring that such packaging and labeling conform with all Applicable Laws, if any, of the FDA for export of the Product and the Demonstration Samples into the Territory and that the Units comply with the Packaging Specifications. Atrix, in consultation with MediGene, shall also be responsible for assuring that packaging and labeling comply with all Applicable Laws where such Product is to be distributed for sale in the Territory. All additional incremental costs resulting from changes to the Packaging Specifications made at the request of MediGene that are not required to export or import the Product to countries in the Territory on a country by country basis under Applicable Laws shall be borne by MediGene. Lead time to implementation of changes at Atrix's or Second Manufacturing Source's manufacturing facility (as the case may be) shall not be more than four (4) months after MediGene's approval of final designs." 12. Section 6.01(f) of the Agreement is hereby deleted in its entirety and replaced with the following: "(f) Co-Promotional Activities of Atrix. When MediGene or YAMANOUCHI or any other sublicensee for a Major Country decides to use a contract sales force to promote Product on behalf of MediGene, YAMANOUCHI or any other sublicensee, respectively, then MediGene will promptly inform Atrix of such decision. Atrix will then have the right to bid within 20 days from receipt of MediGene's decision, or YAMANOUCHl's or any other sub1icensee, respectively, decision to provide the contract sales force support MediGene, or YAMANOUCHI or any other sublicensee, wishes to use and Atrix and MediGene will, or MediGene shall procure that YAMANOUCHI or any other sublicensee will, discuss such bid in good faith. MediGene or YAMANOUCHI or any other sublicensee can decide in their sole discretion whether or not to accept the bid." 13. The following is inserted as new Section 6.02: "Section 6.02 A&S spending levels No later than [**] days prior to the expected date of the First Commercial Sale in any Major Country and prior to the commencement of each Financial Year thereafter, MediGene and Atrix shall agree on the Annual Performance Guidelines for the - ---------- ** Confidential Treatment Requested. 9 succeeding Financial Year for the sale, marketing and distribution of the Product in the Territory. MediGene shall, and shall procure that YAMANOUCHI or any other sublicensee will, provide Atrix with a detailed proposal for the Annual Performance Guidelines no later than [**] days prior to the aforementioned expected date of First Commercial Sale. The Annual Performance Guidelines shall set forth the following on a Product-by-Product and country-by-country basis: (a) the required A&S spending levels for the year, which amounts shall be determined in accordance with Section 16.04; and (b) the minimum sales targets for each Product in each country in the Territory [**] with respect to each Major Country, or, with respect to non-Major Countries in the Territory, on an aggregate basis for all such non-Major Countries, both in number of Units and in aggregate Net Sales (the "Annual Sales Targets") (collectively, the "Annual Performance Guidelines"). MediGene agrees, and shall cause YAMANOUCHI or any other sublicensee to provide, that the Annual Performance Guidelines shall not be changed without the prior written consent of Atrix." 14. Section 7.01 of the Agreement is hereby deleted in its entirety and replaced with the following: "(a) Subject to the terms hereof and save as set out in Section 7.01(b), MediGene agrees to purchase exclusively from Atrix, and Atrix agrees to Manufacture for, and sell exclusively to MediGene during the Term of this Agreement, MediGene's total requirements for the Product and the Demonstration Samples in the Territory on the terms and conditions set forth herein. Subject to MediGene's prior written approval, such approval not to be unreasonably withheld, conditioned or delayed by MediGene, Atrix may subcontract any part of the Manufacturing Process for the Product and the Demonstration Samples to a Third Party provided: (i) the Product, the Demonstration Samples and the facilities continue to meet the requirements as defined in this Agreement, (ii) Atrix has obtained all required Governmental Approvals to subcontract any part of the Manufacturing Process for the Product to be sold in the Territory and (iii) the Third Party has obtained all required Governmental Approvals for the Manufacturing Process for the Product to be sold in the Territory. If subcontracting is initiated by Atrix or requested by the Competent Authorities for any Manufacturing Process for Product to be sold in the Territory, Atrix will bear the cost of validation and necessary stability work, as well as any other directly related costs. (b) Upon expiry of the [**]." - ---------- ** Confidential Treatment Requested. 10 15. Section 7.02 of the Agreement is hereby deleted in its entirety and replaced with the following: "Section 7.02. QUALITY ASSURANCE. (a) Atrix shall Manufacture the Product in accordance with the Specifications. Any modifications of the Specifications require Atrix's, MediGene's and YAMANOUCHI's written approval, which will not unreasonably be withheld or delayed. If MediGene or YAMANOUCHI should come to the conclusion that a modification is required, MediGene will, or will cause YAMANOUCHI to, submit a proposal for modification to Atrix. If Atrix or YAMANOUCHI, as applicable, disapproves, Atrix, MediGene and YAMANOUCHI will amicably determine the further measures to be taken and pending such determination provided that the amendment sought is mandatory pursuant to Applicable Laws or an order of a Competent Authority. Atrix shall consult with MediGene as to any proposed changes in the Specifications, Manufacturing Process, or in Atrix's quality assurance procedures which might render Atrix unable to supply Product in accordance with the terms of this Agreement, prior to making those changes, and obtain MediGene's prior, written consent thereto, which consent will not be unreasonably withheld, conditioned or delayed by MediGene. Atrix shall immediately notify MediGene in writing of any changes required by a Competent Authority in the Specifications or Atrix's quality assurance procedures that would render Atrix unable to supply the Product and/or Demonstration Samples in accordance with the terms of this Agreement. The Parties agree to develop and execute an appropriate action plan in such situation. Any additional costs or expenses shall be shared between the Parties in such proportion as is equal to each Party's relative fault in causing such change or changes to occur; provided, however, that if the Parties cannot reach an agreement in good faith as to the relative fault of each Party or if neither Party is at fault, such additional costs and expenses shall be borne equally by the Parties. (b) Notwithstanding the foregoing, the Parties have defined further responsibilities with regard to quality assurance in a separate Quality Assurance Manual effective as of May 28, 2003, which may be mutually amended by the Parties from time to time and which is attached to this Agreement as Exhibit J (the "Quality Assurances Manual")." 16. The introductory paragraph of Section 7.03 of the Agreement is hereby deleted in its entirety and replaced with the following: "Section 7.03. ATRIX'S DUTIES. Atrix covenants to Manufacture the Product in accordance with the Specifications and Applicable Laws, and to furnish to MediGene with every Shipment a written certificate of analysis and Certificate of Compliance confirming that the Product conforms to the Specifications, and was manufactured and tested in compliance with the Specifications, Applicable Laws and recognized pharmaceutical rules. The Product may be subjected to testing by MediGene at its designated facility in order to verify conformance of the Product with the Specifications. In addition, Atrix shall:" 11 17. The following is hereby added to the end of Section 7.06(a) as a new sentence: "To the extent Atrix is unable to supply Product, [**]." 18. Section 8.07 of the Agreement is hereby deleted in its entirety and replaced with the following: "Section 8.07. FORECASTS AND ORDERS. (a) Not later than six (6) months following submission of the relevant NDA or other equivalent applicable regulatory filing on a country by country basis, MediGene will provide Atrix with a twelve (12) month forecast of MediGene's requirement of each Product, on a Product by Product basis, including Demonstration Samples, and on a country by country basis as follows (the "Initial Forecast"), unless agreed otherwise on a case by case basis in writing: (i) For the first twelve (12) month period covered by the Initial Forecast for each Product, MediGene shall provide quarterly, no less than forty- five (45) days prior to the beginning of each calendar quarter a further twelve month forecast. Said requirements will be based on standard production planning parameters including but not limited to sales forecasts, sales demand forecasts, promotional forecasts, inventory requirements, and the like. The twelve (12) month forecast will be stated in monthly requirements. The second two (2) quarters of the twelve (12) month forecast will be total requirement by stock keeping unit and will be stated as quarterly requirements. The first three (3) months of the twelve (12) month forecast will be firm orders to purchase. The second three (3) months will be allowed to be flexed from the previous forecast by plus or minus [**] per month until fixed by the subsequent forecast; provided that the aggregate adjustment from the quantity set forth in the previous forecast for such three (3) month period shall not exceed [**] in aggregate during that three (3) month period. [**]. Notwithstanding the above, and in respect of the One Month Product and Three Month Product in Germany only, MediGene will provide Atrix with the Initial Forecast as soon as reasonably possible following the date of execution of the Sublicense and Atrix will use reasonable efforts to fulfill purchase orders contained in such Initial Forecast. (ii) After the first twelve (12) months MediGene will provide to Atrix a rolling twelve (12) month forecast for each Product with the first three (3) months of the rolling twelve (12) month forecast a firm order to purchase. Each order in the rolling twelve (12) month forecast shall be provided monthly, no less than twenty (20) days prior to the beginning of each month. All orders will be for full batch quantities [**]. Notwithstanding the foregoing, for the first twelve (12) months after launch of each Product the Parties agree to use commercially reasonable efforts to cause each order to be for full batch quantities, but acknowledge and accept that during such twelve (12) month period orders may be for less than full batch quantities. - ---------- ** Confidential Treatment Requested. 12 (b) It is understood that Atrix will not maintain Product or Demonstration Sample inventory in excess of the forecast, but will produce Product or Demonstration Sample upon receipt of that portion of MediGene's forecasts that constitute firm orders to purchase. The above periods whether fixed or flexible will be adjusted based upon existing lead times at time of start up. (c) MediGene agrees to purchase a sufficient amount of Product to enable MediGene to carry sufficient inventory to allow for fluctuations in sales demand so as to allow Atrix reasonable lead time to meet increased demand. Atrix will use commercially reasonable efforts to meet any increase in demand in excess of the allowed adjustment, but will not be obligated to do so beyond [**] of MediGene's forecast for the relevant twelve (12) month period subject to Section 7.06(c). All forecasts will be made by MediGene to Atrix in good faith based upon standard commercial parameters. From time to time after the Effective Date, the Parties shall consider whether, in light of market demand, manufacturing capacity, inventory levels and other pertinent factors, to revise the schedule for delivery of forecasts and, if appropriate, negotiate in good faith to revise such schedule. (d) The Launch Quantity of the Product when delivered to the common carrier shall not have an expiration date of less than [**] from the date of such delivery, provided (a) Product other than the Launch Quantity shall not have an expiration date of less than [**] once real time stability data is submitted by Atrix to the respective Competent Authority, and/or (b) as the Parties may otherwise agree in writing on a case by case basis. (e) In the event MediGene does not receive a Marketing Authorization in a specified country in the Territory, but Atrix nevertheless has Manufactured the Launch Quantity of the Product for sale in such country in the Territory, the Atrix Manufacturing Cost attributable to the Manufacture of the Launch Quantity for sale in such country shall be [**]." 19. The following is hereby added to Section 10.04 of the Agreement as a new Section 10.04(d): "(d) Notwithstanding the foregoing, the Parties have defined further responsibilities with regard to pharmacovigilance in the Quality Assurance Manual." 20. Section 11.01 of the Agreement is hereby deleted in its entirety and replaced with the following: "(a) Atrix shall, at Atrix's expense seek registration of, maintain, enforce and protect the Atrix Marks in all countries in the Territory in respect of the Product, and MediGene shall provide, and shall procure that its sublicensees provide, at no cost or expense to MediGene and its sublicensees, such assistance to Atrix as may be reasonably required in pursuance of such protection by Atrix. In the event that Atrix desires to or does abandon one or more of the Atrix - ---------- ** Confidential Treatment Requested. 13 Marks, or if Atrix declines responsibility for the maintenance of such rights, Atrix shall provide reasonable prior written notice to MediGene in advance of its intention to abandon or decline responsibility, and MediGene (or at request of MediGene its sublicensees) shall have the right, but not the obligation, to prepare, file, prosecute, and maintain any such rights and such rights shall be transferred to MediGene (or its sublicensees if requested by MediGene). (b) Atrix shall, at Atrix's expense and to the extent commercially reasonable, prosecute through to grant, maintain and protect the Atrigel Patent Rights in full force and effect in all countries in the Territory where such rights exist or could exist in the future. In the event that Atrix desires to or does abandon one or more of the Atrigel Patent Rights, or if Atrix declines responsibility for the maintenance of such rights, Atrix shall provide reasonable prior written notice to MediGene in advance of its intention to abandon or decline responsibility, and MediGene (or its sublicensees upon request by MediGene) shall have the right, but not the obligation, to prepare, file, prosecute, and maintain any such rights and such rights shall be transferred to MediGene (or its sublicensees if requested by MediGene). (c) With regard to Section 3.04, Atrix, in its sole discretion, shall determine whether or not to maintain and protect the Program Technology it creates in accordance with Section 3.04, MediGene, in its sole discretion, shall determine whether or not to maintain and protect the Program Technology it creates in accordance with clause 3.04 and MediGene's sublicensees (if any) at its sole discretion shall determine whether or not to maintain and protect the Program Technology it creates in accordance with clause 3.04. Each Party, at the reasonable expense of the creator, shall provide such assistance to the creator as may be necessary to enable the creator of the Program Technology to maintain the Program Technology. In the event that the creator of the Program Technology does not wish to seek formal protection for or desires to or does abandon any patent application or patent, or if such creator later declines responsibility for such patent application or patent in respect of their Program Technology, such creator shall provide reasonable prior written notice to the others of its intention to abandon or decline responsibility, and the others shall have the equal right at their own cost and expense, but not the obligation, to prepare, file, prosecute, and maintain any such patent application or patent in respect of such Program Technology and shall be entitled to the reasonable assistance (at its own reasonable expense) of the creator. Notwithstanding who applies for or maintains such protection the creator of the Program Technology shall not be prevented from using such Program Technology pursuant to section 3.04(c). 21. Section 11.02 of the Agreement is hereby deleted in its entirety and replaced with the following: "(a) During the Term, each Party shall give prompt notice to the other of any Third Party act which may infringe the Atrigel(R) Patent Rights or the Atrix Marks in the Territory and shall cooperate with each other to terminate such infringement without litigation. Atrix shall, at its sole expense, prosecute the judicial or administrative proceedings against such Third Party infringement. MediGene shall provide such assistance and cooperation to Atrix as may be necessary to successfully prosecute any action against Third Party infringement at Atrix's expense and may deduct the expenses thereof from any amounts payable to Atrix under this Agreement. In the event Atrix fails to institute proceedings in the Territory against any Third Party infringement of the Atrigel(R) Patent Rights and/or the Atrix Marks within forty-five (45) days 14 after notice given by either Party to the other of said Third Party infringement, MediGene (or with MediGene's consent its sublicensees) may take such action as it deems appropriate, including without limitation, the filing of a lawsuit against such Third Party. In such event Atrix will provide such assistance and cooperation to MediGene and its sublicensees as may be necessary, at MediGene's (respectively its sublicensees') expense, and MediGene may deduct all costs and expenses of such actions incurred by MediGene against any amount payable to Atrix under this Agreement, and MediGene and/or its sublicensees may retain all amounts awarded in such action. (b) With respect to patented Program Technology and pursuant to Section 3.04(d), in the event any patent included in the Program Technology is infringed by a Third Party, the Party (the "Enforcer") responsible for prosecution and maintenance of the applicable Program Technology under Section 11.01(c) (subject to Section 3.04) shall have the right to bring and control such action or proceeding, using counsel reasonably acceptable to the Parties, and shall be provided by the other Party(ies), at its own cost and expense, with such assistance and cooperation as may be reasonably necessary to successfully prosecute any action against such Third Party. In the event the Enforcer fails to institute proceedings against any Third Party infringement of the Program Technology within the earlier of (i) the time period required under Applicable Laws or (ii) forty-five (45) days after notice given by either Party to the other of said Third Party infringement, the other Party(s) may take such action as it deems appropriate, including without limitation, the filing of a lawsuit against such Third Party. In such event the Enforcer will provide such assistance and cooperation to the other Party as may be necessary, at the other Party's expense. (c) Neither Atrix nor MediGene may settle an action or proceeding against an infringer related to the Program Technology, and MediGene may not settle an action or proceeding against an infringer related to Atrigel(R) Technology, with respect to an infringement without the written consent of the other Party. Such consent shall not be unreasonably withheld or delayed, but may be withheld if such settlement would materially and adversely affect the interest of such Party, including Atrix's rights hereunder or Atrix's rights in the Atrigel(R) Technology." 22. Section 13.01 of the Agreement is hereby deleted in its entirety and replaced with the following: "13.01 Atrix Co-Marketing Right Upon Failure to Achieve Sales Targets. Subject always to Section 20.04 ("Force Majeure"), if during the [**] and in each Financial Year thereafter, MediGene does not sell Units equal to at least [**] of the Unit amount of the Annual Sales Targets in a country in the Territory [**], the failure having been solely within MediGene's control, then Atrix shall have the right and option, exercisable in its sole discretion, by written notice to that effect delivered by Atrix to MediGene within sixty (60) days after said event occurs, which written notice shall be forwarded by MediGene to YAMANOUCHI without delay, to co-market the Product in each such country in the Territory in which during the [**] and in each Financial Year thereafter, MediGene does not sell Units equal to at least [**] of the Unit amount of the Annual Sales Targets in that country. - ---------- ** Confidential Treatment Requested. 15 If Atrix exercises its right to co-market the Product in such country in the Territory the following shall occur, to the extent allowed by Applicable Laws: (A) MediGene shall grant, and shall procure that YAMANOUCHI or any other sublicensee grants subject to YAMANOUCHI's own rights under the Sublicense, Atrix an irrevocable, exclusive, royalty free license, such that MediGene retains its distribution and marketing rights under the Agreement and YAMANOUCHI retains its distribution and marketing rights under the Sublicense, with the right to sublicense, to market, advertise, promote, distribute, offer for sale, sell and import the Product in such country in the Territory; (B) MediGene shall grant, and shall procure that YAMANOUCHI and any other sublicensee grants, to Atrix an irrevocable, non-exclusive, royalty-free license, with the right to sublicense, to use the YAMANOUCHI Clinical Documentation (or similar documentation of any other sublicensee), the YAMANOUCHI Results (or similar documentation of any other sublicensee) the Marketing Authorizations and make any required filings with the Competent Authorities, to the extent legally permissible, in connection with such activities in that country; (C) Atrix will be solely responsible for its expenses related to marketing of the Product in such country in the Territory and Atrix will retain all revenues from Product that it or its sublicensees sell in such country in the Territory; (D) Atrix and/or its sublicensee shall only be entitled to market one additional brand of the Product and Atrix and/or its sublicensee shall market the Product using a different mark than the Atrix Marks used or associated with the Product in that country in the Territory; (E) subject to and in compliance with all Applicable Laws, Atrix will use commercially reasonable efforts to restrict the sale of such Product by its sublicensees outside of said country in the Territory; and (F) the powers of the Advisory Board will be deemed to be automatically dissolved for the said country as of the date Atrix exercises its right to co-market the Product in that said country. The rights and obligations under this Section 13.01 shall not apply with respect to [**]" 23. Sections 16.01 and 16.02 of the Agreement are hereby deleted in their entirety and replaced with the following: "Section 16.01. Covenant Not To Launch Competitive Product. MediGene hereby covenants and shall cause its Affiliates, and sublicensees to agree not to out-license, commercialize, market, sell, distribute or have marketed, have sold or have distributed any Competitive Product during the first [**] after the effective date of the Sublicense in any country in the Territory in which MediGene retains a license granted by Atrix under Article III. Notwithstanding the foregoing, if during the first [**] after the effective date of the Sublicense MediGene or any of its Affiliates or YAMANOUCHI or its sublicensees acquires an entity or all or substantially all of the assets of an entity and such entity distributes a Competitive Product or such assets include a Competitive Product, MediGene or such Affiliate or YAMANOUCHI or such sublicensee shall have [**] in which to divest itself of such Competitive Product or to otherwise cease marketing, sales and distribution of such Competitive Product, and MediGene shall not be in breach of this Section 16.01 if it or the Affiliate, YAMANOUCHI or sublicensee, as the case may be, so divests or ceases marketing, sales and distribution within such [**] period. - ---------- ** Confidential Treatment Requested. 16 Section 16.02. Limitation To The Territory. (a) MediGene covenants and agrees that during the Term of this Agreement it will not, nor shall it permit its Affiliates or YAMANOUCHI or YAMANOUCHI's Affiliate or its sublicensees, without the prior written authorization of Atrix, to the extent allowed by Applicable Laws: (i) promote or actively solicit sale of the Product or advertise the Product, in any country where MediGene or YAMANOUCHI or its sublicensees does not have, or benefit from nor is entitled to obtain pursuant to this Agreement a necessary Marketing Authorization or in any country that is not part of the Territory; (ii) contact Competent Authorities located outside the Territory about the Product, except as required by Applicable Laws or as may be necessary or appropriate to exercise its contractual rights or carry out its obligations as set forth in this Agreement. (b) To the extent Atrix exercises its rights to grant a license to a Third Party in accordance with Section 3.02(d)(iv), Atrix covenants and agrees that it will not, and shall use commercially reasonable efforts to ensure that such Third Party does not, without the prior written authorization of MediGene, to the extent allowed by Applicable Laws: (i) promote or actively solicit sale of the Product or advertise the Product, in any country where Atrix does not have the right to grant such license under Section 3.02(d)(iv) (the "Licensed Territory"); (ii) allow a Third Party to purchase or cause to be purchased Product which the Third Party has represented, directly or indirectly, as being for the purpose of sale in the Licensed Territory for sale in the Territory but outside the Licensed Territory; and (iii) knowingly sell or distribute for resale the Product to a Third Party who intends to sell such Product in the Territory but outside the Licensed Territory." 24. Section 16.04 of the Agreement is hereby deleted in its entirety and replaced with the following: "Section 16.04. A&S Spending Levels. MediGene covenants and agrees, and shall procure that YAMANOUCHI and other sublicensees will covenant and agree, that during the first [**] following the date of the First Commercial Sale of the Product in a country in the Territory (the [**]), MediGene's, or YAMANOUCHI's and other sublicensees annual A&S spending levels in that country in the Territory (whereby in calculating such A&S spending levels of MediGene the A&S expenditures of YAMANOUCHI and other sublicensees shall be included and vice versa) shall be at least [**] portion of the Annual Sales Target of each Product in a country in the Territory as set forth in the Annual Performance Guidelines established each Financial Year in accordance with the Sublicense. MediGene further covenants and agrees, and shall procure that YAMANOUCHI and other sublicensees will covenant and agree, to maintain after such [**] annual A&S spending levels in the Territory as set forth in the Annual Performance Guidelines established each Financial Year in accordance with Section 5.06 of the Sublicense. (a) MediGene shall provide that, and MediGene shall procure that YAMANOUCHI and other sublicensees shall provide that if, in any given Financial Year, the A&S spending levels are less than the minimum required A&S spending levels for such year as set forth in the Annual Performance Guidelines, that MediGene shall make up the difference by adding the amount of - ---------- ** Confidential Treatment Requested. 17 the shortfall for that year to the minimum A&S requirements for the current year as set forth in the Annual Performance Guidelines and MediGene, shall satisfy the revised minimum aggregate A&S expenditure amount in the current year. (b) If MediGene affirmatively determines to spend less than the A&S commitment as set forth in this Section 16.04 during the current year or any subsequent year as set forth in the Annual Performance Guidelines, MediGene shall immediately notify, Atrix of such determination, whereupon Atrix shall have the right, in its sole discretion, to elect whether to [**]. (c) As an alternative to the obligations and liabilities under Sections 16.04(a) or (b), MediGene agrees, and shall procure that YAMANOUCHI and other sublicensees shall agree, to use reasonable endeavours to make in each country in the Territory [**]." 25. Section 19.01 of the Agreement is hereby deleted in its entirety and replaced with the following: "This Agreement shall commence as of the Effective Date and (i) in respect of countries within the Territory, [**] shall expire on a country-by-country basis on the date that the last applicable Atrigel(R) Patent Right with a Valid Claim expires in such country in the Territory [**]. The period from the Effective Date until expiration of this Agreement in accordance with the foregoing provisions of this Section 19.01 is the "Term". In the event that patent application number [**] has not been granted [**], this Agreement shall, on MediGene's written notice, expire on [**]." 26. Section 20.05 of the Agreement is hereby deleted in its entirety and replaced with the following: "Section 20.05. Governing Law. This Agreement shall be governed by, and construed and enforced in accordance with, the laws of the State of New York, USA, except that no conflicts of laws provision shall be applied to make the laws of any other jurisdiction applicable to this Agreement. The Parties hereby irrevocably submit to the exclusive jurisdiction of the courts located in New York City, New York with respect to any dispute, claim or controversy regarding this Agreement, the interpretation of this Agreement or the rights or obligations of the Parties under this Agreement. 27. Section 20.08 of the Agreement is hereby deleted in its entirety and replaced with the following: "Section 20.08. Notices. All notices, requests and other communications to any party hereunder shall be in writing and shall be deemed to have been given if delivered personally, mailed by certified mail (return receipt requested) or sent by cable, telegram or recognized overnight delivery service to the parties at the following addresses or at such other addresses as, specified by the parties by like notice: - ---------- ** Confidential Treatment Requested. 18 If to Atrix: Atrix Laboratories, Inc. 2579 Midpoint Drive Fort Collins, CO 80525 Attn: Sean Moriarty Vice President, Business Development and Counsel Telephone: (970) 482-5868 Facsimile: (970) 482-9735 Copies to: Morrison & Foerster LLP 5200 Republic Plaza 370 17th Street Denver, Colorado 80202-5638 Attn: Warren L. Troupe, Esq. Telephone: (303) 592-2255 Facsimile: (303) 592-1510 If to MediGene: MediGene Aktiengesellschaft Lochhamer Strasse 11 D-82152 Planegg/Martinsried Germany Attn: Dr. Claudius Wamlek Vice President of Business Development Telephone: 011-49-89-8565-2900 Facsimile: 011-49-89-8565-2920 Notice so given shall be deemed given and received (i) if by international mail on the seventh (7th) day after posting; (ii) by cable, telegram, telex or personal delivery on the date of actual transmission, with evidence of transmission acceptance, or (as the case may be) personal or other delivery; and (iii) if by international courier, on the fourth (4th) business day following the day such notice is delivered to the international courier service, or such earlier delivery date as may be confirmed to the sender by such courier service." 28. Exhibits H, I and J attached to this Second Amendment are hereby added to the Agreement as Exhibits H, I and J. 29. Notwithstanding Section 6.01(e) of the Agreement or any other provision to the contrary, during the term of the Sublicense the Advisory Board shall not meet with respect to and shall not have the power to consider any issue for which [**]. 30. Notwithstanding Sections 10.01 and 10.02 of the Agreement, during the term of the Sublicense, Marketing Authorizations shall be governed by the provisions of Section 9.01 of the Sublicense." - ---------- ** Confidential Treatment Requested. 19 31. MediGene agrees to provide to Atrix all notices or other information that the Sublicense requires MediGene to provide to Atrix. 32. This Second Amendment is expressly subject to and conditioned upon the execution by YAMANOUCHI and MediGene of the Sublicense. The effective date of this Second Amendment (the "Effective Date") shall be the effective date of the Sublicense. The provisions of this Second Amendment shall automatically terminate and become null and void, without any action by either Party, effective upon the termination of the Sublicense. Upon such termination and thereafter the provisions of the Agreement as in effect prior to this Second Amendment shall be in full force and effect. 33. Miscellaneous. (a) This Second Amendment and all rights under this Second Amendment may not be assigned or transferred by either Party without the prior written consent of the other Party. (b) All capitalized terms used and not otherwise defined in this Second Amendment shall have the same meanings as set forth in the Agreement, or, to the extent not defined in the Agreement or this Second Amendment, the Sublicense. (c) Except as expressly modified by the terms of this Second Amendment, the terms and provisions of the Agreement shall remain in full force and effect as originally written. (d) This Second Amendment may be executed by the Parties in counterparts, each of which shall be deemed to be an original, but all such counterparts shall constitute one and the same instrument, and all signatures need not appear on any one counterpart. The Parties may execute this Second Amendment by facsimile signature. (e) The Parties shall each perform such acts, execute and deliver such instruments and documents and do all such other things as may be reasonably necessary to accomplish the transactions contemplated by this Second Amendment. (f) Nothing in this Second Amendment shall be construed to make the relationship of MediGene and Atrix herein a joint venture, association or partnership or make the Parties agents of one another. The Parties are not authorized to act as agents of one another as to any matter or to make any representations to any third parties indicating or implying the existence of any such agency relationship. (g) The Agreement and this Second Amendment constitutes the entire agreement between the Parties relating to the subject matter hereof and supersedes any and all previous agreements and understandings, whether written or oral. No terms or provision of this Second Amendment shall be varied or modified by any prior or subsequent statement, conduct or act of either of the Parties, except only in the event that the Parties amend this Second Amendment by written instruments specifically referring to and executed in the same manner as this Second Amendment. 20 (h) Each of MediGene and Atrix acknowledges that it has been represented by counsel in the negotiation of the terms of this Second Amendment, and that it has reviewed the terms of this Second Amendment with said counsel, and that its decision to enter into this Second Amendment is based on the advice of said counsel. Each of MediGene and Atrix further acknowledges that it is executing this Second Amendment on a voluntary basis, and that it fully understands its final and binding effect. 21 IN WITNESS WHEREOF, the Parties have caused this Second Amendment to be executed by their respective duly authorized representatives as of the Effective Date, ATRIX LABORATORIES, INC. By: /s/ Michael R. Duncan ------------------------------------ Name: Michael R. Duncan Title: Vice President and General Manager MEDIGENE AG By: /s/ Peter Heinrich ------------------------------------ Name: Dr. Peter Heinrich Title: CEO 22 CONFIDENTIAL TREATMENT REQUESTED BY QLT INC. THIRD AMENDMENT TO COLLABORATION, LICENSE AND SUPPLY AGREEMENT THIS THIRD AMENDMENT (the "Amendment") dated the 17th day of May, 2006 (the "Effective Date"). BETWEEN: QLT USA, INC., a Delaware corporation having offices at 2579 Midpoint Drive, Fort Collins, Colorado, U.S.A., 80525 ("QLT USA") AND: MEDIGENE AG, a German corporation having offices at Lochhamer Strasse 11, Planegg/Martinsried, Germany ("MEDIGENE") WHEREAS: A. MediGene and QLT USA (formerly Atrix Laboratories, Inc.) entered into a Collaboration, License and Supply Agreement dated April 4, 2001 as amended by the First Amendment dated September 12, 2002 and by the Second Amendment dated December 22, 2003 (the "Agreement"), wherein QLT USA has licensed to MediGene certain rights to the Product (which includes the U.S. One Month Product, the U.S. Three Month Product, the U.S. Four Month Product and the U.S. Six Month Product (each as defined in the Agreement)) in the Territory (as defined in the Agreement); and B. The parties wish to amend the Agreement to simplify the transfer pricing of the Products, and to provide that MediGene retain and store the retention samples of the Product (as defined in the Agreement), rather than QLT USA, as currently provided, all on the terms and conditions set out in this Amendment. NOW THEREFORE in consideration of the foregoing recitals and the mutual covenants and agreements set out in this Amendment and other good and valuable consideration, the sufficiency of which are acknowledged, the parties to this Amendment agree as follows: 1. INTERPRETATION 1.1 All capitalized terms used in this Amendment and not otherwise defined will have the meaning given to them in the Agreement. 1.2 Except as expressly amended by this Amendment, all other terms and conditions of the Agreement remain unchanged and in full force and effect. 1 2. AMENDMENT 2.1 Effective as of the Effective Date, the Agreement is hereby amended as follows: 2.1.1 The definition of "Atrix", as used throughout the Agreement, shall refer to QLT U.S.A., Inc., a Delaware corporation having offices at 2579 Midpoint Drive, Fort Collins, Colorado, U.S.A., 80525 2.1.2 The definition of "Atrix Manufacturing Cost" is deleted in entirety and replaced with the following: "Atrix Manufacturing Cost" means, with respect of each Unit of Product and with respect to a given point in time, the actual cost of the Manufacture by Atrix of such Product which have been incurred during Atrix's preceding fiscal year (twelve months' period from January 1 through December 31) under a Manufacturing Process, divided by the number of Units of such Product produced during such twelve months' period. The actual cost of the Manufacture shall include the related quality assurance and quality control activities as required by Applicable Laws for the manufacture or sale of such Product in the respective jurisdictions in the Territory (other than the costs set forth in Section 2.03), which cost shall be comprised of the cost of goods produced as determined in accordance with GAAP, and shall include direct labor, direct material, including raw materials and packaging materials, and the allocable portion of the manufacturing overhead of Atrix directly attributable to the Manufacture of such Product, including the cost of those samples that is required to be retained by Atrix, at its expense, under Applicable Laws for quality control to the extent required in accordance with Section 7.03(b), but not including the cost of samples shipped to and purchased by MediGene for retention in Europe for quality control in accordance with Section 7.08. The allocable portion of the manufacturing overhead shall be determined by taking the [**]. Atrix Manufacturing Cost shall exclude selling, general and administrative, research and development, and interest expenses and any and all debt service payments of Atrix. 2.1.3 The following definition of "Fixed Price Period" is added to the definitions under Article I in alphabetical order: "Fixed Price Period" means a fixed [**] time period. The first Fixed Price Period for all Products shall commence on [**] followed by consecutive Fixed Price Periods each commencing on the [**] of the commencing date of the preceding Fixed Price Period. 2.1.4 Section 7.03(b) of the Agreement is deleted in entirety and replaced with the following: "(b) if and only to the extent required by the applicable regulatory authorities in the United States and/or Applicable Laws applicable to Atrix in the United States, [**] a sample of each batch of Product for such period as required by such Applicable Laws and such regulatory authorities;" - ---------- ** Confidential Treatment Requested. 2 2.1.5 A new Section 7.08 is added and shall read as follows: "Section 7.08 Sample Retention by MediGene. MediGene shall retain at its expense a sample of each batch of Product for a period equal to such period as required by Applicable Laws and Competent Authorities in the Territory. Atrix shall ship to MediGene such retention samples of each batch of Product together with the commercial lot that they were obtained from, and the retention samples shall be clearly marked so as to identify them. Atrix shall include the retention samples on the invoice for the shipment, and MediGene shall purchase such shipped retention samples at the Atrix Manufacturing Price. The retained sample shall be sufficient in size as required by Applicable Laws and to allow MediGene to perform tests to determine whether or not the Product conforms to the Specifications. The retained samples shall be kept under the same conditions as those under which the Product is stored at MediGene's facilities." 2.1.6 Section 8.01 is deleted in its entirety and replaced with the following: "Section 8.01. PURCHASE PRICE AND PAYMENT. (a) Purchase Price. Atrix shall sell, and MediGene shall purchase, each Product or Demonstration Sample at the following purchase prices, which prices shall be fixed for the Fixed Price Period, and which may be adjusted at the end of each Fixed Price Period pursuant to Section 8.02 (a) (each price referred to as "Purchase Price"). Commencing effective [**] up to and including [**] the Parties agree that the Purchase Prices for all Product ordered by MediGene within such time period are set as follows: U.S. One Month Product - [**] per Unit U.S. Three Month Product - [**] per Unit U.S. Four Month Product - [**] per Unit U.S. Six Month Product - [**] per Unit Demonstration Samples - [**] per Unit (b) Payment. Atrix shall invoice MediGene at the time of each shipment for all Product and Demonstration Samples shipped by Atrix to MediGene and payment shall be due ten (10) days from the release of such shipment by MediGene's Qualified Person, but in no event later than thirty (30) days from receipt of the invoice." 2.1.7 Section 8.02(a) is deleted in its entirety and replaced with the following: "(a) In the event that upon the last day of any Fixed Price Period for a Product (the "Adjustment Date") the Atrix Manufacturing Cost for such Product determined at such Adjustment Date differs from the last applicable Purchase Price for such Product effective prior - ---------- ** Confidential Treatment Requested. 3 to the Adjustment Date, the Purchase Price shall be adjusted as follows with effect as of the date following the Adjustment Date: If the Atrix Manufacturing Cost at the Adjustment Date is lower than the last effective Purchase Price, the Purchase Price shall be decreased [**] of the difference between the Atrix Manufacturing Cost and the last applicable Purchase Price. If the Atrix Manufacturing Cost at the Adjustment Date is higher than the last effective Purchase Price, the Purchase Price shall be increased by [**] of the difference between the Atrix Manufacturing Cost and the last applicable Purchase Price. For Example: If on [**] the Purchase Price for the U.S. One Month Product shall be [**] and the Atrix Manufacturing Cost for such Product on [**] shall be [**] the Purchase Price for such Product for the next Fixed Price Period from [**] shall be [**]. If on [**] the Purchase Price for the U.S. One Month Product shall be [**] and the Atrix Manufacturing Cost for such Product on such date shall be [**] the Purchase Price for such Product for the next Fixed Price Period from [**]. Atrix shall provide MediGene with such documentation as MediGene shall reasonably request to verify the Atrix Manufacturing Cost for any Product determined in connection with an adjustment of the Purchase Price pursuant to this Section 8.02(a) and with a statement verifying the information and certifying that the documentation and the information contained in the documentation is true and correct." 2.1.8 Sections 8.02(b) is deleted in its entirety and replaced with the following: "(b) In the event of any dispute between the Parties related to the adjustment of the Purchase Price for a Product the dispute will be referred to the Chief Executive Officers of Atrix and MediGene for joint resolution, provided that if the Chief Executive Officers are unable to mutually agree within thirty (30) days from referral after good faith discussions, the dispute will be finally settled by a single arbitrator appointed pursuant to the rules of the American Arbitration Association in accordance with the provisions of its Commercial Arbitration Rules. The place of arbitration will be mutually agreed by the parties, acting reasonably. Each party will bear its own legal and travel costs, with administrative fees to be shared equally by the parties. The language to be used in the arbitration proceedings will be English. Until the dispute on the adjustment of the Purchase Price for a Product is resolved as set out above, MediGene shall pay for Product ordered from and after the end of the last expired Fixed Price Period the Purchase Price in effect for such Product prior to the disputed adjustment. If an adjusted Purchase Price is mutually agreed by the Parties or determined by the arbitrator, and such agreed or determined Purchase Price is greater or less than the Purchase Price actually paid by MediGene for such Product pursuant to the foregoing sentence, MediGene shall promptly pay to Atrix the difference upon receipt of an invoice from Atrix for such amount, or Atrix shall promptly reimburse MediGene for such difference, as the case may be. Notwithstanding the foregoing, commencing twelve (12) months from the date of the First Commercial Sale of each Product, on a Product by Product basis, in the event that the total increase results in an increased Purchase Price which becomes, in - ---------- ** Confidential Treatment Requested. 4 MediGene's sole judgment, commercially non-viable for a given Product in a given country in the Territory, MediGene shall have the right, in its sole discretion, to [**]: (i) [**]; (ii) [**]; and (iii) [**]. 3. GENERAL 3.1 Marginal headings as used in this Amendment are for the convenience of reference only and do not form a part of this Amendment and are not to be used in the interpretation hereof. 3.2 This Agreement will enure to the benefit of and be binding upon the parties and their respective successors and permitted assigns. 3.3 This Agreement may be executed in counterparts with the same effect as if both parties had signed the same document. Both counterparts will be construed together and will constitute one and the same agreement. This Agreement may be executed by the parties and transmitted by facsimile transmission and if so executed and transmitted this Agreement will be for all purposes as effective as if the parties had delivered an executed original Agreement. - ---------- ** Confidential Treatment Requested. 5 IN WITNESS WHEREOF, QLT USA and MediGene hereto have caused this Amendment to be executed in duplicate by their duly authorized officers as of the Effective Date. QLT USA, INC. MEDIGENE AG By: /s/ Michael Duncan By: /s/ Peter Heinrich --------------------------------- ------------------------------------ Name: Michael Duncan Name: Dr. Peter Heinrich Title: President Title: CEO By: /s/ David Speights --------------------------------- Name: David Speights Title: Controller By: /s/ Sean Moriarty --------------------------------- Name: Sean Moriarty Title: Corporate Counsel 6
EX-10.35 5 o34971exv10w35.txt SETTLEMENT, RELEASE & PATENT LICENSE FEB 9, 2007 EXHIBIT 10.35 SETTLEMENT, RELEASE AND PATENT LICENSE This Settlement, Release and Patent License Agreement (this "AGREEMENT") is made as of February 9, 2007 ("EFFECTIVE DATE"), by and among Takeda Pharmaceutical Company Limited, a Japanese corporation with its principal place of business at 1-1 Doshomachi 4-Chome, Chuo-ku, Osaka, Japan 540-8645 ("TAKEDA"), Wako Pure Chemical Industries, Ltd., a Japanese corporation with its principal place of business at 1-2 Doshomachi 3-Chome, Chuo-ku, Osaka, Japan 540-8605 ("WAKO"), TAP Pharmaceutical Products Inc., a Delaware corporation with its principal place of business at 675 N. Field Drive, Lake Forest, Illinois ("TAP"), and Abbott Laboratories, Limited - Laboratories Abbott, Limitee, a corporation organized and existing under the Canadian Business Corporations Act and having its principal place of business at Montreal, Quebec ("ABBOTT-CANADA"), on the one hand, and QLT USA, Inc., a Delaware corporation with its principal place of business at 2579 Midpoint Drive, Fort Collins, Colorado 80525 ("ATRIX") and Sanofi-Synthelabo, Inc., a Delaware corporation with a principal place of business at 55 Corporate Boulevard, Bridgewater, NJ 08807 ("SANOFI"), on the other hand (collectively, the "PARTIES"). WHEREAS, the Parties deem it to be in their best interests and to their mutual advantage to settle their disputes on the terms and conditions set forth in this Agreement, without admitting liability, in order to achieve certainty in their business dealings and avoid the expense of litigation. NOW, THEREFORE, in view of the foregoing and for other good and valuable consideration, receipt and sufficiency of which are hereby acknowledged, the Parties agree as follows: 1. DEFINITIONS. 1.1. CERTAIN DEFINITIONS. For purposes of this Agreement, the following terms shall have the following meanings: (a) "AFFILIATE" shall mean any Person that controls, is controlled by, or is under common control with a Party to this Agreement. For purposes of this definition, "control" shall mean (i) in the case of a corporate entity, direct or indirect ownership of more than fifty percent (50%) of the securities having the right to vote for the election of directors, and (ii) in the case of a non-corporate entity, direct or indirect ownership of a majority of the equity interests with the power to direct the management and policies of such non-corporate entity. Notwithstanding the foregoing, in no event shall Abbott Laboratories be considered an Affiliate of any of the Parties. (b) "CLAIMS" shall mean any and all claims, actions, causes of action, demands, suits, proceedings, administrative proceedings, losses, damages, costs, expenses, liabilities, charges, interest, penalties, fines and charges of whatever nature (including costs of collection, attorneys' fees and other costs of defense, costs of enforcing indemnification provisions, and expenses of investigation), whether known or unknown. (c) "CONTROL" or "CONTROLLED," as to patent rights, shall mean ownership of such patent right or the ability of a Person to grant a license, or sublicense, or covenant not to sue under any such patent rights. (d) "GOVERNMENTAL AUTHORITY" shall mean any nation, territory or government (or union thereof), foreign, domestic or multinational, any state, local or other political subdivision thereof, and any bureau, court, tribunal, board, commission, department, agency or other Person exercising executive, legislative, judicial, regulatory or administrative functions of government. (e) "LICENSOR" or "LICENSORS" shall mean any and each of Takeda, Wako, TAP, and Abbott-Canada, collectively and individually. (f) "LITIGATION" shall mean, collectively, that certain lawsuit captioned "TAP Pharmaceutical Products Inc., Takeda Chemical Industries, Ltd. and Wako Pure Chemical Industries, Ltd. v. Atrix Laboratories, Inc. and Sanofi-Synthelabo Inc.," No. 03-C-7822, United States District Court for the Northern District of Illinois and the appeal pending therefrom captioned "TAP Pharmaceutical Products Inc., Takeda Chemical Industries, Ltd. and Wako Pure Chemical Industries, Ltd. v. Atrix Laboratories, Inc. and Sanofi-Synthelabo Inc.," No. 2006-1258, United States Court of Appeals for the Federal Circuit. (g) "LITIGATION PARTY" or "LITIGATION PARTIES" shall mean any and each of Atrix, Sanofi, Takeda, Wako, and TAP, collectively and individually. (h) "PARTY" shall mean any and each of Atrix, Sanofi, Takeda, Wako, TAP, and Abbott-Canada, collectively and individually. (i) "PERSON" shall mean an individual, corporation, partnership, limited partnership, limited liability company, unincorporated association, trust, joint venture, union or other organization or entity, including a Governmental Authority. (j) "RELEASED PARTY" OR "RELEASED PARTIES" shall mean any and each of Atrix and Sanofi, collectively and individually. (k) "RELEASING PARTY" or "RELEASING PARTIES" shall mean any and each of Takeda, Wako, TAP, and Abbott-Canada, collectively and individually. (l) "SUBJECT PRODUCT" or "SUBJECT PRODUCTS" shall mean (i) the following products marketed or sold on or prior to the Effective Date by Atrix or licensed by Atrix and sold by its Affiliates or licensees in the Territory on or prior to the Effective Date: the Eligard(R) products (which contain leuprolide acetate in 7.5 mg, 22.5 mg, 30 mg, and 45 mg dosages) and dental products called Atridox(TM), Atrisorb Free Flow(TM), Atrisorb-D(TM) and Doxyrobe(TM); and (ii) products that are the same as or have only non-colorable (i.e. insubstantial or immaterial) differences from any of the foregoing products. (m) "SUBJECT PRODUCT PATENT RIGHTS" shall mean any and all rights in the following that are owned, licensed or Controlled by any of the Releasing Parties, and that claim or cover the Subject Products (or the manufacture, use or sale thereof), whether the following are existing as of the Effective Date or thereafter: (i) patents in the Territory; (ii) patent applications in the Territory, including provisional applications, and (iii) any patents issuing therefrom and any divisionals, continuations, continuations-in-part, reissues, re-examinations, extensions, and term extensions (under applicable patent law or regulation or other law or regulation) in the Territory of any of the above-described patents or patent applications. -2- (n) "SUBLICENSEE" shall mean any Person, and their respective sublicensees, to whom a sublicense is granted pursuant to Section 5.2. (o) "TERRITORY" shall mean the United States of America, its territories and possessions including the Commonwealth of Puerto Rico, and Canada. 1.2. ADDITIONAL DEFINITIONS. Certain additional capitalized terms are defined below in the body of this Agreement. 2. RELATIONSHIP OF AGREEMENT WITH MOTION TO DISMISS; STIPULATED ORDER OF DISMISSAL. Forthwith after execution of this Agreement, the Litigation Parties will jointly file a motion to dismiss (the "MOTION TO DISMISS") the appeal in the case entitled "TAP Pharmaceutical Products Inc., Takeda Chemical Industries, Ltd. and Wako Pure Chemical Industries, Ltd. v. Atrix Laboratories, Inc. and Sanofi-Synthelabo Inc.," No. 2006-1258 in the U.S. Court of Appeals for the Federal Circuit (the "Appeals Court") in the form of Exhibit A attached to this Agreement. If the Appeals Court grants the Motion to Dismiss prior to issuing any opinions on the merits of the appeal (including a ruling pursuant to Federal Rule of Appellate Procedure 36), then the Litigation Parties shall, within three business days after the Appeals Court grants the Motion to Dismiss, file a Stipulated Order of Dismissal in the case captioned "TAP Pharmaceutical Products Inc., Takeda Chemical Industries, Ltd. and Wako Pure Chemical Industries, Ltd. v. Atrix Laboratories, Inc. and Sanofi-Synthelabo Inc.," No. 03-C-7822 in the United States District Court for the Northern District of Illinois (the "District Court"), in the form of Exhibit B attached to this Agreement, and make other appropriate filings requesting the District Court -- and take all other actions reasonably required -- to dismiss with prejudice all claims for relief asserted by any Party against any other Party in the Litigation. If the District Court dismisses case no. 03-C-7822 in accordance with the Stipulated Order of Dismissal, (a) Atrix shall and the Releasing Parties shall instruct Patterson, Belknap, Webb & Tyler to instruct the Escrow Agent (as that term is defined in the Escrow Agreement dated June 8, 2006 between Atrix and JPMorgan Chase Bank, N.V. (the "JP Morgan Escrow Agreement")) to deliver the Escrow Funds (as that term is defined in the JP Morgan Escrow Agreement) to Atrix in accordance the terms of the JP Morgan Escrow Agreement; and (b) Atrix and Sanofi shall pay their respective shares of the Settlement Amount in accordance with Section 3.1. If the Appellate Court denies the Motion to Dismiss or issues an opinion on the merits of the appeal prior to granting the Motion to Dismiss, then this Agreement shall automatically and immediately terminate, cease to have any force and effect, and shall be deemed null and void and of no effect on a retroactive basis. 3. MONETARY CONSIDERATION. 3.1. PAYMENT BY ATRIX AND SANOFI. Subject to the conditions set forth in Section 2, which are for the benefit of and may be waived by Atrix and Sanofi jointly, (a) Atrix shall pay to TAP the amount of $112.5 million, and (b) Sanofi shall pay to TAP the amount of $45 million (the amounts in (a) and (b), in the aggregate being the "SETTLEMENT AMOUNT"), in each case, within three business days after both of the following events occur: the Appeals Court grants the Motion to Dismiss and the District Court dismisses case no. 03-C-7822 in accordance with the Stipulated Order of Dismissal. All payments shall be made in United States Dollars. Atrix and Sanofi shall deposit their respective share of the Settlement Amount with their respective legal counsel on the Effective Date to be held in escrow on behalf of such Parties for payment to TAP in accordance -3- with this Agreement. The Settlement Amount shall be paid to TAP by wire transfer of immediately available funds to an account previously designated by TAP to Atrix and Sanofi in writing and TAP shall apportion the Settlement Amount among the other Releasing Parties, if any apportionment is to be made. Payment of the Settlement Amount to TAP shall constitute full payment of any portion of the Settlement Amount to the other Releasing Parties entitled thereto. TAP represents that it will comply with any applicable United States federal, state or local withholding tax obligations with respect to such payments, if any, that TAP makes to the other Releasing Parties. TAP acknowledges that, as between TAP on the one hand and Atrix and Sanofi on the other hand, TAP assumes full responsibility to fulfill any withholding tax obligations with respect to the Settlement Amount. The Settlement Amount, once paid, is not refundable. 3.2. NO OTHER FUNDS TRANSFER. The Settlement Amount represents full and complete payment for all of the rights and releases granted to Atrix, Sanofi and any Atrix and Sanofi Releasees (as defined in Section 4.1) under this Agreement, and neither Atrix, Sanofi nor any Atrix and Sanofi Releasee shall be under any obligation to pay any additional or further amounts to any Releasing Party under this Agreement. 3.3. TAXES. If the United States Internal Revenue Service or any state or local taxing authority within the United States imposes on Atrix or Sanofi any withholding tax on any portion of the Settlement Amount under the Internal Revenue Code of 1986, as amended or the Treasury regulations thereunder, TAP shall indemnify and hold harmless Atrix and Sanofi for the amount of such withholding tax, plus any interest, penalties or additions to tax related thereto. 4. RELEASES, COVENANTS NOT TO SUE, AND DISMISSALS. 4.1. RELEASES BY EACH RELEASING PARTY. Upon full payment of the Settlement Amount, each Releasing Party, each acting on behalf of itself and its respective predecessors, successors, and assigns, does hereby now and shall forever release and discharge Atrix and Sanofi, and their predecessors, successors, assigns and Affiliates, and each of their respective current and former officers, directors, employees, agents, attorneys, representatives, distributors, resellers, licensees, direct or indirect customers and contract manufacturers (collectively and individually, "ATRIX RELEASEES" and "SANOFI RELEASEES"), from and against (a) any and all Claims arising under, related to, or connected with any Subject Product Patent Rights in the Territory with respect to the period before the Effective Date, (b) any and all Claims raised in the Litigation, including but not limited to any requests in the Litigation to recover damages, fees or expenses due for alleged infringement of the Subject Product Patent Rights, or any requests to recover attorneys' fees or costs in connection with the Litigation, (c) any and all Claims arising out of or related to actions taken or statements made concerning or in connection with the Litigation in the Territory, (d) any and all matters which could have been raised (whether or not due to compulsory counterclaim requirements) in, or as a result of, the Litigation in the Territory; and (e) any and all Claims, arising during the period before the Effective Date, related to allegations that the Subject Products (or any aspect thereof for use in the Subject Products) infringe any Subject Product Patent Rights Controlled by a Releasing Party in the Territory. Releasing Parties, acting jointly and severally, represent and warrant, as of the Effective Date, to Atrix and Sanofi that they possess and Control (and have always possessed and Controlled) the exclusive right to sue for infringement or misappropriation of the Subject Product Patent Rights in the Territory and that no other Person has ever had the right to recover damages for infringement or misappropriation of any Subject Product Patent Rights in the Territory. -4- 4.2. RELEASES BY ATRIX AND SANOFI. Upon full payment of the Settlement Amount, Atrix and Sanofi, each acting on behalf of itself and its respective predecessors, successors and assigns, does hereby now and shall forever release and discharge the Releasing Parties, and each of their respective predecessors, successors, assigns and Affiliates, and each of their respective current and former officers, directors, employees, agents, attorneys, representatives, distributors, resellers, licensees, and direct or indirect customers (collectively and individually, "COLLECTIVE TAP RELEASEES"), from and against (a) any and all Claims raised in the Litigation, including but not limited to any Claim that U.S. Patent No. 4,728,721 is invalid or unenforceable in the Territory or should be reexamined or revoked, any Claim that any Releasing Party wrongfully enforced or committed patent misuse with respect to U.S. Patent No. 4,728,721 in the Territory or any claim to recover attorneys' fees or costs in connection with the Litigation, (b) any and all Claims arising out of or related to actions taken or statements made concerning or in connection with the Litigation in the Territory, (c) any and all matters which could have been raised (whether or not due to compulsory counterclaim requirements) in, or as a result of, the Litigation in the Territory, and (d) any and all Claims arising during the period before the Effective Date that U.S. Patent No. 4,728,721 is invalid or unenforceable or should be re-examined, opposed, or revoked in the Territory and/or any and all Claims arising during the period before the Effective Date that any Releasing Party wrongfully enforced or committed patent misuse with respect to U.S. Patent No. 4,728,721 in the Territory. 4.3. COVENANTS NOT TO SUE. No Atrix Releasee or Sanofi Releasee shall now or at any time in the future initiate any arbitration, lawsuit or other proceeding asserting (or otherwise assert, directly or through any third party) any Claim released pursuant to this Agreement. No Collective TAP Releasee shall now or at any time in the future initiate any arbitration, lawsuit or other proceeding asserting (or otherwise assert, directly or through any third party) (a) any Claim released pursuant to this Agreement, or (b) that the Subject Products infringe any Subject Product Patent Rights Controlled by any Collective TAP Releasee in the Territory, provided that nothing shall be construed to release Atrix and Sanofi from their respective obligations to pay their respective share of the Settlement Amount in accordance with Section 3.1 hereof. If any Collective TAP Releasee shall breach any obligation set forth in this Section 4.3, the breaching Party (on behalf of itself and/or its respective Collective TAP Releasee) shall indemnify each Atrix and Sanofi Releasee, and defend and hold each such Atrix and Sanofi Releasee harmless, from and against Claims arising out of or related to such breach. If any Atrix Releasee shall breach any obligation set forth in this Section 4.3, Atrix shall indemnify each such Collective TAP Releasee, and defend and hold each such Collective TAP Releasee harmless, from and against any Claims arising out of or related to such breach. If any Sanofi Releasee shall breach any obligation set forth in this Section 4.3, Sanofi shall indemnify each such Collective TAP Releasee, and defend and hold each such Collective TAP Releasee harmless, from and against any Claims arising out of or related to such breach. This Section 4.3 will be fully enforceable in every respect, at law or in equity, by any non-Party Collective TAP Releasee or non-Party Atrix or Sanofi Releasee as an intended third party beneficiary hereunder. For purposes of clarification, nothing in this Section 4 shall prohibit a Party in any way from bringing claims or counterclaims or instituting judicial, administrative or other legal proceedings outside the Territory, including but not limited to patent opposition or other proceedings in patent offices outside of the Territory. 4.4. RETAINED RIGHTS. Notwithstanding anything to the contrary herein, nothing in Sections 4.2 and 4.3 shall prohibit or restrict any Atrix Releasee or Sanofi Releasee from (a) -5- raising any defenses or counterclaims (including claims of invalidity or non-enforceability) in connection with any action, suit or proceeding brought against such Atrix or Sanofi Releasee for infringement of any Subject Product Patent Rights (or any other patent rights), or (b) instituting judicial, administrative or other legal proceedings within the Territory or outside the Territory challenging the validity or enforceability of, or asserting the noninfringement of, any Subject Product Patent Rights (or any other patent rights) or otherwise claiming that any such patent rights should be re-examined, opposed, or revoked in the Territory. 5. LICENSES. 5.1. LICENSE GRANT TO ATRIX AND SANOFI. Upon full payment of the Settlement Amount, each Licensor hereby grants to Atrix and its Affiliates and Sanofi and its Affiliates a non-exclusive, perpetual, irrevocable, fully paid-up, royalty-free license under the Subject Product Patent Rights to use, make, have made, sell, have sold, offer for sale, import and export, the Subject Products in the Territory, and such license shall be effective retroactive to the Effective Date. Such license shall be sublicensable by Atrix, Sanofi, or their Affiliates and their respective Sublicensees in accordance with Section 5.2. For the avoidance of doubt, the foregoing license includes the right in the Territory to make, have made, import and use components or ingredients of the Subject Products for inclusion in the Subject Products. By way of clarification, Licensors do not grant any express or implied licenses or other rights to Atrix and its Affiliates or Sanofi and its Affiliates outside of the Territory; provided, however, that, for the avoidance of doubt, the manufacture, use, import and/or sale of any Subject Products (or any aspect thereof for use in the Subject Products) by or for Atrix, Sanofi or any of their Affiliates outside the Territory would not constitute a breach or violation of this Agreement (even though such activity is not authorized or licensed by this Agreement either), and therefore, for example, the act of exporting Subject Products from the Territory is not restricted by this Agreement (even though corresponding import, use and/or sale of such products in countries outside the Territory following such export is not licensed or otherwise authorized hereunder), and the Releasing Parties are not waiving any rights they may have, if any, to assert their rights (including but not limited to any patent rights outside the Territory) against import, use and/or sale of such products in countries outside the Territory. 5.2. SUBLICENSES. Each Licensor hereby grants to Atrix, Sanofi, their Affiliates and Sublicensees, the right to sublicense, through multiple levels, in whole or in part, the rights set forth in Section 5.1 to any licensee of the Subject Products in the Territory. Each such sublicense shall be subject to Atrix's and Sanofi's rights and obligations under the terms of this Agreement. Each Licensor acknowledges and agrees that Sanofi is acting as authorized Sublicensee of Atrix under the license granted pursuant to this Section 5.2 and is entitled to all the benefits of such license. 6. COMPROMISE AGREEMENT. This Agreement is a compromise and settlement of disputed Claims and is not intended to be, nor shall it be construed as, an admission of liability or wrongdoing by any Party, or of the validity or invalidity, enforceability or unenforceability, or infringement or non-infringement, of any Subject Product Patent Rights in the Territory. Accordingly, neither this Agreement, nor anything contained in this Agreement, or done or omitted in connection with this Agreement (whether or not this Agreement expires or is terminated), is intended as, or shall be construed as, or may be offered or used, either within the Territory or outside the Territory, by any Collective TAP Releasee, Atrix Releasee or Sanofi -6- Releasee as, an admission, acknowledgement, implication or evidence of infringement or the need for a license by any Party or its Affiliates, or an admission, acknowledgement, implication or evidence of fault, liability or wrongdoing by any Party or its Affiliates or an admission, acknowledgement, implication or evidence, directly or indirectly, against any Party or its Affiliates in any way or for any purpose in any judicial, administrative or other legal proceedings, except solely for the purpose of enforcing this Agreement. 7. PRESS RELEASE/PUBLIC FILINGS. 7.1. PRESS RELEASE. One or more of the Parties may issue press releases regarding this Agreement in the form attached as Exhibit C. Each Party agrees that it will not make public statements regarding this Agreement that are inconsistent with its press release. 7.2. REQUIRED BY LAW. The Parties acknowledge that the terms of this Agreement may be disclosed as required by law, including but not limited to the Securities and Exchange Commission, listing requirements of any securities exchange, or other such regulatory authorities. 8. MATTERS CONCERNING THE LICENSE AND THE AGREEMENT. 8.1. TERM OF LICENSE GRANT. Upon the District Court signing and entering the Stipulated Order of Dismissal and upon full payment of the Settlement Amount, the rights granted in Section 5 shall take effect as of the Effective Date and shall continue until the last to expire of the Subject Product Patent Rights. 8.2. SECTION 365(n). All licenses and rights granted under or pursuant to this Agreement by Licensors to Atrix, its Affiliates, Sanofi, its Affiliates, and their Sublicensees are, and shall otherwise be deemed to be, for purposes of Section 365(n) of Title 11, U.S. Code (the "BANKRUPTCY CODE"), licenses of rights to "intellectual property" as defined in the Bankruptcy Code. The Parties agree that Atrix and its Affiliates, Sanofi and its Affiliates, and their Sublicensees shall retain and may fully exercise all of their rights and elections under the Bankruptcy Code. Licensors agree during the term of this Agreement to create and maintain current copies or, if not amenable to copying, detailed descriptions or other appropriate embodiments, of all such intellectual property. All rights, powers and remedies of Atrix and Sanofi provided under this Section 8.2 are in addition to and not in substitution for any and all other rights, powers and remedies now or hereafter existing at law or in equity in the event of any such commencement of a bankruptcy proceeding by or against any of the Licensors. 8.3. FINAL AND BINDING AGREEMENT. This Agreement constitutes the entire agreement among the Parties to this Agreement with respect to the subject matter of this Agreement and supersedes all prior agreements and understandings, whether written or oral, between or among the Parties, or any of the Parties, in connection with such subject matter. Each Party agrees that it is not relying in any manner on any statement, promise, representation or omission, whether oral or written, express or implied, made by any Person, not specifically set forth in this Agreement. Each Party agrees that it has made such investigation of all matters pertaining to this Agreement that such Party deems necessary, including but not limited to the Subject Products and any other products made, sold, offered for sale, used, exported or imported by Atrix and Sanofi and their Affiliates. Each Party acknowledges that, after execution of this Agreement, such Party may discover facts different from or in addition to those which it now knows or believes to be true. -7- Nevertheless, each Party agrees that this Agreement shall be and remain in full force and effect in all respects, notwithstanding such different or additional facts. 9. REPRESENTATIONS AND WARRANTIES OF THE PARTIES. The Parties make the representations and warranties set forth in this Section 9. In making the representations and warranties that apply to any or all Parties, each Party is making such representations and warranties as to itself and is not making such representations and warranties jointly with any other Party. 9.1. CORPORATE POWER. Each Party represents and warrants that (a) it has the full legal right and power to enter into and perform the transactions contemplated by this Agreement, without need for any consent, approval, authorization, license or order of, or notice to or filing with, any Governmental Authority or other Person; (b) the execution, delivery and performance by such Party of this Agreement and the consummation by such Party of the transactions contemplated hereby have been duly and validly authorized and approved by all necessary corporate action of such Party, including approval of this Agreement by the board of directors and stockholders of such Party, if required; (c) this Agreement evidences the legal, valid and binding obligations of such Party, enforceable against such Party in accordance with its terms; and (d) this Agreement has been duly executed and delivered by such Party. 9.2. DUE ORGANIZATION. Each Party represents and warrants that it is a corporation duly organized, validly existing and in good standing under the laws of the jurisdiction in which it is incorporated and that it has corporate power to own its properties, to conduct its business as currently owned and conducted, and to carry out the transactions contemplated by this Agreement. 9.3. NO ASSIGNMENT OF CLAIMS. Each Party represents and warrants that (a) it has not sold, assigned, conveyed, pledged, encumbered, or otherwise in any way transferred to any Person any Claim released by such Party pursuant to this Agreement and (b) it has not agreed to do any of the foregoing. 9.4. NO OTHER LAWSUITS. Each Releasing Party represents and warrants that as of the Effective Date it has not filed (or caused to be filed through a third party), any legal or administrative proceeding of any kind or nature in the Territory against Atrix, Sanofi or any other Atrix and Sanofi Releasee relating to any Subject Product Patent Rights, except for the Litigation. Atrix and Sanofi each represents and warrants that as of the Effective Date it has not filed (or caused to be filed through a third party), any legal or administrative proceeding of any kind or nature in the Territory against any Collective TAP Releasee relating to any Subject Product Patent Rights, except for the Litigation. 9.5. RIGHT TO GRANT LICENSES. Each Licensor represents, warrants and covenants to Atrix and Sanofi that (a) the Subject Product Patent Rights include any and all rights of any kind in any and all issued or pending patents and/or patent applications that are Controlled, as of the Effective Date, by the Releasing Parties, their Affiliates, or any of them, in the Territory that claim or cover any Subject Product (or any aspect thereof for use in the Subject Products), or the manufacture, use or sale thereof; (b) Licensors own the Subject Product Patent Rights that exist as of the Effective Date and have the right to grant the rights, licenses and covenants set forth in this Agreement, without the need for any licenses, releases, consents, approvals or immunities not yet granted or obtained; and (c) Licensor has not previously granted and shall not grant any rights in the Subject Product Patent Rights that are inconsistent with the rights, licenses and covenants -8- granted to Atrix and Sanofi in this Agreement. Each of TAP and Abbott-Canada represent, warrant and covenant to Atrix and Sanofi that Abbott Laboratories and its affiliates (excluding Abbott-Canada) do not Control as of the Effective Date any rights of any kind in any issued or pending patents and/or patent applications in the Territory that claim or cover any aspect of the Subject Products or for use in the Subject Products. 9.6. INDEPENDENT ADVICE. Each Party represents and warrants that it has received or had the opportunity to obtain independent legal advice from such Party's attorney with respect to the rights and obligations arising from, and the advisability of executing, this Agreement. 9.7. SURVIVAL OF REPRESENTATIONS AND WARRANTIES. All representations, warranties and covenants set forth in this Agreement shall survive the execution and delivery of this Agreement indefinitely. 9.8. NO OTHER REPRESENTATIONS. EXCEPT AS OTHERWISE EXPRESSLY SET FORTH IN THIS AGREEMENT, NONE OF THE PARTIES, EITHER INDIVIDUALLY OR COLLECTIVELY, MAKES ANY REPRESENTATION OR EXTENDS ANY WARRANTY OF ANY KIND, EITHER EXPRESS OR IMPLIED, TO ANY OTHER PARTY, AND EACH PARTY HEREBY DISCLAIMS ALL IMPLIED WARRANTIES, INCLUDING IMPLIED WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, WITH RESPECT TO ANY AND ALL OF THE FOREGOING. 10. GENERAL PROVISIONS. 10.1. AMENDMENTS. This Agreement may be amended, modified or supplemented only by a written instrument executed by all of the Parties to this Agreement. 10.2. SEVERABILITY. If any provision of this Agreement is found invalid or unenforceable by a court of competent jurisdiction, the invalid or unenforceable provision shall either be modified to make it legal and enforceable while retaining as far as possible the original intent of the provision or, if that is not possible, it shall be stricken. In either case, the remainder of the Agreement shall continue in full force and effect. 10.3. RELATIONSHIP OF THE PARTIES. This Agreement shall not constitute any Releasing Party as the agent or legal representative of any Released Party for any purpose whatsoever, and vice versa, and no Releasing Party shall hold itself out as an agent of any Released Party, and vice versa. Except as provided in Section 3.1, this Agreement creates no relationship of joint venturers, partners, associates, employment or principal and agent between or among any Parties, and all Parties are acting as independent contractors. Except as provided in Section 3.1, neither any Releasing Party nor any Released Party is granted herein any right or authority to, and no Party shall attempt to assume or create any obligation or responsibility for or on behalf of any other Party. Neither any Releasing Party nor any Released Party shall have any authority to bind any other Party to any contract, whether of employment or otherwise. 10.4. NO ELECTION OF REMEDIES. Except as otherwise specifically provided herein, the rights and remedies accorded herein to Releasing Parties and Atrix and Sanofi are cumulative and in addition to those provided by law, and may be exercised separately, concurrently, or successively. -9- 10.5. NOTICES. Any notice, request, demand or other communication required or permitted hereunder shall be in writing, shall reference this Agreement and shall be: (a) delivered personally; (b) sent by facsimile, with written confirmation of receipt; (c) sent by registered or certified mail, return receipt requested, postage prepaid; or (d) sent by a private industry express courier, with written confirmation of receipt. No notice shall be effective until actually received. In each case notices shall be addressed to the intended recipient as set forth below: (a) if to Releasing Parties, to: TAP Pharmaceutical Products Inc. 675 N. Field Drive Lake Forest, IL 60045 Attention: Vice President and Chief Legal Counsel Telephone No.: (847) 582-2704 Facsimile No.: (847) 582-5007 And with a required copy to: Patterson Belknap Webb & Tyler 1333 Avenue of the Americas New York, NY 10036 Attention: William F. Cavanaugh, Jr. Telephone No: (212) 336-2793 Facsimile No.: (212) 336-2222 Takeda Pharmaceutical Company Limited 1-1 Doshomachi 4-Chome, Chuo-ku Osaka, Japan, 540-8645 Attention: General Manager, Legal Department With a required copy to: Foley & Lardner 3000 K Street, NW Suite 500 Washington, D.C. 20007 Attention: Michael Kaminski Telephone No.: 202.672.5490 Facsimile No.: 202.672.5399 Wako Pure Chemical Industries, Ltd. 1-2 Doshomachi 3-Chome, Chuo-ku Osaka, Japan, 540-8605 Attention: General Manager, Legal Department -10- With a required copy to: Foley & Lardner 3000 K Street, NW Suite 500 Washington, D.C. 20007 Attention: Michael Kaminski Telephone No.: 202.672.5490 Facsimile No.: 202.672.5399 Abbott Laboratories Ltd. 8401 Trans Canada Highway St. Laurent, Quebec CN H4S 1z1 Attention: President Telephone: (514) 832-7000 (b) if to Atrix, to: QLT USA, Inc. 2579 Midpoint Drive Fort Collins, Colorado 80525 Attention: President Telephone No.: (970) 482-5868 Facsimile No.: (970) 482-9735 With a required copy to: Morrison & Foerster LLP 5200 Republic Plaza 370 Seventeenth Street Denver, CO 80202-5638 Attention: Warren L. Troupe, Esq. Telephone No.: (303) 592-2255 Facsimile No.: (303) 592-1510 (c) if to Sanofi: sanofi-aventis 55 Corporate Boulevard Bridgewater, NJ 08807 Attention: John Spinnato Vice President and General Counsel Telephone No.: (908) 981-6800 Facsimile No.: (908) 981-6801 -11- with a required copy to: Proskauer Rose LLP 1585 Broadway New York, NY 10036-8299 Attention: Bruce E. Fader, Esq. Telephone No.: (212) 969-3415 Facsimile No.: (212) 969-2900 or at such other address for a Party as shall be specified by like notice. 10.6. GOVERNING LAW AND VENUE. This Agreement shall be governed by and construed in accordance with the internal laws of the State of New York without giving effect to any choice or conflict of law provision or rule (whether of the State of New York or any other jurisdiction) that would result in the application of laws of any jurisdiction other than those of the State of New York. All claims or disputes arising under or with respect to this Agreement, or with respect to the interpretation, performance, enforcement, or breach of this Agreement, shall be resolved exclusively in the courts of the State of New York, the courts of the United States in the Southern District of New York, and appellate courts from any thereof and the Parties agree that the exclusive jurisdiction and venue for resolving such claims and disputes shall reside in such courts. Each Party consents that any such action or proceeding may be brought in, and hereby submits to the jurisdiction of, such courts and waives any objection or defense (including, without limitation any defense of inconvenient forum or absence of jurisdiction) that it may now or hereafter have to the venue of any such action or proceeding in any such court. 10.7. COUNTERPARTS AND FACSIMILE SIGNATURES. This Agreement may be executed and delivered in any number of counterparts. When each Party has signed and delivered at least one counterpart to all other Parties, all counterparts, taken together, shall constitute one and the same agreement, which shall be binding and effective on the Parties to this Agreement. Each counterpart shall be deemed an original. Facsimile execution and delivery of this Agreement and any Exhibits by any of the Parties shall be legal, valid and binding execution and delivery of such document for all purposes. 10.8. ASSIGNMENT. Without the consent of Atrix or Sanofi, Releasing Parties may assign this Agreement to an Affiliate or in connection with any merger, acquisition, reorganization, sale or transfer of substantially all of the assets to which this Agreement relates. Notwithstanding the foregoing, any assignment of this Agreement shall not relieve the Releasing Parties from the performance of their obligations under this Agreement and for the avoidance of doubt, any Subject Product Patent Rights that are assigned shall remain subject to the applicable terms of this Agreement. Without the consent of Releasing Parties, Atrix or Sanofi may assign this Agreement to an Affiliate or in connection with any merger, acquisition, reorganization, sale or transfer of substantially all of the assets to which this Agreement relates. Notwithstanding the foregoing, any assignment of this Agreement shall not relieve Atrix or Sanofi from the performance of their obligations under this Agreement. Subject to the foregoing, this Agreement will be binding upon, inure to the benefit of and be enforceable by the Parties and their respective successors and permitted assigns. -12- 10.9. INTERPRETATION. The recitals to this Agreement constitute an integral part of this Agreement. The headings contained in this Agreement are for convenience of reference only and shall not affect in any way the meaning or interpretation of this Agreement. Because all Parties have participated in drafting, reviewing, and editing the language of this Agreement, no presumption for or against any Party arising out of drafting all or any part of this contract shall be applied in any action whatsoever. Whenever the context may require, any pronouns used in this Agreement shall include the corresponding masculine, feminine or neuter forms, and the singular form of nouns and pronouns shall include the plural, and vice versa. 10.10. LICENSE REGISTRATION AND RECORDAL. Atrix and Sanofi shall have the right, at their sole cost and expense, to register, record and otherwise document the license granted under this Agreement in any country in the Territory. Licensors agree to take, at Atrix's or Sanofi's sole cost and expense, all steps reasonably requested by Atrix or Sanofi, respectively, including but not limited to executing a "short form" license, to effect the foregoing registration, recordal or other documentation in any such country in the Territory, and may record such short form license, but no short form license shall in any way alter or otherwise affect the rights and obligations of the Parties hereunder. 10.11. COSTS. Each Party shall bear its own costs and expenses incurred in connection with the Litigation and the negotiation and preparation of this Agreement. 10.12. WAIVER OF JURY TRIAL. The Parties each hereby irrevocably and unconditionally waives all rights to trial by jury in any legal action, proceeding or counterclaim with respect to any matter whatsoever arising out of or in connection with or related to this Agreement or the enforcement thereof. IN WITNESS WHEREOF, the Parties have executed, or caused their duly authorized representatives to execute, this Agreement under seal as of the date first written above. TAKEDA PHARMACEUTICAL COMPANY LIMITED By: /s/ Hiroshi Akimoto ---------------------------------- Hiroshi Akimoto, Ph. D. Title: Managing Director, Member of the Board WAKO PURE CHEMICAL INDUSTRIES, LTD. By: /s/ Kazuo Kamisugi ---------------------------------- Title: Director, Member of the Board General Manager, Licensing and I.P. Dept. -13- TAP PHARMACEUTICAL PRODUCTS INC. By: /s/ Alan MacKenzie ---------------------------------- Alan MacKenzie Title: President ABBOTT LABORATORIES, LIMITED - LABORATORIES ABBOTT, LIMITEE By: /s/ [ILLEGIBLE] ---------------------------------- Title: President, General Manager QLT USA, INC. By: /s/ Sean F. Moriarty ---------------------------------- Sean F. Moriarty, President SANOFI-SYNTHELABO INC. By: /s/ John M. Spinnato ---------------------------------- John M. Spinnato Title: Vice President & General Counsel -14- EXHIBIT A FORM OF JOINT MOTION TO DISMISS EXHIBIT B FORM OF STIPULATED ORDER OF DISMISSAL AND OTHER FILING EXHIBIT C Form of Press Releases EX-10.36 6 o34971exv10w36.txt ELIGARD MANUFACTURING & SUPPLY AGREEMENT 12-22-06 EXHIBIT 10.36 CONFIDENTIAL TREATMENT REQUESTED BY QLT INC. ELIGARD(R) MANUFACTURING AND SUPPLY AGREEMENT BETWEEN QLT USA, INC. AND TOLMAR, INC. TABLE OF CONTENTS
PAGE ---- ARTICLE I DEFINITIONS............................................... 1 ARTICLE II LICENSE GRANT; PROVISION OF MATERIALS..................... 8 Section 2.01 License Grant......................................... 8 Section 2.02 Restrictions and Reservation of Rights................ 8 Section 2.03 Ownership of Improvements............................. 8 Section 2.04 Supplied Materials.................................... 10 Section 2.05 Storage............................................... 11 ARTICLE III MANUFACTURE AND SUPPLY.................................... 11 Section 3.01 Agreement to Purchase and Supply Product.............. 11 Section 3.02 Quality Assurance..................................... 11 Section 3.03 Manufacturer's Duties................................. 12 Section 3.04 Second Source......................................... 13 Section 3.05 Execution of Intermediate Manufacturing Agreement..... 14 ARTICLE IV PURCHASE AND SALE......................................... 14 Section 4.01 Purchase Price and Payment............................ 14 Section 4.02 Invoice; Payment Terms................................ 15 Section 4.03 Purchase Forms........................................ 15 Section 4.04 Confirmation.......................................... 15 Section 4.05 Delivery.............................................. 15 Section 4.06 Forecasts and Orders.................................. 16 Section 4.07 Failure to Supply..................................... 16 ARTICLE V WARRANTY, REJECTION AND INSPECTIONS....................... 17 Section 5.01 Product Warranties.................................... 17 Section 5.02 Rejection of Product for Failure to Conform to Specifications........................................ 17 Section 5.03 Latent Defects........................................ 18 Section 5.04 Inspection Rights..................................... 18 Section 5.05 Product Recall........................................ 19 ARTICLE VI REGULATORY................................................ 20 Section 6.01 QLT USA's Responsibilities............................ 20 Section 6.02 Manufacturer Responsibility........................... 20 Section 6.03 Master File........................................... 20
-i- TABLE OF CONTENTS (continued)
PAGE ---- Section 6.04 Stability Testing and Final Product Release........... 21 ARTICLE VII LIABILITY AND INDEMNIFICATION............................. 21 Section 7.01 QLT USA Indemnification............................... 21 Section 7.02 Manufacturer's Indemnification........................ 21 Section 7.03 Limitation of Losses.................................. 22 Section 7.04 Indemnity Procedure................................... 22 Section 7.05 Maintenance of Insurance.............................. 23 ARTICLE VIII CONFIDENTIALITY........................................... 23 Section 8.01 Maintenance of Confidential Information............... 23 ARTICLE IX TERM AND TERMINATION...................................... 24 Section 9.01 Term.................................................. 24 Section 9.02 Termination By QLT USA................................ 25 Section 9.03 Termination By Manufacturer........................... 25 Section 9.04 Remedies.............................................. 26 Section 9.05 Effect of Termination................................. 26 ARTICLE X MISCELLANEOUS............................................. 26 Section 10.01 Force Majeure......................................... 26 Section 10.02 Applicable Law........................................ 26 Section 10.03 Assignment............................................ 26 Section 10.04 Notices............................................... 27 Section 10.05 Entire Agreement...................................... 28 Section 10.06 Amendments and Waivers................................ 28 Section 10.07 Foreign Corrupt Practices Act......................... 28 Section 10.08 Severability.......................................... 28 Section 10.09 Counterparts.......................................... 28 Section 10.10 Construction.......................................... 29 Section 10.11 Jurisdiction; Service of Process...................... 29 Section 10.12 Waiver of Jury Trial.................................. 29 Section 10.13 Recovery of Fees by Prevailing Party.................. 29 Section 10.14 Resolution of Certain Disputes........................ 29 Section 10.15 Time of the Essence................................... 30
-ii- TABLE OF CONTENTS
PAGE ---- Schedule 1 - Cost Per Unit Exhibit A - Atrigel(R) Patent Rights Exhibit B - Certificate of Analysis Exhibit C - Certificate of Compliance Exhibit D - Components Exhibit E - Quality Agreement Exhibit F - Example of Calculation of Product Manufacturing Cost Per Unit
ELIGARD(R) MANUFACTURING AND SUPPLY AGREEMENT This Eligard(R) Manufacturing and Supply Agreement (this "Agreement") is made on December 22, 2006 (the "Effective Date") by and between QLT USA, Inc., a Delaware corporation having its offices at 2579 Midpoint Drive, Fort Collins, Colorado 80525-4417, USA ("QLT USA"), and Tolmar, Inc., a Delaware corporation, having its offices at 701 Centre Avenue, Fort Collins, Colorado 80526 ("Manufacturer"). Manufacturer and QLT USA are sometimes referred to collectively herein as the "Parties" or individually as a "Party." RECITALS WHEREAS, QLT USA and Manufacturer have entered into that certain Asset Purchase Agreement dated December 20, 2006 (the "Purchase Agreement"), under which Manufacturer has agreed to purchase (the "Transaction") the Generic Dermatology Business (as defined in the Purchase Agreement), the Dental Business (as defined in the Purchase Agreement), the Facility and certain related assets, and to assume certain liabilities (collectively, the "Business") in accordance with the terms and conditions of the Purchase Agreement; WHEREAS, as a result of the Transaction, QLT USA will no longer have the ability to manufacture certain products, but will remain obligated to do so under various license, supply or similar agreements with Third Parties; and WHEREAS, as a condition precedent to the closing of the Transaction, Manufacturer has agreed to enter into this Agreement and the other Manufacturing and Supply Agreements (as defined in the Purchase Agreement) to manufacture and supply various products and compounds for and on behalf of QLT USA. NOW, THEREFORE, in consideration of the foregoing recitals and the mutual covenants and agreements contained herein, the Parties hereto, intending to be legally bound, do hereby agree as follows: ARTICLE I DEFINITIONS (a) As used in this Agreement (including the appendices and exhibits), the following terms shall have the meanings set forth below: "Active Ingredient" means leuprolide acetate. "Affiliate" means, with respect to any Party, an individual, trust, business trust, joint venture, partnership, corporation, association or any other entity which owns, is owned by or is under common ownership with, such Party. For the purposes of this definition, the term "owns" (including, with correlative meanings, the terms "owned by" and "under common ownership with") as used with respect to any Party, shall mean the possession (directly or indirectly) of more than 50% of the outstanding voting securities of a corporation or comparable equity interest in any other type of entity. 1 "Applicable Laws" means all applicable laws, rules, regulations and guidelines that may apply to the marketing, manufacturing, packaging or sale of a Product or the performance of the applicable Party's obligations under this Agreement, including laws, regulations and guidelines governing the import, export, marketing, distribution and sale of a Product, to the extent relevant, and including all cGMP or good clinical practices and other standards or guidelines promulgated by the Competent Authorities and including trade association guidelines, where applicable, as well as United States' export control laws and the United States' Foreign Corrupt Practices Act. "Atrigel(R) Know-How" means all Know-How related to QLT USA's proprietary Atrigel(R) drug delivery system as of the Effective Date and at any time during the Term of this Agreement, which is not covered by the Atrigel(R) Patent Rights, but is necessary or useful to Manufacture the Product for QLT USA, which is provided to Manufacturer by QLT USA pursuant to this Agreement, and which is under the Control of QLT USA as of the Effective Date or at any time during the Term of this Agreement. "Atrigel(R) Patent Rights" means all Patent Rights related to QLT USA's proprietary Atrigel(R) drug delivery system as of the Effective Date and at any time during the Term of this Agreement, which are necessary or useful to Manufacture the Product for QLT USA, and which are under the Control of QLT USA as of the Effective Date. The Atrigel(R) Patent Rights as of the Effective Date are set forth on Exhibit A. "Atrigel(R) Technology" means the Atrigel(R) Patent Rights and the Atrigel(R) Know-How. "Batch" means a specific quantity of a Product, or a Sub Unit, that is intended to have uniform character and quality, within specified limits, and is produced according to a single manufacturing order during the same cycle of Manufacture. "Batch Production Record" means the set of detailed processing instructions, which are to be followed by Manufacturer to Manufacture one Batch of Product within the meaning of 21 CFR part 211.188, or its successor as in effect from time to time. "Certificate of Analysis" means a certificate, in the form attached hereto as Exhibit B, to accompany each Batch of Product that documents the analytical results, including a detailed report on sterility, endotoxin and appearance for that Batch of Product and confirms compliance of that Batch of Product with the Specifications in accordance with Governmental Approvals. "Certificate of Compliance" means a certificate, in the form attached hereto as Exhibit C, to accompany each Batch of Product that certifies the accuracy, completeness and compliance of that Batch of Product with the Specifications and cGMP practices and other Applicable Laws. "cGMP" means current good manufacturing practices as defined and established under Applicable Laws. "Competent Authorities" means collectively the governmental entities responsible for the regulation of medicinal products intended for human use, including the FDA. "Components" shall mean those materials that are to be either (a) supplied by QLT USA or (b) purchased by Manufacturer on behalf of QLT USA, for the Manufacture of a Product 2 pursuant to the Specifications, including the Active Ingredient, inactive ingredients, other raw materials, labels, inserts and other materials, all as set forth in Exhibit D. "Confidential Information" means any confidential information of a Party relating to any use, process, method, compound, research project, work in process, future development, scientific, engineering, manufacturing, marketing, business plan, financial or personnel matter relating to the disclosing Party, its present or future products, sales, suppliers, customers, employees, investors or business, whether in oral, written, graphic or electronic form, including the Specifications and the Quality Agreement, all technical and/or proprietary information relating to the Products or the production process for the Products and information relating to the marketing of, customers for, and sales and pricing of the Products. "Consumer Price Index" means the Consumer Price Index for all Urban Consumers (Consumer Prices - All Urban Consumers, 1982-84 = 100) as published by the Bureau of Labor Statistics of the Department of Labor of the United States Department of Commerce. "Control" means the possession of the ability to grant a license or sublicense as provided for herein without violating the terms of any agreement or other arrangement with any Third Party. "Cost Per Unit" means the price per Unit or Sub Unit, on a Product-by-Product basis, as set forth on Schedule 1. "Demonstration Samples" means Units used to demonstrate the manner in which a Product is prepared and used, and labeled "demonstration samples, for demonstration purposes only, not for human use," as more fully described in the Specifications. "Facility" shall mean the Manufacturer's manufacturing facility located at 701 Centre Avenue, Fort Collins, Colorado 80526. "FDA" means the United States Food and Drug Administration. "FOB the Facility" shall have the meaning set forth in Section 2-319(1)(a) of the Colorado Uniform Commercial Code. "Four Month Product" means the formulation comprised of leuprolide acetate in an Atrigel(R) delivery system that provides for the sustained release of leuprolide acetate over a period of about one hundred and twenty (120) days and not less than one hundred and twelve (112) days with a primary indication for the palliative treatment of prostate cancer. "Full Batch Quantities," with respect to the One Month Product, Three Month Product and Four Month Product, means Batches with a target yield of, in the aggregate, [**], or [**] Sub Units, and with respect to the Six Month Product, means Batches with a target yield of, in the aggregate, [**] Units, or [**] Sub Units, it being understood that QLT USA may request Manufacturer to Package and Ship, but not Manufacture, a Product in less than Full Batch Quantities. - ---------- ** Confidential Treatment Requested. 3 "Governmental Approval" means all permits, licenses and authorizations, including but not limited to, import permits and Marketing Authorizations, required by any Competent Authority as a prerequisite to the Manufacturing, packaging, marketing or selling of a Product or the Units. "Improvement" means any and all developments, inventions or discoveries relating to the Manufacture of pharmaceutical products at the Facility, developed or acquired by Manufacturer at any time during the Term whether in connection with the Product or otherwise. "Intermediate Step Manufacturing Agreement" means an agreement to be entered into between [**] and Manufacturer for the sterilization of syringe A. "Know-How" means all know-how, trade secrets, inventions, data, processes, techniques, procedures, compositions, devices, methods, formulas, protocols and information, whether or not patentable, which are not publicly known, including, without limitation, all chemical, biochemical, toxicological, and scientific research information. "Latent Defect" means any defect in the Product to the extent resulting solely from the Manufacture or Shipping of the Product that is not discovered during routine acceptance or stability testing conducted by Manufacturer or otherwise. "Losses" means any damage, loss, cost or expense (including reasonable attorneys' fees and reasonable costs of investigation incurred in defending against any claim, action, demand, suit or proceeding). "Manufacture," "Manufacturing" or "Manufacturing Process" means the storage, handling, production, processing, and Packaging of a Product, and/or a Demonstration Sample, in accordance with this Agreement and Applicable Laws. "Marketing Authorization" means all necessary and appropriate regulatory approvals, including but not limited to, variations thereto, and pricing and reimbursement approvals, to put a Product on the market. "Master Production Procedures" shall mean a written description of the procedure to be followed for processing a Batch of Product including but not limited to a complete list of all active and inactive ingredients, components, weights and measures, descriptions of drug product containers, closures, packaging materials, and labeling and complete specifications for each, within the meaning of 21 CFR part 211.186, or its successor as in effect from time to time. "One Month Product" means the formulation comprised of leuprolide acetate in an Atrigel(R) delivery system that provides for the sustained release of leuprolide acetate over a period of about thirty (30) days and not less than twenty-eight (28) days with a primary indication for the palliative treatment of prostate cancer. "Package," "Packaging" or "Packaging Specifications" means any and all containers, cartons, shipping cases, inserts, package inserts, labels (including any related artwork and - ---------- ** Confidential Treatment Requested. 4 engineering drawings) or other similar material used in packaging or accompanying the Product in the most current revision approved in each country's specific Governmental Approval. "Patent Rights" means all rights under patents and patent applications, and any and all patents issuing therefrom (including utility, model and design patents and certificates of invention), together with any and all substitutions, extensions (including supplemental protection certificates), registrations, confirmations, reissues, divisionals, continuations, continuations-in-part, re-examinations, renewals and foreign counterparts of the foregoing, and all improvements, supplements, modifications or additions. "Product" means collectively the One Month Product, the Three Month Product, the Four Month Product, and the Six Month Product supplied in Unit packages or any formulation of leuprolide acetate, in any concentration, in the Atrigel(R) delivery system for the palliative treatment of prostate cancer, and includes, as the context requires, each Sub Unit for such Product. "Product Manufacturing Cost" means the actual cost to Manufacture the Product by Manufacturer (including any subcontractor) during each calendar year during the Term, including the related quality assurance and quality control activities as required by Applicable Laws, which actual cost shall be determined in accordance with GAAP, and shall include direct labor, direct material (including raw material and components supplied by Manufacturer but not including the Ordered Components), direct overhead (e.g. depreciation of a packaging line solely dedicated to the Product) and the allocable portion of the indirect Manufacturing overhead directly attributable to the Manufacture of the Product. The allocable portion of the Manufacturing overhead of the Facility shall be equal to [**]. Product Manufacturing Cost shall exclude selling, general and administrative, research and development, interest expenses, any and all debt service payments of Manufacturer, and any other costs not directly associated with the Manufacture of the Product, other than direct and indirect manufacturing overhead. The Parties agree that in no event shall the Product Manufacturing Cost include capital expenditures and improvements to or for the Facility, except as directly or indirectly allocated through Manufacturing overhead. "Product Manufacturing Cost Per Unit" shall be calculated on a Product-by-Product basis by dividing actual Product Manufacturing Costs incurred as set forth above by total Units Manufactured during each calendar year during the Term. In cases where actual Unit production for a particular Batch does not exceed a yield percentage of [**], the related Units and costs shall be excluded in completing the Product Manufacturing Cost Per Unit calculation for the applicable calendar period as set forth in Exhibit F to this Agreement. Also, the allocable Manufacturing overhead component in any one year shall be subject to a cap equal to the [**] during the period of Manufacture multiplied by the prior period's allocable Manufacturing overhead component included within the prior period's Product Manufacturing Cost Per Unit. - ---------- ** Confidential Treatment Requested. 5 "Quality Agreement " means the quality systems agreement, attached hereto as Exhibit E, between QLT USA and Manufacturer, the purpose of which is to measure the conformity of a Product hereunder to the Specifications. "Shipment," "Ship" or "Shipped" means each individual group of Product with respect to which title has passed to QLT USA from Manufacturer. "Six Month Product" means the formulation comprised of leuprolide acetate in an Atrigel(R) delivery system that provides for the sustained release of leuprolide acetate over a period of about one hundred and eighty (180) days and not less than one hundred and sixty-eight (168) days with a primary indication for the palliative treatment of prostate cancer. "Specifications" means the specifications, including the Master Production Procedures, and all Packaging Specifications and labeling specifications, for a Product as may be amended from time to time by the Parties and in compliance with Applicable Laws in the most current revision approved in each country's specific Governmental Approval. "Sub Unit" means any one or more of the Syringe A Sub Unit, Syringe B Sub Unit or the Packaging and Product Release Sub Unit, each as identified on Schedule 1. "Technical Information" shall mean all information, materials, knowledge, data, drawings and other specifications involving or relating to the Manufacture of a Product provided to Manufacturer by QLT USA pursuant to this Agreement, including, without limitation, the Specifications. "Third Party" means any entity other than: (a) Manufacturer, (b) QLT USA or (c) an Affiliate of Manufacturer or QLT USA. "Three Month Product" means the formulation comprised of leuprolide acetate in an Atrigel(R) delivery system that provides for the sustained release of leuprolide acetate over a period of about ninety (90) days and not less than eighty-four (84) days with a primary indication for the treatment of prostate cancer. "Unit" means the Product packaged in a two-part system consisting of (a) one syringe of Atrigel(R) delivery system and a plunger rod in a specified pouch or tray and sterilized by gamma irradiation; (b) one syringe containing sufficient leuprolide acetate for a One Month Product, Three Month Product, Four Month Product or Six Month Product, aseptically filled and lyophilized in the syringe, and a needle packaged in a specified pouch or tray; (c) instructions for use, as such trade or sample package may be changed or reformulated by Manufacturer and QLT USA from time to time; and (d) a commercial trade or sample package. (b) Each of the following terms is defined in the Section set forth opposite such term below: AAA Section 10.14 Agreement Preamble Atrigel(R) Improvement Confidential Rights Section 2.03(a) Atrigel(R) Improvements Section 2.03(a)
6 Business Recitals Disputed Amount Section 4.01 Effective Date Preamble Four-Month Amount Section 2.05 Indemnity Claim Section 7.04 Insurance Section 7.05 Manufacturer Preamble Manufacturing Improvement Confidential Rights Section 2.03(a) Manufacturing Improvements Section 2.03(a) Maximum Supply Amount Section 4.07(a) Ordered Components Section 2.04(c) Other Improvement Confidential Rights Section 2.03(c) Other Improvements Section 2.03(c) Party(ies) Preamble Proposal Section 10.14 Purchase Agreement Recitals Purchase Price Section 4.01(a) QLT USA Preamble Recall Section 5.05 Resolution Date Section 10.14 Revised Purchase Price Section 10.14 Rolling Forecast Section 4.06 Second Source Section 3.04 Term Section 9.01 Testing Period Section 5.02 Transaction Recitals
(c) The Section headings contained in this Agreement are for reference purposes only and shall not affect the meaning or interpretation of this Agreement. Except where the context clearly requires to the contrary: (i) each reference in this Agreement to a designated "Section," "Exhibit" or "Schedule" is to the corresponding Section, Exhibit or Schedule of or to this Agreement; (ii) instances of gender or entity-specific usage (e.g., "his" "her" "its" "person" or "individual") shall not be interpreted to preclude the application of any provision of this Agreement to any individual or entity; (iii) "including" shall mean "including, without limitation"; (iv) references to Applicable Laws shall mean such Applicable Laws in effect during the Term (taking into account any amendments thereto effective at such time without regard to whether such amendments were enacted or adopted after the Effective Date); (v) references to "$" or "dollars" shall mean the lawful currency of the United States; (vi) references to "Federal" or "federal" shall be to laws, agencies or other attributes of the United States (and not to any State or locality thereof); (vii) the meaning of the terms "domestic" and "foreign" shall be determined by reference to the United States; (viii) references to "days" shall mean calendar days; (ix) references to months or years shall be to the actual calendar months or years at issue (taking into account the actual number of days in any such month or year); (x) days, business days and times of day shall be determined by reference to local time in Denver, Colorado; (xi) the English language version of this Agreement 7 shall govern all questions of interpretation relating to this Agreement, notwithstanding that this Agreement may have been translated into, and executed in, other languages; and (xii) the terms "Product" and "Products" shall refer to each individual Product and all Products collectively, unless the context clearly indicates otherwise. (d) This Agreement is entirely independent, separate and severable from the Purchase Agreement and all rights and obligations set forth therein. ARTICLE II LICENSE GRANT; PROVISION OF MATERIALS Section 2.01 LICENSE GRANT. Subject to the terms and conditions of this Agreement, QLT USA hereby grants to Manufacturer for the Term a fully paid-up, royalty-free, non-exclusive, non-transferable, non-sublicensable, right and license to make, have made, and use the Technical Information and Atrigel(R) Technology and the Manufacturing Improvements and the Atrigel(R) Improvements solely to Manufacture the Products, solely at the Facility and solely for sale to QLT USA. In addition, QLT USA shall provide to Manufacturer such Technical Information and Atrigel(R) Technology as is reasonably necessary or advisable to facilitate Manufacturer's Manufacture of the Product. At Manufacturer's request, QLT USA shall answer reasonable questions with respect to the Technical Information and the Atrigel(R) Technology. All Technical Information and Atrigel(R) Technology shall constitute the Confidential Information of QLT USA. Section 2.02 RESTRICTIONS AND RESERVATION OF RIGHTS. Manufacturer agrees not to use the Technical Information and Atrigel(R) Technology or make or sell the Product except as expressly permitted in Section 2.01. All intellectual property rights in and to (a) the Product, the Technical Information and Atrigel(R) Technology are and shall at all times be owned by QLT USA, and (b) the Manufacturing Processes (not related to the Manufacture of the Product or to the Atrigel(R) Technology) are and shall at all times be owned by Manufacturer, subject in the case of both (a) and (b) only to the license rights expressly granted to Manufacturer in Section 2.01 and, as applicable, the provisions of Section 2.03. Any and all rights to the Technical Information and Atrigel(R) Technology not expressly granted to Manufacturer herein are reserved by QLT USA. Any and all rights to the Manufacturing Process (not related to the Manufacture of the Product or to the Atrigel(R) Technology) not expressly granted to QLT USA herein are reserved by Manufacturer. Section 2.03 OWNERSHIP OF IMPROVEMENTS. (a) Manufacturer agrees to disclose promptly in writing to QLT USA all Improvements. Manufacturer further agrees that any and all Improvements to the Manufacturing Process that are exclusively or primarily related to the Products (the "Manufacturing Improvements") or that relate to or utilize the Atrigel(R) Technology (the "Atrigel(R) Improvements"), shall be the sole and exclusive property and Confidential Information of QLT USA. Manufacturer hereby irrevocably assigns and agrees to assign to QLT USA all right, title and interest worldwide in and to the Manufacturing Improvements and the Atrigel(R) Improvements (in each case whether currently existing 8 or conceived, created or otherwise developed later), including, without limitation, all trade secrets, patents, industrial rights and all other intellectual and proprietary rights related thereto (respectively, the "Manufacturing Improvement Confidential Rights" and the "Atrigel(R) Improvement Confidential Rights"), effective immediately upon the inception, conception, creation or development thereof. The Manufacturing Improvement Confidential Rights shall include, without limitation, all rights, whether existing now or in the future, whether statutory or common law, in any jurisdiction in the world, related to the Manufacturing Improvements. The Atrigel(R) Improvement Confidential Rights shall include, without limitation, all rights, whether existing now or in the future, whether statutory or common law, in any jurisdiction in the world, related to the Atrigel(R) Improvements. Except for the license granted to Manufacturer under Section 2.01 or as otherwise agreed in writing by the Parties, Manufacturer retains no rights to use the Manufacturing Improvements or the Atrigel(R) Improvements and agrees not to challenge the validity of QLT USA's ownership in the Manufacturing Improvements and the Atrigel(R) Improvements. (b) To the extent, if any, that any Manufacturing Improvements, Manufacturing Improvement Confidential Rights, Atrigel(R) Improvements, or Atrigel(R) Improvement Confidential Rights are not assignable or that Manufacturer retains any right, title or interest in and to any Manufacturing Improvements, Manufacturing Improvement Confidential Rights, Atrigel(R) Improvements, or Atrigel(R) Improvement Confidential Rights, Manufacturer (i) unconditionally and irrevocably waives the enforcement of such rights, and all claims and causes of action of any kind against QLT USA with respect to such rights; (ii) agrees, at QLT USA's request and expense, to consent to and join in any action to enforce such rights; and (iii) hereby grants to QLT USA a perpetual, irrevocable, fully paid-up, royalty-free, transferable, sublicensable (through multiple levels of sublicenses), exclusive, worldwide right and license to make, have made, use, lease, and sell Manufacturing Improvements and Atrigel(R) Improvements. Manufacturer hereby waives and quitclaims to QLT USA any and all claims, of any nature whatsoever, which Manufacturer now or may hereafter have for infringement of any Manufacturing Improvements, Manufacturing Improvement Confidential Rights, Atrigel(R) Improvements, or Atrigel(R) Improvement Confidential Rights assigned and/or licensed hereunder to QLT USA. (c) All Improvements other than Manufacturing Improvements and Atrigel(R) Improvements (the "Other Improvements") shall be the sole and exclusive property and Confidential Information of Manufacturer. Manufacturer hereby grants to QLT USA a perpetual, irrevocable, fully paid-up, royalty-free, non-exclusive (with the right to sublicense only for the purpose of Manufacturing the Product) worldwide right and license to make, have made, and use only such Other Improvements as are necessary to the Manufacture of the Products and solely for the Manufacture of the Products. QLT USA hereby irrevocably assigns and agrees to assign to Manufacturer any and all right, title and interest worldwide in and to the Other Improvements (whether currently existing or conceived, created or otherwise developed later), including, without limitation, all trade secrets, patents, industrial rights and all other intellectual and proprietary rights related thereto (the "Other Improvement Confidential Rights"), effective immediately upon the inception, conception, creation or development thereof. The Other 9 Improvement Confidential Rights shall include, without limitation, all rights, whether existing now or in the future, whether statutory or common law, in any jurisdiction in the world, related to the Other Improvements. Except for the license granted to QLT USA under this Section 2.03(c) or as otherwise agreed in writing by the Parties QLT USA retains no rights to use the Other Improvements and agrees not to challenge the validity of Manufacturer's ownership in the Other Improvements. (d) To the extent, if any, that any Other Improvements or Other Improvement Confidential Rights are not assignable or that QLT USA retains any right, title or interest in and to any Other Improvements or any Other Improvement Confidential Rights, QLT USA (i) unconditionally and irrevocably waives the enforcement of such rights, and all claims and causes of action of any kind against Manufacturer with respect to such rights; (ii) agrees, at Manufacturer's request and expense, to consent to and join in any action to enforce such rights; and (iii) hereby grants to Manufacturer a perpetual, irrevocable, fully paid-up, royalty-free, transferable, sublicensable (through multiple levels of sublicenses), exclusive, worldwide right and license to make, have made, use, lease, and sell Other Improvements and Other Improvement Confidential Rights. QLT USA hereby waives and quitclaims to Manufacturer any and all claims, of any nature whatsoever, which QLT USA now or may hereafter have for infringement of any Other Improvements or Other Improvement Confidential Rights assigned and/or licensed hereunder to Manufacturer. Section 2.04 SUPPLIED MATERIALS. (a) At least thirty (30) days prior to the scheduled Manufacturing date, QLT USA shall deliver, at its expense, sufficient quantities of the Components to be delivered by QLT USA to the Facility to enable Manufacturer to satisfy its obligations to QLT USA under this Agreement. All Components (including Ordered Components) supplied by QLT USA shall meet the applicable Specifications, including Master Production Procedures, and shall remain the property of QLT USA until incorporated into the Product; (b) Manufacturer will be responsible for supplying sufficient quantities of all materials necessary for Manufacturer to Manufacture the Products (which materials are set forth on Exhibit D) other than the Components to be delivered by QLT USA and the Ordered Components. All such items supplied by Manufacturer shall meet the applicable Specifications, including the Master Production Procedures; and (c) Manufacturer shall order and hold for the benefit of QLT USA and its designees those Components designated as "Ordered Components" on Exhibit D (the "Ordered Components") at such times and in such amounts sufficient to Manufacture Products in accordance with the firm order portion of the Rolling Forecast. Upon receipt of the invoice from the suppliers of the Ordered Components, Manufacturer shall invoice QLT USA therefore at a price equal to the actual cost of the Ordered Components [**] and payment shall be due [**] following QLT USA's receipt of such invoice. For all purposes under this Agreement, Manufacturer shall not be responsible for any delay in - ---------- ** Confidential Treatment Requested. 10 the Ordered Components, any failure of the Ordered Components to satisfy the Specifications, or any other event or circumstance that could or would constitute a breach of this Agreement that directly arises from, relates to, or results from any such delay or failure, except if and to the extent such delay or failure is caused by the gross negligence or willful misconduct of Manufacturer. Section 2.05 STORAGE. Manufacturer shall store the Components as well as finished Products at the Facility, at no expense to QLT USA, in accordance with QLT USA's instructions and Applicable Laws until such time as such Components are incorporated into Products and Shipped to QLT USA or its customers, as applicable; provided, however, that (a) Manufacturer shall not be required to store finished Products at the Facility for more than [**] past the anticipated delivery date; and (b) Manufacturer shall only be obligated to store [**] worth of such Components, in accordance with the firm order portions of the Rolling Forecast [**]. If QLT USA requests Manufacturer to store any Components exceeding the [**], then QLT USA shall notify Manufacturer, in writing, at least thirty (30) days before the date QLT USA intends to deliver such Components exceeding the Four-Month Amount, which request shall be subject to the Manufacturer's prior written consent (which consent shall be granted on a space-available basis). QLT USA shall be responsible for reasonable storage charges for such (i) excess Components, (ii) for any finished Product stored for more than [**] past the anticipated delivery date, and (iii) Ordered Components held for the benefit of QLT USA's designees, in each case, not to exceed [**] for room-temperature storage or [**] for refrigerated storage, plus a reasonable handling charge of [**] to the extent materials or products are reasonably required to be moved. Commencing [**], such storage costs shall increase annually by an amount equal to the [**]. Further, with respect to the Ordered Components held for the benefit of QLT USA's designees, QLT USA shall reimburse Manufacturer for all expenses to ship such Ordered Components to such designees as and when instructed by QLT USA and all such shipments shall be FOB Facility. ARTICLE III MANUFACTURE AND SUPPLY Section 3.01 AGREEMENT TO PURCHASE AND SUPPLY PRODUCT. Subject to the terms and conditions set forth in this Agreement, QLT USA agrees to purchase from Manufacturer, and Manufacturer agrees to Manufacture for, and sell exclusively to QLT USA or its designees during the Term, at least [**] of QLT USA's aggregate Unit requirements for the Products and the Demonstration Samples; provided, however, that a Product shall not be included in such [**] requirement until such time as Manufacturer has received Governmental Approval to Manufacture such Product (and QLT USA shall use commercially reasonable efforts to obtain all Governmental Approvals necessary or advisable in order for the Facility to Manufacture Products for sale in each country in which Products are sold to end users or with respect to which QLT USA has entered into, or hereafter enters into, any license agreement or arrangement) and then only with respect to orders made by QLT USA or its designees after such date. In addition, without limiting the generality of the preceding sentence, QLT USA agrees to purchase from - ---------- ** Confidential Treatment Requested. 11 Manufacturer, in the aggregate, at least (a) [**] during the [**] calendar year, and (b) [**] during the [**] calendar year. Manufacturer shall sell and QLT USA shall purchase the Products in Full Batch Quantities. Section 3.02 QUALITY ASSURANCE. QLT USA shall be responsible for furnishing to Manufacturer appropriate Specifications, including Packaging Specifications to be used in connection with the Manufacture of the Product. Manufacturer shall Manufacture each Product in accordance with the Specifications and the Quality Agreement. Except with respect to the Intermediate Step Manufacturing Agreement, Manufacturer may not subcontract any part of the Manufacturing Process for the Product and the Demonstration Samples to a Third Party, without the prior written consent of QLT USA (which consent may be withheld in QLT USA's sole discretion). Any such permitted subcontractor shall be subject to the terms and conditions of this Agreement, and any costs related thereto shall be borne by Manufacturer. Manufacturer shall consult with QLT USA as to any proposed changes in the Specifications, or the Quality Agreement that might render Manufacturer unable to supply Product in accordance with the terms of this Agreement, prior to making those changes, and obtain QLT USA's prior written consent thereto (which consent may be withheld in QLT USA's sole discretion). Each Party shall immediately notify the other Party in writing of any changes required by a Competent Authority in the Specifications or the Quality Agreement and the Parties agree to develop and execute an appropriate action plan to address such situation. Any additional costs or expenses resulting from changes requested by a Competent Authority (i) specifically related to the Product shall be borne by QLT USA and (ii) any other changes shall be borne by Manufacturer. Independent of any changes required by a Competent Authority, with respect to which the preceding paragraph shall apply, from time to time Manufacturer shall, at QLT USA's expense, make such improvements in the Manufacturing Process as are reasonably requested by QLT USA. Notwithstanding the foregoing, if Manufacturer is required to purchase additional equipment to make such improvements, or if the cost of Manufacture of the Products is materially increased, the Parties shall negotiate in good faith how the cost of such equipment and any such other costs shall be allocated between the Parties. Section 3.03 MANUFACTURER'S DUTIES. Manufacturer covenants to Manufacture each Product (a) within the time periods and in the quantities set forth in the firm order portion of the Rolling Forecast; (b) in accordance with the Specifications (including the Master Production Procedures), the Quality Agreement and Applicable Laws, and label and Package each Product in accordance with such Specifications (including the labeling specifications) and not affix any other labeling to the Product, except with the prior written approval of QLT USA; and (c) to furnish to QLT USA with every Shipment a written Certificate of Analysis and Certificate of Compliance that confirms conformity of the Product to the Specifications. The Product may be subjected to testing by QLT USA or its designees in order to verify conformance of the Product with the Specifications. In addition, unless QLT USA otherwise notifies Manufacturer in writing, Manufacturer shall: (i) upon request, provide QLT USA with a copy of the written Batch Production Record; - ---------- ** Confidential Treatment Requested. 12 (ii) retain a Product sample of each Batch of Product for a period of (A) [**] following the expiration date of such Batch of Product or (B) such longer period as is required by Applicable Laws or a Competent Authority in the country in which the end user to whom the applicable Product is sold is located. Upon the written request of QLT USA, Manufacturer shall make such Product samples available to QLT USA or its designees for inspection in accordance with Section 5.04. The retained Product sample shall be in an amount sufficient in size to allow QLT USA or its designees and Manufacturer to perform tests to determine whether or not the Product conforms to the Specifications. The retained Product sample shall be kept under the approved storage conditions; (iii) maintain records to enable Manufacturer's ability to perform a complete lot history via lot tracing of the Product; (iv) keep on file all manufacturing records and analytical results pertaining to the Manufacture of each Batch of Product (including all Batch Production Records) for a period of (A) [**] or (B) such longer period as is required by Applicable Laws or a Competent Authority in a country in which the customer to whom the applicable Product is sold is located, with such period commencing on the expiration date of the last lot of the last Batch of Product Manufactured and Shipped to QLT USA or its designees. Manufacturer shall make all such records available to QLT USA or its designees upon request; (v) provide to QLT USA or its designees within two (2) business days of receipt by Manufacturer, or immediately upon the receipt of a "warning letter" or similar correspondence, complete copies of any and all inspection reports pertaining to the Manufacture of the Product that Manufacturer receives from any Competent Authority, or which is obtained by Manufacturer from any Third Party or governmental agency; (vi) in accordance with Section 5.04, provide QLT USA or its designees with complete access to all existing and hereafter produced: (A) Batch Production Records; (B) the records maintained under Section 3.03(iii), (C) quality inspection reports of the Product that are externally generated; (D) any and all investigation reports of the Product that are externally generated; and (E) packaging records pertaining to the Product; and (vii) provide to QLT USA or its designees inspection reports, investigation reports or quality inspection reports internally generated or produced by Manufacturer or its Affiliates; [**]. The Parties acknowledge and agree that QLT USA will be purchasing Product from Manufacturer on behalf of its licensees and sublicensees and that such licensees or sublicensees shall be entitled to exercise QLT USA's rights under this Agreement to inspect, monitor, audit or review the book and records of Manufacturer, the Facility and the Manufacturing Process, - ---------- ** Confidential Treatment Requested. 13 whether or not specifically noted in this Agreement, but subject to any limitations or qualifications imposed on such rights under this Agreement. Section 3.04 SECOND SOURCE. Manufacturer will reasonably cooperate with QLT USA, at QLT USA's request, to establish a second source (any and each referred to as a "Second Source") with the ability to Manufacture some or all of the Products, including making available all records relating to the Products and equipment specifications, Know-How and, to the extent reasonably required by QLT USA, personnel employed by Manufacturer who have knowledge regarding the Manufacturing of the Products. QLT USA shall reimburse Manufacturer for Manufacturer's reasonable costs (including personnel time at a full-time employee rate of [**]) incurred in connection with such cooperation. Section 3.05 EXECUTION OF INTERMEDIATE MANUFACTURING AGREEMENT. Prior to the Effective Date, Manufacturer has entered into the Intermediate Step Manufacturing Agreement on substantially the same terms as QLT USA's existing agreement with such Third Party. ARTICLE IV PURCHASE AND SALE Section 4.01 PURCHASE PRICE AND PAYMENT. (a) During the [**] calendar years, Manufacturer shall sell and QLT USA shall purchase the Products and Demonstration Samples, including retention samples, at the Cost Per Unit based on the activities performed by Manufacturer with respect to each Batch as set forth on Schedule 1 (with respect to each Product, the "Purchase Price"). Commencing [**], and annually thereafter, the Purchase Price shall increase annually by an amount equal to the [**]. Any increase in the Purchase Price for a Product under this Section 4.01 shall result in an adjustment to the Sub Unit Cost Per Unit for such Product, such that the cost of each Sub Unit shall constitute the same percentage of the overall Cost Per Unit for such Product as it did before the increase in the Purchase Price. (b) Commencing [**], and annually thereafter, if the Product Manufacturing Cost Per Unit decreases (determined on a Product-by-Product basis), Manufacturer shall give QLT USA notice of such decrease and the Purchase Price for each Product shall be reduced by an amount equal to [**] of the decrease in the Product Manufacturing Cost Per Unit. Manufacturer shall maintain and allow QLT USA to audit, or have audited by a Third Party, from time to time, all such records as are necessary to determine Manufacturer's Product Manufacturing Cost Per Unit. For the avoidance of doubt, in the event the Product Manufacturing Cost Per Unit decreases, there shall be no automatic increase in the Purchase Price of the Products pursuant to Section 4.01(a), and instead both the increase required by Section 4.01(a) and the decrease required by this Section 4.01(b) shall be offset to determine the amount, if any, by which the Purchase Price of the Products shall be increased or decreased. Any decrease in the Product - ---------- ** Confidential Treatment Requested. 14 Manufacturing Cost Per Unit for a Product shall be allocated among the Sub Unit Cost Per Unit for such Product in the same manner as set forth in Section 4.01(a). (c) If QLT USA purchases less than [**], in the aggregate, during any calendar year, then QLT USA and Manufacturer, at Manufacturer's request, will negotiate, in good faith, a revised Purchase Price, on a Product-by-Product basis, within [**] after the end of the calendar year in which less than [**] were purchased. If the Parties cannot reach agreement on a revised Purchase Price, Manufacturer shall have the option of either (i) resolving such dispute in accordance with the procedures set forth in Section 10.14; provided, however, that if Manufacturer exercises such right, Manufacturer shall no longer have the right to [**]. Section 4.02 INVOICE; PAYMENT TERMS. Manufacturer shall invoice QLT USA upon Shipment of the Product and Demonstration Samples Shipped by Manufacturer to QLT USA and payment shall be due thirty (30) days from receipt of the invoice, unless the invoice amount or any portion thereof is the subject of a good faith dispute (the "Disputed Amount") between QLT USA and Manufacturer, in which case QLT USA shall pay the undisputed portion of the invoice on or before the due date of such undisputed portion, provide Manufacturer with notice of the Disputed Amount describing in detail the reason for the Disputed Amount (including, as applicable, any information reasonably necessary to support such dispute). If any invoiced amount (other than the Disputed Amount) is not paid within such time period, a late fee shall accrue equal to one and one-half percent (1.5%) of the unpaid balance per month (commencing on the thirty-first (31st) day following receipt of the invoice). If QLT USA fails to pay any invoiced amount (other than the Disputed Amount) within [**] days after the receipt of the applicable invoice, on more than one occasion during any rolling twelve-month period, Manufacturer shall be entitled to require QLT USA to pay full price for future Products before such Products are Shipped. If any invoiced amount (other than the Disputed Amount) is not paid within [**] after receipt of the applicable invoice, Manufacturer shall be entitled to terminate the Agreement, unless such failure is cured by QLT USA within thirty (30) days after notice thereof is delivered to QLT USA, or may cease production and/or performance hereunder until such breach for non-payment is cured. If the Parties cannot reach agreement on the Disputed Amount, at Manufacturer's request, the Parties shall resolve such dispute in accordance with the procedures set forth in Section 10.14. Section 4.03 PURCHASE FORMS. Manufacturer shall Ship Product and Demonstration Samples in accordance with QLT USA's purchase order form or as otherwise directed by QLT USA in writing. All orders will be for Full Batch Quantities. Purchase orders, purchase order releases, confirmations, acceptances and similar documents submitted by a Party in conducting the activities contemplated under this Agreement are for administrative purposes only and shall not add to or modify the terms of the Agreement. To the extent of any conflict or inconsistency between this Agreement and any such document, the terms of this Agreement shall govern. Section 4.04 CONFIRMATION. Manufacturer shall confirm each purchase order within five (5) business days from the date of receipt of a purchase order and, subject to Section 4.06, - ---------- ** Confidential Treatment Requested. 15 shall supply the Product within a maximum of [**] from the date of acceptance of a purchase order. Failure of Manufacturer to confirm any purchase order shall not relieve Manufacturer of its obligation to supply Product ordered by QLT USA in conformity with this Agreement. Section 4.05 DELIVERY. Delivery terms for Product and Demonstration Samples shall be FOB the Facility. All Products shall be Shipped no later than [**] following the commencement of Manufacturing of such Products. The Product when delivered to the common carrier shall not have an expiration date of less than [**] determined as of such date as the Manufacturing Process for such Product is completed. Title to any Product or Demonstration Samples purchased by QLT USA shall pass to QLT USA upon the earlier of (a) a common carrier accepting possession or control of such Product or Demonstration Samples, as applicable, or (b) passage of such Product or Demonstration Samples, as applicable, from the loading dock of the Facility to QLT USA or its agent. Section 4.06 FORECASTS AND ORDERS. On or prior to the Closing Date, QLT USA will provide Manufacturer with a rolling twelve (12) month forecast (the "Rolling Forecast") of QLT USA's requirement of Product, on a Product-by-Product and a country-by-country basis, including Demonstration Samples, and thereafter provide monthly updates on a rolling 12-month basis at least fifteen (15) days prior to the first day of each month beginning February 2007. The first three (3) months of each Rolling Forecast shall constitute a firm and binding order from QLT USA to purchase the amount and type of Products listed in the first three (3) months of each Rolling Forecast from Manufacturer, which may not be changed by QLT USA or Manufacturer, including through the delivery of subsequent Rolling Forecasts. Each Rolling Forecast shall set forth the number of Full Batch Quantities of syringe A, syringe B and Packaging of Product to be provided by QLT USA only with respect to the firm order portion of the Rolling Forecast. At QLT USA's request and subject to the availability of the Components, Manufacturer shall reprioritize the Manufacture of Product and other products manufactured by Manufacturer for QLT USA. Any request to reprioritize Manufacturing shall be delivered at least [**] prior to the scheduled Manufacturing date. From time to time after the Effective Date, the Parties shall consider whether, in light of market demand, Manufacturing capacity, inventory levels and other pertinent factors, to revise the schedule for delivery of forecasts and, if appropriate, negotiate in good faith to revise such schedule. Section 4.07 FAILURE TO SUPPLY. (a) Manufacturer shall be obligated to provide Product in an amount up to [**] of QLT USA's forecasted amount for any rolling twelve (12) month period, as determined based on the Rolling Forecast for the first month of such twelve (12) month period (the "Maximum Supply Amount"), provided, however, that in no case shall Manufacturer be obligated to provide within any three (3) month period the entire excess of the Maximum Supply Amount over QLT USA's forecasted amount for the applicable rolling twelve (12) month period based on the Rolling Forecast for the first month of such twelve (12) month period. Manufacturer shall immediately notify QLT USA if Manufacturer is unable to fill any order placed by QLT USA pursuant to this Article IV whether or not such failure is because the order exceeds the Maximum Supply Amount; - ---------- ** Confidential Treatment Requested. 16 provided, however, that Manufacturer shall not be deemed unable to fill any order of QLT USA if such order exceeds the Maximum Supply Amount. Any Product purchased by QLT USA from a Third Party or Second Source due to Manufacturer's inability to supply Product to QLT USA, for any reason, shall be deemed purchases made from Manufacturer for purposes of Sections 3.01(a) and 4.01(c). (b) Subject to Section 4.07(a), Manufacturer shall immediately notify QLT USA if Manufacturer is unable to fill any order placed by QLT USA pursuant to this Article IV in accordance with the firm order portions of the Rolling Forecasts (including due to a force majeure). (i) If Manufacturer is unable to cure such failure within thirty (30) days, then at QLT USA's request, Manufacturer shall, at its expense, and as a non-exclusive remedy provide QLT USA with all Know-How and information held by Manufacturer and reasonably necessary to enable QLT USA, the Second Source or any other Third-Party designated by QLT USA to Manufacture the Products or obtain any required Governmental Approvals to do so, and shall assist QLT USA in transferring the Manufacturing Process to QLT USA, such Second Source or such Third-Party designee by providing all technical assistance and documentation reasonably requested by QLT USA. Manufacturer shall reimburse QLT USA for the amount by which the purchase price for the Product obtained from the Second Source exceeds the Purchase Price payable under this Agreement. (ii) If Manufacturer is unable to cure such failure within ninety (90) days, then such an event shall constitute material breach of this Agreement and QLT USA may elect, in its sole discretion, to either (A) immediately terminate this Agreement pursuant to Section 9.02(a) (provided that the thirty (30) day cure period provided for therein shall not apply), or (B) elect to continue to purchase Product from Manufacturer under this Agreement; provided, however, that QLT USA shall have no further obligations to purchase [**] of its requirement for the Products, or otherwise be obligated to purchase any minimum amount of Product, from Manufacturer whether or not such breach is subsequently cured. ARTICLE V WARRANTY, REJECTION AND INSPECTIONS Section 5.01 PRODUCT WARRANTIES. Manufacturer represents, warrants and covenants to QLT USA that the Products and Demonstration Samples Manufactured and/or Shipped pursuant to this Agreement by Manufacturer shall (a) comply with the Specifications, Governmental Approvals and Applicable Laws (including compliance with Applicable Laws related to adulterated or misbranded Products), (b) conform to the Certificate of Analysis and Certificate of Compliance for each such Product, and (c) at the time of Manufacture and delivery to QLT USA - ---------- ** Confidential Treatment Requested. 17 each Product will be free from any liens and encumbrances and QLT USA shall receive good and marketable title to the Product. Section 5.02 REJECTION OF PRODUCT FOR FAILURE TO CONFORM TO SPECIFICATIONS. QLT USA or its designees shall have [**] after the receipt of any Shipment to subject a Product, on a sample basis, to quality control testing to determine conformity with the Specifications (the "Testing Period"). If testing of such samples shows an actual failure to meet the Specifications, QLT USA may return, or cause its designees to return, the entire Batch with respect to such testing shows such failure, or any portion thereof to Manufacturer at Manufacturer's expense [**] within a reasonable time following the Testing Period, provided that notice of nonconformity is received by Manufacturer from QLT USA within [**] after the end of the Testing Period and such notice includes a complete copy of the results of all such testing and any additional documentation necessary for Manufacturer to understand the nature of the failure. QLT USA shall have the option to require Manufacturer (a) to replace, within [**] of receipt of such returned Product, the non-conforming Product with Product that meets the Specifications [**] or (b) to promptly provide QLT USA with full credit. If QLT USA does not notify Manufacturer of the non-conformity of the Product within [**] after the end of the Testing Period, the Product shall be deemed to meet the Specifications, except as set forth in Section 5.03. In either case, the cost of freight and handling to return or replace the goods shall be at the expense of Manufacturer. Notwithstanding anything in this Agreement to the contrary, the Parties may agree to a return of the Product or an adjustment in the purchase price in the event of any failure or defect in the Product. Should there be a dispute between QLT USA and Manufacturer as to whether any Batch of Product fails to meet the Specifications, such dispute shall be finally resolved by testing performed by an independent Third Party mutually agreed upon by QLT USA and Manufacturer. The costs of such testing shall be borne by the Party against whom the discrepancy is resolved. Section 5.03 LATENT DEFECTS. As soon as either Party becomes aware of a Latent Defect in any lot or Batch of Product, but in no case later than [**] after reaching such awareness, it shall immediately notify the other Party and the lot or Batch containing such Latent Defect shall be deemed rejected, but only to the extent QLT USA has first determined that such Latent Defect adversely effects the marketability of the Product. If such defect is the result of Manufacturer's negligence, then, at QLT USA's option, (a) such Product will be replaced by Manufacturer [**] within [**] of receipt of such returned Product, at Manufacturer's expense [**] with conforming Product or (b) Manufacturer will give QLT USA a credit for such Product. If such Product has been sold by QLT USA and if such latent defect is the result of Manufacturer's negligence, Manufacturer shall reimburse QLT USA for QLT USA's actual costs [**] incurred in replacing any Product returned by the customer or other end user due to such latent defect and QLT USA may offset such amount against amounts otherwise payable by QLT USA to Manufacturer. [**] Section 5.04 INSPECTION RIGHTS. (a) Manufacturer shall provide QLT USA with notice within twenty-four (24) hours after receiving notification of any scheduled inspection by any Competent Authority of the Facility, the Manufacturer's books or records, or of the facilities, books - ---------- ** Confidential Treatment Requested. 18 or records of any permitted subcontractor being used to Manufacture the Product. Manufacturer shall inform such Competent Authority that QLT USA or its designees may desire to be present at such inspection; provided that QLT USA's or its designees' right to be present is subject to approval by such Competent Authority and subject to QLT USA or its designees being available at the time and date established by such Competent Authority. Manufacturer shall use reasonable efforts to secure a time and date for such inspection that is reasonably acceptable to QLT USA or its designees. (b) Manufacturer shall upon reasonable [**] prior written notice by QLT USA and during normal business hours, allow QLT USA or its designees and cause any permitted subcontractor to allow QLT USA or its designees, to inspect or audit the Facility and the facilities of any permitted subcontractor used to Manufacture the Product and the Demonstration Samples, to confirm that the facilities and the equipment, personnel and operating and testing procedures used by Manufacturer and such subcontractor in the Manufacture, testing, storage and distribution of the Product are in compliance with Applicable Laws and the Governmental Approvals; provided that such inspection or audit does not unreasonably interfere with Manufacturer's or such subcontractor's normal operations or cause Manufacturer or such subcontractor to violate or be in breach of any confidentiality agreements with any Third Party; and provided further, that any audits or inspections shall be limited to [**] during any calendar year. QLT USA, however, will in good faith attempt to ensure that any audits or inspections performed by QLT USA, its licensees and sublicensees are performed at substantially the same time to alleviate any undue inconvenience to Manufacturer. Notwithstanding the foregoing, no limitation shall apply and QLT USA may inspect or audit the Facility and the books and records at any time if (i) Manufacturer breaches this Agreement, and during the continuance of any such breach, or (ii) any regulatory action by a Competent Authority is initiated or pending related to the Manufacture of the Products or against Manufacturer. Manufacturer shall cause any approved subcontractor to comply with the terms of this provision. (c) Manufacturer shall notify QLT USA at least two (2) business days prior to the date a Batch of Product is expected to be Manufactured and QLT USA or its designees shall have the right to have an employee or other representative monitor the Manufacturing Process during the Manufacture of such Batch. Section 5.05 PRODUCT RECALL. Notwithstanding anything contained in Section 5.02 to the contrary, QLT USA or its designees shall be responsible for conducting any recall of any Product in the event (x) the FDA or any other Competent Authority issues a request, directive, or order that a Product be recalled, (y) a court of competent jurisdiction orders such a recall, or (z) QLT USA or a Third Party (with which QLT USA has a contractual relationship for the license, distribution or sale of such Product) reasonably determine after consultation with each other that a Product should be recalled (in each case, whether voluntary or otherwise, a "Recall") and the cost and expense of a Recall shall be allocated as follows: - ---------- ** Confidential Treatment Requested. 19 (a) if such Recall is caused by or due to (i) the breach by Manufacturer of this Agreement, or (ii) the negligence or willful misconduct of Manufacturer, Manufacturer shall replace all recalled Product and shall bear all costs and expenses related to such Recall [**] and Manufacturer will reimburse QLT USA for any such costs and expenses paid by QLT USA within thirty (30) days of receipt of an invoice for such costs and expenses from QLT USA, and if not so paid QLT USA shall have the right to offset such amounts against amounts otherwise due by QLT USA to Manufacturer hereunder; and (b) if such Recall is caused by or due to reasons other than those set forth in Section 5.05(a), all such costs and expenses shall be borne and paid solely by QLT USA and QLT USA will reimburse Manufacturer for any such costs and expenses paid by Manufacturer within thirty (30) days of receipt of an invoice and appropriate documentation for such costs and expenses from Manufacturer. ARTICLE VI REGULATORY Section 6.01 QLT USA'S RESPONSIBILITIES. QLT USA will be responsible for (a) obtaining and maintaining all necessary Governmental Approvals for the distribution and sale of the Product; (b) maintaining claim files and submitting appropriate reports to the Competent Authorities; (c) promptly notifying Manufacturer of all communications from the Competent Authorities, that impact or change the Manufacturing Process; (d) notifying Manufacturer of any consumer complaints concerning Product, which might reasonably be attributed to Manufacturer's obligations and warranties, within [**] of receipt by QLT USA of any such complaints; and (e) any other obligations or responsibilities relating to the Manufacturing Process required by any Competent Authority and not otherwise expressly the responsibility of Manufacturer under this Agreement or the Transition Services Agreement between the Parties dated of even date herewith. All such information disclosed to Manufacturer shall be considered Confidential Information under Article VII below. Section 6.02 MANUFACTURER RESPONSIBILITY. So long and insofar as necessary to permit it to perform its obligation hereunder, Manufacturer shall maintain or obtain all Manufacturing registrations/validations and records required by applicable Competent Authorities in order for the Facility to Manufacture Products for sale in each country in which Products are sold to end users and provide QLT USA with access to all regulatory records required to be filed with the FDA or any other applicable Competent Authority, including its Annual Registration of Drug Establishment (form FDA 2656e) and its Annual Registration of Device Establishment (form FDA 2891a) granted by the FDA updated and in good order and will make the license and copies of all related documents available to QLT USA and its designees for inspection, upon reasonable request and in accordance with Section 5.04. Manufacturer shall file and maintain a facility master file as required by the FDA and maintain Product complaint files pursuant to applicable federal regulations. Manufacturer will be further responsible for promptly notifying QLT USA of all communications from any Competent Authority that may impact or change the - ---------- ** Confidential Treatment Requested. 20 Manufacturing Process. QLT USA shall pay, or promptly reimburse Manufacturer for, all costs associated with complying with this Section 6.02. Section 6.03 MASTER FILE. Manufacturer shall maintain one or more Facility master files at the FDA and agrees to provide QLT USA with any requisite letters authorizing the FDA access to the Facility master file in conjunction with regulatory review of the Manufacturing Process. Section 6.04 STABILITY TESTING AND FINAL PRODUCT RELEASE. (a) Manufacturer will be responsible for performing ongoing stability studies of the Products, including base components, maintaining stability protocols, storage of stability samples, testing the samples in accordance with the protocols and reports for the studies as set forth in the Quality Agreement. QLT USA shall have access to the stability reports generated by Manufacturer, including historic stability data. QLT USA will inform Manufacturer in writing when it receives Governmental Approvals for its facility to begin stability testing of the Products. Following such date, QLT USA will be responsible for issuing the stability protocols, storage of stability samples, testing the samples in accordance with the protocols and reports for the studies; provided, however, that Manufacturer shall continue to perform stability studies for all Products that were commenced prior to the date QLT USA takes over this responsibility. (b) Until such time as QLT USA is able to do so, Manufacturer shall conduct all finished Product and release testing for the Products in accordance with the Quality Agreement. QLT USA will inform Manufacturer in writing when it receives Governmental Approvals for its facility to conduct all finished Product and release testing for the Products and following such date, Manufacturer shall no longer be responsible therefore. (c) As compensation for Manufacturer's services under this Section 6.04, QLT USA agrees to pay Manufacturer a full-time employee rate of [**]. ARTICLE VII LIABILITY AND INDEMNIFICATION Section 7.01 QLT USA INDEMNIFICATION. QLT USA agrees to indemnify, defend and hold Manufacturer and its Affiliates harmless from and against any Losses that may be incurred or suffered by Manufacturer or its Affiliates in connection with a claim, action or proceeding made or brought by a Third Party relating to or arising out of (a) the use or sale of the Atrigel(R) Technology, the Technical Information, or the Products including, without limitation, those relating to or arising out of any actual or alleged infringement or misappropriation of any patent, trademark, copyright or other intellectual property right in connection with Atrigel(R) Technology, the Technical Information, or any Product or the Manufacture, use, or sale of any Product, except for Losses in which Manufacturer is obligated to indemnify QLT USA under Section 7.02; (b) the breach of QLT USA's representations, warranties or any covenants or - ---------- ** Confidential Treatment Requested. 21 agreements contained in this Agreement; or (c) the gross negligence or willful misconduct of QLT USA. Section 7.02 MANUFACTURER'S INDEMNIFICATION. Manufacturer agrees to indemnify, defend and hold QLT USA and its Affiliates harmless from and against any Losses that may be incurred or suffered by QLT USA or its Affiliates in connection with a claim, action or proceeding made or brought by a Third Party relating to or arising out of (a) the failure of a Product or Demonstration Sample to meet the Specifications due to the Manufacture of such Product or Demonstration Sample or the failure of Manufacturer to Manufacture such Product or Demonstration Sample in accordance with cGMP; (b) the breach of Manufacturer's representations, warranties or any covenants or agreements contained in this Agreement, including the Quality Agreement; or (c) the gross negligence or willful misconduct of Manufacturer. Section 7.03 LIMITATION OF LOSSES. EXCEPT FOR EACH PARTY'S OBLIGATIONS OF CONFIDENTIALITY AND INDEMNIFICATION CONTAINED IN THIS AGREEMENT, NEITHER PARTY OR ITS AFFILIATES SHALL BE LIABLE FOR CONSEQUENTIAL DAMAGES INCLUDING, WITHOUT LIMITATION, LOSS OF PROFITS OR INDIRECT LOSS ARISING OUT OF OR IN ANY WAY RELATED TO THIS AGREEMENT. Section 7.04 INDEMNITY PROCEDURE. Each indemnified Party agrees to give the indemnifying Party prompt written notice of any matter upon which such indemnified Party intends to base a claim for indemnification (an "Indemnity Claim") under this Article VII. The indemnified Party (or the Party seeking indemnification) must promptly notify the other Party in writing of the Indemnity Claim. The indemnifying Party shall have the sole right to control the defense, settlement or other disposition of the Indemnity Claim, provided that the indemnified Party may, at the indemnified Party's own expense, participate jointly with the indemnifying Party in the indemnified Party's defense, settlement or other disposition of any Indemnity Claim. With respect to any Indemnity Claim relating solely to the payment of money damages which could not result in the indemnified Party's becoming subject to injunctive or other equitable relief or otherwise adversely affect the business of the indemnified Party in any manner, and as to which the indemnifying Party shall have acknowledged in writing the obligation to indemnify the indemnified Party hereunder, the indemnifying Party shall have the sole right to defend, settle or otherwise dispose of such Indemnity Claim, on such terms as the indemnifying Party, in its sole discretion, shall deem appropriate, provided that the indemnifying Party shall provide reasonable evidence of its ability to pay any damages claimed and with respect to any such settlement shall have obtained the written release of the indemnified Party from the Indemnity Claim. The indemnifying Party shall obtain the written consent of the indemnified Party, which shall not be unreasonably withheld, prior to ceasing to defend, settling or otherwise disposing of any Indemnity Claim if as a result thereof the indemnified Party would become subject to injunctive or other equitable relief or the business of the indemnified Party would be adversely affected in any manner. In addition, the indemnified Party will provide the indemnifying Party with reasonable assistance in the defense of the Indemnified Claim at the reasonable expense of the indemnifying Party. Notwithstanding the foregoing, if the indemnifying Party shall not be entitled to assume the defense of any Indemnity Claim (and shall be liable for the fees and expenses of counsel incurred by the indemnified Party in defending such Indemnity Claim) if (i) the Indemnity Claim seeks an order, injunction or other equitable relief or relief for other than 22 money damages against the indemnified Party which the indemnifying Party reasonably determines, after conferring with its outside counsel, cannot be separated from any related claim for money damages or (ii) if (A) the indemnifying Party has failed after a reasonable period of time to assume such defense and to employ counsel, or (B) as evidenced by the opinion of counsel, different defenses would be available to the indemnified Party in such action such that a conflict of interest exists that makes control by the Indemnitor not advisable; and in such an event, the indemnified Party shall be entitled but not obligated to, with respect to clause (i), assume the defense of the portion relating to money damages and, with respect to clause (ii), assume the defense of the entire proceeding. Section 7.05 MAINTENANCE OF INSURANCE. Each Party shall, at its own cost and expense, obtain and maintain in full force and effect, during the Term, commercial general liability insurance written on a standard approved policy form, including products and completed operations liability and blanket contractual liability, with limits of liability of not less than [**] combined single limit bodily injury and property damage covering the Party's obligations under this Agreement (collectively, the "Insurance"). Said Insurance can be provided through a combination of primary and excess/umbrella insurance programs. Each Party shall upon written request provide the other Party with certificates of insurance attesting to the existence of such Insurance. However, it is understood and agreed that furnishing of such Insurance coverage will not relieve either Party of its obligations under this Agreement. ARTICLE VIII CONFIDENTIALITY Section 8.01 MAINTENANCE OF CONFIDENTIAL INFORMATION. (a) Each Party covenants and agrees to take all necessary steps to (i) hold in strict confidence any and all such Confidential Information of the other and shall not disclose it to anyone or use it for its own benefit or the benefit of others, except within each Party's own organization, and only to those of its employees who have agreed in writing to protect and preserve the confidentiality of such disclosures and who are designated by each respective Party to evaluate the Confidential Information for necessary business purposes; (ii) prohibit such Confidential Information of the other from being duplicated in any manner (except as necessary for such Party to perform its obligations under this Agreement), and (iii) prohibit the Confidential Information from being published in any form, without the prior express written consent of the other Party. In such case, the Party requesting such consent of the disclosing Party shall cause any person to whom such disclosure may be authorized as aforesaid, to agree to hold such information in confidence and not to use or disclose same to the same extent as such Party. (b) The foregoing obligations, however, shall not apply to information or data that: (i) at the time of or after disclosure, is published, known publicly or becomes part of the public domain through no fault of the receiving Party; (ii) prior to disclosure, is - ---------- ** Confidential Treatment Requested. 23 known by the receiving Party as evidenced by its written records maintained in the ordinary course of business (except for such information that a Party would otherwise be prohibited from disclosing pursuant to the terms of Section 7.01 of the Purchase Agreement); (iii) information which has been or is disclosed to the receiving Party without any obligation of confidentiality from a Third Party not having an obligation of confidentiality with the disclosing Party; (iv) is required by law (including reporting requirements of the Securities Exchange Act of 1934) to be disclosed, provided that each Party shall notify the other Party as soon as possible after learning of the need for the disclosure and undertake its best efforts to maintain the confidentiality of such information; or (v) is disclosed in connection with the filing with, or approval, certification or endorsement from, any governmental body or medical protocol, provided that the information is not the inventive subject matter of an unpublished patent application and that each Party shall notify the other Party of the disclosure as soon as possible after learning of the need for the disclosure and undertake its best efforts to maintain the confidentiality of such information and will notify the other Party if disclosure involves Confidential Information. (c) The mutual obligations of confidentiality under this Article VIII shall survive the expiration or earlier termination of this Agreement for the longer of a period of five (5) years after the expiration or earlier termination of this Agreement and the termination of any trade secret protection applicable to the Confidential Information under Applicable Laws. Upon termination of this Agreement the Parties undertake to refrain from using any of the technical Know-How, specifications and process information acquired from each other Party or made available to the other Party, and to promptly return in full all such Party's specifications to the other Party without retaining any copies thereof except as set forth in Section 8.01(d) of this Agreement. (d) Upon termination of this Agreement, each Party shall destroy or immediately deliver to the other (and cause any of its employees, agents, representatives or sub-contractors to deliver), at such Party's expense, all Confidential Information of the other Party, including, without limitation, any and all copies, duplications, summaries and/or notes thereof or derived therefrom, regardless of the format. Notwithstanding the above, each Party may retain one (1) complete record copy for archiving purposes to confirm compliance with this Agreement or to ensure its compliance with applicable statutory and regulatory requirements. (e) A Party will inform the other Party of any subcontractor, licensee or sublicensee of such Party, and obtain the other Party's prior written consent, which shall not be unreasonably withheld, prior to disclosing any Confidential Information to such sub-contractors, licensee or sublicensee. Each Party is responsible to ensure that every sub-contractor, licensee or sublicensee accepts the confidentiality obligations herein contained in order to protect the other Party's Confidential Information. It is understood by the Parties that QLT USA's existing licensees or sublicensees are currently bound by such restrictions. 24 ARTICLE IX TERM AND TERMINATION Section 9.01 TERM. This Agreement will take effect on the Effective Date and, unless earlier terminated in accordance with this Article IX, will expire on the seven (7) year anniversary of the Effective Date; provided, however, that this Agreement shall be automatically extended for successive terms of four (4) years each, unless either Party notifies the other Party that it does not intend to renew this Agreement at least three (3) years prior to the last day of the then current term (the "Term"). Section 9.02 TERMINATION BY QLT USA. QLT USA may terminate this Agreement as follows: (a) Immediately upon written notice to Manufacturer, if Manufacturer has committed any material breach of this Agreement (except for any breach that is the subject of Section 9.02(b), to which none of the provisions of this Section 9.02(a) shall apply) and Manufacturer fails to cure such breach within thirty (30) days after the date QLT USA first gave Manufacturer written notice thereof, which notice shall specify the details of such breach, provided that no such cure period shall apply to a breach that is not capable of being cured within such period; (b) Immediately upon written notice to Manufacturer, if Manufacturer has two Batches of Products that fail to meet or conform to the Specifications, Applicable Laws or the Certificates of Analysis in any consecutive ninety (90) day period, but only if (i) such failure is due to Manufacturer's negligence, intentional misconduct or failure to follow the Quality Agreement and Master Production Procedures, and (ii) Manufacturer fails to cure such failure within sixty (60) days after learning of it; and provided further, that Manufacturer shall only have the opportunity to cure any such breach [**] provided that no such cure period shall apply to a breach that is not capable of being cured within such period; (c) Immediately in the event that any Competent Authority or Applicable Law, in each case in the United States of America or the European Union, prohibits the Manufacture, distribution or sale of a Product; (d) After [**], upon [**] notice to Manufacturer if QLT USA [**]; or (e) Immediately in the event Manufacturer becomes insolvent or bankrupt. Section 9.03 TERMINATION BY MANUFACTURER. Manufacturer may terminate this Agreement as follows: (a) Immediately upon written notice to QLT USA, if QLT USA has committed any material breach of this Agreement, including without limitation by failing to purchase at least the minimum amount of Products during the [**] of the term of the - ---------- ** Confidential Treatment Requested. 25 Agreement set forth under Section 3.01, and QLT USA fails to cure such breach within thirty (30) days after the date Manufacturer first gave QLT USA written notice thereof, which notice shall specify the details of such breach, provided that QLT USA shall have ninety (90) days to cure any breach under Section 3.01; and provided, further, that no such cure period shall apply to a breach that is not capable of being cured within such period; (b) Subject to the limitations set forth in Section 4.01(c), immediately upon written notice to QLT USA, if QLT USA [**] of the Term, and does not cure such breach within ninety (90) days following written notice of such breach from Manufacturer; or (c) Immediately in the event that if QLT USA becomes insolvent or bankrupt. Section 9.04 REMEDIES. Except as specifically noted herein, all of the non-breaching Party's remedies shall be cumulative, and the exercise of one remedy hereunder by the non-defaulting Party shall not be deemed to be an election of remedies. These remedies shall include the non-breaching Party's right to sue for damages for such breach without terminating this Agreement. Section 9.05 EFFECT OF TERMINATION. Except as otherwise provided in this Agreement, expiration or termination of this Agreement shall not relieve the Parties of any obligation accruing prior to such expiration or termination. Except as set forth below or elsewhere in this Agreement, the obligations and rights of the Parties under Sections 2.02, 2.03, 3.03(i) through (vi), 5.05, 7.01, 7.02, 7.03, 7.04, 10.02, 10.04, 10.05, 10.08, and 10.10 through 10.13, and Article I, Article VIII and this Article IX shall survive expiration or termination of this Agreement. Within thirty (30) days following the expiration or termination of this Agreement, each Party shall comply with Section 8.01(d) as to the destruction (or delivery) of the other Party's Confidential Information, such destruction (or delivery) shall be confirmed in writing to such Party by a responsible officer of the other Party. ARTICLE X MISCELLANEOUS Section 10.01 FORCE MAJEURE. Neither Party shall be liable for or responsible to the other Party nor be deemed to have defaulted under or breached this Agreement for delay or failure to perform its obligations hereunder when such failure or delay is caused by or results from causes beyond the reasonable control of a Party, after reasonable efforts to exercise such control, including, but not limited to war (declared or undeclared), riot, terrorism, political insurrection, rebellion, revolution, acts or orders of or expropriation by any government (whether de facto or de jure), prohibition of the import or export of the Product, quarantine restrictions, or fire, snow, flood, explosion, earthquake or tornadoes, in each case solely with respect to the United States. The Party affected by such event of force majeure shall not later than two (2) business days after the commencement of such event (if practicable in given the circumstances of the event) give the other Party notice of the event and shall use all reasonable means to resume full performance of its obligations under this Agreement as soon as commercially possible. 26 Section 10.02 APPLICABLE LAW. This Agreement is to be construed in accordance with and governed by the internal laws of the State of Colorado, without giving effect to any choice of law rule that would cause the application of the laws of any jurisdiction other than the internal laws of the State of Colorado to the rights and duties of the Parties. Section 10.03 ASSIGNMENT. This Agreement may not be assigned by either Party without the prior written consent of the other, except that upon notice to the other Party, QLT USA may assign all or a portion of its rights and/or obligations hereunder, to any person succeeding to all or substantially all of the business or assets of QLT USA or to any Affiliate of QLT USA, whether in the aggregate, or with respect solely to the Products or the Atrigel(R) Technology, whether through purchase, merger, consolidation or otherwise, as long as such successor, whether by operation of law, by contract, or otherwise, becomes subject to and bound by all of the obligations of QLT USA hereunder. Subject to the foregoing sentence, this Agreement shall bind and inure to the benefit of the Parties hereto and their respective successors and assigns. Section 10.04 NOTICES. All notices, requests, demands and other communications required or permitted under this Agreement shall be in writing and shall be deemed to have been duly given, made and received (a) when delivered personally or by telecopy; (b) one (1) day following the day when deposited with a reputable, established overnight courier service for delivery to the intended addressee; or (c) three (3) days following the day when deposited with the United States Postal Service as first class, registered or certified mail, postage prepaid and addressed as set forth below: If to Manufacturer: Tolmar, Inc. 701 Centre Avenue Fort Collins, Colorado 80526 Attention: Chief Executive Officer Telephone No.: (970) 212-4990 Facsimile No.: (970) 494-0241 With a copy, which shall not Tolmar, Inc. constitute notice, given in the Av. Cabildo 86 manner prescribed above, to: 5 floor (1426) Capital Federal Buenos Aires, Argentina Attention: Secretary Telephone No.: +(54)-11-4776-7197 Facsimile No.: +(54)-11-4899-2828 With a copy, which shall not Holme Roberts & Owen LLP constitute notice, given in the 1700 Lincoln Street, Suite 4100 manner prescribed above, to: Denver, Colorado 80202 Attention: Troy R. Braegger, Esq. Telephone No.: (303) 866-0454 Facsimile No.: (303) 866-0200 27 If to QLT USA: QLT USA, Inc. 2579 Midpoint Drive Fort Collins, Colorado 80525 Attention: Corporate Counsel Telephone No.: (970) 482-5868 Facsimile No.: (970) 482-9735 With a copy, which shall not Morrison & Foerster LLP constitute notice, given in the 5200 Republic Plaza manner prescribed above, to: 370 Seventeenth Street Denver, CO 80202 Attention: Warren L. Troupe, Esq. Telephone No.: (303) 592-1500 Facsimile No.: (303) 592-1510 Either Party may alter its notice address by notifying the other Party of such change of address in conformity with the provisions of this Section 10.04. Section 10.05 ENTIRE AGREEMENT. This Agreement, together with the Exhibits or Schedules hereto, contains the entire understanding between the Parties hereto with respect to the subject matter hereof and supersedes all prior and contemporaneous agreements and understandings, inducements or conditions, express or implied, oral or written, between the Parties. The Parties intend that this Agreement, together with the Exhibits or Schedules hereto, be the several, complete and exclusive embodiment of their agreement, and that any evidence, oral or written, of a prior or contemporaneous agreement that alters or modifies this Agreement shall not be admissible in any Proceeding concerning this Agreement. The express terms hereof control and supersede any course of performance and/or usage of the trade inconsistent with any of the terms hereof. Section 10.06 AMENDMENTS AND WAIVERS. This Agreement may not be amended, supplemented or modified, except by an agreement in writing signed by each of the Parties. Either Party may waive compliance by the other Party with any term or provision of this Agreement; provided, that such waiver shall not operate as a waiver of, or estoppel with respect to, any other or subsequent failure. No waiver shall be effective unless it is in writing and is signed by the Party asserted to have granted such waiver. Section 10.07 FOREIGN CORRUPT PRACTICES ACT. Each Party will not, and shall cause its agents, representatives and employees not to, conduct any activities in connection with the transactions contemplated hereby that would, if performed by a United States corporation, constitute a violation of the United States Foreign Corrupt Practices Act of 1977, as amended. Section 10.08 SEVERABILITY. If any provision of this Agreement, or the application of any such provision to any Person or set of circumstances, shall be determined to be invalid, unlawful, void or unenforceable to any extent, the remainder of this Agreement, and the application of such provision to persons or circumstances other than those as to which it is determined to be invalid, unlawful, void or unenforceable, shall not be impaired or otherwise affected and shall continue to be valid and enforceable to the fullest extent permitted by law. 28 Section 10.09 COUNTERPARTS. This Agreement may be executed (including, without limitation, by facsimile signature) in one or more counterparts, with the same effect as if the Parties had signed the same document. Each counterpart so executed shall be deemed to be an original, and all such counterparts shall be construed together and shall constitute one agreement. Section 10.10 CONSTRUCTION. The construction of this Agreement shall not take into consideration the Party who drafted or whose representative drafted any portion of this Agreement, and no canon of construction shall be applied that resolves ambiguities against the drafter of a document. Each Party acknowledges that: (a) it has read this Agreement; (b) it has been represented in the preparation, negotiation and execution of this Agreement by legal counsel of its own choice or has voluntarily declined to seek such counsel; and (c) it understands the terms and consequences of this Agreement and is fully aware of the legal and binding effect of this Agreement. Section 10.11 JURISDICTION; SERVICE OF PROCESS. Subject to Section 10.14, any Proceeding seeking to enforce any provision of, or based on any right arising out of, this Agreement may be brought against any of the Parties only in the courts of the State of Colorado, City and County of Denver, or, if it has or can acquire the necessary jurisdiction, in the United States District Court for the District of Colorado. Each of the Parties hereby waives, and agrees not to assert, as a defense in any action, suit or proceeding for the interpretation or enforcement of this Agreement, that it is not subject thereto or that such action, suit or proceeding may not be brought or is not maintainable in said courts or that the venue thereof may not be appropriate or that this Agreement may not be enforced in or by such courts and the Parties hereto irrevocably agree that all shall be heard and determined in such a Colorado State or federal court. Process in any Proceeding referred to in the preceding sentence may be served on either Party anywhere in the world. Section 10.12 WAIVER OF JURY TRIAL. THE PARTIES HEREBY EXPRESSLY WAIVE THE RIGHT TO A TRIAL BY JURY IN ANY ACTION OR PROCEEDING BROUGHT BY OR AGAINST EITHER OF THEM RELATING TO THIS AGREEMENT. THE PARTIES ACKNOWLEDGE THAT THIS AGREEMENT INVOLVES COMPLEX TRANSACTIONS AND THAT DISPUTES HEREUNDER WILL BE MORE QUICKLY AND ECONOMICALLY RESOLVED BY AN EXPERIENCED AND EXPERT DECISION MAKER. ACCORDINGLY, THE PARTIES AGREE, BASED ON THE ADVICE OF THEIR COUNSEL, THAT ANY DISPUTE HEREUNDER BE RESOLVED BY A JUDGE APPLYING APPLICABLE LAW. Section 10.13 RECOVERY OF FEES BY PREVAILING PARTY. Except as otherwise specifically provided for in this Agreement, if any legal action, including, without limitation, an action for arbitration or injunctive relief, is brought relating to this Agreement or the breach or alleged breach hereof, the prevailing Party in any final judgment or arbitration award, or the non-dismissing Party in the event of a voluntary dismissal by the Party instituting the action, shall be entitled to the full amount of all reasonable expenses, including all court costs, arbitration fees and actual attorneys' fees paid or incurred in good faith. 29 Section 10.14 RESOLUTION OF CERTAIN DISPUTES. If the Parties cannot resolve the dispute by the date (the "Resolution Date") that is [**] after the date QLT USA receives a written request from Manufacturer to renegotiate the Purchase Price in accordance with Section 4.01(c) or the date payment was due on the invoice, as applicable, the Parties agree to hold a meeting, attended by the Chief Executive Officer or President of each Party, or their executive level designees, to attempt in good faith to negotiate the revised Purchase Price (the "Revised Purchase Price") or to resolve the Disputed Amount. If, within [**] after the Resolution Date, the Parties have not succeeded in negotiating a resolution of the dispute, such dispute shall be submitted to final and binding arbitration under the then current commercial rules and regulations of the American Arbitration Association ("AAA") relating to voluntary arbitrations. The arbitration proceedings shall be held in Denver, Colorado before a single arbitrator to be chosen by the mutual agreement of the Parties from a panel of arbitrators provided by the Judicial Arbiter Group of Denver or, if such group no longer exists or if the Parties cannot reach such mutual agreement within [**] after the Resolution Date, by the AAA. The arbitrator so selected shall have substantial experience in the pharmaceutical industry and be familiar with agreements of this type. The arbitration shall be conducted in accordance with the following time schedule unless otherwise mutually agreed to in writing by the Parties: (a) within [**] after the appointment of the arbitrator, each of QLT USA and Manufacturer shall provide all documents, records and supporting information reasonably necessary to resolve the dispute; (b) within [**] after the date the above records are due, each of QLT USA and Manufacturer shall provide the arbitrator with a sealed envelope containing each Party's best, final and irrevocable offer for the Revised Purchase Price or the resolution of the Disputed Amount, as applicable (each, a "Proposal"), and (c) within [**] thereafter, the arbitrator shall render its decision. To resolve the dispute, the arbitrator shall choose, in its entirety and without any modification, either QLT USA's or Manufacturer's Proposal. The decision of the arbitrator shall be final, binding and conclusive on the Parties. The fees and expenses of the arbitrator shall be shared equally by both Parties. Each Party shall initially bear its own costs and legal fees associated with such arbitration, however, the prevailing Party in any such arbitration shall be entitled to recover from the other Party the reasonable attorney's fees, costs and expenses incurred by such prevailing Party in connection with such arbitration. Section 10.15 TIME OF THE ESSENCE. With regard to all dates and time periods set forth or referred to in this Agreement, time is of the essence. [Signature Page Follows] - ---------- ** Confidential Treatment Requested. 30 IN WITNESS WHEREOF, the Parties hereto have caused this Agreement to be executed by their duly authorized officers as of the Effective Date. MANUFACTURER: TOLMAR, INC. By: /s/ Patricio Martin Rodriguez ----------------------------------- Name: Patricio Martin Rodriguez Title: Vice President QLT USA, INC. By: /s/ Sean F. Moriarty ----------------------------------- Name: Sean F. Moriarty Title: President SCHEDULE 1 COST PER UNIT [**] - -------- **Confidential Treatment Requested. EXHIBIT A PATENT RIGHTS [**] - -------- **Confidential Treatment Requested. EXHIBIT B FORM OF CERTIFICATE OF ANALYSIS Specification: XXXXXX REV: XXX Description: Eligard Product Lot Number: XXXX Test Request No.: QXXXX
- ---------------------------------------------------------------------------------------------------------------------- Characteristic Method Parameter Requirements Results/Reference - ---------------------------------------------------------------------------------------------------------------------- - ---------------------------------------------------------------------------------------------------------------------- - ---------------------------------------------------------------------------------------------------------------------- - ---------------------------------------------------------------------------------------------------------------------- - ---------------------------------------------------------------------------------------------------------------------- - ---------------------------------------------------------------------------------------------------------------------- - ---------------------------------------------------------------------------------------------------------------------- - ---------------------------------------------------------------------------------------------------------------------- - ---------------------------------------------------------------------------------------------------------------------- - ---------------------------------------------------------------------------------------------------------------------- - ----------------------------------------------------------------------------------------------------------------------
Prepared By: Date: -------------------------------- -------------------- QC (Chemistry) Management Prepared By: Date: -------------------------------- -------------------- QC (Microbiology) Management Approved By: Date: -------------------------------- -------------------- Quality Management NOTES - -------------------------------------------------------------------------------- Date of Manufacture: Expiry: See Country-specific requirements - -------------------------------------------------------------------------------- EXHIBIT C FORM OF CERTIFICATE OF COMPLIANCE Issue Date: -------------------- CERTIFICATE OF COMPLIANCE FOR ---------------------------------------------------------------------------- LOT NUMBER ------------------------------------------------------------ MFG DATE EX DATE ----------------------------------------- ----------------- DOSAGE ------------------------------------------------------------------------- QUANTITY OF RELEASABLE UNITS --------------------------------------------------- The Batch production record for this product has been reviewed for accuracy, completeness, and compliance with established written standard procedures and in accordance with cGMP requirements. Any deviations/abnormal occurrences from the aforementioned requirements have been appropriately documented, reviewed, and approved. - -------------------------------------------------------------------------------- QA Approved By: - -------------------------------------------------------------------------------- Name: - -------------------------------------------------------------------------------- Title: - -------------------------------------------------------------------------------- Date: - -------------------------------------------------------------------------------- - -------------------------------------------------------------------------------- cc: All Customers - -------------------------------------------------------------------------------- EXHIBIT D COMPONENTS Legend: X Components or materials to be supplied by QLT USA or Manufacturer, as applicable, at their expense. XX "Ordered Components" -- Components to be ordered by Manufacturer on behalf of, and at the expense of, QLT USA as set forth in Section 2.04(c) [**] - -------- **Confidential Treatment Requested. EXHIBIT E QUALITY SYSTEMS AGREEMENT BETWEEN QLT USA, INC. AND TOLMAR, INC. (CONFIDENTIAL) [**] - -------- **Confidential Treatment Requested. EXHIBIT F EXAMPLE OF MANUFACTURING COST PER UNIT DETERMINATION [**] - -------- **Confidential Treatment Requested.
EX-10.37 7 o34971exv10w37.txt AMENDED AND RESTATED CONTRIBUTION AGREEMENT 2-9-07 EXHIBIT 10.37 CONFIDENTIAL TREATMENT REQUESTED BY QLT INC. ATTORNEY-CLIENT PRIVILEGED COMMUNICATION; SUBJECT TO JOINT DEFENSE AGREEMENT AND COMMON INTEREST PRIVILEGE. SUBJECT FED. R. EVID. 408. AMENDED AND RESTATED CONTRIBUTION AGREEMENT This Amended and Restated Contribution Agreement (this "AGREEMENT") is entered into as of this 9th day of February, 2007 (the "EFFECTIVE DATE") between QLT USA, Inc. (formerly Atrix Laboratories, Inc.), a Delaware corporation having offices at 2579 Midpoint Drive, Fort Collins, Colorado, 80525-4417 ("QLT USA"), and Sanofi-Synthelabo Inc., a Delaware corporation having offices at 55 Corporate Boulevard, Bridgewater, NJ 08807 ("SANOFI-SYNTHELABO"). RECITALS WHEREAS, QLT USA and Sanofi-Synthelabo have previously entered into a Collaboration, License and Supply Agreement dated as of December 8, 2000, as subsequently amended (collectively, the "COLLABORATION AGREEMENT"); WHEREAS, Sanofi-Synthelabo and QLT USA are both defendants in on-going litigation with plaintiffs TAP Pharmaceutical Products, Inc., Takeda Chemical Industries, Ltd. and Wako Pure Chemical Industries Ltd. (each individually, and collectively, "TAP") alleging that QLT USA's Eligard(R) product infringes TAP's patent, US 4,728,721 (the "TAP LITIGATION"); WHEREAS, QLT USA and Sanofi-Synthelabo entered into that certain Contribution Agreement, dated as of November 10, 2006, between QLT USA and Sanofi-Synthelabo (the "EXISTING AGREEMENT"); WHEREAS, each of QLT USA and Sanofi-Synthelabo have agreed to amend and restate the Existing Agreement to reflect the terms of that certain Settlement, Release and Patent License, by and among QLT USA, Sanofi-Synthelabo, TAP and Abbott Laboratories, Limited -- Laboratories Abbott, Limitee, in the form attached hereto as Exhibit B (the "SETTLEMENT AGREEMENT") to settle the TAP Litigation; WHEREAS, without admitting liability to TAP and without admitting liability as between Sanofi-Synthelabo and QLT USA under the Collaboration Agreement, Sanofi-Synthelabo and QLT USA seek to settle the TAP Litigation and certain other past, present or future claims, controversies or disputes in the Territory (as defined in the Collaboration Agreement) between TAP or any of its affiliates, on the one hand, and QLT USA and Sanofi-Synthelabo, on the other hand, with respect to the Eligard(R) product or the Atrigel(R) Technology (as defined in the Collaboration Agreement); WHEREAS, subject to the terms and conditions of this Agreement, QLT USA has agreed to contribute $112,500,000 (the "QLT USA CONTRIBUTION ") towards the settlement of the TAP Litigation; WHEREAS, subject to the terms and conditions of this Agreement, Sanofi-Synthelabo has agreed to contribute $45,000,000 (the "SANOFI-SYNTHELABO CONTRIBUTION" and together with 1 the QLT USA Contribution, the "SETTLEMENT AMOUNT") towards the settlement of the TAP Litigation; WHEREAS, QLT USA has agreed to reimburse Sanofi-Synthelabo [**] which amount represents [**] of the [**] payable to [**], an expert witness utilized by Sanofi-Synthelabo and QLT USA in defending the TAP Litigation; and WHEREAS, QLT USA and Sanofi-Synthelabo have agreed to certain amendments to the Collaboration Agreement which amendments benefit both parties, all as set forth in the Amendment to Agreement in the form attached hereto as Exhibit A (the "AMENDING AGREEMENT"). NOW THEREFORE, in consideration of the mutual covenants and agreements as hereinafter set forth, and other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the parties agree as follows: 1. Concurrently with the execution of this Agreement, QLT USA will deposit the QLT USA Contribution with Morrison & Foerster LLP, as escrow agent for QLT USA, and Sanofi-Synthelabo will deposit the Sanofi-Synthelabo Contribution with Proskauer Rose LLP, as escrow agent for Sanofi-Synthelabo. Morrison & Foerster LLP and Proskauer Rose LLP shall confirm receipt of the respective contribution amounts via email to the other party, and shall release the escrow funds in accordance with the terms of the Settlement Agreement. QLT USA and Sanofi-Synthelabo shall execute the Settlement Agreement after each of Morrison & Foerster LLP and Proskauer Rose LLP have confirmed receipt of the Sanofi-Synthelabo Contribution and the QLT USA Contribution, respectively, as set forth in this Section 1. Each party agrees to comply with the terms and provisions of the Settlement Agreement. 2. Concurrently with the execution of this Agreement, QLT USA will pay the [**], counsel to Sanofi-Synthelabo, or as otherwise directed by Sanofi-Synthelabo. The payment of the [**] by QLT USA shall not waive or otherwise modify, in any respect, the releases set forth in Section 4 of this Agreement. 3. The Amending Agreement will only become effective upon payment by Sanofi-Synthelabo of the Sanofi-Synthelabo Contribution in accordance with the terms of the Settlement Agreement. 4. As additional consideration for entering into this Agreement, effective upon the payment of the Sanofi-Synthelabo Contribution and QLT USA Contribution, by Sanofi-Synthelabo and QLT USA, respectively, in accordance with the terms of the Settlement Agreement, each party releases the other party from any claims, actions, causes of action, demands, suits, proceedings, administrative proceedings, losses, damages, costs, expenses, liabilities, charges, interest, penalties, fines and charges of whatever nature (including costs of collection, attorneys' fees and other costs of defense, costs of enforcing indemnification provisions, and expenses of investigation) arising under, related to, or connected with the TAP Litigation, whether such claims may arise out of, under or pursuant to the Collaboration Agreement or otherwise, including any right or claim for repayment, reimbursement or recapture from a party of the amounts contributed by the other party under this Agreement. In addition, effective upon the payment by Sanofi-Synthelabo of the Sanofi-Synthelabo Contribution in accordance with the terms of the Settlement Agreement, QLT USA releases Sanofi-Synthelabo - ---------- ** Confidential Treatment Requested. 2 from any prior claims, actions, causes of action, demands, suits, proceedings, administrative proceedings, losses, damages, costs, expenses, liabilities, charges, interest, penalties, fines and charges of whatever nature (including costs of collection, attorneys' fees and other costs of defense, costs of enforcing indemnification provisions, and expenses of investigation) arising under, related to, or connected with any previous assertion by QLT USA that Sanofi-Synthelabo failed to use commercially reasonable efforts to promote the sale, marketing and distribution of the Product in the Territory, whether such claims may arise out of, under or pursuant to the Collaboration Agreement or otherwise. For the avoidance of doubt, the releases set forth in this Section 4 shall be deemed not to release a party from any breach by that party of its representations, warranties or covenants under this Agreement. 5. This Agreement and all rights hereunder may not be assigned or transferred by either party. Notwithstanding the foregoing, the Amending Agreement is assignable in accordance with its terms. 6. The parties acknowledge and agree that this Agreement is intended to be a confidential privileged communication between the parties relating to their joint defense of the TAP Litigation. Each party covenants and agrees with the other party that neither party will use this Agreement nor any statement made in conjunction with its negotiation for any purpose adverse to the other party in any context other than the enforcement of this Agreement. Each party hereto waives any right to object to a motion by the other party to preclude this Agreement or any statement made in conjunction with its negotiation from introduction into evidence in any ensuing litigation between the parties or in any litigation between either of the parties and TAP. 7. THIS AGREEMENT AND ANY DISPUTES, CLAIMS OR CONTROVERSIES ARISING FROM OR RELATING TO THIS AGREEMENT SHALL BE DEEMED TO BE MADE IN AND IN ALL RESPECTS SHALL BE INTERPRETED, CONSTRUED AND GOVERNED BY AND IN ACCORDANCE WITH THE LAW OF THE STATE OF NEW YORK WITHOUT REGARD TO THE CONFLICT OF LAW PRINCIPLES. The parties hereby irrevocably submit to the jurisdiction of the courts of the State of New York and the Federal courts of the United States of America located in the County of New York, New York and hereby waive, and agree not to assert, as a defense in any action, suit or proceeding for the interpretation or enforcement hereof, that it is not subject thereto or that such action, suit or proceeding may not be brought or is not maintainable in said courts or that the venue thereof may not be appropriate or that this Agreement or any such document may not be enforced in or by such courts, and the parties hereto irrevocably agree that all shall be heard and determined in such a New York State or Federal court. The parties hereby consent to and grant any such court jurisdiction over the person of such parties and over the subject matter of such dispute and agree that mailing of process or other papers in connection with any such claim by certified mail to the address set forth in the preamble hereto. 8. This Agreement may be executed in one or more counterparts, and by the different parties hereto in separate counterparts, each of which when executed shall be deemed to be an original but all of which taken together shall constitute one and the same agreement. 9. This Agreement shall survive the settlement of the TAP Litigation and the execution of the Settlement Agreement. 10. Notwithstanding anything to the contrary contained in this Agreement, the parties acknowledge that the terms of this Agreement and the Amending Agreement may be disclosed as required by law, including but not limited to the rules and regulations of the Securities and 3 Exchange Commission, the rules and regulations of any securities exchange upon which a party's securities are traded or any other such regulatory authority. In the event of such disclosure, the disclosing party shall give written notice as soon as practicable. 4 IN WITNESS WHEREOF, the Parties hereto have caused this Agreement to be duly executed by their respective authorized officers as of the day and year first above written. QLT USA, INC. By: /s/ Sean F. Moriarty ----------------------------------- Sean F. Moriarty President SANOFI-SYNTHELABO INC. By: /s/ John M. Spinnato ----------------------------------- Name: John M. Spinnato Title: Vice President & General Counsel By: /s/ Laurent Gilhodes ----------------------------------- Name: Laurent Gilhodes Title: Vice President & Controller SANOFI-AVENTIS U.S. LLC By: /s/ John M. Spinnato ----------------------------------- Name: John M. Spinnato Title: Vice President & General Counsel By: /s/ Laurent Gilhodes ----------------------------------- Name: Laurent Gilhodes Title: Vice President & Controller 5 EX-11 8 o34971exv11.txt STATEMENT RE: COMPUTATION OF PER SHARE EARNING EXHIBIT 11 COMPUTATION OF PER SHARE EARNINGS Basic net income per common share is computed using the weighted average number of common shares outstanding during the period. Diluted net income per common share is computed in accordance with the treasury stock method and the "if converted" method, which uses the weighted average number of common shares outstanding during the period and also includes the dilutive effect of potentially issuable common stock from outstanding stock options, warrants, and convertible debt. The effect of approximately 9,692,637 shares related to the assumed conversion of the $ 172.5 million 3% convertible senior notes has been included in the computation of diluted earnings per share for the year ended December 31, 2003. Common shares issuable upon exercise of certain options and warrants are not used in the calculation for the years ended December 31, 2001 to 2006, as the effect would be anti-dilutive.
YEAR ENDED DECEMBER 31, ----------------------------------------------------------------- 2006 2005 2004 2003 2002 --------- ---------- ---------- -------- --------- (In thousands of U.S. dollars except per share information) Net (loss) income from continuing operations........... $ (83,415) $ (313,484) $ (163,204) $ 44,817 $ 13,595 Loss from discontinued operations, net of income tax... (18,190) (11,928) (15,022) - - Net (loss) income before extraordinary gain............ (101,605) (325,412) (178,226) 44,817 13,595 Extraordinary gain..................................... - - 12,517 - - Net (loss) income available to common shareholders..... $(101,605) $(325,412) $ (165,709) $ 44,817 $ 13,595 Basic net (loss) income per common share Continuing operations............................... $ (0.99) $ (3.38) $ (2.23) $ 0.65 $ 0.20 Discontinued operations............................. (0.22) (0.13) (0.20) - - Extraordinary gain.................................. - - 0.17 - - Net (loss) income................................... $ (1.20) $ (3.51) $ (2.26) $ 0.65 $ 0.20 Diluted net (loss) income per common share Continuing operations............................... $ (0.99) $ (3.38) $ (2.23) $ 0.59 $ 0.20 Discontinued operations............................. (0.22) (0.13) (0.20) - - Extraordinary gain.................................. - - 0.17 - - Net (loss) income................................... $ (1.20) $ (3.51) $ (2.26) $ 0.59 $ 0.20 Weighted average number of common shares outstanding (in thousands)...................................... 84,596 92,637 73,240 68,733 68,228 Diluted weighted average number of common shares outstanding (in thousands).......................... 84,596 92,637 73,240 78,665 68,432
EX-21 9 o34971exv21.txt SUBSIDIARIES OF QLT INC. EXHIBIT 21 SUBSIDIARIES OF QLT INC. The following are the subsidiaries of QLT Inc. as of December 31, 2006, omitting those subsidiaries which, considered in the aggregate, would not constitute a significant subsidiary: QLT USA, Inc., organized under the laws of Delaware. QLT Therapeutics, Inc., organized under the laws of Delaware. EX-23 10 o34971exv23.txt CONSENT OF DELOITTE AND TOUCHE LLP EXHIBIT 23 CONSENT OF INDEPENDENT REGISTERED CHARTERED ACCOUNTANTS We consent to the incorporation by reference in the Registration Statement Nos. 333-110306 and 333-126606 of QLT Inc. on Form S-3 and Registration Statement Nos. 333-2488, 333-12422, 333-100070 and 333-120657 of QLT Inc. on Form S-8 of our reports dated February 26, 2007, relating to the financial statements and financial statement schedule (which report expressed an unqualified opinion and includes an explanatory paragraph relating to the adoption of Statement of Financial Accounting Standard No. 123(R) - "Share-Based Payment") of QLT Inc. and management's report on the effectiveness of internal control over financial reporting appearing in the Annual Report on Form 10-K of QLT Inc. for the year ended December 31, 2006. /s/ DELOITTE & TOUCHE LLP Independent Registered Chartered Accountants Vancouver, Canada February 28, 2007 EX-31.1 11 o34971exv31w1.txt SECTION 302 C.E.O. CERTIFICATION EXHIBIT 31.1 CERTIFICATION I, Robert L. Butchofsky, certify that: 1. I have reviewed this annual report of Form 10-K of QLT Inc.; 2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report; 3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report; 4. The registrant's other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15(d) - 15(f)) for the registrant and have: a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared; b) Designed such internal control over financial reporting or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles; c) Evaluated the effectiveness of the registrant's disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and d) Disclosed in this report any change in the registrant's internal control over financial reporting that occurred during the registrant's most recent fiscal quarter (the registrant's fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant's internal control over financial reporting; and 5. The registrant's other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant's auditors and the audit committee of the registrant's board of directors (or persons performing the equivalent functions): a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant's ability to record, process, summarize and report financial information; and b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant's internal control over financial reporting. Date: February 28, 2007 /s/ Robert L. Butchofsky - ------------------------------------ Robert L. Butchofsky President and Chief Executive Officer (Principal Executive Officer) EX-31.2 12 o34971exv31w2.txt SECTION 302 C.F.O. CERTIFICATION EXHIBIT 31.2 CERTIFICATION I, Cameron R. Nelson, certify that: 1. I have reviewed this annual report of Form 10-K of QLT Inc.; 2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report; 3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report; 4. The registrant's other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e) and the internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have: a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared; b) Designed such internal control over financial reporting or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles; c) Evaluated the effectiveness of the registrant's disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and d) Disclosed in this report any change in the registrant's internal control over financial reporting that occurred during the registrant's most recent fiscal quarter (the registrant's fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant's internal control over financial reporting; and 5. The registrant's other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant's auditors and the audit committee of the registrant's board of directors (or persons performing the equivalent functions): a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant's ability to record, process, summarize and report financial information; and b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant's internal control over financial reporting. Date: February 28, 2007 /s/ Cameron R. Nelson - ------------------------------ Cameron R. Nelson Vice President, Finance and Chief Financial Officer (Principal Financial and Accounting Officer) EX-32.1 13 o34971exv32w1.txt SECTION 906 C.E.O. CERTIFICATION EXHIBIT 32.1 CERTIFICATION BY THE CHIEF EXECUTIVE OFFICER PURSUANT TO 18 U.S.C. SECTION 1350, AS ADOPTED PURSUANT TO SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002 In connection with the Annual Report of QLT Inc., or the Company, on Form 10-K for the period ended December 31, 2006 as filed with the Securities and Exchange Commission on the date hereof, or the Form 10-K, I, Robert L. Butchofsky, certify, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that: (1) The Form 10-K fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934 (15 U.S.C. 78m(a) or 78o(d)); and (2) The information contained in the Form 10-K fairly presents, in all material respects, the financial condition and results of operations of the Company. Dated: February 28, 2007 /s/ Robert L. Butchofsky ----------------------------------- Robert L. Butchofsky President and Chief Executive Officer (Principal Executive Officer) QLT Inc. EX-32.2 14 o34971exv32w2.txt SECTION 906 C.F.O. CERTIFICATION EXHIBIT 32.2 CERTIFICATION BY THE CHIEF FINANCIAL OFFICER PURSUANT TO 18 U.S.C. SECTION 1350, AS ADOPTED PURSUANT TO SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002 In connection with the Annual Report of QLT Inc., or the Company, on Form 10-K for the period ended December 31, 2006 as filed with the Securities and Exchange Commission on the date hereof, or the Form 10-K,. I, Cameron R. Nelson, certify, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that: (1) The Form 10-K fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934 (15 U.S.C. 78m(a) or 78o(d)); and (2) The information contained in the Form 10- K fairly presents, in all material respects, the financial condition and results of operations of the Company. Dated: February 28, 2007 /s/ Cameron R. Nelson ------------------------------------- Cameron R. Nelson Vice President, Finance & Chief Financial Officer (Principal Financial and Accounting Officer) QLT Inc. GRAPHIC 15 o34971o3497101.gif GRAPHIC begin 644 o34971o3497101.gif M1TE&.#EA2@)*`>8``%I65=G5T>SKZ?OZ^L/!P(%[=VQG9=73T7MV=;JTL;>Q MK*NGI$`[.KAKC2LG)HX03=S9V&$7/>3CXI&-BJ&=FQH6%CHV->[M[.#>W,C% MQ6%1C-VWQF!;60X#6L7`NX.!A+&NJ\&^O%)-2\_+R'%M:_7U])B*L@<%!G=R M;YB5D]#.S(B%@TE$0LF0J$5#0_/R\;6RL-/0SZ2@GKZ[N(V*B3`K*:ZJJ):2 MD:>CH+NXMM>IO.?,UN+@WI,B6,O(Q;6LR.W9X(1_?9Z:F)R7E-G7U<7`U4Y* M22`<&\K(R*E+=:VIIHV(A/GR]&5A7U514)6/C-C2X>?EY#\Q=D,_/O7T\^KH MY[*7IYPM8<[,R_#O[DQ'1?;K[]W;VM#,R7A38T((5"L=:S4P+\S*RB\E3HE% M8-/-W:(Z:M_=W4,.)]K8U^_DZLS)QQ4,/#4+@D%';T(?S(5"QD<#G\C1P49)$<2L\G*R\S- MSL_0T=+3U-,980QXN1\,?'\P)W\D%A!_$$<4U>KK[.WN[_#Q\NPQ'G\5N2`5 M%!E:%G]&2%#Y0\7"BGD($RID\`EZ4>/$FPI/_KCX,&BC)0E+"HA$ M(+*DR9,H4ZI(-#X^"H&8:`;&JU:M8LVHE=>"1.XE$PI`0I(+.!"=-LOS)8H'&)JI;_^/* MG4NWKKJN1A%!L-!$D)@C3PK4./#G`*^W=A,K7LRXL2>\7W/)P(/`!@,Z:RL8 ML1'&P4!-=.O\Z]N_=X62`D>*)6^??SZ--+ MXX&"19@:#EB@X!%7EG(,,4-`R#8X(8$@J`U`@@$" MQ)6@BCCFN!L6#I0'8W)_5.&`&#;J:.21NRW!P?\ET;&0SE8W(BGEE%LU$<0@ M`_"000&Y#&)ED52&*>96`"SQ1PDA?,#"&R=48(D!!8`YYIQT,L0'`DZP@,<) M?!YQB"4LR"!GG806R@X/*[AP1`5\OJ$%#$2(`>0+#A`PJ*&89JI,%`-6Q"<> M=#@!PPL_8HF"`55V*NRP MGP0@1!-'\'D"'DY,X,.!?W`@`A*\(A$&`NK,D,,@$N"``@PU!CD@#!?@1NRY MZ`X2!1((T*$L'F$T`2PF)011`P)81$%`"E@@4,,$+TZSAC:)U%!!&!4X(<@4 M![\!@+GI1KSJ`$H`4`/_FWS6$(08X6I2@@]&U,```S748(0/U42!0`5O(,)' M`6&D2H%30AR1P1\$X+'K5!+W3&@"*QBQ)Y]TD"!$%*-120X0!3<`3:V(3C^((-"%B`\1O]V4"J*G)3(U$&H.8@@`%O"""5 M5()D,8,"H#\!^NBDEV[ZZ:BGKOKJK+?N^NNPQR[[[+37;OOMN.>N^^Z\]Z[[ M`BO\HNPD(J"@A.]#`+G.Y'AD]`<61RRQN>`\%VY]?CP8P`"CGQJ0PVVQ1#Z- M_T0!%$@6'4LT800R$CB00MC7Q^^=L1RXRV<%(DR00<"RB"^-1"]```MBP(,^ M5``"-N`%#R9SL\')[X'/J4(&4@"`,.RI$@@-#S`A4%0`0=!R`T("K`MB+GP MB*7A0@::P+TV6<``A*&&#J\2)21:<2L"&((3Z+`X"RCA`#Z2HO*T<\4RSB4+ M0U11(QT*N@P?> M#$B1$D!`AI"$GZ8PLJ"`%GK*(`P"P`+@I!/^2#Y$D)4?)I!4T`0!- MF`!]2!$#`UB`AD73($1`Z1!1DI*4:Z@@"89`@2$T(5Y1[$0`A@"`9-T/:@'@ MWVG&&*Q;.C,3?,@!"PRP!J<%*00&,$(#,2&!#/2A@A<,`P"&@`0W6H66#;'E M,^DX`@8LX7&6T-H4S,D''RQ!"S0LH1`",!=T,D2=ZRPC%3BPPDQDP0DKX,,` MB)`!)S2Q`E1;95W\N1"`!M2*"1`!RC9Q#1*(0&T6F8(-#@!/NU!4(1:]Z!$+ M8,),5&&("&,3XX(``G,JYJ0)2:E*6^@$YPV"#RH`01,88$P_H8``1%`F8W"* M$)WN](%.(@0!"F`_BVC!E''_@@XS5?542CHA!0,X0-0:Y0`.V,!+5]*J8IS: MU>L5@`$.;10+,K#!04SA2:9AZCS8VE:Q\0$$**`#R]Y@!"'4E1`AL(")U)H8 MOO8U70/`0@H^NBP'.``$AR5$%9SPSMWH51Z.?2RQ$E``8[Z!`;QDP`0`::HP M(,VS6Y6&C`Y"B#208%<$J(T1%NM`T;IP`#&@@?T81P(?$2`,3@@`W%Y```"P M``.]^:PJJ/`$7`#J,%DXPF8Z8T3?/E`&1N">HS*0*DL<@`,U$`$)ED`"+83! M`)G-:VR?<0`6.(!@K"'!)!X!L]L89KZA]6Z=;("L3SEA"#8UKPSZP&`FYX(J^*# M7#A"A!RA$>IQ[DPQ&(&.<:#C'OOXQT`.LI"'3.0B&_G(2$ZRDI?,Y"8[^_G+0`;!?#V("`P8P0(26`"-I\="$1/+CD$0 M[[42K!X7IT(B0S@!'5QPL1I0P`@(^-L4:%L]-Q-+"%H0+P=F0&?[V!D5D_N` MI`%0`0"$8!SE.`=>,1%@0W,(C080KVI*VJ!'GZ+"@E#S(T90`6(8XPQM]G2= M2H"%%6@A6:=%0`C*BR)3F\(!:1T$""P0HC\@0!)'6$VL9?\MIA+D``6F-<(3 M&EWJ,6.ET\Q&#U!+VR@+!(':'/*U.K"=[>[\,&^-:D+6IB3N:I"[W-0I0<6X MAX+*!K:X9)W]/@=[^'4XO`-DHU$IT3PJ6A M\(7KA@\'",)PP["",-9IXM&HN,5'0P40!+Q13IB!P0L%#O_=%2_P@`=4(`KJ,@!C%3``%@0_-L+/ MPO"'3T44;F"!,(@``"3C``%8:XD7"`$`D-\RY0MG>5E@/O.F&('ZA*`"'DB` M""%`VPT$+X"IHKL"+B@`$E9OO=;'XO6P'T4)M,`!WA*"`E.8`"%>@`,._)V3 M*V^A\0>1AAX*`@($(,`!7I0%,1``"Z2W!/*3#PH^-*$)-[=$`FJ0`2H@P0!: MCSX=M_\''M`A%VMP!(QP!.\3+8R`!V.Q;.P'#P?@`/RD"76P!!;P>)^"`DM1 M2,;W`C?@`"WS!U&0)Q?P,GCP!_H0(C+P!LYW">NW@)U0`$N2"5DT0\C6!-9V M1,8W`[=R_Q04``."8`/AH#[LXSX*R(+MP`)G90E5@`0HD`UMHF58D'W[5X/+ MP`/\A&J"8`!'\`=Y@`+>P`<,0&B<1H0(80%$0A8+0`.4=C]-(`.,SJBXSMZN(=\V(=^^(>`:#LV\`0UP`%A((#*LBSR,3I30`*! M^(B0&(E]F#QY@24%\`9!X$AU6&ABN`Y6``"X!O3>`".:!,59`X](A$;]@*!,EL,X``(F".RE(! M%O`$(:`":\<)%U``9;4`CL0#!>`"##`#[CA).9"HEI2&4C M!C!``A>3B&]`!W"U`AM%DKQB'A<%`31``B2``HTD"VF@)$3UBZ$)`#"`!%Q0 MF:9I7C=92P$U`Q5D`#<@!"LP!5^HFZ9`EA1@2O<%FINT`OP@D+MYFO7Q3"#0 MB#'@-`OU9R0@EK3`!4@``Z:4!Q8D4W[B!$9#`#%PE-.I"9>)"IDY)3Q@`:N% M"0=P+9_``PEP`PAP=HEX!(UX`^#2GG'3F^GD3"\@`L&&"5P`(MQT``2P!'H" MFA50`RT)`B))H`6Z5LZD`@[@G800!$W`:Q2030[01/?#`D^0`>LYE1K*%0;Z M3\Y4``7E4C*@_V4,DXAK@P!]H`#L^:*K\)ZG$)](H@4X8`DE$`,$(`,DX`0H MQ#)M8C(<$`0$(`88()U`"CDQ6E'.9`';!`$4@&6/B0?:10,+P'A9Z@Q"&GO. MM#=(L`)5%9I3P`%/0!]3L*5I>@IK&@HE(`0&``#,1P.%"4%4,']'>@0,8``LT`09.@@!,`5* MX**H"@M[V@DRP``)H`:P^@4=\`4/<`5M@!80Q"G^,CS7TD9_\"';./\(6J,% M:YFLOZ&JK3!;PO8:\"4(N:49O)4&89`#.P"K#]`!^/H`U6H%#'"$A",`8I`" MBD16(F`FE[``#K`$41`P+R!-3O"CYAH^Z+H*U&5=?Q`">,`!0N``"I-=VP4, M@I`K0&"OTHJOU%JM7B`"Y>HS0N680:EB/#"5`Y``$V@`2_`$K=H?$!NQRCJQ MJ5!?]X4()8`"+N`-(.`4_548A_$'2S`$5Z"O#Q`'^(JO$0"U@Q$Q?!`"$S"A MI)@"P>0)"=`',[(".`!=/`NI[#!A8B`1/!"L?E$!;,AA?^!A(+8"/0"U)3NU M)_L`=*``Q"('1/!L+G"H$+6&*C"HEC``62#_`,AZMA);B?>859%;AV0`M?04`,0W)56`!1L[/+8B!,/KN`S!BGKQ)W\0`PXP M`8`F:+2U!+HKM;Q+M0^@-I-@`4Z``#,P)@I@B+!$`AD0L\R[%<[[!R^031DR M`V]@6^1@#NB0:A:0!'F[O;+J`KV(,*`)D"N0`CDPK`S"!S-@:_DT3CBTOOWD MLZOP00DTC!44#*U6#$=PJSPP!5X`!MN+N4<0!C!0!400GGA2EY]"!U/@!`4` M`AE`!%!X'F&5`P@P_[AL`E$<``)&Z<`3!<&J`&RLT01XP#A%=&R3H&R"(`-L M\,&8RP;+,@%NQ%S$B6&/R3@<8*8-?!X"L`#^LCC7\I(\?%,^/`TEH+U,C*][ MP"<6D`";X`,KX*0@M48D``-B``%8RAL"@`4WX+(600=Y,`3+&\;L.\;2H`8: MH`%2P`:*O,ACH`%^,`9I_"G%Q0GAD0$P``"'^BZ^R@$W@+B-D0"^J"RPD0$8 MT+B"C!V$[&XRD+M>X`$'P@45$9IL0@83"GFP8*.6"^HFP`&>!],!W3]`R# MMX`'E>`K%I$'$]D*47"0B6-,0PF3F@)'E@,.9I`0'! M#S&0T9<@`$W@!!Y04@/`!41+`$K5V6>3-C?,`&O(,7W='`\="E5$!2Q@$4(P M`'RP`"P-1<_0!6=HB%5L*Y-IRX1`!4LP!<@83QYUJYT#`V_EQ2B``XJ=VHR% MFIQ`!4W`)DOP(OC7)DMPU,HP3!R`PO_I!"#`E]9$`"7""2R0B;!"@7U2L-KM MW,6QVJ!`2!>``'P2VPY2%GPB`FKM#)UM?DE1Q2'L!"C0!0A0HYG`'TSX*1R0 M`\/MWM4!WY\@2I?X!C0R$1.0+'BP`B+]##'`BZ$DVCG,>@A)@HRD"PB0-7?I\\G4`/\ M_`X)$`;[/0@<$(>4SAV7*4'B=R#E=WY8FE(#``*2(`)I@(3\0HH`B,0&-_$`F34`F$W@DUN:=0^`N;T`#,2P-&"`"#(`# MA"D`7#`#ANBWWP[NQGX*W.`-X/`'3<`"].%_0\#NG!!9>\(`MWX)9L8G#!"N MU"``-T`R4S`%82`6G![PUW&8&7`$)$`#X*N%7/@'7@B&W`@YBE0#170)-^`N M]6;0R3``49``"1`#=2[RQG&8:4`'2UTT-=81U",(%R!F"[``-T!E:S`$BN0` M0[`&0)8!0I`'C.("*^`!L?OU8!_V8C_V9%_V9N^YLPL>2;$43?$4-I;T+[\* M(6#-#O"UTW?A%A$$&P[T4C?P<5.[@A"Y&]9A82!]EY[_"FG``,L"VC"H!6Q2 M`_[*]Q+3EE/S,']`.4Q#!XRG`GA0;)RX"E'@+D?@^9=`!0NP)Q2.\Y)/)X>9 M`\R"`C7P#_WXCP'I\*+P@=2,Q)C`'FQR!#C@EZN_*HX''O M"A(0YT>@!%RN]`M@S9&7S<'?]U?]"EQ@[7C0\)O`!8/]Z2#`U]=/)9;^^:YP M`4'`)UFU"4C@!&K,^.6?*><_DK*0!4'`"$_0WCP`"#1T)PXK/'^(B8J+C(V. MCY"1DI.4E9:7F)F:FYR=GI^@H:*CC@<+I*B:(ZF*)04G;T&3,RZP>02LN;J[ MO+V^O\#!PIZFP[RKO*\G!2^3_X*P"`+&T]35UM?8V=G%VJ'(NR5+T)1B1B/($.*9,1P)**'N_C0P#.1#Z47$X[`"E+1I,V;.',* M*VD2)2\8;R82G$3%25`Z,@;HM*;&Y=*G4*_Q'.F3%XZ@1H9*XI.#Y9LFTJ(& MJR.EB-BS:'U-%5GUI\0P6B7Q0"'Q"(YF:74-,-%!BM*\C*!(^0"X49DYA1G= MT:!!9UM>"\*<,*+"4A80%MY4:"(F,:HR4CIT^.$YT8!RB4N3L$[\D6+1HTIX_F`>#./$!'`NXQ)YISB1G7P7V>#0#?<3CIUPL/DAT!0R89U'("`]P9 M&$D,(*00!`=Q)"C:'N?$*..,,KZ!QXTXYJCCC174X../0`;YHQ8B%&GDD4@6 M2<('3#;IY)-,KM`'"2[&<4,?6&;9QPTX+.#EEV"&F8`/(Y1IYIEH1G'-'*&9 M]]HU+\2`YIQG$A#FG6%2H*66I[F(7T_8$##%"72`D`D&"`S_XD`?-9DHP0%( MA)`""0#D4<,1+.WAHFAL3.'"IZ!^RH`#I)9JZJFE'E'!JJRVZNJJ>.@CZZRT MSDKCK;C2J.FF;-2JSZO`LGH$JL26:D&HR";K@@A.-.OLL]`"8,"TU%9KK0$% M:-#B>A\@<.VWU`(`[;C/BJ#LN2XP4$.QQ-(1;+"Q^LI&E8W9I*$O:]12`1:: MP,#`.1Q45MH+/N`PP0=&U"#1C'C4X,*FYOVYR`MT5FRF`GAF[*6>>W:\Y\%0 MANPD`$D6.0;$;#@@Y,H^.K#CRS@&E>O,--=L\SGSNLC&S3SW?#/,,!_!,LMT M0!S'?-HDP$`%``A,``L5&!%#)/?Z_T+%OQ4(IPE=`061A5@E\*!"!B`T8<'" M-1X1A@M-!*$`(DQH`+%H8.R0%FAS0TB-!PKT[???@"M0P."$%VYX`90"H/CB M)T/,P.*0DW#XY(0K$?CE?7O0#S7OS?UFH`+9$(8#?V1QA!&BD^Y0-U%@+80F M%UEPC@L"X\3%#0:(8('+,L?XA@-&!$$`$D0TFD@#2))@Y7V(!8RI,\PIS%>562 M&%0$<"&((?\`&P>H`0(R,`$8K&$`3N#`!?YP@3#08'7KX$$3-".$CF2"#^6( ME1%`$#]M#*`*D")`"E!0J3!@*H`5H,,41-`V&V1`!1C`"R5:\(!M.3`"26`> M5!"4O-2(Q0X.@ICUH&("*QHM>M1`0@5$0`=WD>`/+K`@'.6(B`N`X$LWL)@> M]\C'/I;)7[!X`IG\.*<9<"`H%:!!!@C)R$96+`,VF$`!`.``M-6H!EK@``F6 MX`%'HFD-27C`%T9)RE*2,@(/0``!/,G*5KIR!%@(8]Y>2M/"UJX1(CG&$83N,3UE+-3#@`EG\`0M'D`$)+`"!/T#@ M"!2P:#L*P!(#K)`3&"#!47!03;[(AQ,#P,#^5F``!OQO1@*T0!-6((0$8.`7 M'36".RN`@`;H5)U7L%LBTH"#*9UM1A4(_T,3:("#`U33J)A-B%2I,8`4.``$ M&6@"';(P@@H4(`,D.,(9Q,J."Y#U*V?=1!92(+O-<&$`8.P`&/CYB"H$``E" M)&(>C.A.S3B``4;@`#DS@`4(%-47%\C`"J;`D@I,80D9D`,0#*O3*[@A?B6` M`!)F,($F&.&;0=&,P\8)`R0$(+:9C6\[-DN-%S3A1C60`2(0\+\CO(ZUK17' M,N"K"15PX!P,@`'VXA,)'Z0H"`!06$OQX``6((`&,B"`%(?!!Q@T028!:8(- M-KR%4*[S"CJP1!H6T`<4+`VRDEV!#+KP3/G:>"'IRY!!9,"2)B2P$PFHP0GV MD#/=HH<'D,I!`?_LVE+UYL$)!5!`3@BP%8.MHC,;5"4&W_C0'D M`"OEXX0L'UA2>F2@`(.`!0-2((&&Q&`!--@J."-;P`5T01=J:($$`0X5@2>$ MX-<@@$PL\&Q-X-)-\2`"#@`""Q%VU294P`$)SGOF`-:``Z`E`H$Y4>)T;N#? M)/>(R1&"[ MD,-0(DFP20K0C[[TH8\>:O#@!ID!S@J2'Y40R(`&`/!IVAB`@`DD0/!_4,.7 MNYOBXHOD^/3@OC4D\*_/CD0"(&!!C.C@A`Q8G@=#T`2U5V\RDF4D8`:'Q4Y' MYWX@`7_Q('_S)V1X8"@?404HP&D#@@._QX!_P`/;M`1:T&@YE8#JU'8%C#AH,&X8#P`('70`0& M<`+HPV7O4`4S@`*)1R@B0`&6!821H`<\V(/J9`9J0(67EX*`8A,"H`5(^(+P M(``R```R#;N>&QN>%UW$360``L+!1[/`"J"4S%>`" M(*"$=`@)#7"%)`@+!I`!&U:(ZR"$[T"$V<`]L#`!W4`%3\``:5@`4^B(E+!` M)&@&3P!B>,``2D!\GJ@6=L@6.L$'0:`/!M"&P_`"9SA8!I`#-9:*DQ!LAY4$ M=I-K3;`PIJ4.NB@5JYAH/(`7?!![1&!IDJ@-52`@S=1U5H,$2Y`'U>4"!2`& M45>,"J0'[&0&E98(%T``!9!]#L!Z?^6-Q@")O!`"3I!V?R`#B6+B`#K5:0O.".NE`%[G(*`?#_ M!@4@`#-$D(GPC.LP`4'1!-U("A<1!*1H`58%D9QPB%>PA9%P=:38!%C0CRI9 M:L=H#52`AD=P"B3``+SQ56&E/F)1`$$!`",9"B!@!(WF!&+`D359"4RP`5HT M"0&P!`N#!RZ0`ZCXE)8@D:Q`E"10`Z=@!"30$25@`14EE&(Q!!*A!>,&"MT4 M<7C@!$)`B%S9"QUF`.[D`"AP@W<9"EY)DC!0`4&``V(Y1XF03*T@)V6"`[WT MF+SD`1%Q`@"P`+M$`#(P>S*A=4XP`0H`F:`9FJ(YFK9$7H@7%`[``4OPF:39 MFJ[YFIYT1^P0`Q:@!1>P`(>IF(BIEF"0\P`!`,4'$#H`/JI`=P``D28``1]P:"6)[Y.9N3B80B<),;J@C[B0JX M>0H"$#4TH"Z-N`@)"@\$(!D.X`,M@(@/D`3B$0`I&B,,L`3+&:+9P`L`#%,!,A$("(1"F8EH-7'"< M`00`,D"3\;JG(0$#(B",*'!K/DJHU6"H[?"@6)A. M$1`$!Z"GCMH-?'``9'4.%>`$>+>F("IGA3&CFYI.21"J.$$%8N=.-7`#/0J1 MEDH-F+H.3"!YF]H#Z2FK-Q$%.=`$0J9U!4``3LF.NSH-O;H..G"E"=@##4"L M2[$&!2",3<"&=_FLQA"MZ^`&U,I./=`"V`H5=<8`[D0'0K"!NKJJI^89&U"N MZM0"$YJN4.&'1S@@3I"K=`BNPR"N[$"NAW6N^IH6%Y`"FGBF0Z"AJ3@`+:`' MCK'_&CIP!3J%KPF;%URP`%@7$`R``MSHB1+;`SU`>3IFL8AHK1OK&;HFC(\F MJ.[WH%=XLBF[&@;[`.C:LJ5!!4/0L"=PJ^L(A(@Z>=0V'O6JL3R[&GZ(A@,R M$">HJ3K5`VZ@@DM[M;D0@R*"H2D`GZ16LM7:?JR(M62+"G&%`P"0;@P0!%BP MHF\FL1A+@A$$JME`L&6[L66S,$>`I]%&LYL:06-[MX*+"BL`M`ZP`!)`MSH1 M!5%P`&-3M'\[A_,ZN)0["EDP`W;J`"20!I6@!SMK$E3@`3B`.`!@!"Y`*A40 M*VCPJND$N"!AMY7;LCRP!-#Y!D:0`FZ;"%Z63BW`!/1`_S$SL`!#,`$K,$E3 M<"F*=RMX4`$.$`8B@`"OZKITE@,H0`(X4!-G,`$&<`,/R:*Q^[VB,`!$0`$B MD&XNL`)B(!Y;8(5LU[O44`)1``&0D@$$D`.29`#BDBX.X"ZQXCN:,2P,L"S2 M4@`3L``$D`%($`-$$`4OT`)QFX!S>PTAH'5+\T%_P`)'P`("037@V\&A\`(> MYDY'4``^L`B'N$X(ZPM1X`,)L``W0`,?0`*ZHS#)2R-X(#0,\+P?T`[!B6PT\H`5-H!04\`9_L`(.,#4Q4`'WZ`BPZ\%+NP#!.""JM'8Z MU0"^VPD8,`)>T@$`'-3`%`%``4C($!GR?HS``.7MB4TEE M4(0(2_P'BE,155`#?0">5ES(EU".WJ0/#@"L.J4'7]P(`L`#`1`#P&4G&=<$ M3F"Z:%QOO:,9S+LV3\8!NY<".7#`*G``&%`%BFL1%WMBDIL-`G!>NSG+B%!E M9N*8L)G+NKS+O-S+OOS+NXP#3G`$JXN%+7`F"Z`G,,P!6K`N_:O&GRP"`*!) M*#`$,@#,G_1E-LL.8>@`ZJ";NMD(56S(5[N[KXH&N?(KP[(VTHP"*P`"G*L0 M%TNU[2`!&'R/>8!,:4G%Y-S/GA"'6(C.%8![6H`"%'#`&7```1`%S8H0`]`& M5M`.7'#_!#Z9"$TP!7^%`71`AOSLSQZ=":W\JN((&`*+"1=``A5P`_Y)``(0 M`A60`BK0!Q701U%8="?4*P3_HTU!]'!L)W=^9U'71HA7AHC;B`F7@TH/A[R/0D$ M:J#H\^%#:2`S/AXU3@TW_M"QA^N1I$@)^)\>1I40)4 M7A@7$)SQT*3X!J7P'>9B/N9D7N9F?O_F:)[F:K[F;-[F;O[F7YT%*TT`=+P) M!W#`D88$U]0(64"_Z?L'XGO`9]6?!`"Q1`"QH"``*X(A_X(A)X&>/T'=K#H5!T)$."?D88%(]GGP^,4,7#`8:'H!!``B)`% M8D#GG8X(B3``$-#0ET`%].N? M8C"=E%`%_EF>5`!<,4"3H^J?9T7M!"!XSD[I3IX!Y$[3H'#M*XT$5B[J_BEX M`D"_M<,(5##KC(@(9U#MB!#N_`+H=YX!#4T`;\``#&!$!K`)(*`V=,`!FP,# M>`#FBI"':G/_!!]T;0HS!>83!FT4!BUW`$=@B:.@`'@0!@.?2-(>"8-I`6J8 M"`LZR(V09Q3]TG]`\=9U\1E_`#RPO^N"`Z(@3`)O1$9@YW2`\A2!".+9?(I` M!<%X-DM`!2YM1`H?RW3@`-/T!QP0]$=`@:+P!B)_-@6O"0?`QA56$]EA],F. MTD;4!$P_.G00!MF$;C5`!R42&3:`WI'%`&?C`IN0!E.P]C4P-?>%\072"#&! M\EK`!52`\T"O,G0P3QF!\M*M"`A0`79E M`%60!E%/!RS`Z8NO,&$E!,T[\Y!``'B0"#-`!Q\2!3AP`S=X`4K0_P=8OPA\ MX`0I,`!1\`;J[H1OX/")D`$5(`T'#P$.8(D2\%FY@PA:\$8`6@$>+PH*4*"( MD!WE=`$4D`+(0*LWT/DBI9I_D`,6P!$K8$0LSP@'WP]/$`87\/Q_$/T@,/U_ M4/U]``@N)7\H%G^'B(F*BXP9>(@'#"M_+R!](0.4"7T+?(Q_!@5_5'@$H#5O MIHP++D1_!$,!_/'0PE):8FIR>C*$E M?*5_*S78C`<5KD1X8D8&?Q<6-S0UATT`AVMX%0O&](K>(X=187V9EC`O?P:$ MN!7ETQ`&AQB@\%'AP!\*1Q@)T/)DU!$9??\8O.#3SE&4`0@`<#'0I)Y)>S44 MY'/"80"?''U@>.*3H8\0@(P`(!ADQ$D?"Z[6K%OD8PH(97ARH``P0(`(!!X' M4`B#H8*,/T0Q$`'#H<88(`3)07# M0A0\3*%%&//01\P]B!0@0@`K3-'<"GS($)T+3F2R"'95(%%#"C)84!T61P2P M2`GO_2'`$4.04,X?N.#@P"$'T+%`&!R00(,K'GZ8$B(+U!`%"5H`X,(D0JS% M``E5="-!0$8T\<%BAU3`R`4Q`%35`BS<<`@"4QAY"`]X!,'A$!3\4TQ7B?3A M`@).%!2$!3A8D,$`-Z`@`#%-X&$$3G_L90P1+C0Q@'U_`/"!$;#]T8<1B-0` M693$3%;9'Q_XQ,(%?!2@A2-<\"&$`6\I(H`3;W#P%JC&\&#J'YQZ"JRH_Z0> MDD,8`6*"`H= M,D)#?XCAP!O:.LL(IZ*ZL`"U?UB+K;;<>OL)"A6$,>X?"!H3!0`LO,"-B!9\ M<,B^&321$@,=V@M)!5O],9D01ZSQ1P(L9%`!9!EH\>@G3QQ!1TTN(#GE)V!9 M$(((HKR"!PH(D=L''E/HR0&E&O]QP,Q_O`O8#'\<.((+0?P1@Q:K+C)`N@3< M8`$6?\!P0C$7B.!$#C-/4`//B+S!@@,6&$&'$;DN`B@B$^3A0@5TT''$&ZV> MQ,,1S5;*%R,PA,$"N@;=(:84A<6*B? M#%AAL9\N3BH?%%20\^-_0'L(#F&X8+G>;S21;#U9T!$UN0E:C44%4U#Q'2(& MB#`%"N[">X@0>/#`.N)TYP'`['O;?A(53"*2,#%8,!!&=0^+$/'$%DPO@PQA M4,=-101/*U[-9:C*KQ$@5:Z\1A1,YZ\KDCD$`'?TA#0P8S?J0 MEH$C\,IE1\"#$QC0,6*PYF2C,`#>P$4,'C@@#+XI6PT&>`BU.2`&RG"``C\Q M-Q^A)P\DR(`,,\`;1*2!$500PLK4DK;!*0($%4#!!7AWB#SHYA`U/,2PGN%C"( MY[EN`$$P`@+-``$>92``Y3`1'RA9XYUE.$=\_B'/5K-C\J*2)IZ9X\C<&!<*F0'`N9XB!08 M[@1O>`,L$[`^CB&B"098PK5DB(0#H3`NG_``88BDD#`\"@D56)DBTC"%,+@" M)!42!@R&T3HZV`!"GWO>T?3WAR%8``$6`,$,A<``502`DXO@0`TR-@(5B"$* M:FI$#8Q0$!YH80F'0`$+IGF(-(A1"\[[PVO^A(<1C"`$)*"#`)80AA"\``%: M_P`!HOBP`@NDX0`B0T05PF```1"!#BGH(25RH$RC5<`)%%B`#2[`@E,"D0#: M2$,::I"8/RSQ>0J@@Q)&X`$2`"4%#A"#`%#@!#$,1@!Z$L_@N,"`0F*+!H@X M5@ZXD(@#.0$'"U#`"UH:A9?&=*8K4,(;#+"`!1R%=8XP*`$*$+(<'`$'?)A` M&'S`@"`,``1'$`,7AGD(/O2$"F`EX!_XD("#M:X&4RCK`B"P2`%(5`8'R@`7 M`."$`UUE`A4(*.OP((,1T%"A;H6K7.EJ5[SJE:^#[0D&HC"%(2',%#3YXR$D M.84AE+4*!F`!$=;@`!G@X`@$$$"F$#$"C&FS`CCP;/\0*I`!,1Q!"'S`@1$R M0`<$O&!`(1!`#HA6``>D@0J4A0`>)O#0(ZVA:B\0`1U2N@`5R,`!:R`""PP0 M@PJ`0`#D6$!2X,@`%"[P"9Z=@$YY4($;1+<&,(@($+1$".(1XB#"C$@`B81J4:6(`!#&!!`!)@!".T MMC0,:RF4OLC%YWD@#&01&P$&4`4`A!F2"&"!"%S0#`JL+B`P6(L64!"F"'%1 M!$-(Q`T<`&7*88#*5L85$;+_S($JUJ#/MRM:#"P@8[&-!CB@F0(%!B`$%S1G M"%2P`0D4@84\..$R`ON#!9!@#BUP,QAA>#*45=`]XR'@`EDP@(:FH`)(,ZQ> MSZM!F(UP%$CW>-*5OG2F-YV(3ANA+!W^`P-(G19\(@(+3NXSJ\W,`@!&30&.#]#VM8@'\'`($%;$4`LD6$`!9` M>$2T*2!-.&L^N#X"@$C`!B'`>P)`H-G(9YYU10]\(B(_^!(*@Q`U``O!>")F@O`R`#_W&"+(@J%)!1+1B#]+$"\R>#-GB#.)B# M.KB#/-B#/OB#0!B$0CB$1%B$1GB$2)B$2KB$3-B$3OB$4!B%4CB%5%B%5GB% M6)B%6KB%7-B%7OB%8!B&8CB&9%B&9GB&:)B&:KB&;-B&;OB&)B'>KB'?-B'?OB'@!B(@CB(A%B(AGB(B)B(BKB(C-B(COB(D!B)DCB) ME%B)EGB)F)B)FGB%5)``GOB)H!C_BJ(XBJ18BJ9XBJB8BJJXBJS8BJ[XBK`8 MB[(XB[18B[9XB[B8B[JXB[S8B[/H`1!@`Q`PC,18C,9XC,B8C,JXC,S8C,[X MC-`8C=(XC=18C=9XC=B8C=JXC=S8C=[XC>`8CN)XC0H0`!ZPB>B8CNJH"!Y@ MCNOXCO!XB>UXCO%8C_;8B/-XC_JXCX68C_SXCP"YA_X8D`19D'$XD#](`"+@ M,@`@,CG``5NF#34PD35`;"1`D1.99XI``+.Q"$U0=?&'D2+!""70=V7(!T]0 M`T=0`S(P"!)@!$?0!`$E`A0I`ESS!P@0!A@Y(R'@`D?@`!Q`!53``-J2!0"P M`GA7`&%`_P&90X`P0=3>0@"\'@"0"EDQDG"$16`"=6`2'_`&DQ`%.',(&?!!;SE-XD0##!`"WM"9,)`'(M!& M3F!I85((XD0!-;!"$TH`(/,/2.`)3<%):6`(`3&;B?`"=08`4IDK64`T%S!R M+\.>1/.>Q2`HWR<`?#2C$X`FZOF?]J*8%K@%2?``5P`$]9`1__$";W69]F!+ MBA`YD&<`'*`M:>``(I`!!%`\-%`0K7D(5KH482($`&``3+,$;Y`"(-`A?2`! M44`#)#`!.$`!)-`$-TF$KD0"&0$`$$`/*<```74#P$!.4_.6-G4JI.`C`-4Z M;Y`V9Y4!5Q$%9%$!0"9)'1(K3,,%""#_`A0P1!1@`TVP$"&1##;!`070812` M'B(C`$\``"AP0U404C)0`32`5`#$>SP3!3+@1H-E@"X8P!$>01RF2`>SC#80!3[`07'C0#(=P M`Z)D4EM!!T,0!2FP$:TZJP^!JU4P`6F:43,012&5ICKQ*"(J(3>9`TT0>H=P MHS:`'DP&`QR``BD0`C&P``!A`QW)HWTP`1RP`D.4!A+2!(M!!04@J\X#`F]Y M`7VP9<-AI,\#!&;P`"Y[!3M@#&6&/,3#`E*:".R3")&#`0Z``!/@`!3@02(` M"P60*),PIAXC_YI*0`>CX:$R$`01^@1O,`0B5@*X1`\\X`05```P,"Y@@%`#PW()@S M@` M:S3KD#J*!`!*P`$BP$<\,P*ZA@M"8+@H`#+JT00NH`07:31*0A)\)(10T`$= MX`<$2F1-<``)^@)&<`-$<`0'D`8L<`0`,`,%D;,#]00L,```0`(@X`":55\& MY`T-:V5G,`(.$`4?$`9#0#\E@`,5L`0<,`5"$`29&P+?1`%TD`,N8/\!2F`! M4/4!1T`!`+`8*G`$2[`"1X!"+Q,")P-.(="_3X`">"`*+S,`=$!J^4(L(H`+ M%%`"1X``2T`'I5L6>&HC!.`!`&8?`&+1EKLZ"4-.`- M?Q"D5NN]SF,`R$,%3J2#"^#")SP%-?!S)LP`#L#%)^Q:`E`Q!1,#5`!%()4# M1[$-%5`!1\`T(@"2>(L(S\=0%8"`U!D8B'#'&TD'.ZP>,_<'-'`X`^!$L?`' M6#`,1I!GB4P`-$`'3:``87(T2E07"%``"97_;*=K!.?H$P1`34&@'O/#R73@ M$`BPDBMX@U30PF0,`%*@NQU0K+$,`(KZ`=V2)PFZ`!8P!""P#^8PF<`3`\X; MIV6B``;@`GMV,.%:`0W+`4=@`]X;!19P%5E@`3!P--FLJFPER2V!%0-W%0@@ M,1^`/#C@#BN@'G!4$B^S`N4P`!F[`L;:!*+@`DN0`<9T"#P*7-V!+H'[J5Q` M!R10``A0`5P#OP[PM2GKCO9R`A`=T1&-!BM;HB@`\`T`<$8-;X6BD&P-<]00O0>TW`%L`-D0+4JZ MS!A,*0I.4`.-5@--H)'"M0+L@P',`$2-1M!XP!U1$`5_.PWLLQ357`-5-P") M=311X`!F0M,\\`%#(@!\`*.,8J,H@`(V,`69L`0BX`T%0-,K,"9NI07-%QDC'!E#("'LS=XDD*05;?\& MBM3>[(TBKZ`D7=`.#G``OJP$!W``=9:SD.-$*D`'8A``$O('(A`$-N``,Y`! M+-#21>Q$UDP#K,$!$$`$6NL-5:`U/-!@5_N]/*U$662#($#?[-T$2(Q+ZJ4% M*,[>)&C(#)`#47`T(!T&!Q``1I`*BYH(!'`[@'P&!<8#GNH"^`4`52`&Y3$3 M3<`!/A`%92T$8E`#UDD2RF8*..U$F,H#0K`.0A(`2HX%0[`"*@`R$(#7O35S M/#`#""`']T%!@=TI?:`"5,X#\O$'^_#A)$`%$O`E#("N.'@!\_WB;##9':!@ M+TX"E,0J[F!/)U``/V(#K;UB#E`#6"`!19$"WN#_WRJ@E`(019,>'%ER`$^0 M!\>S,9QN!"10S4W"!3G0'D=S!D80!%Q`!`:``11@!&*``4V@!,(=WJQ2W.Y0 M.$2@`DX`&2]#`5,`YEH@!#-@Z84C"I%`!QUSW<"0W1^5`Q#P:0)PEA@@!EF- M`1P`3AKI(>E=-"R[PC!;#T%P!/^&!S4P`PO@,A.)@`)^PP[Q`A9C`2<$"F$P M`4?@`F&@VT0\X)6QM$AP`&P3!E-P`#S;!`M`!RS``->RTXE-XD0(1_^NOUI@ MPXS``P!P!"+`I6<@`!9P\A:0OB\@U4&`39"*"!]0`1,?O^;K;>IPDSS``)[M M0"^P8^[N`$>1UEGN$)C#_P(??4!L4P,"W0<^ MG[SJH03N/D]DVP158`,U\*Q`F+N&K@'TD-E_L`!O4``3,`5OQPZ,=@1&,,:^ M@3[).J@Q/>P)1TP``^4,WNJ[@E47,H=?B&4P4+@UBI M_.O$O?;NP#^I9@&/\C+Z8`%?S`,99O@YTP2V&<'8C3P&Y%`PP5J$!D/_@\OOUP`,*T,K;7P\O@_R)8/Q:-`,E MSO\#&4`%69``-5@,7$"/D".!1V@'"``('8*#'45_AXB)BHN+`@H\C)&):0D\ M509IDHE4!)"'5`E95!Y=DQX#FHI=*HP9F7\\.7\734.')"BIB`==J(<",Z^Z MPW\>`1[$R8Q`+3O*S]#1TM/4U=;7V,-T&=G=WMUW)AKCY!IEW^CIU"I'3E-' M67\`%C/JT,;(]OK[_/W^_]5R7`!(L*#!@]76W!#"Y9`0;@@5X8M(L:+%BQ@S M:MS(L6.JB1Y#BAQ)LJ3)DRBM@4S)LJ7+ES!CRGRV
-----END PRIVACY-ENHANCED MESSAGE-----