-----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, Sc4YKtLw8xmClXtG2jVkCzKFeZrFHIDGVsh9DZA0m13o+NZ1zPYYtEUuPguY+J9j hNrAhj50ZObZD++kcM0URQ== 0001144204-07-015314.txt : 20070329 0001144204-07-015314.hdr.sgml : 20070329 20070329170912 ACCESSION NUMBER: 0001144204-07-015314 CONFORMED SUBMISSION TYPE: 10-K PUBLIC DOCUMENT COUNT: 12 CONFORMED PERIOD OF REPORT: 20061231 FILED AS OF DATE: 20070329 DATE AS OF CHANGE: 20070329 FILER: COMPANY DATA: COMPANY CONFORMED NAME: TARGETED GENETICS CORP /WA/ CENTRAL INDEX KEY: 0000921114 STANDARD INDUSTRIAL CLASSIFICATION: BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836] IRS NUMBER: 911549568 STATE OF INCORPORATION: WA FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 10-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-23930 FILM NUMBER: 07728424 BUSINESS ADDRESS: STREET 1: 1100 OLIVE WAY STREET 2: STE 100 CITY: SEATTLE STATE: WA ZIP: 98101 BUSINESS PHONE: 2066237612 MAIL ADDRESS: STREET 1: 1100 OLIVE WAY STREET 2: STE 100 CITY: SEATTLE STATE: WA ZIP: 98101 10-K 1 v06961210k.htm UNITED STATES SECURITIES AND EXCHANGE COMMISSION

 

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

______________

FORM 10-K

______________

(Mark One)

ý      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

¨       TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d)
OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period from _______ to ________                   

Commission file number 0-23930

______________

TARGETED GENETICS CORPORATION

(Exact Name of Registrant as Specified in its Charter)

Washington

      

91-1549568

                        

(State of Incorporation)

 

(IRS Employer Identification No.)

 

1100 Olive Way, Suite 100
Seattle, WA 98101

(Address of principal executive offices, including, zip code)

(206) 623-7612

(Registrant’s telephone number, including area code)

______________

Securities registered pursuant to Section 12(b) of the Act: None

Securities registered pursuant to Section 12(g) of the Act:
Common Stock, $0.01 Par Value

Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes ¨  No ý

Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act. Yes ¨  No ý

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 (or for such shorter period that the Registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ý  No ¨

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 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. ý

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. (Check one):

Large Accelerated Filer ¨

Accelerated Filer ¨

Non-accelerated Filer ý

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Act). Yes ¨  No ý

The aggregate market value of common stock held by non-affiliates of the Registrant as of June 30, 2006 was approximately $22.7 million based on the closing price of $2.30 per share of the Registrant’s common stock as listed on the NASDAQ Capital Market.

Indicate the number of shares outstanding of each of the Registrant’s classes of common stock as of March 16, 2007

Title of Class

      

Number of Shares

                        

Common Stock, $0.01 par value

 

13,108,735

 

DOCUMENTS INCORPORATED BY REFERENCE

(1) The information required by Part III of this report, to the extent not set forth in this report, is incorporated by reference from the Proxy Statement for the 2007 annual meeting of shareholders to be held on May 17, 2007, pursuant to General Instruction G3 to Form 10-K. The definitive proxy statement for the 2007 annual meeting of shareholders will be filed with the Securities and Exchange Commission within 120 days after December 31, 2006, the end of the fiscal year to which this report relates.

 





TARGETED GENETICS CORPORATION
ANNUAL REPORT ON FORM 10-K

TABLE OF CONTENTS

 

     

 

     

Page

   

     

 
  

PART I

  

Item 1.

 

Business

 

1

Item 1A.

 

Risk Factors

 

13

Item 2.

 

Properties

 

22

Item 3.

 

Legal Proceedings

 

23

Item 4.

 

Submission of Matters to a Vote of Security Holders

 

23

     
  

PART II

  

Item 5.

 

Market for Registrant’s Common Equity, Related Shareholder Matters and Issuer Purchases of Equity Securities

 

24

Item 6.

 

Selected Financial Data

 

25

Item 7.

 

Management’s Discussion and Analysis of Financial Condition and Results of Operations

 

26

Item 7A.

 

Quantitative and Qualitative Disclosures About Market Risk

 

37

Item 8.

 

Financial Statements and Supplementary Data

 

39

Item 9.

 

Changes in and Disagreements with Accountants on Accounting and Financial Disclosure

 

61

Item 9A.

 

Controls and Procedures

 

61

     
  

PART III

  

Item 10.

 

Directors and Executive Officers of Registrant

 

61

Item 11.

 

Executive Compensation

 

61

Item 12.

 

Security Ownership of Certain Beneficial Owners and Management and Related Shareholder Matters

 

61

Item 13.

 

Certain Relationships and Related Transactions

 

61

Item 14.

 

Principal Accounting Fees and Services

 

62

     
  

PART IV

  

Item 15.

 

Exhibits, Financial Statement Schedules and Reports on Form 8-K

 

62



i



PART I

Item 1. Business.

This annual report on Form 10-K contains forward-looking statements that involve risks and uncertainties. Forward-looking statements include statements about our product development and commercialization goals and expectations, potential market opportunities, our plans for and anticipated results of our clinical development activities and the potential advantage of our product candidates, our cash resources and future financial condition, our ability to obtain additional funding or enter into strategic collaborations and other statements that are not historical facts. Words such as “may,” “can be,” “may depend,” “will,” “believes,” “estimates,” “expects,” “anticipates,” “plans,” “projects,” “intends,” or statements concerning “potential” or “opportunity” and other words of similar meaning or the negative thereof may identify forward-looking statements, but the absence of these words does not mean that the statement is not forward-looking. In making these statements, we rely on a number of assumptions and make predictions about the future. Our actual results could differ materially from those stated in or implied by forward-looking statements for a number of reasons, including the risks described in the section entitled “Factors Affecting Our Operating Results, Our Business and Our Stock Price” in Part I, Item 1A of this annual report.

You should not unduly rely on these forward-looking statements, which speak only as of the date of this annual report. We undertake no obligation to publicly revise any forward-looking statement after the date of this annual report to reflect circumstances or events occurring after the date of this annual report or to conform the statement to actual results or changes in our expectations. You should, however, review the factors, risks and other information we provide in the reports we file from time to time with the Securities and Exchange Commission, or SEC.

Business Overview

Targeted Genetics Corporation is a clinical-stage biotechnology company. We are at the forefront of developing, with the goal of commercializing, a new class of therapeutic products called gene therapeutics. We believe that a wide range of diseases may potentially be treated or prevented with gene therapeutics. In addition to treating diseases that have not had treatments in the past, we believe that there is a significant opportunity to use gene therapeutics to more effectively treat diseases that are currently treated using other therapeutic classes of drugs including proteins, monoclonal antibodies or small molecule drugs. We are developing several product candidates, two of which are currently in clinical trials. Our clinical-stage candidates are aimed at inflammatory arthritis and HIV/AIDS. Our preclinical product candidates, both in development with collaboration partners, are aimed at congestive heart failure and Huntington’s disease.

Our gene therapeutics consist of a delivery vehicle, called a vector, and genetic material. The role of the vector is to carry the genetic material into a target cell. Once delivered into the cell, the gene can express or direct production of the specific proteins encoded by the gene. Gene therapeutics may be used to treat disease by facilitating the normal protein production or gene regulation capabilities of cells. In addition, gene therapeutics may be used to enable cells to produce more of a certain protein or different proteins than they would normally produce thereby treating a disease state. A new class of gene therapeutics currently receiving attention is RNA interference or RNAi. RNAi comprises small RNA molecules, which once delivered into the cell, may shut down or interfere with cellular functions. The vectors developed by us may be particularly useful for the delivery of this new class of gene therapeutics.

We are a leader in the preclinical and clinical development of adeno-associated viral vectors, or AAV-based gene therapeutics and in the manufacture of AAV-vectors. We have treated over 300 subjects in clinical trials using AAV-based gene therapeutic product candidates. Through our research and development activities, we have acquired expertise and intellectual property related to a variety of gene therapeutic technologies. We believe that our activities have resulted in important characteristics of our business, including:

Diverse product development pipeline. Each of our clinical and preclinical product candidates addresses a different market, in which we believe there is significant medical need for new or improved therapies.



1



We are focused on the following product development programs:

      

Development Status

Description

     

Indication

     

Research &
Preclinical

     

Phase I

     

Phase I/II

     

Phase II

     

Phase III

             

AAV delivery of TNF-alpha antagonist (tgAAC94)

 

Inflammatory Arthritis

 

xxxxxxxx

 

xxxxxxxx

 

xxxxxxxx

    

AAV delivery of HIV antigen (tgAAC09 & HVDDT)

 

HIV/AIDS

 

xxxxxxxx

 

xxxxxxxx

   

xxxxxxxx

  

AAV delivery of SERCA2a

 

Congestive Heart Failure

 

xxxxxxxx

        

AAV expression of htt shRNA (RNAi)

 

Huntington’s disease

 

xxxxxxxx

        

Significant development and manufacturing expertise. We believe we are leaders in the development and application of processes to manufacture our potential products at a scale amenable to late-stage clinical development and expandable to large-scale commercial production. We have established broad capabilities in applying our AAV-based gene therapeutic technologies to multiple product candidates and therapeutic indications. Through our efforts to develop a new class of therapeutics, we have built the development, manufacturing, quality, clinical and regulatory expertise necessary to move candidates from research to the clinic and into clinical development. We believe these capabilities and the expertise gained will serve as critical assets in attracting product collaboration partners and provide a necessary foundation to move gene therapeutics and other product candidates from product discovery to commercialization.

Intellectual property assets. We have developed proprietary intellectual property, including methods of transferring genetic material into cells, processes to manufacture and purify gene therapeutic candidates, uses of AAV to deliver RNA therapeutics including RNAi and other proprietary technologies and processes. Because patent and license rights are important assets of our business, our strategy is to file or license patent applications to protect technology, inventions and improvements to inventions that we consider important to developing our business. We have filed or licensed numerous patents or patent applications with the United States Patent and Trademark Office, or USPTO, and foreign jurisdictions. We also rely on unpatented proprietary technology such as trade secrets, know-how and continuing technological innovations.

Business Strategy

Our current strategic focus includes:

·

Continuing aggressive development of our pipeline. We plan to continue to focus on clinical development efforts that will accelerate development and lead to nearer term clinical trial results and, ultimately, commercialization. Our current priorities are the advancement of tgAAC94 as a therapy to treat inflammatory arthritis and the advancement of our partnered programs, including the development of an HIV/AIDS vaccine and product candidates for the treatment of congestive heart failure and Huntington’s disease.

·

Maximizing the value of our manufacturing and development expertise and our intellectual property. Our strategy is to utilize our product development, regulatory and manufacturing capabilities in new product collaboration opportunities, similar to the collaborations we have entered into with Celladon Corporation, or Celladon, and Sirna Therapeutics, Inc., or Sirna, now a wholly-owned subsidiary of Merck & Co., Inc. In addition, we may evaluate opportunities to exploit the value we have built in manufacturing viral vectors, including AAV vectors, by producing other biologics, or by pursuing contract manufacturing relationships during periods of excess capacity in our manufacturing facility. We also expect to pursue opportunities to license our technology and leverage our portfolio of AAV-related intellectual property assets to generate revenue and value for our shareholders.

·

Pursuing additional product opportunities. Although we have made substantial progress toward the commercialization of AAV-based gene therapeutics, gene therapeutic products have not yet reached commercialization in the U.S., Europe or Japan. We are committed to gene therapeutics but realize it may be prudent to pursue product development opportunities within other classes of therapeutics that have



2



reached commercialization, have garnered acceptance by users and may have shorter and more predictable paths to commercial success. Our focus as a product development company provides us with the expertise to develop products for a variety of disease indications. We are evaluating a range of opportunities that include mergers and acquisitions and product diversification with a particular focus on candidates to which we can apply our significant development expertise. We believe that a combination of novel candidates developed from our expertise in gene therapeutics, along with complementary candidates, may provide a beneficial balance of value and risk diversification for our shareholders.

2006 Achievements

In 2006, we made progress in our development collaborations and our product development programs, expanded and leveraged our patent portfolio and realigned our cost structure to focus our resources on our inflammatory arthritis program. More specifically:

·

In the first half of 2006, we expanded our Phase II HIV/AIDS vaccine clinical trials to Uganda and Zambia.

·

In March 2006, we sold 1.3 million shares of our common stock in a registered offering at a price of $3.90 per share and received net proceeds of approximately $4.8 million.

·

In March 2006, we received approval from the FDA to amend our protocol for the tgAAC94 clinical trial to include a higher dose group and increase the number of patients from 40 to 120. Under the amended protocol, the study is now designated as a Phase I/II trial.

·

In June 2006, we entered into a collaboration and license agreement with the International Aids Vaccine Initiative, or IAVI, a non-profit organization, Columbus Children’s Research Institute, or CCRI, at Columbus Children’s Hospital and The Children’s Hospital of Philadelphia, or CHOP, in support of the development and commercialization of HIV/AIDS vaccines for the developing world. This agreement supersedes our previous agreements with IAVI and CCRI.

·

We reported initial data in June 2006 and additional data in November 2006 on the results of our ongoing Phase I/II clinical trial of our inflammatory arthritis candidate that demonstrated favorable safety and toxicity profiles at all three dose levels and trends toward improvement in signs and symptoms of the disease as measured by a decrease in tenderness and swelling scores.

·

In August 2006, we reported interim results of IAVI’s Phase I clinical trial of our investigational HIV/AIDS vaccine candidate; no safety concerns were identified and the vaccine was well tolerated and modestly immunogenic at the dose levels tested.

·

In November 2006, we entered into an agreement with Biogen Idec to restructure approximately $8.15 million of debt. Under the terms of the agreement, we exchanged $5.65 million of debt for one million shares of our common stock and modified the payment schedule of the remaining debt.

·

In December 2006, we leveraged our portfolio of AAV intellectual property through a license agreement with Amsterdam Molecular Therapeutics B.V., or AMT, providing an upfront license fee of $1.75 million as well as potential milestone payments due upon achievement of certain product development benchmarks and royalties on the sale of any products commercialized using the licensed technology.

·

We were issued additional patents from the USPTO covering our AAV vector patent portfolio, including one for the use of AAV to deliver RNA therapeutics such as RNAi.

Programs in Clinical Trials

Inflammatory Arthritis

According to the College of Rheumatology and the Centers for Disease Control and Prevention, two to three million people in the U.S. are living with inflammatory arthritis, including rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis. Researchers have found that the cytokine called tumor necrosis factor-alpha, or TNF-alpha, plays a pivotal role in this disease process and have shown anti-TNF-alpha therapies to be a valuable strategy to treat inflammatory arthritis. TNF-alpha inhibition is a validated therapeutic strategy for treating a variety of inflammatory diseases. Three TNF-alpha inhibitors are now sold world wide. These products, which are delivered systemically by intravenous infusion or sub-cutaneous injection, can improve the signs and symptoms of the disease,



3



inhibit the structural damage in the joints and positively impact functional outcomes in patients with these inflammatory arthritis conditions. However, some patients do not have a complete response to systemically delivered anti-TNF-alpha agents and still have significant room for improvement in inflammation and tender and swollen joint counts. These patients are potentially ideal candidates for a localized, more concentrated delivery of anti-TNF-alpha therapy administered directly to the joint.

We are developing a product candidate, which we call tgAAC94, for the treatment of inflammatory arthritis. tgAAC94 is an AAV vector product candidate designed to deliver a DNA sequence encoding a potent inhibitor of TNF-alpha. We believe that there may be market receptivity to local delivery of a TNF-alpha antagonist for several types of inflammatory arthritis. In addition, we believe that patients who are partial responders to systemically delivered anti-TNF-alpha therapy or those who are contraindicated for systemic therapy may also be strong candidates for a localized TNF-alpha inhibitor approach. We are designing tgAAC94 for administration by direct injection into affected joints and developing it for use in patients who have one or more joints that have not responded to other therapies, or for patients who may have only a few inflamed joints and may benefit from localized rather than systemic treatment of their disease.

In 2004, we initiated a Phase I clinical trial to evaluate the safety of escalating doses of tgAAC94 in subjects with rheumatoid arthritis, psoriatic arthritis or ankylosing spondylitis. This double-blinded, randomized trial evaluated safety of a single dose of tgAAC94 injected locally into an arthritic joint of subjects suffering from inflammatory arthritis. The subjects of the trial included 12 females and two males with rheumatoid arthritis and one male with ankylosing spondylitis. Subjects received an injection into the knee or ankle and were followed for 24 weeks. Data from the trial demonstrated that intra-articular injections were safe and well-tolerated in subjects who were also taking conventional disease-modifying anti-rheumatic drugs, there were no serious adverse events in treated subjects and those treated with a single dose exhibited measurable improvements in swelling and tenderness. The data also suggested that there may be a dose response effect as subjects who received a higher dose of drug appeared to have greater reductions in mean tenderness and swelling scores than subjects who received the lower dose. There was some improvement in mean tenderness and swelling scores in subjects receiving placebo. In the non-injected joints of the tgAAC94 treated subjects, there also appeared to be a trend in the decrease in mean tenderness and swelling scores over time. These data were presented at the American Society for Gene Therapy-sponsored meeting in the second quarter of 2006.

In 2005, we initiated a follow-on Phase I/II clinical trial of tgAAC94 administered directly to affected joints of subjects with inflammatory arthritis. This double-blinded, placebo-controlled study was designed to evaluate higher doses of tgAAC94 in patients with rheumatoid arthritis, psoriatic arthritis or ankylosing spondylitis who may be receiving concomitant treatments of anti-TNF-alpha therapy, but are partial responders who continue to experience signs and symptoms of inflammatory arthritis in some joints. In the study, approximately 120 adults are being randomized into three dose groups to receive a single intra-articular injection of either tgAAC94 or a placebo, followed by an open-label injection of tgAAC94 after 12 to 30 weeks, depending on when the target joint meets criteria for re-injection. As of October 2006, approximately 61 subjects in the first three cohorts, 34 of whom were receiving concurrent TNF-alpha antagonists, received an injection of blinded study drug into the knee, ankle, wrist, metacarpophalangeal joint or elbow. Preliminary data indicate tgAAC94 is safe and well-tolerated at doses of up to 5x1013 particles in subjects with and without systemic TNF-alpha antagonists. The primary endpoint of the study is the establishment of the safety of higher doses and of repeat administration of tgAAC94 into the joints of subjects with and without concomitant TNF-alpha inhibitor therapy. Secondary endpoints include evaluation of pain, swelling, duration of response and overall disease activity following intra-articular administration of tgAAC94 to affected joints. Additionally, changes in joint inflammation and joint damage will be assessed in a subset of subjects using magnetic resonance imaging.

We reported initial data in June 2006 and additional data in November 2006 that demonstrated:

·

no significant safety concerns have been identified after 4 to 60 weeks of follow-up;

·

fewer subjects receiving tgAAC94 had symptoms requiring re-injection prior to the 30-week time point, compared with subjects in the placebo arm;

·

the time to second injection in subjects randomized to receive tgAAC94 was longer than those who were randomized to receive placebo;

·

a trend toward improvement in tenderness and swelling of injected joint in subjects receiving tgAAC94; and



4



·

these improvements were noted in subjects taking concurrent systemic TNF-alpha antagonist therapy as well as those subjects who were not on these therapies.

Based on the favorable safety profile of the first three dose-escalation cohorts, in October 2006, the Data Monitoring Committee overseeing the study gave permission for the remaining 60 subjects to be enrolled (20 each at the same three dose levels) in order to enhance the understanding of the safety and therapeutic index of tgAAC94. We expect to complete the trial in 2007 and to present data from this trial in upcoming scientific meetings in 2007 and 2008 as appropriate.

HIV/AIDS Vaccine

There is an urgent need to stop the spread of human immunodeficiency virus (HIV) infection worldwide. More than 60 million people have been infected and more than 25 million have died due to HIV/AIDS since the worldwide epidemic began in 1981. In 2005, over 5 million new infections occurred. Of these, more than 85% were in Sub-Saharan Africa and Southeast Asia. Further rises of HIV incidence can only be slowed by a massive expansion of prevention efforts. Historically, vaccines have been the most powerful public health tool able to provide a safe, cost-effective and efficient means of preventing illnesses, disability and death from infectious diseases. A safe and effective preventive HIV vaccine, as part of a comprehensive prevention plan, will significantly reduce the spread of HIV.

Since 2000, we have been developing, as part of a collaboration with IAVI, CHOP and CCRI, an AAV vector prophylactic vaccine candidate, which we call tgAAC09, for high-risk populations in developing nations to protect against the progression of HIV infection to AIDS. The tgAAC09 vaccine contains antigens from HIV Clade C, the clade that is prevalent in the developing world. The program is completely funded by IAVI. This product candidate is currently in Phase I and Phase II clinical trials.

In 2003, IAVI initiated a Phase I initial dose escalation safety trial in humans for tgAAC09 in Europe. Subsequently, this study was amended to include a cohort of volunteers in India. This dose-escalation safety trial was designed to enroll up to 80 volunteers who were uninfected with HIV and in good health. Each participant in this trial received a single injection of the vaccine candidate or placebo and was monitored for safety and immune response. This trial was amended further for the European cohort to evaluate the safety and immunogenicity of this vaccine after a second dose. In August 2006, we reported interim data on the expanded trial demonstrating that no safety concerns identified and the vaccine was well tolerated in healthy volunteers from Belgium, Germany and India who were not infected with HIV. In a subset of the volunteers receiving a single administration of the highest dose of the vaccine, modest immune responses to the HIV antigens were observed.

A Phase II clinical trial of tgAAC09 is ongoing in South Africa, Uganda and Zambia to evaluate a higher dose and to systematically evaluate the utility and optimal timing of boost vaccination. We expect follow-up and data collection and analysis to be complete in the first half of 2007 and to report results of the trial in the second half of 2007.

As part of this public-private collaboration, IAVI funds us, CHOP and CCRI for work that is focused on development and preclinical studies of a vaccine candidate. IAVI funds our development activities based upon an agreed upon annual work plan and budget. IAVI also coordinates and directly funds the cost of clinical trials conducted under the collaboration. We expect to continue to receive funding from IAVI for the development of HIV/AIDS vaccines for the developing world.

Prior to June 2006, we and IAVI extended and expanded the collaboration agreement several times. In June 2006, we and IAVI entered into a new agreement that superseded prior agreements and extended the program term until the expiration of the last patent within the patent rights controlled by us that is utilized in the IAVI vaccine. Among other rights granted under this agreement, IAVI retains the exclusive rights in the developing world for commercialization of any HIV/AIDS vaccine that is developed under the collaboration, and will receive a royalty on income received by us from the development and commercialization of certain vaccines. We also received the rights to utilize the findings from the collaboration to develop and commercialize HIV/AIDS vaccines for the developed world and additional vaccine candidates for any other disease indications. Also as part of this agreement, we granted IAVI the rights to technology and intellectual property utilized in the programs and issued IAVI a small number of shares of our common stock. Either party has the right to terminate the agreement under certain conditions. If IAVI terminates the agreement at will or for technical non-viability, then IAVI will be obligated to pay for the activities contemplated in the work plan in effect for the notice period, which ranges from four to six



5



months. In these cases of termination, IAVI would retain a non-exclusive license to use certain of our intellectual property to research HIV vaccines for the developing world. In other cases of termination, the licenses granted to IAVI under the agreement would remain in effect and we would be obligated to transfer the intellectual property necessary for IAVI to make the HIV vaccine developed under the agreement.

In 2005, we extended the scope of our HIV/AIDS vaccine program to the developed world via a contract awarded by the National Institute of Allergy and Infectious Diseases, or NIAID, to CCRI in collaboration with CHOP and us. NIAID is a component of the National Institutes of Health, Bethesda, Maryland. The NIAID vaccine program will complement work performed under the IAVI vaccine program but will be focused on developing a multi-component vaccine that will contain various antigens from different HIV Clades. This AAV-based HIV vaccine, which we call HVDDT, will be tested in a prime-boost approach using different AAV serotypes. Under this program, we may receive up to $18.2 million over five years for the development, manufacture and preclinical testing of vaccine candidates. Investigators at CHOP and CCRI will design the vaccine candidates and we will manufacture the vectors for testing in clinical trials, which will be conducted in the U.S. The direct costs of any clinical trials will be borne directly by the NIAID. This product candidate is currently undergoing preclinical tests before advancing into clinical trials in healthy volunteers. The NIAID funds this program in annual installments based on an approved work plan and achievement of milestones. Under the terms of the agreement, any party can terminate upon 30 days notice. Upon termination, we would be reimbursed for costs related to the program that occurred up to the termination date.

Preclinical Programs

Congestive Heart Failure

Congestive heart failure, or CHF, is a leading cause of morbidity and mortality in about 5 million Americans. CHF involves a loss of contractility of the heart muscle that in turn decreases the ability of the heart to pump blood. The contraction and expansion of the heart muscle is dependent upon movement of calcium within the heart muscle. One protein that is central to the process of calcium movement in the heart muscle is SERCA2a. The SERCA2a protein is a pump that moves calcium. The relative amount and activity of SERCA2a is decreased in failing hearts. It has not yet been possible to develop conventional pharmaceutical drugs to address this problem. Delivery of the SERCA2a gene directly to the heart muscle should lead to production of more SERCA2a protein and may improve the ability of the heart to contract and thus improve its ability to pump blood.

In 2004, we formed a collaboration with Celladon to evaluate delivery of genes to the heart that may have a therapeutic benefit in the treatment of CHF. This collaboration combines our expertise in the development, manufacture and clinical evaluation of AAV-based therapies with Celladon’s portfolio of genes and cardiovascular expertise.

As part of this collaboration, Celladon provides its intellectual property and funds our product development and manufacturing efforts. We are contributing our proprietary AAV technology for use in the field of CHF to deliver the SERCA2a gene. We will manufacture under cGMP the rAAV1-SERCA2a vector and file appropriate regulatory filings to support the use of the product in clinical trials that are sponsored by Celladon. Celladon made their regulatory filings in the last quarter of 2006 to initiate a Phase I clinical trial in the first half of 2007.

In late 2004, in connection with the formation of this collaboration, we received $6.0 million cash from the sale of our shares of our common stock to investors of Celladon. Since 2004, we have incurred $7.0 million of program related costs to support development activities under the Celladon agreement, which consisted primarily of internal development efforts. We agreed to contribute up to $2.0 million to support these development activities and we are reimbursed for efforts over that amount. As a result, we have recognized cumulative revenue of $5.0 million from Celladon for those costs in excess of the first $2.0 million incurred by us. In the future, we are also entitled to development milestones, royalties on sales and manufacturing profits on potential future products that result from the collaboration.

Both parties have the right to terminate the agreement under certain conditions with a 60 day notice and cure period in some cases. If Celladon were to terminate the agreement in the midst of an approved development plan, Celladon would be obligated to pay us for the following six months of the budget agreed to pursuant to the development plan. If Celladon were to terminate the agreement due to our breach of the agreement or to our insolvency, then the licenses granted to Celladon under the agreement would remain in effect and we would be



6



obligated to transfer, to another manufacturer, the manufacturing technology necessary for Celladon to make the CHF product developed under the agreement. Upon termination of the agreement by either party, other than due to our breach or insolvency, all rights and licenses granted under the agreement would revert to the granting party.

Huntington’s Disease

Huntington’s Disease, or HD, generally shows onset in mid-life and there are currently about 30,000 patients in the U.S. and an additional 120,000 to 250,000 at risk of onset. HD is an incurable neurodegenerative disorder that results from a mutation in the gene that codes for the huntingtin protein. Genes express their information by being copied into a messenger RNA, or mRNA, that instructs the cell machinery to make a specific protein. This mutant HD gene produces a defective huntingtin protein that interferes with normal function of nerve cells in the brain leading to eventual development of the progressive disease. There are no effective drugs to treat or prevent this disease.

HD is a dominant genetic disease, which means that a single copy of the mutant gene can cause the disease. It also means that delivery of a correct copy of the gene will not be effective. Rather, the function of the mutant HD gene must be blocked. A potentially effective way to do this is to use recently discovered entities called small interfering RNA, or siRNA. siRNAs can bind to mRNAs and cause their degradation before the mRNA is used for production of protein. In this way, shRNA can be used to prevent or reduce the production of proteins.

In 2005, we formed a collaboration with Sirna to develop therapies for the treatment of HD. This collaboration also includes two academic groups at the University of Iowa, or UI, and the University of California, San Francisco. Sirna is a leader in the effort to create RNAi-based therapies.

Our HD program is focused on developing therapeutic siRNA to target the gene that encodes the HD protein. This siRNA must be administered directly to the brain, which is the site of the disease. Therefore, infrequent dosing is highly desirable. Consequently, this program uses the AAV delivery system to deliver a gene for a siRNA that targets the HD gene and can be expressed for a prolonged period. The program is based upon initial proof of concept of correction of HD using this approach in a mouse model of HD that was reported by our collaborators at UI.

This program takes advantage of our expertise and intellectual property in AAV delivery systems. In the late 1990’s, as therapeutic RNA molecules such as RNAi, siRNA and shRNA were initially tested in animals, we believe we were the first to develop and file patent applications on the use of AAV vectors to express these potential therapeutics. Expressed therapeutic RNA molecules may have significant advantages over delivery of the oligonucleotides by having increased drug availability and drug half life. Our HD program combines our expertise and intellectual property in production and use of the AAV delivery system and Sirna’s expertise in design of siRNA molecules. The program currently is focused upon generating AAV vectors that express siRNAs that target the HD gene and testing these in animals to select a lead product for formal preclinical testing and progression to clinical studies. We and Sirna are co-developing product candidates under the collaboration and share the costs of development and any future revenues that result from the collaboration. We expect that a substantial portion of our development costs will consist of internal development and manufacturing efforts.

Former Collaborations

Biogen Idec

In connection with our acquisition of Genovo in 2000, we established a three-year, multiple-product development and commercialization collaboration with Biogen, now Biogen Idec. This collaboration ended in 2003 upon the completion of the development period.

Under this collaboration, Biogen paid us $8.0 million in research funding and upfront payments and $1.0 million per year in research and development funding over the initial three-year development period. In connection with an equity purchase commitment agreed to as part of the collaboration, in 2002 and 2003, we raised a total of $8.8 million through the sale of a total of 832,000 shares of our common stock to Biogen at an average price of $10.57 per share. The equity purchase commitment with Biogen has expired. In addition, we borrowed $10.0 million from Biogen under a loan commitment within the collaboration agreement. In 2005, we repaid $2.5 million of the $10.0 million loan principal and modified the loan payment schedule on the remaining $8.15 million of debt so that payments of $2.5 million of principal amount plus accrued interest were due on each of August 1, 2007, 2008 and 2009 and the $650,000 promissory note to Biogen was due August 1, 2007. In



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November 2006, we signed an agreement to further restructure the remaining $8.15 million of debt payable to Biogen Idec, under which Biogen Idec agreed to exchange $5.65 million of debt for one million shares of our common stock with a fair value of $2.9 million. At the time of signing the November 2006 agreement, we made a payment of $500,000 towards the remaining loan balance and agreed to repay the remaining $2.0 million principal balance in two equal installments of $1.0 million each on August 1, 2007 and August 1, 2008. In addition, we agreed to apply one-third of certain up-front payments received from potential future corporate collaborations to the outstanding balance on this loan payable, first to repayment of any accrued and unpaid interest and second to the repayment of outstanding principal in reverse order of maturity. Our outstanding debt to Biogen Idec continues to bear interest at the rate of LIBOR plus 1%. According to SFAS No. 15, “Accounting by Debtors and Creditors of Troubled Debt Restructurings,” we accounted for this transaction as a troubled debt restructuring which resulted in a gain on debt restructuring of $2.6 million. We calculated the gain as the difference between the original principal and interest payments due on the Biogen Idec debt as compared to the cash payments made, the fair value of the shares of our common stock issued in the debt restructuring and the remaining principal and interest payments due. We recorded the loan as the $2.0 million principal amount plus the total estimated future interest payments of $167,000. As a result of the share purchases made under the equity purchase commitment, the shares exchanged as a result of the November 2006 debt restructure and the shares Biogen Idec first received when we purchased Genovo, as of December 31, 2006, Biogen Idec held 2.17 million shares of our common stock, or 19.9% of our common shares outstanding.

In December 2006, we made a $583,000 advance payment to Biogen Idec in accordance with the terms of the note, which requires one-third of certain up-front payments received from potential future collaborators to be applied toward the outstanding loan balance. The receipt of a $1.75 million license fee from AMT triggered this payment which, according to the agreement, was applied first to interest owed through the payment date and then to the long term portion of the note. As a result of this payment, our loan balance obligation is $1.7 million as of December 31, 2006.

From the inception of the collaboration in 2000 through completion of the collaboration in 2003, we earned $11.0 million in revenue from Biogen under this collaboration and received $18.8 million in proceeds from the issuance of debt and sales of equity securities.

Emerald Gene Systems, Ltd.

In 1999, we formed Emerald Gene Systems, Ltd., or Emerald, our joint venture with Elan International Services, Ltd., a wholly-owned subsidiary of Elan Corporation plc, or Elan. Emerald was formed to develop enhanced gene delivery systems. Emerald’s three-year development period ended during 2002 and Emerald had no operating activities after 2002. From inception through March 2004, we accounted for our investment in Emerald under the equity method of accounting. In March 2004, we became the 100% owner of Emerald and consolidated the results into our financial statements until we dissolved Emerald in January 2005.

In 2004, we entered into a termination agreement with Elan. In accordance with the termination agreement, our Series B preferred stock held by Elan was converted into 4.3 million shares of our common stock. As of December 31, 2006, Elan held 1.2 million shares of our common stock, approximately 10.6% of our outstanding common stock. Under the termination agreement Elan is permitted to trade these shares of our common stock in quantities equal to 175% of the volume limitation set forth in Rule 144(e)(1) promulgated under the Securities Act of 1933, as amended, subject to certain exceptions.

Cystic Fibrosis Foundation

Until 2005, we were developing tgAAVCF, a product candidate for treating cystic fibrosis. In 2003, we established a collaboration with the Cystic Fibrosis Foundation related to Phase II clinical trials for tgAAVCF. In 2005, we discontinued the development of tgAAVCF and concluded the collaboration with the Cystic Fibrosis Foundation following the analysis of Phase II clinical trial data in which tgAAVCF failed to achieve the efficacy endpoints of the trial.



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Patents, License Agreements and Proprietary Rights

Our patent position, licensing arrangements and proprietary technology are subject to certain risks and uncertainties. We have included information about these risks and uncertainties in Item 1A. “Risk Factors” and we encourage you to read that discussion.

Patents and licenses are important to our business. Our strategy is to file or license patent applications to protect technology, inventions and improvements to inventions that we consider important to developing our business. We seek patent protection for and license technologies that relate to the candidates in our pipeline and/or that may be important to future product candidates. We have filed or licensed numerous patent or patent applications with the USPTO and foreign jurisdictions. This proprietary intellectual property includes methods of transferring genetic material into cells, processes to manufacture and purify gene delivery product candidates and other proprietary technologies and processes. We also rely on unpatented proprietary technology such as trade secrets, know-how and continuing technological innovations to develop and maintain our competitive position.

The patent positions of pharmaceutical and biotechnology firms, including our patent position, are uncertain and involve complex legal and factual questions for which important legal tenets are largely unresolved, particularly with regard to gene therapy uses. Patent applications may not result in the issuance of patents and the coverage claimed in a patent application may be significantly reduced before a patent is issued.

We have licensed technology underlying several issued and pending patents, including two licenses to patents for the manufacture of AAV vectors and the use of AAV vectors for gene delivery. Our exclusive license with Alkermes, Inc. provides us with rights to patents broadly covering a manufacturing method that we believe is critical to making AAV-based products in a commercially viable, cost-effective manner. This technology, developed by Children’s Hospital in Columbus, Ohio, covers the use of cell lines for manufacturing AAV vectors in multiple disease areas. Our license with the University of Pennsylvania, or Penn, provides us with exclusive and non-exclusive licenses to a group of patents and patent applications filed by Penn with claims that cover AAV and adenoviral vector technologies including manufacturing methods. In addition, the Penn license provides us with exclusive rights to components of a specific serotype of AAV called AAV1. AAV vectors may be particularly well suited for the development of certain product candidates based on characteristics of the AAV1 serotype.

Many of our exclusive licenses include the right to sublicense the rights thereunder to third parties. We have the right to sublicense many of the patent rights in the Penn license and when we enter into such a sublicense, we must pay Penn certain financial payments including sublicense fees. In December 2006, we entered into our first non-exclusive, perpetual sublicense under the Penn license with Amsterdam Molecular Therapeutics B.V., or AMT. Under the AMT license, we sublicensed certain patent rights that we are licensing under the Penn license and AMT paid us an upfront payment of $1.75 million. We may also receive milestone payments based on the progress of the licensed products from clinical trial phases to regulatory approvals and royalties based on a percentage of net sales of the licensed products. We have an obligation to pay Penn a portion of the payments we receive from AMT.

Our licenses have many financial and other obligations. It is standard to pay a licensing upfront payment, annual maintenance fees, product development milestones and a royalty on sales. It is also standard for the term of the license to extend through the life of the patent rights granted under the license. In general, the licensors have the right to terminate the license if we breach the agreement or become insolvent. Exclusive licenses often include diligence requirements that must be met to retain exclusivity. In general, the result of not meeting the diligence hurdles is to lose exclusivity for certain or all indications included in the license field.

Licensing of intellectual property critical to our business involves complex legal, business and scientific issues. If disputes over intellectual property that we have licensed prevent or impair our ability to maintain our current licensing arrangements on acceptable terms, we may be unable to successfully develop or commercialize the affected product candidates.

In connection with our formation in 1989, we entered into a Gene Transfer Technology License Agreement, or Immunex License Agreement, with Immunex Corporation, our parent company at the time of formation. Under the Immunex License Agreement, we received, among other things, an exclusive worldwide license to certain Immunex proprietary technology specifically applicable to gene therapy applications. We and Immunex (and later Amgen, Inc., which acquired Immunex in 2002) have had many discussions regarding, among other things, differing views about our rights to the gene construct coding for TNFR:Fc used in the development of our inflammatory arthritis product candidate tgAAC94. In 2004, Amgen sent a letter to us taking the position that we were not licensed, either



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exclusively or non-exclusively, under Immunex intellectual property covering TNFR:Fc or therapeutic uses for TNFR:Fc. We promptly responded to that letter confirming our confidence that the Immunex License Agreement gives us an exclusive worldwide license to use the gene construct coding for TNFR:Fc for gene therapy applications. Although we have had many conversations since that letter exchange in 2004 this matter has not come to a final resolution. We expect to have further communications with Amgen regarding our differences. Notwithstanding our confidence, it is possible that a resolution of those differences, through litigation or otherwise, could cause delay or discontinuation of our development of tgAAC94 or our inability to commercialize any resulting product.

In addition to patent protection, we rely on trade secret protection for our confidential and proprietary information and technology. To protect our trade secrets, we generally require our employees, consultants, scientific advisors and parties to collaborative agreements to execute confidentiality agreements. In the case of employees and consultants, the agreements also provide that all inventions resulting from work performed by them while employed by us will be our exclusive property. Despite these agreements and other precautions we take to protect our trade secrets and other proprietary unpatented intellectual property, we may be unable to meaningfully protect our trade secrets and other intellectual property from unauthorized use or misappropriation by a third party. These agreements may not provide adequate remedies in the event of unauthorized use or disclosure of our confidential information. In addition, our competitors could obtain rights to our nonexclusively licensed proprietary technology or may independently develop substantially equivalent proprietary information and technology. If our competitors develop and market competing products using our unpatented or nonexclusively licensed intellectual property or substantially similar technology or processes, our products could suffer a reduction in sales or be forced out of the market.

A number of pharmaceutical and biotechnology companies and research and academic institutions have developed technologies, filed patent applications or received patents for technologies that may be related to our business. Some of these technologies, applications or patents may conflict with our technologies or patent applications. This conflict could limit the scope of any patents that we may obtain for our technologies or result in denial of our patent applications. In addition, if patents or patent applications that cover our activities are or have been issued to other companies, we may be required to either obtain a license from the owner or develop or obtain alternative technology. A license may not be available on acceptable terms, if at all, and we may be unable to develop or obtain alternative technology.

As the biotechnology industry expands and more patents are issued, the risk increases that our processes and potential products may give rise to claims that they infringe on the patents of others. These other parties could bring legal actions against us claiming damages and seeking to stop clinical testing, manufacturing and marketing of the affected product or use of the affected process. If we are found by a court to have infringed on the proprietary rights of others, we could also face potential liability for significant damages and be required to obtain a license to the proprietary technology at issue if we continue to commercialize. A required license may not be available on acceptable terms, if at all, which could impair our ability to commercialize our product candidates. Similarly, administrative proceedings, litigation or both may be necessary to enforce patents issued to us, to protect trade secrets or know-how owned by us or to determine the enforceability, scope and validity of the proprietary rights of others. This type of litigation, regardless of its merit, could result in substantial expense to us and significantly divert the efforts of our technical and management personnel. An adverse outcome could adversely affect our business.

Competition

Competition among biotechnology and pharmaceutical companies that research, develop, manufacture and commercialize therapeutic products is significant. Even in the field of gene therapy, numerous companies and institutions are developing or considering the development of gene therapy treatments, including other gene delivery companies, biotechnology companies, pharmaceutical companies, universities, research institutions, governmental agencies and other healthcare providers.

In addition to competition from sources developing competitive gene therapy technologies, our potential products will compete with non-gene therapy products in development and on the market for the therapeutic indications we are targeting. These competitive products could include small molecules, proteins, monoclonal antibodies and other pharmaceutical products, medical devices and surgery. Products in development could make our products obsolete before they ever get to the market. Products on the market could negatively affect the commercial opportunity for our products. Intense competition could heighten disputes pursued in an effort to slow our development including lawsuits, demands, threats or patent challenges. We also compete with others to acquire



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products or technology from research institutions, universities and other companies. In addition, we compete with others to maintain and attract the necessary scientific and business personnel to advance our programs.

Many of our competitors have substantially more financial and other resources, larger research and development staffs and more experience and capabilities in researching, developing and testing products in clinical trials, obtaining U.S. Food and Drug Administration, or FDA, and other regulatory approvals and manufacturing, marketing and distributing products. In addition, the competitive positions of other companies may be strengthened through collaborative relationships, such as those with large pharmaceutical companies or academic institutions. As a result, our competitors may develop, obtain patent protection, receive FDA and other regulatory approvals or commercialize products more rapidly than we do or may manufacture and market their products more successfully than we do.

Our competitors’ technologies and products may be more effective or economically feasible than our potential products. If we are successful in commercializing our products, we will be required to compete with respect to commercial manufacturing efficiency and marketing capabilities, areas in which we have no experience. These developments could limit the prices we are able to charge for any products we are able to commercialize or render our products less competitive or obsolete.

Our lead product candidate, tgAAC94, is aimed at the target market of inflammatory arthritis. A number of products are currently successfully marketed to treat people with inflammatory arthritis, including products which work by the same mechanism of action, TNF-alpha inhibition. TNF-alpha inhibitor products currently on the market include products from Amgen, Johnson & Johnson and Abbott Laboratories. Although tgAAC94 is targeted to people not completely responding to these systemic TNF inhibitor drugs, other companies are also developing products to complement the systemic TNF inhibitors. Products in development or on the market for inflammatory arthritis could negatively affect the development path and market opportunity for tgAAC94.

Governmental Regulation

All of our potential products must receive regulatory approval before they can be marketed. Human therapeutic products are subject to rigorous preclinical and clinical testing and other pre-market approval procedures administered by the FDA and similar authorities in foreign countries. In accordance with the Federal Food, Drug and Cosmetics Act, the FDA exercises regulatory authority over the development, testing, formulation, manufacture, labeling, storage, record keeping, reporting, quality control, advertising, promotion, export and sale of our potential products. Similar requirements are imposed by foreign regulatory agencies. In some cases, state regulations may also apply.

Gene therapeutics are based on relatively new technologies that have not been extensively tested or shown to be effective in humans. The FDA reviews all product candidates for safety at each stage of clinical testing. Safety standards must be met before the FDA permits clinical testing to proceed to the next stage. Also, efficacy must be demonstrated before the FDA grants product approval. Obtaining approval from the FDA and other regulatory authorities for a new therapeutic product candidate, if approval is ever obtained, is likely to take several years. We may encounter difficulties or unanticipated costs in our efforts to secure necessary governmental approvals, which could delay or prevent the marketing of our product candidates. In addition, the regulatory requirements governing gene therapy product candidates and commercialized products are subject to change. The approval process, and ongoing compliance with applicable regulations after approval, involves substantial expenditures of financial and other resources.

Preclinical studies generally require studies in the laboratory or in animals to assess the potential product’s safety and effectiveness. Preclinical studies include laboratory evaluation of toxicity, pharmacokinetics, how the body processes and reacts to the drug and pharmacodynamics, the effects the drug is actually having on the body. Preclinical studies must be conducted in accordance with the FDA’s Good Laboratory Practice regulations and, before any proposed clinical testing in humans can begin, the FDA must review the results of these preclinical studies as part of an Investigational New Drug application.

If preclinical studies of a product candidate, including animal studies, demonstrate safety, and laboratory test results are acceptable, then the potential product will undergo clinical trials to test the therapeutic agent in humans. Human clinical trials are subject to numerous governmental regulations that provide detailed procedural and administrative requirements designed to protect the trial participants. Each institution that conducts human clinical trials has an Institutional Review Board or Ethics Committee charged with evaluating each trial and any trial



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amendments to ensure that the trial is ethical, subjects are protected and the trial meets the institutional requirements. These evaluations include reviews of how the institution will communicate the risks inherent in the clinical trial to potential participants so that the subjects may give their informed consent. Clinical trials must be conducted in accordance with the FDA’s Good Clinical Practices regulations and the protocols the company establishes to govern the trial objectives, the parameters to be used for monitoring safety, the criteria for evaluating the efficacy of the potential product and the rights of each trial participant with respect to safety. FDA regulations require us to submit these protocols as part of the application. A FDA review or approval of the protocols, however, does not necessarily mean that the trial will successfully demonstrate safety and/or efficacy of the potential product.

Institutions that receive NIH funding for research involving recombinant DNA must also comply with the NIH Recombinant DNA Guidelines, and the clinical trials conducted at those institutions are subject to a review by the NIH’s Office of Biotechnology Activities Recombinant DNA Advisory Committee, or RAC. The outcome of this review can be either an approval to initiate the trial without a public review or a requirement that the proposed trial be reviewed at a quarterly committee meeting. A clinical trial will be publicly reviewed when at least three of the committee members or the Director of the Office of Biotechnology Activities recommends a public review. Should the RAC require a public hearing, the start of the trial must be delayed until after the hearing date. Although the NIH guidelines do not have regulatory status, the RAC review process can impede the initiation of the trial, even if the FDA has reviewed the trial and approved its initiation. Additionally, before any clinical trial can be initiated at an NIH-funded site, the Institutional Biosafety Committee of that site must perform a review of the proposed clinical trial and ensure there are no safety issues associated with the trial.

Clinical trials are typically conducted in three phases often involving multiple clinical trials in each phase. In Phase I, clinical trials generally involve a small number of subjects, who may or may not be afflicted with the target disease, to determine the preliminary safety profile. In Phase II, clinical trials are conducted with larger groups of subjects afflicted with the target disease in order to establish preliminary effectiveness and optimal dosages and to obtain additional evidence of safety. In Phase III, large-scale, multi-center, comparative clinical trials are conducted with subjects afflicted with the target disease in order to provide enough data for the statistical proof of efficacy and safety required by the FDA and other regulatory agencies for market approval. We report our progress in each phase of clinical testing to the FDA, which may require modification, suspension or termination of the clinical trial if it deems patient risk too high. The length of the clinical trial period, the number of trials conducted and the number of enrolled subjects per trial vary, depending on our results and FDA requirements for the particular clinical trial. Although we and other companies in our industry have made progress in the field of gene therapy, we cannot predict what the FDA will require in any of these areas to establish to its satisfaction the safety and effectiveness of the product candidate.

If we successfully complete clinical trials for a product candidate, we must obtain FDA approval or similar approval required by foreign regulatory agencies, as well as the approval of several other governmental and nongovernmental agencies, before we can market the product in the U.S. or in foreign countries. Current FDA regulations relating to biologic therapeutics require us to submit an acceptable Biologics License Application, or BLA, to the FDA and receive approval before the FDA will permit commercial marketing. The BLA includes a description of our product development activities, the results of preclinical studies and clinical trials and detailed manufacturing information. Unless the FDA gives expedited review status, this stage of the review process generally takes at least one year. Should the FDA have concerns with respect to the potential product’s safety and efficacy, it may request additional data, which could delay product review or approval. The FDA may ultimately decide that the BLA does not satisfy its criteria for approval and might require us to do any or all of the following:

·

modify the scope of our desired product claims;

·

add warnings or other safety-related information; and/or

·

perform additional testing.

Because the FDA has not yet approved any gene therapy products, it is not clear what, if any, unforeseen issues may arise during the approval process. While we expect this regulatory structure to continue, we also expect the FDA’s regulatory approach to product approval, and its requirements with respect to product testing, to become more predictable as its scientific knowledge and experience in the field of gene therapy increases. Adverse events in the field of gene therapy or other biotechnology-related fields, however, could result in greater governmental regulation, stricter labeling requirements and potential regulatory delays in the testing or approval of gene therapy products.



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Once approved by the FDA, marketed products are subject to continual FDA review. Later discovery of previously unknown problems or failure to comply with applicable regulatory requirements may result in restrictions on marketing a product or in its withdrawal from the market, as well as potential criminal penalties or sanctions. In addition, the FDA requires that manufacturers of a product comply with current Good Manufacturing Practices requirements, both as a condition to product approval and on a continuing basis. In complying with these requirements, we expend significant amounts of time, money and effort in production, record keeping and quality control. Our manufacturing facilities are subject to periodic inspections by the FDA. If major problems are identified during these inspections that could impact patient safety, the FDA could subject us to possible action, such as the suspension of product manufacturing, product seizure, withdrawal of approval or other regulatory sanctions. The FDA could also require us to recall a product.

We are also subject to regulation under the Occupational Safety and Health Act, the Environmental Protection Act, the Toxic Substances Control Act, the Resource Conservation and Recovery Act and other federal, state and local regulations. For example, our controlled use of hazardous materials in our research and development activities must comply with standards prescribed by state and federal law.

Employees

As of December 31, 2006, we had 70 full-time-equivalent employees. Nine of our employees have Ph.D. or M.D. degrees and a significant number of our management and professional employees have prior experience with other biotechnology or pharmaceutical companies. We also rely on a number of temporary staff positions and third party consultants. None of our employees are covered by a collective bargaining agreement.

Available Information

We were incorporated in the state of Washington in 1989. Our executive offices are located at 1100 Olive Way, Suite 100, Seattle, Washington 98101, and our telephone number is (206) 623-7612. We file annual, quarterly and current reports, proxy statements and other information with the SEC. We make available in the investor relations portion of our website, free of charge, copies of our annual report on Form 10-K, quarterly reports on Form 10-Q, current reports on Form 8-K and amendments to these reports after filing these reports to the SEC. Our website is located at www.targetedgenetics.com. You may also obtain free copies of our periodic reports on the SEC web site at http://www.sec.gov.

Item 1A. Risk Factors.

In addition to the other information contained in this annual report, you should carefully read and consider the following risk factors. If any of these risks actually occur, our business, operating results or financial condition could be harmed. This could cause the trading price of our stock to decline, and you could lose all or part of your investment.

Risks Related to Our Business

The audit report prepared by our independent registered public accounting firm includes an explanatory paragraph expressing the substantial doubt about our ability to continue as a going concern.

We estimate that our cash and cash equivalents on hand, which includes the net proceeds of approximately $8.1 million received in our January 2007 private placement of common stock and warrants to purchase common stock, plus expected funding from our partners, will be sufficient to fund our operations into the fourth quarter of 2007. This estimate is based on our ability to perform planned research and development activities and the receipt of expected funding from our partners. Prior to that time, we will need to raise additional capital to continue to fund operations at their current level. In addition, as of December 31, 2006, we owed to Biogen Idec approximately $1.5 million in aggregate principal amount pursuant to an outstanding promissory note. In December 2006, we made a $583,000 advance payment to Biogen Idec in accordance with the terms of the promissory note, which requires one-third of certain up-front payments received from potential future collaborators to be applied toward the outstanding loan balance in reverse order of maturity. The receipt of the $1.75 million license fee from AMT triggered this payment, which was applied first to interest owed through the payment date and then to the long term portion of the promissory note. The terms of the promissory note require us to make annual interest payments and scheduled principal payments of $1.0 million in August 2007 and $525,000 in August 2008.



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If we do not raise additional funds, we would be forced to preserve our cash position through a combination of additional cost reduction measures, sales of assets likely at values significantly below their potential worth, or the pursuit of alternative financing transactions that would likely be on terms substantially more disadvantageous to us and dilutive to our shareholders. We may need to augment our cash through additional and possibly repetitive dilutive financings. If we are unable to raise additional funds, we could be forced to discontinue our operations.

If we are unable to raise additional capital when needed, we will be unable to conduct our operations and develop our potential products.

Because internally generated cash flow will not fund development and commercialization of our product candidates, we will require substantial additional financial resources. Our future capital requirements will depend on many factors, including:

·

the rate and extent of scientific progress in our research and development programs;

·

the timing, costs and scope of, and our success in, conducting clinical trials, obtaining regulatory approvals and pursuing patent prosecutions;

·

competing technological and market developments;

·

the timing and costs of, and our success in, any product commercialization activities and facility expansions, if and as required; and

·

the existence and outcome of any litigation or administrative proceedings involving intellectual property.

Additional sources of financing could involve one or more of the following:

·

entering into additional product development collaborations;

·

mergers and acquisitions;

·

issuing equity in the public or private markets;

·

extending or expanding our current collaborations;

·

selling or licensing our technology or product candidates;

·

borrowing under loan or equipment financing arrangements; and/or

·

issuing debt.

Additional funding may not be available to us on reasonable terms, if at all. Our ability to issue equity, and our ability to issue it at the current market price, may be adversely affected by the fact that we are presently ineligible under SEC rules to utilize Form S-3 for primary offerings of our securities because the aggregate market value of our outstanding common stock held by non-affiliates is less than $75.0 million. Moreover, our ability to raise additional capital may be adversely affected by the fact that the audit report prepared by our independent registered public accounting firm relating to our financial statements for the year ended December 31, 2006 includes a going concern qualification.

The perceived risk associated with the possible sale of a large number of shares of our common stock could cause some of our shareholders to sell their stock, thus causing the price of our stock to decline. In addition, actual or anticipated downward pressure on our stock price due to actual or anticipated sales of stock could cause some institutions or individuals to engage in short sales of our common stock, which may itself cause the price of our stock to decline.

If our stock price declines, we may be unable to raise additional capital. A sustained inability to raise capital could force us to go out of business. Significant declines in the price of our common stock could also impair our ability to attract and retain qualified employees, reduce the liquidity of our common stock and result in the delisting of our common stock from the NASDAQ Capital Market.

The funding that we expect to receive from our collaborations depends on continued scientific progress under the collaborations and our collaborators’ ability and willingness to continue or extend the collaboration. If we are unable to successfully access additional capital, we may need to scale back, delay or terminate one or more of our development programs, curtail capital expenditures or reduce other operating activities. We may also be required to



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relinquish some rights to our technology or product candidates or grant or take licenses on unfavorable terms, either of which would reduce the ultimate value to us of our technology or product candidates.

We expect to continue to operate at a loss and may never become profitable.

Substantially all of our revenue to date has been derived under collaborative research and development agreements relating to the development of our potential product candidates. We have incurred, and will continue to incur for the foreseeable future, significant expense to develop our research and development programs, conduct preclinical studies and clinical trials, seek regulatory approval for our product candidates and provide general and administrative support for these activities. As a result, we have incurred significant net losses since inception, and we expect to continue to incur substantial additional losses in the future. As of December 31, 2006, we had an accumulated deficit of $284.0 million. We may never generate profits and, if we do become profitable, we may be unable to sustain or increase profitability.

All of our product candidates are in early-stage clinical trials or preclinical development, and if we are unable to successfully develop and commercialize our product candidates we will be unable to generate sufficient capital to maintain our business.

In March 2006, we initiated a Phase I/II trial for our inflammatory arthritis product candidate in the United States and Canada. We will not generate any product revenue for at least several years and then only if we can successfully develop and commercialize our product candidates. Commercializing our potential products depends on successful completion of additional research and development and testing, in both preclinical development and clinical trials. Clinical trials may take several years or more to complete. The commencement, cost and rate of completion of our clinical trials may vary or be delayed for many reasons. If we are unable to successfully complete preclinical and clinical development of some or all of our product candidates in a timely manner, we may be unable to generate sufficient product revenue to maintain our business.

Even if our potential products succeed in clinical trials and are approved for marketing, these products may never achieve market acceptance. If we are unsuccessful in commercializing our product candidates for any reason, including greater effectiveness or economic feasibility of competing products or treatments, the failure of the medical community or the public to accept or use any products based on gene delivery, inadequate marketing and distribution capabilities or other reasons discussed elsewhere in this section, we will be unable to generate sufficient product revenue to maintain our business.

Failure to recruit subjects could delay or prevent clinical trials of our potential products, which could delay or prevent the development of potential products.

Identifying and qualifying subjects to participate in clinical trials of our potential products is critically important to our success. The timing of our clinical trials depends on the speed at which we can recruit subjects to participate in testing our product candidates. We have experienced delays in some of our clinical trials, and we may experience similar delays in the future. If subjects are unwilling to participate in our gene therapy trials because of negative publicity from adverse events in the biotechnology or gene therapy industries or for other reasons, including competitive clinical trials for similar patient populations, the timeline for recruiting subjects, conducting trials and obtaining regulatory approval of potential products will be delayed. These delays could result in increased costs, delays in advancing our product development, delays in testing the effectiveness of our technology or termination of the clinical trials altogether.

The regulatory approval process for our product candidates is costly, time-consuming and subject to unpredictable changes and delays, and our product candidates may never receive regulatory approval.

No gene therapy products have received regulatory approval for marketing from the FDA. Because our product candidates involve new and unproven technologies, we believe that the regulatory approval process may proceed more slowly compared to clinical trials involving traditional drugs. The FDA and applicable state and foreign regulators must conclude at each stage of clinical testing that our clinical data suggest acceptable levels of safety in order for us to proceed to the next stage of clinical trials. In addition, gene therapy clinical trials conducted at institutions that receive funding for recombinant DNA research from the NIH are subject to review by the NIH’s Office of Biotechnology Activities Recombinant DNA Advisory Committee, or RAC. Although NIH guidelines do not have regulatory status, the RAC review process can impede the initiation of the trial, even if the FDA has



15



reviewed the trial and approved its initiation. Moreover, before a clinical trial can begin at an NIH-funded institution, that institution’s Institutional Biosafety Committee must review the proposed clinical trial to assess the safety of the trial.

The regulatory process for our product candidates is costly, time-consuming and subject to unpredictable delays. The clinical trial requirements of the FDA, NIH and other agencies and the criteria these regulators use to determine the safety and efficacy of a product candidate vary substantially according to the type, complexity, novelty and intended use of the potential products. In addition, regulatory requirements governing gene therapy products have changed frequently and may change in the future. Accordingly, we cannot predict how long it will take or how much it will cost to obtain regulatory approvals for clinical trials or for manufacturing or marketing our potential products. Some or all of our product candidates may never receive regulatory approval. A product candidate that appears promising at an early stage of research or development may not result in a commercially successful product. Our clinical trials may fail to demonstrate the safety and efficacy of a product candidate or a product candidate may generate unacceptable side effects or other problems during or after clinical trials. Should this occur, we may have to delay or discontinue development of the product candidate, and the partner, if any, that supports development of such product candidate may terminate its support. Delay or failure to obtain, or unexpected costs in obtaining, the regulatory approval necessary to bring a potential product to market will decrease our ability to generate sufficient product revenue to maintain our business.

If we are unable to obtain or maintain licenses for necessary third-party technology on acceptable terms or to develop alternative technology, we may be unable to develop and commercialize our product candidates.

We have entered into exclusive and nonexclusive license agreements that give us and our partners rights to use technologies owned or licensed by commercial and academic organizations in the research, development and commercialization of our potential products. For example, we have a gene therapy technology license agreement with Amgen as the successor to Immunex under which we have licensed rights to certain Immunex proprietary technology specifically applicable to gene therapy applications. In a February 2004 letter, Amgen took the position that we are not licensed, either exclusively or nonexclusively, to use Immunex intellectual property covering TNFR:Fc or therapeutic uses for TNFR:Fc. We have responded with a letter confirming our confidence that the gene therapy technology license agreement provides us with an exclusive worldwide license to use the gene construct coding for TNFR:Fc for gene therapy applications. We have had, and expect to have further, communications with Amgen regarding our differences. Notwithstanding our confidence, it is possible that a resolution of those differences, through litigation or otherwise, could cause delay or discontinuation of our development of tgAAC94 or our inability to commercialize any resulting product.

We believe that we will need to obtain additional licenses to use patents and unpatented technology owned or licensed by others for use, compositions, methods, processes to manufacture compositions, processes to manufacture and purify gene delivery product candidates and other technologies and processes for our present and potential product candidates. If we are unable to maintain our current licenses for third-party technology or obtain additional licenses on acceptable terms, we may be required to expend significant time and resources to develop or license replacement technology. If we are unable to do so, we may be unable to develop or commercialize the affected product candidates. In addition, the license agreements for technology for which we hold exclusive licenses typically contain provisions that require us to meet minimum development milestones in order to maintain the license on an exclusive basis for some or all fields of the license. We also have license agreements for some of our technologies that may require us to sublicense certain of our rights. If we do not meet these requirements, our licensor may convert all or a portion of the license to a nonexclusive license or, in some cases, terminate the license.

In many cases, patent prosecution of our licensed technology is controlled solely by the licensor. If our licensors fail to obtain and maintain patent or other protection for the proprietary intellectual property we license from them, we could lose our rights to the intellectual property or our exclusivity with respect to those rights, and our competitors could market competing products using the intellectual property. Licensing of intellectual property is of critical importance to our business and involves complex legal, business and scientific issues and is complicated by the rapid pace of scientific discovery in our industry. Disputes may arise regarding intellectual property subject to a licensing agreement, including:

·

the scope of rights granted under the license agreement and other interpretation-related issues;

·

the extent to which our technology and processes infringe on intellectual property of the licensor that is not subject to the licensing agreement;



16



·

the sublicensing of patent and other rights under our collaborative development relationships;

·

the ownership of inventions and know-how resulting from the joint creation or use of intellectual property by our licensors and us and our partners; and

·

the priority of invention of patented technology.

If disputes over intellectual property that we have licensed prevent or impair our ability to maintain our current licensing arrangements on acceptable terms, we may be unable to successfully develop and commercialize the affected product candidates.

Litigation involving intellectual property, product liability or other claims and product recalls could strain our resources, subject us to significant liability, damage our reputation or result in the invalidation of our proprietary rights.

As our product development efforts progress, most particularly in potentially significant markets such as HIV/AIDS, congestive heart failure or inflammatory arthritis therapies, the risk increases that others may claim that our processes and product candidates infringe on their intellectual property rights. In addition, administrative proceedings, litigation or both may be necessary to enforce our intellectual property rights or determine the rights of others. Defending or pursuing these claims, regardless of their merit, would be costly and would likely divert management’s attention and resources away from our operations. If there were to be an adverse outcome in litigation or an interference proceeding, we could face potential liability for significant damages or be required to obtain a license to the patented process or technology at issue, or both. If we are unable to obtain a license on acceptable terms, or to develop or obtain alternative technology or processes, we may be unable to manufacture or market any product or potential product that uses the affected process or technology.

Clinical trials and the marketing of any potential products may expose us to liability claims resulting from the testing or use of our products. Gene therapy treatments are new and unproven, and potential known and unknown side effects of gene therapy may be serious and potentially life-threatening. Product liability claims may be made by clinical trial participants, consumers, healthcare providers or other sellers or users of our products. Although we currently maintain liability insurance, the costs of product liability and other claims against us may exceed our insurance coverage. In addition, we may require increased liability coverage as additional product candidates are used in clinical trials or commercialized. Liability insurance is expensive and may not continue to be available on acceptable terms. A product liability or other claim or product recall not covered by or exceeding our insurance coverage could significantly harm our financial condition. In addition, adverse publicity resulting from a product recall or a liability claim against us, one of our partners or another gene therapy company could significantly harm our reputation and make it more difficult to obtain the funding and collaborative partnerships necessary to maintain our business.

If we lose our collaborative partners, we may be unable to develop our potential products.

A portion of our operating expenses are funded through our collaborative agreements with third parties. Our HIV/AIDS vaccine collaboration with CHOP and CCRI is funded through a subcontract with the NIAID, which is a U.S. government agency. We also have contracts with two biotechnology companies, Celladon and Sirna and one public health organization, IAVI. Each of these collaborations provides for funding, collaborative development, intellectual property rights or expertise to develop certain of our product candidates. With limited exceptions, each collaborator has the right to terminate its obligation to provide research funding at any time for scientific or business reasons. In addition, to the extent that funding is provided by a collaborator for non-program-specific uses, the loss of significant amounts of collaborative funding could result in the delay, reduction or termination of additional research and development programs, a reduction in capital expenditures or business development and other operating activities, or any combination of these measures.

If we do not attract and retain qualified personnel, we may be unable to develop and commercialize some of our potential products.

Our future success depends in large part on our ability to attract and retain key technical and management personnel. All of our employees, including our executive officers, can terminate their employment with us at any time. We have programs in place designed to retain personnel, including competitive compensation packages and programs to create a positive work environment. Other companies, research and academic institutions and other



17



organizations in our field compete intensely for employees, however, and we may be unable to retain our existing personnel or attract additional qualified employees and consultants. If we experience significant turnover or difficulty in recruiting new personnel, our research and development of product candidates could be delayed and we could experience difficulty in generating sufficient revenue to maintain our business.

If our partners or scientific consultants terminate, reduce or delay our relationships with them, we may be unable to develop our potential products.

Our partners provide funding, manage regulatory filings, aid and augment our internal research and development efforts and provide access to important intellectual property and know-how. Their activities include, for example, support in processing the regulatory filings of our product candidates and funding clinical trials. Our outside scientific consultants and contractors perform research, develop technology and processes to advance and augment our internal efforts and provide access to important intellectual property and know-how. Their activities include, for example, clinical evaluation of our product candidates, product development activities performed under our research collaborations, research under sponsored research agreements and contract manufacturing services. Collaborations with established pharmaceutical and biotechnology companies and academic, research and public health organizations often provide a measure of validation of our product development efforts in the eyes of securities analysts, investors and the medical community. The development of certain of our potential products, and therefore the success of our business, depends on the performance of our partners, consultants and contractors. If they do not dedicate sufficient time, regulatory or other technical resources to the research and development programs for our product candidates or if they do not perform their obligations as expected, we may experience delays in, and may be unable to continue, the preclinical or clinical development of those product candidates. Each of our collaborations and scientific consulting relationships concludes at the end of the term specified in the applicable agreement unless we and our partners agree to extend the relationship. Any of our partners may decline to extend the collaboration, or may be willing to extend the collaboration only with a significantly reduced scope. Competition for scientific consultants and partners in gene therapy is intense. We may be unable to successfully maintain our existing relationships or establish additional relationships necessary for the development of our product candidates on acceptable terms, if at all. If we are unable to do so, our research and development programs may be delayed or we may lose access to important intellectual property or know-how.

The success of our clinical trials and preclinical studies may not be indicative of results in a large number of subjects of either safety or efficacy.

The successful results of our technology in preclinical studies using animal models may not be predictive of the results that we will see in our clinical trials. In addition, results in early-stage clinical trials are based on limited numbers of subjects and generally test for drug safety rather than efficacy. Our reported progress and results from our early phases of clinical testing of our product candidates may not be indicative of progress or results that will be achieved from larger populations, which could be less favorable. Moreover, we do not know if the favorable results we have achieved in clinical trials will have a lasting or repeatable effect. If a larger group of subjects does not experience positive results or if any favorable results do not demonstrate a beneficial effect, our product candidates that we advance to clinical trials may not receive approval from the FDA for further clinical trials or commercialization. For example, in March 2005, we discontinued the development of tgAAVCF, our product candidate for the treatment of cystic fibrosis, following the analysis of Phase II clinical trial data in which tgAAVCF failed to achieve the efficacy endpoints of the trial.

We may be unable to adequately protect our proprietary rights domestically or overseas, which may limit our ability to successfully market any product candidates.

Our success depends substantially on our ability to protect our proprietary rights and operate without infringing on the proprietary rights of others. We own or license patents and patent applications, and will need to license additional patents, for genes, processes, practices and techniques critical to our present and potential product candidates. If we fail to obtain and maintain patent or other intellectual property protection for this technology, our competitors could market competing products using those genes, processes, practices and techniques. The patent process takes several years and involves considerable expense. In addition, patent applications and patent positions in the field of biotechnology are highly uncertain and involve complex legal, scientific and factual questions. Our patent applications may not result in issued patents and the scope of any patent may be reduced both before and after



18



the patent is issued. Even if we secure a patent, the patent may not provide significant protection and may be circumvented or invalidated.

We also rely on unpatented proprietary technology and technology that we have licensed on a nonexclusive basis. While we take precautions to protect our proprietary unpatented technology, we may be unable to meaningfully protect this technology from unauthorized use or misappropriation by a third party. Our competitors could also obtain rights to our nonexclusively licensed proprietary technology. In any event, other companies may independently develop equivalent proprietary information and techniques. If our competitors develop and market competing products using our unpatented or nonexclusively licensed proprietary technology or substantially similar technology, our products, if successfully developed, could suffer a reduction in sales or be forced out of the market.

If we do not develop adequate development, manufacturing, sales, marketing and distribution capabilities, either alone or with our business partners, we will be unable to generate sufficient product revenue to maintain our business.

Our potential products require significant development of new processes and design for the advancement of the product candidate through manufacture, preclinical and clinical testing. We may be unable to continue development or meet critical milestones with our partners due to technical or scientific issues related to manufacturing or development. We currently do not have the physical capacity to manufacture large-scale quantities of our potential products. This could limit our ability to conduct large clinical trials of a product candidate and to commercially launch a successful product candidate. In order to manufacture product at such scale, we will need to expand or improve our current facilities and staff or supplement them through the use of contract providers. If we are unable to obtain and maintain the necessary manufacturing capabilities, either alone or through third parties, we will be unable to manufacture our potential products in quantities sufficient to sustain our business. Moreover, we are unlikely to become profitable if we, or our contract providers, are unable to manufacture our potential products in a cost-effective manner.

In addition, we have no experience in sales, marketing and distribution. To successfully commercialize any products that may result from our development programs, we will need to develop these capabilities, either on our own or with others. We intend to enter into collaborations with other entities to utilize their mature marketing and distribution capabilities, but we may be unable to enter into marketing and distribution agreements on favorable terms, if at all. If our current or future collaborative partners do not commit sufficient resources to timely marketing and distributing our future products, if any, and we are unable to develop the necessary marketing and distribution capabilities on our own, we will be unable to generate sufficient product revenue to sustain our business.

Post-approval manufacturing or product problems or failure to satisfy applicable regulatory requirements could prevent or limit our ability to market our products.

Commercialization of any products will require continued compliance with FDA and other federal, state and local regulations. For example, our current manufacturing facility, which is designed for manufacturing our AAV vectors for clinical and development purposes, is subject to the Good Manufacturing Practices requirements and other regulations of the FDA, as well as to other federal, state and local regulations such as the Occupational Health and Safety Act, the Toxic Substances Control Act, the Resource Conservation and Recovery Act and the Environmental Protection Act. Any future manufacturing facility that we may construct for large-scale commercial production will also be subject to regulation. We may be unable to obtain regulatory approval for or maintain in operation this or any other manufacturing facility. In addition, we may be unable to attain or maintain compliance with current or future regulations relating to manufacture, safety, handling, storage, record keeping or marketing of potential products. If we fail to comply with applicable regulatory requirements or discover previously unknown manufacturing, contamination, product side effects or other problems after we receive regulatory approval for a potential product, we may suffer restrictions on our ability to market the product or be required to withdraw the product from the market.



19



Risks Related to Our Industry

Adverse events in the field of gene therapy could damage public perception of our potential products and negatively affect governmental approval and regulation.

Public perception of our product candidates could be harmed by negative events in the field of gene transfer. For example, in 2003, fourteen subjects in a French academic clinical trial being treated for x-linked severe combined immunodeficiency in a gene therapy trial using a retroviral vector showed correction of the disease, although three of the subjects subsequently developed leukemia. Serious adverse events, including patient deaths, have occurred in clinical trials. Adverse events in our clinical trials and the resulting publicity, as well as any other adverse events in the field of gene therapy that may occur in the future, could result in a decrease in demand for any products that we may develop. The commercial success of our product candidates will depend in part on public acceptance of the use of gene therapy for preventing or treating human diseases. If public perception is influenced by claims that gene therapy is unsafe, our product candidates may not be accepted by the general public or the medical community. The public and the medical community may conclude that our technology is unsafe.

Future adverse events in gene therapy or the biotechnology industry could also result in greater governmental regulation, unfavorable public perception, stricter labeling requirements and potential regulatory delays in the testing or approval of our potential products. Any increased scrutiny could delay or increase the costs of our product development efforts or clinical trials.

Our use of hazardous materials exposes us to liability risks and regulatory limitations on their use, either of which could reduce our ability to generate product revenue.

Our research and development activities involve the controlled use of hazardous materials, including chemicals, biological materials and radioactive compounds. Our safety procedures for handling, storing and disposing of these materials must comply with federal, state and local laws and regulations, including, among others, those relating to solid and hazardous waste management, biohazard material handling, radiation and air pollution control. We may be required to incur significant costs in the future to comply with environmental or other applicable laws and regulations. In addition, we cannot eliminate the risk of accidental contamination or injury from hazardous materials. If a hazardous material accident were to occur, we could be held liable for any resulting damages, and this liability could exceed our insurance and financial resources. Accidents unrelated to our operations could cause federal, state or local regulatory agencies to restrict our access to hazardous materials needed in our research and development efforts, which could result in delays in our research and development programs. Paying damages or experiencing delays caused by restricted access could reduce our ability to generate revenue and make it more difficult to fund our operations.

The intense competition and rapid technological change in our market may result in failure of our potential products to achieve market acceptance.

We face increasingly intense competition from a number of commercial entities and institutions that are developing gene therapy technologies. Our competitors include early-stage and more established gene delivery companies, other biotechnology companies, pharmaceutical companies, universities, research institutions and government agencies developing gene therapy products or other biotechnology-based therapies designed to treat the diseases on which we focus. We also face competition from companies using more traditional approaches to treating human diseases, such as surgery, medical devices and pharmaceutical products. If our product candidates become commercial gene therapy products, they may affect commercial markets of the analogous protein or traditional pharmaceutical therapy. This may result in lawsuits, demands, threats or patent challenges by others in an effort to reduce our ability to compete. In addition, we compete with other companies to acquire products or technology from research institutions or universities. Many of our competitors have substantially more resources, including research and development personnel, capital and infrastructure, than we do. Many of our competitors also have greater experience and capabilities than we do in:

·

research and development;

·

clinical trials;

·

obtaining FDA and other regulatory approvals;



20



·

manufacturing; and

·

marketing and distribution.

In addition, the competitive positions of other companies, institutions and organizations, including smaller competitors, may be strengthened through collaborative relationships. Consequently, our competitors may be able to develop, obtain patent protection for, obtain regulatory approval for, or commercialize new products more rapidly than we do, or manufacture and market competitive products more successfully than we do. This could limit the prices we could charge for the products that we are able to market or result in our products failing to achieve market acceptance.

Gene therapy is a rapidly evolving field and is expected to continue to undergo significant and rapid technological change and competition. Rapid technological development by our competitors, including development of technologies, products or processes that are more effective or more economically feasible than those we have developed, could result in our actual and proposed technologies, products or processes losing market share or becoming obsolete.

Healthcare reform measures and the unwillingness of third-party payors to provide adequate reimbursement for the cost of our products could impair our ability to successfully commercialize our potential products and become profitable.

Sales of medical products and treatments, both domestically and abroad, substantially depend on the availability of reimbursement to the consumer from third-party payors. Our potential products may not be considered cost-effective by third-party payors, who may not provide coverage at the price set for our products, if at all. If purchasers or users of our products are unable to obtain adequate reimbursement, they may forego or reduce their use of our products. Even if coverage is provided, the approved reimbursement amount may not be high enough to allow us to establish or maintain pricing sufficient to realize a sufficient return on our investment.

Increasing efforts by governmental and third-party payors, such as Medicare, private insurance plans and managed care organizations, to cap or reduce healthcare costs will affect our ability to commercialize our product candidates and become profitable. We believe that third-party payors will attempt to reduce healthcare costs by limiting both coverage and level of reimbursement for new products approved by the FDA. There have been and will continue to be a number of federal and state proposals to implement government controls on pricing, the adoption of which could affect our ability to successfully commercialize our product candidates. Even if the government does not adopt any such proposals or reforms, their announcement could impair our ability to raise capital.

Risks Related to Our Common Stock

If we sell additional shares, our stock price may decline as a result of the dilution that will occur to existing shareholders.

Until we are profitable, we will need significant additional funds to develop our business and sustain our operations. Any additional sales of shares of our common stock are likely to have a dilutive effect on our then-existing shareholders. Subsequent sales of these shares in the open market could also have the effect of lowering our stock price, thereby increasing the number of shares we may need to issue in the future to raise the same dollar amount and consequently further diluting our outstanding shares. These future sales could also have an adverse effect on the market price of our shares and could result in additional dilution to the holders of our shares.

The perceived risk associated with the possible sale of a large number of shares could cause some of our shareholders to sell their stock, thus causing the price of our stock to decline. In addition, actual or anticipated downward pressure on our stock price due to actual or anticipated sales of stock could cause some institutions or individuals to engage in short sales of our common stock, which may itself cause the price of our stock to decline.

If our stock price declines, we may be unable to raise additional capital. A sustained inability to raise capital could force us to go out of business. Significant declines in the price of our common stock could also impair our ability to attract and retain qualified employees, reduce the liquidity of our common stock and result in the delisting of our common stock from the NASDAQ Capital Market.



21



Concentration of ownership of our common stock may give certain shareholders significant influence over our business.

A small number of investors own a significant number of shares of our common stock. As of March 16, 2007, Biogen Idec held approximately 2.2 million shares and Elan held approximately 1.2 million shares of our common stock. Together these holdings represent approximately 25% of our common shares outstanding as of March 16, 2007. This concentration of stock ownership may allow these shareholders to exercise significant control over our strategic decisions and block, delay or substantially influence all matters requiring shareholder approval, such as:

·

election of directors;

·

amendment of our charter documents; or

·

approval of significant corporate transactions, such as a change of control of us.

The interests of these shareholders may conflict with the interests of other holders of our common stock with regard to such matters. Furthermore, this concentration of ownership of our common stock could allow these shareholders to delay, deter or prevent a third party from acquiring control of us at a premium over the then-current market price of our common stock, which could result in a decrease in our stock price.

Both Biogen Idec and Elan have sold shares of our common stock and may continue to do so. Sales of significant value of stock by these investors may introduce increased volatility to the market price of our common stock. In accordance with the termination agreement that we entered into with Elan in March 2004, Elan is only permitted to sell quantities of our stock equal to 175% of the volume limitation set forth in Rule 144(e)(1) promulgated under the Securities Act of 1933, as amended, subject to certain exceptions.

Market fluctuations or volatility could cause the market price of our common stock to decline and limit our ability to raise capital.

The stock market in general and the market for biotechnology-related companies in particular have experienced extreme price and volume fluctuations, often unrelated to the operating performance of the affected companies. The market price of the securities of biotechnology companies, particularly companies such as ours without earnings and product revenue, has been highly volatile and is likely to remain so in the future. Any report of clinical trial results that are below the expectations of financial analysts or investors could result in a decline in our stock price. We believe that in the past, similar levels of volatility have contributed to the decline in the market price of our common stock, and may do so again in the future. Trading volumes of our common stock can increase dramatically, resulting in a volatile market price for our common stock. The trading price of our common stock could decline significantly as a result of sales of a substantial number of shares of our common stock, or the perception that significant sales could occur. In addition, the sale of significant quantities of stock by Elan, Biogen Idec or other holders of significant amounts of shares of our stock, could adversely impact the price of our common stock.

Item 2. Properties.

We lease approximately 42,000 square feet of laboratory, manufacturing and office space in two buildings in Seattle, Washington. The lease on our primary laboratory, manufacturing and office space (representing 37,000 square feet) expires in April 2009 and has one option to renew for an additional five-year period. In the second quarter of 2006, we amended the lease on our administrative office space to reduce our square footage to 5,000 square feet three years before the end of the original lease term. As a result the lease on our administrative space expires in March 2014 and has one option to renew for an additional five-year period. We believe that our Seattle facilities are sufficient to support our research, manufacturing and administrative needs under our current operating plan.

We also lease approximately 76,000 square feet of space in Bothell, Washington, intended for future large-scale manufacturing of our products. The lease on this facility expires in September 2015 and includes an option for us to extend its term for one additional five-year period. While preliminary design activities have been completed, we have never occupied this facility and do not currently plan to commence the construction of this facility unless and until product demands warrant resumption of construction activities. As a result, we are trying to sublease all or part of the facility. Any decision to resume use of the facility will be based on a number of factors, including the progress of our product candidates in clinical development, the estimated duration of facility design and construction, the estimated timing of product manufacturing requirements, the ability of our current manufacturing capabilities to meet demand, and the availability of financial resources.



22



Item 3. Legal Proceedings.

We are not a party to any material legal proceedings.

Item 4. Submission of Matters to a Vote of Security Holders.

No matters were submitted to a vote of our security holders during the fourth quarter of 2006.



23



PART II

Item 5. Market for Registrant’s Common Equity, Related Shareholder Matters and Issuer Purchases of Equity Securities.

Market Information. Our common currently stock trades on the NASDAQ Capital Market under the symbol TGEN. From May 20, 1994 until January 8, 2003, our common stock was traded on the NASDAQ National Market (now known as the NASDAQ Global Market) under the symbol TGEN.

The following table lists, for each calendar quarter indicated, the high and low bid quotations for our common stock, as quoted on the NASDAQ Capital Market. These quotes reflect inter-dealer prices, without retail mark-up or commission, and may not necessarily represent actual transactions. This historical stock price information has been adjusted to reflect our 1-for-10 reverse stock split, which was effected on May 11, 2006.

  

High

 

Low

 

       

 

       

 

2006:

      

4th Quarter

 

$

7.16

 

$  

1.77

3rd Quarter

  

2.40

  

1.71

2nd Quarter

  

4.70

  

1.77

1st Quarter

  

6.30

  

3.90

2005:

      

4th Quarter

 

$

7.20

 

$

4.80

3rd Quarter

  

9.20

  

6.00

2nd Quarter

  

12.50

  

5.00

1st Quarter

  

19.00

  

4.00

The last reported bid quotation for our common stock, as quoted on the NASDAQ Capital Market on March 16, 2007 was $2.79 per share.

Holders. As of March 16, 2007, we had 359 shareholders of record and approximately 18,000 beneficial holders of our common stock.

Dividends. We have never paid cash dividends and do not anticipate paying them in the foreseeable future. In addition, our loan agreement with Biogen Idec restricts the amount of cash dividends we could pay.

Recent Sales of Unregistered Securities. On June 21, 2006, we issued 20,000 shares of common stock to Needham & Company, LLC in lieu of cash payments for expenses and fees, and the issuance of warrants. The compensation due to Needham was in connection with our engagement of Needham and the referral of one of the investors in our registered offering in March 2006 from Needham. We received a release of any claims Needham may have had against us as consideration for the shares. The securities were issued under Section 4(2) of the Securities Act of 1933, as amended, to an institutional investor.

On July 10, 2006, we issued 25,000 shares of common stock to the International AIDS Vaccine Initiative as part of the consideration for the Collaboration and License Agreement, dated January 1, 2005, by and among the International AIDS Vaccine Initiative, Children’s Research Institute, The Children’s Hospital of Philadelphia, and the Company. The securities were issued under Section 4(2) of the Securities Act of 1933, as amended, to an accredited investor.

On November 7, 2006, we issued 1,000,000 shares of common stock to Biogen Idec as part of the consideration for Amendment Number 2 to the Funding Agreement, dated November 7, 2006. The securities were issued under Section 4(2) of the Securities Act of 1933, as amended, to an accredited investor.

Performance Graph. The following graph shows a comparison of cumulative total shareholder return for Targeted Genetics, the NASDAQ Composite Index, and the NASDAQ Biotechnology Index, or NBI. The graph shows the value, as of December 31, 2006, of $100 invested on December 31, 2001 in our common stock, the NASDAQ Composite Index, and the NASDAQ Biotechnology Index.



24




The information contained in the performance graph shall not be deemed to be “soliciting material” or to be “filed” with the SEC, and such information shall not be incorporated by reference into any future filing under the Securities Act or Exchange Act, except to the extent that we specifically incorporate it by reference into such filing.

Item 6. Selected Financial Data.

The selected consolidated financial data set forth below at December 31, 2006 and 2005, and for the fiscal years ended December 31, 2006, 2005 and 2004, are derived from our audited consolidated financial statements included elsewhere in this report. This information should be read in conjunction with those consolidated financial statements, the notes thereto, and with “Management’s Discussion and Analysis of Financial Condition and Results of Operations.” The selected consolidated financial data set forth below at December, 2004, 2003 and 2002, and for the years ended December 31, 2003 and 2002, are derived from our audited consolidated financial statements that are contained in reports previously filed with the SEC, not included herein. All share and per share information herein (including shares outstanding and earnings per share) reflect the retroactive adjustment for a one-for-ten reverse stock split we implemented in May 2006.

 

 

Year Ended December 31,

 

 

   

2006
(1)(4)(5)

   

2005
(1)

   

2004
(1)(2)

   

2003
(1)

   

2002
(1)

 

Statement of Operations Data

 

 

 

 

 

 

 

 

 

 

 

Revenue

 

$

9,864,000

 

$

6,874,000

 

$

9,652,000

 

$

14,073,000

 

$

19,333,000

 

Operating expenses

 

 

46,593,000

 

 

26,221,000

 

 

24,822,000

 

 

27,877,000

 

 

42,074,000

 

Loss from operations

 

 

(36,729,000

)

 

(19,347,000

)

 

(15,170,000

)

 

(13,804,000

)

 

(22,741,000

)

Net loss applicable to common stock

 

$

(33,990,000

)

$

(19,198,000

)

$

(14,257,000

)

$

(14,833,000

)

$

(23,767,000

)

Net loss per basic and diluted common share

 

$

(3.47

)

$

(2.24

)

$

(1.79

)

$

(2.58

)

$

(5.19

)

Shares used in computing basic and diluted net loss per common share

 

 

9,788,000

 

 

8,564,000

 

 

7,945,000

 

 

5,749,000

 

 

4,577,000

 

 

 

 

December 31,

 

 

     

2006

     

2005

     

2004

     

2003

    

2002

 

Balance Sheet Data

 

 

 

 

 

 

 

 

 

 

 

Cash and cash equivalents

 

$

6,206,000

 

$

14,122,000

 

$

34,096,000

 

$

21,057,000

 

$

12,606,000

 

Total assets

 

 

17,467,000

 

 

48,798,000

 

 

69,965,000

 

 

57,672,000

 

 

52,713,000

 

Long-term obligations

 

 

570,000

 

 

8,177,000

 

 

10,182,000

 

 

11,227,000

 

 

20,494,000

 

Preferred stock(3)

 

 

 

 

 

 

 

 

12,015,000

 

 

12,015,000

 

Total shareholders’ equity

 

 

5,367,000

 

 

30,571,000

 

 

49,762,000

 

 

33,479,000

 

 

5,896,000

 

——————

(1)

Operating expenses include restructure charges of $2.0 million in 2006, $1.7 million in 2005, $884,000 in 2004, $5.2 million in 2003, and $2.3 million in 2002. See Note 4 of the notes to our consolidated financial statements.

(2)

Results reflect a $1.0 million gain on the sale of a majority-owned subsidiary in July 2004. See Note 7 of the notes to our consolidated financial statements.



25



(3)

As a result of the expiration of an exchange right of the holder in April 2003, we reclassified the Series B preferred stock from mezzanine equity to shareholders’ equity. The Series B preferred stock was converted by the holder into common stock in March 2004.

(4)

Operating expenses include a goodwill impairment charge of $23.7 million in 2006. See Note 8 of the notes to our consolidated financial statements.

(5)

Reflects a November 2006 $2.6 million gain on the restructuring of our Biogen Idec debt. See Note 5 of the notes to our consolidated financial statements.

Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations.

Overview

Targeted Genetics Corporation is a clinical-stage therapeutic biotechnology company. We are at the forefront of developing, with the goal of commercializing, a new class of therapeutic products called gene therapeutics. We believe that a wide range of diseases may potentially be treated or prevented with gene therapeutics. In addition to treating diseases that have not had treatments in the past, we believe that there is also a significant opportunity to use gene therapeutics to more effectively treat diseases that are currently treated using other therapeutic classes of drugs such as protein-based drugs, monoclonal antibodies, or small molecule drugs.

Gene therapeutics consist of a delivery vehicle, called a vector, and genetic material. The role of the vector is to carry the genetic material into a target cell. Once delivered into the cell, the gene can express or direct production of the specific proteins encoded by the gene. Gene therapeutics may be used to treat disease facilitating the normal protein production or gene regulation capabilities of cells. In addition, gene therapeutics may be used to enable cells to produce more of a certain protein or different proteins than they normally produce thereby treating a disease state. A new class of gene therapeutics currently receiving attention is RNA interference or RNAi. RNAi comprises small RNA molecules that once delivered into the cell may shut down or interfere with cellular functions. The vectors developed by us for delivery of genes may be particularly useful for the delivery of this new class of genetic therapeutics.

We have four product candidates, two of which are currently in clinical trials. Our clinical-stage candidates are aimed at inflammatory arthritis and HIV/AIDS. Our lead product candidate, tgAAC94, for the treatment of inflammatory arthritis is in Phase I/II clinical trials. Our HIV/AIDS prophylactic vaccine product candidate for the developing world, which we are developing in collaboration with IAVI, is in Phase II clinical trials. Our preclinical product candidates, all in development with collaboration partners, are aimed at congestive heart failure, Huntington’s disease and at protecting against the progression of HIV infection to AIDS in the developed world.

Most of our expenses are related to the development of our research and development programs, the conduct of preclinical studies and clinical trials and general and administrative support for these activities. We have financed the company primarily through proceeds from public and private sales of our equity securities, through cash payments received from our collaborative partners for product development and manufacturing activities and through proceeds from the issuance of debt and loan funding under equipment financing arrangements. On January 11, 2007, we sold 2.2 million shares of our common stock in a private placement at a price of $4.00 per share and received net proceeds of approximately $8.1 million. In addition, in connection with the financing we issued warrants to purchase up to 763,000 shares of our common stock.

As of December 31, 2006, our accumulated deficit totaled $284.0 million. We expect to generate substantial additional losses for the foreseeable future, primarily due to the costs associated with funding our inflammatory arthritis clinical development program, developing and maintaining our manufacturing capabilities and developing our intellectual property assets.

We will require access to significantly higher amounts of capital than we currently have in order to successfully develop our lead inflammatory arthritis product candidate or our partnered product candidates. We may be unable to obtain required funding when needed or on acceptable terms, obtain or maintain corporate partnerships or complete acquisition transactions necessary or desirable to complete the development of our product candidates.



26



Critical Accounting Policies, Estimates and Assumptions

Our discussion and analysis of our financial condition and results of operations is based upon financial statements that we have prepared in accordance with accounting principles generally accepted in the United States. As we prepare our financial statements we are required to make estimates and judgments that affect the reported amounts of assets, liabilities, revenues and expenses, and related disclosures. On an on-going basis, we evaluate these estimates, including those related to revenue, accrued restructure charges, goodwill and stock-based compensation. Estimates are based on historical experience, information received from third parties and on various other assumptions that are believed to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Our actual results may differ from these estimates under different assumptions or conditions. Note 1 of the notes to our consolidated financial statements, “Description of Business and Summary of Significant Accounting Policies,” summarizes our significant accounting policies that we believe are critical to the presentation of our consolidated financial statements. Our most critical accounting policies, estimates and assumptions are:

Revenue Recognition Policy

We generate revenue from technology licenses, collaborative research arrangements and agreements to provide research, development and manufacturing services. Revenue under technology licenses and collaborative agreements typically consists of nonrefundable, up-front license fees, collaborative research funding, technology access fees and various other payments. We initially defer revenue from nonrefundable, up-front license fees and technology access payments and then recognize it systematically over the service period of the collaborative agreement, which is often the development period. We recognize revenue associated with performance milestones as earned, typically based upon the achievement of the specific milestones defined in the applicable agreements or ratably amortized over the remaining contract period. We recognize revenue under research and development contracts as the related costs are incurred. When contracts include multiple elements, we follow the Emerging Issues Task Force, or EITF, Issue No. 00-21, “Revenue Arrangements with Multiple Deliverables”, which requires us to satisfy the following before revenue can be recognized: 1) the delivered items have value to the customer on a stand-alone basis, 2) any undelivered items to have objective and reliable evidence of fair value of the undelivered items, and 3) delivery or performance to be probable and within our control for any delivered items that have a right of return. We have determined that for these contracts the manufacturing and the research and development activities can be accounted for as separate units of accounting and we allocate the revenue to each unit based on relative fair value. We classify advance payments received in excess of amounts earned as deferred revenue.

Estimated Restructuring Charges Associated with the Bothell Facility

We have adopted the provisions of Statement of Financial Accounting Standards No. 146, or SFAS No. 146, “Accounting for Costs Associated with Exit or Disposal Activities,” as it relates to our facility in Bothell, Washington and our former facility in Sharon Hill, Pennsylvania and we have recorded restructure charges on the related operating leases. Accrued restructuring charges, and in particular, those charges associated with exiting a facility, are subject to many assumptions and estimates. Under SFAS No. 146, an accrued liability for lease termination costs is initially measured at fair value, based on the remaining lease payments due under the lease and other costs, reduced by sublease rental income that could be reasonably obtained from the property, and discounted using a credit-adjusted risk-free interest rate.

Our assumptions of estimated sublease rental income and the period of time and concessions that we estimate will be necessary to enter into a sublease can significantly impact the accrual and may differ from what actually occurs. We periodically evaluate these restructuring estimates and assumptions and record additional restructure charges as necessary to reflect current market conditions and delays in subleasing the Bothell facility. Changes to our restructuring estimates and assumptions can be material. For example in 2006, we updated our estimates of the cost and anticipated sublease income as well as extended the expected lead time for subleasing the facility. These updates resulted in additional restructure charges of $860,000. As a result of periodic evaluations and updates, we have recorded $7.1 million in additional restructure charges since December 2002 when we first established a restructuring reserve for exiting the Bothell facility. We also record accretion expense based upon changes in the accrued restructure liability that results from the passage of time at an assumed discount rate of 10%. We record accretion expense as a restructuring charge, which totaled $751,000 in 2006, $577,000 in 2005 and $513,000 in 2004.



27



As indicated above the estimated lease restructuring liability includes the benefit of estimated future sublease income, net of related commission costs and lease concessions. If instead, we assumed that the facility would not be subleased before the expiration of the lease in 2015, we would have increased the lease restructuring liability by $1.3 million as of December 31, 2006.

We will continue to evaluate any additional information that may become available with respect to the estimates and assumptions as they relate to the facility, which may result in further significant charges to our results of operations. If circumstances with the lease change, or if we decide to resume use of this facility, any remaining accrued restructure charges related to the facility will be reversed. This reversal would be reflected as a reduction of restructuring expenses and reflected in the period in which use is resumed. We are unable to determine the likelihood of any future adjustments to our accrued restructuring charges.

Goodwill and Other Intangible Assets

When we purchased Genovo in 2000 we recorded intangible assets of $39.5 million on our financial statements, which represented know-how, an assembled workforce and goodwill. Between 2000 and 2002 we recognized $8.1 million of amortization of the goodwill and intangible assets and in 2002 we implemented SFAS No. 142, “Goodwill and Other Intangible Assets.” SFAS No. 142 discontinued amortization of goodwill and requires us to perform goodwill impairment tests annually or more frequently if events and changes in business conditions indicate that the carrying amount of our goodwill may not be recoverable. We assess any potential impairment using a two-step process. Since we have only one reporting unit for purposes of applying SFAS No. 142, the first step requires us to compare the fair value of our total company, as measured by market capitalization to the company’s net book value. If our fair value is greater, then no impairment is indicated. If our fair value is less then the net carrying value of our assets, then we are required to perform the second step to determine the amount, if any, of goodwill impairment. In step two, the implied fair value of goodwill is calculated and compared to its carrying amount. If the goodwill carrying amount exceeds the implied fair value, an impairment loss must be recognized equal to that excess. The implied goodwill amount is determined by allocating our fair value to all of our assets and liabilities including intangible assets such as in process research and development and developed technology as if the company had been acquired in a hypothetical business combination as of the date of the impairment test. We engaged an independent valuation firm to assist with the evaluation, including the assessment of our estimated fair value and the hypothetical purchase price allocations.

As a result of an interim goodwill impairment test performed in the second quarter of 2006, we recognized a non-cash loss on impairment of goodwill of $23.7 million based on an assessment that the implied value of goodwill was $7.9 million.

The process of evaluating the potential impairment of goodwill is subjective and requires significant judgment. In estimating our fair value, we make estimates and judgments about our future revenues and cash flows, application of a discount rate, and the potential control premium relative to the market price of our stock at the valuation date. In estimating the fair value of our net assets, including intangible assets, we make estimates and judgments relating to the fair value of specific assets and liabilities. These estimates generally involve projections of the cash flows which may be provided by specific assets such as in process research and development, completed technology and trademarks and trade names, including assumptions as to the probability of bringing drug candidates to market, the timing of product development, the market size addressed by our potential products, and the application of discount rates. Changes in these estimates could affect our conclusion as to whether an impairment has occurred and could also significantly impact the amount of impairment recorded.

Stock-Based Compensation

Prior to January 1, 2006, we had applied the intrinsic value method of accounting for stock options granted to our employees and directors under the provisions of Accounting Principles Board, or APB, Opinion No. 25, “Accounting for Stock Issued to Employees,” and related interpretations, as permitted by SFAS No. 123 “Accounting for Stock-Based Compensation.” Accordingly, in 2005 and 2004 we did not recognize any stock-based compensation expense for options granted to employees or directors because we grant all options at fair market value on the date of grant.

On January 1, 2006, we adopted SFAS No. 123R, “Share-Based Payment.” We have adopted the SFAS No. 123R fair value recognition provisions using the modified prospective transition method. Under the modified



28



prospective method, compensation expense includes: (a) compensation cost for all share-based stock options granted prior to, but not yet vested as of January 1, 2006, based on the grant-date fair value used for prior pro forma disclosures adjusted for forfeitures and (b) compensation cost for all share-based payments granted subsequent to January 1, 2006, based on the grant-date fair value estimate in accordance with the provisions of SFAS No. 123R. Results for periods prior to January 1, 2006 have not been restated. As a result of adopting SFAS No. 123R, we recorded $861,000 for the year ended December 31, 2006. This expense is classified as follows:

  

Year Ended
December 31, 2006

                                                                                                         

     

  

Research and development

 

$

465,000

General and administrative

  

396,000

Total stock-based compensation

 

$

861,000

The proforma cost of stock option compensation was $1.4 million in 2005 and $1.6 million in 2004 for which no expense was recorded as allowed under the provisions of APB Opinion No. 25. As of December 31, 2006, total unrecognized compensation cost related to unvested options was approximately $581,000, net of estimated forfeitures. We expect to recognize this compensation expense over a weighted average period of approximately 8 months.

Determining the appropriate fair value model and calculating the fair value of share-based payment awards require the input of highly subjective assumptions, including the expected life of the share-based payment awards and stock price volatility. We based our volatility and expected life estimates based on our historical data. The assumptions used in calculating the fair value of share-based payment awards represent our best estimates, but these estimates involve inherent uncertainties and the application of judgment. As a result, if factors change and we use different assumptions, our stock-based compensation expense could be materially different in the future. In addition, we are required to estimate the expected forfeiture rate and only recognize expense for those shares expected to vest. If our actual forfeiture rate is materially different from our estimate, the stock-based compensation expense could be significantly different from what we have recorded in the current period. See Note 1 of the notes to our consolidated financial statements for a further discussion on stock-based compensation.

Application of New Accounting Standards

In July 2006, the FASB issued FASB Interpretation No. 48, “Accounting for Uncertainty in Income Taxes,” or FIN 48. FIN 48 clarifies the accounting for uncertainty in income taxes recognized in an enterprise’s financial statements in accordance with FASB Statement No. 109, “Accounting for Income Taxes.” FIN 48 prescribes a recognition threshold and measurement factors for the financial statement recognition and measurement of a tax position taken or expected to be taken in a tax return. The standard is effective for fiscal years beginning after December 15, 2006 and provides guidance on classification, disclosure, and transition. We are in the process of evaluating the impact of this standard on our financial statements.

In September 2006, the FASB issued SFAS No. 157, “Fair Value Measurements,” or SFAS No. 157. SFAS No. 157 provides guidance for using fair value to measure assets and liabilities and requires expanded information about the extent to which companies measure assets and liabilities at fair value, the information used to measure fair value, and the effect of fair value measurements on earnings. The standard applies whenever other standards require (or permit) assets or liabilities to be measured at fair value. The standard does not expand the use of fair value in any new circumstances. SFAS No. 157 is effective for fiscal years beginning after November 15, 2007. We are in the process of evaluating the adoption of SFAS No. 157.

In September 2006, the Securities and Exchange Commission issued Staff Accounting Bulletin No. 108, “Considering the Effects of Prior Year Misstatements When Quantifying Misstatements in Current Year Financial Statements,” or SAB 108. SAB 108 provides guidance on how prior year misstatements should be taken into consideration when quantifying misstatements in current year financial statements for the purposes of determining whether the current year financial statements are materially misstated. SAB 108 became effective for accounting years ending after November 15, 2006. The adoption of this SAB did not have any impact on our financial statements.



29



The summary of significant accounting policies should be read in conjunction with our consolidated financial statements and related notes and the following discussion of our results of operations and liquidity and capital resources.

Results of Operations

Revenue

 

 

Year Ended December 31,

 

 

     

2006

     

2005

     

2004

 

Revenue from collaborative agreements:

 

 

 

 

 

 

 

HIV/AIDS vaccine – IAVI

 

$

2,262,000

 

$

5,588,000

 

$

8,340,000

 

HIV/AIDS vaccine – NIAID

 

 

1,548,000

 

 

 

 

 

Congestive heart failure – Celladon

 

 

4,220,000

 

 

777,000

 

 

 

Huntington’s disease – Sirna

 

 

47,000

 

 

315,000

 

 

 

Contract manufacturing revenue and other

 

 

37,000

 

 

194,000

 

 

1,312,000

 

Other revenues:

 

 

 

 

 

 

 

 

 

 

License agreements – AMT

 

 

1,750,000

 

 

 

 

 

Total revenue

 

$

9,864,000

 

$

6,874,000

 

$

9,652,000

 

Our total revenue in 2006 was $9.9 million, compared to $6.9 million in 2005. Our revenue in 2006 consists primarily of amounts we earned under our congestive heart failure collaboration with Celladon which increased to $4.2 million in 2006 from $777,000 in 2005. This increase in revenue reflects internal development efforts and the completion of two manufacturing campaigns during 2006. Our revenue in 2006 also includes $1.5 million from our NIAID-funded HIV/AIDS vaccine collaboration with CCRI and CHOP. Our research and development activity in support of this project began in the first quarter of 2006. Revenue from our IAVI collaboration decreased to $2.3 million in 2006 from $5.6 million in 2005 due to the progress of planned development activities and scheduled product manufacturing and the shift of the program toward support of clinical trials. The IAVI vaccine candidate is currently in Phase II clinical trials that are managed, monitored and funded independently by IAVI. We recognized $1.8 million in licensing revenue in 2006 from a license fee received from AMT for a non-exclusive license to certain of our AAV1 vector gene delivery system patent rights. The decrease in total revenue for 2005 compared to 2004 is the result of lower revenues earned in 2005 under our development collaboration with IAVI. Revenue recognized under this collaboration was $5.6 million in 2005 compared to $8.3 million in 2004. The decrease in 2005 revenue earned under our IAVI HIV/AIDS vaccine collaboration as compared to 2004 revenue reflects the completion of several development activities as the program progressed into the Phase I and Phase II clinical trials.

We expect that substantially all of our 2007 revenue will consist of research and development revenue from the NIAID-funded HIV/AIDS vaccine subcontract with CCRI and CHOP and our collaborations with Celladon and IAVI. We expect revenue associated with our NIAID-funded HIV/AIDS vaccine collaboration to increase substantially compared to 2006 due to product development progress and increased manufacturing activities. We expect our revenues associated with IAVI to decline in 2007 compared to 2006 and 2005 due to the continuation of the current Phase II clinical trials during 2007. We also expect our revenues associated with the Celladon collaboration to decrease due to less manufacturing activity as our work transitions towards supporting a Phase I clinical trial. Our revenue for the next several years will depend on the successful achievement of milestones in our current product development collaborations and whether we enter into any new product development collaborations, manufacturing arrangements or licenses.

Operating Expenses

Research and Development. Research and development expenses totaled $14.5 million in 2006, compared to $18.2 million in 2005. This decrease reflects lower costs related to our HIV/AIDS vaccine collaboration with IAVI preclinical development, lower indirect costs as a result of the restructuring efforts implemented in January 2006 and lower costs as a result of suspending our cystic fibrosis program in 2005. These decreases were partly offset by higher costs related to our inflammatory arthritis project during 2006 and costs of the NIAID-funded HIV/AIDS vaccine development program. The increase in research and development expenses in 2005 compared to 2004 reflects the costs associated with our programs in preclinical development, which totaled $8.1 million in 2005 as compared to $5.3 million in 2004. The increase is primarily due to the continued progress of our inflammatory arthritis program and initiation of the Celladon and Sirna collaborations in early 2005. These increases for 2005



30



compared to 2004 were offset by decreased HIV/AIDS vaccine development costs related to the IAVI collaboration as the project progresses through the clinical stages of development.

We currently expect our research and development expenses in 2007 to increase moderately as compared to 2006, as the result of increased levels of development and manufacturing activities relating to the NIAID project and higher clinical trial costs related to our rheumatoid arthritis program. Our research and development expenses fluctuate due to the timing of expenditures for the varying stages of our research, product development and clinical development programs and the availability of capital resources. We expect that our expenses will continue to fluctuate as we proceed with our current development collaboration and enter into potential new development collaborations and licensing agreements.

The following is an allocation of our total research and development expenses between our programs in clinical development and those that are in research or preclinical stages of development:

 

 

Year Ended December 31,

 

 

     

2006

     

2005

     

2004

 

Programs in clinical development:

 

 

 

 

 

 

 

Inflammatory arthritis (initiated Phase I clinical trial in March 2004)

 

$

2,888,000

 

$

2,444,000

 

$

1,771,000

 

IAVI HIV/AIDS vaccine

 

 

1,602,000

 

 

2,836,000

 

 

3,704,000

 

Cystic fibrosis(1) 

 

 

40,000

 

 

534,000

 

 

823,000

 

Indirect costs

 

 

2,823,000

 

 

4,246,000

 

 

5,660,000

 

Total programs in clinical development

 

 

7,353,000

 

 

10,060,000

 

 

11,958,000

 

Programs in research and preclinical development

 

 

7,129,000

 

 

8,139,000

 

 

5,330,000

 

Total research and development expense

 

$

14,482,000

 

$

18,199,000

 

$

17,288,000

 

——————

(1)

No longer in development.

Research and development costs attributable to programs in clinical development include the costs of salaries and benefits, clinical trial costs, outside services, materials and supplies incurred to support the clinical programs. Indirect costs allocated to clinical programs include facility and building occupancy costs, research and development administrative costs, and license and royalty payments. These costs are further allocated between clinical and preclinical programs based on relative levels of program activity. IAVI separately manages and independently funds the clinical trial costs of our AIDS vaccine program. As a result, we do not include those costs in our research and development expenses.

Costs attributed to research and preclinical programs represent our earlier-stage development activities and include research and development and preclincial costs incurred for the NIAID-funded HIV/AIDS vaccine development activities and the congestive heart failure programs as well as other programs prior to their transition into clinical trials. Research and preclinical program expense also includes costs that are not allocable to a clinical development program, such as unallocated manufacturing infrastructure costs. Because we conduct multiple research projects and utilize resources across several programs, our research and preclinical development costs are not directly assigned to individual programs.

For purposes of reimbursement from our collaboration partners, we capture the level of effort expended on a program through our project management system, which is based primarily on human resource time allocated to each program, supplemented by an allocation of indirect costs and other specifically identifiable costs, if any. As a result, the costs allocated to programs identified in the table above do not necessarily reflect the actual costs of the program.

General and Administrative. We incurred general and administrative expenses of $6.4 million in 2006 compared to $6.3 million in 2005. The increase in our general and administrative expense for 2006 reflects inclusion of stock-based compensation expense for general and administrative employees partially offset by lower payroll expenses as a result of a January 2006 restructuring. We incurred general and administrative expenses of $6.3 million in 2005 compared to $6.7 million in 2004. This decrease primarily reflects costs eliminated as a result of our July 2004 sale of CellExSys. We expect our general and administrative expenses in 2007 to increase modestly as compared to 2006, primarily as the result of increased compensation expense.



31



Restructure Charges. Accrued restructuring charges represent our best estimate of the fair value of the liability to exit the Bothell facility as determined under SFAS No. 146, “Accounting for Costs Associated with Exit or Disposal Activities,” and are computed as the fair value of the difference between the remaining lease payments due on these leases and estimated sub-lease costs and rental income. During 2006, we adjusted our liability in March and September to reflect our updated subleasing assumptions for our Bothell facility.

Restructure charges consist of the following:

 

 

Year Ended December 31,

 

 

     

2006

     

2005

    

2004

 

           

Charges related to changes in assumptions

 

$

860,000

 

$

1,132,000

 

$

371,000

 

Accretion expense

 

 

751,000

 

 

577,000

 

 

513,000

 

Employee termination and partial lease termination fee

 

 

395,000

 

 

 

 

 

Total restructuring charges

 

$

2,006,000

 

$

1,709,000

 

$

884,000

 

As of December 31, 2006, our accrued restructure was $7.4 million.

Restructure charges increased to $2.0 million for the year ended December 31, 2006, compared to $1.7 million in 2005 and $884,000 in 2004. Restructuring charges of $860,000 in 2006, $1.1 million in 2005 and $371,000 in 2004 reflect changes in our expectations regarding market conditions for the Bothell facility subleasing market.

In January 2006, we recorded a $221,000 charge related to the employee termination benefits of our restructuring efforts to realign our resources to advance our lead inflammatory arthritis product through clinical trials. In the second quarter of 2006, as a result of first quarter 2006 staff count reductions, we recorded additional restructure charges of $174,000 to reflect a lease buyout for a portion of our Seattle facility lease.

Goodwill Impairment Charge. We periodically and annually on October 1st evaluate the carrying value of our goodwill in accordance with SFAS No. 142, “Goodwill and Other Intangible Assets” and if there is evidence of an impairment in value, we reduce the carrying value of the asset. As discussed in Note 8 of the notes to our consolidated financial statements, we recognized a non-cash loss on impairment of goodwill during second quarter of 2006. As a result of a decline in our share price during June 2006, to a level which reduced market capitalization to an amount less than the fair value of the our net assets, we were required to perform an interim goodwill impairment test. As a result of this evaluation, we recognized a non-cash impairment charge of $23.7 million, which is equal to the recorded value of goodwill in excess of its implied value.

Gain on debt restructure. In November 2006, we signed an agreement to restructure $8.15 million of debt payable to Biogen Idec. Under the agreement, we exchanged $5.65 million of debt for one million shares of our common stock with a fair value of $2.9 million with Biogen Idec and recorded a $2.6 million gain on debt restructuring. Inherent in our determination of the gain on debt restructuring is an estimate of the amounts and timing of future principal and interest payments. To the extent that changes in our estimates result in increases in estimated future interest payments such costs will be accrued, however, to the extent that changes in our estimates result in decreases in estimated future interest payments such gain will be deferred until realized.

Investment Income. Our investment income decreased to $567,000 in 2006 compared to $661,000 in 2005 due to lower average cash balances during 2006 resulting in less earned interest. Our investment income was $661,000 in 2005 compared to $383,000 in 2004, as a result of higher yields on our investments during 2005 due to rising interest rates. Investment income primarily reflects interest income earned on our cash balances. In 2005, our investment income includes the net impact of a loss due to the write down of debentures from Chromos (discussed below) offset by a gain recorded when we received stock in payment of the previously written down debentures. The net affect of these two events was $1,000. See Note 7 of the notes to our consolidated financial statements for further details.

Interest Expense. Our interest expense relates to interest on outstanding loans from Biogen Idec and obligations under equipment financing arrangements that we used to finance purchases of laboratory and computer equipment, furniture and leasehold improvements. Our interest expense decreased to $411,000 in 2006 from $512,000 in 2005 due to average lower debt balances in 2006. In 2005, we made a payment of $2.5 million and in November 2006 we restructured the note to exchange $5.65 million of the balance and made a $500,000 payment. Interest expense increased to $512,000 in 2005 from $476,000 in 2004. The increase in 2005 is due to rising interest rates, which increased the interest due on the Biogen Idec note payable. As a result of the restructuring of the Biogen Idec debt,



32



the carrying value of the remaining debt includes the related estimated future interest payments and accordingly, we do not expect to record future interest charges on this restructured debt.

Gain on sale of majority-owned subsidiary. In 2004, Chromos Molecular Systems, Inc., or Chromos, acquired all of the outstanding shares of our majority-owned subsidiary, CellExSys, through a merger between CellExSys and Chromos Inc., a wholly-owned subsidiary of Chromos. Under the terms of the merger agreement, Chromos issued CellExSys shareholders 1,500,000 shares of Chromos common stock and a secured convertible debenture totaling approximately $3.4 million Canadian (approximately $2.5 million at the time of close). As a result, we recorded a gain of $1.0 million representing the deposits received from Chromos to fund pre-closing operating costs, the fair value of our share of the stock and debenture received and the net liabilities assumed by Chromos.

Liquidity and Capital Resources

We had cash and cash equivalents balances of $6.2 million at December 31, 2006, as compared to $14.1 million at December 31, 2005 and $34.1 million at December 31, 2004. Our cash and cash equivalents decreased in 2006 primarily reflecting our net loss and the resulting cash used in operations of $11.6 million partially offset by the net proceeds of $4.8 million from our March 2006 sale of our common stock. Our cash and cash equivalents decreased in 2005 primarily reflecting our net loss and the resulting cash used in operations of $16.4 million and an early loan repayment to Biogen Idec of $2.5 million.

Our primary sources of capital are from public and private sales of our equity securities, through cash payments received from our collaborative partners and proceeds from the issuance of debt. To a lesser degree, we have also financed our operations through interest earned on our cash and loan funding under equipment leasing agreements and research grants. Our primary expenses are related to the development of our research and development programs, the conduct of preclinical studies and clinical trials and general and administrative support for these activities.

Substantially all of our revenue has been derived under collaborative research and development agreements relating to the development of our potential product candidates. We do not expect the revenue generated from our current or future collaborative research and development arrangement to be sufficient to fully fund the development and commercialization of our product candidates. As a result, we do not expect to generate ongoing positive cash flow from our operations for the foreseeable future and our ability to generate any sustained positive cash flow is dependent upon our success at developing and commercializing our product candidates.

We will require substantial additional financial resources to fund development and commercialization of our lead product candidate in inflammatory arthritis.

We are currently focusing our development funding on our inflammatory arthritis product candidate which is in Phase I/II clinical trials. During 2006, we spent approximately $2.9 million on this program in outside costs and allocated staff costs to support research and development activities and clinical trial costs, and we expect to spend approximately $3 million to $4 million in 2007 on this program, largely for clinical trial expenses. We currently fund all costs of this program from our working capital and expect to do so for the foreseeable future, although our strategy is to ultimately seek a partner to fund later-stage development of this program.

Our operating cash flows are primarily influenced by our losses from operations, net of the effect of non-cash items such as stock-based compensation, depreciation and amortization of our property and equipment, accounts receivable, deferred revenue and restructuring activity. Depreciation and amortization charges for 2006 were $720,000 million, which were down from $1.3 million in 2005 and 2004. The decrease in 2006 as compared to 2005 and 2004 primarily reflects lower depreciation on lab equipment. Stock compensation expense was $861,000 for 2006 compared to no expense in 2005 and 2004 due to the implementation of FASB 123R beginning January 1, 2006. Accounts receivable was higher in 2006 than previous years due to the timing of cash received and significant billings in the fourth quarter of 2006. Deferred revenue activity in 2006 and 2005 compared to 2004 reflects changes in the levels of pre-funded work under our collaborative agreements. Increases in our restructure reserve, offset by payments of rent for our Bothell facility resulted in net increases in reserves of $228,000 in 2006 and $802,000 in 2005. In 2004, rent payments were partially offset by charges, which resulted in a net decrease of $523,000.

Our cash used financing activities in 2006 included $1.2 million of loan repayments including $1.0 million to Biogen Idec and $155,000 to financing companies in payment of our obligations under equipment financing arrangements. This compares to $3.0 million of loan repayments including $2.5 million to Biogen Idec and $499,000 of equipment financing payments in 2005 and $866,000 of equipment financing payments in 2004.



33



Sales of the shares of our common stock contributed significantly to our cash flows from investing activities in both 2006 and in 2004. Our financial results in 2006 include approximately $4.8 million of net proceeds as a result of the sale of 1.3 million shares of our common stock and our financial results in 2004 include approximately $29.8 million of net proceeds as a result of the sale of 1.5 million shares of our common stock.

On January 11, 2007, we sold 2.2 million shares of our common stock in a private placement at a price of $4.00 per share and received net proceeds of approximately $8.1 million. In addition, in connection with the financing we issued warrants to purchase up to 763,000 shares of our common stock. On March 10, 2006, we sold 1.3 million shares of our common stock in a public offering at a price of $3.90 per share and received net proceeds of approximately $4.8 million. We intend to continue to seek appropriate opportunities to access the public and private capital markets, however, our ability to issue equity securities at the current market price will likely be adversely affected by the fact that we are presently ineligible under SEC rules to utilize Form S-3 for primary offerings of our securities because the aggregate market value of our outstanding common stock held by non-affiliates is less than $75 million.

Our near-term financing strategy includes leveraging our development capabilities and intellectual property assets into additional capital raising opportunities, advancing our clinical development programs and accessing the public and private capital markets at appropriate times.

Our development collaborations have typically provided us with funding in several forms, including purchases of our equity securities, loans, payments for reimbursement of research and development costs and milestone fees and payments. We and our partners typically agree on a target disease and create a development plan for the product candidate, which generally extends for multiple one-year terms and is subject to termination or extension. For example, when the IAVI collaboration was initiated in 2000, it originally had a three-year term yet the work plan was established and funded on an annual basis. In 2004, we and IAVI agreed to extend the underlying program through the end of 2006 and in 2006 the program was further extended until the expiration of the term of the last patent within the patent rights controlled by us and utilized in the IAVI vaccine. In 2005, we announced that we extended the scope of our HIV/AIDS vaccine program activities, primarily to the developed world, via the NIAID-funded collaboration with CCRI and CHOP. During 2006, we received $838,000 under this collaboration and our portion of the funding could be up to an additional $17.4 million over the remaining four years of the contract. The funding is awarded to us in annual installments based on an approved work plan and achievement of milestones. The funding from each of our collaborative partners fully offsets our incremental program costs from each collaboration and also partially funds development of our company-funded inflammatory arthritis product candidate and our overhead and fixed costs. Our revenue from collaborative agreements and licenses revenues totaled $9.9 million in 2006, $6.9 million in 2005 and $9.7 million in 2004 and assuming that we complete all of the planned development activities for each of these funded projects, we expect to earn revenue from our collaborative partners of up to $10 million in 2007.

Each of our collaborations has provisions that allow our partners the right to terminate the underlying collaboration and the obligation to provide research funding at any time with as little as 90 days notice. If we were to lose the collaborative funding expected from the NIAID, Celladon or IAVI collaborations and were unable to obtain alternative sources of funding, we would be unable to continue our research and development program for that product candidate and our cash horizon would be shortened.

In addition to the funding necessary to advance our product development and fund our ongoing operating costs, we also have significant outstanding debt, lease commitments and long-term obligations which draw on our cash resources. The following table presents our contractual commitments:

 

 

Payments Due through Year Ended December 31:

 

Contractual Obligations

   

2007

   

2008

   

2009

   

2010

   

2011

   

Thereafter

   

Total

 

                       

Long-term debt obligations

 

$

1,000,000

 

$

525,000

 

$

 

$

 

$

 

$

 

$

1,525,000

 

Interest related to long-term debt obligations

 

 

103,000

 

 

45,000

 

 

 

 

 

 

 

 

 

 

148,000

 

Equipment financing obligations

 

 

26,000

 

 

1,000

 

 

 

 

 

 

 

 

 

 

27,000

 

Interest related to equipment financing obligations

 

 

1,000

 

 

 

 

 

 

 

 

 

 

 

 

1,000

 

Operating lease obligations:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Seattle facilities – occupied

 

 

754,000

 

 

758,000

 

 

276,000

 

 

115,000

 

 

115,000

 

 

258,000

 

 

2,276,000

 

Bothell facility – not occupied

 

 

1,362,000

 

 

1,362,000

 

 

1,362,000

 

 

1,431,000

 

 

1,636,000

 

 

6,134,000

 

 

13,287,000

 

Purchase obligations

 

 

1,585,000

 

 

 

 

 

 

 

 

 

 

 

 

1,585,000

 

Total

 

$

4,831,000

 

$

2,691,000

 

$

1,638,000

 

$

1,546,000

 

$

1,751,000

 

$

6,392,000

 

$

18,849,000

 



34






In 2001, we borrowed $10 million from Biogen Idec to fund our general operations. This note was originally due in August 2006. In 2005, we restructured the repayment of this $10 million of debt and a separate $650,000 loan owed to Biogen Idec we incurred as part of our acquisition of Genovo. Under the amended terms of these loans, we paid $2.5 million of the outstanding debt in 2005 and agreed to make additional payments of $2.5 million in each of August 2007, 2008 and 2009. In addition, we agreed to repay the $650,000 loan in August 2007. Further as part of the September 2005 restructuring agreement, we agreed to apply one-third of certain up-front or milestone payments received from potential corporate collaborations to repayment of the outstanding debt, first to the payment of any accrued and unpaid interest on the principal being repaid, and second to the payment of outstanding principal in reverse order of maturity.

In November 2006, we signed an agreement to further restructure the remaining $8.15 million of debt payable to Biogen Idec. Under the agreement, Biogen Idec agreed to exchange $5.65 million of debt for million shares of our common stock with a fair value of $2.9 million and we agreed to immediately pay $500,000 of the remaining debt. The remaining $2.0 million principal balance bears interest at the rate of LIBOR plus 1% and we agreed to re-pay it in two equal installments of $1.0 million each on August 1, 2007 and August 1, 2008. In addition, the agreement provides for early repayment of the 2007 installment within thirty days of a change in control of the Company. Several of the provisions of the modified loan agreement entered into in 2005 continue including the requirement to apply one-third of certain up-front payments received from potential future corporate collaborations to the outstanding balance on this loan payable. According to SFAS No. 15, “Accounting by Debtors and Creditors of Troubled Debt Restructurings,” we accounted for this transaction as a troubled debt restructuring which resulted in a gain on debt restructuring of $2.6 million. We calculated the gain as the difference between the original principal and interest payments due on the Biogen Idec debt as compared to the cash payments made, the fair value of the common stock issued in the debt restructuring and the remaining principal and interest payments due. We recorded the loan as the $2.0 million principal amount plus the total estimated future interest payments of $167,000.

In December 2006, we made a $583,000 advance payment to Biogen Idec in accordance with the terms of the note which requires one-third of certain up-front payments received from potential future collaborators to be applied toward the outstanding loan balance. The receipt of a $1.75 million license fee from AMT triggered this payment which, according to the agreement, was applied first to interest owed through the payment date and then to the long term portion of the note. As a result of this payment, our loan balance obligation is $1.7 million as of December 31, 2006.

Operating lease obligations represent our commitments for our facilities in Seattle and Bothell, Washington. Lease payments for our laboratory, manufacturing and office space facilities in Seattle will total $2.3 million between January 1, 2007 and the end of the lease in 2014. Lease payments on the Bothell facility will total $13.3 million between January 1, 2007 and the end of the lease in 2015. We are pursuing efforts to sublease or otherwise reduce the costs of our Bothell facility and we may seek to sublease a portion of our laboratory space in our Seattle facility. When we make leasehold improvements to our facilities, we amortize them over the shorter of the useful life of the asset or the remaining term of the lease.

Our research and development expenses fluctuate due to the timing of expenditures for the varying stages of our research, product development and clinical development programs and the availability of capital resources. Because a portion of our revenue and expense is directly tied to our research and development activities, our revenue will fluctuate in part with the level of future research and development activities. We expect that our revenue and expense will continue to fluctuate as we proceed with our current development collaborations, enter into potential new development collaborations and licensing agreements and potentially earn milestone payments.

Over the past several years, we have scaled our development activities to the level of available cash resources and financial support from collaboration partners. Research and development and general and administrative expenses decreased by approximately 15% in 2006 compared to 2005, increased by approximately 2% in 2005 compared to 2004 and are expected to increase modestly in 2007 as a result of additional clinical trial costs to support the advancement of our inflammatory arthritis program and certain incremental costs necessary to support our NIAID-funded HIV/AIDS vaccine project and our collaboration with Celladon. Assuming that our product development programs progress at the rates currently planned, we believe that our net cash requirements during 2007 will range from $13 million to $16 million. This amount is subject to change as the result of the outcome of our product development and business development initiatives and other efforts.



35



We need to raise additional capital to complete our current inflammatory arthritis clinical trial, evaluate the trial results, and assuming satisfactory results, to plan and initiate further clinical testing of our potential inflammatory arthritis product. We expect that our cash and cash equivalents at December 31, 2006, plus the funding expected from our collaborative partners to fund 2007 work activities and proceeds from the sale of shares of our common stock in January 2007, will be sufficient to fund our operations into the fourth quarter of 2007.

The audit report prepared by our independent registered public accounting firm relating to our financial statements for the year ended December 31, 2006 contains a going concern qualification as a result of our limited working capital.

Our near-term financing strategy includes leveraging our development capabilities and intellectual property assets into additional capital raising opportunities, advancing our clinical development programs and accessing the public and private capital markets at appropriate times. Our financing strategy is focused around the advancement of our two programs in clinical development, advancement of our newer development collaborations and generating value out of our other intellectual assets and capabilities. In the biotechnology industry there is a low level of success in clinical trials and our ability to raise capital depends in part on clinical trial success.

We are currently evaluating additional sources of financing that could involve one or more of the following:

·

entering into additional product development collaborations;

·

mergers and acquisitions;

·

issuing equity in the public or private markets;

·

extending or expanding our current collaborations;

·

selling or licensing our technology or product candidates;

·

borrowing under loan or equipment financing arrangements; and/or

·

issuing debt.

Additional funding may not be available to us on reasonable terms, if at all. Our ability to issue equity, and our ability to issue it at the current market price, will likely be adversely affected by the fact that we are presently ineligible under SEC rules to utilize Form S-3 for primary offerings of our securities because the aggregate market value of our outstanding common stock held by non-affiliates is less than $75 million.

If our stock price declines, we may be unable to raise additional capital. A sustained inability to raise capital could force us to go out of business. Significant declines in the price of our common stock could also impair our ability to attract and retain qualified employees, reduce the liquidity of our common stock and result in the delisting of our common stock from the NASDAQ Capital Market.

We expect the level of our future operating expenses to be driven by the needs of our product development programs, our debt obligations and our lease obligations offset by the availability of funds through equity offerings, partner-funded collaborations or other financing or business development activities. The size, scope and pace of our product development activities depend on the availability of these resources. Our future cash requirements will depend on many factors, including:

·

the rate and extent of scientific progress in our research and development programs;

·

the timing, costs and scope of, and our success in, conducting clinical trials, obtaining regulatory approvals and pursuing patent prosecutions;

·

competing technological and market developments;

·

the timing and costs of, and our success in, any product commercialization activities and facility expansions, if and as required; and

·

the existence and outcome of any litigation or administrative proceedings involving intellectual property.

Depending on our ability to successfully access additional funding, we may be forced to implement additional cost reduction measures, such as the reduction in force we implemented in January 2006. Further adjustments may include scaling back or delaying our inflammatory arthritis development program, staff reductions, scaling back our intellectual property prosecution, subleasing portions of our lab facilities, curtailing capital expenditures or reducing other operating activities. We may also be required to relinquish some rights to our technology or product candidates or grant licenses on unfavorable terms, either of which would reduce the ultimate value to us of the technology or product candidates.



36



Off-Balance Sheet Arrangements

Although we do not have any joint ventures or other similar off-balance sheet items, in the ordinary course of business we enter into agreements that require us to indemnify counterparties against third-party claims. These may include agreements with vendors and suppliers, under which we may indemnify them against claims arising from our use of their products or services; agreements with clinical investigators, under which we may indemnify them against claims arising from their use of our product candidates; real estate and equipment leases, under which we may indemnify lessors against third-party claims relating to use of their property; agreements with licensees or licensors, under which we may indemnify the licensee or licensor against claims arising from their use of our intellectual property or our use of their intellectual property; and agreements with initial purchasers and underwriters of our securities, under which we may indemnify them against claims relating to their participation in the transactions.

The nature and terms of these indemnifications vary from contract to contract and generally a maximum obligation is not stated. Because we are unable to estimate our potential obligation, and because management does not expect these indemnifications to have a material adverse effect on our consolidated financial position, results of operations or cash flows, no related liabilities are recorded at December 31, 2006 or 2005. We hold insurance policies that mitigate potential losses arising from certain indemnifications and, historically, we have not incurred significant costs related to performance under these obligations.

Impact of New Accounting Pronouncements

In July 2006, the FASB issued FASB Interpretation No. 48, “Accounting for Uncertainty in Income Taxes,” or FIN 48. FIN 48 clarifies the accounting for uncertainty in income taxes recognized in an enterprise’s financial statements in accordance with FASB Statement No. 109, “Accounting for Income Taxes.” FIN 48 prescribes a recognition threshold and measurement factors for the financial statement recognition and measurement of a tax position taken or expected to be taken in a tax return. The standard is effective for fiscal years beginning after December 15, 2006 and provides guidance on classification, disclosure, and transition. We are in the process of evaluating the impact of this standard on our financial statements.

In September 2006, the FASB issued SFAS No. 157, “Fair Value Measurements,” or SFAS No. 157. SFAS No. 157 provides guidance for using fair value to measure assets and liabilities and requires expanded information about the extent to which companies measure assets and liabilities at fair value, the information used to measure fair value, and the effect of fair value measurements on earnings. The standard applies whenever other standards require (or permit) assets or liabilities to be measured at fair value. The standard does not expand the use of fair value in any new circumstances. SFAS No. 157 is effective for fiscal years beginning after November 15, 2007. We are in the process of evaluating the adoption of SFAS No. 157.

In September 2006, the SEC issued Staff Accounting Bulletin No. 108, “Considering the Effects of Prior Year Misstatements When Quantifying Misstatements in Current Year Financial Statements,” or SAB 108. SAB 108 provides guidance on how prior year misstatements should be taken into consideration when quantifying misstatements in current year financial statements for the purposes of determining whether the current years financial statements are materially misstated. SAB 108 became effective for accounting years ending after November 15, 2006. The adoption of this SAB did not have any impact on our financial statements.

Item 7A. Quantitative and Qualitative Disclosures About Market Risk.

Items with interest rate risk:

·

Short term investments: Because of the short-term nature of our investments, we believe that our exposure to market rate fluctuations on our investments is minimal. Currently, we do not use any derivative or other financial instruments or derivative commodity instruments to hedge any market risks and do not plan to employ these instruments in the future. At December 31, 2006, we held $6.2 million in cash and cash equivalents, which are invested in money market funds and denominated in U.S. dollars. An analysis of the impact on these securities of a hypothetical 10% change in short-term interest rates from those in effect at December 31, 2006, indicates that such a change in interest rates would not have a significant impact on our financial position or on our expected results of operations in 2007.



37



·

Notes payable: Our results of operations are affected by changes in short-term interest rates as a result of a loan from Biogen Idec that contains a variable interest rate. Interest payments on this loan are established quarterly based upon LIBOR, plus 1%. In connection with the restructuring of this debt, as of December 31, 2006, we accrued $167,000 for the related estimated remaining future interest payments on the promissory note at a rate of 6.33%. Changes in market interest rates and the timing of remaining interest payments may ultimately result in adjustments to the gain on debt restructuring we recognized in 2006. The carrying amount of the note payable approximates fair value because the interest rate on this instrument changes with, or approximates, market rates. The following table provides information as of December 31, 2006, about our obligations that are sensitive to changes in interest rate fluctuations:

 

 

Expected Maturity Date

 

 

     

2007

     

2008

     

2009

     

2010

     

2011

     

Total

 

                    

Variable rate note (principal only)

 

$

1,000,000

 

$

525,000

 

$

 

$

 

$

 

$

1,525,000

 

Items with market and foreign currency exchange risk:

·

Investment in Chromos Molecular Systems, Inc.: At December 31, 2006, we held 2.5 million shares of Chromos Molecular Systems, Chromos, common stock with a market value of $0.15 per common share denominated in Canadian dollars. As of December 31, 2006, the Canadian to US exchange rate was US $0.8581 per CA $1.00. As of December 31, 2006, the investment is recorded at $317,000 with a $39,000 unrealized loss and is classified within prepaid expenses and other. We hold these shares of common stock as available-for-sale securities as we periodically sell them on the Toronto Stock Exchange. As a result of selling 280,000 shares of Chromos stock in 2006, we recorded $8,000 of net realized losses and received $49,000 in cash. The amount of potential realizable value in this investment will be determined by the market, the exchange rate between the Canadian and US dollar and our ability to sell the shares in the open market.



38



Item 8. Financial Statements and Supplementary Data.

  

Page

 

     

           

Report of Independent Registered Public Accounting Firm

 

40

Consolidated Balance Sheets as of December 31, 2006 and 2005

 

41

Consolidated Statements of Operations for the years ended December 31, 2006, 2005 and 2004

 

42

Consolidated Statements of Preferred Stock and Shareholders’ Equity for the years ended December 31, 2006, 2005 and 2004

 

43

Consolidated Statements of Cash Flows for the years ended December 31, 2006, 2005 and 2004

 

44

Notes to Consolidated Financial Statements

 

45



39



REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM

The Board of Directors and Shareholders of Targeted Genetics Corporation

We have audited the accompanying consolidated balance sheets of Targeted Genetics Corporation as of December 31, 2006 and 2005, and the related consolidated statements of operations, preferred stock and shareholders’ equity, and cash flows for each of the three years in the period ended December 31, 2006. These financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on these financial statements 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. We were not engaged to perform an audit of the Company’s internal control over financial statement reporting. Our audit included consideration of internal control over financial reporting as a basis for designing audit procedures that are appropriate in the circumstances, but not for the purpose of expressing an opinion on the effectiveness of the Company’s internal control over financial reporting. Accordingly, we express no such opinion. An audit also includes examining, on a test basis, evidence supporting the amounts and disclosures in the financial statements, assessing the accounting principles used and significant estimates made by management, and evaluating the overall financial statement presentation. We believe that our audits provide a reasonable basis for our opinion.

In our opinion, the financial statements referred to above present fairly, in all material respects, the consolidated financial position of Targeted Genetics Corporation at December 31, 2006 and 2005, and the consolidated results of its operations and its cash flows for each of the three years in the period ended December 31, 2006, in conformity with U.S. generally accepted accounting principles.

The accompanying financial statements have been prepared assuming that the Company will continue as a going concern. As more fully described in Note 2 to the consolidated financial statements, the Company has incurred recurring losses and negative cash flows from operations that, due to its limited working capital, raise substantial doubt about its ability to continue as a going concern. Management's plans in regard to these matters are also described in Note 2. The financial statements do not include any adjustments to reflect the possible future effects on the recoverability and classification of assets or the amounts and classification of liabilities that may result from the outcome of this uncertainty.

As discussed in Note 10 to the consolidated financial statements, in 2006 the Company changed its method of accounting for stock-based compensation upon the adoption of Statement of Financial Accounting Standards No. 123R – “Share-Based Payment”, effective January 1, 2006.

/s/ Ernst & Young LLP

Seattle, Washington
March 28, 2007



40



TARGETED GENETICS CORPORATION

CONSOLIDATED BALANCE SHEETS

  

December 31,

 
  

2006

 

2005

 
 

     

  

     

   

ASSETS

       

Current assets:

       

Cash and cash equivalents

 

$

6,206,000

 

$

14,122,000

 

Accounts receivable

  

1,498,000

  

380,000

 

Prepaid expenses and other

  

531,000

  

683,000

 

Total current assets

  

8,235,000

  

15,185,000

 

Property and equipment, net

  

1,100,000

  

1,747,000

 

Goodwill

  

7,926,000

  

31,649,000

 

Other assets

  

206,000

  

217,000

 

Total assets

 

$

17,467,000

 

$

48,798,000

 
        

LIABILITIES AND SHAREHOLDERS’ EQUITY

       

Current liabilities:

       

Accounts payable and accrued expenses

 

$

1,901,000

 

$

1,770,000

 

Accrued employee expenses

  

861,000

  

587,000

 

Current portion of accrued restructure charges

  

1,046,000

  

1,838,000

 

Deferred revenue

  

251,000

  

278,000

 

Current portion of long-term obligations

  

1,129,000

  

155,000

 

Total current liabilities

  

5,188,000

  

4,628,000

 

Accrued restructure charges and deferred rent

  

6,342,000

  

5,422,000

 

Long-term obligations

  

570,000

  

8,177,000

 

Commitments and contingencies (Notes 2 and 6)

       

Shareholders’ equity:

       

Preferred stock, $0.01 par value, 600,000 shares authorized:
Series A preferred stock, 180,000 shares designated, none issued and outstanding

  

  

 

Common stock, $0.01 par value, 18,000,000 shares authorized, 10,921,736 shares issued and outstanding at December 31, 2006 and 8,569,424 shares issued and outstanding at December 31, 2005

  

109,000

  

86,000

 

Additional paid-in capital

  

289,324,000

  

280,543,000

 

Accumulated deficit

  

(284,027,000

)

 

(250,037,000

)

Accumulated other comprehensive loss

  

(39,000

)

 

(21,000

)

Total shareholders’ equity

  

5,367,000

  

30,571,000

 

Total liabilities and shareholders’ equity

 

$

17,467,000

 

$

48,798,000

 



See accompanying notes to consolidated financial statements

41



TARGETED GENETICS CORPORATION

CONSOLIDATED STATEMENTS OF OPERATIONS

  

Year Ended December 31,

 
  

2006

 

2005

 

2004

 
 

     

  

     

  

     

   

Revenue:

          

Collaborative revenue

 

$

8,114,000

 

$

6,874,000

 

$

9,652,000

 

Licensing revenue

  

1,750,000

  

  

 

Total revenue

  

9,864,000

  

6,874,000

  

9,652,000

 

Operating expenses:

          

Research and development

  

14,482,000

  

18,199,000

  

17,288,000

 

General and administrative

  

6,382,000

  

6,313,000

  

6,650,000

 

Restructure charges

  

2,006,000

  

1,709,000

  

884,000

 

Goodwill impairment charge

  

23,723,000

  

  

 

Total operating expenses

  

46,593,000

  

26,221,000

  

24,822,000

 

Loss from operations

  

(36,729,000

)

 

(19,347,000

)

 

(15,170,000

)

Investment income

  

567,000

  

661,000

  

383,000

 

Interest expense

  

(411,000

)

 

(512,000

)

 

(476,000

)

Gain on debt restructuring

  

2,583,000

  

  

 

Gain on sale of majority-owned subsidiary

  

  

  

1,006,000

 

Net loss

 

$

(33,990,000

)

$

(19,198,000

)

$

(14,257,000

)

Net loss per common share (basic and diluted)

 

$

(3.47

)

$

(2.24

)

$

(1.79

)

Shares used in computation of basic and diluted net loss per common share

  

9,788,000

  

8,564,000

  

7,945,000

 



See accompanying notes to consolidated financial statements

42



TARGETED GENETICS CORPORATION

CONSOLIDATED STATEMENTS OF PREFERRED STOCK
AND SHAREHOLDERS’ EQUITY

  


Series B Preferred Stock

 



Common Stock

 

Additional
Paid-In-Capital

 

Accumulated
Deficit

 

Accumulated
Other
Comprehensive
Loss

 

Total
Shareholders’
Equity

 

Shares

 

Amount

Shares

 

Amount

 

    

 

    

 

               

    

 

     

 

               

     

 

                            

    

 

                        

    

 

                            

    

 

                         

 

Balance at December 31, 2003

 

12,015

 

$

 

6,620,623

 

$

66,000

 

$

249,995,000

 

$

(216,582,000

)

$

 

$

33,479,000

 

Net loss and comprehensive loss — 2004

 

  

 

  

  

  

(14,257,000

)

 

  

(14,257,000

)

Conversion of Series B convertible preferred stock

 

(12,015

)   

 

 

433,000

  

5,000

  

(5,000

)   

 

  

  

 

Issuance of shares for cash, net of issue costs of $1,742,000

 

  

 

1,085,426

  

11,000

  

23,755,000

  

  

  

23,766,000

 

Issuance of shares for cash, net of issue costs of $28,000

 

  

 

395,413

  

4,000

  

5,968,000

  

  

  

5,972,000

 

Issuance of shares to acquire minority interest in majority-owned subsidiary

 

  

 

15,877

  

  

750,000

  

  

  

750,000

 

Exercise of stock options

 

  

 

12,294

  

  

52,000

  

  

  

52,000

 

Balance at December 31, 2004

 

 

$

 

8,562,633

 

$

86,000

 

$

280,515,000

 

$

(230,839,000

)

$

 

$

49,762,000

 

Net loss — 2005

 

  

 

  

  

  

(19,198,000

)

 

  

(19,198,000

)

Unrealized loss on available-for-sale securities

 

  

 

  

  

  

  

(21,000

)   

 

(21,000

)

Comprehensive net loss — 2005

                     

(19,219,000

)

Exercise of stock options

 

  

 

6,791

  

  

28,000

  

  

  

28,000

 

Balance at December 31, 2005

 

 

$

 

8,569,424

 

$

86,000

 

$

280,543,000

 

$

(250,037,000

)

$

(21,000

)

$

30,571,000

 

Net loss — 2006

 

  

 

  

  

  

(33, 990,000

)

 

  

(33,990,000

)

Unrealized loss on available-for-sale securities

                  

(18,000

)

 

(18,000

)

Comprehensive net loss — 2006

 

  

 

  

  

  

  

  

(34,008,000

)

Stock-based compensation

 

  

 

  

  

861,000

  

  

  

861,000

 

Issuance of shares for cash, net of issue costs of $162,000

 

  

 

1,279,124

  

13,000

  

4,813,000

  

  

  

4,826,000

 

Issuance of shares to vendors

 

  

 

45,000

  

  

141,000

  

  

  

141,000

 

Issuance of shares in debt restructuring

 

  

 

1,000,000

  

10,000

  

2,890,000

  

  

  

2,900,000

 

Exercise of stock options

 

  

 

28,188

  

  

76,000

  

  

  

76,000

 

Balance at December 31, 2006

 

 

$

 

10,921,736

 

$

109,000

 

$

289,324,000

 

$

(284,027,000

)

$

(39,000

)

$

5,367,000

 



See accompanying notes to consolidated financial statements

43



TARGETED GENETICS CORPORATION

CONSOLIDATED STATEMENTS OF CASH FLOWS

  

Year Ended December 31,

 
  

2006

 

2005

 

2004

 
 

     

  

     

  

     

   

Operating activities:

          

Net loss

 

$

(33,990,000

)   

$

(19,198,000

)   

$

(14,257,000

)

Adjustments to reconcile net loss to net cash used in operating activities:

          

Depreciation and amortization

  

720,000

  

1,319,000

  

1,289,000

 

Non cash interest expense

  

  

27,000

  

63,000

 

Loss (gain) on sale/disposal of fixed assets

  

8,000

  

98,000

  

(51,000

)

Stock-based compensation expense

  

861,000

  

  

 

Stock issued to outside vendors

  

141,000

  

  

 

Goodwill impairment charge

  

23,723,000

  

  

 

Gain on debt restructure

  

(2,583,000

)

 

  

 

Gain on investments

  

(8,000

)

 

(1,000

)

 

 

Gain on sale of majority-owned subsidiary

  

  

  

(1,006,000

)

Changes in assets and liabilities:

          

Decrease (increase) in accounts receivable

  

(1,118,000

)

 

24,000

  

(155,000

)

Decrease (increase) in prepaid expenses and other

  

93,000

  

(107,000

)

 

104,000

 

Decrease in other assets

  

11,000

  

451,000

  

341,000

 

Increase (decrease) in current liabilities

  

405,000

  

(109,000

)

 

(193,000

)

Increase (decrease) in deferred revenue

  

(27,000

)

 

278,000

  

(1,180,000

)

Increase (decrease) in accrued restructure charges and deferred rent

  

128,000

  

827,000

  

(478,000

)

Net cash used in operating activities

  

(11,636,000

)

 

(16,391,000

)

 

(15,523,000

)

Investing activities:

          

Purchases of property and equipment

  

(81,000

)

 

(669,000

)

 

(408,000

)

Proceeds from sales of investments

  

49,000

  

57,000

  

 

Net cash used in investing activities

  

(32,000

)

 

(612,000

)

 

(408,000

)

Financing activities:

          

Net proceeds from sales of capital stock

  

4,826,000

  

  

29,738,000

 

Proceeds from the exercise of stock options

  

76,000

  

28,000

  

52,000

 

Repayment of debt

  

(995,000

)

 

(2,500,000

)

 

 

Proceeds from equipment financing arrangements

  

  

  

46,000

 

Payments under equipment financing arrangements

  

(155,000

)

 

(499,000

)

 

(866,000

)

Net cash provided by (used in) financing activities

  

3,752,000

  

(2,971,000

)

 

28,970,000

 

Net increase (decrease) in cash and cash equivalents

  

(7,916,000

)

 

(19,974,000

)

 

13,039,000

 

Cash and cash equivalents, beginning of year

  

14,122,000

  

34,096,000

  

21,057,000

 

Cash and cash equivalents, end of year

 

$

6,206,000

 

$

14,122,000

 

$

34,096,000

 

Supplemental information:

          

Cash paid for interest

 

$

550,000

 

$

441,000

 

$

413,000

 

Non-cash exchange of common stock issued in debt restructure

 

$

2,900,000

  

  

 



See accompanying notes to consolidated financial statements

44



TARGETED GENETICS CORPORATION

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

1. Description of Business and Summary of Significant Accounting Policies

Description of Business

Targeted Genetics was incorporated in the state of Washington in March 1989. We conduct research and development of gene therapy products and technologies for treating both acquired and inherited diseases. We develop these programs on our own and under various collaborative agreements with others.

Basis of Presentation

Our consolidated financial statements include the accounts of Targeted Genetics, our wholly owned subsidiaries Genovo, Inc. (inactive) and TGCF Manufacturing Corporation (inactive), and until its sale in July 2004, our majority-owned subsidiary, CellExSys, Inc., or CellExSys. All significant intercompany transactions have been eliminated in consolidation.

Reverse Stock Split

In May 2006, our Board of Directors approved a 1-for-10 reverse stock split, which became effective on May 11, 2006. All references to common stock, common shares outstanding, average number of common shares outstanding, per share amounts and options in these financial statements and notes to financial statements have been restated to reflect the 1-for-10 common stock reverse split on a retroactive basis.

Reclassifications

Certain reclassifications have been made to conform prior year classifications to the current year presentation.

Use of Estimates

The preparation of financial statements in conformity with U.S. generally accepted accounting principles requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. Our actual results may differ from those estimates.

Cash Equivalents

Cash equivalents include short-term investments that have a maturity at the time of purchase of three months or less, are readily convertible into cash and we believe have an insignificant level of valuation risk attributable to potential changes in interest rates. We record our cash equivalents at cost, which approximates fair market value, and consist primarily of money market accounts and shares in a limited-term bond fund.

Fair Value of Financial Instruments

We believe that the carrying amounts of financial instruments such as cash and cash equivalents, available-for-sale securities, accounts receivable and accounts payable approximate fair value because of the short-term nature of these items. We believe that the carrying amounts of the notes payable and equipment financing obligations approximate fair value because the interest rates on these instruments change with, or approximate, market interest rates.

Property and Equipment

Property and equipment is stated at cost less accumulated depreciation. We compute depreciation of property and equipment using the straight-line method over the asset’s estimated useful life. The useful lives of our furniture and equipment ranges from three to seven years, and our leasehold improvements are amortized over the shorter of the asset’s estimated useful life or the remainder of the lease term. Our leasehold improvements are currently being amortized over useful lives which range from four to ten years. Depreciation and amortization expense was $720,000 in 2006 and $1.3 million in 2005 and 2004. Depreciation expense includes depreciation of property and equipment acquired under capital leases.



45



TARGETED GENETICS CORPORATION

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

1. Description of Business and Summary of Significant Accounting Policies – (continued)

Prepaid Expenses and Other

Other assets consists primarily of the Chromos Inc., or Chromos, securities that we received as payment on the debenture was and as consideration for the sale of CellExSys in July 2004. In accordance with Statement of Financial Accounting Standard, or SFAS, No. 115, “Accounting for Certain Investments in Debt and Equity Securities,” these investment securities are classified as available-for-sale and reported at fair value, with unrealized gains and losses excluded from earnings and reported as accumulated other comprehensive loss within shareholders’ equity. Upon the sales of Chromos securities, realized gains and losses are computed using the difference between the sales price and the book value which is determined on a specific identification basis. We periodically evaluate the investment securities for other-than-temporary declines in value and record any losses through an adjustment to earnings.

Goodwill and Purchased Intangibles

When we purchased Genovo in 2000, we recorded intangible assets of $39.5 million on our financial statements, which represented know-how, an assembled workforce and goodwill. Between 2000 and 2002 we recognized $8.1 million of amortization of the goodwill and intangible assets and in 2002 we implemented SFAS No. 142, “Goodwill and Other Intangible Assets.” SFAS No. 142 discontinued amortization of goodwill and requires us to perform goodwill impairment tests annually or more frequently if events and changes in business conditions indicate that the carrying amount of our goodwill may not be recoverable. We assess any potential impairment using a two-step process. Since we have only one reporting unit for purposes of applying SFAS No. 142, the first step requires us to compare the fair value of our total company, as measured by market capitalization to our net book value. If our fair value is greater, then no impairment is indicated. If our fair value is less then the net carrying value of its assets, then we are required to perform the second step to determine the amount, if any, of goodwill impairment. In step two, the implied fair value of goodwill is calculated and compared to its carrying amount. If the goodwill carrying amount exceeds the implied fair value, an impairment loss must be recognized equal to that excess. The implied goodwill amount is determined by allocating our fair value to all of our assets and liabilities including intangible assets such as in process research and development and developed technology as if we had been acquired in a hypothetical business combination as of the date of the impairment test. We engaged an independent valuation firm to assist with the evaluation, including the assessment of our estimated fair value and the hypothetical purchase price allocations.

As a result of an interim goodwill impairment test performed in the second quarter of 2006, we recognized a $23.7 million non-cash loss for the impairment of goodwill based on an assessment that the implied value of goodwill was $7.9 million.

Other Assets

In accordance with SFAS No. 144, “Accounting for the Impairment or Disposal of Long-Lived Assets,” we review the carrying value and fair value of long-lived assets whenever events or changes in circumstances indicate that there may be impairment in value. Conditions that would necessitate an impairment assessment include a significant decline in the observable market value of an asset, a significant change in the extent or manner in which an asset is used, or a significant adverse change that would indicate that the carrying amount of an asset or group of assets is not recoverable.

Accrued Restructure Charges

We apply the provisions of SFAS No. 146, “Accounting for Costs Associated with Exit or Disposal Activities,” as it relates to our facilities in Bothell, Washington, our former facility in Sharon Hill, Pennsylvania, employee termination benefits and lease termination fees for facilities related to our administrative office space in Seattle. As a result, we have recorded restructuring charges on the operating leases for these facilities. Accrued restructuring charges, and in particular, those charges associated with exiting a facility, are subject to many assumptions and



46



TARGETED GENETICS CORPORATION

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

1. Description of Business and Summary of Significant Accounting Policies – (continued)

estimates. Under SFAS No. 146, an accrued liability for lease termination costs is initially measured at fair value, based on the remaining lease payments due under the lease and other costs, reduced by sublease rental income that could be reasonably obtained from the property, and discounted using a credit-adjusted risk-free interest rate. We use a risk-free annual interest rate of 10%. The assumptions as to estimated sublease rental income, the period of time to execute a sublease and the costs and concessions necessary to enter into a sublease significantly impact the accrual and may differ from what actually occurs. We review these estimates periodically and adjust the accrual when necessary.

Stock Compensation

Effective January 1, 2006, we adopted SFAS, No. 123R, “Share-Based Payment,” and elected to adopt the modified prospective application method. Accordingly, stock-based compensation cost is measured at the grant date, based on the fair value of the award and is recognized as an expense over the requisite service period. For stock awards granted in 2006, stock-based compensation expenses are recognized over the option vesting period under the straight-line attribution method. For stock awards granted prior to 2006, stock-based compensation expenses are recognized under the multiple option method prescribed by Financial Accounting Standards Board, or FASB, Interpretation No. 28. Previously reported amounts have not been restated.

Prior to January 1, 2006, we presented pro forma disclosure of stock-based compensation expense under SFAS No. 123, “Accounting for Stock-Based Compensation,” and accounted for stock options under Accounting Principles Board Opinion No. 25, “Accounting for Stock Issued to Employees,” which uses the intrinsic value method and generally results in the recognition of no compensation cost for employee stock option grants when priced at the fair value per share on the date of grant. We do not recognize any compensation expense for options granted to employees or directors because we grant all options at fair market value on the date of grant. If we had elected to recognize compensation expense based on the fair market value at the grant dates for the stock options granted, the pro forma net loss and net loss per common share would have been as follows:

  

Year Ended December 31,

 
   

2005

  

2004

 

                                                                                                                                             

     

  

     

   

Net loss:

       

As reported

 

$

(19,198,000

)

$

(14,257,000

)

Add: Stock-based compensation under SFAS 123

  

(1,372,000

)

 

(1,564,000

)

Pro forma

 

$

(20,570,000

)

$

(15,821,000

)

Basic net loss per share:

       

As reported

 

$

(2.24

)

$

(1.79

)

Pro forma

  

(2.40

)

 

(1.99

)

Revenue Recognition under Collaborative Agreements

We generate revenue from technology licenses, collaborative research arrangements and agreements to provide research, development and manufacturing services. Revenue under technology licenses and collaborative agreements typically consists of nonrefundable, up-front license fees, collaborative research funding, technology access fees and various other payments.

We initially defer revenue from nonrefundable, up-front license fees and technology access payments and then recognize it systematically over the service period of the collaborative agreement, which is often the development period. We recognize revenue associated with performance milestones as earned, typically based upon the achievement of the specific milestones defined in the applicable agreements or ratably amortized over the remaining contract period. We recognize revenue under research and development contracts as the related costs are incurred. When contracts include multiple elements we follow the Emerging Issues Task Force, or EITF, Issue No. 00-21, “Revenue Arrangements with Multiple Deliverables” which requires us to satisfy the following before revenue can be recognized: 1) the delivered items have value to the customer on a stand-alone basis, 2) any undelivered items to



47



TARGETED GENETICS CORPORATION

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

1. Description of Business and Summary of Significant Accounting Policies – (continued)

have objective and reliable evidence of fair value of the undelivered items, and 3) delivery or performance to be probable and within our control for any delivered items that have a right of return. We have determined that for these contracts the manufacturing and the research and development activities can be accounted for as separate units of accounting and we allocate the revenue to each unit based on relative fair value. We classify advance payments received in excess of amounts earned as deferred revenue.

Significant Revenue Relationships and Concentration of Risk

Our primary source of revenue is from our collaborative agreements. In 2006, revenues under our collaboration with Celladon Corporation, or Celladon, accounted for the most significant portion of our revenue, followed by revenues from our collaboration with the International AIDS Vaccine Initiative, or IAVI, and our subcontract with the National Institute of Allergy and Infections Diseases, or NIAID. During 2005 and 2004, revenues under our collaboration with IAVI, accounted for a substantial portion of our revenue. During 2005, we were named as a subcontractor to receive up to $18.2 million of a five year, $22 million NIAID contract awarded to the Columbus Children’s Research Institute, or CCRI, in collaboration with The Children’s Hospital of Philadelphia, or CHOP, and us, to develop AAV-based HIV/AIDS vaccine for use in the developed world. For 2007, we expect to earn significant revenues from these three primary collaborators: the NIAID-funded HIV/AIDS vaccine collaboration, the Celladon congestive heart failure collaboration and the IAVI HIV/AIDS vaccine collaboration. A significant change in the level of work or timing of work activities and the funding received from any of these collaborations could disrupt our business and adversely affect our cash flow and results of operations.

Research and Development Costs

Research and development costs include salaries, costs of outside collaborators and outside services, clinical trial expenses, royalty and license costs and allocated facility, occupancy and utility expenses. We expense research and development costs as incurred. Costs and expenses related to programs conducted under collaborative agreements that result in collaborative revenue totaled approximately $5.6 million in 2006, $8.2 million in 2005 and $7.1 million in 2004.

Operating Leases

We have operating leases for our laboratory, manufacturing and office space in facilities located in Seattle and Bothell, Washington. These lease agreements contain rent escalation clauses and rent holidays. For scheduled rent escalation clauses during the lease terms or for rental payments commencing at a date other than the date of initial occupancy, we record minimum rental expenses on a straight-line basis over the terms of the leases in the consolidated statement of operations. When we make leasehold improvements to our facilities, we amortize them over the shorter of the useful life of the asset or the remaining term of the lease. We currently have $409,000 of leasehold improvements related to our Seattle facilities that we are amortizing over the shorter of the useful life of the asset or the remainder of the current lease terms, which expire near the end of the first quarter of 2009 for our main laboratory, manufacturing and office facility and at the end of the first quarter of 2014 for our administrative office space.

Net Loss per Common Share

Net loss per common share is based on net loss divided by the weighted average number of common shares outstanding during the period. For each fiscal year reported our diluted net loss per share is the same as our basic net loss per share because all stock options, warrants and other potentially dilutive securities are antidilutive with respect to computing our net loss per share and therefore we exclude them from our calculation of diluted net loss per share. The total number of shares that we excluded from the calculations of net loss per share were 1,035,085 shares in 2006, 904,087 shares in 2005 and 809,305 shares in 2004.



48



TARGETED GENETICS CORPORATION

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

1. Description of Business and Summary of Significant Accounting Policies – (continued)

In the fourth quarter of 2006, we had net income. To calculate diluted net income per share we computed the weighted average number shares outstanding including common shares and potentially dilutive shares outstanding during the quarter. Potentially dilutive shares consist of common shares issuable upon conversion of the exercise of stock options using the treasury stock method.

Recently Issued Accounting Standards

In July 2006, the FASB issued FASB Interpretation No. 48, “Accounting for Uncertainty in Income Taxes,” or FIN 48. FIN 48 clarifies the accounting for uncertainty in income taxes recognized in an enterprise’s financial statements in accordance with FASB Statement No. 109, “Accounting for Income Taxes.” FIN 48 prescribes a recognition threshold and measurement factors for the financial statement recognition and measurement of a tax position taken or expected to be taken in a tax return. The standard is effective for fiscal years beginning after December 15, 2006 and provides guidance on classification, disclosure, and transition. We are in the process of evaluating the impact of this standard on our financial statements.

In September 2006, the FASB issued SFAS No. 157, “Fair Value Measurements,” or SFAS No. 157. SFAS No. 157 provides guidance for using fair value to measure assets and liabilities and requires expanded information about the extent to which companies measure assets and liabilities at fair value, the information used to measure fair value, and the effect of fair value measurements on earnings. The standard applies whenever other standards require (or permit) assets or liabilities to be measured at fair value. The standard does not expand the use of fair value in any new circumstances. SFAS No. 157 is effective for fiscal years beginning after November 15, 2007. We are in the process of evaluating the adoption of SFAS No. 157.

In September 2006, the Securities and Exchange Commission issued Staff Accounting Bulletin No. 108, “Considering the Effects of Prior Year Misstatements When Quantifying Misstatements in Current Year Financial Statements,” or SAB 108. SAB 108 provides guidance on how prior year misstatements should be taken into consideration when quantifying misstatements in current year financial statements for the purposes of determining whether the current years financial statements are materially misstated. SAB 108 became effective for accounting years ending after November 15, 2006. The adoption of this SAB did not have any impact on our financial statements.

2. Liquidity and Management’s Plans

We have prepared the accompanying financial statements on a going concern basis, which assumes that we will realize our assets and satisfy our liabilities in the normal course of business. However, we have incurred recurring net losses and negative operating cash flows since our inception. For the year ended December 31, 2006 our loss from operations, before a non-cash goodwill impairment charge, was $13.0 million and the net cash used in operating activities was $11.6 million. Our cash balance as of December 31, 2006 was $6.2 million and our accounts receivable balance was $1.5 million, while our current liabilities aggregated $5.2 million. As described in Note 14 of the notes to our consolidated financial statements, on January 11, 2007 we raised $8.1 million through the sale of shares of our common stock. However, these conditions still raise substantial doubt about our ability to continue as a going concern. The accompanying financial statements do not include any adjustments to reflect the possible future effects on the recoverability and classification of assets or the amounts and classifications of liabilities that may result from the outcome of this uncertainty.

We project 2007 net operating cash flow deficits of approximately $13 million to $16 million. This projection assumes that we complete all of the planned development activities for each of our funded projects, resulting in approximately $10 million of 2007 funding from our collaborative partners, and assumes that we achieve our current operating plan, which includes measured spending to support our self-funded inflammatory arthritis clinical trials and increases in staffing and compensation in support of partnered programs.




49



TARGETED GENETICS CORPORATION

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

2. Liquidity and Management’s Plans – (continued)

We believe that our current resources, including the capital raised in January 2007 and the cash received from our collaborative partners, are sufficient to fund our planned operations, including our clinical trials, into the fourth quarter of 2007. We intend to seek additional financing in order to fund our operations further into or through 2008; however, we can not provide assurances that we will be successful in obtaining additional financing when and as needed in the future. If we do not raise additional funds, we may be forced to preserve our cash position through a combination of cost reduction measures, sales of assets likely at values significantly below their potential worth, or the pursuit of alternative financing transactions that may likely be on terms disadvantageous to us and dilutive to our shareholders.

3. Property and Equipment

Property and equipment consisted of the following:

  

December 31,

 
  

2006

 

2005

 

                                                                                                      

     

  

     

   

Furniture and equipment

 

$

6,862,000

 

$

6,783,000

 

Leasehold improvements

  

9,256,000

  

9,756,000

 
   

16,118,000

  

16,539,000

 

Less accumulated depreciation and amortization

  

(15,018,000

)

 

(14,792,000

)

  

$

1,100,000

 

$

1,747,000

 

We finance a portion of our equipment through equipment financing arrangements, which include extensions and purchase options and require us to pledge the financed equipment as security for the financing. The cost of equipment that has been pledged under financing arrangements totaled $335,000 at December 31, 2006 and $1.0 million at December 31, 2005.

4. Restructure Charges

In 2002, we began to pursue options to sublease, or terminate, our lease on the Bothell facility and in 2003 we closed the facility in Sharon Hill, Pennsylvania that we acquired when we acquired Genovo. We record accrued restructure charges as they relate to the leases on these facilities. Accrued restructure charges represent our best estimate of the fair value of the liability remaining under the lease and are computed as the present value of the difference between the remaining lease payments due less the net of sublease income and expense. These assumptions are periodically reviewed and adjustments are made to the accrued restructure charge when necessary. We record accretion expense based upon changes in the accrued restructure liability that result from the passage of time and the assumed discount rate of 10%. Accretion expense is recorded on an ongoing basis through the end of the lease term in September 2015 and is reflected as a restructuring charge in the accompanying consolidated statements of operations.

The tables below present our total estimated restructure charges and a reconciliation of the associated liability:

  

Employee
Termination
Benefits

 

Contract
Termination
Costs

 

Other
Associated

Costs

 

Total

 

                                                                                          

     

  

     

  

     

  

     

  

  

Incurred in 2002

 

$

725,000

 

$

1,602,000

 

$

 

$

2,327,000

 

Incurred in 2003

  

5,000

  

5,153,000

  

32,000

  

5,190,000

 

Incurred in 2004

  

  

884,000

  

  

884,000

 

Incurred in 2005

  

  

1,709,000

  

  

1,709,000

 

Incurred in 2006

  

221,000

  

1,785,000

  

  

2,006,000

 

Cumulative incurred to date

  

951,000

  

11,133,000

  

32,000

  

12,116,000

 

Estimated future charges

  

  

2,992,000

  

  

2,992,000

 

Total expected to be incurred

 

$

951,000

 

$

14,125,000

 

$

32,000

 

$

15,108,000

 



50



TARGETED GENETICS CORPORATION

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

4. Restructure Charges – (continued)

  

Restructuring
Costs

 

                                                                                                                                                                        ;             

     

   

December 31, 2005 accrued liability

 

$

7,149,000

 

Charges related to changes in lease assumptions

  

860,000

 

Charges related to lease amendment

  

174,000

 

Charges related to employee termination benefits

  

221,000

 

Accretion expense

  

751,000

 

Amount paid in 2006

  

(1,778,000

)

December 31, 2006 accrued liability

 

$

7,377,000

 

During the first quarter of 2006, we recorded additional restructure charges of $639,000 as a result of updating our estimates of costs and sublease income associated with exiting the Bothell facility. As part of this assessment we extended our estimate for additional time that may be required to find a sublease tenant and adjusted downward our assumptions with respect to escalation in sublease rental income. In the third quarter of 2006 we recorded additional restructure charges of $221,000 as a result of further extending the anticipated lead time for subleasing the facility. In addition to these adjustments to the accrued restructure liability, which totaled $860,000 and decreased basic and diluted earnings per share by $0.09, we incurred $751,000 of accretion expense in 2006. The total of these charges and adjustments to the liability are reflected as restructure charges in the accompanying consolidated statement of operations.

Restructuring charges also include $221,000 of employee termination benefits recognized during the first quarter of 2006 related to the restructuring announced in January 2006 in order to reduce expenses and realign resources to advance our inflammatory arthritis product through clinical trials. This restructuring resulted in a workforce reduction of 26 employees, primarily in early-stage research and development groups and in operational and general and administrative functions.

In May 2006, we amended the lease for our administrative office space in Seattle to reduce our square footage three years before the end of the original lease term. We entered into this modification to reduce operating costs. Expenses related to the termination of the lease totaling $174,000 are included in restructuring charges in 2006.

Through December 31, 2006, we have recorded contract termination costs totaling $10.0 million for our Bothell facility. We expect to incur an additional $3.0 million in accretion expense and pay $10.4 million in rent through the expiration of the Bothell lease in September 2015. We periodically evaluate our restructuring estimates and assumptions and record additional restructure charges as necessary. Because restructure charges are estimates based upon assumptions regarding the timing and amounts of future events, significant adjustments to the accrual may be necessary in the future based on the actual outcome of events and as we become aware of new facts and circumstances. If we decide to resume use of the Bothell facility, any remaining accrued restructure charges related to the facility will be reversed. This reversal would be reflected as a reduction of restructuring expenses and reflected in the period in which use is resumed. We are unable to determine the likelihood of any future adjustments to our accrued restructuring charges. We have a $200,000 certificate of deposit recorded within other assets that is pledged as collateral for the Bothell facility lease.

5. Long-Term Obligations

Long-term obligations consisted of the following:

  

December 31,

 
  

2006

 

2005

 

                                                                                                      

     

  

     

   

Loans payable to Biogen Idec

 

$

1,672,000

 

$

8,150,000

 

Equipment financing obligations

  

27,000

  

182,000

 
   

1,699,000

  

8,332,000

 

Less current portion

  

(1,129,000

)

 

(155,000

)

  

$

570,000

 

$

8,177,000

 



51



TARGETED GENETICS CORPORATION

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

5. Long-Term Obligations – (continued)

Future aggregate principal payments related to long-term obligations are $1.0 million in 2007, $525,000 in 2008 and zero in 2009, 2010 and 2011.

As of December 31, 2006, we have a $1.7 million loan payable to Biogen Idec, a beneficial owner of approximately 19.9% of our outstanding common shares. Outstanding borrowings under this unsecured loan agreement bear interest at the one-year London Interbank Offered Rate, or LIBOR, plus 1%, which is reset quarterly. The loan contains financial covenants establishing limits on our ability to declare or pay cash dividends and it was originally scheduled to mature in August 2006. During 2001, we borrowed $10.0 million from Biogen Idec to fund our general operations under the terms of an unsecured loan agreement. We also assumed a promissory note payable to Biogen Idec in 2000 as part of our acquisition of Genovo. This promissory note had an outstanding principal amount of $650,000, bore no interest and was originally scheduled to mature in 2005.

In 2005, we modified the terms of our loans payable to Biogen Idec. In connection with these modifications, we made a $2.5 million cash payment to Biogen on September 1, 2005 to reduce the outstanding principal on the $10.0 million loan to $7.5 million and agreed to make scheduled payments of $2.5 million of principal plus accrued interest on each of August 1, 2007, 2008 and 2009. In addition, we agreed to apply one-third of certain up-front payments received from potential future corporate collaborations to the outstanding balance on this loan payable, first to repayment of any accrued and unpaid interest on the principal being repaid, and second to the repayment of outstanding principal in reverse order of maturity. In addition, the maturity date of the $650,000 promissory note to Biogen was extended until August 1, 2007.

In November 2006, we signed an agreement to further restructure the remaining $8.15 million of debt payable to Biogen Idec. Under the agreement, Biogen Idec agreed to exchange $5.65 million of debt for one million shares of our common stock with a fair value of $2.9 million and we agreed to immediately pay $500,000 of the remaining debt. The remaining $2.0 million principal balance continues to bear interest at the rate of LIBOR plus 1% and we agreed to repay the remaining balance in two equal installments of $1.0 million each on August 1, 2007 and 2008 and to accelerate repayment of the full outstanding balance within thirty days of a change in control of the Company. Several of the provisions of the modified loan agreement entered into in 2005 continue to apply including the requirement to apply one-third of certain up-front payments received from potential future corporate collaborations to the outstanding balance on this loan payable. According to SFAS No. 15, “Accounting by Debtors and Creditors of Troubled Debt Restructurings,” we accounted for this transaction as a troubled debt restructuring which resulted in a gain on debt restructuring of $2.6 million. We calculated the gain as the difference between the original principal and interest payments due on the Biogen Idec debt as compared to the cash payments made, the fair value of the common stock issued in the debt restructuring and the remaining principal and interest payments due. We recorded the loan as the $2.0 million principal amount plus the total estimated future interest payments of $167,000.

In December 2006, we made a $583,000 advance payment to Biogen Idec in accordance with the terms of the note which requires one-third of certain up-front payments received from potential future collaborators to be applied toward the outstanding loan balance. The receipt of a $1.75 million license fee from Amsterdam Molecular Therapeutics B.V., or AMT, triggered this payment which, according to the agreement, was applied first to interest owed through the payment date and then to the long term portion of the note. The potential gain from the reduction of future interest payments resulting from the acceleration of this principal payment will be deferred until it is realized.

Equipment financing obligations relate to secured financing for the purchase of capital equipment and leasehold improvements. These obligations bear interest at rates ranging from 8.13% to 8.98% and mature from March 2007 to February 2008.



52



TARGETED GENETICS CORPORATION

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

6. Commitments

We lease our laboratory, manufacturing and office facilities in Seattle, Washington under two non-cancelable operating leases. The lease on our primary laboratory, manufacturing and office space expires in April 2009 and contains an option to renew the lease for a five-year period. In May 2006, we amended the lease on our administrative office space to reduce our square footage three years before the end of the original lease term. The amendment also extended the lease term for five additional years beginning April 2009 with an option to extend for an additional five years. We lease a facility in Bothell, Washington under a non-cancelable operating lease that expires in September 2015, which was intended to accommodate future manufacturing of our product candidates. We have applied SFAS No. 146 as it relates to our Bothell facility lease and have recorded an accrued restructure liability of $7.4 million as of December 31, 2006. This accrual represents the estimated fair value of this liability based on the present value of future lease payments, net of assumed sublease payments. Future lease payments on our facility in Bothell will reduce the amount of the accrued restructure liability and are included in future minimum lease payments under non- cancelable operating leases which are as follows:

Year Ending December 31,

 

Bothell
Facility

 

Research and
Office Facility

 

Total

 

                                                                                                            

     

  

     

  

     

  

  

2007

 

$

1,362,000

 

$

754,000

 

$

2,116,000

 

2008

  

1,362,000

  

758,000

  

2,120,000

 

2009

  

1,362,000

  

276,000

  

1,638,000

 

2010

  

1,431,000

  

115,000

  

1,546,000

 

2011

  

1,636,000

  

115,000

  

1,751,000

 

Thereafter

  

6,134,000

  

258,000

  

6,392,000

 

Total minimum lease payments

 

$

13,287,000

 

$

2,276,000

 

$

15,563,000

 

We recognized rent expense under operating leases of $869,000 in 2006, $1.4 million in 2005 and $1.6 million in 2004.

7. Investment in Chromos Molecular Systems, Inc.

In 2004, our majority-owned subsidiary, CellExSys Inc., was acquired by and merged into Chromos. Chromos is a publicly traded company whose common stock is traded on the Toronto Stock Exchange. At the time of the sale, we owned approximately 79% of CellExSys. As a result of the sale of CellExSys, we received consideration of approximately 1.2 million shares of Chromos common stock and a 79% share of any payments made by Chromos under an interest bearing debenture issued by Chromos. As a result of the sale of our share of CellExSys, we recorded a gain in 2004 of $1.0 million.

At December 31, 2004, we valued our Chromos securities and interest in the debenture at $453,000. Based upon our first quarter 2005 assessment of Chromos’ financial condition, we recorded a $63,000 charge to investment income to reduce the carrying value of the debenture to zero. In the second quarter of 2005, Chromos’ stock price declined and we recorded an $181,000 other-than-temporary impairment charge relating to the decline in value of the Chromos securities. During the second half of the year, Chromos issued us approximately 1.0 million shares of its common stock in connection with the scheduled debt and interest payment under the debenture and also later in 2005, Chromos issued us an additional 894,000 million shares of its common stock as an early payment of the debenture. As the carrying value of the debenture was zero at the time of the payment, we recorded the market value of the shares received as investment income. During 2005, we sold 370,000 shares of Chromos and recognized net losses of $32,000. These securities are sold on a specific identification method based on when we received the shares. The net impact of these charges and the conversion of the debenture was a $1,000 gain.

During 2006, we sold 280,000 shares of Chromos stock, which resulted in remaining holdings of 2.5 million shares of Chromos stock at December 31, 2006.

  

Fair Value

 

Unrealized

Losses

 

Proceeds
from the Sale
of Securities

 

Realized
Gain/Loss

                                                                                                            

     

  

     

  

     

  

     

  

Marketable equity securities

 

$

317,000

 

$

(39,000

)

$

49,000

 

$

8,000



53





TARGETED GENETICS CORPORATION

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

7. Investment in Chromos Molecular Systems, Inc. – (continued)

We will continue to record our common stock investment in Chromos at fair market value and record changes in the fair market value of this stock in accumulated other comprehensive loss. We periodically evaluate our Chromos stock for signs of impairment that may be other-than-temporary which would necessitate a reduction in the carrying value of the investment and charge to expense. Based on our evaluation and our ability and intent to hold those investments for a reasonable period of time sufficient for a recovery of fair value, we do not consider those investments to be other-than-temporarily impaired at December 31, 2006.

8. Goodwill

The table below reflects changes in the balance related to goodwill for the year ended December 31, 2006:

December 31, 2005 goodwill balance

 

$

31,649,000

 

Impairment charge

  

(23,723,000

)

December 31, 2006 goodwill balance

 

$

7,926,000

 

We perform goodwill impairment tests in accordance with SFAS No. 142, “Goodwill and Other Intangible Assets” on an annual basis or more frequently if events and changes in business conditions indicate that the carrying amount of our goodwill may not be recoverable. Normally, we perform our annual impairment test as of October 1st. However, as a result of a decline in market price of our common stock in June 2006, to a level that reduced our market capitalization to an amount less than the fair value of our net assets, we concluded that this was an indicator of impairment of our goodwill and therefore we were required to perform an interim goodwill impairment test. In the first step of this testing, since we are comprised of only one reporting unit, we compared our fair value, as measured by market capitalization and discounted cash flow analysis, to the net carrying value of our assets. Since our indicated fair value was less than the net carrying value of our assets, we were then required to perform the second step of the evaluation and measure the amount of the impairment loss. This analysis requires us to determine the implied value of goodwill by allocating our estimated fair value to its assets and liabilities including intangible assets such as in-process research and development, completed technology, and trademarks and trade names using a hypothetical purchase price allocation as if we had been acquired in a business combination as of the date of the impairment test. This evaluation resulted in an implied goodwill balance of $7.9 million and a second quarter 2006 non-cash goodwill impairment charge of $23.7 million. We performed an annual impairment test as of October 2006 and concluded that no further impairment in the value of our goodwill has occurred.

9. Other Comprehensive Loss

Comprehensive loss is the total of net loss and all other non-owner changes in equity. Comprehensive loss includes unrealized gains and losses from investments and foreign currency translations on our common stock investment in Chromos, as presented in the following table:

  

December 31,

 
  

2006

 

2005

 

2004

 

                                                                                                                 

     

  

     

  

     

   

Net loss as reported

 

$

(33,990,000

)   

$

(19,198,000

)   

$

(14,257,000

)

Other comprehensive loss:

          

Unrealized loss on available-for-sale securities

  

(16,000

)

 

(37,000

)

 

 

Foreign currency translation adjustment

  

(2,000

)

 

16,000

  

 

Other comprehensive loss

 

$

(34,008,000

)

$

(19,219,000

)

$

(14,257,000

)



54



TARGETED GENETICS CORPORATION

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

10. Shareholders’ Equity

Stock Purchase Warrants

In 1999, in connection with a technology license agreement, we issued to Alkermes, Inc. a warrant to purchase 100,000 shares of our common stock at an exercise price of $25.00 per share, expiring in June 2007, and a warrant to purchase 100,000 shares of our common stock at an exercise price of $41.60 per share, expiring in June 2009. Both of these warrants were outstanding at December 31, 2006. We issued additional warrants in connection with the public offering in January 2007, see Note 14 of the notes to our consolidated financial statements for further details.

Shareholder Rights Plan

In 1996, our Board of Directors adopted a shareholder rights plan. Under our rights plan, each holder of a share of outstanding common stock was also entitled to one preferred stock purchase right. The shareholder rights plan expired by its terms in October 2006. We did not renew the shareholder rights plan upon its expiration.

Stock Options

We have various stock option plans, or Option Plans, that provide for the issuance of nonqualified and incentive stock options to acquire up to 1,297,944 shares of our common stock. These stock options may be granted by our Board of Directors to our employees, directors and officers and to consultants, agents, advisors and independent contractors who provide services to us. The exercise price for incentive stock options shall not be less than the fair market value of the shares on the date of grant. Options granted under our Option Plans expire no later than ten years from the date of grant and generally vest and become exercisable over a four-year period following the date of grant. However in 2003, we granted options to purchase 65,500 shares of our common stock with vesting periods which ranged from twelve to eighteen months. In May and June of 2006, as part of an employee retention plan, we granted options to purchase an aggregate of 306,500 shares of our common stock with an accelerated twelve month vesting period. We granted a total of 198,000 of these options to purchase shares of our common stock with exercise prices of $3.80, exceeding the $2.46 fair value of the common stock on the grant date. Every non-employee member of our Board of Directors receives an annual nonqualified stock option grant and these options vest over a twelve month period provided they continue service to us. Upon the exercise of stock options, we issue new shares from shares reserved for issuance under our Option Plans.

Effective January 1, 2006, we adopted SFAS No. 123R, “Share-Based Payment” which requires us to expense the fair value of stock options granted over the vesting period. We adopted SFAS No. 123R using the modified prospective application method and recognized $861,000 of stock-based compensation expense in the year ending December 31, 2006 which reduced our basic and diluted earnings per share by $0.09. This compensation expense includes: (a) compensation cost for all share-based stock options granted prior to, but not yet vested as of January 1, 2006, based on the grant-date fair value used for prior pro forma disclosures adjusted for forfeitures and (b) compensation cost for all share-based payments granted subsequent to January 1, 2006, based on the grant-date fair value estimate in accordance with the provisions of SFAS No. 123R. For the year ending December 31, 2006, we classified $465,000 of the stock-based compensation expense as research and development expense and $396,000 as general and administrative expense. As of December 31, 2006, total unrecognized compensation cost related to unvested options was approximately $581,000, net of estimated forfeitures, which we expect to recognize over a weighted average period of approximately 8 months.



55



TARGETED GENETICS CORPORATION

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

10. Shareholders’ Equity – (continued)

The following table summarizes activity related to our Option Plans:

  

Shares

 

Weighted
Average
Exercise
Price

 

Remaining
Average
Contractual
Term

 

Intrinsic
Value

 

                                                                                                                             

     

 

     

  

     

 

     

  

 

Balance, December 31, 2003

 

409,768

 

$

30.70

      

Granted

 

251,795

  

13.50

      

Exercised

 

(12,294

)

 

4.30

      

Expired

 

(9,767

)

 

48.10

      

Forfeited

 

(30,197

)

 

35.20

      

Balance, December 31, 2004

 

609,305

  

23.60

      

Granted

 

152,820

  

8.80

      

Exercised

 

(6,791

)

 

4.10

      

Expired

 

(8,450

)

 

39.10

      

Forfeited

 

(42,796

)

 

16.10

      

Outstanding, December 31, 2005

 

704,088

  

20.90

      

Granted

 

349,800

  

3.28

      

Exercised

 

(28,188

)

 

2.70

      

Expired

 

(7,963

)

 

43.83

      

Forfeited

 

(182,652

)

 

13.94

      

Outstanding, December 31, 2006

 

835,085

 

$

15.39

 

7.15

 

$

669,000

 

Exercisable at December 31, 2006

 

556,629

 

$

19.85

 

4.20

 

$

324,000

 

The aggregate intrinsic value is determined using the closing price of our common stock of $5.37 on December 31, 2006. The intrinsic value of stock options exercised was $94,000 in 2006, $16,000 in 2005 and $132,000 in 2004. We received $76,000 from the exercise of stock options for the year ended December 31, 2006.

The following table summarizes information regarding our outstanding and exercisable options at December 31, 2006:

  

Outstanding

 

Exercisable

Range of Exercise Prices

 

Number of
Option
Shares

 

Weighted
Average
Exercise
Price

 

Weighted Average
Remaining
Contractual
Life
(Years)

 

Number
of Option

Shares

 

Weighted
Average
Exercise
Price

   

                                                                            

     

 

     

  

     

 

     

 

     

  

$1.80

 – 

$

2.90

  

111,900

 

$

2.45

 

          9.10

        

 

50,471

 

$

2.59

3.80  

 – 

 

3.80

  

197,416

  

3.80

 

9.44

  

96,916

  

3.80

4.30

 – 

 

12.20

  

175,380

  

7.88

 

7.24

  

115,180

  

7.61

12.60

 – 

 

15.60

  

169,574

  

13.29

 

7.10

  

115,959

  

13.36

15.90

 – 

 

148.80

                                                     

 

180,815

  

45.30

 

3.39

  

178,103

  

45.63

Balance, December 31, 2006  

 

835,085

  

15.39

 

7.15

  

556,629

  

19.85

The fair value of each stock option award is estimated on the date of the grant using the Black-Scholes-Merton option pricing model. The weighted average fair value of options granted was $1.84 per share in 2006, $7.50 per share in 2005 and $12.70 per share in 2004. The following are the assumptions for the periods noted:

 

     

2006

     

2005

     

2004

 

                                                                                                                                        

       

Expected dividend rate

 

Nil

 

Nil

 

Nil

 

Expected stock price volatility range

 

1.05 – 1.11

 

1.09 – 1.12

 

1.12 – 1.47

 

Risk-free interest rate range

 

4.25 – 4.85

%   

3.63 – 4.36

%   

2.71 – 4.47

%

Expected life of options range

 

4 – 5 years

 

4 – 5 years

 

4 years

 



56



TARGETED GENETICS CORPORATION

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

10. Shareholders’ Equity – (continued)

Expected Dividend: We do not anticipate any dividends based on our current dividend restrictions related to our Biogen Idec note.

Expected Life: Our expected term represents the period that our stock-based awards are expected to be outstanding. We determine expected life based on historical experience and vesting schedules of similar awards.

Expected Volatility: Our expected volatility represents the weighted average historical volatility of the shares of our common stock for the most recent four-year and five-year periods.

Risk-Free Interest Rate: We base the risk-free interest rate used on the implied yield currently available on U.S. Treasury zero-coupon issues with an equivalent remaining term. Where the expected term of our stock-based awards do not correspond with the terms for which interest rates are quoted, we perform a straight-line interpolation to determine the rate from the available term maturities.

Forfeiture Rate: We apply an estimated forfeiture rate that we derived from historical employee termination behavior. If the actual number of forfeitures differs from our estimates, we may record additional adjustments to compensation expense in future periods.

Reserved Shares

As of December 31, 2006, we had reserved shares of our common stock for future issuance as follows:

Stock options outstanding

     

835,085

Available for future stock option grants under Option Plans

 

128,924

Stock purchase warrants

 

200,000

Total shares reserved

 

1,164,009

11. Collaborative and Other Agreements

We have entered into various product development relationships and license arrangements with pharmaceutical and biotechnology companies and non-profit organizations. Under these partnerships, we typically are reimbursed for research and development activities we perform and in certain cases, we have received milestone and upfront payments. Revenues earned under our research and development collaborations and license agreements are as follows:

  

Year Ended December 31,

  

2006

 

2005

 

2004

                                                                                                    

     

  

     

  

     

  

IAVI

 

$

2,262,000

 

$

5,588,000

 

$

8,340,000

Celladon

  

4,220,000

  

777,000

  

NIAID

  

1,548,000

  

  

AMT license

  

1,750,000

  

  

Sirna and other

  

84,000

  

509,000

  

1,312,000

  

$

9,864,000

 

$

6,874,000

 

$

9,652,000

International AIDS Vaccine Initiative Agreement

In 2000, we entered into a three-year development collaboration with IAVI and Columbus Children’s Research Institute at Children’s Hospital in Columbus, Ohio to develop a vaccine to protect against the progression of HIV infection to AIDS. The collaboration originally had a three-year term yet the work plan was established and funded on an annual basis. In 2004, we and IAVI agreed to extend the underlying program through the end of 2006 and in 2006 the program was further extended until the expiration of the term of the last patent within the patent rights controlled by us and utilized in the IAVI vaccine. Under the terms of the collaboration, IAVI provides funding to us to support development, preclinical studies and manufacturing of product for clinical trials on a cost reimbursement basis. IAVI independently monitors and funds clinical development costs under the collaboration.



57



TARGETED GENETICS CORPORATION

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

11. Collaborative and Other Agreements – (continued)

We expect to receive funding from IAVI for the development of HIV/AIDS vaccines for the developing world. We also received the rights to utilize the findings from the IAVI funded program to develop and commercialize HIV/AIDS vaccines for both the developed world and for any additional vaccine candidates. Among other rights granted under this agreement, IAVI retains the exclusive rights for commercialization in the developing world of any HIV/AIDS vaccine that is developed under the collaboration, and will receive a royalty on income received by us from the development and commercialization of certain vaccines. We granted IAVI the rights to technology and intellectual property utilized in the programs. We also issued IAVI a small number of shares of our common stock.

Celladon Collaboration

In 2004, we formed a collaboration with Celladon focused on the development of AAV-based drugs for the treatment of congestive heart failure. In connection with the formation of this collaboration, certain of Celladon’s investors purchased 395,413 shares of our common stock at $15.20 per share resulting in net proceeds to us of $6.0 million. We recorded the proceeds as equity at the fair value of the common stock, which approximated market value. During 2006, we earned $4.2 million from our development activities under the Celladon collaboration, which consisted primarily of internal development and manufacturing efforts. At the inception of the agreement we agreed to contribute up to $2.0 million to support these development activities and then to be reimbursed for efforts over that amount. We met this limit during 2005. We are also entitled to receive milestone payments during the development of product candidates under the collaboration as well as royalties and manufacturing profits from the commercialization of product candidates developed under the collaboration.

National Institute of Allergy and Infectious Diseases

In 2005, we extended the scope of our HIV/AIDS vaccine program to the developed world via a contract awarded by the National Institute of Allergy and Infectious Diseases, or NIAID, to CCRI in collaboration with CHOP and us. Under this program, we may receive up to $18.2 million over five years for the development, manufacture and preclinical testing of vaccine candidates. Investigators at CHOP and CCRI will design the vaccine candidates and we will manufacture the vectors for the clinical testing that will be conducted in the U.S. The direct costs of any clinical trials will be borne directly by the NIAID and are not part of the contract. This NIAID-funded vaccine program will complement work performed under the IAVI vaccine program but will be focused on candidate HIV/AIDS vaccines for the developed world. Consequently, the vaccine candidates that we will be evaluating in this program will contain certain HIV genes of types that are common in the western world. We began work on our portion of the collaboration in the first quarter of 2006. The funding is awarded to us in annual installments. The total funding amount awarded under our subcontract for the second project year, covering the time period from August 31, 2006 to August 30, 2007, was $5.7 million, of which revenue of $743,000 had been recognized as of December 31, 2006.

Amsterdam Molecular Therapeutics B.V.

In December 2006, we granted a non-exclusive perpetual license for the patent rights related to an AAV1 vector gene delivery system to AMT. Under the agreement, we sublicensed certain patent rights under the Penn agreement and AMT paid us an upfront payment of $1.75 million, and we may receive milestone payments based on the progress of the licensed products from clinical trial phases to regulatory approvals and royalties based on a percentage of net sales of the licensed products.

Sirna Therapeutics Collaboration

In 2005, we established a collaboration with Sirna to develop AAV-based approaches to treating Huntington’s disease. Sirna, now a wholly-owned subsidiary of Merck & Co., Inc., is a leader in the effort to create RNAi-based therapies and leverage the vast potential of this technology to ultimately treat patients in need. We, and Sirna, have agreed to co-develop product candidates under the collaboration, whereby we share the costs of development and any potential future revenues that result from the collaboration. We split the development costs evenly with Sirna. We record revenue and Sirna reimburses us for our program costs that exceed more than half of the total collaboration costs.



58



TARGETED GENETICS CORPORATION

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

11. Collaborative and Other Agreements – (continued)

Former Biogen Collaboration

In 2000, we established a three-year multiple-product development and commercialization collaboration with Biogen (now Biogen Idec) that ended in 2003. As part of this collaboration, Biogen Idec agreed to provide us with loans of up to $10.0 million and committed to purchase, at our discretion, up to $10.0 million shares of our common stock. In 2001, we borrowed $10.0 million under the loan commitment. In 2002, we issued 580,467 shares of our common stock to Biogen Idec at a price of approximately $6.90 per share and received proceeds of $4.0 million and in 2003 we issued 251,484 shares of our common stock to Biogen Idec at a price of $19.10 per share and received proceeds of $4.8 million. In 2006, Biogen Idec agreed to exchange $5.65 million of debt for one million shares of our common stock. As of December 31, 2006, we owed Biogen Idec $1.7 million remaining on a note payable and Biogen Idec owned approximately 2.17 million shares of our common stock representing approximately 19.9% of our total common shares outstanding.

12. Employee Retirement Plan

We sponsor an employee retirement plan under Section 401(k) of the Internal Revenue Code. All of our employees who meet the minimum eligibility requirements are eligible to participate in the plan. Our matching contributions to the 401(k) plan are made at the discretion of our Board of Directors and were $17,000 in 2006, $165,000 in 2005 and $133,000 in 2004. We suspended matching contributions effective February 1, 2006 and reinstated matching contributions effective January 1, 2007.

13. Income Taxes

At December 31, 2006, we had net operating loss carry-forwards of approximately $178.7 million and research tax credit carry-forwards of $8.0 million. The carry-forwards will begin to expire in 2007 if not utilized, and may be further subject to the application of Section 382 of the Internal Revenue Code of 1986, as amended, as discussed further below. We have provided a valuation allowance to offset the deferred tax assets, due to the uncertainty of realizing the benefits of the net deferred tax asset.

Significant components of our deferred tax assets and liabilities were as follows:

  

December 31,

 
  

2006

 

2005

 

                                                                                                                                                 

     

  

     

   

Deferred tax assets

       

Net operating loss carry-forwards

 

$

60,770,000

 

$

57,190,000

 

Capital loss carry-forwards

  

2,000,000

  

1,910,000

 

Research and orphan drug credit carry-forwards

  

8,010,000

  

7,460,000

 

Depreciation and amortization

  

2,410,000

  

3,340,000

 

Restructure and other

  

3,520,000

  

2,810,000

 

Gross deferred tax assets

  

76,710,000

  

72,710,000

 

Valuation allowance for deferred tax assets

  

(76,710,000

)   

 

(72,710,000

)

Net deferred tax asset

 

$

 

$

 

The change in the valuation allowance was $4.0 million for 2006 and $6.7 million for 2005. The capital losses generated by the sale of CellExSys and Chromos shares may only be carried forward to offset future capital gains and will begin to expire after 2009 if not utilized. Our valuation allowances as of December 31, 2006 and December 31, 2005 include an allowance for the capital loss carry-forward.

The effect tax effect of adopting FAS 123R for recording stock compensation expense resulted in an insignificant increase in the deferred tax asset and is included with restructure and other.



59



TARGETED GENETICS CORPORATION

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

13. Income Taxes – (continued)

Our past sales and issuances of stock have likely resulted in ownership changes as defined by Section 382 of the Internal Revenue Code of 1986, as amended. A study has not been done at this time because of the full valuation allowance eliminating potential profit & loss adjustments due to changes in the gross amount of the NOL’s and credits would be offset by a change in the valuation allowance. It appears likely that a future analysis may result in the conclusion that a substantial portion or perhaps essentially all of the NOL’s and credits will expire due to the limitations of Sections 382 and 383. As a result, the utilization of our net operating losses and tax credits will be limited and a portion of the carry-forwards may expire unused.

14. Subsequent Events

In January 2007, we sold 2.2 million shares of our common stock in a private placement at a price of $4.00 per share and received net proceeds of approximately $8.1 million. In addition, in connection with the financing we issued warrants to purchase up to 763,000 shares of our common stock. These warrants expire in January 2012 and are exercisable at $5.41 per share beginning July 19, 2007.

15. Condensed Quarterly Financial Information (unaudited)

The following tables present our unaudited quarterly results for 2006 and 2005. The net loss in the second quarter of 2006 reflects a $23.7 million goodwill impairment charge and the net income in the fourth quarter of 2006 includes a $2.6 million gain on the restructure of Biogen Idec debt. We believe that the following information reflects all normal recurring adjustments for a fair presentation of the information for the periods presented. The operating results for any quarter are not necessarily indicative of results for any future period.

  

Quarter Ended

 
  

March 31,
2006

 

June 30,
2006

 

September 30,
2006

 

December 31,
2006

 

                                                                                                            

     

  

     

  

     

  

     

   

Revenue

 

$

2,430,000

 

$

1,414,000

 

$

2,012,000

 

$

4,008,000

 

Restructure charges

  

1,042,000

  

363,000

  

413,000

  

188,000

 

Loss from operations

  

(3,770,000

)   

 

(27,923,000

)   

 

(3,211,000

)   

 

(1,825,000

)

Net income (loss)

  

(3,732,000

)

 

(27,876,000

)

 

(3,190,000

)

 

808,000

 

Basic and diluted net income (loss) per common share

  

(0.42

)

 

(2.83

)

 

(0.32

)

 

0.08

 

 

  

Quarter Ended

 
  

March 31,
2005

 

June 30,
2005

 

September 30,
2005

 

December 31,
2005

 

                                                                                                            

     

  

     

  

     

  

     

   

Revenue

 

$

2,000,000

 

$

1,462,000

 

$

1,468,000

 

$

1,944,000

 

Restructure charges

  

219,000

  

119,000

  

1,188,000

  

183,000

 

Loss from operations

  

(4,643,000

)   

 

(5,125,000

)   

 

(5,863,000

)   

 

(3,716,000

)

Net loss

  

(4,672,000

)

 

(5,294,000

)

 

(5,683,000

)

 

(3,549,000

)

Basic and diluted net loss per common share

  

(0.55

)

 

(0.62

)

 

(0.66

)

 

(0.41

)



60



Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure.

None.

Item 9A. Controls and Procedures.

Evaluation of disclosure controls and procedures. Our management evaluated, with the participation of our Chief Executive Officer and our Chief Financial Officer, the effectiveness of our disclosure controls and procedures as of the end of the period covered by this Annual Report on Form 10-K. Based on this evaluation, our Chief Executive Officer and our Chief Financial Officer have concluded that our disclosure controls and procedures are effective to ensure that information we are required to disclose in reports that we file or submit under the Securities Exchange Act of 1934 is recorded, processed, summarized and reported within the time periods specified in Securities and Exchange Commission rules and forms.

Changes in internal control over financial reporting. There was no change in our internal control over financial reporting that occurred during the period covered by this annual report on Form 10-K that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.

PART III

Item 10. Directors and Executive Officers of Registrant.

The information required by this Item is incorporated by reference to the sections captioned “Proposal One — Election of Directors,” “Executive Officers” and “Section 16(a) Beneficial Ownership Reporting Compliance” in the proxy statement for our annual meeting of shareholders to be held on May 17, 2007.

Code of Ethics

We have a Code of Conduct, which applies to all employees, officers and directors of Targeted Genetics. Our Code of Conduct meets the requirements of a “code of ethics” as defined by Item 406 of Regulation S-K, and applies to our Chief Executive Officer, Chief Financial Officer (who is both our principal financial and principal accounting officer), as well as all other employees. Our Code of Conduct also meets the requirements of a code of conduct under Marketplace Rule 4350(n) of the National Association of Securities Dealers, Inc. Our Code of Conduct is posted on our website at http://www.targetedgenetics.com in the “Corporate Governance” section of our Investor Relations home page.

Item 11. Executive Compensation.

The information required by this Item with respect to executive compensation is incorporated by reference to the section captioned “Executive Compensation” in the 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 and Related Shareholder Matters.

The information required by this Item is incorporated by reference to the section captioned “Security Ownership” and “Executive Compensation — Equity Compensation Plan Information” in the proxy statement for our annual meeting of shareholders to be held on May 17, 2007.

Item 13. Certain Relationships and Related Transactions.

The information required by this Item with respect to certain relationships and related-party transactions is incorporated by reference to the sections captioned “Executive Compensation — Post-Employment Compensation” in the proxy statement for our annual meeting of shareholders to be held on May 17, 2007.



61



Item 14. Principal Accountant Fees and Services.

The information required by this Item with respect to principal accountant fees and services is incorporated by reference to the section captioned “Proposal Four — Ratification of Independent Registered Public Accounting Firm” in the proxy statement for our annual meeting of shareholders to be held on May 17, 2007.

PART IV

Item 15. Exhibits, Financial Statement Schedules and Reports on Form 8-K.

1. Financial Statements

The following consolidated financial statements are submitted in Part II, Item 8 of this annual report:

  

Page

 

     

          

Report of Independent Registered Public Accounting Firm

 

40

Consolidated Balance Sheets as of December 31, 2006 and 2005

 

41

Consolidated Statements of Operations for the years ended December 31, 2006 2005 and 2004

 

42

Consolidated Statements of Preferred Stock and Shareholders’ Equity for the years ended December 31, 2006, 2005 and 2004

 

43

Consolidated Statements of Cash Flows for the years ended December 31, 2006, 2005 and 2004

 

44

Notes to Consolidated Financial Statements

 

45

2. Financial Statement Schedules

All financial statement schedules have been omitted because the required information is either included in the consolidated financial statements or the notes thereto or is not applicable.



62



SIGNATURES

Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized in the city of Seattle, state of Washington, on March 29, 2007.

 

TARGETED GENETICS CORPORATION

                                                                                         

 

                                                                                           

 

By: 

/s/ H. Stewart Parker

  

H. Stewart Parker
President and Chief Executive Officer

POWER OF ATTORNEY

Each person whose individual signature appears below hereby authorizes and appoints H. Stewart Parker and David J. Poston, and each of them, with full power of substitution and resubstitution and full power to act without the other, as his or her true and lawful attorney-in-fact and agent to act in his or her name, place and stead and to execute in the name and on behalf of each person, individually and in each capacity stated below, and to file, any and all amendments to this report, and to file the same, with all exhibits thereto, and other documents in connection therewith, with the Securities and Exchange Commission, granting unto said attorneys-in-fact and agents, and each of them, full power and authority to do and perform each and every act and thing, ratifying and confirming all that said attorneys-in-fact and agents or any of them or their or his or her substitute or substitutes may lawfully do or cause to be done by virtue thereof.

Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed below by the following persons on behalf of the registrant and in the capacities and on the dates indicated.

Signature

 

Title

 

Date

 

     

 

     

                                      

/s/ H. Stewart Parker

 

President, Chief Executive Officer and

 

March 29, 2007

H. Stewart Parker

 

Director (Principal Executive Officer)

  
     

/s/ David J. Poston

 

Vice President, Finance, Chief Financial Officer and Treasurer

 

March 29, 2007

David J. Poston

 

(Principal Financial and Principal Accounting Officer)

  
     

/s/ Jeremy L. Curnock Cook

 

Chairman of the Board

 

March 29, 2007

Jeremy L. Curnock Cook

    
     

/s/ Jack L. Bowman

 

Director

 

March 29, 2007

Jack L. Bowman

    
     

/s/ Joseph M. Davie, Ph.D., M.D.

 

Director

 

March 29, 2007

Joseph M. Davie, Ph.D., M.D.

    
     

/s/ Roger L. Hawley

 

Director

 

March 29, 2007

Roger L. Hawley

    
     

/s/ Nelson L. Levy, Ph.D., M.D.

 

Director

 

March 29, 2007

Nelson L. Levy, Ph.D., M.D.

    
     

/s/ Michael S. Perry, D.V.M., Ph.D.

 

Director

 

March 29, 2007

Michael S. Perry, D.V.M., Ph.D.

    




63



 

    

Incorporated by Reference

  

Exhibit
Number

 

Exhibit Description

 

Form

 

Date of
First Filing

 

Exhibit Number

 

Filed
Herewith

 

     

 

     

              

     

 

     

 

     

 

3.1

 

Amended and Restated Articles of Incorporation

 

8-K

 

5/12/06

 

3.1

  

3.2

 

Amended and Restated Bylaws

 

10-K

 

3/17/97

 

3.2

  

4.1

 

Registration Rights Agreement among Targeted Genetics Corporation and certain investors dated as of January 8, 2007

 

8-K

 

1/8/07

 

10.2

  

10.1

 

Form of Indemnification Agreement between Targeted Genetics and its officers and directors

 

10-K

 

3/23/00

 

10.1

  

10.2

 

Form of Senior Management Employment Agreement between Targeted Genetics and certain executive officers

 

10-K

 

3/17/97

 

10.2

  

10.3

 

Change in Control Agreement, dated as of September 14, 2006, between Targeted Genetics Corporation and David J. Poston

 

8-K

 

9/20/06

 

10.1

  

10.4

 

Gene Transfer Technology License Agreement, dated as of February 18, 1992, between Immunex Corporation and Targeted Genetics Corporation*

 

10-K

 

3/23/00

 

10.3

  

10.5

 

Exclusive Sublicense Agreement, dated June 9, 1999, between Targeted Genetics and Alkermes, Inc.*

 

10-Q

 

8/5/99

 

10.36

  

10.5(a)

 

Amendment Agreement to Exclusive Sublicense Agreement, dated as of March 12, 2002, between Targeted Genetics and Alkermes, Inc.*

 

10-K

 

3/12/04

 

10.52

  

10.5(b)

 

Amendment No. 2 to Exclusive Sublicense Agreement, dated as of May 29, 2003, between Targeted Genetics and Alkermes, Inc.*

 

8-K

 

7/22/03

 

10.01

  

10.5(c)

 

Amendment No. 3 to Exclusive Sublicense Agreement, dated as of March 9, 2007, between Targeted Genetics and Alkermes, Inc.*

       

X

10.6

 

Termination Agreement, dated March 31, 2004, among Targeted Genetics, Elan Corporation PLC, Elan Pharma International Limited, Elan International Services, Ltd. and Emerald Gene Systems, Ltd.*

 

8-K

 

4/06/04

 

99.2

  

10.7

 

Funding Agreement dated as of August 8, 2000, between Targeted Genetics and Biogen, Inc.

 

8-K

 

9/13/00

 

10.2

  

10.7(a)

 

Amendment to Funding Agreement, dated as of July 14, 2003, between Targeted Genetics and Biogen, Inc.

 

8-K

 

7/22/03

 

10.03

  

10.7(b)

 

Amendment No. 2 to Funding Agreement, dated September 1, 2005, between Targeted Genetics and Biogen Idec

 

8-K

 

9/1/05

 

10.1

  

10.7(c)

 

Amendment No. 3 to Funding Agreement, dated November 7, 2006, between Targeted Genetics Corporation and Biogen Idec MA Inc.

 

8-K

 

11/7/06

 

10.1

  

10.8

 

Amended and Restated Promissory Note issued by Targeted Genetics Corporation to Biogen Idec MA Inc. dated November 7, 2006

 

8-K

 

11/7/06

 

10.2

  




64



 

    

Incorporated by Reference

  

Exhibit
Number

 

Exhibit Description

 

Form

 

Date of
First Filing

 

Exhibit Number

 

Filed
Herewith

 

     

 

     

              

     

 

     

 

     

 

10.9

 

Collaboration Agreement, dated December 31, 2004, between Targeted Genetics and Celladon Corporation.*

 

10-K

 

3/4/05

 

10.56

  

10.10

 

Manufacturing Agreement, dated December 31, 2004, between Targeted Genetics and Celladon Corporation.*

 

10-K

 

3/4/05

 

10.57

  

10.11

 

Common Stock Purchase Agreement, dated December 31, 2004, by and among Targeted Genetics, Enterprise Partners and Venrock Partners.

 

10-K

 

3/4/05

 

10.58

  

10.12

 

Agreement Under an NIH Prime Award, dated February 8, 2006, between The Children’s Hospital of Philadelphia and Targeted Genetics Corporation*

 

10-K

 

3/16/06

 

10.36

  

10.12(a)

 

Modification of Agreement, dated October 27, 2006, between The Children’s Hospital of Philadelphia and Targeted Genetics Corporation

 

8-K

 

11/1/06

 

10.1

  

10.13

 

Collaboration and License Agreement, dated as of January 1, 2005, by and among Targeted Genetics Corporation, the International AIDS Vaccine Initiative, Columbus Children’s Research Institute and The Children’s Hospital of Philadelphia*

 

10-Q

 

8/9/06

 

10.3

  

10.14

 

Securities Purchase Agreement among Targeted Genetics Corporation and certain investors dated January 8, 2007

 

8-K

 

1/8/07

 

10.1

  

10.15

 

Form of Warrant to Purchase Shares of Common Stock of Targeted Genetics Corporation dated January 11, 2007

 

8-K

 

1/8/07

 

10.3

  

10.16

 

License Agreement, effective June 1, 2002, by and between The Trustees of the University of Pennyslvania and Targeted Genetics Corporation*

       

X

10.17

 

License Agreement, effective December 5, 2006, by and between Amsterdam Molecular Therapeutics B.V. and Targeted Genetics Corporation*

       

X

10.18

 

Patent License Agreement – Exclusive, dated April 29, 2004, between the National Institutes for Health and Targeted Genetics Corporation*

       

X

10.18(a)

 

Amendment No. 1 to OTT License Agreement Number L-086-2000/0, dated August 14, 2006, between the National Institutes for Health and Targeted Genetics Corporation*

       

X

10.19

 

Office Lease, dated as of October 7, 1996, between Benaroya Capital Company, LLC and Targeted Genetics

 

10-K

 

3/17/97

 

10.26

  

10.19(a)

 

First Lease Amendment, dated May 12, 1997, between Targeted Genetics and Benaroya Capital Company, LLC

 

10-Q

 

8/14/01

 

10.1

  



65



 

    

Incorporated by Reference

  

Exhibit
Number

 

Exhibit Description

 

Form

 

Date of
First Filing

 

Exhibit Number

 

Filed
Herewith

 

     

 

     

              

     

 

     

 

     

 

10.19(b)

 

Second Lease Amendment, dated February 25, 2000, between Targeted Genetics and Benaroya Capital Company, LLC

 

10-Q

 

8/14/01

 

10.2

  

10.19(c)

 

Third Lease Amendment, dated April 19, 2000, between Targeted Genetics and Benaroya Capital Company, LLC

 

10-Q

 

8/14/01

 

10.3

  

10.19(d)

 

Fourth Lease Amendment, dated March 28, 2001, between Targeted Genetics and Benaroya Capital Company, LLC

 

10-Q

 

8/14/01

 

10.4

  

10.19(e)

 

Fifth Lease Amendment, dated January 2, 2004, between Targeted Genetics and Benaroya Capital Company, LLC*

 

8-K

 

1/13/04

 

10.03

  

10.19(f)

 

Sixth Lease Amendment, dated as of April 1, 2006,  between Met Park West IV, LLC (successor in interest to Benaroya Capital Company, LLC) and Targeted Genetics Corporation

 

10-Q

 

5/4/06

 

10.4

  

10.19(g)

 

Seventh Lease Amendment, dated as of June 7, 2006, between Met Park West IV, LLC (successor in interest to Benaroya Capital Company, LLC) and Targeted Genetics Corporation

 

8-K

 

6/21/06

 

10.1

  

10.20

 

Canyon Park Building Lease, dated as of June 30, 2000, between Targeted Genetics and CarrAmerica Corporation

 

10-Q

 

8/11/00

 

10.1

  

10.21

 

Olive Way Building Lease, dated as of November 20, 1993, as amended, between Targeted Genetics and Ironwood Apartments, Inc. (successor in interest to Metropolitan Federal Savings and Loan Association)

 

10-K

 

3/23/00

 

10.29

  

10.21(a)

 

Fifth Amendment to Lease Agreement, dated as of June 20, 2003, between Targeted Genetics and Ironwood Apartments, Inc.

 

8-K

 

7/22/03

 

10.02

  

10.21(b)

 

Sixth Amendment to Lease Agreement, dated as of November 1, 2003, between Targeted Genetics and Ironwood Apartments, Inc.*

 

8-K

 

1/13/04

 

10.01

  

10.22

 

1992 Restated Stock Option Plan

 

S-8

 

7/10/98

 

99.1

  

10.23

 

Stock Option Plan for Nonemployee Directors

 

10-Q

 

3/31/98

 

10.34

  

10.24

 

1999 Stock Option Plan, as amended and restated March 22, 2004

 

S-8

 

6/17/04

 

10.1

  

10.25

 

2000 Genovo Inc. Roll-Over Stock Option Plan

 

S-8

 

10/19/00

 

99.1

  

21.1

 

Subsidiaries of Targeted Genetics

       

X

23.1

 

Consent of Independent Registered Public Accounting Firm

       

X

31.1

 

Certification of Chief Executive Officer pursuant to Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended

       

X




66



 

    

Incorporated by Reference

  

Exhibit
Number

 

Exhibit Description

 

Form

 

Date of
First Filing

 

Exhibit Number

 

Filed
Herewith

 

     

 

     

              

     

 

     

 

     

 

31.2

 

Certification of Chief Financial Officer pursuant to Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended

       

X

32.1

 

Certification of Chief Executive Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002

       

X

32.2

 

Certification of Chief Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002

       

X




67


EX-10.5(C) 2 v069612_ex10-5c.htm
 
 
*Certain confidential information contained in this document, marked by brackets, has been omitted and filed with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
 
AMENDMENT NO. 3 TO
EXCLUSIVE SUBLICENSE AGREEMENT
 
THIS AMENDMENT NO. 3 to the exclusive sublicense agreement (the “Amendment”) is made and entered into as of March 9, 2007 by and between Alkermes, Inc., a Pennsylvania corporation with its principal offices at 88 Sidney Street, Cambridge, MA 02139 (hereinafter referred to as “Alkermes”), and Targeted Genetics Corporation, a Washington corporation with its principal offices at 1100 Olive Way, Suite 100, Seattle, Washington 98101 (hereinafter referred to as “Targeted”).
 
WHEREAS, Alkermes and Targeted entered into an Exclusive Sublicense Agreement dated as of June 9, 1999, as previously amended on March 12, 2002 and May 29, 2003 (the “Agreement”); and
 
WHEREAS, the parties desire to amend the diligence requirements of the Agreement in accordance with the terms and conditions hereinafter set forth.
 
NOW, THEREFORE, in consideration of the foregoing premises, the parties hereto agree as follows:
 
1. Unless otherwise provided herein, all defined terms utilized in this Amendment shall have the same meanings as set forth in the Agreement.
 
2. Section 2.6 of the Agreement shall be amended and replaced as follows:
 
At any time after the date which is the [*] anniversary of the Effective Date, Targeted shall, upon receipt of notice from Alkermes to such effect, enter into good faith negotiations to enter into a sublicense agreement with a proposed sublicensee designated by Alkermes in such notice, with respect to any of the Additional Fields of Use for which Targeted, its Affiliates or Sublicensee(s) have not initiated Phase I Clinical Trials; provided that entering into such negotiations is not inconsistent with obligations of Targeted to any Sublicensee. Targeted shall consider a request from Alkermes to conduct good faith negotiations to enter into a sublicense agreement with a proposed sublicensee, prior to the [*] anniversary, in fields in which Targeted does not have any ongoing research efforts, but shall have no obligation to enter into such sublicense agreement. Any sublicense agreement described in this Section 2.6, if entered into, shall be subject to Section 2.4 above.
 
3. Except as specifically modified or amended hereby, the Agreement shall remain in full force and effect. No oral promise, covenant or representation of any character or nature has been made to induce any party to enter into this Amendment. No provision of this Amendment may be modified or amended except expressly in a writing signed by all parties nor shall any term be waived except expressly in a writing signed by the party charged therewith.
 
*Confidential Treatment Requested

 
4. This Amendment may be executed in two or more counterparts, each which shall be deemed an original but all of which taken together constitute one and the same instrument.
 
IN WITNESS WHEREOF, the parties hereto have signed this Amendment as of the day and year first above written.

   
 
Alkermes, Inc.
 
Targeted Genetics Corporation
 
By: /s/ Michael Landine
Print Name: Michael Landine
Its: Vice President
 
By: /s/ B.G. Susan Robinson
Print Name: B.G. Susan Robinson
Its: Vice President, Business Development

-2-


 

EX-10.16 3 v069612_ex10-16.htm
 
 
*Certain confidential information contained in this document, marked by brackets, has been omitted and filed with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
 
LICENSE AGREEMENT
 
This License Agreement (“Agreement”) is made by and between The Trustees of the University of Pennsylvania, a Pennsylvania nonprofit corporation, with offices located at 3160 Chestnut Street, Suite 200, Philadelphia, Pennsylvania 19104-6283 (“Penn”) and Targeted Genetics Corporation, a corporation organized and existing under the laws of Washington (“Targeted”), having a place of business at 1100 Olive Way, Suite 100, Seattle, Washington 98101.

Subject to Section 12.11, this Agreement is effective as of the 1st day of June, 2002 (“Effective Date”).

RECITALS
 
WHEREAS, Genovo, Inc., a corporation organized and existing under the laws of Delaware (“Genovo”), having a place of business at 512 Elmwood Avenue, Sharon Hill, PA 19079 and Penn are parties to the following three agreements, each dated as of June 30, 1995, and each as amended through the Effective Date (collectively sometimes called the “Existing Agreements”): that certain Sponsored Research Agreement, pursuant to which Genovo funded certain research at Penn relating to new strategies for gene therapy (“Sponsored Research Agreement”); that certain License Agreement Lung and Liver Fields pursuant to which Penn has granted certain licenses and other rights to Genovo relating to certain liver and lung fields (“Liver/Lung License”); and that certain License Agreement Additional Fields pursuant to which Penn has granted certain licenses and other rights to Genovo relating to certain other fields (“Additional Fields License”); and

WHEREAS, the Sponsored Research Agreement has now been terminated in accordance with that certain letter agreement between the parties dated February 27, 2001; and

WHEREAS, Penn owns and is a proprietor of certain intellectual property, including items developed under the Sponsored Research Agreement and items discovered or developed prior thereto and agreed to be subject to one or more of the Existing Agreements; and

WHEREAS, Genovo has become an Affiliate of Targeted in a transaction in which former shareholders of Genovo have become shareholders of Targeted; and
 
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WHEREAS, Genovo and Targeted intend to pursue further research directed toward the development and improvement of gene therapy products and potential commercialization thereof in one or more applications, and Penn desires that they do so; and

WHEREAS, Penn has determined that the exploitation of such intellectual property and improvements thereto as described herein is in the best interests of Penn, is consistent with its educational and research missions and goals, and is likely to facilitate the accomplishment of the goals that originally supported the Existing Agreements; and

WHEREAS, The Wistar Institute of Anatomy and Biology (“Wistar”) is the joint owner with Penn of the United States patents and related pending applications and foreign counterparts thereof listed in Attachment 1 (specifically, Penn docket H1255, hereafter the “Penn/Wistar Patents”); and

WHEREAS, Penn may, with Wistar’s written approval, enter into binding agreements for the granting of licenses with respect to the Penn/Wistar Patent Application;

NOW, THEREFORE, in consideration of the premises and of the promises and covenants contained herein and intending to be legally bound hereby, the parties agree as follows:

ARTICLE 1 - DEFINITIONS
 
For the purposes of this Agreement, in addition to the other terms defined above or elsewhere in this Agreement, the following words and phrases shall have the meanings set forth herein.

1.1 [*],” as to a product (and as to the point in time when this definition is referenced in this Agreement as to such product), means that such product [*] achieved the milestone in [*] and has since the achievement of such milestone progressed as applicable [*] set forth below:

 
(a)
[*] on such product with the appropriate health regulatory authority(ies) in at least one Major Nation, and Targeted, a Covered Affiliate, or their collaborators or sublicensees [*];

 
(b)
[*] clinical trials of such product have been [*] within [*] year [*] for such product [*], and Targeted, a Covered Affiliate, or their collaborators or sublicensees exert commercially reasonable efforts to conduct and complete [*];

 
(c)
where [*] trials were [*] for such product, [*] clinical trials of such product have been [*] within [*] years after the [*] of such [*] clinical trials, and Targeted, a Covered Affiliate, or their collaborators or sublicensees exert commercially reasonable efforts to conduct and complete such [*] trials of such product, including the [*];
 

*Confidential Treatment Requested.
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(d)
[*] clinical trials of such product have been [*] within [*] years after the [*] (or [*] years after the [*] where [*] trials were [*] for such product) clinical trials for such product, and Targeted, a Covered Affiliate, or their collaborators or sublicensees exert commercially reasonable efforts to conduct and complete such [*] clinical trials of such product, including the [*] ;

 
(e)
[*] for such product has been [*] with the appropriate health regulatory authority(ies) in at least one Major Nation within [*] years after the [*] for such product, and Targeted, a Covered Affiliate, or their collaborators or sublicensees exert commercially reasonable efforts to [*] of such [*] until at least one such [*] or until all [*] (it being understood that the product will no longer be in [*] if all such [*] in all Major Nations have been [*]; and

 
(f)
such product [*] in at least one Major Nation within [*] such product by the appropriate health regulatory authority(ies) in that Major Nation (including [*] in such Major Nation);

provided, however, that (1) if Targeted [*] (even if, in Targeted’s [*], it is prudent for Targeted to do so), Targeted will not be considered to be exerting commercially reasonable efforts as to the conduct of such clinical trial; (2) the time periods specified in this Section as applied to a product shall be tolled during any period or periods in which Targeted is, beyond its reasonable control, prevented from developing such product by government-imposed moratoriums, laws or rulings that prevent others generally from developing similar products, it being understood that if a clinical trial is halted or suspended because of [*] to Targeted’s conduct of the trial, such action will not toll the time periods specified in this Section as applied to the product involved in such trial; and (3) if at any time or times Targeted believes that it may not be able to advance a particular product through one or more of the above stages of development within any of the specific time periods specified in this Section (whether or not due to factors described in clause (2) above), it may so notify Penn, together with a reasonably detailed description of the factors or reasons why Targeted believes it should nevertheless continue to be considered to have such product under [*] whereupon Penn and Targeted will over a period of at least [*] to reach agreement on extension(s) to such time period(s) as shall be reasonable in the circumstances.

1.2 Affiliate” of an entity means and includes the entities that, directly or indirectly, own or control more than 50% of the voting interests (or equivalent control) of such entity (“Parent”), or more than 50% of the voting interests (or equivalent control) of which is, directly or indirectly, owned or controlled by such entity or its Parent. “Affiliated” refers to Affiliates. “Covered Affiliate” refers to an affiliate of Targeted that has agreed in writing to be bound by Targeted’s rights and obligations under this Agreement; Penn acknowledges that Genovo, by its signature agreeing to be bound by all the terms and obligations of Targeted below, is a Covered Affiliate.

*Confidential Treatment Requested.
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1.3 Bankruptcy Event” means voluntary or involuntary proceedings by or against Targeted are instituted in bankruptcy or under any insolvency law, or a receiver or custodian is appointed for Targeted, or proceedings are instituted by or against Targeted for corporate reorganization or the dissolution of Targeted, which proceedings, if involuntary, shall not have been dismissed within sixty (60) days after the date of filing, or Targeted makes an assignment for the benefit of creditors, or substantially all of the assets of Targeted are seized or attached and not released within sixty (60) days thereafter.

1.4 [*]” includes [*].

1.5 Calendar Quarter” means each three-month period, or any portion thereof, beginning on January 1, April 1, July 1 and October 1.

1.6 Calendar Year” means a period of twelve (12) months beginning on January 1 and ending on December 31.

1.7 [*] Field” means the prevention, treatment or cure of [*] whether by in vivo or ex vivo means (together with preparation, research, development, and attempts to do the foregoing).

1.8 Confidential Information” means and includes all technical information, inventions, developments, discoveries, software, know-how, methods, techniques, formulae, data, processes and other proprietary ideas, whether or not patentable or copyrightable, that Penn identifies as confidential or proprietary at the time it is delivered or communicated to Targeted.

1.9 "[*]" means, with respect to a Penn Licensed Product: (a) the [*] (or its equivalent) filed on such Penn Licensed Product in any Major Nation; and (b) up to [*] additional [*] each of which is [*], and for which [*] within the next [*] years for a Penn Licensed Product incorporating the same [*] as such Penn Licensed Product and/or [*] of up to [*] additional [*] in such Penn Licensed Product. Targeted shall designate the additional [*] and additional [*] referred to in clause (b) within [*] following the [*] on such Penn Licensed Product in any Major Nation; provided, however, that as to Penn Licensed Products covered by Group 2 Patents, Targeted may designate such additional [*] and additional [*] at an earlier time as described in Section 4.2.3. If, within such [*] following the [*] or equivalent referred to in clause (a), none of Targeted or its Affiliates or licensees has actually [*] or equivalent in at least one Major Nation for a Penn Licensed Product directed to a [*] that was so designated, then that [*] shall from that time forward no longer be among the [*] with respect to the Penn Licensed Product that was the subject [*] referred to in clause (a).
 
*Confidential Treatment Requested.
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1.10  Fair Market Value” means:

1.10.1 in the case of a Sale, the cash consideration which Targeted or its Covered Affiliate or sublicensee would realize from an unaffiliated, unrelated buyer under no obligation to buy in an arm’s length sale of an identical item sold in the same quantity and at the same time and place of the transaction; or

1.10.2 in the case of a transaction other than a Sale, the cash consideration which a willing party would realize from an unaffiliated, unrelated third party under no obligation to transact in an arm’s length transaction of the same type and at the same time and place of transaction; provided, however, that where Sales or other transactions are made in connection with patient assistance programs or other charitable purposes or to physicians or hospitals for promotional purposes, “Fair Market Value” for purposes hereof shall mean the actual consideration received, if any.
 
1.11  Federal Government Interest” means the rights of the United States Government under Public Laws 96-517, 97-256 and 98-620, codified at 35 U.S.C. 200-212, and any regulations issued thereunder, as such statute or regulations may be amended from time to time hereafter.

1.12 [*]” means [*].

1.13  [*] Letter Agreement” means that certain letter agreement among [*] dated as of August 27, 1999, as amended through the Effective Date.

1.14 [*] Field” means the prevention, treatment, or cure of [*] whether by in vivo or ex vivo means (together with preparation, research, development, and attempts to do the foregoing).

1.15 Major Nation(s)” means any one or more of Canada, France, Germany, Japan, the United Kingdom, or the United States. It is agreed for the avoidance of doubt that any filings or other actions or proceedings with or in the European Agency for the Evaluation of Medicinal Products or its successor will be considered to be with or in the health regulatory agency in at least one Major Nation.

1.16 Net Sales” means the gross sales amounts or, if such consideration is in a form other than cash or cash equivalents, the Fair Market Value, received by Targeted or its Covered Affiliates or their sublicensees from the Sale of any Penn Licensed Product(s), less qualifying costs directly attributable to such Sale borne by Targeted, its Covered Affiliate or their sublicensees. Such qualifying costs shall be limited to the following:

1.16.1 Discounts, in amounts customary in the trade, for quantity purchases, prompt payments and for wholesalers and distributors;

*Confidential Treatment Requested.
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1.16.2 Credits or refunds, not exceeding the original invoice amount, for claims or returns;

1.16.3 Prepaid outbound packing, transportation expenses and transportation insurance premiums;

1.16.4 Sales and use taxes and other fees imposed by a governmental agency; and

1.16.5 Retroactive price reductions or rebates as required by law,

all in accordance with U.S. generally accepted accounting principles consistently applied.

1.17 Non-Targeted Party” means any person or entity that is not Penn, Targeted, an Affiliate of Penn, a Covered Affiliate, a sublicensee of Targeted or of a Covered Affiliate (which term refers to persons or entities to the extent acting under an express sublicense of rights of Targeted or a Covered Affiliate under this Agreement), or another collaborator or distributor of Targeted, a Covered Affiliate, or their sublicensees.

1.18 Penn Licensed Product(s)” means

1.18.1  products that in the absence of this Agreement would, where and when made, used, sold, or imported, infringe at least one issued claim or pending claim of Penn Patent Rights; and

1.18.2  products that are made using a process or machine that in the absence of this Agreement would, where and when used, infringe at least one issued claim or pending claim of Penn Patent Rights.

All Penn Licensed Products intended to [*] shall be considered [*] Penn Licensed Product for purposes of Sections 4.1 and 4.3.

1.19 [*]” means [*].
 
1.20 Penn Patent Rights” means those patents and patent applications listed in Attachment 1 to this Agreement and all foreign counterparts thereof, as well as continuation, continuation-in-part, provided that such continuation-in-part relates directly to existing patents or patent applications and not to any new matter, divisional and re-issue applications thereof, together with any and all patents issuing thereupon or upon any foreign counterparts thereof; provided, however, that Targeted and Genovo acknowledge that the invention relating to [*], was made at Penn following [*]. Targeted and Genovo hereby acknowledge that they have no rights in this invention relating to [*], as defined in these applications and divisionals, continuations, re-examinations, re-issues, and any foreign counterparts thereof, and any patents issuing therefrom. Targeted and Genovo agree that they will not make or pursue any claims that this invention as so defined is or should have been part of the Penn Patent Rights.
 
*Confidential Treatment Requested.
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1.20.1 Group 1 Patents” means those Penn Patent Rights that are so designated in Attachment 1.

1.20.2 Group 2 Patents” means those Penn Patent Rights that are so designated in Attachment 1.

1.20.3 Group 3 Patents” means those Penn Patent Rights that are so Designated in Attachment 1.

1.20.4 Group 4 Patents” means those Penn Patent Rights that are so designated in Attachment 1.

1.20.5 Group 5 Patents” means those Penn Patent Rights that are so designated in Attachment 1.
 
1.21 Penn Technical Information” means research and development information, unpatented inventions, know-how, and technical data developed by Dr. James Wilson, or other employees of Penn with a duty to assign their rights to Penn, under the Sponsored Research Agreement designated in Attachment 2 or described in the Penn Patent Rights, and not otherwise covered by Penn Patent Rights.

1.22 Phase I Trials” “Phase II Trials” and “Phase III Trials” mean, respectively, human clinical trials designated by the U.S. Food and Drug Administration (FDA) as Phase I, Phase II (or Phase I/II), or Phase III trials.

1.23 Sale” means any bona fide transaction for which consideration is received or expected for the sale, use, lease, transfer, or other disposition of Penn Licensed Product(s); provided, however, that the sale, lease, transfer, or other disposition of any Penn Licensed Product between Targeted, its Covered Affiliates, or their sublicensees, and another entity in such group, other than to a non-Covered-Affiliate distributor or to an end user, shall not be considered a Sale. In such cases, “Net Sales” hereunder shall be determined using the invoiced or otherwise recognized sales price by the transferee party, Covered Affiliate, or sublicensee to the non-Covered-Affiliate distributor or the end user, less the qualifying costs allowed under Section 1.16. A Sale of Penn Licensed Product(s) shall be deemed completed at the time Targeted, its Covered Affiliate or their sublicensee invoices, ships, or receives payment for such Penn Licensed Product(s), whichever occurs first. Sale shall not include any use of Penn Licensed Products in preclinical work, clinical trials, or internal research by Targeted, its Covered Affiliates, or their sublicensees or other collaborators, distributors, or contractors, or [*].
 
*Confidential Treatment Requested.
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1.24 Senior Officer(s)” means, as to Targeted at any relevant time, the then-incumbent Chief Executive Officer of Targeted, and as to Penn at any relevant time, the Managing Director, Center for Technology Transfer.

1.25 [*] Field” means the prevention, treatment, or cure of any disease or diseases in whole or in part through [*], whether by in vivo or ex vivo means (together with preparation, research, development, and attempts to do the foregoing). For purposes hereof, the [*] are more fully described in Attachment 3.

ARTICLE 2 - LICENSE GRANTS AND DILIGENCE
 
2.1 Group 1 Patents.

2.1.1 Group 1 License Grant. Penn hereby grants to Targeted and the Covered Affiliates for the term of this Agreement the worldwide right and license, with the right to grant sublicenses, to develop, have developed, make, have made, use, have used, import, have imported, sell, offer for sale and have sold Penn Licensed Products under the Group 1 Patents [*] to Targeted.

2.1.2 Group 1 Diligence Outside the [*] Field and the [*] Field. Penn shall have the right, at its option, to [*] the right and license under this Section 2.1 from [*] outside of the [*] Field and also outside of the [*] Field, if Targeted [*] of the following conditions, provided that, except as to the condition stated in clause (e) below, Penn exercises such right by written notice to Targeted within [*] after Penn's receipt of Targeted's Development Plan for the period in which such condition was due, or receipt of explicit written notice from Targeted, in response to Penn's written inquiry, that such condition has not been satisfied, whichever occurs first, and that Penn gives Targeted at least [*] prior notice of Penn’s intention to exercise such right:

 
(a)
Targeted and its Affiliates and sublicensees [*] covered by the Group 1 Patents prior to the end of the [*];

(b)
Targeted and its Affiliates and sublicensees [*] at any time after the [*] anniversary of the Effective Date, to have [*] trials utilizing and exercising commercially reasonable progress toward [*], without [*], for at least [*] under the Group 1 Patents for use outside of both the [*] Field and the [*] Field;

(c)
Targeted and its Affiliates and sublicensees [*] at any time after the [*] anniversary of the Effective Date, to have [*] trials utilizing and exercising commercially reasonable progress toward [*], without [*], for at least [*] under the Group 1 Patents for use outside of both the [*] Field and the [*] Field;
 
*Confidential Treatment Requested.
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(d)
Targeted and its Affiliates and sublicensees [*], at any time after the [*] anniversary of the Effective Date, to have [*] trials utilizing and exercising commercially reasonable progress toward [*], without [*], for at least [*] under the Group 1 Patents for use outside of both the [*] Field and the [*] Field; or

(e)
Targeted, its Affiliates, and sublicensees [*], at any time after the [*] anniversary of the Effective Date, to have [*] at least [*] under the Group 1 Patents for use outside of both the [*] Field and the [*] Field.

2.1.3 Group 1 Specific-[*] Sublicenses after Year [*]. [*], Targeted shall make non-exclusive, commercial-use [*] under the Group 1 Patents available to third parties on commercially reasonable terms, provided that (unless Targeted [*] in its discretion): (a) each such sublicense is restricted to [*]; (b) such [*] is(are) not the subject of any sublicense previously granted by Targeted or its Affiliates on an exclusive basis, nor is any such exclusive sublicense with respect to such [*] then in active negotiation; (c) such sublicense does not permit use in or application to the [*] Field or in or to the [*] Field or in or to the [*] Field; and (d) such sublicense does not permit use or application to any product in an [*] applicable to any Penn Licensed Product that is then in [*] by Targeted, its Affiliates or their licensees. Where Targeted has [*] for such a sublicense and [*] within [*] thereafter, Targeted shall either inform Penn [*], together with a statement of the terms on which [*], or else Targeted shall [*], then Penn shall have the right to [*], provided that [*] under clauses (a) - (d) above (reading references to [*] to refer [*], and recognizing that Penn will [*] criteria under clauses (b) and (d) [*] with relevant information with respect thereto), and [*].

2.1.4 Group 1 Diligence in the [*] Field. Penn shall have the right, at its option, to [*] the right and license under this Section 2.1 [*] in the [*] Field if Targeted and its Affiliates and sublicensees [*], at any time after the [*] anniversary of the Effective Date, to have [*] at least [*] under the Group 1 Patents for use in the [*] Field, provided that Penn gives Targeted at [*] prior notice of Penn’s intention to exercise such right.

2.1.5 Group 1 Diligence in the [*] Field. Penn shall have the right, at its option, to [*] the right and license under this Section 2.1 [*] in the [*] Field if Targeted and its Affiliates and sublicensees [*], at any time after the [*] anniversary of the Effective Date, to have [*] at least [*] under the Group 1 Patents for use in the [*] Field, provided that Penn gives Targeted at least [*] prior notice of Penn’s intention to exercise such right.

2.2 Group 2 Patents.
 
2.2.1 Group 2 License Grant. Penn hereby grants to Targeted and the Covered Affiliates for the term of this Agreement the worldwide right and license, with the right to grant sublicenses, to develop, have developed, make, have made, use, have used, import, have imported, sell, offer for sale and have sold Penn Licensed Products under the Group 2 Patents [*].
 
*Confidential Treatment Requested.
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2.2.2 Group 2 Licenses to [*]. Penn retains the right to license [*] (“[*]”) non-exclusively to develop, have developed, make, have made, use, have used, import, have imported, sell, offer for sale and have sold Penn Licensed Products under the Group 2 Patents solely [*] Field, and solely in conjunction with [*]’s proprietary [*] technology that exists as of the Effective Date, including any improvements and modifications thereof, (currently referred to as [*]’s “[*]” and “[*]” technologies, including any modifications and improvements of the foregoing, and inclusive of subsequent improvements thereto, provided that the technology remains a [*] operably linked to some [*] proprietary [*] technology) and that is substantial and necessary to be used for such development, making, use, importation or sale of such Penn Licensed Products; provided, however, that:

(a)
[*] may be permitted to grant sublicenses under such license, provided that the sublicensee is similarly bound to use such Penn Licensed Patents solely in conjunction with such [*] proprietary [*] technology; and

(b)
Notwithstanding the foregoing in any transaction or transactions between [*] or its sublicensees on the one hand and either Targeted or [*] on the other, in any such transaction(s), rights to the Group 2 Patents will be obtained from Targeted based upon its rights under this Agreement and/or [*] based upon its sublicense from Targeted.

2.2.3 Group 2 Specified [*] Sublicenses in Years [*]. [*], Targeted shall make non-exclusive, commercial-use [*] under the Group 2 Patents available to third parties on commercially reasonable terms, provided that (unless Targeted [*] in its discretion): (a) each such sublicense is restricted to [*]; (b) neither such [*], nor the delivery thereof, are at the time such sublicense is sought or under negotiation the subject of any on-going research, development, regulatory or commercial project at Targeted or its Affiliates in which at least one of the [*] has been [*]; (c) such [*] is(are) not the subject of any sublicense previously granted by Targeted or its Affiliates on an exclusive basis, nor is any such exclusive sublicense with respect to such [*] then in active negotiation; (d) such third party or its Affiliate is then actively funding substantial and on-going research at Penn in the Institute for Human Gene Therapy; (e) such sublicense does not permit use in or application to the [*] Field or in or to the [*] Field or in or to the [*] Field; and (f) such sublicense does not permit use or application to an [*] applicable to any Penn Licensed Product that is then either in [*] by Targeted or its Affiliates or that is otherwise then the subject of any on-going research, development, regulatory or commercial project at Targeted, its Affiliates or their licensees in which at least [*] and as to which the [*] have been determined pursuant to Section 1.9 or Section 4.2.3. Where Targeted has [*] for such a sublicense and [*] within [*] thereafter, Targeted shall either inform Penn of [*], together with a statement of the terms on which [*], or else Targeted shall [*], then Penn shall have the right to [*], provided that [*] under clauses (a) - (f) above (reading references to [*] to refer [*], and recognizing that Penn will [*].
 
*Confidential Treatment Requested.
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2.2.4 Group 2 Specified [*] Sublicenses after [*]. [*], Targeted shall make non-exclusive, commercial-use [*] under the Group 2 Patents available to third parties on commercially reasonable terms, provided that (unless Targeted [*] in its discretion): (a) each such sublicense is restricted to [*] identified in such sublicense; (b) such [*] is(are) not the subject of any sublicense previously granted by Targeted or its Affiliates on an exclusive basis, nor is any such exclusive sublicense with respect to such [*] then in active negotiation; (c) such sublicense does not permit use in or application to the [*] Field or in or to the [*] Field or in or to the [*] Field; and (d) such sublicense does not permit use or application to an [*] applicable to any Penn Licensed Product that is then in [*] by Targeted, its Affiliates or their licensees. Where Targeted has [*] and [*] within [*] thereafter, Targeted shall either inform Penn [*], together with a statement of the terms on which [*], or else Targeted shall [*] then Penn shall have the right to [*], provided that [*] under clauses (a) - (d) above (reading references to [*] to refer [*] and recognizing that Penn will [*].

2.2.5 Group 2 Diligence outside the [*] Field and the [*] Field. Penn shall have the right, at its option, to [*] the right and license under this Section 2.2 [*] outside of the [*] Field and also outside of the [*] Field, if Targeted and its Affiliates and sublicensees [*], at any time after the [*] anniversary of the Effective Date, to have [*] at least [*] under the Group 2 Patents for use outside of both the [*] Field and the [*] Field, provided that Penn gives Targeted at least [*] prior notice of Penn’s intention to exercise such right. Targeted shall have the right, at its option and by notice to Penn given at any time on or before the [*] anniversary of the Effective Date, to [*] the right and license under this Section 2.2 (or with respect to one or more of the Penn Patent Rights included in Group 2) [*] outside the [*] Field and the [*] Field from the date of such notice forward.

2.2.6 Group 2 Diligence in the [*] Field. Penn shall have the right, at its option, to [*] the right and license under this Section 2.2 [*] in the [*] Field if Targeted and its Affiliates and sublicensees [*], at any time after the [*] anniversary of the Effective Date, to have [*] at least [*] under the Group 2 Patents for use in the [*] Field, provided that Penn gives Targeted at least [*] prior notice of Penn’s intention to exercise such right. Targeted shall have the right, at its option and by notice to Penn given at any time on or before the [*] anniversary of the Effective Date, to [*] the right and license under this Section 2.2 (or with respect to one or more of the Penn Patent Rights included in Group 2) [*] in the [*] Field from the date of such notice forward.
 
2.2.7 Group 2 Diligence in the [*] Field. Penn shall have the right, at its option, to [*] the right and license under this Section 2.2 [*] in the [*] Field if Targeted and its Affiliates and sublicensees [*], at any time after the [*] anniversary of the Effective Date, to have [*] at least [*] under the Group 2 Patents for use in the [*] Field, provided that Penn gives Targeted at least [*] prior notice of Penn’s intention to exercise such right. Targeted shall have the right, at its option and by notice to Penn given at any time on or before the [*] anniversary of the Effective Date, to [*] the right and license under this Section 2.2 (or with respect to one or more of the Penn Patent Rights included in Group 2) [*] in [*] Field from the date of such notice forward.
 
*Confidential Treatment Requested.
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2.3 Group 3 Patents.

2.3.1 Group 3 License Grant. Penn hereby grants to Targeted and the Covered Affiliates for the term of this Agreement the worldwide right and license, with the right to grant sublicenses, to develop, have developed, make, have made, use, have used, import, have imported, sell, offer for sale and have sold Penn Licensed Products under the Group 3 Patents in [*].

2.3.2 Group 3 Specified [*] Sublicenses after Year [*]. [*], Targeted shall make non-exclusive, commercial-use [*] under the Group 3 Patents available to third parties on commercially reasonable terms, provided that (unless Targeted [*]in its discretion): (a) each such sublicense is restricted to [*] identified in such sublicense; (b) such [*] is(are) not the subject of any sublicense previously granted by Targeted or its Affiliates on an exclusive basis, nor is any such exclusive sublicense with respect to such [*] then in active negotiation; (c) such sublicense does not permit use in or application to the [*] Field or in or to the [*] Field or in or to the [*] Field; and (d) such sublicense does not permit use or application to any product in an [*] applicable to any Penn Licensed Product that is then in [*] by Targeted, its Affiliates or their licensees. Where Targeted has [*] and [*] within [*] thereafter, Targeted shall either inform Penn [*], together with a statement of the terms on which [*], or else Targeted shall [*] under the Group 3 Patents, provided that [*] under clauses (a) - (d) above (reading references therein to [*] to refer [*] and recognizing that Penn will [*]).

2.3.3 Group 3 Diligence outside the [*] Field and the [*] Field. Penn shall have the right, at its option, to [*] the right and license under this Section 2.3 [*] outside of the [*] Field and also outside of the [*] Field, if Targeted and its Affiliates and sublicensees [*], at any time after the [*] anniversary of the Effective Date, to have [*] at least [*] under the Group 3 Patents for use outside of both the [*] Field and the [*] Field, provided that Penn gives Targeted at least [*] prior notice of Penn’s intention to exercise such right. Targeted shall have the right, at its option and by notice to Penn given at any time on or before the [*] anniversary of the Effective Date, to [*] the right and license under this Section 2.3 (or with respect to one or more of the Penn Patent Rights included in Group 3) [*] outside the [*] Field and the [*] Field from the date of such notice forward.

2.3.4 Group 3 Diligence in the [*] Field. Penn shall have the right, at its option, to [*] the right and license under this Section 2.3 [*] in the [*] Field if Targeted and its Affiliates and sublicensees [*], at any time after the [*] anniversary of the Effective Date, to have [*] at least [*] under the Group 3 Patents for use in the [*] Field, provided that Penn gives Targeted at least [*] prior notice of Penn’s intention to exercise such right. Targeted shall have the right, at its option and by notice to Penn given at any time on or before the [*] anniversary of the Effective Date, to [*] the right and license under this Section 2.3 (or with respect to one or more of the Penn Patent Rights included in Group 3) [*] in the [*] Field from the date of such notice forward.
 
*Confidential Treatment Requested.
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2.3.5 Group 3 Diligence in the [*] Field. Penn shall have the right, at its option, to [*] the right and license under this Section 2.3 [*] in the [*] Field if Targeted and its Affiliates and sublicensees [*], at any time after the [*] anniversary of the Effective Date, to have [*] at least [*] under the Group 3 Patents for use in the [*] Field, provided that Penn gives Targeted at least [*] prior notice of Penn’s intention to exercise such right. Targeted shall have the right, at its option and by notice to Penn given at any time on or before the [*] anniversary of the Effective Date, to [*] the right and license under this Section 2.3 (or with respect to one or more of the Penn Patent Rights included in Group 3) [*] in the [*] Field from the date of such notice forward.

2.4 Group 4 Patents.

2.4.1 Group 4 License Grant. Penn hereby grants to Targeted and the Covered Affiliates for the term of this Agreement the worldwide right and license, with the right to grant sublicenses, to develop, have developed, make, have made, use, have used, import, have imported, sell, offer for sale and have sold Penn Licensed Products under the Group 4 Patents [*].

2.4.2 Group 4 Diligence in the [*] Field. Penn shall have the right, at its option, to [*] the right and license under this Section 2.4 [*] in the [*] Field if Targeted and its Affiliates and sublicensees [*], at any time after the [*] anniversary of the Effective Date, to have [*] at least [*] under the Group 4 Patents for use in the [*] Field, provided that Penn gives Targeted at least [*] prior notice of Penn’s intention to exercise such right. Targeted shall have the right, at its option and by notice to Penn given at any time on or before the [*] anniversary of the Effective Date, to [*] the right and license under this Section 2.4 (or with respect to one or more of the Penn Patent Rights included in Group 4) [*] in the [*] Field from the date of such notice forward.

2.4.3 Group 4 Diligence in the [*] Field. Penn shall have the right, at its option, to [*] the right and license under this Section 2.4 [*] in the [*] Field if Targeted and its Affiliates and sublicensees [*], at any time after the [*] anniversary of the Effective Date, to have [*] at least [*] under the Group 4 Patents for use in the [*] Field, provided that Penn gives Targeted at least [*] prior notice of Penn’s intention to exercise such right. Targeted shall have the right, at its option and by notice to Penn given at any time on or before the [*] anniversary of the Effective Date, to [*] the right and license under this Section 2.4 (or with respect to one or more of the Penn Patent Rights included in Group 4) [*] in the [*] Field from the date of such notice forward.

2.5 Group 5 Patents.
 
2.5.1 Group 5 License Grant. Penn hereby grants to Targeted and the Covered Affiliates for the term of this Agreement the worldwide right and license, with the right to grant sublicenses, to develop, have developed, make, have made, use, have used, import, have imported, sell, offer for sale and have sold Penn Licensed Products under the Group 5 Patents [*].
 
*Confidential Treatment Requested.
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2.5.2 Group 5 Diligence in the [*] Field. Penn shall have the right, at its option, to [*] the right and license under this Section 2.5 [*] in the [*] Field if Targeted and its Affiliates and sublicensees [*], at any time after the [*] anniversary of the Effective Date, to have [*] at least [*] under the Group 5 Patents for use in the [*] Field, provided that Penn gives Targeted at least [*] prior notice of Penn’s intention to exercise such right. Targeted shall have the right, at its option and by notice to Penn given at any time on or before the [*] anniversary of the Effective Date, to [*] the right and license under this Section 2.5 (or with respect to one or more of the Penn Patent Rights included in Group 5) [*] in [*] Field from the date of such notice forward.

2.5.3 Group 5 Diligence in the [*] Field. Penn shall have the right, at its option, to [*] the right and license under this Section 2.5 [*] in the [*] Field if Targeted and its Affiliates and sublicensees [*], at any time after the [*] anniversary of the Effective Date, to have [*] at least [*] under the Group 5 Patents for use in the [*] Field, provided that Penn gives Targeted at least [*] prior notice of Penn’s intention to exercise such right. Targeted shall have the right, at its option and by notice to Penn given at any time on or before the [*] anniversary of the Effective Date, to [*] the right and license under this Section 2.5 (or with respect to one or more of the Penn Patent Rights included in Group 5) [*] in [*] Field from the date of such notice forward.

2.6 No Implied Diligence. Targeted’s diligence obligations with respect to this Agreement and the licenses granted hereunder are as explicitly stated in this Article 2, and no other or additional diligence or efforts obligations are implied, nor shall any be inferred.

2.7 Retained Research Rights. For all exclusive licenses granted under this Article 2: (i) Penn retains the reserved right to use, and to permit other for-profit or nonprofit organizations to use, the Penn Patent Rights strictly for educational and for research purposes and to use or commercialize the results thereof, provided that any and all such commercialization of results, if not otherwise sublicensed by Targeted in its sole discretion and without obligation to do so, may be done, and is done, without any further use of or commercialization of any of the Penn Patent Rights within the scope of any exclusive rights of Targeted or the Covered Affiliates hereunder, and that such restriction is incorporated into a written agreement with such organization; and (ii) Wistar retains the reserved right to use and permit other for-profit or nonprofit organizations to use the Penn/Wistar Patent strictly for educational and research purposes and to use or commercialize the results thereof, provided that any and all such commercialization of results, if not otherwise sublicensed by Targeted in its sole discretion and without obligation to do so, may be done, and is done, without any further use of or commercialization of any of the Penn Patent Rights within the scope of any exclusive rights of Targeted or the Covered Affiliates hereunder, and that such restriction is incorporated into a written agreement with such organization.
 
*Confidential Treatment Requested.
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2.8 Government Interest. Targeted acknowledges that in accordance with the Federal Government Interest, the United States government retains certain rights in intellectual property funded in whole or part under any contract, grant or similar agreement with a Federal agency, including but not limited to the requirement that Penn Licensed Products subject to Sale in the United States must be substantially manufactured in the United States. The license grant of this Article 2 is expressly subject to all of such rights.

2.9 Penn Technical Information. Penn, to the extent it has rights in the Penn Technical Information, hereby irrevocably grants Targeted and the Covered Affiliates a non-exclusive, royalty-free, paid-up right and license, without right to sublicense, to make, use, sell, import, reproduce, disclose and otherwise exploit the same during and after the term of this Agreement.
 
2.10 No Implied Licenses. No other rights or licenses are granted by implication hereunder. Targeted acknowledges that Penn shall have the right, in its sole discretion and without obligation to Targeted, to grant other parties licenses under the Penn Patent Rights so long as the same do not conflict with, and are not within the scope of, any of the exclusive rights or licenses granted hereunder to Targeted and the Covered Affiliates.

ARTICLE 3 - SUBLICENSES

3.1 The right to sublicense conferred upon Targeted and the Covered Affiliates under this Agreement shall be subject to the following conditions:

3.1.1 Any sublicenses shall be subject to the terms and conditions granted to Targeted and the Covered Affiliates under this Agreement.

3.1.2 No sublicensee (excluding, for this purpose, [*] under that certain [*], among [*], as amended, and [*] under the [*] Letter Agreement, but including, for this purpose, any sub-sublicensee of [*] under such agreement(s)) shall have the power to grant further sublicenses without the express approval of Penn, which approval shall not be unreasonably withheld.

3.1.3 Targeted shall forward to Penn, within thirty (30) days of execution, a complete and accurate copy written in the English language of each sublicense granted hereunder for which Targeted has exclusive rights. Penn’s receipt of such sublicense shall not constitute an approval of such sublicense or a waiver of any of Penn’s rights or Targeted’s obligations hereunder.

3.1.4 Targeted shall not grant any sublicense under any Penn Patent Rights in fields where Targeted has non-exclusive license rights hereunder unless:
 
*Confidential Treatment Requested.
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(a)
such license to Targeted hereunder was initially non-exclusive or became non-exclusive due to an election by Targeted as provided herein (rather than due to [*], and such sublicense is not a [*]; or

 
(b)
the conditions in provision (a) apply except that the sublicense is a [*] and Targeted has obtained Penn’s prior written approval of such sublicense, which approval shall not be reasonably withheld or delayed; or

 
(c)
if the license to Targeted [*], Targeted has obtained Penn’s prior written approval of such sublicense.

3.1.5 If Targeted becomes subject to a Bankruptcy Event, all payments then or thereafter due and owing to Targeted from its sublicensees shall upon notice from Penn to any such sublicensee become payable directly to Penn for the account of Targeted; provided however, that Penn shall remit to Targeted the amount by which such payments exceed the amounts owed by Targeted to Penn.

3.1.6 Notwithstanding any such sublicense, Targeted shall remain primarily liable to Penn for all of Targeted’s duties and obligations contained in this Agreement, and any act or omission of a Covered Affiliate or sublicensee of Targeted which would be a breach of this Agreement if performed by Targeted shall be deemed to be a breach by Targeted of this Agreement.

3.2 Targeted and Penn acknowledge that (i) for purposes of the [*] Letter Agreement, [*] by this Agreement, but, rather, shall only have been amended hereby, and (ii) [*] shall not be bound by any amendment or alteration of the Existing Agreements, or any of them, to the extent the same may bear on the rights or obligations of [*] under the [*] Letter Agreement. Accordingly, Targeted and Penn agree that this Agreement is intended to be, and shall be construed to be, consistent with the [*] Letter Agreement, [*] Letter Agreement shall remain in full force and effect.
 
ARTICLE 4 - ROYALTIES AND MILESTONES
 
4.1 Royalties.

4.1.1 In further consideration of the licenses granted pursuant to Article 2, but subject to Section 4.1.4, Targeted shall pay to Penn a royalty in accordance with the following table for the Net Sales received by Targeted, the Covered Affiliates, or their sublicensees with respect to each particular Penn Licensed Product that has been, or that later is, in whole or in part developed by [*] under a right or sublicense granted by Targeted or a Covered Affiliate or otherwise collaboratively by [*] on the one hand and by Targeted and/or Covered Affiliates on the other:
 
*Confidential Treatment Requested.
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For the portion of Net Sales of such Penn Licensed Product in a Calendar Year:
The royalty rate for such Net Sales will be:
Less than or equal to [*]
[*]
Greater than [*] and less than or equal to [*]
[*]
Greater than [*] and less than or equal to [*]
[*]
Greater than [*]
[*]

4.1.2 In further consideration of the licenses granted pursuant to Article 2, but subject to Section 4.1.4, Targeted shall pay to Penn a royalty in accordance with the following table for the Net Sales received by Targeted, the Covered Affiliates, or their sublicensees with respect to each particular Penn Licensed Product to which Section 4.1.1 above is not applicable:

For the portion of Net Sales of such Penn Licensed Product in a Calendar Year:
The royalty rate for such Net Sales will be:
Less than or equal to $[*]
[*]
Greater than $[*] and less than or equal to $[*]
[*]
Greater than $[*] and less than or equal to $[*]
[*]
Greater than $[*]
[*]
 
*Confidential Treatment Requested.
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4.1.3 For purposes of each of Section 4.1.1 and Section 4.1.2: (i) no additional or multiple royalties shall be payable with respect to the Net Sales of any Penn Licensed Product, regardless of the number of Penn Patent Rights, or claims of Penn Patent Rights, that would in the absence of this Agreement be infringed by such Penn Licensed Product or processes or machines used to make it, even if such Penn Patent Rights include those from more than one of the patent groups defined in Section 1.20; (ii) the Net Sales thresholds in such sections will be [*], but where the same Penn Licensed Product is [*], or otherwise to accommodate the same to [*], the Net Sales thereof in all such nations, markets and indications shall be [*] for purposes of Section 4.1.2; and (iii) all Net Sales of any particular Penn Licensed Product received by any of Targeted, Covered Affiliates, or their sublicensees will be [*] for purposes of Section 4.1.2.

4.1.4 The royalties otherwise payable under Section 4.1.1 or 4.1.2 shall be [*] with respect to the Net Sales of any Penn Licensed Product that, at the time of its Sale and in the patent jurisdiction of its Sale, has a competing product also licensed under the Penn Patent Rights on sale.

4.1.5 Targeted shall promptly pay to Penn the scheduled percentage, as set forth below, of any sublicense initiation fee, or other such consideration not associated with Sales, paid to Targeted or a Covered Affiliate by each sublicensee that is not Targeted or a Covered Affiliate. All such considerations [*] shall be exempt. In addition, Targeted shall not be required to [*] Penn a percentage of i) [*]; ii) [*] or iii) [*]. Any non-cash consideration received by Targeted or a Covered Affiliate from such sublicensees shall be valued at its Fair Market Value as of the date of receipt. Where any rights under this Agreement to Penn Patent Rights are sublicensed by Targeted or a Covered Affiliate in [*], the aggregate of any sublicense initiation fees or other such consideration not associated with Sales received by Targeted or the Covered Affiliate shall for purposes of this Section be [*] under this Agreement, on the one hand, and such other rights or interests, on the other, in a manner that consistently and equitably reflects the [*] that have been so sublicensed toward Targeted’s or the Covered Affiliate’s having [*]. If and to the extent that any such fees or other such consideration is received due to the occurrence of [*] that is described in Section 4.3 or due to the occurrence of [*] with respect to the same Penn Licensed Product that occurred after a Section 4.3 milestone, the amount paid or payable to Penn under Section 4.3 with respect to such Penn Licensed Product [*], but [*]. The scheduled percentages shall be:

[*]% of such sublicensing fees for any sublicense executed prior to [*] such Penn Licensed Product.

[*]% of such sublicensing fees for any sublicense executed after [*] such Penn Licensed Product.
 
[*]% of such sublicensing fees for any sublicense executed following the [*] such Penn Licensed Product.
 
*Confidential Treatment Requested.
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For example, if entry into [*] for a Penn Licensed Product provides to Penn a $[*] milestone payment from Targeted pursuant to Section 4.3.2, and a sublicensing deal [*] after completion of [*], to the extent applicable to the Penn Patent Rights, provides for a $ [*] milestone payment to Targeted for entry into [*] for such Penn Licensed Product, then Targeted would owe Penn [*]% [*] milestone payment (i.e., $[*] ), [*].

4.1.6 Any right of Penn or a third party to practice the Penn Patent Rights for educational or research purposes under Section 2.7 shall be royalty-free.
 
4.1.7 In further consideration for agreeing to this Agreement, Targeted shall issue to Penn within two business days following the effectiveness of this Agreement sixty-five thousand (65,000) shares of voting Common Stock of Targeted. Penn will in connection with such issuance execute and deliver a stock subscription agreement containing standard investor representations with respect to such shares.

4.2 Development Plan, Progress Reports, Financial Reports; Maintenance Fees.

4.2.1 Targeted will provide Penn with a written plan (the “Development Plan”) within thirty (30) days after the of signing this Agreement by both parties. The Development Plan will [*]. The Development Plan will separately address activities applicable to Group 1 Patents, Group 2 Patents, Group 3 Patents, Group 4 Patents, and Group 5 Patents, respectively.

4.2.2 At or within thirty (30) days following each anniversary of the Effective Date, Targeted will provide Penn with a written progress report that describes the progress made against the Development Plan (as supplemented by progress reports, where applicable), including the progress made by any Targeted Covered Affiliates or sublicensees, submitted a year earlier and plans for development in the coming year. Each such annual progress report will be deemed to update and supplement the then-current Development Plan.

4.2.3 At or within thirty (30) days after the time Targeted, or any Targeted Covered Affiliates or sublicensees files an IND with respect to a particular Penn Licensed Product, Targeted will provide Penn with a written development plan for that Penn Licensed Product (the “Product-Specific Plan”). Each Product-Specific Plan will outline [*].

4.2.4 Penn shall keep all such reports referred to in Sections 4.2.1 through 4.2.3 confidential under Section 5.2 for five (5) years or until the time, if any, of the first commercial Sale of any Penn Licensed Product(s) as provided below, whichever comes first. Targeted shall also notify Penn within thirty (30) days of the first commercial Sale of any Penn Licensed Product.
 
4.2.5 Targeted shall provide Penn with the following financial statements and information (which may be consolidated with one or more of Targeted’s Affiliates, if Targeted regularly so consolidates its financial statements) prepared according to U.S. generally accepted accounting principles consistently applied, where applicable:
 
*Confidential Treatment Requested.
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(a)
Unaudited financial statements forty-five (45) days following the end of each Calendar Quarter. The format and detail of such statements shall be agreed upon in advance by Penn and Targeted.

(b)
Audited financial statements, produced by a certified public accounting firm, ninety (90) days following the end of each of Targeted’s fiscal years, as well as a copy of any management letter recommendations submitted by the auditors.

(c)
Copies of all reports made available to shareholders, including 10K and 10Q filings made to the United States Securities and Exchange Commission.

4.2.6 Targeted shall pay to Penn the following license maintenance fees until the first commercial Sale of a Penn Licensed Product (after which time no further maintenance fees will be payable under this Section 4.2.6): [*] dollars ($[*]) on the [*] anniversary of the Effective Date, [*] dollars ($[*]) on the [*] anniversary of the Effective Date, [*] dollars ($[*]) on the [*] anniversary of the Effective Date, [*] dollars ($[*]) on the [*] anniversary of the Effective Date, [*] dollars ($[*]) on the [*] anniversary of the Effective Date, and [*] dollars ($[*]) on the [*] anniversary of the Effective Date. 

4.2.7 Following the first commercial Sale of a Penn Licensed Product, Targeted shall pay to Penn a maintenance fee of [*] dollars ($[*]) on each anniversary of the Effective Date during the term of this Agreement which shall be [*].
 
4.3 Milestone Fees.

4.3.1 Subject to Sections 4.3.3 and 4.3.4, Targeted shall pay to Penn a non-refundable milestone fee as listed below for [*] reaches each of the following milestones, where such Penn Licensed Product has been or is in whole or in part developed by [*] under a right or sublicense granted by Targeted or a Covered Affiliate or otherwise collaboratively by [*] on the one hand and by Targeted and/or Covered Affiliates on the other:

Milestone
Fee Due
[*]
$[*]
[*]
$[*]
[*]
$[*]
 
*Confidential Treatment Requested.
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4.3.2 Subject to Sections 4.3.3 and 4.3.4, Targeted shall pay to Penn a non-refundable milestone fee as listed below for [*] reaches each of the following milestones, where Section 4.3.1 is not applicable to such Penn Licensed Product:

Milestone
Fee Due
[*]
$[*]
[*]
$[*]
[*]
$[*]
 
4.3.3 If and to the extent that any fees or other such consideration is paid to Penn by Targeted pursuant to Section 4.1.5 due to the occurrence of a milestone that is described in Section 4.3.1 or Section 4.3.2, or due to the occurrence of any other developmental milestone with respect to the same Penn Licensed Product that occurred prior to the milestone described in Section 4.3.1 or Section 4.3.2, the amount so paid to Penn under Section 4.1.5 with respect to such occurrence shall be [*] with respect to such milestone, but such [*]. For example, if a sublicensing deal entered by Targeted prior to completion of [*] for a Penn Licensed Product to which Section 4.3.1 is not applicable, to the extent applicable to the Penn Patent Rights, provides for a $[*] milestone payment to Targeted for entry into [*] for such Penn Licensed Product, Targeted would have paid Penn [*]% of such milestone payment pursuant to Section 4.1.5 (i.e., $[*]). When such Penn Licensed Product enters [*], Targeted would owe Penn a $[*] milestone payment pursuant to Section 4.3.2, but [*].

4.3.4 The milestone fees otherwise payable under Section 4.3.1 or 4.3.2 shall be [*] with respect to any Penn Licensed Product that, at the time a milestone was achieved, had a competing product licensed under the Penn Patent Rights on sale.
 
4.4 Royalty Reports and Records.

4.4.1 Targeted shall deliver to Penn within sixty (60) days after the end of each Calendar Quarter a report, certified by the chief financial officer of Targeted setting forth in reasonable detail the calculation of the royalties due to Penn for such Calendar Quarter, including, without limitation:

(i)
Number of Penn Licensed Products involved in Sales, listed by country if readily available;

(ii)
Gross consideration for Sales of Penn Licensed Products, including all amounts invoiced, billed, or received;

(iii)
Qualifying costs, as defined in Section 1.16, listed by category of cost;
 
*Confidential Treatment Requested.
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(iv)
Net Sales of Penn Licensed Products listed by country if readily available; and

(v)
Royalties owed to Penn, listed by category, including without limitation earned and sublicensee-derived categories.

4.4.2 Royalties payable under Section 4.1 hereof shall be paid within sixty (60) days following the last day of the Calendar Quarter in which the royalties accrue and shall accompany the report of Section 4.4.1.

4.4.3 Targeted must maintain and cause its Covered Affiliates, sublicensees, and sub-sublicensees, to maintain, complete and accurate books and records which enable the royalties, fees, and payments payable under this Agreement to be verified. The records for each Calendar Quarter must be maintained for three years after the submission of each report under Article 4. Upon reasonable prior notice to Targeted, Targeted must provide Penn with access to all books and records relating to the Sales of Penn Licensed Products by Targeted and its Covered Affiliates, and sublicensees to conduct a review or audit of those books and records. Access to these books and records pertaining to Net Sales must be made available no more than once each Calendar Year for each Penn Licensed Product, during normal business hours, and once each year for each Penn Licensed Product during each of the three years after expiration or termination of this Agreement. If a review or audit of the books of Targeted determines that any of Targeted, its Covered Affiliates, or sublicensees has underpaid royalties on a Penn Licensed Product by [*] or more, Targeted must pay the costs and expenses of Penn and its accountants in connection with such review or audit. Notwithstanding the foregoing, Targeted agrees to conduct, at its expense, an independent audit of Sales and royalties with respect to a Penn Licensed Product at least every two (2) years once annual Sales of such Penn Licensed Product are greater than five million dollars ($5,000,000) per annum. The audit shall address, at a minimum, the amount of gross sales by or on behalf of Targeted, its Covered Affiliates, or sublicensees during the audit period, the amount of funds owed to Penn under this Agreement, and whether the amount owed has been paid to Penn and is reflected in the records of the Targeted. A report by the auditors shall be submitted promptly to Penn upon completion.
 
4.5 Currency, Place of Payment, Interest.

4.5.1 All dollar amounts referred to in this Agreement are expressed in United States dollars. All payments to Penn under this Agreement shall be made in United States dollars by check payable to “The Trustees of the University of Pennsylvania.”
 
4.5.2 If Targeted, a Covered Affiliate, or their sublicensee receives revenues from Sales of Penn Licensed Products in currency other than United States dollars, revenues shall be converted into United States dollars at the conversion rate for the foreign currency as published in the eastern edition of The Wall Street Journal as of the last business day of the applicable Calendar Quarter.
 
*Confidential Treatment Requested.
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4.5.3 Amounts that are not paid when due shall accrue interest from the due date until paid, at a rate equal to one and one quarter percent (1.25%) per month (or the maximum allowed by law, if less).

ARTICLE 5 - CONFIDENTIALITY

5.1 Targeted shall use best efforts to maintain in confidence and not to disclose to any third party other than Covered Affiliates any Confidential Information of Penn received pursuant to this Agreement or the Existing Agreements. Targeted agrees to ensure that its and its Covered Affiliates’ employees have access to Confidential Information only on a need-to-know basis and are obligated in writing to abide by Targeted’s obligations hereunder. The foregoing obligation shall not apply to:

5.1.1 information that is or was known to Targeted or its Covered Affiliates prior to the time of disclosure or that is or was at any time independently developed by Targeted or its Covered Affiliates without use of Confidential Information of Penn, in each case to the extent evidenced by written records;

5.1.2 information disclosed to Targeted or its Covered Affiliates by a third party that has a right to make such disclosure;

5.1.3 information that becomes patented, published or otherwise part of the public domain otherwise than due to a breach of this Agreement by Targeted or its Covered Affiliates;

5.1.4 information that is required to be disclosed by any statute, law, rule, regulation or order of any governmental authority or a court of competent jurisdiction; provided that Targeted shall use its best efforts to obtain confidential treatment of such information by the agency or court; or

5.1.5 information, to the extent it is disclosed pursuant to a confidentiality agreement binding the recipient to confidentiality obligations at least as strict as those binding Targeted under this Section.

5.2 Penn shall not be obligated to accept any confidential information from Targeted except for the reports required in Sections 4.2 and 4.4 and the results of any audit or review under Section 4.4.3. Penn shall use best efforts to maintain in confidence and not to disclose to any third party (subject to the same exceptions accorded Targeted under Section 5.1) such reports or results received, except that Penn may disclose to Wistar information from such reports or results. Wistar shall use best efforts to maintain in confidence and not to disclose to any third party (subject to the same exceptions accorded Targeted under Section 5.1) information received from Penn under this section. Penn bears no institutional responsibility for maintaining the confidentiality of any other confidential information of Targeted disclosed to Penn under this Agreement or the Existing Agreements.
 
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5.3 The placement of a copyright notice on any Confidential Information shall not be construed to mean that such information has been published and will not release Targeted from its obligation of confidence hereunder.

ARTICLE 6 - TERM AND TERMINATION

6.1 This Agreement, unless sooner terminated as provided herein, shall terminate upon the expiration of the last to expire or become abandoned of the Penn Patent Rights.

6.2 Targeted may, at its option, terminate this Agreement at any time by doing all of the following:

6.2.1 By ceasing to make, have made, use and sell all Penn Licensed Products; and

6.2.2 By terminating all sublicenses, and causing all sublicensees to cease making, having made, using and selling all Penn Licensed Products and terminate any sub-sublicensees; and

6.2.3 By giving sixty (60) days notice to Penn of such cessation and of Targeted’s intent to terminate; and

6.2.4 By tendering payment of all accrued royalties.

6.3 Penn may terminate this Agreement if any of the following occur:

6.3.1 Targeted becomes more than sixty (60) days in arrears in payment of royalties, maintenance fees, patent expenses or any other expenses due pursuant to this Agreement and Targeted does not provide full payment within thirty (30) days of written demand; provided, however, that if Targeted disputes in good faith the existence of an arrearage in payment,

 
(a)
Targeted shall, within thirty (30) days after the demand for payment under this Section, remedy any such arrearage to the extent its existence is not the subject of such good faith dispute; and

 
(b)
if either of the parties has, within thirty (30) days after the demand for payment under this Section, initiated the dispute resolution procedures of Article 11 in order to attempt to resolve such good faith dispute, Penn shall wait for the additional time designated therein before taking action to terminate this Agreement; or
 
-24-

 
6.3.2 Targeted becomes subject to a Bankruptcy Event; or

6.3.3 Targeted materially breaches this Agreement and does not cure such material breach within one hundred eighty (180) days after written notice thereof.

6.4 If Targeted becomes subject to a Bankruptcy Event, all duties of Penn and all rights (but not financial and indemnification obligations accrued prior to termination) of Targeted under this Agreement shall immediately terminate without the necessity of any action being taken either by Penn or by Targeted, and, to the extent allowed by law, [*] shall become a direct licensee of Penn to the extent of any sublicense existing between [*] and Targeted immediately preceding the Bankruptcy Event, without further action by Targeted, Penn or [*].

6.5 Targeted’s obligation to pay royalties and all other obligations accrued under Articles 4 and 7 hereof and other considerations owed under this Agreement that have matured as of the date of termination shall survive termination of this Agreement. In addition, the provisions of Section 2.9, Article 3, and (for a period of five (5) years following such termination) Article 5, and the provisions of Articles 6, 9, 10, 11 and 12 shall survive such termination.

ARTICLE 7 - PATENT MAINTENANCE AND REIMBURSEMENT

7.1 Penn shall control and diligently prosecute and maintain Penn Patent Rights. Penn and Targeted shall decide upon a mutually agreeable choice of patent counsel and a mutually agreeable budget for and course of prosecution, and Targeted shall be copied on all substantive correspondence regarding such Penn Patent Rights. The parties acknowledge that neither of them currently has an intention to terminate or substantially reduce the scope of the engagement of the patent counsel used for such purposes by Penn prior to and as of the Effective Date. Subject to Sections 7.2 and 7.3, Targeted shall pay, or shall reimburse Penn within sixty (60) days of receipt of invoice for, all documented third party attorneys’ fees, expenses, official fees and other charges incident to the preparation, prosecution, licensing and maintenance of Penn Patent Rights, including interferences, oppositions, etc. brought or defended in accordance with the mutually agreed budget for and course of prosecution. Penn shall provide Targeted with itemized statements reflecting these expenses quarterly. In the event that Penn should decide not to file, prosecute or maintain applications and patents for such Penn Patent Rights, Targeted shall have the opportunity to do so at Targeted’s sole expense.
 
7.2 Except with respect to licenses granted by Penn to [*] pursuant to Section 2.2.2, if Penn at any time prior to or after the Effective Date grants or has granted any rights or licenses to or for the benefit of any Non-Targeted Party under any of the Penn Patent Rights, i.e., where it may do so outside the scope of the exclusive rights of Targeted or the Covered Affiliates hereunder, Penn shall [*].
 
*Confidential Treatment Requested.
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7.3 If Targeted elects to discontinue payment for the filing, prosecution, and/or maintenance of any patent application and/or patent contained in the Penn Patent Rights (or with respect to any particular claims therein), it shall so notify Penn, and any such patent application or patent (or such claims, as applicable) shall thereupon be excluded from the definition of Penn Patent Rights and from the scope of the licenses granted under this Agreement, and all rights relating thereto shall revert to Penn and may be freely used or licensed by Penn.

7.4 Targeted, the Covered Affiliates, and their sublicensees shall comply with all United States and foreign laws with respect to patent marking of Penn Licensed Products.

ARTICLE 8 - INFRINGEMENT AND LITIGATION
 
8.1 Penn and Targeted are responsible for notifying each other promptly of any infringement of Penn Patent Rights which may come to their attention, including notice to the other of any certification filed under the United States “Drug Price Competition and Patent Term Restoration Act of 1984”. Penn and Targeted shall consult one another in a timely manner concerning any appropriate response thereto.

8.2 Targeted shall have the right, but not the obligation, to prosecute such infringement at its own expense. Targeted shall not settle or compromise any such suit in a manner that imposes any obligations or restrictions on Penn or grants any rights the Penn Patent Rights (other than to the extent Targeted has the right to grant such rights under this Agreement), without Penn’s written permission. Financial recoveries from any such litigation will first be applied to reimburse each party for its litigation expenditures with additional recoveries being paid to Targeted, subject to a royalty due Penn based on the provisions of Article 4 hereof.

8.3 Such rights under Section 8.2 shall be subject to the continuing right of Penn to intervene at Penn’s own expense and join Targeted or its Covered Affiliates, who shall still prosecute, in any claim or suit for infringement of the Penn Patent Rights. Any consideration received by Targeted or its Covered Affiliates in settlement of any claim or suit shall be shared between Penn and Targeted (or such Covered Affiliate) in proportion with the share of litigation expenses incurred by each in such infringement action provided that Penn has paid at least [*] percent ([*]%) of the aggregate amount of such litigation expenses. In the event that Penn does not satisfy the foregoing requirement, financial recoveries from any such litigation will first be applied to reimburse both parties for their litigation expenditures with additional recoveries being paid to Targeted, subject to a royalty due Penn based upon the provisions of Article 4 hereof.
 
8.4 If Targeted and the Covered Affiliates fail to prosecute such infringement, Penn shall have the right, but not the obligation, to prosecute such infringement at its own expense. In such event, financial recoveries will first be applied to reimburse each party for its litigation expenditures with additional recoveries being retained by Penn; provided however, that Penn shall not settle such infringement if such settlement affects Penn Patent Rights other than those specifically at issue in such infringement action without Targeted’s written permission, which shall not be unreasonably withheld.
 
*Confidential Treatment Requested.
-26-

 
8.5 In any action to enforce any of the Penn Patent Rights, either party, at the request and expense of the other party, shall cooperate to the fullest extent reasonably possible. This provision shall not be construed to require either party to undertake any activities, including legal discovery, at the request of any third party except as may be required by lawful process of a court of competent jurisdiction.

ARTICLE 9 - DISCLAIMER OF WARRANTY; INDEMNIFICATION
 
9.1 EXCEPT AS SET FORTH IN SECTION 9.5, THE PENN PATENT RIGHTS, PENN TECHNICAL INFORMATION, PENN LICENSED PRODUCTS AND ALL OTHER TECHNOLOGY LICENSED UNDER THIS AGREEMENT ARE PROVIDED ON AN “AS IS” BASIS AND PENN AND WISTAR MAKE NO REPRESENTATIONS OR WARRANTIES, EXPRESS OR IMPLIED, WITH RESPECT THERETO. BY WAY OF EXAMPLE BUT NOT OF LIMITATION, PENN AND WISTAR MAKE NO REPRESENTATIONS OR WARRANTIES (i) OF COMMERCIAL UTILITY; (ii) OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE; OR (iii) THAT THE USE OF THE PENN PATENT RIGHTS, PENN TECHNICAL INFORMATION, PENN LICENSED PRODUCTS AND ALL TECHNOLOGY LICENSED UNDER THIS AGREEMENT WILL NOT INFRINGE ANY PATENT, COPYRIGHT OR TRADEMARK OR OTHER PROPRIETARY OR PROPERTY RIGHTS OF OTHERS. PENN AND WISTAR SHALL NOT BE LIABLE TO TARGETED, TARGETED’S SUCCESSORS OR ASSIGNS OR ANY THIRD PARTY WITH RESPECT TO: ANY CLAIM ARISING FROM THE USE OF THE PENN PATENT RIGHTS, PENN TECHNICAL INFORMATION, PENN LICENSED PRODUCTS AND ALL TECHNOLOGY LICENSED UNDER THIS AGREEMENT OR FROM THE MANUFACTURE, USE OR SALE OF PENN LICENSED PRODUCTS; OR ANY CLAIM FOR LOSS OF PROFITS, LOSS OR INTERRUPTION OF BUSINESS, OR FOR INDIRECT, SPECIAL OR CONSEQUENTIAL DAMAGES OF ANY KIND.

9.2 Targeted will defend, indemnify and hold harmless Penn and Wistar and their trustees, officers, agents and employees (individually, an “Indemnified Party”, and collectively, the “Indemnified Parties”), from and against any and all liability, loss, damage, action, claim or expense suffered or incurred by the Indemnified Parties (including attorney’s fees) (individually, a “Liability”, and collectively, the “Liabilities”) that results from or arises out of: (a) the development, use, manufacture, promotion, sale or other disposition of any Penn Technical Information, Penn Patent Rights or Penn Licensed Products by Targeted, Covered Affiliates, their sublicensees, or their other collaborators or distributors; (b) breach by Targeted of any covenant or agreement contained in this Agreement; and (c) the enforcement by an Indemnified Party of its rights under this Section. Without limiting the foregoing, Targeted will defend, indemnify and hold harmless the Indemnified Parties from and against any Liabilities resulting from:
 
-27-

 
9.2.1 any product liability or other claim of any kind related to the use by a third party of a Penn Licensed Product that was manufactured, sold or otherwise disposed by Targeted, Covered Affiliates, or their sublicensees, or their other collaborators or distributors, pursuant to and within the scope of such relationships;

9.2.2 a claim by [*] or any other party which Targeted has granted or promised to grant a license or option to license that this Agreement violates the terms of any agreement to which any of them is a party;

9.2.3 a claim by a third party that the use by Targeted, Covered Affiliates, their sublicensees, or their other collaborators or distributors, pursuant to and within the scope of such relationships, of Penn Technical Information or Penn Patent Rights or the design, composition, manufacture, use, sale or other disposition of any Penn Licensed Product by them infringes or violates any patent, copyright, trademark or other intellectual property rights of such third party; and

9.2.4 clinical trials or studies conducted by or on behalf of Targeted, Covered Affiliates, their sublicensees, or their other collaborators or distributors, pursuant to and within the scope of such relationships, relating to the Penn Technical Information, Penn Patent Rights or Penn Licensed Products, including, without limitation, any claim by or on behalf of a human subject of any such clinical trial or study, any claim arising from the procedures specified in any protocol used in any such clinical trial or study, any claim of deviation, authorized or unauthorized, from the protocols of any such clinical trial or study, and any claim resulting from or arising out of the manufacture or quality control by a third party of any substance administered in any clinical trial or study.

Notwithstanding the foregoing, however, the Liabilities shall not include, and in no instance shall Targeted be required to indemnify any Indemnified Party with respect to, any liability, claims, lawsuits, losses, damages, costs or expenses to the extent the same are determined to be the result of any Indemnified Party’s gross negligence or willful misconduct.
 
9.3 The Indemnified Party shall promptly notify Targeted of any claim or action giving rise to Liabilities subject to the provisions of the foregoing Section. Targeted shall have the right to defend or to cause to be defended any such claim or action, at its cost and expense. Targeted shall not settle or compromise any such claim or action in a manner that imposes any restrictions or obligations on Penn or Wistar or grants any rights to Penn Patent Rights or Penn Licensed Products (other than to the extent Targeted has the right to grant such rights under this Agreement) without Penn’s prior written consent. If Targeted or a Covered Affiliate or their sublicensee fails or declines to assume the defense of any such claim or action within thirty (30) days after notice thereof, Penn may assume the defense of such claim or action for the account and at the risk of Targeted, and any Liabilities related thereto shall be conclusively deemed a liability of Targeted; provided however, that Penn shall not settle such claim or action if such settlement affects Penn Patent Rights other than those specifically at issue in such claim or action without Targeted’s written permission, which shall not be unreasonably withheld. Targeted shall pay promptly to the Indemnified Party any Liabilities to which the foregoing indemnity relates, as incurred. The indemnification rights of Penn and Wistar or other Indemnified Party contained herein are in addition to all other rights which such Indemnified Party may have at law or in equity or otherwise.
 
*Confidential Treatment Requested.
 
-28-

 
9.4 Insurance.

9.4.1 Targeted shall procure and maintain a policy or policies of commercial general liability insurance, including broad form and contractual liability, in a minimum amount of $[*] combined single limit per occurrence and in the aggregate as respects personal injury, bodily injury and property damage arising out of Targeted’s performance of this Agreement.

9.4.2 Targeted shall, upon commencement of clinical trials involving Penn Licensed Products, procure and maintain a policy or policies of product liability insurance in a minimum amount of $[*] combined single limit per occurrence and in the aggregate as respects bodily injury and property damage arising out of Targeted’s performance of this Agreement.

9.4.3 The policy or policies of insurance specified herein shall be issued by an insurance carrier with an A.M. Best rating of A or better and shall name Penn and Wistar as an additional insured with respect to Targeted’s performance of this Agreement. Targeted shall provide Penn with certificates evidencing the insurance coverage required herein and all subsequent renewals thereof. Such certificates shall provide that Targeted’s insurance carrier(s) notify Penn in writing at least 30 days prior to cancellation or material change in coverage. Penn will retain such certificates and notices from Targeted’s insurance carrier and provide copies of the same to Wistar upon written request.

9.4.4 Penn shall periodically review the adequacy of the minimum limits of liability specified herein. Further, Penn reserves the right to require Targeted to adjust such coverage limits in accordance with prevailing industry norms. The specified minimum insurance amounts shall not constitute a limitation on Targeted’s obligation to indemnify Penn or Wistar under this Agreement.

9.5 Penn hereby represents that (i) to its knowledge it has the lawful right to grant the licenses granted herein, and (ii) all actions necessary with respect to due authorization, execution and performance of this Agreement to make it legal, valid, binding and enforceable with regard to Penn have been taken.
 
*Confidential Treatment Requested.
 
-29-

 
9.6 Except as provided in Section 12.11, Targeted hereby represents that (i) to its knowledge it has the lawful right to enter into and to perform its obligations under this Agreement, and (ii) except for board approval of the issuance of the shares referred to in Section 4.1.7 (which approval Targeted will attempt to obtain as soon as practicable following the signature of this Agreement), all actions necessary with respect to due authorization, execution and performance of this Agreement to make it legal, valid, binding and enforceable with regard to Targeted have been taken.
 
ARTICLE 10 - USE OF PENN’S NAME; INDEPENDENT CONTRACTOR
 
10.1 Targeted, the Covered Affiliates, and their employees and agents shall not use, and shall not permit their sublicensees or their other collaborators or distributors, within the scope of such relationships, to use, Penn’s or Wistar’s name, any adaptation thereof, any Penn or Wistar logotype, trademark, service mark or slogan or the name, mark or logotype of any Penn or Wistar representative or organization in any way without the prior, written consent of Penn or Wistar. Notwithstanding the foregoing, Targeted, the Covered Affiliates, their sublicensees or their other collaborators or distributors may use Penn’s or Wistar’s name as required to comply with any federal or state securities law.

10.2 Nothing herein shall be deemed to establish a relationship of principal and agent between Penn and Targeted, nor any of their agents or employees for any purpose whatsoever. This Agreement shall not be construed as constituting Penn and Targeted as partners, or as creating any other form of legal association or arrangement which would impose liability upon one party for the act or failure to act of the other party.

ARTICLE 11 - DISPUTE RESOLUTION

Any unresolved dispute or difference between the parties arising out of or in connection with this Agreement shall at the option of either party be referred for review by the parties’ respective Senior Officers prior to either party’s taking any formal legal enforcement action with respect thereto. The Senior Officers shall discuss the dispute or difference, and shall meet with respect thereto if either of them believes a meeting or meetings to be useful. The Senior Officers have thirty (30) days (or such lesser or longer period as they may agree is a useful period for their discussions) to try to resolve the dispute or difference, after which time each party may take such other action as it deems appropriate.

ARTICLE 12 - ADDITIONAL PROVISIONS

12.1 Targeted shall comply with all prevailing laws, rules and regulations pertaining to the development, testing, manufacture, marketing, sale, use, import or export of products. Without limiting the foregoing, it is understood that this Agreement may be subject to United States laws and regulations controlling the export of technical data, computer software, laboratory prototypes and other commodities, articles and information, including the Arms Export Control Act as amended in the Export Administration Act of 1979, and that the parties’ obligations hereunder are contingent upon compliance with applicable United States export laws and regulations. The transfer of certain technical data and commodities may require a license from the cognizant agency of the United States Government and/or written assurances by Targeted that Targeted shall not export data or commodities to certain foreign countries without prior approval of such agency. Penn neither represents that a license is not required nor that, if required, it will issue.
 
-30-

 
12.2 This Agreement and the rights and duties appertaining thereto may not be assigned by Targeted without first obtaining the express written consent of Penn, except that Targeted may assign its rights hereunder to [*] upon reasonable notice and an agreement by such Covered Affiliate or [*], as the case may be, to be bound by the rights and obligations of Targeted under this Agreement, without further consent. Any other such purported assignment, without the written consent of Penn, shall be null and of no effect. Penn shall not unreasonably withhold consent for Targeted to assign this Agreement to a Covered Affiliate or to a purchaser of all or substantially all of Targeted’s business, or to the owner of all or substantially all of Targeted’s business pursuant to a merger or consolidation plan.

12.3 Notices, payments, statements, reports and other communications under this Agreement shall be in writing and shall be deemed to have been received as of the date dispatched if sent by personal delivery, public overnight courier (e.g. Federal Express), certified mail, return receipt requested as follows:

If for Penn:

University of Pennsylvania
Center for Technology Transfer
3160 Chestnut Street, Suite 200
Philadelphia, PA 19104-6283
Attention: Managing Director

with a copy to:

Office of General Counsel
University of Pennsylvania
133 South 36th Street, Suite 300
Philadelphia, PA 19104-3246
Attention: General Counsel
 
*Confidential Treatment Requested.
 
-31-

 
If for Targeted:

Targeted Genetics Corporation
1100 Olive Way, Suite 100
Seattle, Washington 98101
Attn: Chief Executive Officer

with a copy to:

Orrick, Herrington & Sutcliffe LLP
719 Second Avenue, Suite 900
Seattle, WA 98104
Attention: Roger M. Tolbert, Esq.
 
Either party may change its official address upon written notice to the other party.

12.4 This Agreement shall be construed and governed in accordance with the laws of the Commonwealth of Pennsylvania, without giving effect to conflict of law provisions.

12.5 Except as provided in Section 3.2, this Agreement is intended to supersede the Liver/Lung License and the Additional Fields License. The parties acknowledge that the Sponsored Research Agreement was previously terminated and that this is the entire agreement between the parties with respect to the subject matter hereof. Any modification of this Agreement shall be in writing and signed by an authorized representative of each party.

12.6 A waiver by either party of a breach or violation of any provision of this Agreement will not constitute or be construed as a waiver of any subsequent breach or violation of that provision or as a waiver of any breach or violation of any other provision of this Agreement.

12.7 Any of the provisions of this Agreement which are determined to be invalid or unenforceable in any jurisdiction shall be ineffective to the extent of such invalidity or unenforceability in such jurisdiction, without rendering invalid or unenforceable the remaining provisions hereof or affecting the validity or enforceability of any of the terms of this Agreement in any other jurisdiction.

12.8 The headings and captions used in this Agreement are for convenience of reference only and shall not affect its construction or interpretation.

12.9 Nothing in this Agreement, express or implied, is intended to confer on any person, other than the parties hereto, the Covered Affiliates, or their permitted assigns, any benefits, rights or remedies.
 
*Confidential Treatment Requested.
-32-

 
12.10 Penn and Targeted shall not discriminate against any employee or applicant for employment because of race, color, sex, sexual or affectional preference, age, religion, national or ethnic origin, or handicap.

12.11 The parties acknowledge that Targeted has agreed that it will not enter into this Agreement without the approval of [*]. Accordingly, this Agreement shall not become effective unless and until it is approved for all purposes by [*]; provided, however, that if such approval is not obtained on or before the later of the fifteenth (15th) day after the date this Agreement is signed by both Targeted and Penn and the fifth (5th) day after Penn notifies Targeted that this Agreement has been approved in writing by Wistar (unless such period is extended as Penn and Targeted may mutually agree is reasonable under the circumstances), this Agreement shall not become effective and shall be considered null and void at the end of such period. Targeted shall notify Penn of such approval within five business days after such [*] approval is obtained. Similarly, this Agreement requires the approval of the Board of Directors of Targeted, and shall not become effective unless and until such approval is obtained; provided, however, that if such approval is not obtained on or before the later of the fifteenth (15th) day after the date this Agreement is signed by both Targeted and Penn and the fifth (5th) day after Penn notifies Targeted that this Agreement has been approved in writing by Wistar (unless such period is extended as Penn and Targeted may mutually agree is reasonable under the circumstances), this Agreement shall not become effective and shall be considered null and void at the end of such period. The “Effective Date” shall for all purposes under this Agreement remain June 1, 2002, and once effective, the parties intend that such effectiveness will be as of the Effective Date, notwithstanding that the effectiveness of this Agreement occurs at a later date, upon such approval by [*] and the Board of Directors of Targeted.

[Signature page follows]
*Confidential Treatment Requested.
-33-


IN WITNESS WHEREOF the parties, intending to be legally bound, have caused this Agreement to be executed by their duly authorized representatives as of the Effective Date.
 
THE TRUSTEES OF THE UNIVERSITY OF PENNSYLVANIA
 
         
By: /s/ Louis P. Berneman      
 
Printed Name: Louis P. Perneman
Title: Managing Director, Center for Technology Transfer
   
 
Date Signed: 8/19/02
 
TARGETED GENETICS CORPORATION
 
         
By: /s/ H. Stewart Parker      
 
Name: H. Stewart Parker
Title: Chief Executive Officer
   
 
Date Signed: 10/18/02
 
Genovo hereby agrees to be bound by the rights and obligations of Targeted under the foregoing Agreement, subject to the terms and conditions thereof, which shall be applicable to Genovo as well as to Targeted.
 
GENOVO, INC
 
         
By: /s/ H. Stewart Parker      
 
Name: H. Stewart Parker
Title: Pres & CEO
   
 
Date Signed: 10/18/02
 
Consented to and approved:
 
THE WISTAR INSTITUTE of ANATOMY and BIOLOGY
 
         
By: /s/ Russel E. Kaufman      
 
Printed Name: Russel E. Kaufman, M.D.
Title: Director and CEO
   
 
Date Signed: 10/9/02
 
-34-

 
ATTACHMENT 1
 
PENN PATENT RIGHTS
 
I. THE PENN LICENSED PATENTS IN THE FOLLOWING TABLE ARE THE GROUP 1 PATENTS:

Penn
Docket
Number
Targeted
Docket
Number
Attorney
File
Number
Brief Title
Patent Numbers and
Dates
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*] 
[*] 
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]

*Confidential Treatment Requested.
-35-


II. THE PENN LICENSED PATENTS IN THE FOLLOWING TABLE ARE THE GROUP 2 PATENTS:

Penn
Docket
Number
Targeted
Docket
Number
Attorney
File
Number
Brief Title
Patent Numbers and
Dates
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
 
*Confidential Treatment Requested.
-36-


III. THE PENN LICENSED PATENTS IN THE FOLLOWING TABLE ARE THE GROUP 3 PATENTS:
 
Penn
Docket
Number
Targeted
Docket
Number
Attorney
File
Number
Brief Title
Patent Numbers and
Dates
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
 
*Confidential Treatment Requested.
-37-

 
IV. THE PENN LICENSED PATENTS IN THE FOLLOWING TABLE ARE THE GROUP 4 PATENTS:
 
Penn
Docket
Number
Targeted
Docket
Number
Attorney
File
Number
Brief Title
Patent Numbers and
Dates
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
 
*Confidential Treatment Requested.
 
-38-


GROUP 4 PATENTS (CONTINUED):

[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]

*Confidential Treatment Requested.
 
-39-

 
V. THE PENN LICENSED PATENTS IN THE FOLLOWING TABLE ARE THE GROUP 5 PATENTS:

Penn Docket Number
Targeted Docket Number
Attorney File Number
Brief Title
Patent Numbers and Dates
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
 
*Confidential Treatment Requested.
 
-40-


GROUP 5 PATENTS (CONTINUED):

[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]

*Confidential Treatment Requested.
-41-


ATTACHMENT 2
 
The following recombinant adenoviruses and viral seed banks are Penn Technical Information, unless otherwise covered by Penn Patent Rights and include without limitation the particular samples thereof previously made, as described below:

Vector
 
Penn ID
 
Manufacture
 Date of
Particular
Samples
 
Vial # of
Samples
[*]
 
[*]
       
       
11/27/96
 
21
       
11/27/96
 
22
       
11/27/96
 
23
       
11/27/96
 
24
       
11/27/96
 
25
[*]
 
[*]
       
       
4/8/99
 
3
       
4/8/99
 
4
       
4/8/99
 
5
       
4/8/99
 
6
       
4/8/99
 
7
[*]
 
[*]
       
       
12/1/98
 
35
       
12/1/98
 
36
       
12/1/98
 
37
       
12/1/98
 
38
       
12/1/98
 
39
 
*Confidential Treatment Requested.
-42-


ATTACHMENT 2, CONTINUED

Vector
 
Penn ID
 
Manufacture
Date of
Particular
Samples
 
Vial # of
Samples
[*]
 
[*]
       
       
12/30/98
 
50
       
12/30/98
 
51
       
12/30/98
 
52
       
12/30/98
 
53
       
12/30/98
 
54
[*]
 
[*]
       
       
6/29/99
 
31
       
6/29/99
 
32
       
6/29/99
 
33
       
6/29/99
 
34
       
6/29/99
 
35
[*]
 
[*]
       
       
12/23/98
 
36
       
12/23/98
 
37
       
12/23/98
 
38
       
12/23/98
 
39
       
12/23/98
 
40
             

*Confidential Treatment Requested.
-43-


ATTACHMENT #3
 
[*]
 
*Confidential Treatment Requested.
-44-

EX-10.17 4 v069612_ex10-17.htm
 
 
*Certain confidential information contained in this document, marked by brackets, has been omitted and filed with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
 
LICENSE AGREEMENT
 
THIS AGREEMENT (the “Agreement”) is made and is effective December 5, 2006, (the “Effective Date”) by and between Targeted Genetics Corporation, a corporation having a principal place of business at 1100 Olive Way, Suite 100, Seattle, Washington 98101 (“TGC”), and Amsterdam Molecular Therapeutics B.V. (“AMT”), a corporation having a principal place of business at Meibergdreef 61, 1100 DA Amsterdam, The Netherlands.
 
RECITALS
 
WHEREAS, TGC has exclusively licensed the Licensed Patent Rights (relating to an AAV1 Vector gene delivery system) from the University of Pennsylvania as part of a license agreement entered into between TGC and the University of Pennsylvania (“UPenn”) with the effective date of June 1, 2002 (“UPenn Agreement”).
 
WHEREAS, AMT is developing an AAV1 product to treat LPL type 1 and LPL type 5 deficiency that requires a license to the Licensed Patent Rights and therefore seeks a license to the Licensed Patent Rights in the Field, as such terms are defined herein; and
 
WHEREAS, TGC is willing to grant such a license on the terms set forth herein and the University of Pennsylvania is willing to acknowledge such grant of a sublicense.
 
NOW THEREFORE, the parties agree as follows:
 
1. DEFINITIONS
 
1.1 “AAV1 Vector” means the adeno-associated virus serotype 1 vector technology which includes without limitation the AAV serotype 1 rep, cap, and ITR sequences and proteins whether utilized in whole or in part to deliver therapeutic genes into cells, and which is the subject of the Licensed Patent Rights
 
1.2 “Affiliate” means any company or other legal entity other than AMT in whatever country organized, controlling, controlled by or under common control with AMT. The term “control” means possession, direct or indirect, of the powers to direct, cause or significantly influence the direction of the management and policies of the company or entity in question, whether through the ownership of voting securities, by contract or otherwise.
 
1.3 “Federal Government Interest” means the rights of the United States Government under Public Laws 96-517, 97-256 and 98-620, codified at 35 U.S.C. 200-212, and any regulations issued thereunder, as such statute or regulations may be amended from time to time hereafter.
 

 
1.4 “Field” means treatment of LPL deficiency type 1 and LPL deficiency type 5 by in vivo gene therapy utilizing an AAV1 Vector encoding the LPL gene.
 
1.5 “Included CIPs” has the meaning given in Paragraph 1.9.
 
1.6 “License” has the meaning given in Paragraph 2.1.
 
1.7 “LPL” means Lipoprotein Lipase.
 
1.8 “Licensed Patent Rights” means rights to any subject matter described or claimed in U.S. Patent Nos. 6,759,237 and 7,105,345;and all foreign counterparts including all continuations, divisionals, and any continuation-in-part applications, to the extent that such continuation-in- part (or any continuation or divisional thereof) has claims directed to subject matter enabled and described in U.S. Patent Nos. 6.759,237 and 7,105,345 and such claims are necessary or relevant for the Field ( collectively, “Included CIPs”); any patents issuing on said applications, continuing applications, divisional applications, including reissues and reexaminations thereof, and any foreign applications or patents corresponding directly thereto.
 
1.9 “Licensed Product” means a product in the Field that, absent the License, would in the country of sale infringe any Valid Claim within the Licensed Patent Rights in such country.
 
1.10 “Net Sales” means [*].
 
1.11 “Person” means an individual, sole proprietorship, partnership, limited partnership, limited liability partnership, corporation, limited liability company, business trust, joint stock company, trust, unincorporated association, joint venture, or other similar entity or organization, including without limitation, a government or political subdivision, department or agency of a government.
 
1.12 “Royalties” has the meaning given in Paragraph 4.1.
 
1.13 “Third Party” means any Person other than AMT, TGC or any of their respective Affiliates.
 
1.14 “Valid Claim” means
 
 
i)
a claim of an issued and unexpired patent included within Licensed Patent Rights, which has not been held permanently revoked, unenforceable or invalid by a decision of a court or other governmental agency of competent jurisdiction, unappealable or un-appealed within the time allowed for appeal, and which has not been admitted to be invalid or unenforceable through reissue or disclaimer or otherwise; or
 
*Confidential Treatment Requested

 
 
ii)
a claim of a pending patent application included within Licensed Patent Rights which claim was filed and is being prosecuted in good faith and has not been abandoned or finally disallowed without the possibility of appeal or refiling of the application, provided that no more than [eight (8)] years have passed since the earliest priority date for such application.
 
2. GRANT
 
2.1 TGC grants to AMT a non-exclusive, non-sublicensable license under the Licensed Patent Rights in each country of the world where there are Valid Claims of Licensed Patent Rights, to make, have made, develop, use, sell, offer to sell and import Licensed Products (the “License”).
 
2.2 AMT acknowledges that in accordance with the Federal Government Interest, the United States government retains certain rights in intellectual property funded in whole or part under any contract, grant or similar agreement with a Federal agency, including but not limited to the requirement that Licensed Products subject to sale in the United States must be substantially manufactured in the United States. The license grant of this Article 2 is expressly subject to all of such rights.
 
2.3 UPenn retains the reserved right to use, and to permit other for-profit or nonprofit organizations to use, the Licensed Patent Rights strictly for educational and for research purposes. Any such rights of U Penn or a third party to practice the Licensed Patent Rights for educational or research purposes shall be royalty-free.
 
3. CONSIDERATION AND MAINTENANCE FEES
 
3.1 Upon signing this Agreement, AMT shall pay to TGC a $1,750,000 fee in consideration of the License.
 
3.2 Upon the first anniversary of the Effective Date and upon each anniversary during the Term thereafter, AMT shall pay to TGC a $[*] maintenance fee for maintenance of the License.
 
4. ROYALTIES AND PAYMENTS
 
4.1 AMT shall pay to TGC earned royalties based on Net Sales (“Royalties”) in the amount of: (i) [*] percent ([*]%) of the Net Sales of Licensed Products if cumulative Net Sales are less than $[*], or (ii) [*] percent ([*]%) of the Net Sales of Licensed Products if cumulative Net Sales are equal to or greater than $[*] but less than $[*], or (iii) [*] percent ([*]%) of Net Sales of Licensed Products if cumulative Net Sales are $[*] or more. [*] The Net Sales thresholds in such section (i)-(iii) will be applied separately to each distinct Licensed Product, but where the same Licensed Product is packaged or labeled differently in different nations, or otherwise to accommodate the same to different markets or indications, the Net Sales thereof in all such nations, markets and indications shall be aggregated.
 
*Confidential Treatment Requested

 
4.2 In addition to the Royalties and other payments set forth herein, AMT shall pay TGC the following “Milestone Payments.” For the purposes of this Agreement, the human clinical trial designations of phase I, phase II, phase III, and Biologic License Application, or BLA, while referring to United States Food and Drug Administration shall also be construed to mean any such jurisdiction the equivalent designation applied to clinical trial and drug development of similar status by the appropriate foreign governmental health regulatory agency. [*]:
 
Section
 
Milestone
 
Milestone Payments
4.2.1
 
[*]
 
$[*]
4.2.2
 
[*]
 
$[*]
4.2.3
 
[*]
 
$[*]
4.2.4
 
[*]
 
$[*]
4.2.5
 
[*]
 
$[*]
 
4.3 Royalties accruing to TGC shall be paid to TGC on a quarterly basis. Each such payment will be for royalties which accrued within the most recently completed calendar quarter and payment shall be made by AMT within thirty (30) days of the end of such calendar quarter.
 
4.4 Milestone Payments shall be paid to TGC within thirty (30) days of achievement.
 
4.5 Royalty or Milestone Amounts that are not paid when due shall accrue interest from the due date until paid, at a rate equal to one and one quarter percent (1.25%) per month (or the maximum allowed by law, if less).
 
4.6 AMT must maintain complete and accurate books and records which enable the Royalties, fees, and payments payable under this Agreement to be verified. The records for each calendar quarter must be maintained for three (3) years after the submission of each report under Article 4. Upon reasonable prior written notice to AMT from TGC, AMT shall permit a certified public accountant or a person possessing similar professional status and associated with an independent accounting firm reasonably acceptable to AMT to inspect all books and records relating to the sales of Licensed Products by AMT as necessary to verify the same. Access to these books and records pertaining to Net Sales must be made available no more than once each calendar year for each Licensed Product, during normal business hours, and once each year for each Licensed Product during each of the three (3) years after expiration or termination of this Agreement. The accounting firm shall enter into appropriate obligations with AMT to treat all information it receives during its inspection in confidence. The accounting firm shall disclose to the parties only whether such books and records are correct and details concerning any discrepancies, but no other information shall be disclosed to TGC. The charges of the accounting firm shall be paid by TCG, except if a review or audit of such books and records of AMT determines that AMT has underpaid royalties on Licensed Products by five percent (5%) or more then AMT must pay the charges of the accounting firm in connection with such review or audit. Notwithstanding the foregoing, AMT agrees to conduct, at its expense, an independent audit of sales and Royalties with respect to a Licensed Product at least every two (2) years once annual sales of such Licensed Product are greater than five million dollars ($5,000,000) per annum. The audit shall address, at a minimum, the amount of gross sales by or on behalf of AMT during the audit period, the amount of funds owed to TGC under this Agreement, and whether the amount owed has been paid to TGC and is reflected in the records of the AMT. A report by the auditors shall be submitted promptly to TGC upon completion.
 
*Confidential Treatment Requested

 
4.7 In the event that any patent or any claim thereof included within the Licensed Patent Rights shall be held invalid or unenforceable in a final decision by a court of competent jurisdiction from which no appeal has or can be taken, any and all obligation to pay Royalties based solely on such patent or claim shall cease as of the date of such final decision.
 
4.8 Any component of Net Sales denominated in currencies other than U.S. Dollars shall be converted into U.S. Dollars in accordance with the provisions of this paragraph, and reported in U.S. Dollars. All payments required under this Agreement from time to time shall be made in U.S. Dollars. Any currency conversions shall be made using the average quarterly exchange rates published regularly by Citibank, New York, or its successor. The average will be calculated by summing the exchange rates for the final business day of each of the three (3) months in the applicable calendar quarter and dividing by three (3). All currency conversions will be calculated to an accuracy of three (3) digits after the decimal point.
 
5. PATENT FILING, PROSECUTION AND MAINTENANCE
 
5.1 As between the parties, TGC shall have the responsibility for the preparation, filing, prosecution and maintenance of the Licensed Patent Rights in the United States and foreign countries for which patent protection has been sought. TGC shall maintain the Licensed Patent Rights in all territories for the maximum time period permitted by applicable law, including by timely paying all applicable maintenance fees and diligently prosecuting any patent applications and diligently defending any Third Party challenges to validity or enforceability.
 
*Confidential Treatment Requested

 
6. PATENT INFRINGEMENT
 
6.1 In the event that AMT learns of the infringement of any Licensed Patent Rights by the manufacture, use or sale of a product in the Field, AMT shall so inform TGC in writing and shall provide TGC with reasonable evidence of such infringement.
 
6.2 As between the parties, TGC shall have the first right but not the obligation to prosecute such infringement of the Licensed Patent Rights. In the event such infringement relates specifically to the manufacture, use or sale of a product in the Field, AMT shall have the right but not the obligation to participate in such infringement litigation and be represented by counsel of its choice at its own expense. In the event TGC notifies AMT that it will not bring such action as it relates specifically to the manufacture, use or sale of a product in the Field, AMT at it is own expense shall have the right to bring such action and shall cause TGC to be joined in such action in jurisdictions where it is necessary for TGC to be named in order for AMT to have standing in such infringement litigations; provided, however, that AMT shall allow TGC to participate and be represented by counsel of its own choice at AMT’s sole expense. AMT shall not nor shall AMT cause TGC to settle or compromise any such suit in a manner that imposes any obligations or restrictions on TGC or grants any License Patent Rights without TGC’s written permission.
 
6.3 Each party shall, at the request and expense of the party initiating such suit, cooperate in all respects, including being joined as a named party, and, to the extent possible, have its employees testify when requested and make available relevant records, papers, information, samples, specimens, and the like. No such suit shall be settled by a party in any manner which diminishes the rights of the other party hereto under this Agreement without the written agreement of both parties.
 
6.4 Any legal action against a third party under this Section 6 shall be at the expense of the party on account of whom suit is brought and recoveries recovered thereby shall first be allocated to reimburse the expenses of the parties on a pro rata basis, after which, when the infringement relates to the manufacture, use or sale of a product in the Field,, any remaining recoveries shall belong to AMT and AMT shall pay TGC royalty amounts set forth in Section 4 on such remaining recoveries as if such recoveries were Net Sales.
 
7. REPORTING
 
7.1 AMT will make quarterly royalty reports to TGC on or before each January 30, April 30, July 30 and October 30 of each year (i.e., within thirty (30) days from the end of each calendar quarter) and certified by the chief financial officer of AMT. Each such royalty report will cover AMT’s most recently completed calendar quarter and will show: (a) the gross sales and Net Sales of Licensed Products sold by AMT during the most recently completed calendar quarter, including (i) all amounts invoiced, billed, or received; and (ii) the number of units and the country of sale; and (b) the Royalties payable hereunder with respect to such. If no sales of Licensed Products have been made during any reporting period, a statement to this effect shall be provided by AMT to TGC.
 
7.2 Progress Reports.
 
*Confidential Treatment Requested

 
7.2.1 AMT will provide TGC with a written plan relating to AMT’s development in the Field (the “Development Plan”) within thirty (30) days after the signing of this Agreement by both parties. The Development Plan will outline the disease indications, patient populations to be addressed, publicly available information on competition and estimates of development timelines for AMT’s products in the Field. The Development Plan will separately address activities applicable to each Licensed Product.

7.2.2 At or within thirty (30) days following each anniversary of the Effective Date, AMT will provide TGC with a written progress report that describes any progress made against the Development Plan (as supplemented by progress reports, where applicable) submitted a year earlier and plans for development in the coming year. AMT shall also notify TGC within thirty (30) days of the first commercial sale of any Licensed Product.

7.2.3 AMT will provide TGC with audited financial statements, produced by a certified public accounting firm, ninety (90) days following the end of each of AMT’s fiscal years, as well as a copy of any management letter recommendations submitted by the auditors.

7.2.4 Where applicable AMT will provide TGC with copies of reports such as Form 10-K and Form 10-Q filings made to the United States Securities and Exchange Commission or other similar regulatory agency outside of the United States.

7.2.5 TGC shall keep the Development Plan, all such progress reports, financial statements and any other information AMT provided to TCG under this Section 7 confidential, other than the provision of such reports to the University of Pennsylvania as required under the UPenn Agreement, for five (5) years or until the time, if any, of the first commercial sale of any Licensed Product(s).
 
8. TERM OF THE AGREEMENT
 
8.1 Unless otherwise terminated in accordance with the terms of this Agreement, this Agreement shall be in force from the Effective Date until the last to expire Valid Claim of Licensed Patent Rights (the “Term”).
 
8.2 Any termination of this Agreement shall not affect the rights and obligations set forth in the following Articles:

Article 6.4 Allocation of Patent Infringement Recovery
Article 11.2 Disposition of Licensed Products on Hand upon Termination
Article 13 Use of Names and Trademarks
Article 15 Indemnification
Article 20 Failure to Perform
Article 21 Governing Law
 
9. TERMINATION BY TGC
 
9.1 If AMT violates or fails to pay Royalties, Milestone Payments or fees under Articles 3 or 4, or (ii) breaches or fails to perform, or has any other default, under any contractual obligation of AMT to TGC and fails to repair any default in Sections 9.1(i) or 9.1(ii) within thirty (30) days after receipt of such notice of breach, TGC shall have the right to terminate this Agreement by a second written notice (“Notice of Termination”) to AMT. If a Notice of Termination is sent to AMT, this Agreement shall terminate fifteen (15) days after receipt of such notice unless other terms are mutually agreed upon.
 
*Confidential Treatment Requested

 
9.2 If AMT shall cease its operations other than in connection with a reorganization of its business in connection with a redomociliation or other corporate event unrelated to the solvency of AMT, become bankrupt or insolvent, apply for or consent to the appointment of a trustee, receiver or liquidator of its assets or seek relief under any law for the aid of debtors then TGC shall have the right to terminate the License.
 
10. TERMINATION BY AMT
 
10.1 AMT shall have the right to terminate this Agreement at any time, effective sixty (60) days after receipt by TGC of a written notice of termination delivered pursuant to this section.
 
10.2 AMT may terminate this Agreement with immediate effect by giving written notice to TGC, if TGC ceases its operations, becomes insolvent, applies for or consents to the appointment of a trustee, receiver or liquidator of its assets, or seeks relief under any law for the aid of debtors. If TGC violates or fails to perform any material term or covenant of this Agreement, then AMT may give written notice of such default (“Notice of Default”) to TGC. If TGC fails to repair such default within thirty (30) days after receipt of such Notice of Default, AMT shall have the right to terminate this Agreement by a Notice of Termination to TGC, effective immediately.
 
11. EFFECT OF TERMINATION, DISPOSITION OF LICENSED PRODUCTS UPON TERMINATION
 
11.1 Effect of Termination. Upon the termination of this Agreement, except pursuant to Paragraph 10.2, the License granted by TGC to AMT hereunder shall revert to TGC.
 
11.2 Upon termination of this Agreement for any reason, except pursuant to Paragraph 10.2, AMT shall have the right to dispose of all previously made or partially made Licensed Products, within a period of three (3) months; provided, however, that the sale of such Licensed Products shall be subject to the terms of this Agreement including, but not limited to, the payment of Royalties at the rate and at the time provided herein and the rendering of reports.
 
11.3 Upon termination of this Agreement for any reason, except pursuant to Paragraph 10.2, AMT shall pay, within thirty (30) days to TGC, pursuant to Section 3 and 4, any and all amounts due within sixty (60) days of receipt by TGC of a notice of termination from AMT.
 
11.4 Upon the termination of this Agreement pursuant to Paragraph 10.2 or the termination of the UPenn Agreement, TGC’s rights hereunder shall be assigned directly to the UPenn and shall remain in full force and effect under the terms hereof; and, provided that AMT is not in material breach of this Agreement, the rights and obligations of AMT herein (including but not limited to the License) shall continue in full force and effect without expansion, restriction, inhibition or diminution; provided that [*].
 
*Confidential Treatment Requested

 
11.5  Nothing herein shall constitute a waiver of either party's right to seek damages in the event of a material breach of this Agreement by the other party.
 
12. PATENT MARKING
 
12.1 AMT agrees to mark all Licensed Products made, used or sold under the terms of this Agreement, or their containers, in accordance with the applicable patent marking laws.
 
13. USE OF NAMES AND TRADEMARKS
 
13.1 Unless required by law, nothing contained in this Agreement shall be construed as conferring any right to use in advertising, publicity, or other promotional activities any name, trade name, trademark, or other designation of either party hereto or the UPenn (including any contraction or abbreviation of the foregoing).
 
13.2 Unless required by law, neither party shall disclose, at any time, the financial terms or events upon which financial obligations are triggered in the License, save that TGC and AMT shall have the right to do so (i) to the extent such disclosure is required in publicly filed financial statements or other public statements under rules governing a stock exchange (e.g., the rules of the United States Securities and Exchange Commission, NASDAQ, NYSE, Amsterdam, UKLA or any other stock exchange on which securities issued by either Party may be listed); and (ii) to its actual or potential investment bankers; (iii) to existing and potential investors in connection with an offering or placement of securities for purposes of obtaining financing for its business and to actual and prospective lenders for the purpose of obtaining financing for its business; and (iv) to a bona fide potential acquiror or merger partner for the purposes of evaluating entering into a merger or acquisition, provided, however, any such persons must be obligated to hold in confidence and not make use of such confidential information for any purpose. A press release acknowledging the grant of the License by TGC to AMT shall be publicly disclosed by either or both parties, only upon mutual agreement of the text of such release by both parties.
 
14. REPRESENTATIONS, WARRANTIES AND COVENANTS
 
14.1 Each party hereby represents, warrants, and covenants to the other party as of the Effective Date as follows:
 
i) such party (i) has the power and authority and the legal right to enter into this Agreement and perform its obligations hereunder, and (ii) has taken all necessary action on its part required to authorize the execution and delivery of this Agreement and the performance of its obligations hereunder. This Agreement has been duly executed and delivered on behalf of such party and constitutes a legal, valid, binding obligation of such party and is enforceable against it in accordance with its terms;
 
*Confidential Treatment Requested

 
ii) such party is not aware of any pending or threatened litigation (and has not received any communication) that alleges that such party’s activities related to this Agreement have violated, or that by conducting the activities as contemplated herein such party would violate, any of the intellectual property rights of any other Person;
 
iii) all necessary consents, approvals and authorizations of all governmental authorities and other Persons or entities required to be obtained by such party in connection with this Agreement have been obtained; and
 
14.2 TGC hereby represents, warrants, and covenants to AMT as of the Effective Date that TGC is the exclusive licensee of the Licensed Patent Rights. During the term of this Agreement, TGC shall use its best efforts not to encumber or diminish the rights granted to AMT hereunder, including, without limitation, by not committing any acts or permitting the occurrence of any omissions that would cause the breach or termination of the UPenn Agreement. TGC shall promptly provide AMT with notice of any alleged breach or termination of the UPenn Agreement. As of the date hereof, TGC is not in breach of the UPenn Agreement, and it is in full force and effect.
 
15. DISCLAIMER OF WARRANTY; INDEMNIFICATION
 
15.1 THE LICENSED PATENT RIGHTS AND LICENSED PRODUCTS ARE PROVIDED ON AN “AS IS” BASIS AND TGC MAKES NO REPRESENTATIONS OR WARRANTIES, EXPRESS OR IMPLIED, WITH RESPECT THERETO. BY WAY OF EXAMPLE BUT NOT OF LIMITATION, TGC MAKES NO REPRESENTATION OR WARRANTY: (i) OF COMMERCIAL UTILITY; (ii) OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE; OR (iii) THAT THE USE OF THE LICENSED PATENT RIGHTS AND LICENSED PRODUCTS UNDER THIS AGREEMENT WILL NOT INFRINGE ANY PATENT, COPYRIGHT OR TRADEMARK OR OTHER PROPRIETARY OR PROPERTY RIGHTS OF OTHERS. TGC SHALL NOT BE LIABLE TO AMT OR ANY THIRD PARTY WITH RESPECT TO: ANY CLAIM ARISING FROM THE USE OF THE LICENSED PATENT RIGHTS AND LICENSED PRODUCTS LICENSED UNDER THIS AGREEMENT OR FROM THE MANUFACTURE, USE OR SALE OF LICENSED PRODUCTS; OR ANY CLAIM FOR LOSS OF PROFITS, LOSS OR INTERRUPTION OF BUSINESS, OR FOR INDIRECT, SPECIAL OR CONSEQUENTIAL DAMAGES OF ANY KIND.
 
15.2 AMT will defend, indemnify and hold harmless TGC and its trustees, officers, agents and employees and UPenn and its trustees, officers, agents and employees both collectively and severally (individually, an “Indemnified Party”, and collectively, the “Indemnified Parties”), from and against any and all liability, loss, damage, action, claim or expense suffered or incurred by the Indemnified Parties (including attorney’s fees) (individually, a “Liability”, and collectively, the “Liabilities”) that results from or arises out of (a) the development, use, manufacture, promotion, sale or other disposition of any Licensed Product by AMT or its collaborators or distributors; and (b) any breach by AMT of any covenant or agreement contained in this Agreement; and (c) the enforcement by an Indemnified Party of its rights under this Section. . Without limiting the foregoing, AMT will defend, indemnify and hold harmless the Indemnified Parties from and against any Liabilities resulting from:
 
*Confidential Treatment Requested

 
15.2.1 any product liability or other claim of any kind related to the use by a third party of a Licensed Product that was manufactured, sold or otherwise disposed of by AMT, or its collaborators or distributors, pursuant to and within the scope of such relationships;
 
15.2.2 a claim by a third party that the use by AMT or its collaborators or distributors, pursuant to and within the scope of such relationships, of Licensed Patent Rights or the design, composition, manufacture, use, sale or other disposition of any Licensed Product by AMT infringes or violates any patent, copyright, trademark or other intellectual property rights of such third party; and
 
15.2.3  clinical trials or studies conducted by or on behalf of AMT, or its collaborators or distributors, pursuant to and within the scope of such relationships, relating to the Licensed Products and Licensed Patent Rights, including, without limitation, any claim by or on behalf of a human subject of any such clinical trial or study, any claim arising from the procedures specified in any protocol used in any such clinical trial or study, any claim of deviation, authorized or unauthorized, from the protocols of any such clinical trial or study, and any claim resulting from or arising out of the manufacture or quality control by a third party of any substance administered in any clinical trial or study.

Notwithstanding the foregoing, however, the Liabilities shall not include, and in no instance shall AMT be required to indemnify any Indemnified Party with respect to, any liability, claims, lawsuits, losses, damages, costs or expenses to the extent the same are determined to be the result of any Indemnified Party’s gross negligence or willful misconduct.
 
15.3 The Indemnified Party shall promptly notify AMT of any claim or action giving rise to Liabilities subject to the provisions of the foregoing Section. AMT shall have the right to defend or to cause to be defended any such claim or action, at its cost and expense. AMT shall not settle or compromise any such claim or action in a manner that imposes any restrictions or obligations on TGC or grants any rights to Licensed Patent Rights or Licensed Products (other than to the extent AMT has the right to grant such rights under this Agreement) without TGC’s prior written consent. If AMT fails or declines to assume the defense of any such claim or action within thirty (30) days after notice thereof, TGC may assume the defense of such claim or action for the account and at the risk of AMT, and any Liabilities related thereto shall be conclusively deemed a liability of AMT; provided however, that TGC shall not settle such claim or action if such settlement affects Licensed Patent Rights other than those specifically at issue in such claim or action without AMT’s written permission, which shall not be unreasonably withheld. AMT shall pay promptly to the Indemnified Party any Liabilities to which the foregoing indemnity relates, as incurred. The indemnification rights of TGC or other Indemnified Party contained herein are in addition to all other rights which such Indemnified Party may have at law or in equity or otherwise.
 
16. INSURANCE
 
16.1 AMT shall procure and maintain a policy or policies of commercial general liability insurance, including broad form and contractual liability, in a minimum amount of $[*] combined single limit per occurrence and in the aggregate as respects personal injury, bodily injury and property damage arising out of AMT’s performance of this Agreement.
 
*Confidential Treatment Requested

 
16.2 AMT shall, upon commencement of clinical trials involving Licensed Products, procure and maintain a policy or policies of product liability insurance in a minimum amount of $[*] combined single limit per occurrence and in the aggregate as respects bodily injury and property damage arising out of AMT’s performance of this Agreement.
 
16.3 AMT shall provide TGC with certificates evidencing the insurance coverage required herein and all subsequent renewals thereof. Such certificates shall provide that AMT’s insurance carrier(s) notify TGC in writing at least 30 days prior to cancellation or material change in coverage. TGC will retain such certificates and notices from AMT’s insurance carrier.
 
16.4 TGC shall periodically review the adequacy of the minimum limits of liability specified herein. Further, TGC reserves the right to require AMT to adjust such coverage limits in accordance with prevailing industry norms, to the extent TGC is required to do the same by UPenn pursuant to the UPenn Agreement. The specified minimum insurance amounts shall not constitute a limitation on AMT’s obligation to indemnify TGC under this Agreement.
 
17. NOTICES
 
17.1 Any notice or payment required to be given to either party shall be deemed to have been properly given and to be effective (a) on the date of delivery if delivered in person or (b) five (5) days after mailing if mailed by a nationally recognized courier or by first-class certified mail, postage paid, to the respective addresses given below, or to such other address designated by written notice, or sent via facsimile transmission to the number specified below.
 
For AMT:
Meibergdreef 61
P.O. Box 22506
1100 DA Amsterdam
The Netherlands
Fax: 31 (0) 20 566 92 72
Attention: CFO
 
For TGC:
1100 Olive Way, Suite 100
Seattle, Washington 98101
Fax: +1 206 223-0288
Attention: Chief Executive Officer
 
18. ASSIGNABILITY
 
18.1 This Agreement is binding upon and shall inure to the benefit of the parties and their successors and assigns.
 
18.2 This Agreement may not be assigned by AMT without first obtaining the express written consent of TGC. TGC shall not unreasonably withhold consent for AMT to assign this Agreement to a Third Party in the event that AMT transfers all or substantially all of the business of AMT to which the License relates to a Third Party. Such Third Party shall assume all royalty obligations to TGC hereunder. TGC further acknowledges that it shall not be entitled to any Royalty or other compensation from the transaction pursuant to which the transfer to a Third Party of all or substantially all of the business of AMT to which the License relates took place.
 
*Confidential Treatment Requested

 
19. WAIVER
 
19.1 It is agreed that no waiver by either party hereto of any breach or default of any of the covenants or agreements herein set forth shall be deemed a waiver as to any subsequent and/or similar breach or default.
 
19.2 UPenn, by its signature on this Agreement, expressly acknowledges and agrees (1) to the terms of this sublicense; (2) to the extent that any term of this sublicense is in conflict with the UPenn Agreement, the terms of this Agreement shall govern as to the rights and obligations of AMT to TGC and AMT to UPenn pursuant to this Agreement; and (3) to the extent any term of this sublicense is in conflict with the UPenn Agreement, other than the UPenn Agreement terms of Section 4.1.2 and 4.1.5, 4.3.2 and 4.3.3, the terms of this Agreement shall govern as to the obligation of TGC to UPenn as they relate to this specific Agreement. TGC shall be obligated to comply with Sections 4.1.2, 4.1.5, 4.3.2 and 4.3.3 of the UPenn Agreement as they relate to the financial obligations of TGC to UPenn arising from the grant of this sublicense to AMT, unless mutually agreed otherwise between TGC and UPenn.
 
20. FAILURE TO PERFORM
 
20.1 In the event of a failure of performance due under the terms of this Agreement and if it becomes necessary for either party to undertake legal action against the other on account thereof, then the prevailing party shall be entitled to reasonable attorney’s fees in addition to costs and necessary disbursements.
 
21. GOVERNING LAW
 
21.1 This Agreement shall be interpreted and construed in accordance with the laws of the Commonwealth of Pennsylvania without regard to the principles of conflicts of laws, but the scope and validity of any patent or patent application shall be governed by the applicable laws of the country of such patent or patent application. Each party hereby submits itself to the non-exclusive jurisdiction of the federal or state courts located in the Commonwealth of Pennsylvania, and any courts of appeal therefrom, and waives any objection (on grounds of lack of jurisdiction, or forum non conveniens or otherwise) to the exercise of such jurisdiction over it by any such courts, in connection with any action that may be brought in such courts.
 

 
22. FORCE MAJEURE
 
22.1 For a period of ninety (90) days, the parties to this Agreement shall be excused from any performance required hereunder if such performance is rendered impossible or unfeasible due to any catastrophe or other major event beyond their reasonable control, including, without limitation, war, riot, and insurrection; laws, proclamations, edicts, ordinances or regulations; strikes, lockouts or other serious labor disputes; and floods, fires, explosions, or other natural disasters. When such events have abated, the parties’ respective obligations hereunder shall resume.
 
23. RIGHTS IN BANKRUPTCY
 
23.1 All rights and licenses (including but not limited to the License) granted under or pursuant to this Agreement by TGC to AMT are, and shall otherwise be deemed to be, for purposes of Section 365(n) of the U.S. Bankruptcy Code, licenses of right to “intellectual property” as defined under Section 101 of the U.S. Banckruptcy Code. The parties agree that AMT, as licensee of such rights under this Agreement, shall retain and may fully exercise all of its rights and elections under the U.S. Bankruptcy Code and to the fullest extent permitted by law.
 
24. MISCELLANEOUS
 
24.1 The headings of the several sections are inserted for convenience of reference only and are not intended to be a part of or to affect the meaning or interpretation of this Agreement. The English language is the official language of this Agreement and that text of the Agreement shall prevail over any translation thereof.
 
24.2 This Agreement will not be binding upon the parties until it has been signed below on behalf of each party, in which event, it shall be effective as of the dated recited on page one.
 
24.3 No amendment or modification hereof shall be valid or binding upon the parties unless made in writing and signed on behalf of each party.
 
24.4 This Agreement embodies the entire understanding of the parties and shall supersede all previous communications, representations or understandings, either oral or written, between the parties relating to the subject matter hereof.
 
24.5 If any provisions contained in this Agreement are or become invalid, are ruled illegal by any court of competent jurisdiction or are deemed unenforceable under then current applicable law from time to time in effect during the term hereof, it is the intention of the parties that the remainder of this Agreement shall not be affected thereby, provided that a party’s rights under this Agreement are not materially affected. It is further the intention of the parties that in lieu of each such provision which is invalid, illegal, or unenforceable, there be substituted or added as part of this Agreement a provision which shall be as similar as possible in economic and business objectives as intended by the parties to such invalid, illegal or unenforceable, provision, but shall be valid, legal and enforceable.
 


IN WITNESS WHEREOF, both TGC and AMT have executed this Agreement, in duplicate originals, by their respective officers hereunto duly authorized, on the day and year hereinafter written.
 
Amsterdam Molecular Therapeutics, B.V.
 
Targeted Genetics Corporation
     
By   /s/ Ronald H.W. Loryn
 
By   /s/ H. Stewart Parker

 

Name Ronald H.W. Loryn
 
Name H. Stewart Parker
     
Title CEO
 
Title Pres & CEO

Acknowledged and accepted by:

The Trustees of the University of Pennsylvania

By   /s/ John S. Zawad

Name John S. Zawad, Ph.D.

Title Managing Director



ATTACHMENT 1

Articles from the UPenn Agreement which would be added to this Agreement, pursuant to Section 11.4 of this Agreement .

9.5- Penn hereby represents that (i) to its knowledge it has the lawful right to grant the licenses granted herein, and (ii) all actions necessary with respect to due authorization, execution and performance of this Agreement to make it legal, valid, binding and enforceable with regard to Penn have been taken.

12.1 Targeted shall comply with all prevailing laws, rules and regulations pertaining to the development, testing, manufacture, marketing, sale, use, import or export of products. Without limiting the foregoing, it is understood that this Agreement may be subject to United States laws and regulations controlling the export of technical data, computer software, laboratory prototypes and other commodities, articles and information, including the Arms Export Control Act as amended in the Export Administration Act of 1979, and that the parties’ obligations hereunder are contingent upon compliance with applicable United States export laws and regulations. The transfer of certain technical data and commodities may require a license from the cognizant agency of the United States Government and/or written assurances by Targeted that Targeted shall not export data or commodities to certain foreign countries without prior approval of such agency. Penn neither represents that a license is not required nor that, if required, it will issue.
 
12.9 Nothing in this Agreement, express or implied, is intended to confer on any person, other than the parties hereto, the Covered Affiliates, or their permitted assigns, any benefits, rights or remedies.

12.10 Penn and Targeted shall not discriminate against any employee or applicant for employment because of race, color, sex, sexual or affectional preference, age, religion, national or ethnic origin, or handicap.


 
EX-10.18 5 v069612_ex10-18.htm
 
 
*Certain confidential information contained in this document, marked by brackets, has been omitted and filed with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
 
PUBLIC HEALTH SERVICE
 
PATENT LICENSE AGREEMENT--EXCLUSIVE
 
COVER PAGE
 
For PHS internal use only:
 
  Patent License Number:  
     
  L-086-00/0  
     
  Serial Number(s) of Licensed Patent(s) and/or Patent Application(s):  
     
  07/891,962 (E-148-1992/0-US-01); 08/455,231 (E-148-1992/0-US-08);  
     
  08/626,953 (E-148-1992/0-US-10); and 09/235,375 (E-148-1992/0-US-11)  
     
  Licensee:  
     
  Targeted Genetics Corporation, a corporation of Washington  
     
  having a principal place of business at 1100 Olive Way, Suite 100,  
     
  Seattle, WA 98101  
     
  Cooperative Research and Development Agreement (CRADA) Number (if applicable):  
     
  None  
     
  Additional Remarks:  
     
 
Related to License L-059-93/0
 
     
     
     
  Public Benefit(s):  
     
     
 
This Patent License Agreement, hereinafter referred to as the "Agreement", consists of this Cover Page, an attached Agreement, a Signature Page, Appendix A (List of Patent(s) and/or Patent Application(s)), Appendix B (Fields of Use and Territory), Appendix C (Royalties), Appendix D (Modifications), Appendix E (Benchmarks), and Appendix F (Commercial Development Plan). The Parties to this Agreement are:

 
1)
The National Institutes of Health ("NIH"), the Centers for Disease Control and Prevention ("CDC"), or the Food and Drug Administration ("FDA"), hereinafter singly or collectively referred to as "PHS", agencies of the United States Public Health Service within the Department of Health and Human Services ("DHHS"); and

 
2)
The person, corporation, or institution identified above and/or on the Signature Page, having offices at the address indicated on the Signature Page, and its Affiliates as defined in Appendix D, Paragraph 2.14, hereinafter referred to as "Licensee".
 

 
PHS PATENT LICENSE AGREEMENT--EXCLUSIVE
 
PHS and Licensee agree as follows:
 
1.
BACKGROUND
 
 
1.01
In the course of conducting biomedical and behavioral research, PHS investigators made inventions that may have commercial applicability.
 
 
1.02
By assignment of rights from PHS employees and other inventors, DHHS, on behalf of the United States Government, owns intellectual property rights claimed in any United States and/or foreign patent applications or patents corresponding to the assigned inventions. DHHS also owns any tangible embodiments of these inventions actually reduced to practice by PHS.
 
 
1.03
The Secretary of DHHS has delegated to PHS the authority to enter into this Agreement for the licensing of rights to these inventions.
 
 
1.04
PHS desires to transfer these inventions to the private sector through commercialization licenses to facilitate the commercial development of products and processes for public use and benefit.
 
 
1.05
Licensee desires to acquire commercialization rights to certain of these inventions in order to develop processes, methods, and/or marketable products for public use and benefit.
 
2.
DEFINITIONS
 
 
2.01
"Benchmarks" mean the performance milestones that are set forth in Appendix E.
 
 
2.02
"Commercial Development Plan" means the written commercialization plan attached as Appendix F.
 
 
2.03
"First Commercial Sale" means the initial transfer by or on behalf of Licensee or its sublicensees of Licensed Products or the initial practice of a Licensed Process by or on behalf of Licensee or its sublicensees in exchange for cash or some equivalent to which value can be assigned for the purpose of determining Net Sales.
 
 
2.04
"Government" means the Government of the United States of America.
 
 
2.05
"Licensed Fields of Use" means the fields of use identified in Appendix B.
 
Page 2 of 30


 
2.06
"Licensed Patent Rights" shall mean:
 
 
a)
Patent applications (including provisional patent applications and PCT patent applications) and/or patents listed in Appendix A, all divisions and continuations of these applications, all patents issuing from such applications, divisions, and continuations, and any reissues, reexaminations, and extensions of all such patents;
 
 
b)
to the extent that the following contain one or more claims directed to the invention or inventions disclosed in a) above: i) continuations-in-part of a) above; ii) all divisions and continuations of these continuations-in-part; iii) all patents issuing from such continuations-in-part, divisions, and continuations; iv) priority patent application(s) of a) above; and v) any reissues, reexaminations, and extensions of all such patents;
 
 
c)
to the extent that the following contain one or more claims directed to the invention or inventions disclosed in a) above: all counterpart foreign and U.S. patent applications and patents to a) and b) above, including those listed in Appendix A.
 
Licensed Patent Rights shall not include b) or c) above to the extent that they contain one or more claims directed to new matter which is not the subject matter disclosed in a) above.
 
 
2.07
"Licensed Process(es)" means processes which, in the course of being practiced would be within the scope of one or more claims of the Licensed Patent Rights that have not been held unpatentable, invalid or unenforceable by an unappealed or unappealable judgment of a court of competent jurisdiction.
 
 
2.08
"Licensed Product(s)" means tangible materials which, in the course of manufacture, use, sale, or importation would be within the scope of one or more claims of the Licensed Patent Rights that have not been held unpatentable, invalid or unenforceable by an unappealed or unappealable judgment of a court of competent jurisdiction.
 
 
2.09
"Licensed Territory" means the geographical area identified in Appendix B.
 
 
2.10
"Net Sales" means the total gross receipts for sales of Licensed Products or practice of Licensed Processes by or on behalf of Licensee or its sublicensees, and from leasing, renting, or otherwise making Licensed Products available to others without sale or other dispositions, whether invoiced or not, less returns and allowances, packing costs, insurance costs, freight out, taxes or excise duties imposed on the transaction (if separately invoiced), and wholesaler and cash discounts in amounts customary in the trade to the extent actually granted. No deductions shall be made for commissions paid to individuals, whether they be with independent sales agencies or regularly employed by Licensee, or sublicensees, and on its payroll, or for the cost of collections.
 
 
2.11
"Practical Application" means to manufacture in the case of a composition or product, to practice in the case of a process or method, or to operate in the case of a machine or system; and in each case, under such conditions as to establish that the invention is being utilized and that its benefits are to the extent permitted by law or Government regulations available to the public on reasonable terms.
 
 
2.12
"Research License" means a nontransferable, nonexclusive license to make and to use the Licensed Products or Licensed Processes as defined by the Licensed Patent Rights for purposes of research and not for purposes of commercial manufacture or distribution or in lieu of purchase.
 
Page 3 of 30

 
3.
GRANT OF RIGHTS
 
 
3.01
PHS hereby grants and Licensee accepts, subject to the terms and conditions of this Agreement, an exclusive license under the Licensed Patent Rights in the Licensed Territory to make and have made, to use and have used, to sell and have sold, to offer to sell, and to import any Licensed Products in the Licensed Fields of Use and to practice and have practiced any Licensed Processes in the Licensed Fields of Use.
 
 
3.02
This Agreement confers no license or rights by implication, estoppel, or otherwise under any patent applications or patents of PHS other than Licensed Patent Rights regardless of whether such patents are dominant or subordinate to Licensed Patent Rights.
 
4.
SUBLICENSING
 
 
4.01
Upon written approval by PHS, which approval will not be unreasonably withheld, Licensee may enter into sublicensing agreements under the Licensed Patent Rights.
 
 
4.02
Licensee agrees that any sublicenses granted by it shall provide that the obligations to PHS of Paragraphs 5.01-5.04, 8.01, 10.01, 10.02, 12.05, and 13.07-13.09 of this Agreement shall be binding upon the sublicensee as if it were a party to this Agreement. Licensee further agrees to attach copies of these Paragraphs to all sublicense agreements.
 
 
4.03
Any sublicenses granted by Licensee shall provide for the termination of the sublicense, or the conversion to a license directly between such sublicensees and PHS, at the option of the sublicensee, upon termination of this Agreement under Article 13. Such conversion is subject to PHS approval and contingent upon acceptance by the sublicensee of the remaining provisions of this Agreement.
 
 
4.04
Licensee agrees to forward to PHS a copy of each fully executed sublicense agreement postmarked within thirty (30) days of the execution of such agreement. To the extent permitted by law, PHS agrees to maintain each such sublicense agreement in confidence.
 
5.
STATUTORY AND PHS REQUIREMENTS AND RESERVED GOVERNMENT RIGHTS
 
 
5.01
(a)
PHS reserves on behalf of the Government an irrevocable, nonexclusive, nontransferable, royalty-free license for the practice of all inventions licensed under the Licensed Patent Rights throughout the world by or on behalf of the Government and on behalf of any foreign government or international organization pursuant to any existing or future treaty or agreement to which the Government is a signatory. Prior to the First Commercial Sale, Licensee agrees to provide PHS reasonable quantities of Licensed Products or materials made through the Licensed Processes for PHS research use.
 
 
(b)
In the event that Licensed Patent Rights are Subject Inventions made under a Cooperative Research and Development Agreement (CRADA), Licensee grants to the Government, pursuant to 15 U.S.C. §3710a(b)(1)(A), a nonexclusive, nontransferable, irrevocable, paid-up license to practice Licensed Patent Rights or have Licensed Patent Rights practiced throughout the world by or on behalf of the Government. In the exercise of such license, the Government shall not publicly disclose trade secrets or commercial or financial information that is privileged or confidential within the meaning of 5 U.S.C. §552(b)(4) or which would be considered as such if it had been obtained from a non-Federal party. Prior to the First Commercial Sale, Licensee agrees to provide PHS reasonable quantities of Licensed Products or materials made through the Licensed Processes for PHS research use.
 
Page 4 of 30


 
5.02
Licensee agrees that products used or sold in the United States embodying Licensed Products or produced through use of Licensed Processes shall be manufactured substantially in the United States, unless a written waiver is obtained in advance from PHS.
 
 
5.03
Licensee acknowledges that PHS may enter into future Cooperative Research and Development Agreements (CRADAs) under the Federal Technology Transfer Act of 1986 that relate to the subject matter of this Agreement. Licensee agrees not to unreasonably deny requests for a Research License from such future collaborators with PHS when acquiring such rights is necessary in order to make a Cooperative Research and Development Agreement (CRADA) project feasible. Licensee may request an opportunity to join as a party to the proposed Cooperative Research and Development Agreement (CRADA).
 
 
5.04
(a)
In addition to the reserved license of Paragraph 5.01 above, PHS reserves the right to grant nonexclusive Research Licenses directly or to require Licensee to grant nonexclusive Research Licenses on reasonable terms. The purpose of this Research License is to encourage basic research, whether conducted at an academic or corporate facility. In order to safeguard the Licensed Patent Rights, however, PHS shall consult with Licensee before granting to commercial entities a Research License or providing to them research samples of materials made through the Licensed Processes.
 
 
(b)
In exceptional circumstances, and in the event that Licensed Patent Rights are Subject Inventions made under a Cooperative Research and Development Agreement (CRADA), the Government, pursuant to 15 U.S.C. §3710a(b)(1)(B), retains the right to require the Licensee to grant to a responsible applicant a nonexclusive, partially exclusive, or exclusive sublicense to use Licensed Patent Rights in Licensee's field of use on terms that are reasonable under the circumstances; or if Licensee fails to grant such a license, the Government retains the right to grant the license itself. The exercise of such rights by the Government shall only be in exceptional circumstances and only if the Government determines (i) the action is necessary to meet health or safety needs that are not reasonably satisfied by Licensee; (ii) the action is necessary to meet requirements for public use specified by Federal regulations, and such requirements are not reasonably satisfied by the Licensee; or (iii) the Licensee has failed to comply with an agreement containing provisions described in 15 U.S.C. §3710a(c)(4)(B). The determination made by the Government under this Article is subject to administrative appeal and judicial review under 35 U.S.C. §203(2).
 
6.
ROYALTIES AND REIMBURSEMENT
 
 
6.01
Licensee agrees to pay to PHS a noncreditable, nonrefundable license issue royalty as set forth in Appendix C within thirty (30) days from the date that this Agreement becomes effective.
 
 
6.02
Licensee agrees to pay to PHS a nonrefundable minimum annual royalty as set forth in Appendix C. The minimum annual royalty is due and payable on January 1 of each calendar year and may be credited against any earned royalties due for sales made in that year. The minimum annual royalty due for the first calendar year of this Agreement may be prorated according to the fraction of the calendar year remaining between the effective date of this Agreement and the next subsequent January 1.
 
 
6.03
Licensee agrees to pay PHS earned royalties as set forth in Appendix C.
 
 
6.04
Licensee agrees to pay PHS benchmark royalties as set forth in Appendix C.
 
 
6.05
Licensee agrees to pay PHS sublicensing royalties as set forth in Appendix C.
 
Page 5 of 30


 
6.06
A patent or patent application licensed under this Agreement shall cease to fall within the Licensed Patent Rights for the purpose of computing earned royalty payments in any given country on the earliest of the dates that a) the application has been abandoned and not continued, b) the patent expires or irrevocably lapses, or c) the claim has been held to be invalid or unenforceable by an unappealed or unappealable decision of a court of competent jurisdiction or administrative agency.
 
 
6.07
No multiple royalties shall be payable because any Licensed Products or Licensed Processes are covered by more than one of the Licensed Patent Rights.
 
 
6.08
On sales of Licensed Products by Licensee to sublicensees or on sales made in other than an arm's-length transaction, the value of the Net Sales attributed under this Article 6 to such a transaction shall be that which would have been received in an arm's-length transaction, based on sales of like quantity and quality products on or about the time of such transaction.
 
 
6.09
With regard to expenses associated with the preparation, filing, prosecution, and maintenance of all patent applications and patents included within the Licensed Patent Rights incurred by PHS prior to the effective date of this Agreement, Licensee shall pay to PHS, as an additional royalty, within sixty (60) days of PHS's submission of a statement and request for payment to Licensee, an amount equivalent to such patent expenses previously incurred by PHS.
 
 
6.10
With regard to expenses associated with the preparation, filing, prosecution, and maintenance of all patent applications and patents included within the Licensed Patent Rights incurred by PHS on or after the effective date of this Agreement, PHS, at its sole option, may require Licensee:
 
(a) to pay PHS on an annual basis, within sixty (60) days of PHS's submission of a statement and request for payment, a royalty amount equivalent to all such patent expenses incurred during the previous calendar year(s); or
 
(b) to pay such expenses directly to the law firm employed by PHS to handle such functions. However, in such event, PHS and not Licensee shall be the client of such law firm.
 
In limited circumstances, Licensee may be given the right to assume responsibility for the preparation, filing, prosecution, or maintenance of any patent application or patent included with the Licensed Patent Rights. In that event, Licensee shall directly pay the attorneys or agents engaged to prepare, file, prosecute, or maintain such patent applications or patents and shall provide to PHS copies of each invoice associated with such services as well as documentation that such invoices have been paid.
 
 
6.11
Licensee may elect to surrender its rights in any country of the Licensed Territory under any Licensed Patent Rights upon ninety (90) days written notice to PHS and owe no payment obligation under Article 6.10 for patent-related expenses incurred in that country after ninety (90) days of the effective date of such written notice.
 
7.
PATENT FILING, PROSECUTION, AND MAINTENANCE
 
 
7.01
Except as otherwise provided in this Article 7, PHS agrees to take responsibility for, but to consult with, the Licensee in the preparation, filing, prosecution, and maintenance of any and all patent applications or patents included in the Licensed Patent Rights and shall furnish copies of relevant patent-related documents to Licensee.
 
Page 6 of 30


 
7.02
Upon PHS's written request, Licensee shall assume the responsibility for the preparation, filing, prosecution, and maintenance of any and all patent applications or patents included in the Licensed Patent Rights and shall on an ongoing basis promptly furnish copies of all patent-related documents to PHS. In such event, Licensee shall, subject to the prior approval of PHS, select registered patent attorneys or patent agents to provide such services on behalf of Licensee and PHS. PHS shall provide appropriate powers of attorney and other documents necessary to undertake such actions to the patent attorneys or patent agents providing such services. Licensee and its attorneys or agents shall consult with PHS in all aspects of the preparation, filing, prosecution and maintenance of patent applications and patents included within the Licensed Patent Rights and shall provide PHS sufficient opportunity to comment on any document that Licensee intends to file or to cause to be filed with the relevant intellectual property or patent office.
 
 
7.03
At any time, PHS may provide Licensee with written notice that PHS wishes to assume control of the preparation, filing, prosecution, and maintenance of any and all patent applications or patents included in the Licensed Patent Rights. If PHS elects to assume such responsibilities, Licensee agrees to cooperate fully with PHS, its attorneys, and agents in the preparation, filing, prosecution, and maintenance of any and all patent applications or patents included in the Licensed Patent Rights and to provide PHS with complete copies of any and all documents or other materials that PHS deems necessary to undertake such responsibilities. Licensee shall be responsible for all costs associated with transferring patent prosecution responsibilities to an attorney or agent of PHS's choice.
 
 
7.04
Each party shall promptly inform the other as to all matters that come to its attention that may affect the preparation, filing, prosecution, or maintenance of the Licensed Patent Rights and permit each other to provide comments and suggestions with respect to the preparation, filing, prosecution, and maintenance of Licensed Patent Rights, which comments and suggestions shall be considered by the other party.
 
8.
RECORD KEEPING
 
 
8.01
Licensee agrees to keep accurate and correct records of Licensed Products made, used, sold, or imported and Licensed Processes practiced under this Agreement appropriate to determine the amount of royalties due PHS. Such records shall be retained for at least five (5) years following a given reporting period and shall be available during normal business hours for inspection at the expense of PHS by an accountant or other designated auditor selected by PHS for the sole purpose of verifying reports and payments hereunder. The accountant or auditor shall only disclose to PHS information relating to the accuracy of reports and payments made under this Agreement. If an inspection shows an underreporting or underpayment in excess of five percent (5%) for any twelve (12) month period, then Licensee shall reimburse PHS for the cost of the inspection at the time Licensee pays the unreported royalties, including any late charges as required by Paragraph 9.08 of this Agreement. All payments required under this Paragraph shall be due within thirty (30) days of the date PHS provides Licensee notice of the payment due.
 
 
8.02
Licensee agrees to have an audit of sales and royalties conducted by an independent auditor at least every two (2) years if annual sales of the Licensed Product or Licensed Processes are over two (2) million dollars. The audit shall address, at a minimum, the amount of gross sales by or on behalf of Licensee during the audit period, terms of the license as to percentage or fixed royalty to be remitted to the Government, the amount of royalty funds owed to the Government under this Agreement, and whether the royalty amount owed has been paid to the Government and is reflected in the records of the Licensee. The audit shall also indicate the PHS license number, product, and the time period being audited. A report certified by the auditor shall be submitted promptly by the auditor directly to PHS on completion. Licensee shall pay for the entire cost of the audit.
 
Page 7 of 30

 
9.
REPORTS ON PROGRESS, BENCHMARKS, SALES, AND PAYMENTS
 
 
9.01
Prior to signing this Agreement, Licensee has provided to PHS the Commercial Development Plan at Appendix F, under which Licensee intends to bring the subject matter of the Licensed Patent Rights to the point of Practical Application. This Commercial Development Plan is hereby incorporated by reference into this Agreement. Based on this plan, performance Benchmarks are determined as specified in Appendix E.
 
 
9.02
Licensee shall provide written annual reports on its product development progress or efforts to commercialize under the Commercial Development Plan for each of the Licensed Fields of Use within sixty (60) days after December 31 of each calendar year. These progress reports shall include, but not be limited to: progress on research and development, status of applications for regulatory approvals, manufacturing, sublicensing, marketing, importing, and sales during the preceding calendar year, as well as plans for the present calendar year. PHS also encourages these reports to include information on any of Licensee's public service activities that relate to the Licensed Patent Rights. If reported progress differs from that projected in the Commercial Development Plan and Benchmarks, Licensee shall explain the reasons for such differences. In any such annual report, Licensee may propose amendments to the Commercial Development Plan, acceptance of which by PHS may not be denied unreasonably. Licensee agrees to provide any additional information reasonably required by PHS to evaluate Licensee's performance under this Agreement. Licensee may amend the Benchmarks at any time upon written consent by PHS. PHS shall not unreasonably withhold approval of any request of Licensee to extend the time periods of this schedule if such request is supported by a reasonable showing by Licensee of diligence in its performance under the Commercial Development Plan and toward bringing the Licensed Products to the point of Practical Application as defined in 37 CFR §404.3(d). Licensee shall amend the Commercial Development Plan and Benchmarks at the request of PHS to address any Licensed Fields of Use not specifically addressed in the plan originally submitted.
 
 
9.03
Licensee shall report to PHS the dates for achieving Benchmarks specified in Appendix E and the First Commercial Sale in each country in the Licensed Territory within thirty (30) days of such occurrences.
 
 
9.04
Licensee shall submit to PHS within sixty (60) days after each calendar half-year ending June 30 and December 31 a royalty report setting forth for the preceding half-year period the amount of the Licensed Products sold or Licensed Processes practiced by or on behalf of Licensee in each country within the Licensed Territory, the Net Sales, and the amount of royalty accordingly due. With each such royalty report, Licensee shall submit payment of the earned royalties due. If no earned royalties are due to PHS for any reporting period, the written report shall so state. The royalty report shall be certified as correct by an authorized officer of Licensee and shall include a detailed listing of all deductions made under Paragraph 2.10 to determine Net Sales made under Article 6 to determine royalties due.
 
 
9.05
Licensee agrees to forward semi-annually to PHS a copy of such reports received by Licensee from its sublicensees during the preceding half-year period as shall be pertinent to a royalty accounting to PHS by Licensee for activities under the sublicense.
 
Page 8 of 30


 
9.06
Royalties due under Article 6 shall be paid in U.S. dollars. For conversion of foreign currency to U.S. dollars, the conversion rate shall be the New York foreign exchange rate quoted in The Wall Street Journal on the day that the payment is due. All checks and bank drafts shall be drawn on United States banks and shall be payable, as appropriate, to "NIH/Patent Licensing." All such payments shall be sent to the following address: NIH, P.O. Box 360120, Pittsburgh, PA 15251-6120. Any loss of exchange, value, taxes, or other expenses incurred in the transfer or conversion to U.S. dollars shall be paid entirely by Licensee. The royalty report required by Paragraph 9.04 of this Agreement shall accompany each such payment, and a copy of such report shall also be mailed to PHS at its address for notices indicated on the Signature Page of this Agreement.
 
 
9.07
Licensee shall be solely responsible for determining if any tax on royalty income is owed outside the United States and shall pay any such tax and be responsible for all filings with appropriate agencies of foreign governments.
 
 
9.08
Interest and penalties may be assessed by PHS on any overdue payments in accordance with the Federal Debt Collection Act. The payment of such late charges shall not prevent PHS from exercising any other rights it may have as a consequence of the lateness of any payment.
 
 
9.09
All plans and reports required by this Article 9 and marked "confidential" by Licensee shall, to the extent permitted by law, be treated by PHS as commercial and financial information obtained from a person and as privileged and confidential, and any proposed disclosure of such records by the PHS under the Freedom of Information Act (FOIA), 5 U.S.C. §552 shall be subject to the predisclosure notification requirements of 45 CFR §5.65(d).
 
10.
PERFORMANCE
 
 
10.01
Licensee shall use its reasonable best efforts to bring the Licensed Products and Licensed Processes to Practical Application. "Reasonable best efforts" for the purposes of this provision shall include adherence to the Commercial Development Plan at Appendix F and performance of the Benchmarks at Appendix E. The efforts of a sublicensee shall be considered the efforts of Licensee.
 
 
10.02
Upon the First Commercial Sale, until the expiration of this Agreement, Licensee shall use its reasonable best efforts to make Licensed Products and Licensed Processes reasonably accessible to the United States public.
 
11.
INFRINGEMENT AND PATENT ENFORCEMENT
 
 
11.01
PHS and Licensee agree to notify each other promptly of each infringement or possible infringement of the Licensed Patent Rights, as well as any facts which may affect the validity, scope, or enforceability of the Licensed Patent Rights of which either Party becomes aware.
 
Page 9 of 30


 
11.02
Pursuant to this Agreement and the provisions of Chapter 29 of title 35, United States Code, Licensee may: a) bring suit in its own name, at its own expense, and on its own behalf for infringement of presumably valid claims in the Licensed Patent Rights; b) in any such suit, enjoin infringement and collect for its use, damages, profits, and awards of whatever nature recoverable for such infringement; and c) settle any claim or suit for infringement of the Licensed Patent Rights provided, however, that PHS and appropriate Government authorities shall have the first right to take such actions. If Licensee desires to initiate a suit for patent infringement, Licensee shall notify PHS in writing. If PHS does not notify Licensee of its intent to pursue legal action within ninety (90) days, Licensee will be free to initiate suit. PHS shall have a continuing right to intervene in such suit. Licensee shall take no action to compel the Government either to initiate or to join in any such suit for patent infringement. Licensee may request the Government to initiate or join in any such suit if necessary to avoid dismissal of the suit. Should the Government be made a party to any such suit, Licensee shall reimburse the Government for any costs, expenses, or fees which the Government incurs as a result of such motion or other action, including any and all costs incurred by the Government in opposing any such motion or other action. In all cases, Licensee agrees to keep PHS reasonably apprised of the status and progress of any litigation. Before Licensee commences an infringement action, Licensee shall notify PHS and give careful consideration to the views of PHS and to any potential effects of the litigation on the public health in deciding whether to bring suit.
 
 
11.03
In the event that a declaratory judgment action alleging invalidity or non-infringement of any of the Licensed Patent Rights shall be brought against Licensee or raised by way of counterclaim or affirmative defense in an infringement suit brought by Licensee under Paragraph 11.02, pursuant to this Agreement and the provisions of Chapter 29 of Title 35, United States Code or other statutes, Licensee may: a) defend the suit in its own name, at its own expense, and on its own behalf for presumably valid claims in the Licensed Patent Rights; b) in any such suit, ultimately to enjoin infringement and to collect for its use, damages, profits, and awards of whatever nature recoverable for such infringement; and c) settle any claim or suit for declaratory judgment involving the Licensed Patent Rights-provided, however, that PHS and appropriate Government authorities shall have the first right to take such actions and shall have a continuing right to intervene in such suit. If PHS does not notify Licensee of its intent to respond to the legal action within a reasonable time, Licensee will be free to do so. Licensee shall take no action to compel the Government either to initiate or to join in any such declaratory judgment action. Licensee may request the Government to initiate or to join any such suit if necessary to avoid dismissal of the suit. Should the Government be made a party to any such suit by motion or any other action of Licensee, Licensee shall reimburse the Government for any costs, expenses, or fees which the Government incurs as a result of such motion or other action. If Licensee elects not to defend against such declaratory judgment action, PHS, at its option, may do so at its own expense. In all cases, Licensee agrees to keep PHS reasonably apprised of the status and progress of any litigation. Before Licensee commences an infringement action, Licensee shall notify PHS and give careful consideration to the views of PHS and to any potential effects of the litigation on the public health in deciding whether to bring suit.
 
 
11.04
In any action under Paragraphs 11.02 or 11.03, the expenses including costs, fees, attorney fees, and disbursements, shall be paid by Licensee. The value of any recovery made by Licensee through court judgment or settlement shall be treated as Net Sales and subject to earned royalties.
 
 
11.05
PHS shall cooperate fully with Licensee in connection with any action under Paragraphs 11.02 or 11.03. PHS agrees promptly to provide access to all necessary documents and to render reasonable assistance in response to a request by Licensee.
 
12.
NEGATION OF WARRANTIES AND INDEMNIFICATION
 
 
12.01
PHS offers no warranties other than those specified in Article 1.
 
Page 10 of 30


 
12.02
PHS does not warrant the validity of the Licensed Patent Rights and makes no representations whatsoever with regard to the scope of the Licensed Patent Rights, or that the Licensed Patent Rights may be exploited without infringing other patents or other intellectual property rights of third parties.
 
 
12.03
PHS MAKES NO WARRANTIES, EXPRESSED OR IMPLIED, OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE OF ANY SUBJECT MATTER DEFINED BY THE CLAIMS OF THE LICENSED PATENT RIGHTS OR TANGIBLE MATERIALS RELATED THERETO.
 
 
12.04
PHS does not represent that it will commence legal actions against third parties infringing the Licensed Patent Rights.
 
 
12.05
Licensee shall indemnify and hold PHS, its employees, students, fellows, agents, and consultants harmless from and against all liability, demands, damages, expenses, and losses, including but not limited to death, personal injury, illness, or property damage in connection with or arising out of: a) the use by or on behalf of Licensee, its sublicensees, directors, employees, or third parties of any Licensed Patent Rights; or b) the design, manufacture, distribution, or use of any Licensed Products, Licensed Processes or materials by Licensee, or other products or processes developed in connection with or arising out of the Licensed Patent Rights. Licensee agrees to maintain a liability insurance program consistent with sound business practice.
 
13.
TERM, TERMINATION, AND MODIFICATION OF RIGHTS
 
 
13.01
This Agreement is effective when signed by all parties and shall extend to the expiration of the last to expire of the Licensed Patent Rights unless sooner terminated as provided in this Article 13.
 
 
13.02
In the event that Licensee is in default in the performance of any material obligations under this Agreement, including but not limited to the obligations listed in Article 13.05, and if the default has not been remedied within ninety (90) days after the date of notice in writing of such default, PHS may terminate this Agreement by written notice and pursue outstanding amounts owed through procedures provided by the Federal Debt Collection Act.
 
 
13.03
In the event that Licensee becomes insolvent, files a petition in bankruptcy, has such a petition filed against it, determines to file a petition in bankruptcy, or receives notice of a third party's intention to file an involuntary petition in bankruptcy, Licensee shall immediately notify PHS in writing. Furthermore, PHS shall have the right to terminate this Agreement immediately upon Licensee's receipt of written notice.
 
 
13.04
Licensee shall have a unilateral right to terminate this Agreement and/or any licenses in any country or territory by giving PHS sixty (60) days written notice to that effect.
 
Page 11 of 30


 
13.05
PHS shall specifically have the right to terminate or modify, at its option, this Agreement, if PHS determines that the Licensee: 1) is not executing the Commercial Development Plan submitted with its request for a license and the Licensee cannot otherwise demonstrate to PHS's satisfaction that the Licensee has taken, or can be expected to take within a reasonable time, effective steps to achieve Practical Application of the Licensed Products or Licensed Processes; 2) has not achieved the Benchmarks as may be modified under Paragraph 9.02; 3) has willfully made a false statement of, or willfully omitted, a material fact in the license application or in any report required by the license Agreement; 4) has committed a material breach of a covenant or agreement contained in the license; 5) is not keeping Licensed Products or Licensed Processes reasonably available to the public after commercial use commences; 6) cannot reasonably satisfy unmet health and safety needs; or 7) cannot reasonably justify a failure to comply with the domestic production requirement of Paragraph 5.02 unless waived. In making this determination, PHS will take into account the normal course of such commercial development programs conducted with sound and reasonable business practices and judgment and the annual reports submitted by Licensee under Paragraph 9.02. Prior to invoking this right, PHS shall give written notice to Licensee providing Licensee specific notice of, and a ninety (90) day opportunity to respond to, PHS's concerns as to the previous items 1) to 7). If Licensee fails to alleviate PHS's concerns as to the previous items 1) to 7) or fails to initiate corrective action to PHS's satisfaction, PHS may terminate this Agreement.
 
 
13.06
When the public health and safety so require, and after written notice to Licensee providing Licensee a sixty (60) day opportunity to respond, PHS shall have the right to require Licensee to grant sublicenses to responsible applicants, on reasonable terms, in any Licensed Fields of Use under the Licensed Patent Rights, unless Licensee can reasonably demonstrate that the granting of the sublicense would not materially increase the availability to the public of the subject matter of the Licensed Patent Rights. PHS will not require the granting of a sublicense unless the responsible applicant has first negotiated in good faith with Licensee.
 
 
13.07
PHS reserves the right according to 35 U.S.C. §209(f)(4) to terminate or modify this Agreement if it is determined that such action is necessary to meet requirements for public use specified by federal regulations issued after the date of the license and such requirements are not reasonably satisfied by Licensee.
 
 
13.08
Within thirty (30) days of receipt of written notice of PHS's unilateral decision to modify or terminate this Agreement, Licensee may, consistent with the provisions of 37 CFR §404.11, appeal the decision by written submission to the designated PHS official. The decision of the designated PHS official shall be the final agency decision. Licensee may thereafter exercise any and all administrative or judicial remedies that may be available.
 
 
13.09
Within ninety (90) days of expiration or termination of this Agreement under this Article 13, a final report shall be submitted by Licensee. Any royalty payments, including those incurred but not yet paid (such as the full minimum annual royalty), and those related to patent expense, due to PHS shall become immediately due and payable upon termination or expiration. If terminated under this Article 13, sublicensees may elect to convert their sublicenses to direct licenses with PHS pursuant to Paragraph 4.03. Unless otherwise specifically provided for under this Agreement, upon termination or expiration of this Agreement, Licensee shall return all Licensed Products or other materials included within the Licensed Patent Rights to PHS or provide PHS with certification of the destruction thereof.
 
14.
GENERAL PROVISIONS
 
 
14.01
Neither Party may waive or release any of its rights or interests in this Agreement except in writing. The failure of the Government to assert a right hereunder or to insist upon compliance with any term or condition of this Agreement shall not constitute a waiver of that right by the Government or excuse a similar subsequent failure to perform any such term or condition by Licensee.
 
Page 12 of 30

 
 
14.02
This Agreement constitutes the entire agreement between the Parties relating to the subject matter of the Licensed Patent Rights, and all prior negotiations, representations, agreements, and understandings are merged into, extinguished by, and completely expressed by this Agreement.
 
 
14.03
The provisions of this Agreement are severable, and in the event that any provision of this Agreement shall be determined to be invalid or unenforceable under any controlling body of law, such determination shall not in any way affect the validity or enforceability of the remaining provisions of this Agreement.
 
 
14.04
If either Party desires a modification to this Agreement, the Parties shall, upon reasonable notice of the proposed modification by the Party desiring the change, confer in good faith to determine the desirability of such modification. No modification will be effective until a written amendment is signed by the signatories to this Agreement or their designees.
 
 
14.05
The construction, validity, performance, and effect of this Agreement shall be governed by Federal law as applied by the Federal courts in the District of Columbia.
 
 
14.06
All notices required or permitted by this Agreement shall be given by prepaid, first class, registered or certified mail or by an express/overnight delivery service provided by a commercial carrier, properly addressed to the other Party at the address designated on the following Signature Page, or to such other address as may be designated in writing by such other Party. Notices shall be considered timely if such notices are received on or before the established deadline date or sent on or before the deadline date as verifiable by U.S. Postal Service postmark or dated receipt from a commercial carrier. Parties should request a legibly dated U.S. Postal Service postmark or obtain a dated receipt from a commercial carrier or the U.S. Postal Service. Private metered postmarks shall not be acceptable as proof of timely mailing.
 
 
14.07
This Agreement shall not be assigned by Licensee except: a) with the prior written consent of PHS, such consent not to be withheld unreasonably; or b) as part of a sale or transfer of substantially the entire business of Licensee relating to operations which concern this Agreement. Licensee shall notify PHS within ten (10) days of any assignment of this Agreement by Licensee, and Licensee shall pay PHS, as an additional royalty, one percent (1%) of the fair market value of any consideration received for any assignment of this Agreement within thirty (30) days of such assignment.
 
 
14.08
Licensee agrees in its use of any PHS-supplied materials to comply with all applicable statutes, regulations, and guidelines, including PHS and DHHS regulations and guidelines. Licensee agrees not to use the materials for research involving human subjects or clinical trials in the United States without complying with 21 CFR Part 50 and 45 CFR Part 46. Licensee agrees not to use the materials for research involving human subjects or clinical trials outside of the United States without notifying PHS, in writing, of such research or trials and complying with the applicable regulations of the appropriate national control authorities. Written notification to PHS of research involving human subjects or clinical trials outside of the United States shall be given no later than sixty (60) days prior to commencement of such research or trials.
 
 
14.09
Licensee acknowledges that it is subject to and agrees to abide by the United States laws and regulations (including the Export Administration Act of 1979 and Arms Export Control Act) controlling the export of technical data, computer software, laboratory prototypes, biological material, and other commodities. The transfer of such items may require a license from the cognizant Agency of the U.S. Government or written assurances by Licensee that it shall not export such items to certain foreign countries without prior approval of such agency. PHS neither represents that a license is or is not required or that, if required, it shall be issued.
 
Page 13 of 30


 
14.10
Licensee agrees to mark the Licensed Products or their packaging sold in the United States with all applicable U.S. patent numbers and similarly to indicate "Patent Pending" status. All Licensed Products manufactured in, shipped to, or sold in other countries shall be marked in such a manner as to preserve PHS patent rights in such countries.
 
 
14.11
By entering into this Agreement, PHS does not directly or indirectly endorse any product or service provided, or to be provided, by Licensee whether directly or indirectly related to this Agreement. Licensee shall not state or imply that this Agreement is an endorsement by the Government, PHS, any other Government organizational unit, or any Government employee. Additionally, Licensee shall not use the names of NIH, CDC, PHS, or DHHS or the Government or their employees in any advertising, promotional, or sales literature without the prior written consent of PHS.
 
 
14.12
The Parties agree to attempt to settle amicably any controversy or claim arising under this Agreement or a breach of this Agreement, except for appeals of modifications or termination decisions provided for in Article 13. Licensee agrees first to appeal any such unsettled claims or controversies to the designated PHS official, or designee, whose decision shall be considered the final agency decision. Thereafter, Licensee may exercise any administrative or judicial remedies that may be available.
 
 
14.13
Nothing relating to the grant of a license, nor the grant itself, shall be construed to confer upon any person any immunity from or defenses under the antitrust laws or from a charge of patent misuse, and the acquisition and use of rights pursuant to 37 CFR Part 404 shall not be immunized from the operation of state or Federal law by reason of the source of the grant.
 
 
14.14
Paragraphs 4.03, 8.01, 9.05-9.07, 12.01-12.05, 13.08, 13.09, and 14.12 of this Agreement shall survive termination of this Agreement.
 
 
SIGNATURES BEGIN ON NEXT PAGE
 
Page 14 of 30

 
PHS PATENT LICENSE AGREEMENT--EXCLUSIVE
 
SIGNATURE PAGE
 
For PHS:
 
/s/ Steven M. Ferguson    5/7/04
Steven M. Ferguson, MBA 
Director, Division of Technology Development and Transfer
Office of Technology Transfer
National Institutes of Health
  Date
     
Mailing Address for Notices:
Office of Technology Transfer
National Institutes of Health
6011 Executive Boulevard, Suite 325
Rockville, Maryland 20852-3804 U.S.A.
   
 
For Licensee (Upon, information and belief, the undersigned expressly certifies or affirms that the contents of any statements of Licensee made or referred to in this document are truthful and accurate.):
 
by:
Targeted Genetics Corporation
   
Licensee    
     
/s/ H. Stewart Parker
 
5/21/04
Signature of Authorized Official 
  Date
     
H. Stewart Parker 
   
Printed Name    
     
Pres & CEO     
Title    
     
Official and Mailing Address for Notices:    
     
Targeted Genetics Corporation     
     
1100 Olive Way, Suite 100     
     
Seattle, WA 98101    
     
Attention:      
 
Any false or misleading statements made, presented, or submitted to the Government, including any relevant omissions, under this Agreement and during the course of negotiation of this Agreement are subject to all applicable civil and criminal statutes including Federal statutes 31 U.S.C. §§3801-3812 (civil liability) and 18 U.S.C. §1001 (criminal liability including fine(s) and/or imprisonment).
 
Page 15 of 30

 
APPENDIX A--PATENT(S) OR PATENT APPLICATION(S)
 
Patent(s) or Patent Application(s):
 
A. U.S. Patents:
 
 
1.
5,587,308 issued December 24, 1996 entitled “Modified Adeno-Associated Virus Vector Capable of Expression from a Novel Promoter” (NIH Ref: E-148-1992/0-US-01);
 
 
2.
5,989,540 issued November 23, 1999 entitled “Modified Adeno-Associated Virus Vector Capable of Expression from a Novel Promoter” (NIH Ref: E-148-1992/0-US-08);
 
 
3.
5,866,696 issued February 2, 1999 entitled “Modified Adeno-Associated Virus Vector Capable of Expression from a Novel Promoter” (NIH Ref: E-148-1992/0-US-10); and
 
 
4.
6,165,781 issued December 26, 2000 entitled “Modified Adeno-Associated Virus Vector Capable of Expression from a Novel Promoter” (NIH Ref: E-148-1992/0-US-11).
 
B. PCT Patent Application and related Foreign Patents and Patent Applications:
 
 
1.
PCT/US93/05310 filed June 2, 1993 and published as WO 93/24641 December 9, 1993 which claims priority to U.S. Patent Application 07/891,962 filed June 2, 1992, now U.S. Patent 5,587,308 issued December 24, 1996 (NIH Ref: E-148-1992/0-PCT-02);
 
 
2.
Australian Patent 673367 issued November 7, 1996 from Australian Patent Application 45981/93 having an international filing date of June 2, 1993 (NIH Ref: E-1481992/0-AU-03);
 
 
3.
Canadian Patent Application 2,136,441 having an international filing date of June 2, 1993 (NIH Ref: E-148-1992/0-CA-04);
 
 
4.
European Patent 0644944 issued November 21, 2001 from European Application EP 93 916425.7 having an international filing date of June 2, 1993 including all designated countries where the patent grant was registered (NIH Ref: E-148-1992/0-EP-06);
 
 
5.
Hong Kong Patent 1014549 issued June 7, 2002 from Hong Kong Application KH 9811581435 having an international filing date of June 3, 1993 (NIH Ref: E-148-1992/0-HK-07); and
 
 
6.
European Patent Application EP 01 107900.0, a divisional application of EP 93 916425.7 having an international filing date of June 2, 1993 (NIH Ref: E-148-1992/0-EP-05).
 
Page 16 of 30

 
APPENDIX B--LICENSED FIELDS OF USE AND TERRITORY
 
Licensed Fields of Use:
The development of compositions and methods utilizing Adeno-Associated Viral Vectors embodied in the Licensed Patent Rights which are useful in the treatment and prophylaxis of human and animal diseases. This field of use is separate and distinct form that of the Agreement between Licensee and PHS, having PHS reference number L-059-1993/0 effective March 18, 1994 and does not include compositions and methods for the treatment and prophylaxis of cystic fibrosis.
   
Licensed Territory:  Worldwide
 
 
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Page 17 of 30


APPENDIX C--ROYALTIES
 
Royalties:
 
A.
License Issue Royalty pursuant to Paragraph 6.01 as amended and set forth in Appendix D of this Agreement:
 
Licensee agrees to pay to PHS, a non-refundable, non-creditable License Issue Royalty in the amount of [*] Dollars ($[*]). The License Issue Royalty as set forth herein is due as of the effective date of this Agreement and is payable to PHS within thirty (30) days thereof.
 
B.
Minimum Annual Royalty pursuant to Paragraph 6.02 as amended and set forth in Appendix D of this Agreement:
 
Licensee agrees to pay to PHS, a non-refundable, non-creditable Minimum Annual Royalty in the amount of [*] Dollars ($[*]). The Minimum Annual Royalty for the first calendar year of this Agreement is due as of the effective date of this Agreement and is payable to PHS within thirty (30) days thereof and of the effective date of this Agreement and will be prorated according to the fraction of the calendar year remaining between the effective date of this Agreement and the next subsequent January 1. Beginning on the first January 1 after the effective date of this Agreement and for each subsequent calendar year of this Agreement the Minimum Annual Royalty is due on January 1 and is payable to PHS within thirty (30) days thereof.
 
C.
Earned Royalty(ies) pursuant to Paragraph 6.03, as amended and set forth in Appendix D, of this Agreement:
 
Licensee agrees to pay to PHS, according to schedule as set forth in Paragraph 9.04 of this Agreement, an Earned Royalty amount calculated on the basis of Net Sales according to percentage set forth below:
 
 
1.
[*] Percent ([*]%) of Net Sales of Licensee and its sublicensees of all Licensed Products manufactured and sold in the Licensed Territory.
 
Notwithstanding the foregoing, Licensee shall be entitled to a [*] Percent ([*]%) [*] against the earned royalty rate set forth in Paragraph C.1. above for each percent of royalty in excess of [*] Percent ([*]%) Licensee must pay to other unaffiliated licensors for the manufacture and sale of Licensed Products. Said reduction, however, shall not reduce the earned royalty rate for Licensed Products below [*] ([*]) of the rate provided for in Paragraph C.1. above.
 
The remainder of this page intentionally left blank
 
*Confidential Treatment Requested.
Page 18 of 30


D.
Benchmark Royalty(ies) pursuant to Paragraph 6.04 of this Agreement:
 
Licensee agrees to pay to PHS Benchmark Royalties in the amounts set forth herein:
 
Benchmark
Benchmark Royalty
For each [*] up to a total of [*], at the time of [*] of a [*] or equivalent clinical trial for a particular [*]
[*]
For each [*], up to a total of [*], at the time of [*] of enrollment in [*] or equivalent clinical trial for a particular [*]
[*]
For each [*], up to a total of [*], at the time of [*] approval or equivalent for a particular [*]
[*]
 
Each Benchmark Royalty payment as set forth herein is due to PHS upon Licensee, its sublicensees, or other Person, as set forth in Appendix D, Paragraph 2.14 of this Agreement, acting by or on behalf of Licensee, achieving the Benchmark and is payable to PHS within thirty (30) days thereof or in the event that a sublicense achieves the benchmark and sublicensee is responsible for making a benchmark/milestone payment to Licensee upon achieving the benchmark/milestone the Benchmark Royalty is payable to PHS by Licensee within thirty (30) days of receipt by Licensee from sublicense of the benchmark/milestone payment due from sublicense.
 
E.
Sublicensing Royalty pursuant to Paragraph 6.05, as amended and set forth in Appendix D, of this Agreement:
 
(1) In addition to any royalties paid to PHS on behalf of sublicensees as provided for in Section C above, Licensee agrees to pay to PHS, upon granting of a sublicense as provided for in Article 4 of this Agreement, either (i) in the case that such sublicense includes other assets owned or licensed by Licensee, an [*] of the fair market value of any consideration received for granting each sublicense, or (ii) if Licensee grants a sublicense as provided for in Article 4 of this Agreement and that sublicense consists only of the grant of rights as provided in Article 3 of his Agreement and no other assets owned or licensed by Licensee, then Licensee shall pay to PHS an additional royalty in the amount of [*] percent ([*]%) of the RMCV received for granting such sublicense. The Sublicensing Royalty as set forth herein is due to PHS upon the effective date of the sublicense and is payable to PHS within thirty (30) days of receipt of the payment by Licensee from sublicense of the FMCV. Furthermore, within thirty (30) days of the effective date of the sublicense Licensee will contact PHS and arrange to meet with PHS to discuss and agree to the FMCV received for the granting of each sublicense.
 
F.
Assignment Royalty pursuant to Paragraph 14.07, as amended and set forth in Appendix D, of this Agreement:
 
Upon assignment of this Agreement by Licensee, in accordance with Paragraph 14.07 of this Agreement, the Benchmark Royalty, due with respect to [*], as set forth in Section D above, will be amended to increase from the current amount of [*] Dollars ($[*]) for each [*] up to and including [*] to [*] Dollars ($[*]) for each [*] up to and including [*]. Payment will be due in accordance with the terms and conditions set forth in Section D above.
 
*Confidential Treatment Requested.
Page 19 of 30

 
APPENDIX DMODIFICATIONS
 
PHS and Licensee agree to the following modifications to the Articles and Paragraphs of this Agreement:
 
Article 2. DEFINITIONS
 
Paragraphs 2.06, 2.07, 2.08 and 2.10 are amended to read as follows:
 
 
2.06
"Licensed Patent Rights" shall mean:
 
 
a)
Patent applications (including PCT patent applications) and/or patents listed in Appendix A, all divisions and continuations of these applications, all patents issuing from such applications, divisions, and continuations, and any reissues, reexaminations, substitutions, renewals, confirmations, supplementary protection certificates, registrations, revalidations, additions of or to and extensions of all such patents;
 
 
b)
to the extent that the following contain one or more claims directed to the invention or inventions disclosed in a) above: i) continuations-in-part of a) above; ii) all divisions and continuations of these continuations-in-part; iii) all patents issuing from such continuations-in-part, divisions, and continuations; iv) priority patent application(s) of a) above; and v) any reissues, reexaminations, substitutions, renewals, confirmations, supplementary protection certificates, registrations, revalidations, additions of or to and extensions of all such patents;
 
 
c)
to the extent that the following contain one or more claims directed to the invention or inventions disclosed in a) above: all counterpart foreign and U.S. patent applications and patents to a) and b) above, including those listed in Appendix A.
 
Licensed Patent Rights shall not include b) or c) above to the extent that they contain one or more claims directed to new matter which is not the subject matter disclosed in a) above. Notwithstanding the foregoing, Licensed Patent Rights shall not include U.S. Patent 5,590,279 issued November 23, 1999 except to the extent that the application from which this patent issued, U.S. Patent Application Serial Number 08/455,552 filed May 31, 1995 (NIH Ref: E-148-1992/0-US-09), is necessary to establish a claim of priority under the provisions of Title 35 of the United States Code for any other patent or patent application included within the Licensed Patent Rights as set forth in subparagraphs a), b) and c) above.
 
 
2.07
Licensed Process(es)” means processes which, in the course of being practiced would be within the scope of one or more claims of the Licensed Patent Rights that have not been held unpatentable, invalid or unenforceable by an unappealed or unappealable judgment of a court of competent jurisdiction. Nothwithstanding the foregoing, for purposes of calculating Net Sales as set forth in Paragraph 2.10 of this Agreement, Licensed Process(es) means processes which, in the course of being practiced would be within the scope of one or more claims of an issued patent within the Licensed Patent Rights that has not been held unpatentable, invalid or unenforceable by an unappealed or unappealable judgment of a court of competent jurisdiction.
 
 
2.08
Licensed Product(s)” means tangible materials which, in the course of manufacture, use, sale, or importation would be within the scope of one or more claims of the Licensed Patent Rights that have not been held unpatentable, invalid or unenforceable by an unappealed or unappealable judgment of a court of competent jurisdiction. Notwithstanding the foregoing, for purposes of calculating Net Sales as set forth in Paragraph 2.10 of this Agreement, Licensed Product(s) means products which, in the course of being practiced would be within the scope of one or more claims of an issued patent within the Licensed Patent Rights that has not been held unpatentable, invalid or unenforceable by an unappealed or unappealable judgment of a court of competent jurisdiction.
 
Page 20 of 30

 
 
2.10
“Net Sales” means the total gross receipts for sales of Licensed Products or practice of Licensed Processes by or on behalf of Licensee or its sublicensees, and from leasing, renting, or otherwise making Licensed Products available to others without sale or other dispositions, whether invoiced or not, less returns and allowances, packing costs, insurance costs, freight out, taxes or excise duties imposed on the transaction (if separately invoiced), and wholesaler and cash discounts in amounts customary in the trade to the extent actually granted. No deductions shall be made for commissions paid to individuals, whether they be with independent sales agencies or regularly employed by Licensee, or sublicensees, and on its payroll, or for cost of collections. Notwithstanding the foregoing, transfers to Affiliates, sublicensees, partners, or contractors for research purposes, including clinical trials, and including transfers at Licensee’s fully-allocated manufacturing cost, shall not be considered a part of Net Sales.
 
New Paragraphs 2.13 through 2.17 are added to the Agreement and read as follows:
 
 
2.13
Person” means an individual, corporation, partnership, trust, business trust, association, joint stock company, joint venture, pool, syndicate, sole proprietorship, unincorporated organization, governmental authority or any other form of entity not specifically listed herein.
 
 
2.14
Affiliate(s)” shall mean, with respect to Licensee, any other Person which during the term of this Agreement controls, is controlled by or is under common control with Licensee, but for only so long as such Person controls, is controlled by or is under common control with Licensee. For this purpose, control means the possession of the power to direct or cause the direction of the management and the policies of an entity, whether through ownership directly or indirectly of fifty percent (50%) or more of the stock entitled to vote, and for non-stock organizations, the right to receive fifty percent (50%) or more of the profits by contract or otherwise, or where control of fifty percent (50%) or more of such rights is not permitted in the country where such Person exists, the maximum permitted in such a country.
 
Page 21 of 30


 
2.15
Indication(s)” means a disease or other physiologic condition, for example hemophilia or heart failure, to be treated with a Licensed Product wherein the Licensed Product contains a separate and distinct therapeutic gene of interest, for exampled a Factor VII gene, a Factor IX gene or the adenylate cyclase IV gene.
 
 
2.16
Cystic Fibrosis License” means the license, having PHS Reference Number L-059-93/0, between PHS and Licensee effective March 18, 1994, which includes the Licensed Patent Rights.
 
 
2.17
Fair Market Value of Consideration (FMCV)” means cash received by Licensee without obligation for use by Licensee in funding research and development or manufacturing efforts of a product candidate. Payments intended to be considered include, but are not limited to, upfront payments for access to technology and for acknowledgement of investment in the development of the technology, and any premium paid over market price if equity is a component of the consideration received by Licensee upon sublicensing and there is no obligation to use that premium to fund R&D efforts. FMCV does not include clinical development and commercialization milestones paid by sublicensees since milestones are governed by Appendix C, Section D, and it does not include monies received from a sublicense for funding R&D efforts or equity purchased at market value by the sublicense.
 
Article 5.
STATUTORY AND PHS REQUIREMENTS AND RESERVED GOVERNMENT RIGHTS
 
Paragraphs 5.01 and 5.04 are amended to read as follows:
 
 
5.01
PHS reserves on behalf of the Government an irrevocable, nonexclusive, nontransferable, royalty-free license for the practice of all inventions licensed under the Licensed Patent Rights throughout the world by or on behalf of the Government and on behalf of any foreign government or international organization pursuant to ay existing or future treaty or agreement to which the Government is a signatory. Prior to the First Commercial Sale, Licensee agrees to provide PHS reasonable quantities of Licensed Products or materials made through the Licensed Processes for PHS research use, but not human clinical use. Notwithstanding the foregoing, Licensee agrees, if a written request is made by PHS, to negotiate in good faith with PHS a separate agreement or an amendment to this Agreement regarding the supply of Licensed Products or materials made through Licensed Processes for PHS use in human clinical trials.
 
 
5.04
In addition to the reserved license in Paragraph 5.01 above, PHS reserves the right to grant nonexclusive Research Licenses directly or to require Licensee to grant nonexclusive Research Licenses on reasonable terms. The purpose of this Research License is to encourage basic research, whether conducted at an academic or corporate facility. In order to safeguard the Licensed Patent Rights, however, PHS shall consult with Licensee before granting to commercial entities a Research License or providing to them research samples of materials made through the Licensed Processes.
 
Article 6.
ROYALTIES AND REIMBURSEMENT
 
Paragraphs 6.01 through 6.05 and 6.09 through 6.10 are amended to read as follows:
 
 
6.01
Licensee agrees to pay to PHS a noncreditable, nonrefundable License Issue Royalty as set forth in Appendix C, Section A.
 
 
6.02
Licensee agrees to pay to PHS a nonrefundable Minimum Annual Royalty as set forth in Appendix C, Section B.
 
 
6.03
Licensee agrees to pay PHS earned royalties as set forth in Appendix C, Section C.
 
 
6.04
Licensee agrees to pay PHS benchmark royalties as set forth in Appendix C, Section D.
 
Page 22 of 30

 
 
6.05
Licensee agrees to pay PHS sublicensing royalties as set forth in Appendix C, Section E.
 
 
6.09
With regard to expenses associated with the preparation, filing, prosecution, and maintenance of all patent applications and patents included within the Licensed Patent Rights incurred by PHS prior to the effective date of this Agreement Licensee shall pay to PHS, as an additional royalty, within sixty (60) days of PHS's submission of a statement and request for payment to Licensee, an amount equivalent to such patent expenses previously incurred by PHS. Notwithstanding the foregoing, if Licensee has previously paid to PHS said expenses under Paragraph 6.08 of the Cystic Fibrosis License no additional payment of said expenses by Licensee will be required.
 
 
6.10
With regard to expenses associated with the preparation, filing, prosecution, and maintenance of all patent applications and patents included within the Licensed Patent Rights incurred by PHS on or after the effective date of this Agreement, PHS, at its sole option, may require Licensee:
 
(a) to pay PHS on an annual basis, within sixty (60) days of PHS's submission of a statement and request for payment, a royalty amount equivalent to all such patent expenses incurred during the previous calendar year(s); or
 
(b) to pay such expenses directly to the law firm employed by PHS to handle such functions. However, in such event, PHS and not Licensee shall be the client of such law firm.
 
PHS has given Licensee the right to assume responsibility for the preparation, filing, prosecution, or maintenance of any patent application or patent included within the Licensed Patent Rights under the provisions of Paragraph 7.01 of the Cystic Fibrosis License. In the event that the Cystic Fibrosis License is terminated or expired prior to the expiration of this Agreement Licensee will continue to have, unless this Agreement has been terminated or expired, or PHS has agreed to resume responsibility for the preparation, filing, prosecution or maintenance of any patent application or patent included in the Licensed Patent Rights in writing, the right to assume responsibility for the preparation, filing, prosecution or maintenance of any patent application or patent included in the Licensed Patent Rights. As long as Licensee has responsibility for the preparation, filing, prosecution or maintenance of any patent application or patent included in the Licensed Patent Rights Licensee shall directly pay the attorneys or agents engaged to prepare, file, prosecute, or maintain such patent applications or patents and shall provide to PHS, if requested, copies of each invoice associated with such services as well as documentation that such invoices have been paid. Notwithstanding the foregoing, if Licensee has previously paid, to PHS or directly to the attorneys or agents engaged to prepare, file, prosecute or maintain the patents and patent applications included in the Licensed Patent Rights, said expenses under Paragraph 6.08 of the Cystic Fibrosis License no additional payment of said expenses by Licensee will be required.
 
Page 23 of 30


Article 7.
PATENT FILING, PROSECUTION, AND MAINTENANCE
 
Paragraph 7.01 is deleted in its entirety.
 
Paragraph 7.02 is amended to read as follows:
 
 
7.02
Licensee, in accordance with the provisions of Paragraph 7.01 of the Cystic Fibrosis License has assumed the responsibility for the preparation, filing, prosecution, and maintenance of any and all patent applications or patents included in the Licensed Patent Rights and shall on an ongoing basis promptly furnish copies of all patent-related documents to PHS. Licensee has, subject to the pror approval of PHS, select registered patent attorneys or patent agents to provide such services on behalf of Licensee and PHS. PHS has provided appropriate powers of attorney and other documents necessary to undertake such actions to the patent attorneys or patent agents providing such services. Licensee and its attorneys or agents shall consult with PHS in all aspects of the preparation, filing, prosecution and maintenance of patent applications and patents included within the Licensed Patent Rights and hall provide PHS sufficient opportunity to comment on any document that Licensee intends to file or to cause to be filed with the relevant intellectual property or patent office.
 
Article 8.
RECORD KEEPING
 
Paragraph 8.02 is amended to read as follows:
 
 
8.02
Licensee agrees to have an audit on sales and royalties conducted by an independent auditor at lease every two (2) years, but not more than once per year, if annual sales of the Licensed Product or Licensed Processes are over two (2) million dollars. The audit shall address, at a minimum, the amount of gross sales by or on behalf of Licensee during the audit period, terms of the license as to percentage or fixed royalty to be remitted to the Government, the amount of royalty funds owed to the Government under this Agreement, and whether the royalty amount owed has been paid to the Government and is reflected in the records of the Licensee. The audit shall also indicate the PHS license number, product, and the time period being audited. A report certified by the auditor shall be submitted promptly by the auditor directly to PHS on completion. Licensee shall pay for the entire cost of the audit.
 
Article 9.
REPORTS ON PROGRESS, BENCHMARKS, SALES, AND PAYMENTS
 
Paragraphs 9.04, 9.05 and 9.06 are amended to read as follows:
 
 
9.04
Prior to First Commercial Sale, Licensee shall submit to PHS within sixty (60) days after each calendar year ending December 31 a royalty report setting forth for the preceding year period the amount of the Licensed Products sold or Licensed Processes practiced by or on behalf of Licensee in each country within the Licensed Territory, the Net Sales, and the amount of royalty accordingly due. With each such royalty report, Licensee shall submit payment of the earned royalties due. If no earned royalties are due to PHS for any reporting period the written report shall so state. After First Commercial Sale, Licensee shall submit to PHS within sixty (60) days after each calendar half-year ending June 30 and December 31 a royalty report setting forth the preceding half-year period the amount of the Licensed Products sold or Licensed Processes practiced by or on behalf of Licensee in each country within the Licensed Territory, the Net Sales, and the amount of royalty accordingly due. With each such royalty report, Licensee shall submit payment of the earned royalties due. If no earned royalties are due to PHS for any reporting period the written report shall so state. Any royalty report submitted pursuant to this paragraph shall be certified as correct by an authorized officer of Licensee and shall include a detailed listing of all deductions made under Paragraph 2.10 to determine Net Sales made under Article 6 to determine royalties due.
 
 
9.05
Licensee agrees to forward, on an annual basis prior to the First Commercial Sale and semi-annually after First Commercial Sale, to PHS a copy of such reports received by Licensee from its sublicensees during the preceding year or half-year period respectively, as shall be pertinent to a royalty accounting to PHS by Licensee for activities under the sublicense.
 
Page 24 of 30

 
 
9.06
Royalties due under Article 6 shall be paid in U.S. dollars. For conversion of foreign currency to U.S. dollars, the conversion rate shall be the average New York foreign exchange rate quoted in The Wall Street Journal for the previous thirty (30) trading days prior to the date the payment is due. All checks and bank drafts shall be drawn on United States banks and shall be payable, as appropriate, to "NIH/Patent Licensing." All such payments shall be sent to the following address: NIH, P.O. Box 360120, Pittsburgh, PA 15251-6120. Any loss of exchange, value, taxes, or other expenses incurred in the transfer or conversion to U.S. dollars shall be paid entirely by Licensee. The royalty report required by Paragraph 9.04 of this Agreement shall accompany each such payment, and a copy of such report shall also be mailed to PHS at its address for notices indicated on the Signature Page of this Agreement.
 
Article 10.
PERFORMANCE
 
Paragraphs 10.01 and 10.02 are amended to read as follows:
 
 
10.01
Licensee shall use its commercially reasonable best efforts to bring the Licensed Products and Licensed Processes to Practical Application. “Commercially reasonable best efforts” for the purposes of this provision shall include adherence to the Commercial Development Plan at Appendix F and performance of the Benchmarks at Appendix E. The efforts of a sublicense shall be considered the efforts of Licensee.
 
 
10.02
Upon the First Commercial Sale, until the expiration of this Agreement, Licensee shall use its commercially reasonable best efforts to make Licensed Products and Licensed Processes reasonably accessible to the United States public.
 
Article 11.
INFRINGEMENT AND PATENT ENFORCEMENT
 
New Paragraph 11.06 is added to read as follows:
 
 
11.06
Notwithstanding the provisions of Paragraphs 11.02, 11.03 and 11.04 of this Agreement PHS and/or the appropriate Government authorities may undertake an action under Paragraph 11.02 or Paragraph 11.03 of this Agreement without the consent of Licensee. In the event that PHS and/or appropriate Government authorities undertake an action under Paragraph 11.02 or Paragraph 11.03 of this Agreement, without the consent of Licensee, Licensee shall not be required to reimburse PHS and/or appropriate Government authorities for the expenses associated with said action. However, if PHS and/or appropriate Government authorities undertake an action under Paragraphs 11.02 or 11.03 of this Agreement, without the consent of Licensee, PHS and/or appropriate Government authorities will retain any and all proceeds that may be obtained if PHS and/or appropriate Government authorities are awarded judgment in any such action. Furthermore, PHS and/or appropriate Government authorities may settle any litigation undertaken by PHS and/or appropriate Government authorities without the consent of Licensee a) by requiring Licensee to grant a sublicense, negotiated by PHS and/or appropriate Government authorities, to all parties adverse to PHS and/or appropriate Government authorities entering into the settlement or b) Licensee must agree to convert this agreement to a non-exclusive license.
 
Article 12.
NEGATION OF WARRANTIES AND INDEMNIFICATION
 
Paragraph 12.04 is amended to read as follows:
 
 
12.04
PHS and Licensee do not represent that either party will commence legal actions against third parties infringing the Licensed Patent Rights.
 
Page 25 of 30

 
Article 14.
GENERAL PROVISIONS
 
Paragraph 14.07 is amended to read as follows:
 
 
14.07
This Agreement shall not be assigned by Licensee, to a third party other than an Affiliate as set forth in Paragraph 2.14 if this Agreement except: a) with the prior written consent of PHS, such consent not to be withheld unreasonably; or b) as part of a sale or transfer of substantially the entire business of Licensee relating to operations which concern this Agreement. Licensee shall notify PHS within ten (10) days of any assignment of this Agreement by Licensee, and Licensee shall pay PHS, as an additional royalty, an Assignment Royalty as set forth in Appendix C, Section F. Notwithstanding the foregoing, no Assignment Royalty, as set forth in Appendix C, Section F, would be due and payable to PHS upon assignment of this Agreement to an Affiliate as set forth in Paragraph 2.14 of this Agreement.
 
Page 26 of 30

 
APPENDIX E--BENCHMARKS AND PERFORMANCE
 
Licensee agrees to the following Benchmarks for its performance under this Agreement and, within thirty (30) days of achieving a Benchmark, shall notify PHS that the Benchmark has been achieved.
 
Benchmark
Projected Date for Achieving Benchmark
1. Select [*] for further clinical development
[*] of the effective date of this Agreement
2. Begin [*] or equivalent clinical trials for the [*] and provide PHS with a [*]
[*]
3. If only a [*] has been selected to date, [*] for further clinical development
Within [*] of the effective date of this Agreement
4. [*] or equivalent clinical trials for the [*] and provide PHS with a [*]
[*]
5. If less than [*] have been selected to date, select a [*] for further clinical development
[*] of the effective date of this Agreement
6. Begin [*] or equivalent clinical trials for the [*] and provide PHS with a [*]
[*]

*Confidential Treatment Requested.
 
Page 27 of 30

 
APPENDIX FCOMMERCIAL DEVELOPMENT PLAN
 
[*]

Page 28 of 30

EX-10.18(A) 6 v069612_ex10-18a.htm
 
 
*Certain confidential information contained in this document, marked by brackets, has been omitted and filed with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
 
Amendment No. 1 to OTT License Agreement Number L-086-2000/0
 
This is the First Amendment to the OTT License Agreement Number L-086-2000/0 dated May 21, 2004 by and between the United States Public Health Service as represented by the Office of Technology Transfer, National Institutes of Health having offices at 6011 Executive Boulevard, Suite 325, Rockville, MD 20852-3804 (“PHS”) and Targeted Genetics Corporation (“TGC”), a corporation of Washington having a principal place of business at 1100 Olive Way, Suite 100, Seattle, WA 98101(hereinafter, First Amendment).
 
WHEREAS, the parties would like to amend the License Agreement having OTT License Agreement Number L-086-2000/0 (hereinafter, “License Agreement”) in connection with the development and commercialization of HIV vaccine Licensed Products by the International Aids Vaccine Initiative (“IAVI”), in collaboration with Licensee, for use and sale in the Developing World.
 
WHEREAS, the parties are also amending the License Agreement to improve the administration of the License Agreement.
 
In consideration of the value of the availability of vaccines in the Developing World to accomplishing the public health mission of the National Institutes of Health the parties agree to amend the License Agreement as follows:
 
1.
The Recitations on the Cover Page of the “Agreement” are amended to add a Reference to Appendix G - Royalty Payment Options which is also being added by this First Amendment The amended text of the recitations reads as follows:
 
This Patent License Agreement, hereinafter referred to as the “Agreement”, consists of this Cover Page, an attached Agreement, a Signature Page, Appendix A (List of Patent(s) and/or Patent Application(s)), Appendix B (Fields of Use and Territory), Appendix C (Royalties), Appendix D (Modifications), Appendix E (Benchmarks), Appendix F (Commercial Development Plan) and Appendix G (Royalty Payment Options). The Parties to this Agreement are:
 
 
1)
The National Institutes of Health (“NIH”), the Centers for Disease Control and Prevention (“CDC”), or the Food and Drug Administration (“FDA”), hereinafter singly or collectively referred to as “PHS”, agencies of the United States Public Health Service within the Department of Health and Human Services (“DHHS”); and
 
 
2)
The person, corporation, or institution identified above and/or on the Signature Page, having offices at the address indicated on the Signature Page, and its Affiliates as defined in Appendix D, Paragraph 2.14, hereinafter referred to as “Licensee”.
 
 
Page 1 of 8

 
2.
Appendix C, Section C Earned Royalties is amended to read as follows:
 
 
C.
Earned Royalty(ies) pursuant to Paragraph 6.03, as amended and set forth in Appendix D, of this Agreement:
 
Licensee agrees to pay to PHS, according to schedule as set forth in Paragraph 9.04 of this Agreement, an Earned Royalty amount calculated on the basis of Net Sales according to percentage set forth below:
 
 
1.
[*] Percent ([*]%) of Net Sales of Licensee and its sublicensees of all Licensed Products manufactured and sold in the Licensed Territory.
 
Notwithstanding the foregoing, Licensee shall be entitled to a One Percent (1.0%) credit against the earned royalty rate set forth in Paragraph C.1. above for each percent of royalty in excess of [*] Percent ([*]%) Licensee must pay to other unaffiliated licensors for the manufacture and sale of Licensed Products. Said reduction, however, shall not reduce the earned royalty rate for Licensed Products below [*] provided for in Paragraph C.1. above.
 
Notwithstanding the foregoing, Earned Royalty(ies) will be waived by PHS related to sales of any HIV vaccine Licensed Products in the Developing World, for use in the Developing World, which have been specifically developed through a collaboration between the Licensee and the International AIDS Vaccine Initiative (IAVI), an IRS certified 501(c)3 tax exempt organization, with principal offices at 110 William Street, Floor 27, New York, NY 10038-3001. Should Licensee receive any sales royalty from sales of Licensed Products by IAVI or its designee in the Developing World, TGC and PHS shall mutually agree on compensation from Licensee to PHS.
 
Any other Licensed Product which is not the direct result of the above-mentioned collaboration and is not intended solely for use and sale in the Developing World will be subject to all applicable Earned Royalty obligations.
 
First Amendment Continues on Next Page
 
*Confidential Treatment Requested.
Page 2 of 8

 
3.
Appendix C, Section D shall be amended to read as follows.
 
 
D.
Benchmark Royalty(ies) pursuant to Paragraph 6.04, as amended and set forth in Appendix D, of this Agreement:
 
Licensee agrees to pay to PHS Benchmark Royalties in the amounts set forth herein:
 
Benchmark
Benchmark Royalty
For each [*] up to a total of [*], at the time of [*] of a [*] or equivalent clinical trial for a particular [*]
[*]
For each [*], up to a total of [*], at the time of [*] of a [*] or equivalent clinical trial for a particular [*]
[*]
For each [*], up to a total of [*], at the time of [*] for a particular [*]
[*]
 
Each Benchmark Royalty payment as set forth herein is due to PHS upon Licensee, its sublicensees, or other Person, as set forth in Appendix D, Paragraph 2.14 of this Agreement, acting by or on behalf of Licensee, achieving the Benchmark and is payable to PHS within thirty (30) days thereof or in the event that a sublicensee achieves the benchmark and sublicensee is responsible for making a benchmark/milestone payment to Licensee upon achieving the benchmark/milestone the Benchmark Royalty is payable to PHS by Licensee within thirty (30) days of receipt by Licensee from sublicensee of the benchmark/milestone payment due from sublicensee.
 
Notwithstanding the foregoing, Benchmark Royalty(ies) will be waived by PHS, as set forth in Appendix D, Paragraph 2.14 of this Agreement if and only if the Benchmark is achieved during the course of development of an HIV vaccine Licensed Product which is specific for use and sale in the Developing World and is the direct result of a collaboration between the Licensee and IAVI.
 
Any other Licensed Product which is not the direct result of the above-mentioned collaboration and is not intended solely for use and sale in the developing world will be subject to all applicable Benchmark Royalties.
 
4.
Appendix D - Modifications is amended to add the following Paragraph 2.18 to Article 2 - Definitions:
 
 
2.18.
Developing World means those countries defined from time to time by the World Bank as having “low-income economies” or “middle-income economies” (whether lower-middle or upper-middle).
 
*Confidential Treatment Requested.
Page 3 of 8

 
5.
Appendix D - Modifications is changed to amend Paragraph 9.06 to reflect that Appendix G has been added to the Agreement. Paragraph 9.06 as amended reads as follows:
 
 
9.06
Royalties due under Article 6 shall be paid in U.S. dollars and payment options are listed in Appendix G. For conversion of foreign currency to U.S. dollars, the conversion rate shall be the average New York foreign exchange rate quoted in The Wall Street Journal for the previous thirty (30) trading days prior to the date the payment is due. All checks and bank drafts shall be drawn on United States banks and shall be payable, as appropriate, to “NIH/Patent Licensing”. Any loss of exchange, value, taxes, or other expenses incurred in the transfer or conversion to U.S. dollars shall be paid entirely by Licensee. The royalty report required by Paragraph 9.04 of this Agreement shall accompany each such payment, and a copy of such report shall also be mailed to PHS at its address for Agreement Notices indicated on the Signature Page of this First Amendment.
 
First Amendment Continues on Next Page
 
Page 4 of 8


6.
Appendix G - Royalty Payment Information is added to the Agreement in order to facilitate the administration of the Agreement in the future. New Appendix G reads as follows:
 
APPENDIX G - ROYALTY PAYMENT OPTIONS
 
NIH/PHS License Agreements
 
*In order to process payment via Electronic Funds Transfer sender MUST supply the following information:
 
Procedure for Transfer of Electronic Funds to NIH for Royalty Payments
 
Bank Name: Federal Reserve Bank
 
[*]
TREAS NYC
[*]
OBI=Licensee Name and OTT Reference Number
Dollar Amount Wired=$$
 
NOTE: Only U.S. banks can wire directly to the Federal Reserve Bank. Foreign banks cannot wire directly to the Federal Reserve Bank, but must go through an intermediary U.S. bank. Foreign banks may send the wire transfer to the U.S. bank of their choice, who, in turn forwards the wire transfer to the Federal Reserve Bank.
 
Mailing Address for Royalty Payments:
 
National Institutes of Health
P.O. Box 360120
Pittsburgh, PA 15251-6120 USA
 
Overnight Mail for Royalty Payments only
 
National Institutes of Health
360120
Mellon Client Service Center
Room 670
500 Ross Street
Pittsburgh, PA 15262-0001
 
(412) 234-4381 (Customer Service)
 
Please make checks payable to: NIH/Patent Licensing
 
The OTT Reference Number MUST appear on checks, reports and correspondence
 
*Confidential Treatment Requested.
Page 5 of 8

 
6.
This First Amendment is effective on the date on which the last party executes this First Amendment.
 
7.
Unless expressly modified by this First Amendment the terms and conditions of the License Agreement are incorporated in their entirety into the terms and conditions of this First Amendment and this First Amendment together with the License Agreement constitute the entire agreement between the parties and all prior negotiations, representations, agreements, and understandings are merged into, extinguished by, and completely expressed by this First Amendment.
 
SIGNATURES BEGIN ON NEXT PAGE
 
Page 6 of 8

 
SIGNATURE PAGE
 
For PHS:
 
/s/ Steven M. Ferguson    8/14/06 
Steven M. Ferguson, MBA 
Director, Division of Technology Development and Transfer
Office of Technology Transfer
National Institutes of Health
  Date
     
Mailing Address for Agreement Notices:
Chief, Monitoring and Enforcement Branch
Office of Technology Transfer
National Institutes of Health
6011 Executive Boulevard, Suite 325
Rockville, Maryland 20852-3804 U.S.A.
   
 
For Licensee (Upon, information and belief, the undersigned expressly certifies or affirms that the contents of any statements of Licensee made or referred to in this document are truthful and accurate):
 
By:
Targeted Genetics Corporation
Licensee
 
/s/ B.G. Susan Robinson     08-18-06 
Signature of Authorized Official 
  Date
     
B.G. Susan Robinson 
   
Printed Name    
     
VP, Business Development     
Title    
 
I.
Official and Mailing Address for Agreement Notices:
 
Targeted Genetics Corporation
1100 Olive Way, Suite 100
Seattle, WA 98101
 
Page 7 of 8

 
II.
Official and Mailing Address for Financial Notices (Licensee’s contact person for royalty payments)
 
  Susan Robinson   
 
Name  
     
 
Vice President, Business Development   
  Title  
     
  Mailing Address:  
     
 
1100 Olive Way, Suite 100
 
     
 
Seattle, WA 98101 
 
     
     
     
     
 
Email Address:  susan.robinson@targen.com   
     
Phone:  206-521-7330   
     
Fax:   206-512-4782  
 
 
Any false or misleading statements made, presented, or submitted to the Government, including any relevant omissions, under this Agreement and during the course of negotiation of this Agreement are subject to all applicable civil and criminal statutes including Federal statutes 31 U.S.C. §§3801-3812 (civil liability) and 18 U.S.C. §1001 (criminal liability including fine(s) or imprisonment).
 
Page 8 of 8

 
EX-21 7 v069612_ex21.htm Unassociated Document
EXHIBIT 21.1

SUBSIDIARIES OF TARGETED GENETICS CORPORATION

As of December 31, 2006, the following companies are subsidiaries of Targeted Genetics Corporation:

Name of Subsidiary
 
Jurisdiction of Incorporation
Genovo, Inc.
 
Delaware
TGCF Manufacturing, Inc.
 
Washington


EX-23.1 8 v069612_ex23-1.htm Unassociated Document
Exhibit 23.1


Consent of Independent Registered Public Accounting Firm

We consent to the incorporation by reference in the Registration Statements on Form S-3 (Nos. 333-116600, 333-74976, 333-107822 and 333-140187) of Targeted Genetics Corporation and the related Prospectuses and to the incorporation by reference in the Registration Statements on Form S-8 (Nos. 333-03889, 333-28151, 333-58907, 333-61738, 333-78523 and 333-48220) pertaining to Targeted Genetics Corporation’s 1992 Restated Stock Option Plan, Stock Option Plan for Nonemployee Directors, 1999 Stock Option Plan and Genovo Roll-over Stock Option Plan of our report dated March 28, 2007, with respect to the consolidated financial statements of Targeted Genetics Corporation included in the Annual Report (Form 10-K) for the year ended December 31, 2006.


/s/ Ernst & Young LLP

Seattle, Washington
March 28, 2007

EX-31.1 9 v069612_ex31-1.htm
EXHIBIT 31.1

CERTIFICATION

I, H. Stewart Parker, certify that:

1. I have reviewed this quarterly report on Form 10-K of Targeted Genetics Corporation;

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 quarterly 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 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)) 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) 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

c) 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 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 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 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.
 
     
Dated: March 29, 2007   /s/ H. Stewart Parker 
 
H. Stewart Parker
President, Chief Executive Officer and Director
 
 
 

 
 
EX-31.2 10 v069612_ex31-2.htm
 
EXHIBIT 31.2
CERTIFICATION

I, David J. Poston, certify that:

1. I have reviewed this quarterly report on Form 10-K of Targeted Genetics Corporation;

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 quarterly 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 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)) 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) 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

c) disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal 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 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 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.
 
     
Dated: March 29, 2007   /s/ David J. Poston
 
David J. Poston
Vice President and Chief Financial Officer
 
 
 

 
EX-32.1 11 v069612_ex32-1.htm
 
EXHIBIT 32.1

CERTIFICATE 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 Targeted Genetics Corporation (the “Company”) on Form 10-K for the year ended December 31, 2006 as filed with the Securities & Exchange Commission on the date hereof (the “Report”), I, H. Stewart Parker, Chief Executive Officer of the Company, certify, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that to the best of my knowledge:

         (1)          The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and

         (2)          The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
 
     
    /s/ H. Stewart Parker
 
H. Stewart Parker
President, Chief Executive Officer and Director
March 29, 2007
 
A signed original of this written statement required by Section 906 has been provided to the Company and will be retained by the Company and furnished to the Securities and Exchange Commission or its staff upon request.
 
This certification is being furnished to the Securities and Exchange Commission as Exhibit 32 to the Form 10-K pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 (subsections (a) and (b) of Section 1350, Chapter 63 of Title 18, United States Code) and in accordance with Item 601(b)(32)(ii) of Regulation S-K. This certification is not being “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, and is not and should not be deemed to be incorporated by reference into the Form 10-K or any filing under the Securities Act of 1933 or the Securities Exchange Act of 1934.
 
 
 

 
EX-32.2 12 v069612_ex32-2.htm
 
EXHIBIT 32.2

CERTIFICATE 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 Targeted Genetics Corporation (the “Company”) on Form 10-K for the year ended December 31, 2006 as filed with the Securities & Exchange Commission on the date hereof (the “Report”), I, David J. Poston, Chief Financial Officer of the Company, certify, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that to the best of my knowledge:

         (1)          The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and

         (2)          The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
 
     
    /s/ David J. Poston
 
David J. Poston
Vice President and Chief Financial Officer
March 29, 2007
 
A signed original of this written statement required by Section 906 has been provided to the Company and will be retained by the Company and furnished to the Securities and Exchange Commission or its staff upon request.
 
This certification is being furnished to the Securities and Exchange Commission as Exhibit 32 to the Form 10-K pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 (subsections (a) and (b) of Section 1350, Chapter 63 of Title 18, United States Code) and in accordance with Item 601(b)(32)(ii) of Regulation S-K. This certification is not being “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, and is not and should not be deemed to be incorporated by reference into the Form 10-K or any filing under the Securities Act of 1933 or the Securities Exchange Act of 1934.
 
 
 

 
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