-----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, UzT4nx48woNSCrEcAnMmdw3IaBoMpYr9HWazXIHR1v/Eyx8quqH417osU3Jz/dPV 46aRSjP3b470AZtTQA+f0g== 0001047469-10-002143.txt : 20100312 0001047469-10-002143.hdr.sgml : 20100312 20100312162320 ACCESSION NUMBER: 0001047469-10-002143 CONFORMED SUBMISSION TYPE: 10-K PUBLIC DOCUMENT COUNT: 12 CONFORMED PERIOD OF REPORT: 20091231 FILED AS OF DATE: 20100312 DATE AS OF CHANGE: 20100312 FILER: COMPANY DATA: COMPANY CONFORMED NAME: DYAX CORP CENTRAL INDEX KEY: 0000907562 STANDARD INDUSTRIAL CLASSIFICATION: SERVICES-COMMERCIAL PHYSICAL & BIOLOGICAL RESEARCH [8731] IRS NUMBER: 043053198 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 10-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-24537 FILM NUMBER: 10678052 BUSINESS ADDRESS: STREET 1: ONE KENDALL SQ BLDG 600 5TH FL CITY: CAMBRIDGE STATE: MA ZIP: 02139 MAIL ADDRESS: STREET 1: ONE KENDALL SQ BLDG 600 STREET 2: 5TH FL CITY: CAMBRIDGE STATE: MA ZIP: 02139 FORMER COMPANY: FORMER CONFORMED NAME: BIOTAGE INC DATE OF NAME CHANGE: 19951117 10-K 1 a2196756z10-k.htm 10-K

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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549



FORM 10-K


ý

 

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

For the fiscal year ended December 31, 2009

OR

o

 

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 000-24537



DYAX CORP.
(Exact name of registrant as specified in its charter)

Delaware
(State of Incorporation)
  04-3053198
(IRS Employer Identification No.)

300 Technology Square, Cambridge, Massachusetts 02139
(Address of principal executive offices and zip code)

Registrant's telephone number, including area code: (617) 225-2500

Securities registered pursuant to Section 12(b) of the Act:


Title of each class:
Common Stock, $.01 Par Value

 

Name of each exchange on which registered:
The NASDAQ Stock Market LLC
(NASDAQ Global Market)

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



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

         Indicate by checkmark 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 Company was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ý    No o

         Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Website, if any, every Interactive Date File required to be submitted and posted pursuant to Rule 405 of Regulation S-T during the preceeding 12 months (or for such shorter period that the registrant was required to submit and post such files). Yes o    No o

         Indicate by checkmark 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, a non-accelerated filer, or a smaller reporting company. See definition of "large accelerated filer," "accelerated filer," and "smaller reporting company" in Rule 12b-2 of the Exchange Act. (Check one):

Large accelerated filer o   Accelerated filer ý   Non-accelerated filer o
(Do not check if a smaller reporting company)
  Smaller reporting company o

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

         The aggregate market value of the registrant's common stock held by nonaffiliates of the registrant as of the last business day of the registrant's most recently completed fiscal second quarter, June 30, 2009, based on the last reported sale price of the registrant's common stock of $2.14 per share was $128,564,046. The number of shares outstanding of the registrant's Common Stock, $.01 Par Value, as of February 19, 2010, was 78,125,483.

DOCUMENTS INCORPORATED BY REFERENCE

         Portions of the registrant's Definitive Proxy Statement for its 2010 Annual Meeting of Shareholders scheduled to be held on May 6, 2010, which Definitive Proxy Statement will be filed with the Securities and Exchange Commission not later than 120 days after the registrant's fiscal year-end of December 31, 2009, are incorporated by reference into Part III of this Form 10-K.


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        As used in this Form 10-K, "Dyax," "the Company," "we," "our," and "us" refer to Dyax Corp., except where the context otherwise requires or as otherwise indicated.


NOTE REGARDING FORWARD-LOOKING STATEMENTS

        This Annual Report on Form 10-K contains forward-looking statements, including statements regarding:

    our ability to commercialize KALBITOR® (ecallantide);

    plans to seek market approval for KALBITOR in markets outside the United States;

    plans and anticipated timing for pursuing additional indications and uses for DX-88;

    plans to enter into additional collaborative and licensing arrangements for DX-88 and for other compounds in development;

    the timing and availability of data from clinical trials;

    our assessment of competitors and potential competitors and the anticipated impact of potentially competitive products on our future revenue and business;

    estimates of potential markets for our products and product candidates;

    the sufficiency of our cash, cash equivalents and short-term investments;

    expected future operating results;

    our assessment of the impact of recent accounting pronouncements.

        Statements that are not historical facts are based on our current expectations, beliefs, assumptions, estimates, forecasts and projections for our business and the industry and markets in which we compete. We often use the words or phrases of expectation or uncertainty like "believe," "anticipate," "plan," "expect," "intend," "project," "future," "may," "will," "could," "would" and similar words to help identify forward-looking statements. The statements contained in this report are not guarantees of future performance and involve certain risks, uncertainties and assumptions, which are difficult to predict. Therefore, actual outcomes and results may differ materially from what is expressed in such forward-looking statements. Risks and uncertainties which may affect us are set forth in Item 1A of this report entitled "Risk Factors". You should carefully review the risks described therein and in other documents we file from time to time with the Securities and Exchange Commission ("SEC"), including the Quarterly Reports on Form 10-Q to be filed in 2010. We caution you not to place undue reliance on these forward looking statements, which speak only as of the date on which they are made. We undertake no intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.


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DYAX CORP.

ANNUAL REPORT ON FORM 10-K

For the year ended December 31, 2009

INDEX

Item No.
   
  Page  

 

PART I

       

1.

 

Business

    1  

1A.

 

Risk Factors

    19  

1B.

 

Unresolved Staff Comments

    38  

2.

 

Properties

    38  

3.

 

Legal Proceedings

    38  

4.

 

Submission of Matters to a Vote of Security Holders

    38  

 

PART II

       

5.

 

Market for the Company's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities

    39  

6.

 

Selected Consolidated Financial Data

    40  

7.

 

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

    41  

7A.

 

Quantitative and Qualitative Disclosures about Market Risk

    53  

8.

 

Financial Statements and Supplementary Data

    54  

9.

 

Changes in and Disagreements with Accountants on Accounting and Financial Disclosure

    85  

9A.

 

Controls and Procedures

    85  

9B.

 

Other Information

    85  

 

PART III

       

10.

 

Directors, Executive Officers and Corporate Governance

    86  

11.

 

Executive Compensation

    86  

12.

 

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

    86  

13.

 

Certain Relationships and Related Transactions, and Director Independence

    87  

14.

 

Principal Accounting Fees and Services

    87  

 

PART IV

       

15.

 

Exhibits, Financial Statement Schedules

    87  

 

Signatures

    93  

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PART I

ITEM 1.    BUSINESS

OVERVIEW

        We are a biopharmaceutical company focused on the discovery, development and commercialization of novel biotherapeutics for unmet medical needs, with an emphasis on inflammatory and oncology indications. Our lead product DX-88 has recently been approved under the brand name KALBITOR® (ecallantide) by the United States Food and Drug Administration (FDA) for treatment of acute attacks of hereditary angioedema (HAE) in patients 16 years of age and older. We currently commercialize KALBITOR on our own in the United States and intend to seek approval and commercialize KALBITOR through partners for HAE and other angioedema indications in markets outside of the United States.

        In addition to its approved commercial use for HAE in the United States, we are also developing DX-88 through collaborations in other indications. These include use of DX-88 for the reduction of blood loss during surgery in collaboration with Cubist Pharmaceuticals (Cubist), and for treatment of retinal diseases in collaboration with Fovea Pharmaceuticals (Fovea), which was acquired by sanofi-aventis in 2009. We are also exploring use of DX-88 for treatment of ACE inhibitor-induced angioedema, a life threatening inflammatory response brought on by adverse reactions to ACE inhibitors; and acquired angioedema, a condition associated with B-cell lymphoma and autoimmune disorders.

        Beyond DX-88, we have also developed a pipeline of promising drug candidates using our proprietary drug discovery technology, known as phage display. We use phage display to identify antibody, small protein and peptide compounds with potential for clinical development. This pipeline includes DX-2240 and DX-2400, two fully human monoclonal antibodies with therapeutic potential in oncology indications. In 2008, we entered into an exclusive license agreement under which sanofi-aventis will be responsible for the continued development of DX-2240. DX-2400 is currently in preclinical development within our internal development pipeline.

        Although we use our phage display technology primarily to advance our own internal development activities, we also leverage it through licenses and collaborations designed to generate revenues and provide us access to co-develop and/or co-promote drug candidates identified by other biopharmaceutical and pharmaceutical companies. Through our Licensing and Funded Research Program (LFRP), we have more than 70 ongoing license agreements. To date, our licensees have advanced 18 product candidates into clinical trials and one product that has received market approval from the FDA.

KALBITOR AND THE DX-88 FRANCHISE

        DX-88 is a compound that we developed using our phage display technology, which we have shown in vitro to be a high affinity, high specificity inhibitor of human plasma kallikrein. Plasma kallikrein, an enzyme found in blood, is believed to be a key component responsible for the regulation of the inflammation and coagulation pathways. Excess plasma kallikrein activity is thought to play a role in a number of inflammatory and autoimmune diseases, including HAE.

        HAE is a rare, genetic disorder characterized by severe, debilitating and often painful swelling, which can occur in the abdomen, face, hands, feet and airway. HAE is caused by low or dysfunctional levels of C1 esterase inhibitor (C1-INH), a naturally occurring molecule that inhibits plasma kallikrein, a key mediator of inflammation, and other serine proteases in the blood. It is estimated that HAE affects between 1 in 10,000 to 1 in 50,000 people around the world. Despite the fact that 85% of patients experience symptoms before age 20, 68% of patients are not diagnosed until after age 20, which makes it difficult to accurately determine the size of the HAE patient population. HAE patient

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association registries estimate there is an immediately addressable target population of approximately 6,500 patients in the United States.

KALBITOR

        In December 2009, DX-88 was approved by the FDA under the brand name KALBITOR (ecallantide) for treatment of HAE in patients 16 years of age and older regardless of anatomic location. KALBITOR, a potent, selective and reversible plasma kallikrein inhibitor discovered and developed by Dyax, is the first subcutaneous HAE treatment approved in the United States.

        As part of product approval, we have established a Risk Evaluation and Mitigation Strategy (REMS) program to communicate the risk of anaphylaxis and the importance of distinguishing between hypersensitivity reaction and HAE attack symptoms. To communicate these risks, the REMS requires a Medication Guide be dispensed with each dose of KALBITOR and a "Dear Healthcare Professional" letter be provided to doctors identified as likely to prescribe KALBITOR and treat HAE patients. KALBITOR should only be administered by a healthcare professional with appropriate medical support to manage anaphylaxis and HAE.

        We have also initiated a Phase 4 observational study to evaluate immunogenicity and hypersensitivity with exposure to KALBITOR for treatment of acute attacks of HAE. The study is designed to identify predictive risk factors and develop effective screening tools to mitigate the risk of hypersensitivity and anaphylaxis. This 4-year study was initiated in February 2010.

Sales and Marketing

        We have established a commercial organization to support sales of KALBITOR in the United States. We believe that a field-based team of approximately 25 professionals, consisting of sales representatives, medical science liasons and corporate account directors, is appropriate to effectively market KALBITOR in the United States, where patients are treated primarily by a limited number of specialty physicians, consisting mainly of allergists and immunologists. If KALBITOR is approved in territories outside of the United States, we intend to enter into license or collaboration agreements to commercialize KALBITOR through one or more marketing partners with established distribution systems and direct sales forces in such territories.

Distribution

        In November 2009, we entered into separate agreements with three wholly-owned subsidiaries of AmerisourceBergen Specialty Group, Inc. (ABSG) to establish an exclusive distribution network for KALBITOR and to provide comprehensive call center services to support its commercialization. The ABSG agreements consist of:

    an agreement with US Bioservices Corporation (US Bio), under which US Bio will serve as our exclusive specialty pharmacy for KALBITOR in the United States, and will also manage the KALBITOR Access program for patients and healthcare providers seeking information and access to KALBITOR;

    an agreement with ASD Specialty Healthcare Inc. (ASD), under which ASD will serve as our exclusive wholesale distributor for KALBITOR to treating hospitals in the United States; and

    an agreement with Integrated Commercialization Solutions, Inc. (ICS), under which ICS will provide warehousing, inventory management and other logistical services in connection with the distribution of KALBITOR throughout the United States.

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        All three agreements have an initial term of three years, although each contains customary termination provisions and may be terminated by us for any reason upon six months prior written notice.

KALBITOR AccessSM

        In furtherance of our efforts to facilitate access to KALBITOR in the United States, we have created the KALBITOR Access program, designed as a one-stop point of contact for information about KALBITOR, which offers treatment support service for patients with HAE and their healthcare providers. KALBITOR case managers provide comprehensive product and disease information, treatment site coordination, financial assistance for qualified patients and reimbursement facilitation services.

Manufacturing

        In connection with the commercial launch of KALBITOR in the United States, we have established a commercial supply chain, consisting of single-source third party suppliers to manufacture, test and distribute this product. All third party manufacturers involved in the KALBITOR manufacturing process are required to comply with current good manufacturing practices, or cGMPs.

        To date, the DX-88 drug substance used in the production of KALBITOR has been manufactured in the United Kingdom by Avecia Biologics Limited, which was recently acquired by Merck & Co., Inc. (Avecia). As a result of previously completed manufacturing activities conducted at Avecia, we have significant inventories of DX-88 drug substance, which we believe are sufficient to supply all ongoing studies relating to DX-88 and KALBITOR, and to meet the anticipated market demand for KALBITOR well into 2011. Under existing arrangements with Avecia, they have agreed to conduct additional manufacturing runs in 2011 and 2012, as necessary to supplement existing inventory. Additionally, we are in the process of evaluating alternative arrangements for long-term commercial supply of DX-88 drug substance.

        DX-88 drug substance is filled, labeled and packaged into the final form of KALBITOR drug product by Hollister-Steir at its facilities in Spokane, Washington under a commercial supply agreement. This process, known in the industry as the "fill and finish" process, is not unique to KALBITOR and alternative manufacturers are readily available in the event that we elect, or are required, to relocate the "fill and finish" process.

KALBITOR Outside of the United States

        In markets outside of the United States, we intend to seek approval and commercialize KALBITOR for HAE and other angioedema indications in conjunction with one or more partners. For the European Union, our current plan is to submit a marketing authorization application with the European Medicines Agency (EMA) during the first half of 2010, seeking approval for the commercialization of KALBITOR for HAE.

DX-88 FRANCHISE

DX-88 for Treatment of Other Angioedemas

        In addition to its approved commercial use, we are also developing DX-88 in other angioedema indications. One such angioedema is induced by the use of so-called ACE inhibitors. With an estimated 51 million prescriptions written annually worldwide, ACE inhibitors are widely prescribed to reduce Angiotensin Converting Enzyme (ACE) and generally reduce high blood pressure and vascular constriction. It is estimated that up to 2% of patients treated with ACE inhibitors suffer from angioedema attacks and these attacks represent approximately 30% of all angioedemas treated in

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emergency rooms. Research suggests the use of ACE inhibitors increases the relative activity of bradykinin, a protein that causes blood vessels to enlarge, or dilate, which can also cause the swelling known as angioedema. As a specific inhibitor of plasma kallikrein, an enzyme needed to produce bradykinin, DX-88 has the potential to be effective for treating this condition. We are working with investigators affiliated with the University of Cincinnati as they initiate an investigator sponsored study for drug-induced angioedema.

        Another angioedema indication in which DX-88 has the potential to be effective is known as acquired angioedema, a condition associated with B-cell lymphoma and autoimmune disorders. We are currently working with Dr. Marco Cicardi, of the University of Milan, as he initiates a compassionate use program for DX-88 in this indication.

DX-88 for On-Pump Cardiac Surgery

        Industry publications report that there are an estimated one million procedures performed worldwide each year involving on-pump cardiac surgery. On-pump cardiac procedures, which are performed for patients who have narrowings or blockages of the coronary arteries, often involve use of a heart-lung machine commonly referred to as the "pump". In these procedures, the heart is stopped with medications, and the pump does the work of the heart and lungs during surgery. This allows the surgeon to position the heart as needed, to accurately identify the arteries and to perform the bypass while the heart is stationary.

        The use of the pump during cardiac procedures elicits an adverse systemic inflammatory response. Many patients undergoing on-pump cardiac procedures experience significant intraoperative blood loss that requires transfusion. Plasma kallikrein has been implicated in the body's response to on-pump heart surgery as a major contributor to the significant blood loss seen in on-pump cardiac patients and to the pathologic inflammation that plays a role in the complications of on-pump cardiac procedures.

        In 2008, we entered into an exclusive license and collaboration agreement with Cubist for the development and commercialization in North America and Europe of the intravenous formulation of DX-88 for the reduction of blood loss during surgery. Under this agreement, Cubist assumed responsibility for all further development and costs associated with DX-88 in the licensed indications in the Cubist territory. Under the terms of the license agreement, we received a $15 million upfront payment and an additional $2.5 million milestone payment in 2008. In addition, we are eligible to receive (i) up to $214 million in clinical, regulatory and sales-based milestone payments, and (ii) tiered royalties, ranging from the low teens to low twenties, based on sales of DX-88 by Cubist.

        Cubist has assumed responsibility for two studies of DX-88 (also known internally at Cubist as CB-500,929) within its licensed surgical indications. The first, known as CONSERVTM 1, was a dose ranging study evaluating 5, 25 and 75 milligram doses of DX-88 versus placebo in patients undergoing primary coronary artery bypass graft (CABG) surgery who are at a low risk of bleeding complications. The second trial, known as CONSERVTM 2, compared a single 75 milligram dose of DX-88 to tranexamic acid in patients at a higher risk of bleeding. In December 2009, enrollment in both CONSERV-1 and CONSERV-2 was closed after a statistically significant difference in mortality was observed by the Data Safety Monitoring Board between the DX-88 and control arms in CONSERV-2. No difference was observed in serious adverse events between the active and control arm in CONSERV-1 at the interim look. Cubist plans to conduct a full dataset review of safety and efficacy in the patients enrolled in both CONSERV-1 and CONSERV-2 and expects to be in a position to determine next steps for this program late in the second quarter of 2010.

DX-88 for Ophthalmic Indications

        We have entered into a license agreement with Fovea Pharmaceuticals SA, which was acquired by sanofi-aventis in 2009, for the development and commercialization of DX-88 for treatment of retinal

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diseases in the European Union. Under this agreement, Fovea will fully fund development for the first indication, retinal vein occlusion-induced macular edema, for which a Phase 1 trial was initiated in the third quarter of 2009. We retain all rights to commercialize DX-88 in this indication outside of the European Union. Under the license agreement, we do not receive milestone payments, but are entitled to receive tiered royalties, ranging from the high teens to mid twenties, based on sales of DX-88 by Fovea in the European Union. Conversely, if we elect to commercialize DX-88 in this indication outside of the European Union, Fovea will be entitled to receive royalties from us, ranging from the low to mid teens, based on our sales of DX-88 outside the European Union. The term of the agreement continues until the expiration of the licensed patents or, if later, the eleventh anniversary of the first commercial sale of DX-88 in an ophthalmic indication. The agreement may be terminated by Fovea on prior notice to us and by either party for cause.

Goals for DX-88 Development Programs

        Our goal for the ongoing development of DX-88 is to ensure that we and our various collaborators develop DX-88 in multiple indications and obtain marketing approval from the FDA and international regulatory agencies in such indications. Cash inflows from these programs, other than upfront and milestone payments, will not commence until after marketing approvals are obtained, and then only if the product candidate finds acceptance in the marketplace as a treatment for its disease indication. Because of the many risks and uncertainties related to the completion of clinical trials, receipt of marketing approvals and acceptance in the marketplace, we cannot predict when cash inflows from these programs will commence, if ever.

OTHER DISCOVERY AND DEVELOPMENT PROGRAMS

Pipeline Programs

        Our phage display technology and expertise has allowed us to develop a pipeline of drug candidates in addition to DX-88. Of our existing pipeline candidates, the most advanced are DX-2240 and DX-2400, two fully human monoclonal antibodies with therapeutic potential in oncology indications.

        Our DX-2240 antibody has a novel mechanism of action that targets the Tie-1 receptor on tumor blood vessels. In preclinical animal models, DX-2240 has demonstrated activity against a broad range of solid tumor types. Data also indicates increased activity when combined with antiangiogenic therapies such as Avastin® and Nexavar®. In 2008, we entered into an agreement with sanofi-aventis, under which we granted sanofi-aventis exclusive worldwide rights to develop and commercialize DX-2240 as a therapeutic product, as well as a non-exclusive license to our proprietary antibody phage display technology. Under the terms of the DX-2240 license agreement, we received license fees and milestone payments of $23.2 million in 2008. In addition, we are eligible to receive (i) up to an aggregate of $233 million in additional license fees and milestone payments, which maximum aggregate payment assumes full development and commercial success of DX-2240, and (ii) tiered royalties, ranging from the mid-to-high single digits, based on sales of DX-2240 by sanofi-aventis. As exclusive licensee, sanofi-aventis will be responsible for the ongoing development and commercialization of DX-2240.

        Our DX-2400 antibody is a specific inhibitor of Matrix Metalloproteinase-14 (MMP-14), a protease expressed on tumor cells and tumor blood vessels. To date, small molecule approaches have failed to produce compounds that distinguish between closely related MMPs. In contrast, our technology has allowed us to identify a highly selective inhibitor of MMP-14 that does not inhibit other proteases that we have tested. In animal models, DX-2400 has been shown to significantly inhibit tumor progression and metastasis in a dose-dependent manner in breast, prostate and melanoma tumors. DX-2400 is currently in preclinical development within our development pipeline.

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Co-Development Programs

        We collaborate with other biopharmaceutical companies to discover and jointly develop therapeutic leads. In our typical co-development collaborations, we use our phage display libraries to identify antibody, peptide and small protein compounds that bind to disease targets provided by our co-development collaborator. With our collaborator, we evaluate the leads that we generate during the research phase of our collaboration to determine if we wish to jointly develop and commercialize such leads as therapeutics. Our co-development collaborators currently include Athera Biotechnologies AB, Commonwealth Scientific and Industrial Research Organisation (CSIRO) and Syntonix Pharmaceuticals, Inc. a wholly owned subsidiary of Biogen Idec.

LICENSING AND FUNDED RESEARCH PROGRAM

        Under our LFRP, we maintain more than 70 revenue generating licenses and collaborations with other biopharmaceutical and pharmaceutical companies. Currently, the types of licenses and collaborations that we enter into have one of three distinct structures:

    Patent Licenses.  Under our patent license program, we grant other biopharmaceutical and pharmaceutical companies non-exclusive licenses to use our core phage display patents (known as the Ladner patents), to discover and develop biologic compounds for use in specified fields. We generally grant licenses on a non-exclusive basis so that we may retain broad rights to practice our phage display technology in multiple fields. Our license agreements generally provide for up-front license fees, annual maintenance fees, milestone payments based on successful product development, and royalties based on any future product sales. In addition, under the terms of our license agreements, most licensees have agreed not to sue us for using phage display improvement patents which they developed and some have granted us specific access to certain phage-display technologies which they have developed or which they control. We believe that these provisions allow us to practice enhancements to phage display developed by our licensees. We currently have approximately 45 patent licensees worldwide.

    Library Licenses.  Under our library license program, we grant our licensees rights to use our proprietary phage display libraries in connection with their internal therapeutic development programs. We also provide these licensees with related materials and training so that they may rapidly identify compounds that bind with high affinity to therapeutic targets. The period during which our licensees may use our libraries is typically limited to a 4 to 5 year term. Library license agreements contain significant up-front license fees, annual maintenance fees, milestone payments based on successful product development, and royalties based on any future product sales. We have approximately 20 library licensees including Amgen, Aveo, Biogen Idec, Boehringer Ingelheim, CSL, ImClone Systems, Human Genome Sciences, Merck Serono, sanofi-aventis, Trubion, and Zymogenetics.

    Funded Research.  Under our funded research program, we perform funded research for various collaborators using our phage display technology to identify, characterize and optimize antibodies that bind to disease targets provided by the collaborators. Our funded research collaborators with products currently in development include AstraZeneca, Baxter Healthcare, Biogen Idec, Glenmark, Merck Serono, Organon, and Trubion.

Cross-Licensed Technology

        The use of our antibody library involves technology that we have cross-licensed from other biotechnology companies, including Affimed Therapeutics AG, Affitech A/S, Biosite, Inc. (now owned by Inverness Medical Innovations), Cambridge Antibody Technology Limited or CAT (now known as MedImmune Limited and owned by AstraZeneca), Domantis Limited (a wholly-owned subsidiary of GlaxoSmithKline), Genentech, Inc. and XOMA Ltd. Under the terms of our cross-license agreement

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with CAT, we are required to pay milestone and low single-digit royalty payments to CAT in connection with antibody products developed and commercialized by our licensees. These payments are passed through from our licensees. Under the agreement, we also granted CAT a worldwide license to use our antibody libraries to discover and develop antibody products. In consideration for this license, we will receive no milestone payments but are eligible to receive low single-digit royalty payments on antibody products developed by CAT or its licensees under the agreement. None of our other cross-license agreements contain financial obligations applicable to our LFRP licensees or collaborators.

LFRP Product Development

        Currently, 18 product candidates generated by our licensees or collaborators under the LFRP are in clinical trials, two of which are in Phase 3 clinical development, four are in Phase 2 clinical development and twelve are in Phase 1 clinical development. In addition, one product has received market approval from the FDA. Furthermore, we estimate that our licensees and collaborators have over 70 additional product candidates in various stages of research and preclinical development. We anticipate that we will receive milestones and royalties from our licensees and collaborators to the extent that these product candidates advance in development and are ultimately commercialized.

        We expect to continue to enter into licenses and collaborations that are designed to maximize the strategic value of our proprietary phage display technology. For example, in February 2009, we expanded our antibody funded research and library license agreement with Biogen Idec. Under the terms of the expanded agreement, we have guaranteed a minimum of ten additional product licenses to Biogen Idec. Additionally, we have granted Biogen Idec a non-exclusive license to our antibody libraries and we will conduct antibody discovery funded research over a three-year period. In exchange, we received a $5.0 million upfront fee, guaranteed research funding, and are eligible to receive $85 million in development and sales milestones, as well as low single-digit royalties based on sales for each antibody product commercialized by Biogen Idec using our technology.

Cowen Healthcare Financing

        In 2008, we entered into an agreement with Cowen Healthcare Royalty Partners (Cowen Healthcare) for a $50.0 million loan secured by our LFRP. This loan is the Tranche A loan. In March 2009, we amended and restated the loan agreement with Cowen Healthcare to include a Tranche B loan of $15.0 million. We used $35.1 million from the proceeds of the Tranche A loan to pay off our remaining obligation under a then existing agreement with Paul Royalty Fund Holdings II, LP (Paul Royalty). The Tranche A and Tranche B loans (collectively, the Loan) have an outstanding balance at December 31, 2009 of $59.7 million.

        The Loan matures in August 2016. The Tranche A portion bears interest at an annual rate of 16%, payable quarterly, and the Tranche B portion bears interest at an annual rate of 21.5%, payable quarterly. The Loan may be prepaid without penalty, in whole or in part, beginning in August 2012. In connection with the Loan, we have entered into a security agreement granting Cowen Healthcare a security interest in the intellectual property related to the LFRP, and the revenues generated through our licensing of the intellectual property related to the LFRP. The security agreement does not apply to our internal drug development or to any of our co-development programs.

        Under the terms of the loan agreement, we are required to repay the Loan based on the annual net LFRP receipts. Until June 30, 2013, required payments are tiered as follows: 75% of the first $10.0 million in specified annual LFRP receipts, 50% of the next $5.0 million and 25% of annual included LFRP receipts over $15.0 million. After June 30, 2013, and until the maturity date or the complete amortization of the Loan, Cowen Healthcare will receive 90% of all included LFRP receipts. If the Cowen Healthcare portion of LFRP receipts for any quarter exceeds the interest for that quarter, then the principal balance will be reduced. Any unpaid principal will be due upon the maturity of the

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Loan. If the Cowen Healthcare portion of LFRP revenues for any quarterly period is insufficient to cover the cash interest due for that period, the deficiency may be added to the outstanding principal or paid in cash. After five years, we must repay to Cowen Healthcare all additional accumulated principal above the original $50.0 million and $15.0 million loan amounts of Tranche A and Tranche B, respectively. In addition, under the terms of the Agreement, we are permitted to sell or otherwise transfer collateral generating cash proceeds of up to $25.0 million. Twenty percent of these cash proceeds will be applied to amortize principal on the Loan plus any applicable prepayment premium and an additional 5.0% of such proceeds will be paid to Cowen Healthcare as a cash premium.

LFRP Strategy

        Recently, many large pharmaceutical companies have taken steps to acquire or exclusively license drug discovery technologies. As a result, discovery technologies with proven success such as phage display are becoming less accessible within the industry. We believe that this trend provides us with a more favorable position from which to leverage our technology and structure potential LFRP opportunities with greater strategic benefit. In evaluating future opportunities, we will consider the following criteria:

    the level of technical and commercial resources that potential collaborators would commit to our programs;

    the amount of up-front payments we would receive, as well as milestone and royalty payments; and

    our ability to retain certain rights, including, for example, co-development and co-promotion rights that we feel increase the overall potential value of the collaboration.

OUR PHAGE DISPLAY TECHNOLOGY

What Is Phage Display?

        Living organisms, such as viruses, have the ability to display a foreign gene product, or protein, on their surfaces. Based on this ability of organisms to display proteins, our scientists in the late 1980s invented protein phage display, a novel method to individually display up to tens of billions of human antibodies, peptides or small proteins on the surface of a small bacterial virus called a bacteriophage, or phage. Using phage display, we have built large collections, or libraries, of antibodies, small proteins or peptides that we use to rapidly identify those compounds that bind with high affinity and high specificity to targets of interest.

        Through the use of our proprietary phage display technology, we have been able to establish a broad discovery platform to identify compounds that interact with a wide array of targets, including membrane proteins and circulating proteins which have been shown to be involved in pathologic processes. Our discovery capabilities have been further enhanced through automation, which has enabled us to evaluate a large number of molecules binding to each target. In this way we can rapidly identify and select a specific antibody, peptide or small protein with the desired biochemical and biological characteristics. While our discovery research efforts are focused primarily on monoclonal antibodies, we are also testing the in vitro and in vivo activity of several of our peptide and small protein compounds.

        Scientists can use phage display to improve the speed and cost effectiveness of drug discovery and optimization. Phage display offers important advantages over, and can be used to improve, other drug discovery technologies that are currently employed to identify biopharmaceutical leads.

        Over the past several years, we have brought on-line high-throughput automated capacity, developed state-of-the-art antibody phage display libraries, and successfully implemented a strategy

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under which, as of today, we believe we have obtained freedom to operate in the antibody phage display area through cross-licenses with Affimed Therapeutics, Affitech, Biosite, CAT, Domantis, Genentech and XOMA. As a result of these activities, we now have an industry-leading technology that allows us to identify fully human antibodies with high specificity and high affinity and to move product candidates rapidly into both in vitro testing and optimization.

        Although we use this technology primarily to advance our own internal development activities, we also leverage it broadly through licenses and collaborations so that other biopharmaceutical and pharmaceutical companies can use it to discover and develop biopharmaceutical leads.

        Our phage display process generally consists of the following steps:

    Generating a phage display library

    Screening the phage display library against a target of interest

    Evaluating the selected compounds that bind to the target of interest

Generating a Phage Display Library

        The generation of a phage display library is based upon a single protein framework and contains tens of billions of variants of this protein. The first step in generating a library is the selection of the protein framework upon which the library will be created. This selection is based on the desired product properties, such as structure, size, stability, or lack of immunogenicity. We then determine which amino acids in the framework will be varied, but do not vary amino acids that contribute to the framework structure. We also control the exact numbers and types of different amino acids that are varied, so that the resulting phage display library consists of a diverse set of chemical entities, each of which retains the desired physical and chemical properties of the original framework.

        The next step is the creation of a collection of genes that encode the designed variations of the framework protein. We can easily generate diverse collections of up to hundreds of millions of different synthetic DNA sequences. Each new DNA sequence, or gene, encodes a single protein sequence that may be displayed on the surface of the individual phage that contains this gene. The scientists combine the new DNA sequences with phage genome DNA and certain enzymes so that the new DNA is inserted into a specific location of the phage genome. The result is that the new protein is displayed on the phage surface fused to one of the naturally occurring phage proteins. The phage acts as a physical link between the displayed protein and its gene.

        In addition to fused synthetic DNA sequences, we may also use cDNA, or genomic DNA, which are sequences that represent all of the expressed genes in a cell or organism, to create a library. We have also inserted genes from antibody expressing human cells into the phage genome. Using these genes, we have constructed phage display libraries that express tens of billions of different human antibodies on the phage surface. From one of these libraries, individual antibody fragments can be selected and used to express highly specific human monoclonal antibodies.

        The new phage genome is then transferred into laboratory bacteria, where the phage genome directs the bacterial cells to produce thousands of copies of each new phage. The collection of phage displaying multiple antibodies, peptides or small proteins is referred to as a phage display library. Because we can reproduce the phage display library by infecting a new culture of laboratory bacteria to produce millions of additional copies of each phage, we can use each library for a potentially unlimited number of selections.

Screening the Phage Display Library Against a Target of Interest

        We can then select binding compounds with high affinity and high specificity by exposing the library to a specified target of interest and isolating the various phage that display compounds that bind

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to the target. Each individual phage contains the gene encoding one potential binding compound, and once its displayed protein is selected in the screening procedure, it can be retrieved and amplified by growth in laboratory bacteria.

        To identify specific binders from a phage display library, we expose the library to the target under desired binding conditions. The target may be attached to a fixed surface, such as the bottom of a tube, or a bead, allowing removal of phage that do not express binding compounds that recognize the target. Once these unbound phage are washed away, the phage containing the selected binding compounds can be released from the target. Since the phage are still viable, they can be amplified rapidly by again infecting bacteria. The capacity of the phage to replicate itself is an important feature that makes it particularly well suited for rapid discovery of specific binding compounds. We can amplify a single phage by infecting bacteria and producing millions of identical phage in one day.

        If the binding affinities of the compounds identified in an initial screening for a target are not considered sufficiently high, information derived from the binding compounds identified in the initial screening can be used to design a new focused library. The design, construction and screening of a second generation library, known as affinity maturation, can lead to increases of 10- to 100-fold or more in the affinity of the binding compounds for the target.

Evaluating the Selected Compounds That Bind to the Target of Interest

        Screening phage display libraries generally results in the identification of one or more groups of related binding compounds such as antibodies, peptides or small proteins. These groups of compounds are valuable in providing information about which chemical features are necessary for binding to the target with affinity and specificity, as well as which features can be altered without affecting binding. Using DNA sequencing, we can determine the amino acid sequences of the binding compounds and identify the essential components of desired binding properties by comparing similarities and differences in such sequences. If desired, scientists can further optimize the binding compounds by building additional phage display libraries based on these key components and repeating this process. We can complete the entire selection process in several weeks. We can produce small amounts of the binding compound by growing and purifying the phage. For production of larger amounts, we can remove the gene from the phage DNA and place it into a standard recombinant protein expression system. Alternatively, if the identified binding compound is sufficiently small, it can be chemically synthesized. These binding compounds can be evaluated for desired properties including affinity, specificity and stability under conditions that will be encountered during its intended use. From each group of compounds, scientists can identify, develop and test a compound with the desired properties for utility as a biopharmaceutical, diagnostic, research reagent or affinity separations product.

        The entire phage display process for identifying compounds that bind to targets of interest is nearly identical whether the ultimate product is to be used for biopharmaceuticals, diagnostics, research reagents or separations, which allows for an efficient use of scientific resources across a broad array of commercial applications.

Advantages of Phage Display Technology in Therapeutic Drug Discovery

        We believe our phage display technology has the following advantages over other drug discovery technologies:

    Diversity and abundance. Many of our phage display libraries contain billions of potential binding compounds that are rationally-designed variations of a particular antibody, peptide or small protein framework. The size and diversity of our libraries significantly increases the likelihood of identifying binding compounds with high affinity and high specificity for the target. Once we generate libraries, we can reproduce them rapidly in phage and use them for an unlimited number of screenings.

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    Speed and cost effectiveness. We can construct phage display libraries in a few months and rapidly select binding compounds for characterization in screening assays. Conventional or combinatorial chemistry approaches require between several months and several years to complete this process. Similarly, mouse and human-mouse technologies generally require four to six months to identify an antibody. As a result, our phage display technology can significantly reduce the time and expense required to identify an antibody, peptide or small protein with desired binding characteristics.

    Automated parallel screening. In an automated format, we can apply our phage display technology to many targets simultaneously to discover specific, high-affinity proteins, including human monoclonal antibodies, for each target. In contrast, human-mouse antibody technologies identify antibodies that bind to a single target per test group of mice and are difficult to automate. Among antibody technologies, phage display is particularly well suited for functional genomic applications, due to the large number of genetic targets that need to be screened for specific antibodies.

    Rapid optimization. We screen phage display libraries to identify binding compounds with high affinity and high specificity for the desired target and can design and produce successive generations of phage display libraries to further optimize the leads. We have demonstrated between 10- and 1000-fold improvement in binding affinity with second-generation phage display libraries.

COMPETITION

        We compete in an industry characterized by intense competition and rapid technological change. New developments occur and are expected to continue to occur at a rapid pace. Discoveries or commercial developments by our competitors may render some or all of our technologies, products or potential products obsolete or non-competitive.

        Our principal focus is on the development of therapeutic products. We will conduct research and development programs to develop and test product candidates and demonstrate to appropriate regulatory agencies that these products are safe and effective for therapeutic use in particular indications. Therefore our principal competition going forward, as further described below, will be companies who either are already marketing products in those indications or are developing new products for those indications.

        For KALBITOR as a treatment for HAE, our principal competitors include:

    ViroPharma Inc.—In October 2008, ViroPharma received FDA approval for its plasma-derived C1-esterase inhibitor, known as Cinryze™, which is administered intravenously. Cinryze was approved for routine prophylaxis against angioedema attacks in adolescent and adult patients with HAE, and has orphan drug designation from the FDA. Cinryze was launched in December 2008. ViroPharma also submitted a supplemental Biologics License Application to the FDA for the use of Cinryze as a treatment for acute attacks of HAE, and on June 3, 2009, the FDA issued a complete response letter requesting that ViroPharma conduct an additional clinical study. In June 2009, FDA approved patient labeling for Cinryze to include self-administration for routine prophylaxis, once patients are properly trained by their healthcare provider.

    CSL Behring—In October 2009, CSL Behring received FDA approval for its plasma-derived C1-esterase inhibitor, known as Berinert®, which is administered intravenously. Berinert was approved for treatment of acute abdominal or facial attacks of HAE in adult and adolescent patients, and has orphan drug designation from the FDA. Berinert was launched in the US in January 2010. CSL Behring also completed Mutual Recognition Procedure in December 2008, allowing the sale of Berinert® P in more than 20 European countries. Berinert® P has been sold in a subset of European countries since 1985.

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    Jerini AG/Shire plc—Jerini AG received European Union market approval in July 2008 for its bradykinin receptor antagonist, known as Firazyr®, which is delivered by subcutaneous injection. In April 2008, the FDA issued a Not Approvable letter for Firazyr. Firazyr has orphan drug designations from the FDA and in Europe. Jerini/Shire initiated a new Phase 3 United States trial in June 2009.

    Pharming Group NV—Pharming filed for market approval from the European Medicines Agency (EMA) for its recombinant C1-esterase inhibitor, known as Rhucin®, which is delivered intravenously. In December 2007 and March 2008, Pharming received negative opinions from the EMA. In September 2009, Pharming filed a new Marketing Authorization Application (MAA) with the EMA. In January 2010, the company reported that it has received the Day 120 List of Questions from the Committee for Medicinal Products for Human Use and that at this stage, no major concerns have been raised. Pharming has also reported that a pre-BLA meeting with the FDA occurred in December 2009. Rhucin has Fast Track status from the FDA and orphan drug designations from the FDA and in Europe.

        Other competitors for the treatment of HAE include companies that market or are developing corticosteroid drugs or other anti-inflammatory compounds.

        The principal competitors for DX-88 as a treatment for reducing blood loss in cardiac surgery procedures are manufacturers of aminocaproic acid. A number of other organizations, including Novo Nordisk A/S, Vanderbilt University and The Medicines Company, are developing other products for this indication.

        For our potential oncology product candidates, our potential competitors include numerous pharmaceutical and biotechnology companies, many of which have greater financial resources and experience than we do.

        In addition, most large pharmaceutical companies seek to develop orally available small molecule compounds against many of the targets for which we and others are seeking to develop antibody, peptide and/or small protein products.

        Our phage display technology is one of several technologies available to generate libraries of compounds that can be leveraged to discover new antibody, peptide and/or small protein products. The primary competing technology platforms that pharmaceutical, diagnostics and biotechnology companies use to identify antibodies that bind to a desired target are transgenic mouse technology and the humanization of murine antibodies derived from hybridomas. Medarex (a wholly-owned subsidiary of Bristol-Myers Squibb), Genmab A/S, and PDL Biopharma are leaders in these technologies. Further, other companies such as BioInvent International AB and XOMA Ltd. have access to phage display technology and compete with us by offering licenses and research services to pharmaceutical and biotechnology companies.

        In addition, we may experience competition from companies that have acquired or may acquire technology from universities and other research institutions. As these companies develop their technologies, they may develop proprietary positions that may prevent us from successfully commercializing our products.

PATENTS AND PROPRIETARY RIGHTS

        Our success is significantly dependent upon our ability to obtain patent protection for our products and technologies, to defend and enforce our issued patents, including patents related to phage display, and to avoid the infringement of patents issued to others. Our policy generally is to file for patent protection on methods and technology useful for the display of binding molecules and on biopharmaceutical, diagnostic and separation product candidates.

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        Our proprietary position in the field of phage display is based upon patent rights, technology, proprietary information, trade secrets and know-how. Our patents and patent applications for basic phage display, known as the Ladner patents, include United States Patent Nos. 5,837,500, which expires June 29, 2010, 5,571,698, which expires June 29, 2010, 5,403,484, which expires April 4, 2012, 5,223,409, which expires June 29, 2010, 6,979,538, which expires June 29, 2010, 7,118,879, which expires June 29, 2010, 7,208,293, which expires June 29, 2010, and issued patents in Canada, Israel, and Japan, as well as pending patent applications in the United States and other countries. These basic phage display patent rights contain claims covering inventions in the field of the surface display of proteins and certain other peptides, including surface display on bacteriophage.

        With respect to specific aspects of our phage display libraries, patent rights claiming our currently licensed antibody phage display libraries and methods of making and using such libraries include issued patents in Australia and pending patent applications in the United States and other countries. These patent rights are expected to expire in 2021. Patent rights claiming our currently licensed peptide libraries include United States Patent No. 7,413,537, which expires November 29, 2012 and issued patents in Canada, Japan and Europe. We have filed suit in the United States District Court for the District of Columbia to obtain a patent term adjustment for United States Patent No. 7,413,537 based on an erroneous calculation of the patent's term by the United States Patent Office. This action, which is expected to be successful based on a recent ruling by the United States Court of Appeals for the Federal Circuit, could extend the patent's expiration date by 1,614 days to May 1, 2017.

        With respect to DX-88, our patent rights include United States Patent Nos. 5,994,125, which expires January 11, 2014, 5,795,865, which expires August 18, 2015, 6,057,287, which expires August 18, 2015, 6,333,402, which expires January 11, 2014, 7,064,107, which expires June 6, 2023, 7,153,829, which expires July 2, 2023, 7,166,576, which expires September 27, 2024, 7,235,530, which expires September 27, 2024, 7,276,480, which expires June 6, 2023 and European Patent No. 739355 which expires January 11, 2015, as well as issued patents in Australia, Canada and Japan, claiming sequences of peptides that have human kallikrein inhibitory activity, including the sequence for DX-88, and polynucleotide sequences encoding these peptides, as well as methods of using such peptides.

        For our other therapeutic product candidates, we file for patent protection on groups of antibodies, peptides and small proteins that we identify using phage display.

        There are no legal challenges to our phage display patent rights or our other issued or pending patent rights in any major markets. However, we cannot assure that a challenge will not be brought in the future. We plan to protect our patent rights in a manner consistent with our product development and business strategies. If we bring legal action against an alleged infringer of any of our patents, we expect the alleged infringer to claim that our patent is invalid, not infringed, or not enforceable for one or more reasons, thus subjecting that patent to a judicial determination of infringement, validity and enforceability. In addition, in certain situations, an alleged infringer could seek a declaratory judgment of non-infringement, invalidity or unenforceability of one or more of our patents. We cannot be sure that we will have sufficient resources to enforce or defend our patents against any such challenges or that a challenge will not result in an adverse judgment against us or the loss of one or more of our patents. Uncertainties resulting from the initiation and continuation of any patent or related litigation, including those involving our patent rights, could have a material adverse effect on our ability to maintain and expand our licensing program and collaborations, and to compete in the marketplace.

        Our first phage display patent in Europe, European Patent No. 436,597, known as the 597 Patent, was ultimately revoked in 2002 in a proceeding in the European Patent Office. As a result, we are not able to prevent other parties from using certain aspects of our phage display technology in Europe.

        Our phage display patent rights are central to our non-exclusive patent licensing program and our performance under our related agreement with Cowen Healthcare. We offer non-exclusive licenses under our phage display patent rights to companies and non-profit institutions in the fields of

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therapeutics, diagnostics and other select fields. In jurisdictions where we have not applied for, obtained, or maintained patent rights, we will be unable to prevent others from developing or selling products or technologies derived using phage display. In addition, in jurisdictions where we have phage display patent rights, we cannot assure that we will be able to prevent others from selling or importing products or technologies derived using phage display.

        We are aware that other parties have patents and pending applications to various products and processes relating to phage display technology. Through licensing our phage display patent rights, we have secured a limited ability to practice under some of the third party patent rights relating to phage display technology. These rights are a result of our standard license agreement, which contains a covenant by the licensee that it will not sue us under the licensee's phage display improvement patents. In addition, we have sought and obtained affirmative rights of license or ownership under certain patent rights relating to phage display technology owned by other parties. For example, in addition to our amended license agreement with CAT, we have entered into licensing agreements with Affimed Therapeutics, Affitech, Biosite, Domantis and Genentech, Inc. under which we granted each of those companies rights to practice our phage display patents and in return received rights to practice under their phage display related patents. These types of agreements in which each party licenses technology to the other are referred to as cross-licensing agreements. We have also entered into a cross-licensing agreement with XOMA Ireland Limited under which we received a license to use XOMA's antibody expression technology to develop antibody products for ourselves and our collaborators. We also received a license from XOMA to produce antibodies. In exchange we agreed to pay XOMA a license fee and a royalty in connection with the sale of any of our antibody products. We also granted XOMA a license to our phage display patents and agreed to provide them with limited quantities of our antibody phage display libraries.

        Under the terms of our amended and restated license agreement with CAT, we were granted a worldwide license under their antibody phage display patents to discover and develop antibody products. In consideration for this license, CAT is eligible to receive milestone payments and low single-digit royalty payments in connection with antibody products developed and commercialized by us or our licensees under the agreement.

        Under the agreement, we also granted CAT a worldwide license to use our antibody libraries to discover and develop antibody products. In consideration for this license, we will receive no milestone payments but are eligible to receive a low single-digit royalty payments on antibody products developed by CAT or its licensees under the agreement.

GOVERNMENT REGULATION

        The preclinical studies and clinical testing, manufacture, labeling, storage, record keeping, advertising, promotion, export, and marketing, among other things, of our products and product candidates, including KALBITOR, are subject to extensive regulation by governmental authorities in the United States and other countries. In the United States, pharmaceutical products are regulated by the FDA under the Federal Food, Drug, and Cosmetic Act and other laws, including, in the case of biologics, the Public Health Service Act. KALBITOR is regulated by the FDA as a biologic. Biologics require the submission of a Biologics License Application, or BLA, and approval by FDA prior to being marketed in the United States. Manufacturers of biologics may also be subject to state regulation. Failure to comply with FDA requirements, both before and after product approval, may subject us and/or our partners, contract manufacturers, and suppliers to administrative or judicial sanctions, including FDA refusal to approve applications, warning letters, product recalls, product seizures, total or partial suspension of production or distribution, fines and/or criminal prosecution.

        The steps required before a biologic may be approved for marketing in the United States generally include:

    preclinical laboratory tests and animal tests;

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    submission to the FDA of an Investigational New Drug Application for human clinical testing, which must become effective before human clinical trials may commence;

    adequate and well-controlled human clinical trials to establish the safety and efficacy of the product;

    submission to the FDA of a BLA;

    FDA pre-approval inspection of product manufacturers; and

    FDA review and approval of BLA.

        Preclinical studies include laboratory evaluation, as well as animal studies to assess the potential safety and efficacy of the product candidate. Preclinical safety tests must be conducted in compliance with FDA regulations regarding good laboratory practices. The results of the preclinical tests, together with manufacturing information and analytical data, are submitted to the FDA as part of an Investigational New Drug Application, or IND, which must become effective before human clinical trials may be commenced. The IND will automatically become effective 30 days after receipt by the FDA, unless the FDA before that time raises concerns about the drug candidate or the conduct of the trials as outlined in the IND. The IND sponsor and the FDA must resolve any outstanding concerns before clinical trials can proceed. We cannot assure you that submission of an IND will result in FDA authorization to commence clinical trials or that once commenced, other concerns will not arise.

        Clinical trials involve the administration of the investigational product to healthy volunteers or to patients, under the supervision of qualified principal investigators. Each clinical study at each clinical site must be reviewed and approved by an independent institutional review board, prior to the recruitment of subjects.

        Clinical trials are typically conducted in three sequential phases, but the phases may overlap and different trials may be initiated with the same drug candidate within the same phase of development in similar or differing patient populations. Phase 1 studies may be conducted in a limited number of patients, but are usually conducted in healthy volunteer subjects. The drug is usually tested for safety and, as appropriate, for absorption, metabolism, distribution, excretion, pharmaco-dynamics and pharmaco-kinetics.

        Phase 2 usually involves studies in a larger, but still limited patient population to evaluate preliminarily the efficacy of the drug candidate for specific, targeted indications; to determine dosage tolerance and optimal dosage; and to identify possible short-term adverse effects and safety risks.

        Phase 3 trials are undertaken to further evaluate clinical efficacy of a specific endpoint and to test further for safety within an expanded patient population at geographically dispersed clinical study sites. Phase 1, Phase 2 or Phase 3 testing might not be completed successfully within any specific time period, if at all, with respect to any of our product candidates. Results from one trial are not necessarily predictive of results from later trials. Furthermore, the FDA may suspend clinical trials at any time on various grounds, including a finding that the subjects or patients are being exposed to an unacceptable health risk.

        The results of the preclinical studies and clinical trials, together with other detailed information, including information on the manufacture and composition of the product, are submitted to the FDA as part of a BLA requesting approval to market the product candidate. Under the Prescription Drug User Fee Act, as amended, the fees payable to the FDA for reviewing a BLA, as well as annual fees for commercial manufacturing establishments and for approved products, can be substantial. Each BLA submitted to the FDA for approval is typically reviewed for administrative completeness and reviewability within 45 to 60 days following submission of the application. If found complete, the FDA will "file" the BLA, thus triggering a full review of the application. The FDA may refuse to file any BLA that it deems incomplete or not properly reviewable. The FDA's established goals for the review

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of a BLA is six months for Priority applications and 10 months for Standard applications, whereupon a review decision is to be made. The FDA, however, may not approve a drug within these established goals and its review goals are subject to change from time to time. Further, the outcome of the review, even if generally favorable, may not be an actual approval but an "action letter" that describes additional work that must be done before the application can be approved. Before approving a BLA, the FDA may inspect the facilities at which the product is manufactured and will not approve the product unless current Good Manufacturing Practices, or cGMP, compliance is satisfactory. The FDA may deny approval of a BLA if applicable statutory or regulatory criteria are not satisfied, or may require additional testing or information, which can delay the approval process. FDA approval of any application may include many delays or never be granted. If a product is approved, the approval will impose limitations on the indicated uses for which the product may be marketed, may require that warning statements be included in the product labeling, and may require that additional studies be conducted following approval as a condition of the approval, may impose restrictions and conditions on product distribution, prescribing or dispensing in the form of a risk management plan, or otherwise limit the scope of any approval. To market a product for other indicated uses, or to make certain manufacturing or other changes requires FDA review and approval of a BLA Supplement or new BLA. Further post—marketing testing and surveillance to monitor the safety or efficacy of a product is required. Also, product approvals may be withdrawn if compliance with regulatory standards is not maintained or if safety or manufacturing problems occur following initial marketing. In addition new government requirements may be established that could delay or prevent regulatory approval of our product candidates under development.

        The United States Congress and regulatory authorities, including the FDA, are considering whether an abbreviated approval process for so-called generic or "follow-on" biological products should be adopted. An abbreviated approval process is currently available under the Federal Food, Drug and Cosmetic Act for generic versions of conventional chemical drug compounds, sometimes referred to as small molecule compounds, but not for biological products approved under the Public Health Service Act through a BLA. Currently, an applicant for a generic version of a small molecule compound only has to reference in its application an approved product for which full clinical data demonstrating safety and effectiveness exist for the approved conditions of use; demonstrate that its product has the same active ingredients, dosage form, strength, route of administration and conditions of use and is absorbed in the body at the same rate and to the same extent as the referenced approved drug; include certifications to non-infringement of valid patents listed with the FDA for the referenced approved drug; and await the expiration of any non-patent exclusivity. Various proposals have been made to establish an abbreviated approval process to permit approval of generic or follow-on versions of biological products. It is unclear as to when, or if, any such proposals may be adopted but any such abbreviated approval process could have a material impact on our business as follow-on products may be significantly less costly to bring to market and may be priced significantly lower than our products would be.

        Both before and after the FDA approves a product, the manufacturer and the holder or holders of the BLA for the product are subject to comprehensive regulatory oversight. For example, quality control and manufacturing procedures must conform to cGMP requirements, and the FDA periodically inspects manufacturing facilities to assess compliance with cGMP. Accordingly, manufacturers must continue to spend time, money and effort to maintain cGMP compliance.

Orphan Drug Designation

        We have received orphan drug designation from the FDA for KALBITOR. Under the Orphan Drug Act, the FDA may grant orphan drug designation to drugs intended to treat a "rare disease or condition," which generally is a disease or condition that affects fewer than 200,000 individuals in the United States. Orphan drug designation must be requested before submitting a BLA. After the FDA

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grants orphan drug designation, the generic identity of the therapeutic agent and its potential orphan use are publicly disclosed by the FDA. Orphan drug designation does not convey any advantage in, or shorten the duration of, the regulatory review and approval process. If a product which has an orphan drug designation subsequently receives the first FDA approval for the indication for which it has such designation, the product is entitled to orphan exclusivity, i.e., the FDA may not approve any other applications to market the same drug for the same indication for a period of seven years, except in limited circumstances.

Foreign Regulation

        In addition to regulations in the United States, we are subject to a variety of foreign regulatory requirements governing human clinical trials and marketing approval for drugs. The foreign regulatory approval process includes all of the risks associated with FDA approval set forth above, as well as additional country-specific regulations. Whether or not we obtain FDA approval for a product, we must obtain approval of a product by the comparable regulatory authorities of foreign countries before we can commence clinical trials or marketing of the product in those countries. The approval process varies from country to country, and the time may be longer or shorter than that required for FDA approval. The requirements governing the conduct of clinical trials, product licensing, pricing and reimbursement vary greatly from country to country.

        For example, under European Union regulatory systems, we may submit marketing authorizations either under a centralized or decentralized procedure. The centralized procedure provides for the grant of a single marketing authorization that is valid for all European Union member states. The decentralized procedure provides for mutual recognition of national approval decisions, and the holder of a national marketing authorization may submit an application to the remaining member states.

Reimbursement

        Sales of pharmaceutical products depend in significant part on the coverage and reimbursement policies of government programs, including Medicare and Medicaid in the United States, and other third-party payers. These health insurance programs may restrict coverage of some products by using payer formularies under which only selected drugs are covered, variable co-payments that make drugs that are not preferred by the payer more expensive for patients, and by using utilization management controls, such as requirements for prior authorization or prior failure on another type of treatment. Payers may especially impose these obstacles to coverage for higher-priced drugs, and consequently KALBITOR may be subject to payer-driven restrictions.

        In addition, in some foreign countries, the proposed pricing for a drug must be approved before it may be lawfully marketed. The requirements governing drug pricing vary widely from country to country. For example, the European Union provides options for its member states to restrict the range of medicinal products for which their national health insurance systems provide reimbursement and to control the prices and/or reimbursement of medicinal products for human use. A member state may approve a specific price or level of reimbursement for the medicinal product, or it may instead adopt a system of direct or indirect controls on the profitability of the company placing the medicinal product on the market.

        In furtherance of our efforts to facilitate access to KALBITOR in the United States, we have created the KALBITOR Access program, a treatment support service for patients with HAE and their healthcare providers. KALBITOR case managers provide education about HAE and KALBITOR and help facilitate solutions for reimbursement, coverage and treatment site coordination.

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OUR BUSINESS STRATEGY

        Our strategic goal is to develop new biotherapeutics for unmet medical needs, with an emphasis on inflammatory and oncology indications. We intend to accomplish this goal through the following activities:

    KALBITOR.  We will continue to focus our internal efforts on the commercialization of KALBITOR for treatment of acute attacks of HAE. We are commercializing KALBITOR on our own in the United States and intend to establish partnerships in other major markets.

    DX-88 Franchise.  We plan to expand our development of DX-88 beyond HAE in other angioedema indications, including acquired and ACE inhibitor-induced angioedemas. In addition to the development in angioedema indications, ongoing development of DX-88 is being conducted by partners in other indications. We will continue to explore the therapeutic potential of DX-88 in other potential indications as well.

    Emerging Pipeline and Phage Display Technology.  We will continue to use our proprietary phage display technology to identify new drug candidates and advance others within our preclinical pipeline. These preclinical drug candidates may be developed independently or through strategic partnerships with other biotechnology and pharmaceutical companies. Although we will continue to seek to retain ownership and control of our internally discovered drug candidates by taking them further into preclinical and clinical development, we will also partner certain candidates, as we have with our DX-2240 antibody, in order to balance the risks associated with drug discovery and maximize return for our stockholders.

    Licensing and Funded Research Program.  We will also continue to leverage our phage display technology through our LFRP in order to generate ongoing future revenues and to gain rights to co-develop and/or co-promote drug candidates identified by certain of our collaborators.

OUR CORPORATE INFORMATION

        We are a Delaware corporation, incorporated in 1989, and merged with Protein Engineering Corporation in 1995. Our principal executive offices are located at 300 Technology Square, Cambridge, Massachusetts 02139, and our telephone number is (617) 225-2500. Our web site address is http://www.dyax.com.

Segment Information

        We provide financial information by geographical area in Note 14 to our Consolidated Financial Statements included in Item 8 of this report. We are incorporating that information into this section by this reference.

Employees

        As of February 1, 2010, we had 121 employees, including 21 with Ph.D.s and/or M.D.s. Approximately 54 of our employees are in research and development, and 67 in marketing, business development and administration. Our workforce is non-unionized, and we believe that our relations with employees are good.

Additional Information

        We make our Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K, and amendments to these reports filed pursuant to Section 13(a) or 15(d) of the Securities Exchange Act of 1934 available without charge through our website, www.dyax.com, as soon as reasonably practicable after filing them with the Securities and Exchange Commission. Information contained on the website is not part of this report.

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ITEM 1A.    RISK FACTORS

Risks Related To Our Business

We have a history of net losses, expect to incur significant additional net losses and may never achieve or sustain profitability.

        We have incurred net losses since our inception in 1989, including net losses of $62.4 million, $66.5 million and $56.3 million for the years ended December 31, 2009, 2008 and 2007, respectively. As of December 31, 2009, we had an accumulated deficit of approximately $417.8 million. We expect to incur substantial additional net losses over the next several years as our research, development, preclinical testing, clinical trial and commercial activities increase.

        We have generated minimal revenue from product sales to date, and it is possible that we will never have significant product sales revenue. Currently, we generate most of our revenue from collaborators through license and milestone fees, research and development funding, and maintenance fees that we receive in connection with the licensing of our phage display technology. To become profitable, we, either alone or with our collaborators, must successfully develop, manufacture and market our current product candidates, including KALBITOR, and other products and continue to leverage our phage display technology to generate research funding and licensing revenue. It is possible that we will never have significant product sales revenue or receive significant royalties on our licensed product candidates or licensed technology in order to achieve or sustain future profitability.

We will need substantial additional capital in the future and may be unable to raise the capital that we will need to sustain our operations.

        We require significant capital to fund our operations to commercialize KALBITOR and to develop and commercialize other product candidates. Our future capital requirements will depend on many factors, including:

    future sales levels of KALBITOR and other commercial products and the profitability of such sales, if any;

    the timing and cost to develop, obtain regulatory approvals for and commercialize our pipeline products;

    maintaining or expanding our existing collaborative and license arrangements and entering into additional arrangements on terms that are favorable to us;

    the amount and timing of milestone and royalty payments from our collaborators and licensees related to their progress in developing and commercializing products;

    our decision to manufacture, or have third parties manufacture, the materials used in KALBITOR and other pipeline products;

    competing technological and market developments;

    the progress of our drug discovery and development programs;

    the costs of prosecuting, maintaining, defending and enforcing our patents and other intellectual property rights;

    the amount and timing of additional capital equipment purchases; and

    the overall condition of the financial markets.

        We expect that existing cash, cash equivalents, and investments together with anticipated cash flow from existing product development, collaborations and license fees will be sufficient to support our

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current operations into 2011. We will need additional funds if our cash requirements exceed our current expectations or if we generate less revenue than we expect.

        We may seek additional funding through collaborative arrangements, and public or private financings (including our existing equity line of credit), or other means. We may not be able to obtain financing on acceptable terms or at all, and we may not be able to enter into additional collaborative arrangements. Arrangements with collaborators or others may require us to relinquish rights to certain of our technologies, product candidates or products. The terms of any financing may adversely affect the holdings or the rights of our stockholders and if we are unable to obtain funding on a timely basis, we may be required to curtail significantly our research, development or commercialization programs which could adversely affect our business prospects.

Our revenues and operating results have fluctuated significantly in the past, and we expect this to continue in the future.

        Our revenues and operating results have fluctuated significantly on a quarter to quarter basis. We expect these fluctuations to continue in the future. Fluctuations in revenues and operating results will depend on:

    the future sales of KALBITOR, if any, and related costs to commercialize the product;

    the cost and timing of our increased research and development, manufacturing and commercialization expenditures;

    the establishment of new collaborative and licensing arrangements;

    the timing and results of clinical trials, including a failure to receive the required regulatory approvals to commercialize our product candidates;

    the timing, receipt and amount of payments, if any, from current and prospective collaborators, including the completion of certain milestones; and

    revenue recognition and other accepted accounting policies.

        Our revenues and costs in any period are not reliable indicators of our future operating results. If the revenues we receive are less than the revenues we expect for a given fiscal period, then we may be unable to reduce our expenses quickly enough to compensate for the shortfall. In addition, our fluctuating operating results may fail to meet the expectations of securities analysts or investors which may cause the price of our common stock to decline.

We depend heavily on the success of our lead product, KALBITOR, which was approved in the United States for treatment of acute attacks of HAE in patients 16 years and older.

        Our ability to generate product sales will depend on commercial success of KALBITOR in the United States and whether physicians, patients and healthcare payers view KALBITOR as therapeutically effective relative to cost. We initiated the commercial launch of KALBITOR in the United States in February 2010.

        The commercial success of KALBITOR and our ability to generate and increase product sales will depend on several factors, including the following:

    the number of patients with HAE who are diagnosed with the disease and identified to us;

    the number of patients with HAE that may be treated with KALBITOR;

    HAE patient's ability to obtain and maintain sufficient coverage or reimbursement by third-party payers;

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    acceptance of KALBITOR in the medical community;

    ability to effectively market and distribute KALBITOR in the United States;

    the maintenance of marketing approval in the United States and the receipt and maintenance of marketing approval from foreign regulatory authorities; and

    establishment and maintenance of commercial manufacturing capabilities ourselves or through third-party manufacturers.

        If we are unable to develop sales of KALBITOR in the United States and commercialize KALBITOR in additional countries or if we are significantly delayed or limited in doing so, our business prospects would be adversely affected.

Because the target patient population of KALBITOR for treatment of HAE is small and has not been definitively determined, we must be able to successfully identify HAE patients and achieve a significant market share in order to achieve or maintain profitability.

        The prevalence of HAE patients which has been estimated at approximately 1 in 10,000 to 1 in 50,000 people around the world, has not been definitively determined. There can be no guarantee that any of our programs will be effective at identifying HAE patients and the number of HAE patients in the United States may turn out to be lower than expected or may not otherwise utilize treatment with KALBITOR, all of which would adversely affect our results of operations and business prospects.

If HAE patients are unable to obtain and maintain reimbursement for KALBITOR from government health administration authorities, private health insurers and other organizations, KALBITOR may be too costly for regular use and our ability to generate product sales would be harmed.

        We may not be able to sell KALBITOR on a profitable basis or our profitability may be reduced if we are required to sell our product at lower than anticipated prices or if reimbursement is unavailable or limited in scope or amount. KALBITOR is significantly more expensive than traditional drug treatments and most patients require some form of third party insurance coverage in order to afford its cost. Our future revenues and profitability will be adversely affected if HAE patients cannot depend on governmental, private and other third-party payers, such as Medicare and Medicaid in the United States or country specific governmental organizations, to defray the cost of KALBITOR. If these entities refuse to provide coverage and reimbursement with respect to KALBITOR or determine to provide a lower level of coverage and reimbursement than anticipated, KALBITOR may be too costly for general use, and physicians may not prescribe it.

        In addition to potential restrictions on insurance coverage, the amount of reimbursement for KALBITOR may also reduce our ability to profitably commercialize KALBITOR. In the United States and elsewhere, there have been, and we expect there will continue to be, actions and proposals to control and reduce healthcare costs. Government and other third-party payers are challenging the prices charged for healthcare products and increasingly limiting and attempting to limit both coverage and level of reimbursement for prescription drugs.

        It is possible that we will never have significant KALBITOR sales revenue in order to achieve or sustain future profitability.

We may not be able to gain or maintain market acceptance among the medical community or patients for KALBITOR which would prevent us from achieving or maintaining profitability in the future.

        We cannot be certain that KALBITOR will gain or maintain market acceptance among physicians, patients, healthcare payers, and others. Although we have received regulatory approval for KALBITOR in the United States, such approval does not guarantee future revenue. We cannot predict whether

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physicians, other healthcare providers, government agencies or private insurers will determine that KALBITOR is safe and therapeutically effective relative to cost. Medical doctors' willingness to prescribe, and patients' willingness to accept, KALBITOR depends on many factors, including prevalence and severity of adverse side effects in both clinical trials and commercial use, effectiveness of our marketing strategy and the pricing of KALBITOR, publicity concerning our products or competing products, HAE patient's ability to obtain and maintain third-party coverage or reimbursement, and availability of alternative treatments. If KALBITOR fails to achieve market acceptance, we may not be able to market and sell it successfully, which would limit our ability to generate revenue and adversely affect our results of operations and business prospects.

If we fail to comply with continuing regulations, we could lose our approvals to market KALBITOR, and our business would be adversely affected.

        We cannot guarantee that we will be able to maintain our regulatory approval for KALBITOR in the United States. We and our future partners, contract manufacturers and suppliers are subject to rigorous and extensive regulation by the FDA, other federal and state agencies, and governmental authorities in other countries. These regulations continue to apply after product approval, and cover, among other things, testing, manufacturing, quality control, labeling, advertising, promotion, adverse event reporting requirements, and export of biologics.

        As a condition of approval for marketing KALBITOR, the FDA or governmental authorities in other countries may require us to conduct additional clinical trials. For example, in connection with the approval of KALBITOR in the United States, we have agreed to initiate a Phase 4 clinical study to evaluate immunogenicity and hypersensitivity with exposure to KALBITOR for treatment of acute attacks of HAE. The FDA can propose to withdraw approval if new clinical data or information shows that KALBITOR is not safe for use or determines that such study is inadequate. We are required to report any serious and unexpected adverse experiences and certain quality problems with KALBITOR to the FDA and other health agencies. We, the FDA or another health agency may have to notify healthcare providers of any such developments. The discovery of any previously unknown problems with KALBITOR, or its manufacturer may result in restrictions on KALBITOR, and the manufacturer or manufacturing facility, including withdrawal of KALBITOR from the market. Certain changes to an approved product, including the way it is manufactured or promoted, often require prior regulatory approval before the product as modified may be marketed.

        Our third-party manufacturing facilities were subjected to inspection prior to grant of marketing approval and are subject to continued review and periodic inspections by the regulatory authorities. Any third party we would use to manufacture KALBITOR for sale must also be licensed by applicable regulatory authorities. Although we have established a corporate compliance program, we cannot guarantee that we are and will continue to be in compliance with all applicable laws and regulations. Failure to comply with the laws, including statutes and regulations, administered by the FDA or other agencies could result in:

    administrative and judicial sanctions, including warning letters;

    fines and other civil penalties;

    withdrawal of a previously granted approval;

    interruption of production;

    operating restrictions;

    product recall or seizure; injunctions; and

    criminal prosecution.

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        The discovery of previously unknown problems with a product, including KALBITOR, or the facility used to produce the product could result in a regulatory authority imposing restrictions on us, or could cause us to voluntarily adopt such restrictions, including withdrawal of KALBITOR from the market.

        If we do not maintain our regulatory approval for KALBITOR in the United States, our results of operations and business prospects will be materially harmed.

If the use of KALBITOR harms people, or is perceived to harm patients even when such harm is unrelated to KALBITOR, our regulatory approvals could be revoked or otherwise negatively impacted and we could be subject to costly and damaging product liability claims.

        The testing, manufacturing, marketing and sale of drugs for use in humans exposes us to product liability risks. Side effects and other problems from using KALBITOR could (1) lessen the frequency with which physicians decide to prescribe KALBITOR, (2) encourage physicians to stop prescribing KALBITOR to their patients who previously had been prescribed KALBITOR, (3) cause serious adverse events and give rise to product liability claims against us, and (4) result in our need to withdraw or recall KALBITOR from the marketplace. Some of these risks are unknown at this time.

        We have tested KALBITOR in only a small number of patients. As more patients begin to use KALBITOR, new risks and side effects may be discovered, and risks previously viewed as inconsequential could be determined to be significant. Previously unknown risks and adverse effects of KALBITOR may also be discovered in connection with unapproved, or off-label, uses of KALBITOR. We do not promote, or in any way support or encourage the promotion of KALBITOR for off-label uses in violation of relevant law, but physicians are permitted to use products for off-label uses. In addition, we expect to study DX-88 in diseases other than HAE in controlled clinical settings, and expect independent investigators to do so as well. In the event of any new risks or adverse effects discovered as new patients are treated for HAE, regulatory authorities may revoke their approvals; we may be required to conduct additional clinical trials, make changes in labeling of KALBITOR, reformulate KALBITOR or make changes and obtain new approvals for our and our suppliers' manufacturing facilities. We may also experience a significant drop in the potential sales of KALBITOR, experience harm to our reputation and the reputation of KALBITOR in the marketplace or become subject to government investigations or lawsuits, including class actions. Any of these results could decrease or prevent any sales of KALBITOR or substantially increase the costs and expenses of commercializing and marketing KALBITOR.

        We may be sued by people who use KALBITOR, whether as a prescribed therapy, during a clinical trial, during an investigator initiated study, or otherwise. Any informed consents or waivers obtained from people who enroll in our trials or use KALBITOR may not protect us from liability or litigation. Our product liability insurance may not cover all potential types of liabilities or may not cover certain liabilities completely. Moreover, we may not be able to maintain our insurance on acceptable terms. In addition, negative publicity relating to the use of KALBITOR or a product candidate, or to a product liability claim, may make it more difficult, or impossible, for us to market and sell KALBITOR. As a result of these factors, a product liability claim, even if successfully defended, could have a material adverse effect on our business, financial condition or results of operations.

        During the course of treatment, patients may suffer adverse events, including death, for reasons that may or may not be related to KALBITOR. Such events could subject us to costly litigation, require us to pay substantial amounts of money to injured patients, delay, negatively impact or end our opportunity to receive or maintain regulatory approval to market KALBITOR, or require us to suspend or abandon our commercialization efforts. Even in a circumstance in which we do not believe that an adverse event is related to KALBITOR, the investigation into the circumstance may be time consuming or may be inconclusive. These investigations may interrupt our sales efforts, delay our regulatory

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approval process in other countries, or impact and limit the type of regulatory approvals KALBITOR receives or maintains.

Although we obtained regulatory approval of KALBITOR for treatment of acute attacks of HAE in patients 16 years and older in the United States, we may be unable to obtain regulatory approval for KALBITOR in any other territory.

        Governments in countries outside the United States also regulate drugs distributed in such countries and facilities in such countries where such drugs are manufactured, and obtaining their approvals can also be lengthy, expensive and highly uncertain. The approval process varies from country to country and the requirements governing the conduct of clinical trials, product manufacturing, product licensing, pricing and reimbursement vary greatly from country to country. In certain jurisdictions, we are required to finalize operational, reimbursement, price approval and funding processes prior to marketing our products. We may not receive regulatory approval for KALBITOR in countries other than the United States on a timely basis, if ever. Even if approval is granted in any such country, the approval may require limitations on the indicated uses for which the drug may be marketed. Failure to obtain regulatory approval for KALBITOR in territories outside the United States could have a material adverse affect on our business prospects.

If we are unable to establish and maintain effective sales, marketing and distribution capabilities, or to enter into agreements with third parties to do so, we will be unable to successfully commercialize KALBITOR.

        We are marketing and selling KALBITOR ourselves in the United States, and have only limited experience with marketing, sales or distribution of drug products. If we are unable to adequately establish the capabilities to sell, market and distribute KALBITOR, either ourself or by entering into agreements with others, or to maintain such capabilities, we will not be able to successfully sell KALBITOR. In that event, we will not be able to generate significant product sales. We cannot guarantee that we will be able to establish and maintain our own capabilities or enter into and maintain any marketing or distribution agreements with third-party providers on acceptable terms, if at all.

        In the United States, we sell KALBITOR to ABSG which provides an exclusive distribution network for KALBITOR, including a call center to support its commercialization. ABSG in turn sells KALBITOR to health-care providers and hospitals. ABSG does not set or determine demand for KALBITOR. We expect our exclusive distribution arrangement with ABSG to continue for the foreseeable future. Our ability to successfully commercialize KALBITOR will depend, in part, on the extent to which we are able to provide adequate distribution of KALBITOR to patients through ABSG. It is possible that ABSG could change their policies or fees, or both, at some time in the future. This could result in their refusal to distribute smaller volume products such as KALBITOR, or cause higher product distribution costs, lower margins or the need to find alternative methods of distributing KALBITOR. Although we have contractual remedies to mitigate these risks for the three-year term of the contract with ABSG and we also believe we can find alternative distributors on a relatively short notice, our product sales during that period of time may suffer and we may incur additional costs to replace a distributor. A significant reduction in product sales to ABSG, any cancellation of orders they have made with us or any failure to pay for the products we have shipped to them could materially and adversely affect our results of operations and financial condition.

        We have hired sales and marketing professionals for the commercialization of KALBITOR throughout the United States. Even with these sales and marketing personnel, we may not have the necessary size and experience of the sales and marketing force and the appropriate distribution capabilities necessary to successfully market and sell KALBITOR. Establishing and maintaining sales, marketing and distribution capabilities are expensive and time-consuming. Our expenses associated with building up and maintaining the sales force and distribution capabilities may be disproportional compared to the revenues we may be able to generate on sales of KALBITOR. We cannot guarantee that we will be successful in commercializing KALBITOR and a failure to do so would adversely affect our business prospects.

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If we market KALBITOR in a manner that violates health care fraud and abuse laws, we may be subject to civil or criminal penalties.

        In addition to FDA and related regulatory requirements, we are subject to health care "fraud and abuse" laws, such as the federal False Claims Act, the anti-kickback provisions of the federal Social Security Act, and other state and federal laws and regulations. Federal and state anti-kickback laws prohibit, among other things, knowingly and willfully offering, paying, soliciting or receiving remuneration to induce, or in return for purchasing, leasing, ordering or arranging for the purchase, lease or order of any health care item or service reimbursable under Medicare, Medicaid, or other federally or state financed health care programs. This statute has been interpreted to apply to arrangements between pharmaceutical manufacturers on the one hand and prescribers, patients, purchasers and formulary managers on the other. Although there are a number of statutory exemptions and regulatory safe harbors protecting certain common activities from prosecution, the exemptions and safe harbors are drawn narrowly, and practices that involve remuneration intended to induce prescribing, purchasing, or recommending may be subject to scrutiny if they do not qualify for an exemption or safe harbor.

        Federal false claims laws prohibit any person from knowingly presenting, or causing to be presented, a false claim for payment to the federal government, or knowingly making, or causing to be made, a false statement to get a false claim paid. Pharmaceutical companies have been prosecuted under these laws for a variety of alleged promotional and marketing activities, such as allegedly providing free product to customers with the expectation that the customers would bill federal programs for the product; reporting to pricing services inflated average wholesale prices that were then used by federal programs to set reimbursement rates; engaging in promotion for uses that the FDA has not approved, or "off-label" uses, that caused claims to be submitted to Medicaid for non-covered off-label uses; and submitting inflated best price information to the Medicaid Rebate Program.

        Although physicians are permitted to, based on their medical judgment, prescribe products for indications other than those cleared or approved by the FDA, manufacturers are prohibited from promoting their products for such off-label uses. We market KALBITOR for acute attacks of HAE in patients 16 years and older and provide promotional materials and training programs to physicians regarding the use of KALBITOR for this indication. Although we believe our marketing, promotional materials and training programs for physicians do not constitute off-label promotion of KALBITOR, the FDA may disagree. If the FDA determines that our promotional materials, training or other activities constitute off-label promotion of KALBITOR, it could request that we modify our training or promotional materials or other activities or subject us to regulatory enforcement actions, including the issuance of a warning letter, injunction, seizure, civil fine and criminal penalties. It is also possible that other federal, state or foreign enforcement authorities might take action if they believe that the alleged improper promotion led to the submission and payment of claims for an unapproved use, which could result in significant fines or penalties under other statutory authorities, such as laws prohibiting false claims for reimbursement. Even if it is later determined we are not in violation of these laws, we may be faced with negative publicity, incur significant expenses defending our position and have to divert significant management resources from other matters.

        The majority of states also have statutes or regulations similar to the federal anti-kickback law and false claims laws, which apply to items and services reimbursed under Medicaid and other state programs, or, in several states, apply regardless of the payer. Sanctions under these federal and state laws may include civil monetary penalties, exclusion of a manufacturer's products from reimbursement under government programs, criminal fines, and imprisonment. Even if we are not determined to have violated these laws, government investigations into these issues typically require the expenditure of significant resources and generate negative publicity, which would also harm our financial condition. Because of the breadth of these laws and the narrowness of the safe harbors and because government

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scrutiny in this area is high, it is possible that some of our business activities could come under that scrutiny.

        In recent years, several states and localities, including California, the District of Columbia, Maine, Massachusetts, Minnesota, Nevada, New Mexico, Vermont, and West Virginia, have enacted legislation requiring pharmaceutical companies to establish marketing compliance programs, and file periodic reports with the state or make periodic public disclosures on sales, marketing, pricing, clinical trials, and other activities. Similar legislation is being considered in other states. Many of these requirements are new and uncertain, and the penalties for failure to comply with these requirements are unclear. Nonetheless, although we have established compliance policies that comport with the Code of Interactions with Healthcare Providers adopted by Pharmaceutical Research Manufacturers of America (PhRMA Code) and the Office of Inspector General's (OIG) Compliance Program Guidance for Pharmaceutical Manufacturers, if we are found not to be in full compliance with these laws, we could face enforcement action and fines and other penalties, and could receive adverse publicity.

The FDA is requiring us to implement a Risk Evaluation and Mitigation Strategy (REMS) for KALBITOR. Additionally, the FDA or similar agencies in other jurisdictions may require us to restrict the distribution or use of KALBITOR or other future products or take other potentially limiting or costly actions if we or others identify side effects after the product is on the market.

        The FDA is requiring that we implement a REMS for KALBITOR and conduct post-marketing studies to assess a risk of hypersensitivity reactions, including anaphylaxis. The REMS consists of a Medication Guide and a communication plan to healthcare providers.

        Regulatory agencies could impose new requirements or change existing regulations or promulgate new ones at any time that may affect our ability to obtain or maintain approval of KALBITOR or future products or require significant additional costs to obtain or maintain such approvals. For example, the FDA or similar agencies in other jurisdictions may require us to restrict the distribution or use of KALBITOR, if we or others identify side effects after KALBITOR is on the market. Changes in KALBITOR's approval or restrictions on its use could make it difficult to achieve market acceptance, and we may not be able to market and sell KALBITOR successfully, or at all, which would limit our ability to generate product sales and adversely affect our results of operations and business prospects.

We rely on third-party manufacturers to produce our preclinical and clinical drug supplies and we intend to rely on third parties to produce commercial supplies of KALBITOR and any future approved product candidates. Any failure by a third-party manufacturer to produce supplies for us may delay or impair our ability to develop, obtain regulatory approval for or commercialize our product candidates.

        We have relied upon a small number of third-party manufacturers for the manufacture of our product candidates for preclinical and clinical testing purposes and intend to continue to do so in the future. As a result, we depend on collaborators, partners, licensees and other third parties to manufacture clinical and commercial scale quantities of our biopharmaceutical candidates in a timely and effective manner and in accordance with government regulations. If these third party arrangements are not successful, it will adversely affect our ability to develop, obtain regulatory approval for or commercialize our product candidates.

        We have identified only a few facilities that are capable of producing material for preclinical and clinical studies and we cannot assure you that they will be able to supply sufficient clinical materials during the clinical development of our biopharmaceutical candidates. Reliance on third-party manufacturers entails risks to which we would not be subject if we manufactured product candidates ourselves, including reliance on the third party for regulatory compliance and quality assurance, the possibility of breach of the manufacturing agreement by the third party because of factors beyond our

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control (including a failure to synthesize and manufacture our product candidates in accordance with our product specifications) and the possibility of termination or nonrenewal of the agreement by the third party, based on its own business priorities, at a time that is costly or damaging to us. In addition, the FDA and other regulatory authorities require that our product candidates be manufactured according to cGMP and similar foreign standards. Any failure by our third-party manufacturers to comply with cGMP or failure to scale up manufacturing processes, including any failure to deliver sufficient quantities of product candidates in a timely manner, could lead to a delay in, or failure to obtain, regulatory approval of any of our product candidates.

        In addition, as our drug development pipeline increases and matures, we will have a greater need for clinical trial and commercial manufacturing capacity. We do not own or operate manufacturing facilities for the production of clinical or commercial quantities of our product candidates and we currently have no plans to build our own clinical or commercial scale manufacturing capabilities. To meet our projected needs for commercial manufacturing, third parties with whom we currently work will need to increase their scale of production or we will need to secure alternate suppliers.

We are dependent on a single contract manufacturer to produce drug substance for DX-88, which may adversely affect our ability to commercialize KALBITOR and other potential DX-88 products.

        We currently rely on Avecia Biologics Limited (Avecia), which was recently acquired by Merck & Co., Inc. (Avecia), to produce the bulk drug substance used in the manufacture of KALBITOR and other potential DX-88 products. Our business, therefore, faces risks of difficulties with, and interruptions in, performance by Avecia, the occurrence of which could adversely impact the availability and/or sales of KALBITOR and other potential DX-88 products in the future. The failure of Avecia to supply manufactured product on a timely basis or at all, or to manufacture our drug substance in compliance with our specifications or applicable quality requirements or in volumes sufficient to meet demand could adversely affect our ability to sell KALBITOR and other potential DX-88 products, could harm our relationships with our collaborators or customers and could negatively affect our revenues and operating results. If the operations of Avecia are disrupted, we may be forced to secure alternative sources of supply, which may be unavailable on commercially acceptable terms, cause delays in our ability to deliver products to our customers, increase our costs and negatively affect our operating results.

        In addition, failure to comply with applicable good manufacturing practices and other governmental regulations and standards could be the basis for action by the FDA or corresponding foreign agency to withdraw approval for KALBITOR or any other product previously granted to us and for other regulatory action, including recall or seizure, fines, imposition of operating restrictions, total or partial suspension of production or injunctions.

        We do not currently have a long-term supply commercial supply agreement with Avecia for the production of DX-88 drug substance. We are working to establish a long-term supply contract with Avecia or an alternative contract manufacturer. However, we cannot guarantee that we will be able to enter into long-term supply contracts on commercially reasonable terms, or at all. We believe that our current supply of the DX-88 drug substance used to manufacture KALBITOR will be sufficient to meet market demand for KALBITOR well into 2011, but these estimates are subject to changes in market conditions and other factors beyond our control. If we are unable to execute a long-term supply agreement or otherwise secure a dependable source for drug substance before our current inventory of DX-88 drug substance is exhausted, it could adversely affect our ability to further develop and commercialize KALBITOR and other potential DX-88 products, generate revenue from product sales, increase our costs and negatively affect our operating results.

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Our biopharmaceutical product candidates must undergo rigorous clinical trials which could substantially delay or prevent their development or marketing.

        Before we can commercialize any biopharmaceutical product, we must engage in a rigorous clinical trial and regulatory approval process mandated by the FDA and analogous foreign regulatory agencies. This process is lengthy and expensive, and approval is never certain. Positive results from preclinical studies and early clinical trials do not ensure positive results in late stage clinical trials designed to permit application for regulatory approval. We cannot accurately predict when planned clinical trials will begin or be completed. Many factors affect patient enrollment, including the size of the patient population, the proximity of patients to clinical sites, the eligibility criteria for the trial, alternative therapies, competing clinical trials and new drugs approved for the conditions that we are investigating. As a result of all of these factors, our future trials may take longer to enroll patients than we anticipate. Such delays may increase our costs and slow down our product development and the regulatory approval process. Our product development costs will also increase if we need to perform more or larger clinical trials than planned. The occurrence of any of these events will delay our ability to commercialize products, generate revenue from product sales and impair our ability to become profitable, which may cause us to have insufficient capital resources to support our operations.

        Products that we or our collaborators develop could take a significantly longer time to gain regulatory approval than we expect or may never gain approval. If we or our collaborators do not receive these necessary approvals, we will not be able to generate substantial product or royalty revenues and may not become profitable. We and our collaborators may encounter significant delays or excessive costs in our efforts to secure regulatory approvals. Factors that raise uncertainty in obtaining these regulatory approvals include the following:

    we must demonstrate through clinical trials that the proposed product is safe and effective for its intended use;

    we have limited experience in conducting the clinical trials necessary to obtain regulatory approval; and

    data obtained from preclinical and clinical activities are subject to varying interpretations, which could delay, limit or prevent regulatory approvals.

        Regulatory authorities may delay, suspend or terminate clinical trials at any time if they believe that the patients participating in trials are being exposed to unacceptable health risks or if they find deficiencies in the clinical trial procedures. There is no guarantee that we will be able to resolve such issues, either quickly, or at all. In addition, our or our collaborators' failure to comply with applicable regulatory requirements may result in criminal prosecution, civil penalties and other actions that could impair our ability to conduct our business.

We lack experience in and/or capacity for conducting clinical trials and handling regulatory processes. This lack of experience and/or capacity may adversely affect our ability to commercialize any biopharmaceuticals that we may develop.

        We have hired experienced clinical development and regulatory staff to develop and supervise our clinical trials and regulatory processes. However, we will remain dependent upon third party contract research organizations to carry out some of our clinical and preclinical research studies for the foreseeable future. As a result, we have had and will continue to have less control over the conduct of the clinical trials, the timing and completion of the trials, the required reporting of adverse events and the management of data developed through the trials than would be the case if we were relying entirely upon our own staff. Communicating with outside parties can also be challenging, potentially leading to mistakes as well as difficulties in coordinating activities. Outside parties may have staffing difficulties, may undergo changes in priorities or may become financially distressed, adversely affecting their

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willingness or ability to conduct our trials. For example, in 2008, the contract research organization collecting and assembling the data from our EDEMA4 trial announced that it was terminating that line of business, which forced us to find a new contractor and delay the filing of our BLA for HAE by almost two months. We may also experience unexpected cost increases that are beyond our control.

        Problems with the timeliness or quality of the work of a contract research organization may lead us to seek to terminate the relationship and use an alternative service provider. However, changing our service provider may be costly and may delay our trials, and contractual restrictions may make such a change difficult or impossible. Additionally, it may be impossible to find a replacement organization that can conduct our trials in an acceptable manner and at an acceptable cost.

Government regulation of drug development is costly, time consuming and fraught with uncertainty, and our products in development cannot be sold if we do not gain regulatory approval.

        We and our licensees and partners conduct research, preclinical testing and clinical trials for our product candidates. These activities are subject to extensive regulation by numerous state and federal governmental authorities in the United States, such as the FDA, as well as foreign countries, such as the EMEA in European countries, Canada and Australia. Currently, we are required in the United States and in foreign countries to obtain approval from those countries' regulatory authorities before we can manufacture (or have our third-party manufacturers produce), market and sell our products in those countries. The FDA and other United States and foreign regulatory agencies have substantial authority to fail to approve commencement of, suspend or terminate clinical trials, require additional testing and delay or withhold registration and marketing approval of our product candidates.

        Obtaining regulatory approval has been and continues to be increasingly difficult and costly and takes many years, and if obtained is costly to maintain. With the occurrence of a number of high profile safety events with certain pharmaceutical products, regulatory authorities, and in particular the FDA, members of Congress, the United States Government Accountability Office (GAO), Congressional committees, private health/science foundations and organizations, medical professionals, including physicians and investigators, and the general public are increasingly concerned about potential or perceived safety issues associated with pharmaceutical and biological products, whether under study for initial approval or already marketed.

        This increasing concern has produced greater scrutiny, which may lead to fewer treatments being approved by the FDA or other regulatory bodies, as well as restrictive labeling of a product or a class of products for safety reasons, potentially including a boxed warning or additional limitations on the use of products, pharmacovigilance programs for approved products or requirement of risk management activities related to the promotion and sale of a product.

        If regulatory authorities determine that we or our licensees or partners conducting research and development activities on our behalf have not complied with regulations in the research and development of a product candidate, new indication for an existing product or information to support a current indication, then they may not approve the product candidate or new indication or maintain approval of the current indication in its current form or at all, and we will not be able to market and sell it. If we were unable to market and sell our product candidates, our business and results of operations would be materially and adversely affected.

Product liability and other claims arising in connection with the testing our product candidates in human clinical trials may reduce demand for our products or result in substantial damages.

        We face an inherent risk of product liability exposure related to KALBITOR and the testing our product candidates in human clinical trials.

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        An individual may bring a product liability claim against us if KALBITOR or one of our product candidates causes, or merely appears to have caused, an injury. Moreover, in some of our clinical trials, we test our product candidates in indications where the onset of certain symptoms or "attacks" could be fatal. Although the protocols for these trials include emergency treatments in the event a patient appears to be suffering a potentially fatal incident, patient deaths may nonetheless occur. As a result, we may face additional liability if we are found or alleged to be responsible for any such deaths.

        These types of product liability claims may result in:

    decreased demand for KALBITOR and other product candidates;

    injury to our reputation;

    withdrawal of clinical trial volunteers;

    related litigation costs; and

    substantial monetary awards to plaintiffs.

        Although we currently maintain product liability insurance, we may not have sufficient insurance coverage, and we may not be able to obtain sufficient coverage at a reasonable cost. Our inability to obtain product liability insurance at an acceptable cost or to otherwise protect against potential product liability claims could prevent or inhibit the commercialization of any products that we or our collaborators develop, including KALBITOR. If we are successfully sued for any injury caused by our products or processes, then our liability could exceed our product liability insurance coverage and our total assets.

Competition and technological change may make our potential products and technologies less attractive or obsolete.

        We compete in industries characterized by intense competition and rapid technological change. New developments occur and are expected to continue to occur at a rapid pace. Discoveries or commercial developments by our competitors may render some or all of our technologies, products or potential products obsolete or non-competitive.

        Our principal focus is on the development of human therapeutic products. We plan to conduct research and development programs to develop and test product candidates and demonstrate to appropriate regulatory agencies that these products are safe and effective for therapeutic use in particular indications. Therefore our principal competition going forward, as further described below, will be companies who either are already marketing products in those indications or are developing new products for those indications. Many of our competitors have greater financial resources and experience than we do.

        For KALBITOR as a treatment for HAE, our principal competitors include:

    ViroPharma Inc.—In October 2008, ViroPharma received FDA approval for its plasma-derived C1-esterase inhibitor, known as Cinryze™, which is administered intravenously. Cinryze was approved for routine prophylaxis against angioedema attacks in adolescent and adult patients with HAE, and has orphan drug designation from the FDA. Cinryze was launched in December 2008. ViroPharma also submitted a supplemental Biologics License Application to the FDA for the use of Cinryze as a treatment for acute attacks of HAE, and on June 3, 2009, the FDA issued a complete response letter requesting that ViroPharma conduct an additional clinical study. In June 2009, FDA approved patient labeling for Cinryze to include self-administration for routine prophylaxis, once patients are properly trained by their healthcare provider.

    CSL Behring—In October 2009, CSL Behring received FDA approval for its plasma-derived C1-esterase inhibitor, known as Berinert®, which is administered intravenously. Berinert was

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      approved for treatment of acute abdominal or facial attacks of HAE in adult and adolescent patients, and has orphan drug designation from the FDA. Berinert was launched in the US in January 2010. CSL Behring also completed Mutual Recognition Procedure in December 2008, allowing the sale of Berinert® P in more than 20 European countries. Berinert® P has been sold in a subset of European countries since 1985.

    Jerini AG/Shire plc—Jerini AG received European Union market approval in July 2008 for its bradykinin receptor antagonist, known as Firazyr®, which is delivered by subcutaneous injection. In April 2008, the FDA issued a Not Approvable letter for Firazyr. Firazyr has orphan drug designations from the FDA and in Europe. Jerini/Shire initiated a new Phase 3 United States trial in June 2009.

    Pharming Group NV—Pharming filed for market approval from the EMA for its recombinant C1-esterase inhibitor, known as Rhucin®, which is delivered intravenously. In December 2007 and March 2008, Pharming received negative opinions from the EMA. In September 2009, Pharming filed a new MAA with the EMA. In January 2010, the company reported that it has received the Day 120 List of Questions from the Committee for Medicinal Products for Human Use and that at this stage, no major concerns have been raised. Pharming has also reported that a pre-BLA meeting with the FDA occurred in December 2009. Rhucin has Fast Track status from the FDA and orphan drug designations from the FDA and in Europe.

        Other competitors include companies that market or are developing corticosteroid drugs or other anti-inflammatory compounds.

        The principal competitors for DX-88 as a treatment for reducing blood loss in cardiac surgery procedures, are manufacturers of aminocaproic acid, a drug used in this indication. A number of other organizations, including Novo Nordisk A/S, Pfizer Inc., Vanderbilt University and The Medicines Company, are developing other products for this indication.

        For our potential oncology product candidates, our potential competitors include numerous pharmaceutical and biotechnology companies, many of which have greater financial resources and experience than we do.

        In addition, most large pharmaceutical companies seek to develop orally available small molecule compounds against many of the targets for which we and others are seeking to develop antibody, peptide and/or small protein products.

        Our phage display technology is one of several technologies available to generate libraries of compounds that can be leveraged to discover new antibody, peptide and/or small protein products. The primary competing technology platforms that pharmaceutical, diagnostics and biotechnology companies use to identify antibodies that bind to a desired target are transgenic mouse technology and the humanization of murine antibodies derived from hybridomas. Medarex (a wholly-owned subsidiary of Bristol-Myers Squibb), Genmab A/S, and PDL Biopharma are leaders in these technologies. Further, other companies such as BioInvent International AB and XOMA Ltd. have access to phage display technology and compete with us by offering licenses and research services to pharmaceutical and biotechnology companies.

        In addition, we may experience competition from companies that have acquired or may acquire technology from universities and other research institutions. As these companies develop their technologies, they may develop proprietary positions that may prevent us from successfully commercializing our products.

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If we fail to establish and maintain strategic license, research and collaborative relationships, or if our collaborators are not able to successfully develop and commercialize product candidates, our ability to generate revenues could be adversely affected.

        Our business strategy includes leveraging certain product candidates, as well as our proprietary phage display technology, through collaborations and licenses that are structured to generate revenues through license fees, technical and clinical milestone payments, and royalties. We have entered into, and anticipate continuing to enter into, collaborative and other similar types of arrangements with third parties to develop, manufacture and market drug candidates and drug products.

        In addition, for us to continue to receive any significant payments from our LFRP related licenses and collaborations and generate sufficient revenues to meet the required payments under our agreement with Cowen Healthcare, the relevant product candidates must advance through clinical trials, establish safety and efficacy, and achieve regulatory approvals, obtain market acceptance and generate revenues.

        Reliance on license and collaboration agreements involves a number of risks as our licensees and collaborators:

    are not obligated to develop or market product candidates discovered using our phage display technology;

    may not perform their obligations as expected, or may pursue alternative technologies or develop competing products;

    control many of the decisions with respect to research, clinical trials and commercialization of product candidates we discover or develop with them or have licensed to them;

    may terminate their collaborative arrangements with us under specified circumstances, including, for example, a change of control, with short notice; and

    may disagree with us as to whether a milestone or royalty payment is due or as to the amount that is due under the terms of our collaborative arrangements.

        We cannot assure you that we will be able to maintain our current licensing and collaborative efforts, nor can we assure the success of any current or future licensing and collaborative relationships. An inability to establish new relationships on terms favorable to us, work successfully with current licensees and collaborators, or failure of any significant portion of our LFRP related licensing and collaborative efforts would result in a material adverse impact on our business, operating results and financial condition.

Our success depends significantly upon our ability to obtain and maintain intellectual property protection for our products and technologies and upon third parties not having or obtaining patents that would prevent us from commercializing any of our products.

        We face risks and uncertainties related to our intellectual property rights. For example:

    we may be unable to obtain or maintain patent or other intellectual property protection for any products or processes that we may develop or have developed;

    third parties may obtain patents covering the manufacture, use or sale of these products or processes, which may prevent us from commercializing any of our products under development globally or in certain regions; or

    our patents or any future patents that we may obtain may not prevent other companies from competing with us by designing their products or conducting their activities so as to avoid the coverage of our patents.

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        Patent rights relating to our phage display technology are central to our LFRP. As part of our LFRP, we generally seek to negotiate license agreements with parties practicing technology covered by our patents. In countries where we do not have and/or have not applied for phage display patent rights, we will be unable to prevent others from using phage display or developing or selling products or technologies derived using phage display. In addition, in jurisdictions where we have phage display patent rights, we may be unable to prevent others from selling or importing products or technologies derived elsewhere using phage display. Any inability to protect and enforce such phage display patent rights, whether by any inability to license or any invalidity of our patents or otherwise, could negatively affect future licensing opportunities and revenues from existing agreements under the LFRP.

        In all of our activities, we also rely substantially upon proprietary materials, information, trade secrets and know-how to conduct our research and development activities and to attract and retain collaborators, licensees and customers. Although we take steps to protect our proprietary rights and information, including the use of confidentiality and other agreements with our employees and consultants and in our academic and commercial relationships, these steps may be inadequate, these agreements may be violated, or there may be no adequate remedy available for a violation. Also, our trade secrets or similar technology may otherwise become known to, or be independently developed or duplicated by, our competitors.

        Before we and our collaborators can market some of our processes or products, we and our collaborators may need to obtain licenses from other parties who have patent or other intellectual property rights covering those processes or products. Third parties have patent rights related to phage display, particularly in the area of antibodies. While we have gained access to key patents in the antibody area through the cross licenses with Affimed Therapeutics AG, Affitech AS, Biosite Incorporated (now owned by Inverness Medical Innovations), CAT, Domantis Limited (a wholly-owned subsidiary of GlaxoSmithKline), Genentech, Inc. and XOMA Ireland Limited, other third party patent owners may contend that we need a license or other rights under their patents in order for us to commercialize a process or product. In addition, we may choose to license patent rights from other third parties. In order for us to commercialize a process or product, we may need to license the patent or other rights of other parties. If a third party does not offer us a needed license or offers us a license only on terms that are unacceptable, we may be unable to commercialize one or more of our products. If a third party does not offer a needed license to our collaborators and as a result our collaborators stop work under their agreement with us, we might lose future milestone payments and royalties, which would adversely affect us. If we decide not to seek a license, or if licenses are not available on reasonable terms, we may become subject to infringement claims or other legal proceedings, which could result in substantial legal expenses. If we are unsuccessful in these actions, adverse decisions may prevent us from commercializing the affected process or products and could require us to pay substantial monetary damages.

        We seek affirmative rights of license or ownership under existing patent rights relating to phage display technology of others. For example, through our patent licensing program, we have secured a limited freedom to practice some of these patent rights pursuant to our standard license agreement, which contains a covenant by the licensee that it will not sue us under certain of the licensee's phage display improvement patents. We cannot guarantee, however, that we will be successful in enforcing any agreements from our licensees, including agreements not to sue under their phage display improvement patents, or in acquiring similar agreements in the future, or that we will be able to obtain commercially satisfactory licenses to the technology and patents of others. If we cannot obtain and maintain these licenses and enforce these agreements, this could have a material adverse impact on our business.

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Proceedings to obtain, enforce or defend patents and to defend against charges of infringement are time consuming and expensive activities. Unfavorable outcomes in these proceedings could limit our patent rights and our activities, which could materially affect our business.

        Obtaining, protecting and defending against patent and proprietary rights can be expensive. For example, if a competitor files a patent application claiming technology also invented by us, we may have to participate in an expensive and time-consuming interference proceeding before the United States Patent and Trademark Office to address who was first to invent the subject matter of the claim and whether that subject matter was patentable. Moreover, an unfavorable outcome in an interference proceeding could require us to cease using the technology or to attempt to license rights to it from the prevailing party. Our business would be harmed if a prevailing third party does not offer us a license on terms that are acceptable to us.

        In patent offices outside the United States, we may be forced to respond to third party challenges to our patents. For example, our first phage display patent in Europe, European Patent No. 436,597, known as the 597 Patent, was ultimately revoked in 2002 in proceedings in the European Patent Office. We are not able to prevent other parties from using certain aspects of our phage display technology in Europe.

        The issues relating to the validity, enforceability and possible infringement of our patents present complex factual and legal issues that we periodically reevaluate. Third parties have patent rights related to phage display, particularly in the area of antibodies. While we have gained access to key patents in the antibody area through our cross-licensing agreements with Affimed, Affitech, Biosite, Domantis, Genentech, XOMA and CAT, other third party patent owners may contend that we need a license or other rights under their patents in order for us to commercialize a process or product. In addition, we may choose to license patent rights from third parties. While we believe that we will be able to obtain any needed licenses, we cannot assure you that these licenses, or licenses to other patent rights that we identify as necessary in the future, will be available on reasonable terms, if at all. If we decide not to seek a license, or if licenses are not available on reasonable terms, we may become subject to infringement claims or other legal proceedings, which could result in substantial legal expenses. If we are unsuccessful in these actions, adverse decisions may prevent us from commercializing the affected process or products. Moreover, if we are unable to maintain the covenants with regard to phage display improvements that we obtain from our licensees through our patent licensing program and the licenses that we have obtained to third party phage display patent rights, it could have a material adverse effect on our business.

        We would expect to incur substantial costs in connection with any litigation or patent proceeding. In addition, our management's efforts would be diverted, regardless of the results of the litigation or proceeding. An unfavorable result could subject us to significant liabilities to third parties, require us to cease manufacturing or selling the affected products or using the affected processes, require us to license the disputed rights from third parties or result in awards of substantial damages against us. Our business will be harmed if we cannot obtain a license, can obtain a license only on terms we consider to be unacceptable or if we are unable to redesign our products or processes to avoid infringement.

        In all of our activities, we substantially rely on proprietary materials and information, trade secrets and know-how to conduct research and development activities and to attract and retain collaborative partners, licensees and customers. Although we take steps to protect these materials and information, including the use of confidentiality and other agreements with our employees and consultants in both academic commercial relationships, we cannot assure you that these steps will be adequate, that these agreements will not be violated, or that there will be an available or sufficient remedy for any such violation, or that others will not also develop the same or similar proprietary information.

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Failure to meet our Cowen Healthcare debt service obligations could adversely affect our financial condition and our loan agreement obligations could impair our operating flexibility.

        We have a loan with Cowen Healthcare which has an aggregate principal balance of $59.7 million at December 31, 2009. The loan bears interest at a rate of 16% per annum for Tranche A and 21.5% per annum for Tranche B payable quarterly, all of which matures in August 2016. In connection with the loan, we have entered into a security agreement granting Cowen Healthcare a security interest in substantially all of the assets related to our LFRP. We are required to repay the loan based on a percentage of LFRP related revenues, including royalties, milestones, and license fees received by us under the LFRP. If the LFRP revenues for any quarterly period are insufficient to cover the cash interest due for that period, the deficiency may be added to the outstanding loan principal or paid in cash by us. We may prepay the loan in whole or in part at any time after August 2012. In the event of certain changes of control or mergers or sales of all or substantially all of our assets, any or all of the loan may become due and payable at Cowen Healthcare's option, including a prepayment premium prior to August 2012. We must comply with certain loan covenants which if not observed could make all loan principal, interest and all other amounts payable under the loan immediately due and payable.

        Our obligations under the Cowen Healthcare agreement require that we dedicate a substantial portion of cash flow from our LFRP receipts to service the loan, which will reduce the amount of cash flow available for other purposes. If the LFRP fails to generate sufficient receipts to fund quarterly principal and interest payments to Cowen, we will be required to fund such obligations from cash on hand or from other sources, further decreasing the funds available to operate our business. In the event that amounts due under the loan are accelerated, payment would significantly reduce our cash, cash equivalents and short-term investments and we may not have sufficient funds to pay the debt if any of it is accelerated.

        As a result of the security interest granted to Cowen Healthcare, we may not sell our rights to part or all of those assets, or take certain other actions, without first obtaining permission from Cowen. This requirement could delay, hinder or condition our ability to enter into corporate partnerships or strategic alliances with respect to these assets.

        The obligations and restrictions under the Cowen Healthcare agreement may limit our operating flexibility, make it difficult to pursue our business strategy and make us more vulnerable to economic downturns and adverse developments in our business.

If we lose or are unable to hire and retain qualified personnel, then we may not be able to develop our products or processes.

        We are highly dependent on qualified scientific and management personnel, and we face intense competition from other companies and research and academic institutions for qualified personnel. If we lose an executive officer, a manager of one of our principal business units or research programs, or a significant number of any of our staff or are unable to hire and retain qualified personnel, then our ability to develop and commercialize our products and processes may be delayed which would have an adverse effect on our business, financial condition, and results of operations.

We use and generate hazardous materials in our business, and any claims relating to the improper handling, storage, release or disposal of these materials could be time-consuming and expensive.

        Our phage display research and development involves the controlled storage, use and disposal of chemicals and solvents, as well as biological and radioactive materials. We are subject to foreign, federal, state and local laws and regulations governing the use, manufacture and storage and the handling and disposal of materials and waste products. Although we believe that our safety procedures for handling and disposing of these hazardous materials comply with the standards prescribed by laws and regulations, we cannot completely eliminate the risk of contamination or injury from hazardous

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materials. If an accident occurs, an injured party could seek to hold us liable for any damages that result and any liability could exceed the limits or fall outside the coverage of our insurance. We may not be able to maintain insurance on acceptable terms, or at all. We may incur significant costs to comply with current or future environmental laws and regulations.

Our business is subject to risks associated with international contractors and exchange rate risk.

        Since the closing of our European subsidiary operations in 2008, none of our business is conducted in currencies other than our reporting currency, the United States dollar. We do, however, rely on an international contract manufacturer for the production of our drug substance for DX-88. We recognize foreign currency gains or losses arising from our transactions in the period in which we incur those gains or losses. As a result, currency fluctuations among the United States dollar and the currencies in which we do business have caused foreign currency transaction gains and losses in the past and will likely do so in the future. Because of the variability of currency exposures and the potential volatility of currency exchange rates, we may suffer significant foreign currency transaction losses in the future due to the effect of exchange rate fluctuations.

Compliance with changing regulations relating to corporate governance and public disclosure may result in additional expenses.

        Keeping abreast of, and in compliance with, changing laws, regulations, and standards relating to corporate governance and public disclosure, including the Sarbanes-Oxley Act of 2002, new SEC regulations, and NASDAQ Global Market rules, have required an increased amount of management attention and external resources. We intend to invest all reasonably necessary resources to comply with evolving corporate governance and public disclosure standards, and this investment may result in increased general and administrative expenses and a diversion of management time and attention from revenue-generating activities to compliance activities.

We may not succeed in acquiring technology and integrating complementary businesses.

        We may acquire additional technology and complementary businesses in the future. Acquisitions involve many risks, any one of which could materially harm our business, including:

    the diversion of management's attention from core business concerns;

    the failure to exploit acquired technologies effectively or integrate successfully the acquired businesses;

    the loss of key employees from either our current business or any acquired businesses; and

    the assumption of significant liabilities of acquired businesses.

        We may be unable to make any future acquisitions in an effective manner. In addition, the ownership represented by the shares of our common stock held by our existing stockholders will be diluted if we issue equity securities in connection with any acquisition. If we make any significant acquisitions using cash consideration, we may be required to use a substantial portion of our available cash. If we issue debt securities to finance acquisitions, then the debt holders would have rights senior to the holders of shares of our common stock to make claims on our assets and the terms of any debt could restrict our operations, including our ability to pay dividends on our shares of common stock. Acquisition financing may not be available on acceptable terms, or at all. In addition, we may be required to amortize significant amounts of intangible assets in connection with future acquisitions. We might also have to recognize significant amounts of goodwill that will have to be tested periodically for impairment. These amounts could be significant, which could harm our operating results.

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Risks Related To Our Common Stock

Our common stock may continue to have a volatile public trading price and low trading volume.

        The market price of our common stock has been highly volatile. Since our initial public offering in August 2000 through February 20, 2010, the price of our common stock on the NASDAQ Global Market has ranged between $54.12 and $1.05. The market has experienced significant price and volume fluctuations for many reasons, some of which may be unrelated to our operating performance.

        Many factors may have an effect on the market price of our common stock, including:

    public announcements by us, our competitors or others;

    developments concerning proprietary rights, including patents and litigation matters;

    publicity regarding actual or potential clinical results or developments with respect to products or compounds we or our collaborators are developing;

    regulatory decisions in both the United States and abroad;

    public concern about the safety or efficacy of new technologies;

    issuance of new debt or equity securities;

    general market conditions and comments by securities analysts; and

    quarterly fluctuations in our revenues and financial results.

        While we cannot predict the effect that these factors may have on the price of our common stock, these factors, either individually or in the aggregate, could result in significant variations in price during any given period of time.

Anti-takeover provisions in our governing documents and under Delaware law and our shareholder rights plan may make an acquisition of us more difficult.

        We are incorporated in Delaware. We are subject to various legal and contractual provisions that may make a change in control of us more difficult. Our board of directors has the flexibility to adopt additional anti-takeover measures.

        Our charter authorizes our board of directors to issue up to 1,000,000 shares of preferred stock and to determine the terms of those shares of stock without any further action by our stockholders. If the board of directors exercises this power to issue preferred stock, it could be more difficult for a third party to acquire a majority of our outstanding voting stock. Our charter also provides staggered terms for the members of our board of directors. This may prevent stockholders from replacing the entire board in a single proxy contest, making it more difficult for a third party to acquire control of us without the consent of our board of directors. Our equity incentive plans generally permit our board of directors to provide for acceleration of vesting of options granted under these plans in the event of certain transactions that result in a change of control. If our board of directors used its authority to accelerate vesting of options, then this action could make an acquisition more costly, and it could prevent an acquisition from going forward. Our shareholder rights plan could result in the significant dilution of the proportionate ownership of any person that engages in an unsolicited attempt to take over our company and, accordingly, could discourage potential acquirers.

        Section 203 of the Delaware General Corporation Law prohibits a person from engaging in a business combination with any holder of 15% or more of its capital stock until the holder has held the stock for three years unless, among other possibilities, the board of directors approves the transaction. This provision could have the effect of delaying or preventing a change of control of Dyax, whether or not it is desired by or beneficial to our stockholders.

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        The provisions described above, as well as other provisions in our charter and bylaws and under the Delaware General Corporation Law, may make it more difficult for a third party to acquire our company, even if the acquisition attempt was at a premium over the market value of our common stock at that time.

ITEM 1B.    UNRESOLVED STAFF COMMENTS

        None.

ITEM 2.    PROPERTIES

        We lease space at 300 Technology Square in Cambridge, Massachusetts. This building serves as our corporate headquarters and research facility. In August 2009, we amended our lease to reduce our occupancy from approximately 91,000 square feet to 67,000 square feet. Of the 67,000 square feet that we currently lease, we sublease approximately 24,000 square feet to two tenants under separate sublease agreements, each of which will expire on October 31, 2011. Our lease will expire on February 29, 2012, although we have the option to extend our lease for two additional five-year terms. We had previously provided the lessor with a Letter of Credit and under the terms of the lease, as amended, the Letter of Credit balance was reduced to approximately $2.0 million in January 2010.

        Through our subsidiary, Dyax S.A., we had leased 10,000 square feet of laboratory and office space in Liege, Belgium. In connection with the closure of our Liege-based research facility during 2008, this facility was vacated and the lease was terminated in June 2009.

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

        During the quarter ended December 31, 2009, no matters were submitted to a vote of security holders through the solicitation of proxies or otherwise.

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PART II

ITEM 5.    MARKET FOR THE COMPANY'S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES

        Our common stock is traded on The NASDAQ Global Market under the symbol DYAX. As of February 19, 2010, there were 78,125,483 shares of our common stock outstanding, which were held by approximately 172 common stockholders of record.

        The following table sets forth, for the periods indicated, the high and low selling prices for our common stock as reported on NASDAQ Global Market:

 
  High   Low  

Fiscal year ended December 31, 2009

             
 

First Quarter

  $ 3.84   $ 1.80  
 

Second Quarter

  $ 2.57   $ 1.55  
 

Third Quarter

  $ 4.39   $ 2.13  
 

Fourth Quarter

  $ 4.69   $ 2.97  

 

 
  High   Low  

Fiscal year ended December 31, 2008

             
 

First Quarter

  $ 4.93   $ 3.15  
 

Second Quarter

  $ 5.18   $ 3.05  
 

Third Quarter

  $ 5.35   $ 2.80  
 

Fourth Quarter

  $ 4.53   $ 1.94  

        We have never declared or paid cash dividends on our capital stock. We currently intend to retain our future earnings, if any, for use in our business and therefore do not anticipate paying cash dividends in the foreseeable future. Payment of future dividends, if any, will be at the discretion of our Board of Directors after taking into account various factors, including our financial condition, operating results, current and anticipated cash needs and plans for expansion.

        We provide equity compensation plan information in Item 12 "Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters". We are incorporating that information into this section by this reference.

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ITEM 6.    SELECTED CONSOLIDATED FINANCIAL DATA

        The following table summarizes certain selected consolidated financial data, which should be read in conjunction with "Management's Discussion and Analysis of Financial Condition and Results of Operations" and our consolidated financial statements and related notes included elsewhere in this Form 10-K. The selected consolidated financial data at December 31, 2009 and 2008, and for the years ended December 31, 2009, 2008 and 2007 have been prepared from our audited financial statements included in this Form 10-K. The selected consolidated financial data at December 31, 2007, 2006 and 2005, and for the years ended December 31, 2006 and 2005 have been prepared from our audited financial statements not included in this Annual Report on Form 10-K.

 
  December 31,  
 
  2009   2008   2007   2006   2005  
 
  (In thousands, except share and per share data)
 

Consolidated Statement of Operations Data:

                               

Product development and license fee revenues

  $ 21,643   $ 43,429   $ 26,096   $ 12,776   $ 19,859  
 

Net research and development

    46,587     68,077     57,010     37,537     26,688  
 

Marketing, general and administrative expenses

    25,843     22,663     15,740     14,658     12,784  
 

Equity loss in joint venture (Dyax-Genzyme LLC)

            3,831     10,352     11,952  
 

Restructuring costs

    2,331     4,631              
 

Impairment of fixed assets

    955     352              
                       

Total operating expenses

    75,716     95,723     76,581     62,547     51,424  
                       

Loss from operations

    (54,073 )   (52,294 )   (50,485 )   (49,771 )   (31,565 )
 

Other (expense) income, net

    (8,346 )   (5,910 )   (5,824 )   (552 )   621  
 

Loss on extinguishment of debt

        (8,264 )            
                       

Net loss

  $ (62,419 ) $ (66,468 ) $ (56,309 ) $ (50,323 ) $ (30,944 )
                       

Basic and diluted net loss per share

  $ (0.90 ) $ (1.08 ) $ (1.06 ) $ (1.18 ) $ (0.87 )
                       

Shares used in computing basic and diluted net loss per share

    69,151,841     61,626,095     53,072,993     42,532,466     35,455,782  
                       

 

 
  December 31,  
 
  2009   2008   2007   2006   2005  
 
  (In thousands)
 

Consolidated Balance Sheet Data:

                               

Cash and cash equivalents

  $ 29,386   $ 27,668   $ 29,356   $ 11,295   $ 8,640  

Short-term investments

    23,009     30,792     34,055     47,169     42,024  

Long-term investments

                1,992      

Working capital

    34,126     40,736     53,115     46,369     41,756  

Total assets

    64,801     75,075     83,615     88,173     75,917  

Long-term obligations, less current portion

    58,749     48,499     30,016     40,210     9,819  

Accumulated deficit

    (417,819 )   (355,400 )   (288,932 )   (232,623 )   (182,300 )

Total stockholders' equity (deficit)

    (38,602 )   (20,044 )   29,496     23,461     40,938  

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ITEM 7.    MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

Overview

        We are a biopharmaceutical company focused on the discovery, development and commercialization of novel biotherapeutics for unmet medical needs, with an emphasis on inflammatory and oncology indications. Our lead product DX-88 has recently been approved under the brand name KALBITOR (ecallantide) by the FDA for treatment of acute attacks of HAE in patients 16 years of age and older. We currently commercialize KALBITOR on our own in the United States and intend to seek approval and commercialize KALBITOR through partners for HAE and other angioedema indications in markets outside of the United States.

        In addition to its approved commercial use for HAE in the United States, we are also developing DX-88 through collaborations in other indications. These include use of DX-88 for the reduction of blood loss during surgery in collaboration with Cubist, and for treatment of retinal diseases in collaboration with Fovea, which was acquired by sanofi-aventis in 2009. We are also exploring use of DX-88 for treatment of ACE inhibitor-induced angioedema, a life threatening inflammatory response brought on by adverse reactions to ACE inhibitors; and acquired angioedema, a condition associated with B-cell lymphoma and autoimmune disorders.

        Beyond DX-88, we have also developed a pipeline of promising drug candidates using our proprietary drug discovery technology, known as phage display. We use phage display to identify antibody, small protein and peptide compounds with potential for clinical development. This pipeline includes DX-2240 and DX-2400, two fully human monoclonal antibodies with therapeutic potential in oncology indications. In 2008, we entered into an exclusive license agreement under which sanofi-aventis will be responsible for the continued development of DX-2240. DX-2400 is currently in preclinical development within our internal development pipeline.

        Although we use our phage display technology primarily to advance our own internal development activities, we also leverage it through licenses and collaborations designed to generate revenues and provide us access to co-develop and/or co-promote drug candidates identified by other biopharmaceutical and pharmaceutical companies. Through our LFRP, we have more than 70 ongoing license agreements. To date our licensees have advanced 19 product candidates into clinical trials including one product that has received market approval from the FDA.

        We incurred a net loss in 2009 and expect to continue to incur significant operating losses over the next few years. We have generated minimal revenue from product sales to date, and it is possible that we will never have significant product sales revenue. Currently, we generate most of our revenue from collaborators through license and milestone fees, research and development funding, and maintenance fees that we receive in connection with the licensing of our phage display technology. To become profitable, we, either alone or with our collaborators, must successfully market and sell KALBITOR and develop, manufacture and market our other product candidates, including DX-88 for indications besides HAE, and continue to leverage our phage display technology to generate research funding and licensing revenue. It is possible that we will never have significant product sales revenue or receive significant royalties on our licensed product candidates or licensed technology in order to achieve or sustain future profitability.

Clinical Development Programs

KALBITOR AND THE DX-88 FRANCHISE

        DX-88 is a compound that we developed using our phage display technology, which we have shown in vitro to be a high affinity, high specificity inhibitor of human plasma kallikrein. Plasma kallikrein, an enzyme found in blood, is believed to be a key component responsible for the regulation of the

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inflammation and coagulation pathways. Excess plasma kallikrein activity is thought to play a role in a number of inflammatory and autoimmune diseases, including HAE.

        HAE is a rare, genetic disorder characterized by severe, debilitating and often painful swelling, which can occur in the abdomen, face, hands, feet and airway. HAE is caused by low or dysfunctional levels of C1-INH, a naturally occurring molecule that inhibits plasma kallikrein, a key mediator of inflammation, and other serine proteases in the blood. It is estimated that HAE affects between 1 in 10,000 to 1 in 50,000 people around the world. Despite the fact that 85% of patients experience symptoms before age 20, 68% of patients are not diagnosed until after age 20, which makes it difficult to accurately determine the size of the HAE patient population. HAE patient association registries estimate there is an immediately addressable target population of approximately 6,500 patients in the United States.

KALBITOR

        In December 2009, DX-88 was approved by the FDA under the brand name KALBITOR (ecallantide) for treatment of HAE in patients 16 years of age and older regardless of anatomic location. KALBITOR, a potent, selective and reversible plasma kallikrein inhibitor discovered and developed by Dyax, is the first subcutaneous HAE treatment approved in the United States.

        As part of product approval, we have established a REMS program to communicate the risk of anaphylaxis and the importance of distinguishing between hypersensitivity reaction and HAE attack symptoms. To communicate these risks, the REMS requires a Medication Guide be dispensed with each dose of KALBITOR and a "Dear Healthcare Professional" letter be provided to doctors identified as likely to prescribe KALBITOR and treat HAE patients. KALBITOR should only be administered by a healthcare professional with appropriate medical support to manage anaphylaxis and HAE.

        We have also initiated a Phase 4 observational study to evaluate immunogenicity and hypersensitivity with exposure to KALBITOR for treatment of acute attacks of HAE. The study is designed to identify predictive risk factors and develop effective screening tools to mitigate the risk of hypersensitivity and anaphylaxis. This 4-year study was initiated in February 2010.

DX-88 FRANCHISE

DX-88 for treatment of Other Angioedemas

        In addition to its approved commercial use, we are also developing DX-88 in other angioedema indications. Another form of angioedema is induced by the use of so-called ACE inhibitors. With an estimated 51 million prescriptions written annually worldwide, ACE inhibitors are widely prescribed to reduce ACE and generally reduce high blood pressure and vascular constriction. It is estimated that up to 2% of patients treated with ACE inhibitors suffer from angioedema attacks, which represents approximately 30% of all angioedemas treated in emergency rooms. Research suggests the use of ACE inhibitors increases the relative activity of bradykinin, a protein that causes blood vessels to enlarge, or dilate, which can also cause the swelling known as angioedema. As a specific inhibitor of plasma kallikrein, an enzyme needed to produce bradykinin, DX-88 has the potential to be effective for treating this condition. We are working with investigators affiliated with the University of Cincinnati as they initiate an investigator sponsored study for drug-induced angioedema.

        Acquired angioedema is a condition associated with B-cell lymphoma and autoimmune disorders. We are currently working with Dr. Marco Cicardi, of the University of Milan, as he initiates a compassionate use program for DX-88 in this indication.

DX-88 for On-Pump Cardiac Surgery

        Industry publications report that there are an estimated one million procedures performed worldwide each year involving on-pump cardiac surgery. On-pump cardiac procedures, which are

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performed for patients who have narrowings or blockages of the coronary arteries, often involve use of a heart-lung machine commonly referred to as the "pump". In these procedures, the heart is stopped with medications, and the pump does the work of the heart and lungs during surgery. This allows the surgeon to position the heart as needed, to accurately identify the arteries and to perform the bypass while the heart is stationary.

        The use of the pump during cardiac procedures elicits an adverse systemic inflammatory response. Many patients undergoing on-pump cardiac procedures experience significant intraoperative blood loss that requires transfusion. Plasma kallikrein has been implicated in the body's response to on-pump heart surgery as a major contributor to the significant blood loss seen in on-pump cardiac patients and to the pathologic inflammation that plays a role in the complications of on-pump cardiac procedures.

        In 2008, we entered into an exclusive license and collaboration agreement with Cubist for the development and commercialization in North America and Europe of the intravenous formulation of DX-88 for the reduction of blood loss during surgery. Under this agreement, Cubist assumed responsibility for all further development and costs associated with DX-88 in the licensed indications in the Cubist territory. Under the terms of the license agreement, we received a $15 million upfront payment and an additional $2.5 million milestone payment in 2008. In addition, we are eligible to receive (i) up to $214 million in clinical, regulatory and sales-based milestone payments, and (ii) tiered royalties, ranging from the low teens to low twenties, based on sales of DX-88 by Cubist.

        Cubist has assumed responsibility for two studies of DX-88 (also known internally at Cubist as CB-500,929) within its licensed surgical indications. The first, known as CONSERV-1, was a dose ranging study evaluating 5, 25 and 75 milligram doses of DX-88 versus placebo in patients undergoing primary CABG surgery who are at a low risk of bleeding complications. The second trial, known as CONSERV-2, compared a single 75 milligram dose of DX-88 to tranexamic acid in patients at a higher risk of bleeding. In December 2009, enrollment in both CONSERV-1 and CONSERV-2 was closed after a statistically significant difference in mortality was observed by the Data Safety Monitoring Board between the DX-88 and control arms in CONSERV-2. No difference was observed in serious adverse events between the active and control arm in CONSERV-1 at the interim look. Cubist plans to conduct a full dataset review of safety and efficacy in the patients enrolled in both CONSERV-1 and CONSERV-2 and expects to be in a position to determine next steps for this program late in the second quarter of 2010.

        During 2008, research and development expenses for this program totaled $3.9 million and we billed Cubist $1.7 million for reimbursement of services related to these expenses incurred in 2008. There were no costs incurred by us in 2009 and no future expenditures are expected to be incurred by us for this program.

DX-88 for Ophthalmic Indications

        We have entered into a license agreement with Fovea Pharmaceuticals SA, which was acquired by sanofi-aventis in 2009, for the development of DX-88 for treatment of retinal diseases in the European Union. Under this agreement, Fovea will fully fund development for the first indication, retinal vein occlusion-induced macular edema, for which a Phase 1 trial was initiated in the third quarter of 2009. We retain all rights to commercialize DX-88 in this indication outside of the European Union. Under the license agreement, we do not receive milestone payments, but are entitled to receive tiered royalties, ranging from the high teens to mid twenties, based on sales of DX-88 by Fovea in the European Union. Conversely, if we elect to commercialize DX-88 in this indication outside of the European Union, Fovea will be entitled to receive royalties from us, ranging from the low to mid teens, based on sales of DX-88 outside the European Union.

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Goals for Clinical Development Programs

        Our goal for the ongoing development of DX-88 is to ensure that we and our various collaborators develop DX-88 in multiple indications and obtain marketing approval from the FDA and international regulatory agencies in such indications. Cash inflows from these programs, other than upfront and milestone payments from our collaborations will not commence until after marketing approvals are obtained, and then only if the product candidate finds acceptance in the marketplace as a treatment for its disease indication. Because of the many risks and uncertainties related to the completion of clinical trials, receipt of marketing approvals and acceptance in the marketplace, we cannot predict when cash inflows from these programs will commence, if ever.

Other Discovery and Development Programs

        Our phage display technology and expertise has allowed us to develop a pipeline of drug candidates in addition to DX-88. Of our existing pipeline candidates, the most advanced are DX-2240 and DX-2400, two fully human monoclonal antibodies with therapeutic potential in oncology indications.

        Our DX-2240 antibody has a novel mechanism of action that targets the Tie-1 receptor on tumor blood vessels. In preclinical animal models, DX-2240 has demonstrated activity against a broad range of solid tumor types. Data also indicates increased activity when combined with antiangiogenic therapies such as Avastin® and Nexavar®. In February 2008, we entered into agreements with sanofi-aventis, under which we granted sanofi-aventis exclusive worldwide rights to develop and commercialize DX-2240 as a therapeutic product, as well as a non-exclusive license to our proprietary antibody phage display technology. Under the terms of the DX-2240 license agreement, we received license fees and milestone payments of $23.2 million in 2008. In addition, we are eligible to receive (i) up to an aggregate of $233 million in additional license fees and milestone payments, which maximum aggregate payment assumes full development and commercial success of DX-2240, and (ii) tiered royalties, ranging from the mid-to-high single digits, based on sales of DX-2240 by sanofi-aventis. As exclusive licensee, sanofi-aventis will be responsible for the ongoing development and commercialization of DX-2240.

        Our DX-2400 antibody is a specific inhibitor of Matrix Metalloproteinase-14 (MMP-14), a protease expressed on tumor cells and tumor blood vessels. To date, small molecule approaches have failed to produce compounds that distinguish between closely related MMPs. In contrast, our technology has allowed us to identify a highly selective inhibitor of MMP-14 that does not inhibit other proteases that we have tested. In animal models, DX-2400 has been shown to significantly inhibit tumor progression and metastasis in a dose-dependent manner in breast, prostate and melanoma tumors. Herceptin®, a leading breast cancer treatment, is effective in only the subtype of breast tumors which are Her2+. Current data suggests that DX-2400 may be effective against both Her2+ and Her2- breast tumors, potentially offering promise for treatment of a wider range of breast cancer patients. DX-2400 is currently in preclinical development within our development pipeline.

        Given the uncertainties of the research and development process, it is not possible to predict with confidence if we will be able to enter into additional partnerships or otherwise internally develop any of these other preclinical drug candidates into marketable pharmaceutical products. We monitor the results of our discovery research and our nonclinical and clinical trials and frequently evaluate our preclinical pipeline in light of new data and scientific, business and commercial insights with the objective of balancing risk and potential. This process can result in relatively abrupt changes in focus and priority as new information becomes available and we gain additional insights into ongoing programs and potential new programs.

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Results of Operations

        Revenues.    Substantially all our revenue has come from licensing, funded research and development fees, including milestone payments from our licensees and collaborators. This revenue fluctuates from year to year due to the timing of the clinical activities of our collaborators and licensees. Our lead product DX-88 has recently been approved under the brand name KALBITOR by the FDA for treatment of acute attacks of HAE in patients 16 years of age and older. KALBITOR became commercially available in February 2010 and product sales are expected to commence during the first quarter of 2010.

        Total revenue for 2009 was $21.6 million, compared with $43.4 million in 2008 and $26.1 million in 2007. The decrease in revenue from 2008 to 2009 is primarily due to revenue recognized in 2008 of $23.2 million associated with our sanofi-aventis license agreement. Under this exclusive worldwide license, sanofi-aventis received rights for the development and commercialization of the fully human monoclonal antibody DX-2240 as a therapeutic product. There was no revenue recognized associated with this license in 2009. The 2009 decrease is partially offset by an increase of $1.1 million in revenue from our license agreement with Cubist, as well as an increase in patent and library license revenue, including milestones and royalties.

        The increase of $17.3 million in revenue from 2007 to 2008 reflects revenue of $23.2 million associated with our agreement with sanofi-aventis, $3.2 million from our agreement with Cubist, and an increase in patent and library license fees, primarily due to new agreements and milestones in 2008. These increases were partially offset by $15.0 million recognized in 2007 from a fully paid-up license agreement with Morphosys.

        Research and Development.    Our research and development expenses are summarized as follows:

 
  Year Ended December 31,  
 
  2009   2008   2007  
 
  (In thousands)
 

KALBITOR costs included within research and development expenses

  $ 17,429   $ 31,229   $ 25,858  

DX-88 drug substance manufacturing costs

    8,599     2,838     7,339  

Other research and development expenses

    20,559     34,010     30,813  
               

Research and development expenses

    46,587     68,077     64,010  

Less research and development expenses reimbursed by former joint venture (Dyax-Genzyme LLC)

            (7,000 )
               

Net research and development expenses

    46,587     68,077     57,010  

Equity loss in former joint venture (Dyax-Genzyme LLC) separately classified within the consolidated statements of operations and comprehensive loss

            3,831  
               

Research and development expenses adjusted to include equity loss in former joint venture

  $ 46,587   $ 68,077   $ 60,841  
               

        Our research and development expenses arise primarily from compensation and related costs for personnel dedicated to research and development activities and for the fees paid and costs reimbursed to outside parties to conduct research, clinical trials and to manufacture drug material prior to FDA approval. While expenses we incur on the KALBITOR program for HAE are included in our research and development expenses, expenses through February 20, 2007 were reimbursed by the Dyax-Genzyme LLC joint venture and excluded from net research and development expenses. When we jointly funded the losses of that program with Genzyme, our equity loss in joint venture represented our share of all expenses for the development of KALBITOR through February 20, 2007 by Dyax-Genzyme LLC. Subsequent to the termination of the joint venture on February 20, 2007, there

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has been no reimbursement from Genzyme nor any equity loss in the joint venture. Our research and development expenses fluctuate year to year as they are dependent on the timing, size and scope of our development programs.

        Included in research and development costs are $26.0 million and $34.1 million in 2009 and 2008, respectively, for costs associated with KALBITOR and DX-88 inventory. The decrease in KALBITOR related development costs from 2008 to 2009 is primarily attributable to $7.4 million of decreased clinical costs for our EDEMA4 Phase 3 trial which was completed in 2008, as well as lower personnel expenses as a result of the workforce reduction in March 2009. These decreases were partially offset by a $5.8 million increase in costs to manufacture KALBITOR drug substance during 2009.

        Other research and development expenses decreased by approximately $13.5 million in 2009, primarily related to cost savings of approximately $7.7 million as a result of the workforce reduction in March 2009, and $2.0 million from the closure of our Liege, Belgium research facility in the second quarter of 2008. License expense and other external research and development costs also decreased during the 2009.

        Costs associated with KALBITOR increased from 2007 to 2008 primarily due to increased clinical costs for our EDEMA4 Phase 3 trial, as well as an increase in personnel expenses required to support the advancement of the HAE program, and were partially offset by a $4.5 million decrease in manufacturing costs related to the process validation campaign completed in 2007.

        Other research and development expenses increased by approximately $3.2 million from 2007 to 2008, excluding reimbursements by the joint venture and equity loss in joint venture. This increase was net of a $2.9 million decrease associated with the closure of our Liege operations in 2008. Third-party license fees associated with the LFRP and other licensing increased $4.5 million in 2008. Other development costs for preclinical candidates increased approximately $1.0 million in 2008 primarily due to an increase in personnel expenses.

        Marketing, General and Administrative.    Our general and administrative expenses consist primarily of the costs of our management and administrative staff, as well as expenses related to business development, protecting our intellectual property, administrative occupancy, professional fees, market research and promotion activities and the reporting requirements of a public company. General and administrative expenses were $25.8 million in 2009 compared to $22.7 million in 2008 and $15.7 million in 2007. The higher general and administrative costs in 2009 were primarily due to an increase in infrastructure to support plans for commercialization of KALBITOR, which include the expansion of the sales and marketing department as well as other external marketing activities, and a $1.1 million charge for share-based compensation expense for amendments to the exercise and vesting schedules of certain options in 2009. The increase from 2007 to 2008 was also primarily due to increased infrastructure to support plans for commercialization of KALBITOR.

        Restructuring and Impairment.    In March 2009, we implemented a workforce reduction to focus necessary resources on the commercialization of DX-88 and to support our long-term financial success. As a result, during the first quarter of 2009, we recorded one-time restructuring charges related to the workforce reduction of approximately $1.9 million.

        As a result of the decrease in necessary facility space following the workforce reduction in March 2009, we amended our facility lease during the third quarter of 2009 to reduce our leased space. As a result, a one-time charge of approximately $1.4 million was recorded of which, approximately $955,000 was recorded as a result of the write-down of leasehold improvements.

        In 2008, we incurred restructuring fees of $4.6 million and recorded an impairment charge related to fixed assets of $352,000 in connection with the closing of our Liege research facility.

        Loss on Extinguishment of Debt.    In 2008, we incurred a one-time loss on extinguishment of debt of $8.3 million related to fully paying off our debt with Paul Royalty.

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        Interest Expense.    Interest expense was $10.1 million in 2009 compared to $7.8 million in 2008 and $9.1 million in 2007. The 2009 increase is primarily due to interest on the $15.0 million Tranche B loan from Cowen Healthcare which was received in March 2009. The decrease in 2008 compared to 2007 is primarily due to replacing our loan with Paul Royalty in August 2008 with a lower interest loan from Cowen Healthcare. Interest on the Paul Royalty agreement was calculated using the effective interest method based on our expected future payments to Paul Royalty. See Notes to Consolidated Financial Statements, Note 8 of Item 8 "Financial Statements and Supplementary Data" for additional information regarding these agreements.

        Interest and Other Income.    Interest income was $248,000, $1.5 million and $3.3 million in 2009, 2008 and 2007, respectively. The decrease from 2008 to 2009 was due to lower investment balances and significantly lower interest rates on our investments. The decrease from 2007 to 2008 was primarily due to significantly lower interest rates on our investments.

        In 1999, we received an €825,000 grant from the Walloon region of Belgium, which included specific criteria regarding employment and investment levels that needed to be met. In connection with the closure of our Liege, Belgium facility in 2008, we refunded approximately $162,000 of the grant. In October 2009, all remaining investment criteria were met. As a result, the residual grant balance of approximately $1.0 million was released from short-term liabilities on the consolidated balance sheet and recognized as Other Income in the Statement of Operations during the fourth quarter of 2009.

Liquidity and Capital Resources

 
  December 31,  
 
  2009   2008  
 
  (in thousands)
 

Cash and cash equivalents

  $ 29,386   $ 27,668  

Short-term investments

    23,009     30,792  
           

Total cash, cash equivalents and investments

  $ 52,395   $ 58,460  
           

        The following table summarizes our cash flow activity:

 
  Years Ended December 31,  
 
  2009   2008   2007  
 
  (in thousands)
 

Net cash used in operating activities

    (54,227 )   (20,488 )   (40,217 )

Net cash provided by investing activities

    6,989     3,764     35,303  

Net cash provided by financing activities

    48,942     14,984     22,921  

Effect of foreign currency translation on cash balances

    14     52     54  
               

Net increase (decrease) in cash and cash equivalents

  $ 1,718   $ (1,688 ) $ 18,061  
               

        We require cash to fund our operating activities, make capital expenditures, acquisitions and investments, and service debt. Through December 31, 2009, we have funded our operations principally through the sale of equity securities, which have provided aggregate net cash proceeds since inception of approximately $335 million. We have also borrowed funds under our loan agreement with Cowen Healthcare, which are secured by certain assets associated with our LFRP. In addition, we generate funds from product development and license fees. Our excess funds are currently invested in short-term investments primarily consisting of United States Treasury notes and bills and money market funds backed by United States Treasury obligations.

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Operating Activities.

        In 2009, the principal use of cash in our operations was to fund our net loss which was $62.4 million. Of this net loss, certain costs were non-cash charges, such as depreciation and amortization costs of $2.8 million, interest expense of $1.6 million, non-cash income of $1.5 million primarily due to the recognition of $1.0 million in income related to the Walloon grant, impairment of fixed assets totaling $1.0 million, and stock-based compensation expense of $5.3 million. In addition to non-cash charges, we also had a net change in other operating assets and liabilities which used cash of $895,000, including decreases in deferred revenue of $1.3 million and accounts payable and accrued expenses of $845,000 and an increase in other long-term liabilities of $595,000. These were offset by a decrease in accounts receivable of $2.0 million. The increase in cash used for operating activities in 2009 compared to 2008 was $33.7 million, primarily due to revenue deferred in 2008 and the debt extinguishment cost in 2008.

        In 2008, the principal use of cash in our operations was to fund our net loss which was $66.5 million. Of this net loss, certain costs were non-cash charges, such as depreciation and amortization costs of $3.4 million, interest expense of $7.4 million and stock-based compensation expense of $4.5 million, and certain revenues, for which we received payment totaling $21.9 million, were deferred for financial reporting purposes in 2008. In addition, when we repaid the Paul Royalty loan, $8.3 million was recorded as loss on extinguishment of debt and that cash payment is reflected in financing activities. The decrease in cash used in operating activities was $19.7 million from 2008 to 2007, primarily due to the revenue deferred in 2008.

        For 2007, our net loss was $56.3 million, of which certain costs were non-cash charges such as depreciation and amortization of $2.6 million, interest expense of $8.2 million, stock-based compensation expense of $2.9 million, and equity on loss of joint venture of $3.8 million. The increase in cash used in operating activities was $9.1 million from 2007 to 2006, primarily due to a higher net loss.

Investing Activities.

        Our investing activities for 2009 consisted of investment maturities totaling of approximately $39.0 million, offset by purchases of additional securities of $31.5 million and the purchase of approximately $589,000 of fixed assets.

        Our investing activities for 2008 primarily consist of the timing of the maturity and purchase of our short-term investments and a $1.6 million decrease in restricted cash from a contractual reduction of our letter of credit that serves as our security deposit for the lease of our facility in Cambridge, Massachusetts. In addition, we purchased fixed assets totaling $1.4 million.

        Our investing activities for 2007 are related to the $17.0 million of cash received in connection with the purchase of Genzyme's interest in the Dyax-Genzyme LLC joint venture, the release of $7.2 million from restricted cash in association with paying off the Genzyme note, the purchase of fixed assets totaling $1.1 million, and the timing of the maturity and purchase of our short-term investments.

Financing Activities.

        Our financing activities for 2009 consisted of equity offerings providing net proceeds of $38.2 million from the sale of 14,780,570 shares of our common stock and net proceeds of $14.8 million from the Tranche B loan with Cowen Healthcare, which was an amendment to our existing loan agreement with Cowen Healthcare. This Tranche B loan is secured by our LFRP on the same terms as the initial Tranche A loan, which was executed in 2008. We also repaid long-term obligations, totaling $4.6 million, primarily principal payments to Cowen Healthcare on these loans.

        Our financing activities for 2008 primarily consist of net proceeds of $49.6 million from our note payable to Cowen Healthcare, a $10.0 million private sale of common stock, proceeds from long-term

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obligations of $1.1 million and $1.5 million in proceeds from the issuance of common stock under our employee stock purchase plan and the exercise of stock options. We also repaid the Paul Royalty loan for $35.1 million and other long-term obligations of $12.1 million.

        Our financing activities for 2007 primarily consist of the net proceeds of $41.3 million from an equity offering, and the repayment of long-term obligations of $19.6 million, which includes $7.2 million to pay off the Genzyme note, and payments to Paul Royalty.

        We have financed fixed asset purchases through capital leases and debt. Capital lease obligations are collateralized by the assets under lease.

        In conjunction with our collaboration agreement with Genzyme for the development of DX-88, Genzyme had loaned us $7.0 million pursuant to a senior secured promissory note. In 2007, we paid all the principal and accrued interest due under this note, and the $7.2 million letter of credit that secured the loan was released and the cash collateral was reclassified from restricted cash.

        In 2008, we entered into an equity line of credit arrangement with Azimuth Opportunity Ltd. (Azimuth) evidenced by a Common Stock Purchase Agreement which provides that Azimuth is committed to purchase up to $50.0 million of our common stock, or the number of shares which is one share less than twenty percent of the issued and outstanding shares of our common stock as of October 30, 2008 (which limitation is subject to automatic reduction in certain circumstances), over the 18-month term of the Purchase Agreement, which term was extended through January 7, 2011. In the second quarter of 2009, we made one draw of approximately $1.6 million under this agreement. As of December 31, 2009, $48.4 million of our common stock remains issuable pursuant to this agreement. From time to time during the term of the purchase agreement, and at our sole discretion, we may present Azimuth with draw down notices to purchase Dyax common stock over 10 consecutive trading days or such other period mutually agreed upon by us and Azimuth. Each draw down is subject to limitations based on the price of our common stock and a limit of 2.5% of our market capitalization at the time of such drawn down, provided, however, Azimuth will not be required to purchase more than approximately $8.3 million of our common stock in any single draw down excluding shares under any call option, as described below. We are able to present Azimuth with up to 24 draw notices during the term of the purchase agreement, with a minimum of five trading days required between each draw down period. Unless otherwise agreed by us and Azimuth only one drawn is allowed in each draw down pricing period, with a minimum price of $2.00 per share.

        In 2008 and 2009, we completed several partnerships and financial transactions and we expect to continue to manage our cash requirements by completing additional partnerships, collaborations and strategic transactions. We expect that existing cash, cash equivalents, and short-term investments together with anticipated cash flow from existing product development, collaborations and license agreements, future product sales of KALBITOR and proceeds available under our existing equity line of credit agreement arrangements will be sufficient to support our current operations into 2011. We will need additional funds if our cash requirements exceed our current expectations or if we generate less revenue than we expect during this period.

        We may seek additional funding through some combination of our existing equity line of credit agreement with Azimuth, collaborative arrangements and public or private equity or debt financings. We may not be able to obtain financing on acceptable terms or at all, and we may not be able to enter into additional collaborative arrangements. Arrangements with collaborators or others may require us to relinquish rights to certain of our technologies, product candidates or products. The terms of any financing may adversely affect the holdings or the rights of our stockholders, if we need additional funds and are unable to obtain funding on a timely basis, we might need to curtail significantly our research, development or commercialization programs in an effort to provide sufficient funds to continue operations, which would adversely affect our business prospects.

        We have no off-balance sheet arrangements with the exception of operating leases.

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Contractual Obligations

        Contractual obligations represent future cash commitments and liabilities under agreements with third parties, and exclude contingent liabilities for which we cannot reasonably predict future payment. The following chart represents our total contractual obligations, including principal and interest, at December 31, 2009, aggregated by type (in thousands):

 
  Payments due by period  
Contractual obligations
  Total   Less than 1 year   1–3 years   3–5 years   More than
5 years
 

Note Payable(1)

  $ 107,509   $ 9,465   $ 21,195   $ 65,432   $ 11,417  

Capital leases

    817     604     213          

Leasehold improvement arrangements

    894     413     481          

Operating lease obligations(2)

    6,359     2,682     3,634     43      

Patent and product license obligations(3)

    3,668     419     1,696     587     966  

Obligations for research, development and manufacturing(4)

    3,348     2,957     321     70      
                       

Total contractual obligations

  $ 122,595   $ 16,540   $ 27,540   $ 66,132   $ 12,383  
                       

(1)
These amounts represent projected future principal and interest payments to Cowen Healthcare based on our current LFRP projections, which are subject to uncertainties based on the timing and amounts of the receipt of cash under the LFRP. See Notes to the Financial Statements, Note 8 of Item 8 "Financial Statements and Supplementary Data."

(2)
These amounts are net of contractually committed sublease income.

(3)
These amounts exclude any royalties and milestones that may become due in connection with the development or commercialization of our product candidates. Since the prospect of development and commercialization of any product candidate is uncertain, the timing and amount of any potential future royalties and other milestones are not currently calculable in any manner that would fairly present future obligations.

(4)
These amounts represent the cash commitment due on research, development and manufacturing contracts. We will not owe any royalties or milestones in connection with these contracts.

Critical Accounting Estimates

        Our discussion and analysis of our results of operations and liquidity and capital resources are based on our consolidated financial statements, which have been prepared in accordance with accounting principles generally accepted in the United States of America. The preparation of these financial statements requires us to make estimates and judgments that affect the reported amounts of assets, liabilities, revenues and expenses. On an ongoing basis, we evaluate our estimates and judgments, including those related to revenue recognition, receivable collectibles, royalty interest obligations, useful lives with respect to long-lived and intangible assets and valuation of common stock, related stock options, and deferred tax assets. We base our estimates on historical and anticipated results and trends and on various other assumptions that we believe are reasonable under the circumstances, including assumptions as to future events. These estimates form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. By their nature, estimates are subject to an inherent degree of uncertainty. Actual results may differ from our estimates. We believe that our judgment and assumptions with respect to the following significant accounting policies are most critical to the accounting estimates used in the preparation of our consolidated financial statements.

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        Share-Based Compensation.    Effective January 1, 2006, we adopted the provisions of Accounting Standards Codification (ASC) 718, "Accounting for Stock-Based Compensation" which required us to recognize the expense related to the fair value of stock-based compensation awards in our consolidated statement of operations. ASC 718 requires companies to estimate the fair value of stock-based awards on the date of grant using an option-pricing model. We use the Black-Scholes option pricing model. A number of assumptions are used by the Black-Scholes option-pricing model to compute the grant date fair value, including expected price volatility, option term, risk-free interest rate, and dividend yield. Expected volatilities are based on historical volatilities of our stock. The expected option term is derived from historical data on exercise behavior. The dividend yield is based on historical dividend payments. The risk-free rate for periods within the contractual life of the option is based on the United States treasury yield curve in effect at the time of grant. The value of the portion of the award that is ultimately expected to vest is recognized as expense over the requisite service periods in our consolidated statement of operations. We recognize expense on a straight-line basis over the requisite service period for each separately vesting portion of the award as if the award was, in-substance, multiple awards. The equity-based compensation expense recorded in future income statements could fluctuate based on the terms of the awards, the assumptions used in the valuation model, or the status of those employees receiving awards.

        Revenue Recognition.    We make significant assumptions and estimates relating to revenue recognition, which include the expected term of the agreement and total expected cost. Our assumptions and estimates may prove to be inaccurate. Therefore, although we make every effort to ensure the accuracy of our estimates, any significant unanticipated changes in our estimates could have a material impact on revenues and our results of operations.

        We enter into biopharmaceutical product development agreements with collaborative partners for the research and development of therapeutic, diagnostic and separations products. The terms of the agreements may include non-refundable signing and licensing fees, funding for research and development, milestone payments and royalties on any product sales derived from collaborations. These multiple element arrangements are analyzed to determine whether the deliverables, which often include a license and performance obligations such as research and steering committee services, can be separated or whether they must be accounted for as a single unit of accounting.

        We recognize up-front license payments as revenue upon delivery of the license only if the license has stand-alone value and the fair value of the undelivered performance obligations, typically including research and/or steering committee services, can be determined. If the fair value of the undelivered performance obligations can be determined, such obligations are accounted for separately the obligations are fulfilled. If the license is considered to either not have stand-alone value or have stand-alone value but the fair value of any of the undelivered performance obligations cannot be determined, the arrangement would then be accounted for as a single unit of accounting and the license payments and payments for performance obligations are recognized as revenue over the estimated period of when the performance obligations are performed.

        Steering committee services that are not inconsequential or perfunctory and that are determined to be performance obligations are combined with other research services or performance obligations required under an arrangement, if any, in determining the level of effort required in an arrangement and the period over which we expect to complete its aggregate performance obligations.

        Whenever we determine that an arrangement should be accounted for as a single unit of accounting, it must determine the period over which the performance obligations will be performed and revenue will be recognized. Revenue will be recognized using either a proportional performance or straight-line method. We recognize revenue using the proportional performance method when the level of effort required to complete its performance obligations under an arrangement can be reasonably

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estimated and such performance obligations are provided on a best-efforts basis. Direct labor hours or full-time equivalents are typically used as the measure of performance.

        If we cannot reasonable estimate the level of effort to complete our performance obligations under an arrangement, then revenue under the arrangement would be recognized on a straight-line basis over the period we expect to complete our performance obligations.

        Many of the our collaboration agreements entitle us to additional payments upon the achievement of performance-based milestones. If the achievement of a milestone is considered probable at the inception of the collaboration, the related milestone payment is included with other collaboration consideration, such as up-front fees and research funding, in our revenue model. Milestones that involve substantial effort on our part and the achievement of which are not considered probable at the inception of the collaboration are considered "substantive milestones." Substantive milestones are included in our revenue model when achievement of the milestone is considered probable. As future substantive milestones are achieved, a portion of the milestone payment, equal to the percentage of the performance period completed when the milestone is achieved, multiplied by the amount of the milestone payment, will be recognized as revenue upon achievement of such milestone. The remaining portion of the milestone will be recognized over the remaining performance period using the proportional performance or straight-line method. Milestones that are tied to regulatory approval are not considered probable of being achieved until such approval is received. Milestones tied to counter-party performance are not included in our revenue model until the performance conditions are met.

        Royalty revenue is recognized upon the sale of the related products provided we have no remaining performance obligations under the arrangement. Costs of revenues related to product development and license fees are classified as research and development in the consolidated statements of operations and comprehensive loss.

        We generally license our patent rights covering phage display on a non-exclusive basis to third parties for use in connection with the research and development of therapeutic, diagnostic, and other products.

        Standard terms of the patent rights agreements generally include non-refundable signing fees, non-refundable license maintenance fees, development milestone payments and royalties on product sales. Signing fees and maintenance fees are generally recognized on a straight line basis over the term of the agreement. Perpetual patent licenses are recognized immediately if we have no future obligations, the payments are upfront and the license is non-exclusive.

        Standard terms of the proprietary phage display library agreements generally include non-refundable signing fees, license maintenance fees, development milestone payments, product license payments and royalties on product sales. Signing fees and maintenance fees are generally recognized on a straight line basis over the term of the agreement. As milestones are achieved under a phage display library license, a portion of the milestone payment, equal to the percentage of the performance period completed when the milestone is achieved, multiplied by the amount of the milestone payment, will be recognized. The remaining portion of the milestone will be recognized over the remaining performance period on a straight-line basis. Milestone payments under these license arrangements are recognized when the milestone is achieved if we have no future obligations under the license. Product license payments are recognized as revenue when the license is issued if we have no future obligations under the agreement. If there are future obligations under the agreement, product license payments are recognized as revenue only to the extent of the fair value of the license. Amounts paid in excess of fair value are recognized in a manner similar to milestone payments. Royalty revenue is recognized upon the sale of the related products provided we have no remaining performance obligations under the arrangement.

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        Royalty Interest Obligation.    Prior to August 2008, under our Royalty Interest Assignment Agreement with Paul Royalty, we had recorded the upfront cash proceeds of $30.0 million, less $500,000 in cost reimbursements paid to Paul Royalty, as a debt instrument. Based upon our best estimate of future royalty interest obligation payments, interest expense was calculated using the effective interest method. Our best estimate of future royalty interest obligation payments was based upon returning to Paul Royalty an internal rate of return of 25% through future net LFRP receipts. In August 2008, we repaid this loan and no longer estimate interest on this agreement.

Tax Loss Carryforwards

        As of December 31, 2009 and 2008, we had federal net operating loss (NOL) carryforwards of approximately $286.5 million and $243.1 million, respectively, which may be available to offset future federal income tax liabilities and which began to expire in 2010. We have recorded a deferred tax asset of approximately $1.8 million reflecting the benefit of deductions from the exercise of stock options. This deferred asset has been fully reserved until it is more likely than not that the benefit from the exercise of stock options will be realized. The benefit from this $1.8 million deferred tax asset will be recorded as a credit to additional paid-in capital when realized. As required by ASC 740, our management has evaluated the positive and negative evidence bearing upon the realizability of our deferred tax assets, which are comprised principally of NOL and research and experimentation credit carryforwards. Management has determined at this time that it is more likely than not that we will not recognize the benefits of federal and state deferred tax assets and, as a result, a valuation allowance of approximately $180.5 million has been established at December 31, 2009.

Recent Accounting Pronouncements

        In October 2009, the Financial Accounting Standards Board (FASB) issued a new accounting standard which amends existing revenue recognition accounting pronouncements for Multiple-Deliverable Revenue Arrangements. This new standard provides accounting principles and application guidance on whether multiple deliverables exist, how the arrangement should be separated, and the consideration allocated. This guidance eliminates the requirement to establish the fair value of undelivered products and services and instead provides for separate revenue recognition based upon management's estimate of the selling price for an undelivered item in circumstances when there is no other means to determine the fair value of that undelivered item. Multiple-deliverable revenue arrangement guidance previously required that the fair value of the undelivered item be the price of the item either sold in a separate transaction between unrelated third parties or the price charged for each item when the item is sold separately by the vendor. This was difficult to determine when the product was not individually sold because of its unique features. Under the previous guidance, if the fair value of all of the elements in the arrangement was not determinable, then revenue was deferred until all of the items were delivered or fair value was determined. This new approach is effective prospectively for revenue arrangements entered into or materially modified in fiscal years beginning on or after June 15, 2010. We are currently evaluating the potential impact of this standard on our financial results.

        Accounting Standards Update (ASU) No. 2009-16 prescribes the information that a reporting entity must provide in its financial reports about a transfer of financial assets; the effects of a transfer on its financial position, financial performance, and cash flows; and a transferor's continuing involvement in transferred financial assets. Specifically, among other aspects, this standard amends previously issued accounting guidance, modifies the financial-components approach and removes the concept of a qualifying special purpose entity when accounting for transfers and servicing of financial assets and extinguishments of liabilities, and removes the exception from applying the general accounting principles for the consolidation of variable interest entities that are qualifying special-purpose entities. This new accounting standard is effective for transfers of financial assets occurring on or after January 1, 2010. The adoption of this standard will not have an impact on our financial position or results of operations.

ITEM 7A.    QUANTITATIVE AND QUALITATIVE DISCLOSURE ABOUT MARKET RISK

        None.

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ITEM 8.    FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA


Index to Consolidated Financial Statements

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REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM

To the Board of Directors and Stockholders of Dyax Corp.:

        In our opinion, the consolidated financial statements listed in the accompanying index present fairly, in all material respects, the financial position of Dyax Corp. and its subsidiaries at December 31, 2009 and 2008, and the results of their operations and their cash flows for each of the three years in the period ended December 31, 2009 in conformity with accounting principles generally accepted in the United States of America. In addition, in our opinion, the financial statement schedule listed in the accompanying index presents fairly, in all material respects, the information set forth therein when read in conjunction with the related consolidated financial statements. Also in our opinion, the Company maintained, in all material respects, effective internal control over financial reporting as of December 31, 2009, based on criteria established in Internal Control—Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission (COSO). The Company's management is responsible for these financial statements and financial statement schedule, for maintaining effective internal control over financial reporting and for its assessment of the effectiveness of internal control over financial reporting, included in Management's Report on Internal Control over Financial Reporting appearing in Item 9A. Our responsibility is to express opinions on these financial statements, on the financial statement schedule, and on the Company's internal control over financial reporting based on our integrated 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 audits to obtain reasonable assurance about whether the financial statements are free of material misstatement and whether effective internal control over financial reporting was maintained in all material respects. Our audits of the financial statements included 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. Our audit of internal control over financial reporting included obtaining an understanding of internal control over financial reporting, assessing the risk that a material weakness exists, and testing and evaluating the design and operating effectiveness of internal control based on the assessed risk. Our audits also included performing such other procedures as we considered necessary in the circumstances. We believe that our audits provide a reasonable basis for our opinions.

        A company's internal control over financial reporting is a process designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles. A company's internal control over financial reporting includes those policies and procedures that (i) pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of the assets of the company; (ii) provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with generally accepted accounting principles, and that receipts and expenditures of the company are being made only in accordance with authorizations of management and directors of the company; and (iii) provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use, or disposition of the company's assets that could have a material effect on the financial statements.

        Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Also, projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate.

/s/ PricewaterhouseCoopers LLP

Boston, Massachusetts
March 12, 2010

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Dyax Corp. and Subsidiaries

Consolidated Balance Sheets

 
  December 31,
2009
  December 31,
2008
 
 
  (In thousands, except share data)
 

ASSETS

 

Current assets:

             
 

Cash and cash equivalents

  $ 29,386   $ 27,668  
 

Short-term investments

    23,009     30,792  
 

Accounts receivable, net of allowances for doubtful accounts of $25 and $42 at December 31, 2009 and 2008, respectively

    2,723     4,692  
 

Inventory

    578      
 

Other current assets

    2,816     2,470  
           
   

Total current assets

    58,512     65,622  

Fixed assets, net

    3,508     6,137  

Restricted cash

    2,177     2,888  

Other assets

    604     428  
           
   

Total assets

  $ 64,801   $ 75,075  
           

LIABILITIES AND STOCKHOLDERS' DEFICIT

 

Current liabilities:

             
 

Accounts payable and accrued expenses

  $ 11,787   $ 12,069  
 

Current portion of deferred revenue

    10,345     10,700  
 

Current portion of long-term obligations

    890     1,134  
 

Other current liabilities

    1,364     983  
           
   

Total current liabilities

    24,386     24,886  

Deferred revenue

    19,785     20,686  

Note payable

    58,096     46,947  

Long-term obligations

    653     1,552  

Deferred rent and other long-term liabilities

    483     1,048  
           
   

Total liabilities

    103,403     95,119  

Commitments and Contingencies (Notes 8, 11, 15)

             

Stockholders' deficit:

             
 

Preferred stock, $0.01 par value; 1,000,000 shares authorized; 0 shares issued and outstanding

         
 

Common stock, $0.01 par value; 125,000,000 shares authorized; 78,074,052 and 63,040,420 shares issued and outstanding at December 31, 2009 and 2008, respectively

    781     630  
 

Additional paid-in capital

    378,421     334,082  
 

Accumulated deficit

    (417,819 )   (355,400 )
 

Accumulated other comprehensive income

    15     644  
           
   

Total stockholders' deficit

    (38,602 )   (20,044 )
           
   

Total liabilities and stockholders' deficit

  $ 64,801   $ 75,075  
           

The accompanying notes are an integral part of the consolidated financial statements.

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Dyax Corp. and Subsidiaries

Consolidated Statements of Operations and Comprehensive Loss

 
  Years Ended December 31,  
 
  2009   2008   2007  
 
  (In thousands, except share and per share data)
 

Product development and license fee revenues

  $ 21,643   $ 43,429   $ 26,096  
 

Research and development:

                   
   

Research and development expenses

    46,587     68,077     64,010  
   

Less research and development expenses reimbursed by joint venture (Dyax-Genzyme LLC)

            (7,000 )
               
   

Net research and development

    46,587     68,077     57,010  
 

Marketing, general and administrative expenses

    25,843     22,663     15,740  
 

Equity loss in joint venture (Dyax-Genzyme LLC)

            3,831  
 

Restructuring costs

    2,331     4,631      
 

Impairment of fixed assets

    955     352      
               

Total operating expenses

    75,716     95,723     76,581  
               

Loss from operations

    (54,073 )   (52,294 )   (50,485 )

Other income (expense):

                   
 

Interest and other income

    1,736     1,843     3,258  
 

Interest expense

    (10,082 )   (7,753 )   (9,082 )
 

Loss on extinguishment of debt

        (8,264 )    
               
 

Total other income expense, net

    (8,346 )   (14,174 )   (5,824 )
               

Net loss

    (62,419 )   (66,468 )   (56,309 )

Other comprehensive (loss) income:

                   
 

Foreign currency translation adjustments

    (492 )   71     24  
 

Unrealized gain (loss) on investments

    (137 )   45     99  
               

Comprehensive loss

    (63,048 )   (66,352 )   (56,186 )
               

Basic and diluted net loss per share:

                   
 

Net loss

  $ (0.90 ) $ (1.08 ) $ (1.06 )
               

Shares used in computing basic and diluted net loss per share

    69,151,841     61,626,095     53,072,993  
               

The accompanying notes are an integral part of the consolidated financial statements.

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Dyax Corp. and Subsidiaries

Consolidated Statements of Changes in Stockholders' Equity (Deficit)

For the years ended December 31, 2009, 2008 and 2007

(In thousands, except share data)

 
  Common Stock    
   
  Accumulated
Other
Comprehensive
Income (Loss)
   
 
 
  Additional
Paid-in
Capital
  Accumulated
Deficit
   
 
 
  Shares   Par Value   Total  

Balance at December 31, 2006

    43,700,101   $ 437   $ 255,242   $ (232,623 ) $ 405   $ 23,461  

Exercise of stock options

    152,139     1     325             326  

Issuance of common stock for employee stock purchase plan

    99,938     1     247             248  

Shares issued to purchase joint venture (Dyax-Genzyme LLC)

    4,400,000     44     17,398             17,442  

Sale of common stock, net of expenses of $191

    12,075,000     121     41,211             41,332  

Compensation expense associated with stock options

            2,873             2,873  

Unrealized gain on investments

                    99     99  

Foreign currency translation

                    24     24  

Net loss

                (56,309 )       (56,309 )
                           

Balance at December 31, 2007

    60,427,178     604     317,296     (288,932 )   528     29,496  

Exercise of stock options

    505,269     5     1,173             1,178  

Issuance of common stock for employee stock purchase plan

    99,941     1     286             287  

Sale of common stock

    2,008,032     20     9,980             10,000  

Compensation expense associated with stock options

            4,494             4,494  

Issuance of warrants

            853             853  

Unrealized gain on investments

                    45     45  

Foreign currency translation

                    71     71  

Net loss

                (66,468 )       (66,468 )
                           

Balance at December 31, 2008

    63,040,420     630     334,082     (355,400 )   644     (20,044 )

Exercise of stock options

    153,125     2     302             304  

Issuance of common stock for employee stock purchase plan

    99,937     1     222             223  

Sale of common stock

    14,780,570     148     38,054             38,202  

Compensation expense associated with stock options

            5,284             5,284  

Issuance of warrants

            477             477  

Unrealized gain on investments

                    (137 )   (137 )

Foreign currency translation

                    (492 )   (492 )

Net loss

                (62,419 )       (62,419 )
                           

Balance at December 31, 2009

    78,074,052   $ 781   $ 378,421   $ (417,819 ) $ 15   $ (38,602 )
                           

The accompanying notes are an integral part of the consolidated financial statements.

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Consolidated Statements of Cash Flows

 
  Years Ended December 31,  
 
  2009   2008   2007  
 
  (In thousands)
 

Cash flows from operating activities:

                   
 

Net loss

  $ (62,419 ) $ (66,468 ) $ (56,309 )
 

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

                   
   

Amortization of investment premium/discount

    142     50     (962 )
   

Depreciation and amortization of fixed assets

    2,230     2,812     3,012  
   

Amortization of intangibles

    419     516     526  
   

Non-cash interest expense

    1,634     7,386     8,210  
   

Impairment of fixed assets

    955     352      
   

Gain on disposal of fixed assets

    (42 )   (350 )    
   

Compensation expenses associated with stock-based compensation plans

    5,282     4,494     2,873  
   

Equity loss in joint venture (Dyax-Genzyme LLC)

            3,831  
   

Extinguishment of debt

        8,264      
   

Provision for doubtful accounts

    (42 )   (13 )   (25 )
   

Non-cash other income

    (1,491 )        
   

Other

            285  
 

Changes in operating assets and liabilities

                   
   

Accounts receivable

    2,011     (561 )   (1,973 )
   

Net amount due from joint venture (Dyax-Genzyme LLC)

            461  
   

Prepaid research and development and other assets

    (141 )   90     (762 )
   

Inventory

    (70 )        
   

Accounts payable and accrued expenses

    (845 )   1,203     789  
   

Deferred revenue

    (1,255 )   21,879     (399 )
   

Other long-term liabilities

    (595 )   (142 )   226  
               
 

Net cash used in operating activities

    (54,227 )   (20,488 )   (40,217 )
               

Cash flows from investing activities:

                   
   

Purchase of investments

    (31,501 )   (41,732 )   (63,153 )
   

Proceeds from maturity of investments

    39,005     44,990     79,320  
   

Purchase of fixed assets

    (589 )   (1,439 )   (1,065 )
   

Proceeds from sale of fixed assets

    74     350      
   

Cash received in purchase of joint venture (Dyax-Genzyme LLC)

            17,000  
   

Restricted cash

        1,595     7,038  
   

Investment in joint venture (Dyax-Genzyme LLC)

            (3,837 )
               
 

Net cash provided by investing activities

    6,989     3,764     35,303  
               

Cash flows from financing activities:

                   
   

Net proceeds from common stock offerings

    38,202     10,000     41,332  
   

Proceeds from note payable

    14,820     49,600      
   

Proceeds from long-term obligations, net of fees

        1,103     663  
   

Repayment of Paul Royalty on extinguishment of debt

        (35,080 )    
   

Repayment of long-term obligations

    (4,607 )   (12,104 )   (19,648 )
   

Proceeds from the issuance of common stock under employee stock purchase plan and exercise of stock options

    527     1,465     574  
               
 

Net cash provided by financing activities

    48,942     14,984     22,921  
 

Effect of foreign currency translation on cash balances

    14     52     54  
 

Net increase (decrease) in cash and cash equivalents

    1,718     (1,688 )   18,061  
 

Cash and cash equivalents at beginning of the period

    27,668     29,356     11,295  
               
 

Cash and cash equivalents at end of the period

  $ 29,386   $ 27,668   $ 29,356  
               
 

Supplemental disclosure of cash flow information:

                   
   

Interest paid

  $ 8,558   $ 3,595   $ 849  
               
 

Supplemental disclosure of non cash investing and financing activities:

                   
 

Acquisition of property and equipment under long-term obligations

  $   $ 31   $ 432  
               
 

Shares issued to purchase joint venture assets (Dyax-Genzyme LLC)

  $   $   $ 17,442  
               
 

Warrant issued in connection with note payable

  $ 477   $ 853   $  
               

The accompanying notes are an integral part of the consolidated financial statements.

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Notes to Consolidated Financial Statements

1. Nature of Business

        Dyax Corp. (Dyax or the Company) is a biopharmaceutical company focused on the discovery, development and commercialization of novel biotherapeutics for unmet medical needs, with an emphasis on inflammatory and oncology indications. The Company's lead product was approved in December, 2009 under the brand name KALBITOR (ecallantide) by the United States Food and Drug Administration (FDA) for treatment of acute attacks of hereditary angioedema in patients 16 years of age and older. Dyax uses its proprietary drug discovery technology, known as phage display, to identify antibody, small protein and peptide compounds for clinical development. This technology has provided an internal pipeline of promising drug candidates and numerous licenses and collaborators that generate revenues through funded research, license fees, milestone payments and royalties.

        The Company is subject to risks common to companies in the biotechnology industry including, but not limited to, risks relating to preclinical and clinical trials and the regulatory approval process, dependence on collaborative arrangements, development by its competitors of new technological innovations, dependence on key personnel, protection of proprietary technology, and compliance with the FDA and other governmental regulations and approval requirements.

        The Company expects that existing cash, cash equivalents, and short-term investments together with anticipated cash flow from existing product development, collaborations and license fees, future product sales of KALBITOR and proceeds available under an existing equity line of credit agreement will be sufficient to support the Company's current operations into 2011. If the Company's cash requirements exceed its current expectations or if the Company generates less revenue than it expects, the Company will need additional funds. The Company may seek additional funding through its existing equity line of credit, collaborative arrangements, and public or private financings. However, the Company may not be able to obtain financing on acceptable terms or at all, and the Company may not be able to enter into additional collaborative arrangements. Arrangements with collaborators or others may require the Company to relinquish rights to certain of its technologies, product candidates or products. The terms of any financing may adversely affect the holdings or the rights of the Company's stockholders. If the Company needs additional funds and it is unable to obtain funding on a timely basis, the Company may be required to significantly curtail its research, development or commercialization programs in an effort to provide sufficient funds to continue its operations, which could adversely affect its business prospects.

2. Accounting Policies

        Basis of Consolidation:    The accompanying consolidated financial statements include the accounts of the Company, Dyax-Genzyme LLC and the Company's European research subsidiaries Dyax S.A. and Dyax BV (formerly known as TargetQuest BV). All inter-company accounts and transactions have been eliminated.

        Use of Estimates:    The preparation of financial statements in conformity with accounting principles generally accepted in the United States of America requires management to make certain estimates and assumptions that affect the amounts of assets and liabilities reported and disclosure of contingent assets and liabilities at the dates of the financial statements and the reported amounts of revenue and expenses during the reporting periods. The significant estimates and assumptions in these financial statements include revenue recognition, useful lives with respect to long lived assets, valuation of stock options, accrued expenses and tax valuation reserves. Actual results could differ from those estimates.

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Notes to Consolidated Financial Statements (Continued)

2. Accounting Policies (Continued)

        Concentration of Credit Risk:    Financial instruments that potentially subject the Company to concentrations of credit risk consist principally of cash, cash equivalents, short-term investments and trade accounts receivable. At December 31, 2009 and 2008, approximately 81% and 89% of the Company's cash, cash equivalents and short-term investments were invested in money market funds backed by United States Treasury obligations, United States Treasury notes and bills, and obligations of United States government agencies held by one financial institution. The Company also maintains balances in various operating accounts in excess of federally insured limits.

        The Company provides most of its services and licenses its technology to pharmaceutical and biomedical companies worldwide. Concentrations of credit risk with respect to trade receivable balances are limited due to the diverse number of customers comprising the Company's customer base. One customer accounted for approximately 64% of the Company's accounts receivable balance at December 31, 2009 and the majority of this balance was paid subsequent to year end. Two customers accounted for approximately 48% and 35% of the Company's accounts receivable balance at December 31, 2008.

        Cash and Cash Equivalents:    All highly liquid investments purchased with an original maturity of three months or less are considered to be cash equivalents. Cash and cash equivalents consist principally of cash and United States Treasury funds.

        Investments:    Short-term investments primarily consist of investments with original maturities greater than ninety days and remaining maturities less than one year as of year end. The Company has also classified its investments with maturities beyond one year as short-term, based on their highly liquid nature and because such marketable securities represent the investment of cash that is available for current operations. The Company considers its investment portfolio of investments available-for-sale. Accordingly, these investments are recorded at fair value, which is based on quoted market prices. As of December 31, 2009, the Company's investments consisted of United States Treasury notes and bills with an amortized cost and estimated fair value of $23.0 million and had an unrealized gain of $15,000, which is recorded in other comprehensive income on the accompanying consolidated balance sheets. As of December 31, 2008, the Company's short-term investments consisted of United States Treasury notes and bills with an amortized cost of $30.6 million, an estimated fair value of $30.8 million and had an unrealized gain of $153,000 which is recorded in other comprehensive income on the accompanying consolidated balance sheets.

        Inventories:    Inventories are stated at the lower of cost or market with cost determined under the first-in, first-out, or FIFO, basis. The Company evaluates inventory levels, and would write-down inventory that is expected to expire prior to being sold, inventory that has a cost basis in excess of its expected net realizable value, inventory in excess of expected sales requirements, or inventory that fails to meet commercial sale specifications, through a charge to product costs. If actual market conditions are less favorable than those projected by management, additional inventory write-downs may be required. Charges for inventory write-downs are not reversed if it is later determined that the product is saleable. Included in the cost of inventory are employee stock-based compensation costs capitalized under ASC 718.

        Fixed Assets:    Property and equipment are recorded at cost and depreciated over the estimated useful lives of the related assets using the straight-line method. Laboratory and production equipment, and furniture and office equipment are depreciated over a three to seven year period. Leasehold

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Notes to Consolidated Financial Statements (Continued)

2. Accounting Policies (Continued)


improvements are recorded at cost and are amortized over the lesser of the non-cancelable term of the related lease or their estimated useful lives. Leased equipment is amortized over the lesser of the life of the lease or their estimated useful lives. Maintenance and repairs are charged to expense as incurred. When assets are retired or otherwise disposed of, the cost of these assets and related accumulated depreciation and amortization are eliminated from the balance sheet and any resulting gains or losses are included in operations in the period of disposal.

        Intangibles:    Intangibles are recorded at cost and amortized over the estimated useful lives.

        Impairment of Long-Lived Assets:    The Company reviews its long-lived assets for impairment whenever events or changes in business circumstances indicate that the carrying amount of assets may not be fully recoverable or that the useful lives of these assets are no longer appropriate. Each impairment test is based on a comparison of the undiscounted cash flow to the recorded value of the asset. If an impairment is indicated, the asset is written down to its estimated fair value on a discounted cash flow basis.

        Revenue Recognition:    The Company enters into agreements with collaborative partners for the research and development of therapeutic, diagnostic and separations products. The terms of the agreements may include non-refundable signing and licensing fees, funding for research and development, milestone payments and royalties on any product sales derived from collaborations. These multiple element arrangements are analyzed to determine whether the deliverables, which often include a license and performance obligations such as research and steering committee services, can be separated or whether they must be accounted for as a single unit of accounting.

        The Company recognizes up-front license payments as revenue upon delivery of the license only if the license has stand-alone value and the fair value of the undelivered performance obligations, typically including research and/or steering committee services, can be determined. If the fair value of the undelivered performance obligations can be determined, such obligations are accounted for separately the obligations are fulfilled. If the license is considered to either not have stand-alone value or have stand-alone value but the fair value of any of the undelivered performance obligations cannot be determined, the arrangement would then be accounted for as a single unit of accounting and the license payments and payments for performance obligations are recognized as revenue over the estimated period of when the performance obligations are performed.

        Steering committee services that are not inconsequential or perfunctory and that are determined to be performance obligations are combined with other research services or performance obligations required under an arrangement, if any, in determining the level of effort required in an arrangement and the period over which the Company expects to complete its aggregate performance obligations.

        Whenever the Company determines that an arrangement should be accounted for as a single unit of accounting, it must determine the period over which the performance obligations will be performed and revenue will be recognized. Revenue will be recognized using either a proportional performance or straight-line method. The Company recognizes revenue using the proportional performance method when the level of effort required to complete its performance obligations under an arrangement can be reasonably estimated and such performance obligations are provided on a best-efforts basis. Direct labor hours or full-time equivalents are typically used as the measure of performance.

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Notes to Consolidated Financial Statements (Continued)

2. Accounting Policies (Continued)

        If the Company cannot reasonably estimate the level of effort to complete its performance obligations under an arrangement, then revenue under the arrangement would be recognized on a straight-line basis over the period the Company is expected to complete its performance obligations.

        Many of the Company's collaboration agreements entitle it to additional payments upon the achievement of performance-based milestones. If the achievement of a milestone is considered probable at the inception of the collaboration, the related milestone payment is included with other collaboration consideration, such as up-front fees and research funding, in the Company's revenue model. Milestones that involve substantial effort on the Company's part and the achievement of which are not considered probable at the inception of the collaboration are considered "substantive milestones." Substantive milestones are included in the Company's revenue model when achievement of the milestone is considered probable. As future substantive milestones are achieved, a portion of the milestone payment, equal to the percentage of the performance period completed when the milestone is achieved, multiplied by the amount of the milestone payment, will be recognized as revenue upon achievement of such milestone. The remaining portion of the milestone will be recognized over the remaining performance period using the proportional performance or straight-line method. Milestones that are tied to regulatory approval are not considered probable of being achieved until such approval is received. Milestones tied to counter-party performance are not included in the Company's revenue model until the performance conditions are met.

        Royalty revenue is recognized upon the sale of the related products provided the Company has no remaining performance obligations under the arrangement. Costs of revenues related to product development and license fees are classified as research and development in the consolidated statements of operations and comprehensive loss.

        The Company generally licenses its patent rights covering phage display on a non-exclusive basis to third parties for use in connection with the research and development of therapeutic, diagnostic, and other products.

        Standard terms of the patent rights agreements generally include non-refundable signing fees, non-refundable license maintenance fees, development milestone payments and royalties on product sales. Signing fees and maintenance fees are generally recognized on a straight line basis over the term of the agreement. Perpetual patent licenses are recognized immediately if the Company has no future obligations, the payments are upfront and the license is non-exclusive.

        Standard terms of the proprietary phage display library agreements generally include non-refundable signing fees, license maintenance fees, development milestone payments, product license payments and royalties on product sales. Signing fees and maintenance fees are generally recognized on a straight line basis over the term of the agreement. As milestones are achieved under a phage display library license, a portion of the milestone payment, equal to the percentage of the performance period completed when the milestone is achieved, multiplied by the amount of the milestone payment, will be recognized. The remaining portion of the milestone will be recognized over the remaining performance period on a straight-line basis. Milestone payments under these license arrangements are recognized when the milestone is achieved if the Company has no future obligations under the license. Product license payments are recognized as revenue when the license is issued if the Company has no future obligations under the agreement. If there are future obligations under the agreement, product license payments are recognized as revenue only to the extent of the fair value of the license. Amounts paid in excess of fair value are recognized in a manner similar to milestone

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Notes to Consolidated Financial Statements (Continued)

2. Accounting Policies (Continued)


payments. Royalty revenue is recognized upon the sale of the related products provided the Company has no remaining performance obligations under the arrangement.

        Payments received that have not met the appropriate criteria for revenue recognition are recorded as deferred revenue.

        Three different companies accounted for approximately 23%, 20% and 12% of product development and license fee revenue for the year ended December 31, 2009. For the years ended December 31, 2008 and 2007, two different companies accounted for 54% and 58%, respectively, of product development and license fee revenue.

        Guarantees:    The Company has determined that it is not a party to any agreements that fall within the scope of Guarantees of indebtedness in accordance with ASC 460, Guarantees. The Company generally does not provide indemnification with respect to the license of its phage display technology. The Company does generally provide indemnifications for claims of third parties that arise out of activities that the Company performs under its collaboration, product development and cross-licensing activities. The maximum potential amount of future payments the Company could be required to make under the indemnification provisions in some instances may be unlimited. The Company has not incurred any costs to defend lawsuits or settle claims related to any indemnification obligations under its license agreements. As a result, the Company believes the estimated fair value of these obligations is minimal. The Company has no liabilities recorded for any of its indemnification obligations recorded as of December 31, 2009 and 2008.

        Investment in Joint Venture (Dyax—Genzyme LLC):    Prior to February 20, 2007, the Company had a collaboration agreement with Genzyme for the development and commercialization of DX-88 for hereditary angioedema (HAE). Under this collaboration, the Company and Genzyme formed a joint venture, known as Dyax—Genzyme LLC, through which they jointly owned the rights to DX-88 for treatment of HAE. Research and development expenses incurred by each party related to the HAE program were billed to and reimbursed by the LLC. The Company presented this reimbursement as a reduction in research and development expenses because it included funding that the Company provided to the LLC. Prior to termination of the LLC on February 20, 2007, the Company accounted for its interest in the LLC using the equity method of accounting.

        Research and Development:    Research and development costs include all direct costs, including salaries and benefits for research and development personnel, outside consultants, costs of clinical trials, sponsored research, clinical trials insurance, other outside costs, depreciation and facility costs related to the development of drug candidates. Through February 20, 2007, these costs are partially offset by the reimbursement of expenses by the Dyax-Genzyme LLC. Prepaid research and development on the consolidated balance sheets represents external drug manufacturing costs, and research and development service costs that have been paid for in absence of the related product being received or the services being performed.

        Income Taxes:    The Company utilizes the asset and liability method of accounting for income taxes in accordance with ASC 740. Under this method, deferred tax assets and liabilities are recognized for the expected future tax consequences of temporary differences between the carrying amounts and the tax basis of assets and liabilities using the current statutory tax rates. At December 31, 2009 and 2008, there were no unrecognized tax benefits.

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Notes to Consolidated Financial Statements (Continued)

2. Accounting Policies (Continued)

        The Company accounts for uncertain tax positions using a "more-likely-than-not" threshold for recognizing and resolving uncertain tax positions. The evaluation of uncertain tax positions is based on factors that include, but are not limited to, changes in tax law, the measurement of tax positions taken or expected to be taken in tax returns, the effective settlement of matters subject to audit, new audit activity and changes in facts or circumstances related to a tax position. The Company evaluates uncertain tax positions on a quarterly basis and adjust the level of the liability to reflect any subsequent changes in the relevant facts surrounding the uncertain positions.

        Translation of Foreign Currencies:    Assets and liabilities of the Company's foreign subsidiaries are translated at period end exchange rates. Amounts included in the statements of operations are translated at the average exchange rate for the period. Beginning July 1, 2009, all currency translation adjustments are recorded to other income (expense) in the consolidated statement of operations. Prior to the closure of the Liege, Belgium facility, currency translation adjustments were made directly to accumulated other comprehensive income (loss) in the consolidated balance sheets. The change is a result of the closure of the Liege, Belgium facility. For the years ending December 31, 2008 and 2007, the translation of foreign currencies generated gains of $71,000 and $24,000, respectively.

        Share-Based Compensation:    The Company's share-based compensation program consists of share-based awards granted to employees in the form of stock options, as well as its employee stock purchase plan. The Company's share-based compensation expense is recorded in accordance with ASC 718.

        Net Loss Per Share:    The Company is required to present two net loss per share (EPS) amounts, basic and diluted. Basic net loss per share is computed using the weighted average number of shares of common stock outstanding. Diluted net loss per share does not differ from basic net loss per share since potential common shares from the exercise of stock options or warrants are anti-dilutive for all periods presented and, therefore, are excluded from the calculation of diluted net loss per share. Stock options and warrants to purchase a total of 8,798,956, 8,708,609 and 7,011,450 shares were outstanding at December 31, 2009, 2008 and 2007, respectively.

        Comprehensive Income (Loss):    The Company accounts for comprehensive income (loss) under ASC 220, Comprehensive Income, which established standards for reporting and displaying comprehensive income (loss) and its components in a full set of general purpose financial statements. The statement required that all components of comprehensive income (loss) be reported in a financial statement that is displayed with the same prominence as other financial statements.

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Notes to Consolidated Financial Statements (Continued)

2. Accounting Policies (Continued)

        Accumulated other comprehensive income (loss) is calculated as follows:

 
  Unrealized
Gain (Loss) on
Investments
  Foreign Currency
Translation
Adjustment
  Accumulated Other
Comprehensive
Income
 
 
  (In thousands)
 

Balance at January 1, 2007

  $ 8   $ 397   $ 405  

Change for 2007

    99     24     123  
               

Balance at December 31, 2007

    107     421     528  

Change for 2008

    45     71     116  
               

Balance at December 31, 2008

    152     492     644  

Change for 2009

    (137 )   (492 )   (629 )
               

Balance at December 31, 2009

  $ 15   $   $ 15  
               

        Business Segments:    The Company discloses business segments under ASC 280, Segment Reporting. The topic established standards for reporting information about operating segments in annual financial statements of public enterprises and in interim financial reports issued to shareholders. It also established standards for related disclosures about products and services, geographic areas and major customers. Prior to the 2008 closing of the research facility in Liege, Belgium, the Company operated as one business segment in two geographic areas. Subsequent to the closing, the Company operates as one business segment with one geographic area.

        Recent Accounting Pronouncements:    In October 2009, the FASB issued a new accounting standard which amends existing revenue recognition accounting pronouncements for Multiple-Deliverable Revenue Arrangements. This new standard provides accounting principles and application guidance on whether multiple deliverables exist, how the arrangement should be separated, and the consideration allocated. This guidance eliminates the requirement to establish the fair value of undelivered products and services and instead provides for separate revenue recognition based upon management's estimate of the selling price for an undelivered item in circumstances when there is no other means to determine the fair value of that undelivered item. Multiple-deliverable revenue arrangement guidance previously required that the fair value of the undelivered item be the price of the item either sold in a separate transaction between unrelated third parties or the price charged for each item when the item is sold separately by the vendor. This was difficult to determine when the product was not individually sold because of its unique features. Under the previous guidance, if the fair value of all of the elements in the arrangement was not determinable, then revenue was deferred until all of the items were delivered or fair value was determined. This new approach is effective prospectively for revenue arrangements entered into or materially modified in fiscal years beginning on or after June 15, 2010. The Company is currently evaluating the potential impact of this standard on its financial results.

        ASU No. 2009-16 prescribes the information that a reporting entity must provide in its financial reports about a transfer of financial assets; the effects of a transfer on its financial position, financial performance, and cash flows; and a transferor's continuing involvement in transferred financial assets. Specifically, among other aspects, this standard amends previously issued accounting guidance, modifies the financial-components approach and removes the concept of a qualifying special purpose entity when accounting for transfers and servicing of financial assets and extinguishments of liabilities, and removes the exception from applying the general accounting principles for the consolidation of variable interest

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Notes to Consolidated Financial Statements (Continued)

2. Accounting Policies (Continued)


entities that are qualifying special-purpose entities. This new accounting standard is effective for transfers of financial assets occurring on or after January 1, 2010. The adoption of this standard will not have an impact on the Company's financial position or results of operations.

3. Fair Value Measurements

        Effective January 1, 2009, the Company adopted newly issued accounting standard for fair value measurements of all nonfinancial assets and liabilities not recognized or disclosed at fair value in the financial statements on a recurring basis. The adoption of this accounting standard did not have an impact on the financial results of the Company.

        The following tables present information about the Company's financial assets that have been measured at fair value as of December 31, 2009 and 2008 and indicate the fair value hierarchy of the valuation inputs utilized to determine such fair value. In general, fair values determined by Level 1 inputs utilize quoted prices (unadjusted) in active markets for identical assets or liabilities. Fair values determined by Level 2 inputs utilize observable inputs other than Level 1 prices, such as quoted prices, for similar assets or liabilities, quoted prices in markets that are not active or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the related assets or liabilities. Fair values determined by Level 3 inputs are unobservable data points for the asset or liability, and includes situations where there is little, if any, market activity for the asset or liability.

Description
  December 31,
2009
  Quoted
Prices in
Active
Markets
(Level 1)
  Significant
Other
Observable
Inputs
(Level 2)
  Significant
Unobservable
Inputs
(Level 3)
 

Assets:

                         

Cash equivalents

  $ 19,638   $ 19,638   $   $  

Marketable debt securities

    23,009     23,009          
                   

Total

  $ 42,647   $ 42,647   $   $  
                   

 

Description
  December 31, 2008   Quoted Prices in Active Markets (Level 1)   Significant Other Observable Inputs (Level 2)   Significant Unobservable Inputs (Level 3)  

Assets:

                         

Cash equivalents

  $ 20,716   $ 20,716   $   $  

Marketable debt securities

    30,792     30,792          
                   

Total

  $ 51,508   $ 51,508   $   $  
                   

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Notes to Consolidated Financial Statements (Continued)

3. Fair Value Measurements (Continued)

        As of December 31, 2009 and 2008, the Company's short-term investments consisted of United States Treasury notes and bills which are categorized as Level 1. The fair values of cash equivalents and marketable debt securities are determined through market, observable and corroborated sources. The carrying amounts reflected in the consolidated balance sheets for cash, cash equivalents, accounts receivable, other current assets, accounts payable and accrued expenses and other current liabilities approximate fair value due to their short-term maturities.

4. Inventory

        On December 1, 2009, the Company received approval of KALBITOR by the FDA. Subsequent to approval, all costs associated with the manufacturing of KALBITOR were capitalized as inventory. As of December 31, 2009, the Company had a total of $578,000 of inventory, consisting of $472,000 of raw materials and $106,000 of work in process.

5. Strategic Collaborations

sanofi-aventis

        In 2008, the Company entered into two agreements with sanofi-aventis. The first was an exclusive worldwide license for the development and commercialization of the fully human monoclonal antibody DX-2240 as a therapeutic product (DX-2240 license). The second agreement, was a standard non-exclusive license to the Company's proprietary antibody phage display technology (sanofi-aventis phage display license). The Company evaluated the agreements and it was determined they should be treated as two separate agreements for the purpose of determining revenue recognition.

        Under the DX-2240 license, the Company is eligible to receive clinical and sales milestones and royalties based on commercial sales of DX-2240 and other antibodies developed by sanofi-aventis. As an exclusive licensee, sanofi-aventis will be responsible for the ongoing development, commercialization and consolidation of sales of DX-2240.

        The Company treated the DX-2240 license as a multiple deliverable arrangement and determined that the performance obligations under the DX-2240 agreement, including the DX-2240 license, transfer of DX-2240 inventory and know-how and the transfer of additional specified deliverables, represented a single unit of accounting.

        As a result of the DX-2240 license, the Company received approximately $23.2 million of cash, net of taxes, in 2008. The Company recognized revenue of $23.2 million associated with the DX-2240 license, when the final performance obligation was completed in the fourth quarter of 2008.

        The sanofi-aventis phage display license included a non-refundable signing fee, non-refundable maintenance fees, downstream development milestone payments and royalties on product sales. For certain other future antibody product candidates discovered by sanofi-aventis under the sanofi-aventis phage display license, the Company will retain co-development and profit sharing rights, while sanofi-aventis will maintain ultimate responsibility for development and commercialization, and will book sales worldwide.

        The Company treated the sanofi-aventis phage display license as a multiple deliverable arrangement and determined that the performance obligations under the agreement, including access to

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5. Strategic Collaborations (Continued)


the library, training and when and if available additional quantities of the antibody library and material updates, represented a single unit of accounting.

        Revenue for the sanofi-aventis phage display license is recognized over the performance period on a straight-line basis. During the year ended December 31, 2009 and 2008, the Company recognized $408,000 and $530,000, respectively, related to the sanofi-aventis phage display license.

Cubist Pharmaceuticals, Inc.

        In 2008, Dyax entered into an exclusive license and collaboration agreement with Cubist Pharmaceuticals, Inc. (Cubist), for the development and commercialization in North America and Europe of the intravenous formulation of DX-88 for the reduction of blood loss during surgery. Under this agreement, Cubist has assumed responsibility for all further development and costs associated with DX-88 in the licensed indications in the Cubist territory. The Company will be eligible to receive additional clinical, regulatory and sales-based milestone payments. The Company is also entitled to receive tiered, double-digit royalties based on sales of DX-88 by Cubist. The agreement also provides an option for the Company to retain certain United States co-promotion rights. The Company applied the provisions of multiple deliverable arrangements in accordance with ASC 605 to determine whether the performance obligations under this agreement, including development, participation in steering committees, and manufacturing services should be accounted for as a single unit or multiple units of accounting. At this time the scope and timing of future development of this program are the responsibility of Cubist and therefore, the Company can not reasonably estimate the level of effort required to fulfill its obligations under this collaboration. As a result, the Company is recognizing revenue under the Cubist collaboration on a straight-lined basis over the development period of DX-88 in the Cubist territory, which is currently estimated at five years.

        The Company received $17.5 million in license and milestone fees in 2008 as a result of the Cubist agreement. Additionally, the Company received $3.6 million for drug product supply and reimbursement of costs incurred in 2008 related to the conduct of the Phase 2 clinical trial, known as Kalahari 1. These amounts, and any future reimbursements and milestones, are being recorded as revenue over the estimated development period of five years. The Company periodically reassesses the length of the estimated development period based upon the completed effort. As of December 31, 2009, the Company has deferred $13.8 million of revenue related to this agreement, which is recorded in deferred revenue on the accompanying consolidated balance sheets. The Company recognized revenue of $4.3 million and $3.2 million related to this agreement for the year ended December 31, 2009 and 2008, respectively.

MedImmune Limited

        Under the terms of an amended and restated cross-licensing agreement between the Company and MedImmune Limited (formerly Cambridge Antibody Technology, or CAT), MedImmune has granted the Company worldwide licenses for research and certain other purposes under all of MedImmune's antibody phage display patents (the MedImmune patents). The Company has also received options for licenses to develop therapeutic and diagnostic antibody products under the MedImmune patents. MedImmune will receive milestone and royalty payments in connection with antibody products advanced into clinical trials by the Company, its collaborators or its customers, which will be recorded as research and development expenses. MedImmune also has rights to share the Company's revenues

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5. Strategic Collaborations (Continued)


from certain other applications of antibody phage display technology. Under the agreement, the Company also granted CAT a worldwide license to use Dyax's antibody libraries to discover and develop antibody products. In consideration for this license, the Company receives no milestone payments but is eligible to receive a low single-digit royalty payment on antibody products developed by CAT or its licensees under the agreement.

6. Fixed Assets

        Fixed assets consist of the following:

 
  December 31,  
 
  2009   2008  
 
  (In thousands)
 

Laboratory equipment

  $ 9,082   $ 9,471  

Furniture and office equipment

    1,093     1,225  

Software and computers

    4,115     3,971  

Leasehold improvements

    6,844     10,460  
           

Total

    21,134     25,127  

Less: accumulated depreciation and amortization

    (17,626 )   (18,990 )
           

  $ 3,508   $ 6,137  
           

        There were $1.9 million and $3.1 million of assets under capital leases, which included laboratory and office equipment, with related accumulated amortization of $1.1 million and $1.4 million, at December 31, 2009 and 2008, respectively. Amortization of assets under capital leases is included in depreciation and amortization of fixed assets on the consolidated statements of cash flow.

7. Accounts Payable and Accrued Expenses

        Accounts payable and accrued expenses consist of the following:

 
  December 31,  
 
  2009   2008  
 
  (In thousands)
 

Accounts payable

  $ 686   $ 1,325  

Accrued employee compensation and related taxes

    4,296     4,914  

Accrued external research and development and contract manufacturing

    2,431     3,529  

Accrued license fees

    2,047     73  

Other accrued liabilities

    2,327     2,228  
           

  $ 11,787   $ 12,069  
           

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Notes to Consolidated Financial Statements (Continued)

8. Long-term Obligations

        Long-term obligations and note payable consists of the following:

 
  December 31,  
 
  2009   2008  
 
  (In thousands)
 

Note payable

  $ 58,096   $ 46,947  

Obligations under capital lease arrangements

    760     1,603  

Obligation under leasehold improvement arrangements

    783     1,083  
           

Total

    59,639     49,633  

Less: current portion

    (890 )   (1,134 )
           

Long-term obligations

  $ 58,749   $ 48,499  
           

        Minimum future payments under the Company's long-term obligations and note payable as of December 31, 2009 are as follows:

 
  (In thousands)  

2010

  $ 10,482  

2011

    10,544  

2012

    11,345  

2013

    23,802  

2014

    41,630  

Thereafter

    11,417  
       

Total future minimum payments

    109,220  

Less: amount representing interest

    (47,962 )
       

Present value of future minimum payments

    61,258  

Less: current portion

    (890 )

Less: unamortized portion of discount and warrant

    (1,619 )
       

Long-term obligations and note payable

  $ 58,749  
       

Note Payable:

        In 2008, the Company entered into an agreement with Cowen Healthcare Royalty Partners, LP (Cowen Healthcare) for a $50.0 million loan secured by the Company's phage display Licensing and Funded Research Program (LFRP). This loan is the Tranche A loan. In March 2009, the Company amended and restated the loan agreement with Cowen Healthcare to include a Tranche B loan of $15.0 million. The Company used $35.1 million from the proceeds of the Tranche A loan to pay off its remaining obligation under a then existing agreement with Paul Royalty Fund Holdings II, LP (Paul Royalty).

        The Tranche A and Tranche B loans (collectively, the Loan) mature in August 2016. The Tranche A portion bears interest at an annual rate of 16%, payable quarterly, and the Tranche B portion bears interest at an annual rate of 21.5%, payable quarterly. The Loan may be prepaid without penalty, in whole or in part, beginning in August 2012. In connection with the Loan, the Company has entered into a security agreement granting Cowen Healthcare a security interest in the intellectual

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8. Long-term Obligations (Continued)


property related to the LFRP, and the revenues generated by the Company through the license of the intellectual property related to the LFRP. The security agreement does not apply to the Company's internal drug development or to any of the Company's co-development programs.

        Under the terms of the loan agreements, the Company is required to repay the Loan based on the annual net LFRP receipts. Until June 30, 2013, required payments are tiered as follows: 75% of the first $10.0 million in specified annual LFRP receipts, 50% of the next $5.0 million and 25% of annual included LFRP receipts over $15.0 million. After June 30, 2013, and until the maturity date or the complete amortization of the Loan, Cowen Healthcare will receive 90% of all included LFRP receipts. If the Cowen Healthcare portion of LFRP receipts for any quarter exceeds the interest for that quarter, then the principal balance will be reduced. Any unpaid principal will be due upon the maturity of the Loan. If the Cowen Healthcare portion of LFRP revenues for any quarterly period is insufficient to cover the cash interest due for that period, the deficiency may be added to the outstanding principal or paid in cash by the Company. After five years, the Company must repay to Cowen Healthcare all additional accumulated principal above the original $50.0 million and $15.0 million loan amounts of Tranche A and Tranche B, respectively. In addition, under the terms of the Agreement, we are permitted to sell or otherwise transfer collateral generating cash proceeds of up to $25.0 million. Twenty percent of these cash proceeds will be applied to principal and accrued interest on the Loan including any applicable prepayment premium and an additional 5.0% of such proceeds will be paid to Cowen Healthcare as a cash premium.

        In connection with the Tranche A loan, the Company issued to Cowen Healthcare a warrant to purchase 250,000 shares of the Company's common stock at a 50% premium over the 30-day average closing price. The warrant has an eight-year term and is exercisable beginning on August 5, 2009. The Company estimated the relative fair value of the warrant to be $853,000, using the Black-Scholes valuation model, assuming a volatility factor of 83.64%, risk-free interest rate of 4.07%, an eight-year expected term and an expected dividend yield of zero. In conjunction with the Tranche B loan, the Company issued to Cowen Healthcare a warrant to purchase 250,000 shares of the Company's common stock at a 25% premium over the 45-day average closing price. The warrant expires in August 2016 and is exercisable beginning on March 27, 2010. The Company has estimated the relative fair value of the warrant to be $477,000, using the Black-Scholes valuation model, assuming a volatility factor of 85.98%, risk-free interest rate of 2.77%, a seven-year, four-month expected term and an expected dividend yield of zero. The relative fair values of the warrants are recorded in additional paid-in capital on the Company's consolidated balance sheets.

        The cash proceeds from the Loan were recorded as a note payable on the Company's consolidated balance sheet. The note payable balance was reduced by $1.3 million for the fair value of the Tranche A and Tranche B warrants, and by $580,000 for payment of Cowen Healthcare's legal fees in conjunction with the Loan. Each of these amounts is being accreted over the life of the note. During years ended December 31, 2009 and 2008, the Company recorded $226,000 and $64,000, respectively, of accretion associated with the debt discount and the warrants, $9.7 million and $3.3 million, respectively, in interest expense, and made payments to Cowen totaling $11.7 million and $5.1 million, respectively. During the years ended December 31, 2009 and 2008, $3.4 million and $1.9 million, respectively, was allocated to the reduction of the principal balance. As of December 31, 2009, there was $1.4 million of accrued interest payable in relation to this loan which is recorded on the Company's consolidated balance sheet. The Loan principal balance at December 31, 2009 and 2008 was $59.7 million and $48.1 million, respectively. The amount recorded on the Company's consolidated balance sheets at

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8. Long-term Obligations (Continued)


December 31, 2009 and 2008, which is net of accrued interest payable and the unamortized portions of the discount and warrants, is $58.1 million and $46.9 million, respectively. The estimated fair value of the note payable was $53.4 million at December 31, 2009.

Obligations under royalty interest assignment agreement with Paul Royalty:

        In 2006, the Company entered into a Royalty Interest Assignment Agreement with Paul Royalty Fund Holdings II, LP, under which it received an upfront payment of $30 million. In exchange for this payment, the Company assigned Paul Royalty a portion of milestones, royalties and other license fees to be received by it under the LFRP through 2017. This agreement was extinguished in 2008 using proceeds from the Cowen Healthcare note payable, at which time all Paul Royalty rights to LFRP receipts were terminated.

        Under the terms of the agreement, Paul Royalty was assigned a portion of the annual net LFRP receipts which were to have continued for up to 12 years, depending upon the performance of the LFRP. The upfront cash payment of $30.0 million, less the $500,000 in cost reimbursements paid to Paul Royalty was recorded as a debt instrument in long-term obligations on the Company's consolidated balance sheet. Based upon estimated future payments expected under this agreement, the Company determined the interest expense by using the effective interest method. The best estimate of future payments was based upon returning to Paul Royalty an internal rate of return of 25%. Due to the application of the effective interest method and the total expected payments, the Company recorded interest expense of $4.1 million and $8.2 million for the years ended December 31, 2008 and 2007, respectively. During the year ended December 31, 2008 and 2007, the Company made payments totaling $40.2 million and $10.9 million, respectively, related to this obligation to Paul Royalty, including the 2008 pay-off amounts.

        In 2008, the Company paid off this loan with a $35.1 million cash payment, of which $27.0 million was allocated to the principal amount, and $8.1 million was recorded as loss on extinguishment of debt on the Company's consolidated statements of operations and comprehensive loss.

        The Company capitalized $257,000 of debt issuance costs related to this agreement which, prior to August 5, 2008, was being amortized over the term of the related debt using the effective interest method. In August 2008, the unamortized debt issuance costs were fully amortized, and $212,000 of expense is included in loss on extinguishment of debt.

Obligations under capital lease arrangements:

        Between 2001 and 2006 the Company signed capital lease and debt agreements for the purchase of qualified fixed assets and leasehold improvements. Interest pursuant to these agreements ranges between 0% and 11.18%. Principal and interest are payable ratably over 24 months to 60 months. Capital lease obligations are collateralized by the assets under lease. During the year ended December 31, 2009, no equipment was sold and leased back from lenders. During each of the years ended December 31, 2008 and 2007, the Company sold to and leased back from the lenders $1.1 million of leasehold improvements, laboratory, production and office equipment. As of December 31, 2009 and 2008, there was $760,000 and $1.6 million (included in obligations under capital lease arrangements) outstanding related to capital leases, which is included in long-term obligations, including current portion of long-term obligations, on the Company's consolidated balance sheets.

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8. Long-term Obligations (Continued)

Obligation under leasehold improvement arrangements:

        In 2001, the Company entered into an agreement to initially lease laboratory and office space in Cambridge, Massachusetts. Under the terms of the agreement, the landlord loaned the Company approximately $2.4 million to be used towards the cost of leasehold improvements. The loan bears interest at a rate of 12.00% and is payable in 98 equal monthly installments through February 2012. As of December 31, 2009, and 2008, there was $783,000 and $1.1 million outstanding under the loan, which is included in long-term obligations, including current portion of long-term obligations, on the Company's consolidated balance sheets.

Operating Leases

        The Company leases space in Cambridge, Massachusetts which serves as its corporate headquarters and research facility. As part of the lease agreement, the Company received a $2.3 million leasehold improvement incentive in 2002. The leasehold improvement incentive was recorded as deferred rent and is being amortized as a reduction to rent expense over the lease term. The lease will expire on February 29, 2012, and the Company has the option to extend for two additional five-year terms.

        In August 2009, the Company amended its lease to reduce its occupied space from approximately 91,000 square feet to 67,000 square feet. Under terms of the amended sublease agreement, the Letter of Credit in the amount of $2.7 million as of December 31, 2009, was further reduced to $2.0 million in January 2010. The cash collateral is included in restricted cash on the consolidated balance sheets.

        Of the 67,000 square feet that the Company currently leases, it subleases approximately 24,000 square feet to two tenants under separate sublease agreements, each of which will expire on October 31, 2011.

        Through Dyax S.A., the Company had leased 10,000 square feet of laboratory and office space in Liege, Belgium. In connection with the closure of the Liege-based research facility during 2008, this facility has been vacated and the lease was terminated in June 2009.

        Gross minimum future lease payments under the Company's non-cancelable operating leases as of December 31, 2009 are as follows:

 
  (In thousands)  

2010

  $ 4,125  

2011

    4,125  

2012

    712  

2013

    43  

2014

     

Thereafter

     
       

Total

  $ 9,005  
       

        Rent expense for the years ended December 31, 2009, 2008, and 2007 was approximately $5.1 million, $6.2 million and $5.3 million, respectively. Rent expense for December 31, 2009, 2008 and 2007 is reflected as net of sublease payments of $1.5 million, $1.5 million and $261,000 respectively.

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9. Restructuring and Impairment Charges

        In March 2009, the Company eliminated positions from various departments to focus necessary resources on the commercialization of its lead product candidate, DX-88. As a result of the restructuring, during the three months ended March 31, 2009, the Company recorded one-time charges of approximately $1.9 million, which includes severance related charges of approximately $1.6 million, outplacement costs of approximately $107,000, stock compensation expense of $237,000 for amendments to the exercise and vesting schedules to certain options and other exit costs of $26,000. All amounts were paid as of December 31, 2009.

        As a result of the decrease in necessary facility space following the workforce reduction, the Company amended its facility lease during the third quarter of 2009 to reduce the leased space, and a one-time charge of approximately $1.4 million was recorded, of which approximately $955,000 was a result of the write-down of leasehold improvements. This charge is net of $355,000 of amortization of deferred rent. During 2009, $750,000 related to this restructuring charge was paid. There was no residual balance to be paid as of December 31, 2009.

        During 2008, a charge of approximately $4.6 million was recorded in connection with the closure of the Company's Liege, Belgium research facility. This amount included severance related charges of approximately $3.6 million, contract termination costs of approximately $688,000 and other exit costs of $362,000. These restructuring charges were fully paid as of December 31, 2008. In addition, during 2008, a non-cash charge of approximately $352,000 was recorded for the impairment of fixed assets in connection with the closure of the research facility.

        In 1999, the Company received an €825,000 grant from the Walloon region of Belgium, which included specific criteria regarding employment and investment levels that needed to be met. Pursuant to the closure of the Liege, Belgium facility in 2008, the Company refunded approximately $162,000 of the grant. In October 2009, all investment criteria were met. As a result, the residual balance of approximately $1.0 million was released from short-term liabilities on the consolidated balance sheet and recognized as Other Income in the Statement of Operations.

10. Stockholders' Deficit

        Preferred Stock:    As of December 31, 2009 and 2008, there were a total of 1,000,000 shares of $0.01 par value preferred stock authorized with 950,000 undesignated and 50,000 shares of previously undesignated preferred stock designated as Series A Junior Participating Preferred Stock.

        Common Stock:    In 2007, the Company issued and sold an aggregate of 12,075,000 shares of its common stock in an underwritten public offering at a price of $3.67 per share including 1,575,000 shares issued when the underwriters exercised their over-allotment option at the public offering price. The aggregate net proceeds to the Company were approximately $41.3 million after deducting underwriting discounts and commissions and offering expenses.

        In 2008, the Company entered into an agreement whereby Dompé Farmaceutici S.p.A. (Dompé) purchased 2,008,032 shares of Dyax common stock in a private placement at $4.98 per share, which represented a 57% premium over the closing price and a total investment of $10.0 million.

        In 2008, the Company entered into a Common Stock Purchase Agreement with Azimuth Opportunity, Ltd. (Azimuth) which allows the Company to issue and sell up to an aggregate amount of $50 million in common stock with a minimum price of $2.00 per share, less the agreed upon discount

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10. Stockholders' Deficit (Continued)


which ranges from 4.05% to 6.25% based on the Company's stock price. The term of this agreement extends through January 7, 2011. In April 2009, pursuant to a single draw down notice, the Company issued 740,965 shares of its common stock to Azimuth and received net proceeds of approximately $1.6 million. As of December 31, 2009, $48.4 million of the Company's common stock remains issuable pursuant to this agreement, if, at the Company's sole discretion, it presents draw down notices.

        In June 2009, the Company issued an aggregate of 8,539,605 shares of its common stock in an underwritten public offering at a price of $2.02 per share. The aggregate net proceeds to the Company were approximately $16.1 million after deducting underwriting fees and offering expenses.

        In October 2009, the Company issued 5,500,000 shares of its common stock in an underwritten public offering. The aggregate net proceeds to the Company were approximately $20.5 million, after deducting underwriting fees and offering expenses.

Stock-Based Compensation Expense

        The Company measures compensation cost for all stock awards at fair value on date of grant and recognition of compensation over the service period for awards expected to vest. The fair value of stock options was determined using the Black-Scholes valuation model. Such value is recognized as expense over the service period, net of estimated forfeitures and adjusted for actual forfeitures. The estimation of stock options that will ultimately vest requires significant judgment. The Company considers many factors when estimating expected forfeitures, including historical experience. Actual results and future changes in estimates may differ substantially from the Company's current estimates.

        The following table reflects stock compensation expense recorded during the years ended December 31, 2009, 2008 and 2007 (in thousands):

 
  Year Ended
December 31,
2009
  Year Ended
December 31,
2008
  Year Ended
December 31,
2007
 

Compensation expense related to:

                   

Equity incentive plan

  $ 5,136   $ 4,369   $ 2,771  

Employee stock purchase plan

    146     125     102  
               

  $ 5,282   $ 4,494   $ 2,873  
               

Stock-based compensation expense charged to:

                   

Research and development expenses

  $ 1,768   $ 2,512   $ 1,638  
               

General and administrative expenses

  $ 3,277   $ 1,982   $ 1,235  
               

Restructuring charges

  $ 237   $   $  
               

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10. Stockholders' Deficit (Continued)

Valuation Assumptions for Stock Options

        For the years ended December 31, 2009, 2008 and 2007, 2,305,655, 2,578,000, and 1,950,505 stock options were granted, respectively. The fair value of each option was estimated on the date of grant using the Black-Scholes option-pricing model with the following assumptions:

 
  Year Ended December 31,  
 
  2009   2008   2007  

Expected Option Term (in years)

    5.5–6     6     6  

Risk-free interest rate

    2.20%–2.99 %   2.70%–3.47 %   3.94%–4.7 5

Expected dividend yield

    0     0     0  

Volatility factor

    77%–79 %   74%–78 %   80%–84 %

Valuation Assumptions for Employee Stock Purchase Plans

        The fair value of shares issued under the employee stock purchase plan was estimated on the commencement date of each offering period using the Black-Scholes option-pricing model with the following assumptions:

 
  Year Ended December 31,  
 
  2009   2008   2007  

Expected Option Term (in years)

    0.5     0.5     0.5  

Risk-free interest rate

    0.03%–0.33 %   0.42%–1.99 %   3.56%–4.91 %

Expected dividend yield

    0     0     0  

Volatility factor

    74%–150 %   57%–114 %   54%–96 %

        Expected volatilities are based on historical volatilities of our common stock; the expected life represents the weighted average period of time that options granted are expected to be outstanding giving consideration to vesting schedules and our historical exercise and cancellation patterns; and the risk-free rate is based on the United States Treasury yield curve in effect at the time of grant for periods corresponding with the expected life of the option.

Equity Incentive Plan

        The Company's 1995 Equity Incentive Plan (the "Plan"), as amended, is an equity plan under which equity awards, including awards of restricted stock and incentive and nonqualified stock options to purchase shares of common stock may be granted to employees, consultants and directors of the Company by action of the Compensation Committee of the Board of Directors. Options are generally granted at the current fair market value on the date of grant, generally vest ratably over a 48-month period, and expire within ten years from date of grant. The Plan is intended to attract and retain employees and to provide an incentive for them to assist the Company to achieve long-range performance goals and to enable them to participate in the long-term growth of the Company. At December 31, 2009, a total of 6,422,818 shares were available for future grants under the Plan.

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10. Stockholders' Deficit (Continued)

Stock Option Activity

        The following table summarizes stock option activity for the year ended December 31, 2009:

 
  Number of
Options
  Weighted-Avg.
Exercise Price
  Weighted-Avg.
Remaining
Contractual Life
  Aggregate
Intrinsic Value
(in thousands)
 

Outstanding as of December 31, 2008

    8,458,609   $ 5.28     7.12        

Granted at fair market value

    2,305,655     2.62              

Exercised

    (153,125 )   1.98              

Forfeited

    (1,003,304 )   3.58              

Expired

    (1,308,879 )   6.41              
                         

Outstanding as of December 31, 2009

    8,298,956     4.63     6.92   $ 2,497  
                         

Exercisable as of December 31, 2009

    5,329,155   $ 5.36     5.95   $ 1,225  
                         

Vested and unvested expected to vest as of December 31, 2009

    7,887,443   $ 4.70     0.39   $ 2,297  
                         

        The aggregate intrinsic value in the table above represents the total intrinsic value, based on the Company's common stock closing price of $3.39 as of December 31, 2009, which would have been received by the option holders had all option holders exercised their options and sold the underlying common stock as of that date. The total number of in-the-money options exercisable as of December 31, 2009 was 1,446,600.

        The weighted average grant date fair value of options, as determined under ASC 718, granted during the years ended December 31, 2009, 2008 and 2007 was $1.81, $4.06 and $3.00 per share, respectively. The total intrinsic value of options exercised during years ended December 31, 2009, 2008 and 2007 was approximately $196,000, $972,000, and $294,000, respectively. The total cash received from employees as a result of employee stock option exercises during the years ended December 31, 2009, 2008 and 2007 was approximately $179,000, $184,000, and $113,000, respectively.

        As of December 31, 2009 future compensation cost related to non-vested stock options is approximately $8.7 million and will be recognized over an estimated weighted average period of approximately 1.28 years.

        The following table summarizes unvested stock option activity for the year ended December 31, 2009:

 
  Non-vested Number of Options  

Unvested balance at December 31, 2008

    3,553,070  

Granted at fair market value

    2,305,655  

Vested

    (1,885,620 )

Forfeited

    (1,003,304 )
       

Unvested balance at December 31, 2009

    2,969,801  
       

        The total fair value of shares vested during the year ended December 31, 2009 was $3.9 million.

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Dyax Corp. and Subsidiaries

Notes to Consolidated Financial Statements (Continued)

10. Stockholders' Deficit (Continued)

        The Company settles employee stock option exercises with newly issued shares of common stock.

Employee Stock Purchase Plan

        The Company's 1998 Employee Stock Purchase Plan (the "Purchase Plan"), as amended, allows employees to purchase shares of the Company's common stock at a discount from fair market value. Under this plan, eligible employees may purchase shares during six-month offering periods commencing on January 1 and July 1 of each year at a price per share of 85% of the lower of the fair market value price per share on the first or last day of each six-month offering period. Participating employees may elect to have up to 10% of their base pay withheld and applied toward the purchase of such shares, subject to the limitation of 875 shares per participant per quarter. The rights of participating employees under this plan terminate upon voluntary withdrawal from the plan at any time or upon termination of employment. The compensation expense in connection with the plan for the years ended December 31, 2009, 2008 and 2007 was approximately $146,000, $125,000 and $102,000, respectively. There were 99,937 and 99,941 shares purchased under the employee stock purchase plan during the years ended December 31, 2009 and 2008, respectively. At December 31, 2009, a total of 694,014 shares were reserved and available for issuance under this plan.

11. Employee Savings and Retirement Plans

        The Company has an employee savings and retirement plan (the "Retirement Plan"), qualified under Section 401(k) of the Internal Revenue Code, covering substantially all of the Company's employees. Employees may elect to contribute a portion of their pretax compensation to the Retirement Plan up to the annual maximum allowed under the Retirement Plan. Employees are 100% vested in company matching contributions which have been 50% of employee contributions up to 6% of eligible pay. For the years ended December 31, 2009, 2008 and 2007, the Company's matching contributions amounted to $401,000, $423,000 and $385,000, respectively.

12. Income Taxes

        Deferred tax assets and deferred tax liabilities are recognized based on temporary differences between the financial reporting and tax basis of assets and liabilities using future expected enacted rates. A valuation allowance is recorded against deferred tax assets if it is more likely than not that some or all of the deferred tax assets will not be realized.

        The provision for income taxes for continuing operations was at rates different from the United States federal statutory income tax rate for the following reasons:

 
  2009   2008   2007  

Statutory federal income taxes

    34.00 %   34.00 %   34.00 %

State income taxes, net of federal benefit

    (2.63 )%   4.18 %   4.83 %

Research and development tax credits

    6.94 %   2.69 %   4.52 %

Other

    (1.28 )%   (2.71 )%   0.09 %

True up and expiring NOLs and research credits

    24.10 %   (5.99 )%   (6.84 )%

Valuation allowance

    (61.13 )%   (32.17 )%   (36.60 )%
               

Effective income tax rate

    %   %   %
               

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Dyax Corp. and Subsidiaries

Notes to Consolidated Financial Statements (Continued)

12. Income Taxes (Continued)

        The principal components of the Company's deferred tax assets and liabilities at December 31, 2009 and 2008, respectively are as follows:

 
  2009   2008   2007  
 
  (in Thousands)
 

Deferred Tax Asset:

                   

Allowance for doubtful accounts

  $ 10   $ 17   $ 22  

Depreciation and amortization

    1,634     2,352     2,091  

Accrued expenses

    49     164     101  

Other

    100     89     (165 )

Stock based compensation

    2,294     1,229     2,068  

Deferred revenue

    11,438     12,027     3,393  

Research credit carryforwards

    58,335     33,304     29,753  

Net operating loss carryforwards

    106,653     93,398     83,800  
               

Total gross deferred tax asset

    180,513     142,580     121,063  

Valuation allowance

    (180,513 )   (142,580 )   (121,063 )
               

Net deferred tax asset

  $   $   $  
               

        As of December 31, 2009 and 2008, the Company had federal net operating loss (NOL) of $286.5 million and $243.1 million, respectively, available to reduce future taxable income, which expires at various times beginning in 2010 through 2029. The Company also has federal research and experimentation credit carryforwards of approximately $54.3 million and $29.5 million as of December 31 2009 and 2008, respectively, available to reduce future tax liabilities, which will expire at various dates beginning in 2012 through 2029. The Company has state net operating loss carryforwards of approximately $175.0 million and $171.2 million as of December 31, 2009 and 2008, respectively, available to reduce state future taxable income, which expires at various dates beginning in 2010 through 2014. The Company also has state research and development and investment tax credit carryforwards of approximately $6.2 million and $5.8 million as of December 31, 2009 and 2008, respectively, available to reduce future tax liabilities, which expire at various dates beginning in 2011 through 2024.

        The Company has recorded a deferred tax asset of approximately $1.8 million and $1.9 million at December 31, 2009 and 2008, reflecting the benefit of deductions from the exercise of stock options which has been fully reserved until it is more likely than not that the benefit will be realized. The benefit from this $1.8 million deferred tax asset will be recorded as a credit to additional paid-in capital if and when realized through a reduction of cash taxes.

        The Company adopted stock-based compensation accounting application in accordance with ASC 714 effective on January 1, 2006. This change in method of accounting required an adjustment during 2006 to the Company's additional-paid-in-capital for the excess or shortfall of estimated future tax benefits of option exercises compared to the estimated future tax benefits recorded on the Company's financial statements due to this accounting method change. The change in accounting method did not require a change in the additional-paid-in-capital. All future tax benefits associated with option exercises will be recorded directly to additional paid in capital in accordance with ASC 714.

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Dyax Corp. and Subsidiaries

Notes to Consolidated Financial Statements (Continued)

12. Income Taxes (Continued)

        As required by ASC 740, the Company's management has evaluated the positive and negative evidence bearing upon the realizability of its deferred tax assets, and has determined that it is not more likely than not that the Company will recognize the benefits of the deferred tax assets. Accordingly, a valuation allowance of approximately $180.5 million and $142.6 million has been established at December 31, 2009 and 2008, respectively.

        The Company accounts for uncertain tax positions using a "more-likely-than-not" threshold for recognizing and resolving uncertain tax positions. The evaluation of uncertain tax positions is based on factors that include, but are not limited to, changes in tax law, the measurement of tax positions taken or expected to be taken in tax returns, the effective settlement of matters subject to audit, new audit activity and changes in facts or circumstances related to a tax position. The Company evaluates uncertain tax positions on a quarterly basis and adjust the level of the liability to reflect any subsequent changes in the relevant facts surrounding the uncertain positions. As of December 31, 2009, the Company had no unrecognized tax benefits.

        The Company recognizes interest and penalties related to uncertain tax positions in income tax expense. As of December 31, 2009, the Company had no accrued interest or penalties related to uncertain tax position.

        Utilization of the NOL and tax credit carryforwards may be subject to a substantial annual limitation due to ownership change limitations that have occurred previously or that could occur in the future provided by Section 382 of the Internal Revenue Code of 1986, as well as similar state and foreign provisions. These ownership changes may limit the amount of NOL and tax credits carryforwards that can be utilized annually to offset future taxable income and tax, respectively. In general, and ownership change, as defined by Section 382, results from transactions increasing the ownership of certain shareholders or public groups in the stock of a corporation by more that 50 percentage points over a three-year period. Since the Company's formation, the Company has raised capital through the issuance of capital stock on several occasions which, combined with the purchasing shareholders' subsequent disposition of those shares, may have resulted in a change of control, as defined by Section 382, or could result in a change of control in the future upon subsequent disposition. The Company has not currently completed a study to assess whether a change of control has occurred or whether there have been multiple changes of control since the Company's formation due to the significant complexity and cost associated with the study and that there could be additional changes in control in the future. If the Company has experienced a change of control at any time since its formation, utilization of its NOL or tax credits carryforwards would be subject to an annual limitation under Section 382. Further, until a study is completed and any limitation known, no amounts are being presented as an uncertain tax position.

        In addition to uncertainties surrounding the use of NOL carryforwards in a change of control, the Company has identified orphan drug and research and development credits as material components of its deferred tax asset. The uncertainties in these components arise from judgments in the allocation of costs utilized to calculate these credits. The Company has not conducted studies to analyze these credits to substantiate the amounts due to the significant complexity and cost associated with such study. Any limitation may result in expiration of a portion of the NOL or tax credits carryforwards before utilization. Further, until a study is completed and any limitation known, no amounts are being presented as an uncertain tax position.

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Dyax Corp. and Subsidiaries

Notes to Consolidated Financial Statements (Continued)

12. Income Taxes (Continued)

        A full valuation allowance has been provided against the Company's NOL carryforwards and research and development credits and, if an adjustment is required, this adjustment would be offset by an adjustment to the valuation allowance. Thus there would be no impact to the consolidated balance sheet or statement of operations if an adjustment were required.

        The tax years 1995 through 2009 remain open to examination by major taxing jurisdictions to which the Company is subject, which are primarily in the United States, as carryforward attributes generated in years past may still be adjusted upon examination by the Internal Revenue Service or state tax authorities if they have or will be used in a future period. The Company is currently not under examination by in any jurisdictions for any tax years.

13. Investment in Joint Venture (Dyax-Genzyme LLC) and Other Related Party Transactions

        Prior to February 20, 2007, the Company had a collaboration agreement with Genzyme for the development and commercialization of KALBITOR. Under this collaboration, the Company and Genzyme formed a joint venture, known as Dyax-Genzyme LLC, through which they jointly owned the rights to KALBITOR. Dyax and Genzyme were each responsible for approximately 50% of ongoing costs incurred in connection with the development and commercialization of KALBITOR and each would have been entitled to receive approximately 50% of any profits realized as a result. In addition, the Company was entitled to receive potential milestone payments from Genzyme in connection with the development of KALBITOR.

        On February 20, 2007, the Company and Genzyme reached a mutual agreement to terminate this collaboration. Pursuant to the termination agreement, Genzyme made a $17.0 million cash payment to the Dyax-Genzyme LLC. Furthermore, Genzyme assigned to Dyax all of its interests in the LLC, thereby transferring all the rights to the LLC's assets to Dyax, including the $17.0 million cash payment. As a result Dyax now owns all of the rights to DX-88 worldwide including the right to develop and commercialize KALBITOR. In exchange, Dyax issued to Genzyme 4.4 million shares of its common stock. Dyax's acquisition of Genzyme's 49.99% portion of the LLC was accounted for as a purchase of assets. Genzyme also agreed to provide transition services for a period following the termination of the agreements. In 2007, the transitional service fees totaled $1.1 million. There were no transitional service fees in 2009 or 2008 and no future transitional service fees are expected to be incurred.

        Before termination of the collaboration, research and development expenses incurred by each party related to the joint venture were billed to and reimbursed by Dyax-Genzyme LLC. The Company and Genzyme were each required to fund 50% of the monthly expenses of Dyax-Genzyme LLC. The Company accounted for its interest in Dyax-Genzyme LLC using the equity method of accounting. Under this method, the reimbursement of expenses to Dyax was recorded as a reduction to research and development expenses because it included funding that the Company provided to Dyax-Genzyme LLC. Dyax's 50.01% share of Dyax-Genzyme LLC loss was recorded as an Equity Loss in Joint Venture (Dyax-Genzyme LLC) in the consolidated statements of operations and comprehensive loss. Subsequent to the termination of the LLC and acquisition of 100% of its assets by Dyax, the LLC investment and related accounts have been consolidated in the Company's financial statements.

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Dyax Corp. and Subsidiaries

Notes to Consolidated Financial Statements (Continued)

13. Investment in Joint Venture (Dyax-Genzyme LLC) and Other Related Party Transactions (Continued)

        Summary financial information for Dyax-Genzyme LLC for the year ended December 31, 2007 is as follows:

 
  Year ended
December 31,
2007
 

Research and development

  $ 7,461  

Selling and marketing

    162  

General and administrative

    38  
       

Net loss

  $ 7,661  
       

        The Company's Chairman, who is also its former President and Chief Executive Officer, was an outside director of Genzyme Corporation until May 2007.

        At December 31, 2009 and 2008, Genzyme owned approximately 4.3% and 7.9%, respectively, of the Company's common stock outstanding.

        During 2004, the Company signed a library license agreement with Genzyme consistent with its standard license terms. The Company received a $1.3 million upfront payment from Genzyme and recorded license revenue of $75,000 and $225,000 for the years ended December 31, 2009 and 2008, respectively, in connection with the technology access fees on this agreement. As of December 31, 2009 and 2008, there were no outstanding accounts receivable due from Genzyme related to the library license agreement.

14. Business Segments

        The Company discloses business segments under ASC 280, Segment Reporting. The statement established standards for reporting information about operating segments in annual financial statements of public enterprises and in interim financial reports issued to shareholders. It also established standards for related disclosures about products and services, geographic areas and major customers. Prior to the 2008 closing of the research facility in Liege, Belgium, the Company operated as one business segment in two geographic areas. Subsequent to the closing, the Company operates as one business segment with one geographic area.

15. Litigation

        As of December 31, 2009, the Company was not engaged in any active court proceedings. The Company makes provisions for claims specifically identified for which it believes the likelihood of an unfavorable outcome is probable and reasonably estimable. The Company records at least the minimum estimated liability related to claims where there is a range of loss and the loss is considered probable. As additional information becomes available, the Company assesses the potential liability related to its pending claims and revises its estimates. Future revisions in the estimates of the potential liability could materially impact the results of operations and financial position. The Company maintains insurance coverage that limits the exposure for any single claim as well as total amounts incurred per policy year, and it believes that its insurance coverage is adequate. The Company makes every effort to use the best information available in determining the level of liability reserves.

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Dyax Corp. and Subsidiaries

Notes to Consolidated Financial Statements (Continued)

16. Subsequent Events

        Material subsequent events up to filing date of this Form 10-K have been considered for disclosure.

17. Unaudited Quarterly Operating Results

        The following is a summary of unaudited quarterly results of operations for the years ended December 31, 2009 and 2008:

Year ended December 31, 2009
  First
Quarter
  Second
Quarter
  Third
Quarter
  Fourth
Quarter
 
 
  (in thousands, except share and per share)
 

Revenue

  $ 5,979   $ 4,818   $ 4,508   $ 6,338  

Loss from operations

  $ (23,057 ) $ (11,767 ) $ (9,860 ) $ (9,389 )

Net loss

  $ (24,891 ) $ (14,419 ) $ (12,193 ) $ (10,916 )

Shares used in computing basic and diluted net loss per share

    63,089,821     63,679,410     72,485,047     77,759,647  

Basic and diluted net loss per share:

  $ (0.39 ) $ (0.23 ) $ (0.17 ) $ (0.14 )

 

Year ended December 31, 2008
  First
Quarter
  Second
Quarter
  Third
Quarter
  Fourth
Quarter
 
 
  (in thousands, except share and per share)
 

Revenue

  $ 2,643   $ 3,831   $ 5,490   $ 31,465  

Income (loss) from operations

  $ (20,024 ) $ (23,515 ) $ (16,766 ) $ 8,011  

Net (loss) income

  $ (21,335 ) $ (24,912 ) $ (26,639 ) $ 6,418  

Shares used in computing basic net (loss) income per share

    60,504,620     60,562,606     62,439,236     62,974,171  

Shares used in computing diluted net (loss) income per share

    60,504,620     60,562,606     62,439,236     63,210,448  

Basic and diluted net (loss) income per share:

  $ (0.35 ) $ (0.41 ) $ (0.43 ) $ 0.10  

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ITEM 9.    CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE

        None.

ITEM 9A.    CONTROLS AND PROCEDURES

Conclusion Regarding the Effectiveness of Disclosure Controls and Procedures

        We maintain disclosure controls and procedures that are designed to ensure that information required to be disclosed in the Company's reports under the Securities Exchange Act of 1934, as amended (the Exchange Act), is recorded, processed, summarized and reported within the time periods specified in the SEC's rules and forms, and that such information is accumulated and communicated to management, including our Chief Executive Officer (CEO) and Chief Financial Officer (CFO), as appropriate, to allow timely decisions regarding required disclosure. In designing and evaluating the disclosure controls and procedures, management recognized that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving the desired control objectives, as the Company's are designed to do, and management necessarily was required to apply its judgment in evaluating the risk related to controls and procedures.

        In connection with the preparation of this Form 10-K, as of December 31, 2009, an evaluation was performed under the supervision and with the participation of our management, including the CEO and CFO, of the effectiveness of the design and operation of our disclosure controls and procedures (as defined in Rule 13a-15(e) under the Exchange Act). Based on that evaluation, our CEO and CFO concluded that our disclosure controls and procedures were effective as of December 31, 2009. These conclusions were communicated to the Audit Committee.

Management's Report on Internal Control Over Financial Reporting

        Our management is responsible for establishing and maintaining adequate internal control over financial reporting as defined in Rule 13a-15(f) under the Exchange Act. Our internal control system is designed to provide reasonable assurance to the Company's management and Board of Directors regarding the preparation and fair presentation of published financial statements. All internal control systems, no matter how well designed, have inherent limitations. Therefore, even those systems determined to be effective can provide only reasonable assurance with respect to financial statement preparation and presentation.

        Our management has assessed the effectiveness of our internal control over financial reporting as of December 31, 2009. In making its assessment of internal control over financial reporting, management used the criteria set forth by the Committee of Sponsoring Organizations (COSO) of the Treadway Commission in Internal Control—Integrated Framework. Based on this assessment, our CEO and CFO concluded that our internal control over financial reporting was effective as of December 31, 2009 based on the criteria set forth by COSO in Internal Control—Integrated Framework.

        Our independent registered public accounting firm, PricewaterhouseCoopers LLP, has issued an attestation report on the effectiveness of our internal control over financial reporting. This report appears in Item 8 above.

        Change in Internal Control Over Financial Reporting—There were no changes in our internal control over financial reporting that occurred during our last fiscal quarter that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

ITEM 9B.    OTHER INFORMATION

        None.

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PART III

ITEM 10.    DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE

        Portions of the response to this item are incorporated herein by reference from the discussion responsive thereto under the captions "Election of Directors—Nominees for Director", "Section 16(a) Beneficial Ownership Reporting Compliance", "Executive Officers" and "Corporate Governance—Board and Committee Matters" in the Company's Definitive Proxy Statement relating to the 2010 Annual Meeting of Stockholders (the 2010 Proxy Statement).

        We have adopted a Code of Business Conduct and Ethics (the code of ethics) that applies to all of our directors, officers and employees. The code of ethics is available on our website at www.dyax.com. In addition, if we make any substantive amendments to the code of ethics or grant any waiver, including any implicit waiver, from a provision of the code to any of our executive officers or directors, we will disclose the nature of such amendment or waiver as required by applicable law.

ITEM 11.    EXECUTIVE COMPENSATION

        The response to this item is incorporated herein by reference from the discussion responsive thereto under the following captions in the 2010 Proxy Statement: "Executive Compensation" and "Corporate Governance—Compensation Committee Interlocks and Insider Participation."

ITEM 12.    SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS

        The response to this item is incorporated herein by reference in part from the discussion responsive thereto under the caption "Share Ownership" in the 2010 Proxy Statement.

        The following table provides information about the securities authorized for issuance under the Company's equity compensation plans as of December 31, 2009:

Equity Compensation Plan Information

Plan Category
  Number of securities
to be issued
upon exercise of
outstanding options,
warrants and rights
  Weighted-average
exercise price of
outstanding options,
warrants and rights
  Number of securities
remaining available for
future issuance under
equity compensation plans
(excluding securities
reflected in column (a))
 
 
  (a)
  (b)
  (c)
 

Equity compensation plans approved by security holders(1)

    8,798,956   $ 4.60     6,422,818  

Equity compensation plans not approved by security holders:

            694,014  
 

Totals:

    8,798,956 (2) $ 4.60     7,116,832 (3)

(1)
Consists of the Amended and Restated 1995 Equity Incentive Plan, as amended, and the 1998 Employee Stock Purchase Plan, as amended.

(2)
Does not include the purchase of 49,972 shares on January 1, 2010 for purchase rights which accrued from July 1 through December 31, 2009. Additionally excluded are purchase rights currently accruing under the 1998 Employee Stock Purchase Plan, because the purchase price (and therefore the number of shares to be purchased) will not be determined until the end of the purchase period, which is June 30, 2010.

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(3)
Includes 50,000 shares issuable under the 1998 Employee Stock Purchase Plan, of which 49,972 shares were purchased on January 1, 2010 for purchase rights which accrued from July 1, 2009 through December 31, 2009, and up to 50,000, which are issuable in connection with the current offering period which ends on June 30, 2010. The remaining shares consist of 594,042 under the 1995 Amended and Restated Equity Incentive Plan. The plan may be amended, suspended, or terminated by the Compensation Committee of the Board of Directors at any time, subject to any required stockholder approval.

ITEM 13.    CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE

        The response to this item is incorporated herein by reference from the discussion responsive thereto under the caption "Election of Directors—Certain Relationships and Related Transactions" and "Corporate Governance—Board and Committee Matters" in the 2010 Proxy Statement.

ITEM 14.    PRINCIPAL ACCOUNTING FEES AND SERVICES

        The response to this item is incorporated herein by reference from the discussion responsive thereto under the captions "Corporate Governance—Board and Committee Matters" and "Audit Committee Report—Audit Fees" in the 2010 Proxy Statement.


PART IV

ITEM 15.    EXHIBITS, FINANCIAL STATEMENT SCHEDULES

(a)
1.    FINANCIAL STATEMENTS

The financial statements are included under Part II, Item 8 of this Report.

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2.     FINANCIAL STATEMENTS SCHEDULE

SCHEDULE II—VALUATION AND QUALIFYING ACCOUNTS
For the years ended December 2009, 2008 and 2007
(In thousands)

 
   
  Additions    
   
 
 
  Balance at
Beginning of
Period
  Charge to
Expenses
  Charge to
Other
Accounts
  Deductions   Balance at
End of
Period
 

Allowance for Doubtful Accounts:

                               

2009

  $ 42   $ (42 ) $ 25   $   $ 25  

2008

  $ 55   $ 14   $   $ 27   $ 42  

2007

  $ 80   $ 25   $   $ 50   $ 55  

 

 
  Balance at
Beginning of
Period
  Additions   Deductions   Balance at
End of
Period
 

Deferred Tax Asset Valuation Allowance:

                         

2009

  $ 142,580   $ 48,191   $ 10,258   $ 180,513  

2008

  $ 121,063   $ 25,039   $ 3,522   $ 142,580  

2007

  $ 100,458   $ 23,709   $ 3,104   $ 121,063  

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3.     EXHIBITS—

        The exhibits are listed below under Part IV, Item 15(b) of this Report.

(b)   EXHIBITS

Exhibit No.   Description
3.1   Amended and Restated Certificate of Incorporation of the Company. Filed as Exhibit 3.1 to the Company's Quarterly Report on Form 10-Q (File No. 000-24537) for the quarter ended September 30, 2008 and incorporated herein by reference.

3.2

 

Amended and Restated By-laws of the Company. Filed as Exhibit 3.2 to the Company's Quarterly Report on Form 10-Q (File No. 000-24537) for the quarter ended September 30, 2008 and incorporated herein by reference.

3.3

 

Certificate of Designations Designating the Series A Junior Participating Preferred Stock of the Company. Filed as Exhibit 3.1 to the Company's Current Report on Form 8-K (File No. 000-24537) filed on June 27, 2001 and incorporated herein by reference.

4.1

 

Specimen Common Stock Certificate. Filed as Exhibit 4.1 to the Company's Registration Statement on Form S-1 (File No. 333-37394) and incorporated herein by reference.

4.2

 

Amendment No. 1 to Rights Agreement, effective as of June 24, 2009 between American Stock Transfer & Trust Company, as Rights Agent, and the Company. Filed as Exhibit 4.1 to the Company's Current Report on Form 8-K (File No. 000-24537) filed on June 25, 2009 and incorporated herein by reference.

4.3

 

Form of Warrant issued to Cowen Healthcare Royalty Partners, L.P. on August 5, 2008 and March 18, 2009. Filed as an exhibit to Exhibit 10.4 to the Company's Quarterly Report on Form 10-Q (File No. 000-24537) for the quarter ended September 30, 2008 and incorporated herein by reference.

10.1(a)

 

Amended and Restated 1995 Equity Incentive Plan. Filed herewith.

10.1(b)

 

Form of the Company's Incentive Stock Option Certificate under the Company's Amended and Restated 1995 Equity Incentive Plan for all U.S. employees, including its executive officers. Filed as Exhibit 10.1 to the Company's Quarterly Report on Form 10-Q (File No. 000-24537) for the quarter ended September 30, 2004 and incorporated herein by reference.

10.1(c)

 

Form of the Company's Nonstatutory Stock Option Certificate under the Company's Amended and Restated 1995 Equity Incentive Plan for its U.S. employees, including its executive officers. Filed as Exhibit 10.1 to the Company's Quarterly Report on Form 10-Q (File No. 000-24537) for the quarter ended September 30, 2004 and incorporated herein by reference.

10.1(d)

 

Form of the Company's Nonstatutory Stock Option Certificate under the Company's Amended and Restated 1995 Equity Incentive Plan for its non-employee directors. Filed as Exhibit 10.1 to the Company's Quarterly Report on Form 10-Q (File No. 000-24537) for the quarter ended September 30, 2004 and incorporated herein by reference.

10.2

 

1998 Employee Stock Purchase Plan, as amended on March 25, 2009. Filed herewith.

10.3*

 

Form of Change of Control Agreement between the Company and Clive R. Wood, Ph.D. and Ivana Magovcevic-Liebisch, Ph.D., J.D. Filed as Exhibit 10.3 to the Company's Annual Report on Form 10-K (File No. 000-24537) for the year ended December 31, 2003 and incorporated herein by reference.

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Exhibit No.   Description
10.4*   Employment Letter Agreement, dated as of September 1, 1999, between George Migausky and the Company. Filed as Exhibit 10.1 to the Company's Quarterly Report on Form 10-Q (File No. 000-24537) for the quarter ended September 30, 2008 and incorporated herein by reference.

10.5*

 

Employment Letter Agreement dated as of June 27, 2003 between the Company and Clive R. Wood, Ph.D. Filed as Exhibit 10.3 to the Company's Quarterly Report on Form 10-Q (File No. 000-24537) for the quarter ended March 31, 2004 and incorporated herein by reference.

10.6*

 

Employment Letter Agreement between the Company and Gustav Christensen dated as of April 26, 2007. Filed as Exhibit 10.1 to the Company's Current Report on Form 8-K (File No. 000-24537) filed on May 2, 2007 and incorporated herein by reference.

10.7*

 

Form of Indemnification Agreement by and between certain directors and executive officers of the Company and the Company. Filed as Exhibit 10.32 to the Company's Registration Statement on Form S-1 (File No. 333-37394) and incorporated herein by reference.

10.8*

 

Severance Letter Agreement between Dyax Corp. and Ivana Magovcevic-Liebisch, Ph.D. J.D. dated as of November 16, 2006. Filed as Exhibit 10.1 to the Company's Current Report on Form 8-K (File No. 000-24537) filed on November 17, 2006 and incorporated herein by reference.

10.10*

 

Retirement Agreement and General Release between the Company and Stephen S. Galliker dates as of July 16, 2008. Filed as Exhibit 10.3 to the Company's Quarterly Report on Form 10-Q (File No. 000-24537) for the quarter ended September 30, 2008 and incorporated herein by reference.

10.11

 

Amended and Restated Registration Rights Agreement, dated as of February 12, 2001, between holders of the Company's capital stock named therein and the Company. Filed as Exhibit 10.33 to the Company's Annual Report on Form 10-K (File No. 000-24537) for the year ended December 31, 2000 and incorporated herein by reference.

10.12

 

Lease, dated as of June 13, 2001, between the Massachusetts Institute of Technology and the Company. Filed as Exhibit 10.1 to the Company's Quarterly Report on Form 10-Q (File No. 000-24537) for the quarter ended June 30, 2001 and incorporated herein by reference.

10.13

 

Master Lease Agreement and related documents between the Company and General Electric Capital Corporation dated as of May 1, 2001. Filed as Exhibit 10.1 to the Company's Quarterly Report on Form 10-Q (File No. 000-24537) for the quarter ended March 31, 2002 and incorporated herein by reference.

10.14†

 

Fourth Amendment to Lease dated August 25, 2009 by and between the Company and ARE-Tech Square, LLC. Filed as Exhibit 10.1 to the Company's Quarterly Report on Form 10-Q (File No. 000-24537) for the quarter ended September 30, 2009 and incorporated herein by reference.

10.15†

 

Amended and Restated License Agreement between XOMA Ireland Limited and the Company dated as of October 27, 2006. Filed as Exhibit 10.20(b) to the Company's Annual Report on Form 10-K (File No. 000-24537) for the year ended December 31, 2007 and incorporated herein by reference.

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Exhibit No.   Description
10.16(a)†   Amendment Agreement between Cambridge Antibody Technology Limited and the Company dated as of January 6, 2003. Filed as Exhibit 10.1 to the Company's Quarterly Report on Form 10-Q (File No. 000-24537) for the quarter ended March 31, 2003 and incorporated herein by reference.

10.16(b)†

 

Second Amendment Agreement between Cambridge Antibody Technology Limited and the Company dated as of September 18, 2003. Filed as Exhibit 99.2 to the Company's Current Report on Form 8-K (File No. 000-24537) filed on December 29, 2003 and incorporated herein by reference.

10.16(c)†

 

Amended and Restated License Agreement between the Company and Cambridge Antibody Technology Limited dated as of July 30, 2007. Filed as Exhibit 10.1 to the Company's Quarterly Report on Form 10-Q (File No. 000-24537) for the quarter ended September 30, 2007 and incorporated herein by reference.

10.17†

 

Product License Agreement between sanofi-aventis and the Company dated as of February 11, 2008. Filed as Exhibit 10.1 to the Company's Quarterly Report on Form 10-Q (File No. 000-24537) for the quarter ended March 31, 2008 and incorporated herein by reference.

10.18†

 

License and Collaboration Agreement between Cubist Pharmaceuticals, Inc. and the Company dated as of April 23, 2008. Filed as Exhibit 10.1 to the Company's Quarterly Report on Form 10-Q (File No. 000-24537) for the quarter ended June 30, 2008 and incorporated herein by reference.

10.19†

 

License Agreement between Fovea Pharmaceuticals SA and the Company dated as of February 10, 2009. Filed herewith.

10.20†

 

Distribution Agreement by and between US Bioservices Corporation dated as of November 19, 2009. Filed herewith.

10.21†

 

Distribution Agreement by and between ASD Specialty Healthcare Inc. dated as of November 19, 2009. Filed herewith.

10.22†

 

Distribution Agreement by and between Integrated Commercialization Solutions, Inc. dated as of November 19, 2009. Filed herewith.

10.23

 

Securities Sale Agreement between Dompé Farmaceutici S.p.A. and the Company dated as of July 14, 2008. Filed as Exhibit 10.2 to the Company's Quarterly Report on Form 10-Q (File No. 000-24537) for the quarter ended September 30, 2008 and incorporated herein by reference.

10.24

 

Common Stock Purchase Agreement between Azimuth Opportunity Ltd. and the Company dated as of October 30, 2008. Filed as Exhibit 10.1 to the Company's Current Report on Form 8-K (File No. 000-24537) filed on October 30, 2008 and incorporated herein by reference.

10.25†

 

Amended and Restated Loan Agreement by and between Cowen Healthcare Royalty Partners, L.P. and the Company dated as of March 18, 2009. Filed as Exhibit 10.1 to the Company's Amendment No. 1 to the Quarterly Report on Form 10-Q/A (File No. 000-24537) for the quarter ended June 30, 2009 and incorporated herein by reference.

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Exhibit No.   Description
10.26†   Termination Agreement by and between the Company and Genzyme Corporation dated February 20, 2007. Filed as Exhibit 10.2 to the Company's Quarterly Report on Form 10-Q (File No. 000-024537) for the quarter ended March 31, 2007 and incorporated herein by reference.

10.27

 

Information regarding modification of director compensation, incorporated by reference from Item 1.01 of the Company's Form 8-K (File No. 000-24537) filed on May 23, 2006.

10.28*

 

Summary of Executive Compensation for Named Executive Officers. Filed as Exhibit 10.1 to the Company's Current Report on Form 8-K (File No. 000-24537) filed on February 17, 2009 and incorporated herein by reference.

14.1

 

Code of Business Conduct and Ethics of the Company. Filed as Exhibit 14.1 to the Company's Annual Report on Form 10-K (File No. 000-24537) for the year ended December 31, 2005 and incorporated herein by reference.

21.1

 

Subsidiaries of the Company. Filed herewith.

23.1

 

Consent of PricewaterhouseCoopers LLP, an independent registered public accounting firm. Filed herewith.

31.1

 

Certification of Chief Executive Officer Pursuant to §240.13a-14 or §240.15d-14 of the Securities Exchange Act of 1934, as amended. Filed herewith.

31.2

 

Certification of Chief Financial Officer Pursuant to §240.13a-14 or §240.15d-14 of the Securities Exchange Act of 1934, as amended. Filed herewith.

32.1

 

Certification pursuant to 18 U.S.C. Section 1350. Filed herewith.

*
Indicates a contract with management.

This Exhibit has been filed separately with the Commission pursuant to an application for confidential treatment. The confidential portions of this Exhibit have been omitted and are marked by an asterisk.

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SIGNATURES

        Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the Company has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized, this twelfth day of March, 2010.

    DYAX CORP.

 

 

By:

 

/s/ GUSTAV A. CHRISTENSEN

Gustav A. Christensen
Chief Executive Officer

        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 Company in the capacities and on the dates indicated.

Name
 
Title
 
Date

 

 

 

 

 

/s/ GUSTAV A. CHRISTENSEN


Gustav Christensen
 

President and Chief Executive
Officer, and (Principal Executive Officer) and Director

  March 12, 2010

/s/ GEORGE MIGAUSKY


George Migausky
 

Executive Vice President and
Chief Financial Officer
(Principal Financial Officer and Principal Accounting Officer)

 

March 12, 2010

/s/ HENRY E. BLAIR


Henry E. Blair
 

Chairman of the Board of Directors

 

March 12, 2010

/s/ CONSTANTINE E. ANAGNOSTOPOULOS


Constantine E. Anagnostopoulos
 

Director

 

March 12, 2010

/s/ SUSAN B. BAYH


Susan B. Bayh
 

Director

 

March 12, 2010

/s/ JAMES W. FORDYCE


James W. Fordyce
 

Director

 

March 12, 2010

/s/ THOMAS L. KEMPNER


Thomas L. Kempner
 

Director

 

March 12, 2010

/s/ HENRY R. LEWIS


Henry R. Lewis
 

Director

 

March 12, 2010

/s/ DAVID J. MCLACHLAN


David J. McLachlan
 

Director

 

March 12, 2010

/s/ MARY ANN GRAY


Mary Ann Gray
 

Director

 

March 12, 2010

93



EX-10.1(A) 2 a2196756zex-10_1a.htm EXHIBIT 10.1(A)

Exhibit 10.1(a)

 

DYAX CORP.

 

AMENDED AND RESTATED 1995 EQUITY INCENTIVE PLAN

 

Section 1.  Purpose

 

The purpose of the Dyax Corp. 1995 Equity Incentive Plan (the “Plan”) is to attract and retain key employees and directors and consultants of the Company and its Affiliates, to provide an incentive for them to assist the Company to achieve long-range performance goals, and to enable them to participate in the long-term growth of the Company.

 

Section 2.  Definitions

 

“Affiliate” means any business entity in which the Company owns directly or indirectly 50% or more of the total combined voting power or has a significant financial interest as determined by the Committee.

 

“Award” means any Option, Stock Appreciation Right, Performance Share, Restricted Stock, Stock Unit or Other Stock-Based Award awarded under the Plan.

 

“Board” means the Board of Directors of the Company.

 

“Code” means the Internal Revenue Code of 1986, as amended from time to time, and any successor to such Code.

 

“Committee” means the Compensation Committee of the Board or such other committee of the Board appointed by the Board to administer the Plan or a specified portion thereof; provided, however, that in any instance the Board of Directors may take away any action delegated to the Committee hereunder.  If a Committee is authorized to grant Awards to a Reporting Person or a “covered employee” within the meaning of Section 162(m) of the Code, each member shall be a “Non-Employee Director” or the equivalent within the meaning of Rule 16b-3 under the Exchange Act or an “outside director” or the equivalent within the meaning of Section 162(m) of the Code, respectively.

 

“Common Stock” or “Stock” means the Common Stock, $0.01 par value, of the Company.

 

“Company” means Dyax Corp., a Delaware corporation.

 

“Designated Beneficiary” means the beneficiary designated by a Participant, in a manner determined by the Committee, to receive amounts due or exercise rights of the Participant in the event of the Participant’s death.  In the absence of an effective designation by a Participant, “Designated Beneficiary” shall mean the Participant’s estate.

 



 

“Effective Date” means July 13, 1995.

 

“Fair Market Value” means, with respect to Common Stock or any other property, the fair market value of such property as determined by the Committee in good faith or in the manner established by the Committee from time to time.  Unless otherwise determined by the Committee in good faith, the per share Fair Market Value of the Common Stock as of any date shall mean (i) if the Common Stock is then listed or admitted to trading on a national securities exchange, the last reported sale price on such date on the principal national securities exchange on which the Common Stock is then listed or admitted to trading or, if no such reported sale takes place on such date, the average of the closing bid and asked prices on such exchange on such date or (ii) if the Common Stock is then traded in the over-the-counter market, the average of the closing bid and asked prices on such date, as reported by The Wall Street Journal or other appropriate publication selected by the Committee, for the over-the-counter market.

 

“Incentive Stock Option” means an option to purchase shares of Common Stock awarded to a Participant under Section 6 that is intended to meet the requirements of Section 422 of the Code or any successor provision, and any regulation thereunder.

 

“Nonstatutory Stock Option” means an option to purchase shares of Common Stock awarded to a Participant under Section 6 that is not intended to be an Incentive Stock Option.

 

“Option” means an Incentive Stock Option or a Nonstatutory Stock Option.

 

“Other Stock-Based Award” means an Award, other than an Option, Stock Appreciation Right, Performance Share, Restricted Stock or Stock Unit, having a Common Stock element and awarded to a Participant under Section 11.

 

“Participant” means a person selected by the Committee to receive an Award under the Plan.

 

“Performance Cycle” or “Cycle” means the period of time selected by the Committee during which performance is measured for the purpose of determining the extent to which an award of Performance Shares has been earned.

 

“Performance Goals” means with respect to any Performance Cycle, one or more objective performance goals based on one or more of the following objective criteria established by the Committee prior to the beginning of such Performance Cycle or within such period after the beginning of the Performance Cycle as shall meet the requirements to be considered “pre-established performance goals” for purposes of Code Section 162(m):  (i) increases in the price of the Common Stock, (ii) product or service sales or market share, (iii) revenues, (iv) return on equity, assets, or capital, (v) economic profit (economic value added), (vi) total shareholder return, (vii) costs, (viii) expenses, (ix) margins, (x) earnings or earnings per share, (xi) cash flow, (xii) cash balances (xiii) customer satisfaction, (xiv) operating profit, (xv) research and development progress, (xvi) clinical trial progress, (xvii) licensing, (xviii) product development, (xix) manufacturing, or (xx) any combination of the foregoing, including without limitation, goals based on any of such measures relative to appropriate peer groups or market indices.  Such Performance Goals may be particular to a Participant or may be based, in whole or in part, on the performance of the division, department, line of business, subsidiary, or other business unit,

 

2



 

whether or not legally constituted, in which the Participant works or on the performance of the Company generally.

 

“Performance Shares” mean shares of Common Stock, which may be earned by the achievement of performance goals, awarded to a Participant under Section 8.

 

“Reporting Person” means a person subject to Section 16 of the Securities Exchange Act of 1934 or any successor provision.

 

“Restricted Period” means the period of time selected by the Committee during which an Award may be forfeited to the Company pursuant to the terms and conditions of such Award.

 

“Restricted Stock” means shares of Common Stock subject to forfeiture awarded to a Participant under Section 9.

 

“Stock Appreciation Right” or “SAR” means a right to receive any excess in value of shares of Common Stock over the exercise price awarded to a Participant under Section 7.

 

“Stock Unit” means an award of Common Stock or units, including without limitation units of Restricted Stock, that are valued in whole or in part by reference to, or otherwise based on, the value of Common Stock, awarded to a Participant under Section 10.

 

“Transferable for value” means a transfer on terms that would prevent the Company from relying on Securities and Exchange Commission Form S-8 (or any successor form) with respect to the issuance of the Common Stock underlying the respective Award.

 

Section 3.  Administration

 

The Plan shall be administered by the Committee; provided, however, that in any instance the Board of Directors may take any action delegated hereunder to the Committee.  The Committee shall have authority to adopt, alter and repeal such administrative rules, guidelines and practices governing the operation of the Plan as it shall from time to time consider advisable, and to interpret the provisions of the Plan.  The Committee’s decisions shall be final and binding.  To the extent permitted by applicable law, the Committee may delegate to one or more executive officers of the Company the power to make Awards to Participants who are not Reporting Persons or covered employees and all determinations under the Plan with respect thereto, provided that the Committee shall fix the maximum amount of such Awards for all such Participants and a maximum for any one Participant.

 

Section 4.  Eligibility

 

All employees and, in the case of Awards other than Incentive Stock Options, directors and consultants of the Company or any Affiliate, capable of contributing significantly to the successful performance of the Company, other than a person who has irrevocably elected not to be eligible, are eligible to be Participants in the Plan.  Incentive Stock Options may be awarded only to persons eligible to receive such Options under the Code.

 

3



 

Section 5.  Stock Available for Awards

 

(a)           Subject to adjustment under subsection (b), and after giving effect to the 0.652-for-one reverse stock split of the Company’s Common Stock affected in March 1998, Awards may be made under the Plan for up to Eight Million Three Hundred Fifty Thousand (18,350,000) shares of Common Stock, which number includes shares previously issued upon exercise of options granted under the Plan.  The maximum number of shares of Common Stock subject to Awards that may be granted to any Participant shall not exceed 225,000 shares in the aggregate in any calendar year, except that for grants to a new employee during the calendar year in which his or her service as an employee first commences such number shall not exceed 450,000 shares, and that both limits are subject to adjustment under subsection (b).  If any Award in respect of shares of Common Stock expires or is terminated unexercised or is forfeited, the shares subject to such Award, to the extent of such expiration, termination or forfeiture, shall again be available for award under the Plan.  Common Stock issued through the assumption or substitution of outstanding grants from an acquired company shall not reduce the shares available for Awards under the Plan.  Shares issued under the Plan may consist in whole or in part of authorized but unissued shares or treasury shares.

 

(b)           In the event that any stock dividend, extraordinary cash dividend, creation of a class of equity securities, recapitalization, reorganization, merger, consolidation, split-up, spin-off, combination, exchange of shares, warrants or rights offering to purchase Common Stock at a price substantially below fair market value, or other similar transaction affects the Common Stock then an equitable adjustment shall be made (subject, in the case of Incentive Stock Options, to any limitation required under the Code) to any or all of (i) the number and kind of shares in respect of which Awards may be made under the Plan, (ii) the number and kind of shares subject to outstanding Awards, and (iii) the award, exercise or conversion price with respect to any of the foregoing as determined by the Committee to be appropriate, and if considered appropriate, the Committee may make provision for a cash payment with respect to an outstanding Award, provided that the number of shares subject to any Award shall always be a whole number.

 

Section 6.  Stock Options

 

(a)           Subject to the provisions of the Plan, the Committee may award Incentive Stock Options and Nonstatutory Stock Options and determine the number of shares to be covered by each Option, the option price therefor and the conditions and limitations applicable to the exercise of the Option.  The terms and conditions of Incentive Stock Options shall be subject to and comply with Section 422 of the Code or any successor provision and any regulations thereunder.  No Incentive Stock Option may be granted hereunder more than ten years after the last date on which the Plan was approved for purposes of Section 422 of the Code.

 

(b)           The Committee shall establish the option price at the time each Option is awarded, which price shall not be less than 100% of the Fair Market Value of the Common Stock on the date of award.

 

(c)           Each Option shall be exercisable at such times and subject to such terms and conditions as the Committee may specify in the applicable Award or thereafter.  The Committee

 

4



 

may impose such conditions with respect to the exercise of Options, including conditions relating to applicable federal or state securities laws, as it considers necessary or advisable.

 

(d)           No shares shall be delivered pursuant to any exercise of an Option until payment in full of the option price therefor is received by the Company.  Such payment may be made in whole or in part in cash or, to the extent permitted by the Committee at or after the award of the Option, by delivery of a note or shares of Common Stock owned by the optionee, including Restricted Stock, or by retaining shares otherwise issuable pursuant to the Option, in each case valued at their Fair Market Value on the date of delivery or retention, or such other lawful consideration as the Committee may determine.

 

(e)           The Committee may provide that, subject to such conditions as it considers appropriate, upon the delivery or retention of shares to the Company in payment of an Option, the Participant automatically be awarded an Option for up to the number of shares so delivered.

 

Section 7.  Stock Appreciation Rights

 

(a)           Subject to the provisions of the Plan, the Committee may award SARs in tandem with an Option (at or after the award of the Option), or alone and unrelated to an Option.  SARs in tandem with an Option shall terminate to the extent that the related Option is exercised, and the related Option shall terminate to the extent that the tandem SARs are exercised.  SARs granted in tandem with Options shall have an exercise price not less than the exercise price of the related Option.  SARs granted alone and unrelated to an Option shall have an exercise price not less than 100% of the Fair Market Value of the Common Stock on the date of award may be granted at such exercise prices as the Committee may determine.  The Committee shall determine the manner of calculating the excess in value of the shares of Common Stock over the exercise price of a Stock Appreciation Right.

 

(b)           An SAR related to an Option, which SAR can only be exercised upon or during limited periods following a change in control of the Company, may entitle the Participant to receive an amount based upon the highest price paid or offered for Common Stock in any transaction relating to the change in control or paid during the thirty-day period immediately preceding the occurrence of the change in control in any transaction reported in any stock market in which the Common Stock is usually traded.

 

Section 8.  Performance Shares

 

(a)           Subject to the provisions of the Plan, the Committee may award Performance Shares and determine the number of such shares for each Performance Cycle and the duration of each Performance Cycle.  There may be more than one Performance Cycle in existence at any one time, and the duration of Performance Cycles may differ from each other.  The payment value of Performance Shares shall be equal to the Fair Market Value of the Common Stock on the date the Performance Shares are earned or, in the discretion of the Committee, on the date the Committee determines that the Performance Shares have been earned.

 

(b)           The Committee shall establish Performance Goals for each Cycle, for the purpose of determining the extent to which Performance Shares awarded for such Cycle are earned, on the basis of such criteria and to accomplish such objectives as the Committee may from time to

 

5



 

time select.  During any Cycle, the Committee may adjust the performance goals for such Cycle as it deems equitable in recognition of unusual or non-recurring events affecting the Company, changes in applicable tax laws or accounting principles, or such other factors as the Committee may determine.

 

(c)           As soon as practicable after the end of a Performance Cycle, the Committee shall determine the number of Performance Shares that have been earned on the basis of performance in relation to the established performance goals.  The payment values of earned Performance Shares shall be distributed to the Participant or, if the Participant has died, to the Participant’s Designated Beneficiary, as soon as practicable thereafter.  The Committee shall determine, at or after the time of award, whether payment values will be settled in whole or in part in cash or other property, including Common Stock or Awards.

 

Section 9.  Restricted Stock

 

(a)           Subject to the provisions of the Plan, the Committee may award shares of Restricted Stock and determine the duration of the Restricted Period during which, and the conditions under which, the shares may be forfeited to the Company and the other terms and conditions of such Awards.  Shares of Restricted Stock may be issued for no cash consideration or such minimum consideration as may be required by applicable law.

 

(b)           Shares of Restricted Stock may not be sold, assigned, transferred, pledged or otherwise encumbered, except as permitted by the Committee, during the Restricted Period.  Shares of Restricted Stock shall be evidenced in such manner as the Committee may determine.  Any certificates issued in respect of shares of Restricted Stock shall be registered in the name of the Participant and unless otherwise determined by the Committee, deposited by the Participant, together with a stock power endorsed in blank, with the Company.  At the expiration of the Restricted Period, the Company shall deliver such certificates to the Participant or if the Participant has died, to the Participant’s Designated Beneficiary.

 

Section 10.  Stock Units

 

(a)           Subject to the provisions of the Plan, the Committee may award Stock Units subject to such terms, restrictions, conditions, performance criteria, vesting requirements and payment rules as the Committee shall determine.

 

(b)           Shares of Common Stock awarded in connection with a Stock Unit Award shall be issued for no cash consideration or such minimum consideration as may be required by applicable law.

 

Section 11.            Other Stock-Based Awards

 

(a)           Subject to the provisions of the Plan, the Committee may make other awards of Common Stock and other awards that are valued in whole or in part by reference to, or are otherwise based on, Common Stock, including without limitation convertible preferred stock, convertible debentures, exchangeable securities and Common Stock awards or options.  Other Stock-Based Awards may be granted either alone or in tandem with other Awards granted under the Plan and/or cash awards made outside of the Plan.

 

6



 

(b)           The Committee may establish performance goals, which may be based on performance goals related to book value, subsidiary performance or such other criteria as the Committee may determine, Restricted Periods, Performance Cycles, conversion prices, maturities and security, if any, for any Other Stock-Based Award.  Other Stock-Based Awards may be sold to Participants at the face value thereof or any discount therefrom or awarded for no consideration or such minimum consideration as may be required by applicable law.

 

Section 12.  General Provisions Applicable to Awards

 

(a)           Documentation.  Each Award under the Plan shall be evidenced by a writing delivered to the Participant specifying the terms and conditions thereof and containing such other terms and conditions not inconsistent with the provisions of the Plan as the Committee considers necessary or advisable to achieve the purposes of the Plan or to comply with applicable tax and regulatory laws and accounting principles.

 

(b)           Committee Discretion.  Each type of Award may be made alone, in addition to or in relation to any other type of Award, in the discretion of the Committee.  The terms of each type of Award need not be identical, and the Committee need not treat Participants uniformly.   Except as otherwise provided by the Plan or a particular Award, any determination with respect to an Award may be made by the Committee at the time of award or at any time thereafter, including without limitation any determination regarding the achievement or satisfaction of any Performance Goals, restrictions or other conditions to vesting, exercise, or settlement of an Award.

 

(c)           Settlement.  The Committee shall determine whether Awards are settled in whole or in part in cash, Common Stock, other securities of the Company, Awards or other property, and the manner of determining the amount or value thereof.   Without limiting the foregoing, the Committee may, subject to applicable law, permit such payment to be made in whole or in part in cash or by surrender of shares of Common Stock (which may be shares retained from the respective Award) valued at their Fair Market Value on the date of surrender, or such other lawful consideration, including a payment commitment of a financial or brokerage institution, as the Committee may determine.  The Company may accept, in lieu of actual delivery of stock certificates, an attestation by the Participant in form acceptable to the Committee that he or she owns of record the shares to be tendered free and clear of claims and other encumbrances.  The Committee may permit a Participant to defer all or any portion of a payment under the Plan, including the crediting of interest on deferred amounts denominated in cash and dividend equivalents on amounts denominated in Common Stock.

 

(d)           Dividends and Cash Awards.  In the discretion of the Committee, any Award under the Plan may provide the Participant with (i) dividends or dividend equivalents payable currently or deferred with or without interest, and (ii) cash payments in lieu of or in addition to an Award.

 

(e)           Termination of Service.  The Committee shall determine the effect on an Award of the disability, death, retirement or other termination of employment or other service of a Participant and the extent to which, and the period during which, the Participant’s legal representative, guardian or Designated Beneficiary may receive payment of an Award or

 

7



 

exercise rights thereunder.  Unless the Committee otherwise provides in any case, a Participant’s employment or other service shall have terminated for purposes of this Plan at the time the entity by which the Participant is employed or to which he or she renders such service ceases to be an Affiliate of the Company.

 

(f)           Change in Control.  In order to preserve a Participant’s rights under an Award in the event of a change in control of the Company (as defined by the Committee), the Committee in its discretion may, at the time an Award is made or at any time thereafter, take one or more of the following actions: (i) provide for the acceleration of any time period relating to the exercise or realization of the Award, (ii) provide for the purchase of the Award upon the Participant’s request for an amount of cash or other property that could have been received upon the exercise or realization of the Award had the Award been currently exercisable or payable, (iii) adjust the terms of the Award in a manner determined by the Committee to reflect the change in control, (iv) cause the Award to be assumed, or new rights substituted therefor, by another entity, or (v) make such other provision as the Committee may consider equitable and in the best interests of the Company.

 

(g)           Loans.  The Committee may authorize the making of loans or cash payments to Participants in connection with any Award under the Plan, which loans may be secured by any security, including Common Stock, underlying or related to such Award (provided that such Loan shall not exceed the Fair Market Value of the security subject to such Award), and which may be forgiven upon such terms and conditions as the Committee may establish at the time of such loan or at any time thereafter.

 

(h)           Withholding Taxes.  The Participant shall pay to the Company, or make provision satisfactory to the Committee for payment of, any taxes required by law to be withheld in respect of Awards under the Plan no later than the date of the event creating the tax liability.  In the Committee’s discretion, such tax obligations may be paid in whole or in part in shares of Common Stock, including shares retained from the Award creating the tax obligation, valued at their Fair Market Value on the date of delivery.  The Company and its Affiliates may, to the extent permitted by law, deduct any such tax obligations from any payment of any kind otherwise due to the Participant.

 

(i)            Foreign Nationals.  Awards may be made to Participants who are foreign nationals or employed outside the United States on such terms and conditions different from those specified in the Plan as the Committee considers necessary or advisable to achieve the purposes of the Plan or to comply with applicable laws.

 

(j)            Amendment of Award.  The Committee may amend, modify or terminate any outstanding Award, including changing the date of vesting, exercise or settlement, causing the Award to be assumed by another entity, and converting an Incentive Stock Option to a Nonstatutory Stock Option, provided that the Participant’s consent to such action shall be required unless the Committee determines that the action, taking into account any related action, would not materially and adversely affect the Participant.  The foregoing notwithstanding, without further approval of the stockholders of the Company, the Committee shall not authorize the amendment of any outstanding Option or Stock Appreciation Right to reduce the exercise

 

8



 

price and no Option or Stock Appreciation Right shall be canceled and replaced with an Award exercisable for Common Stock at a lower exercise price.

 

(k)           Limitations on Transferability of Awards.  No Award shall be transferable except upon such terms and conditions and to such extent as the Committee determines, provided that no Award shall be transferable for value and Incentive Stock Options may be transferable only to the extent permitted by the Code.

 

(l)            Section 409A.       No Award to any Participant subject to United States income taxation shall provide for the deferral of compensation that does not comply with Section 409A of the Code and any regulations thereunder.

 

Section 13.  Miscellaneous

 

(a)           No Right To Employment.  No person shall have any claim or right to be granted an Award, and the grant of an Award shall not be construed as giving a Participant the right to continued employment  Neither the adoption, maintenance, or operation of the Plan nor any Award hereunder shall confer upon any person any right with respect to the continuance of his or her employment by or other service with the Company or any Affiliate nor shall they interfere with the rights of the Company or any Affiliate to terminate or otherwise change the terms of such service at any time, including, without limitation, the right to promote, demote or otherwise re-assign any person from one position to another within the Company or any Affiliate.  Unless the Committee otherwise provides in any case, the service of a Participant with an Affiliate shall be deemed to terminate for purposes of the Plan when such Affiliate ceases to be an Affiliate of the Company.

 

(b)           No Rights As Stockholder.  Subject to the provisions of the applicable Award, no Participant or Designated Beneficiary shall have any rights as a stockholder with respect to any shares of Common Stock to be distributed under the Plan until he or she becomes the holder thereof.  A Participant to whom Common Stock is awarded shall be considered the holder of the Stock at the time of the Award except as otherwise provided in the applicable Award.

 

(c)           Effective Date.  Subject to the approval of the stockholders of the Company, the Plan shall be effective on the Effective Date.  Before such approval, Awards may be made under the Plan expressly subject to such approval.

 

(d)           Amendment of Plan.  The Committee may amend, suspend or terminate the Plan or any portion thereof at any time, subject to any stockholder approval that the Committee determines to be necessary or advisable.

 

(e)           Governing Law.  The provisions of the Plan shall be governed by and interpreted in accordance with the laws of the State of Delaware.

 


 

This Plan was approved by the Board of Directors on July 13, 1995.

 

This Plan was approved by the stockholders on August 8, 1995.

 

9



 

This Plan was amended by the Board of Directors on October 17, 1996, and such amendment was approved by the stockholders effective as of October 23, 1996.

 

This Plan was further amended by the Board of Directors on October 22, 1997 and on January 28, 1998, and such amendments were approved by the stockholders effective as of March 23, 1998.

 

This Plan was further amended by the Board of Directors on August 13, 1998, and such amendment was approved by the stockholders effective as of August 28, 1998.

 

This Plan was further amended by the Board of Directors on August 5, 1999, and such amendment was approved by the stockholders effective as of October 29, 1999.

 

This Plan was further amended by the Board of Directors on March 16, 2000, and such amendment was approved by the stockholders effective as of March 20, 2000.

 

This Plan was further amended by the Board of Directors on October 26, 2001.

 

This Plan was further amended by the Board of Directors on February 7, 2002, and such amendment was approved by the stockholders effective as of May 16, 2002.

 

This Plan was further amended by the Board of Directors on March 2, 2005, and such amendment was approved by the stockholders effective as of May 19, 2005.

 

This Plan was further amended by the Compensation Committee of the Board of Directors on April 4, 2007 and such amendment was approved by the stockholders effective as of May 17, 2007.

 

This Plan was further amended by the Compensation Committee of the Board of Directors on March 25, 2009 and such amendment was approved by the stockholders effective as of May 14, 2009.

 

10



EX-10.2 3 a2196756zex-10_2.htm EXHIBIT 10.2

Exhibit 10.2

 

DYAX CORP.

 

1998 Employee Stock Purchase Plan

 

1.             Purpose.

 

The purpose of this 1998 Employee Stock Purchase Plan (the “Plan”) is to provide employees of Dyax Corp. (the “Company”), and its subsidiaries incorporated under the laws of a jurisdiction within the United States of America (“US Subsidiaries”), who wish to become shareholders of the Company, an opportunity to purchase Common Stock, $0.01 par value, of the Company (the “Common Stock”) directly from the Company.  The Plan is intended to qualify as an “employee stock purchase plan” within the meaning of Section 423 of the Internal Revenue Code of 1986, as amended (the “Code”).

 

2.             Eligible Employees.

 

Subject to the provisions of Sections 7, 8, 9 and 10 below, any individual who is a full-time employee (as defined below) of the Company or of any of its subsidiaries (as defined in Section 424(f) of the Code) designated for eligibility to participate in the Plan by the Board of Directors is eligible to participate in any Offering of Shares (as defined in Section 3 below) made by the Company hereunder.  “Board of Directors” means the Company’s Board of Directors or any committee to whom it delegates its authority hereunder, and “full-time employee” shall mean any employee whose customary employment is:

 

(a)           20 hours or more per week and

 

(b)           more than five months in the calendar year during which the Offering Date (as defined in Section 3 below) occurs (or in the calendar year immediately preceding such calendar year if there has been no change in the terms of employment that would make the employee ineligible to participate in the current calendar year).

 

3.             Offering Dates.

 

From time to time, the Company, by action of the Board of Directors, will grant rights to purchase Shares to employees eligible to participate in the Plan pursuant to one or more offerings (each of which is an “Offering” on a date or series of dates (each of which is an “Offering Date”) designated for this purpose by the Board of Directors.

 

4.             Prices.

 

The price per share for each grant of rights hereunder shall be the lesser of:

 

(a)           eighty-five percent (85%) of the fair market value of a Share on the Offering Date on which such right was granted; or

 

(b)           eighty-five percent (85%) of the fair market value of a Share on the date such right is exercised.

 



 

At its discretion, the Board of Directors may determine a higher price for a grant of rights.

 

5.             Exercise of Rights and Method of Payment.

 

(a)           Rights granted under the Plan will be exercisable periodically on specified dates as determined by the Board of Directors. Unless a participating employee withdraws from the Plan as provided in Section 11, and subject to the other terms of the Plan, the employee’s option for the purchase of Shares will be exercised automatically on each Purchase Date of an Offering Period, and the maximum number of shares subject to the option will be purchased at the applicable purchase price with the accumulated contributions in the employee’s account.

 

(b)           The method of payment for Shares purchased upon exercise of rights granted hereunder shall be through regular payroll deductions or by lump sum cash payment, by delivery of shares of Common Stock valued at fair market value (as determined by the Board of Directors) on the date of delivery, or by some combination thereof, as determined by the Board of Directors.  No interest shall be paid upon payroll deductions unless specifically provided for by the Board of Directors.

 

(c)           Any payments received by the Company from a participating employee and not utilized for the purchase of Shares upon exercise of a right granted hereunder shall be promptly returned to such employee by the Company after termination of the right to which the payment relates.

 

6.             Term of Rights.

 

The total period from an Offering Date to the last date on which rights granted on that Offering Date are exercisable (the “Offering Period”) shall in no event be longer than twenty-seven (27) months or such longer period as may then be consistent with Section 423 of the Code.  The Board of Directors when it authorizes an Offering may designate one or more exercise periods during the Offering Period when shares will be purchased upon exercise of employees’ options (each, an “Exercise Period”).  Rights granted on an Offering Date shall be exercisable in full on the Offering Date or in such proportion on the last day of each exercise period as the Board of Directors determines.

 

7.             Shares Subject to the Plan.

 

(a)           The number of shares of Common Stock that may be sold pursuant to rights granted under the Plan may not exceed 1,330,000 shares (the “Shares”); provided, however, that the maximum number of Shares which shall be available for sale under the Plan during any Exercise Period shall not exceed the number of Shares equal to 25,000 Shares multiplied by the number of calendar quarters included in such Exercise Period and, if necessary, the number of Shares sold during an Exercise Period shall be cut back in accordance with Section 7(b).  Appropriate adjustments in the above figures, in the number of Shares covered by outstanding rights granted hereunder, in the exercise price of the rights and in the maximum number of Shares which an employee may purchase (pursuant to this Section 7(a), and Sections 9 and 10 below) shall be made to give effect to any mergers, consolidations, reorganizations, recapitalizations, stock splits, stock dividends or other relevant changes in the capitalization of

 



 

the Company occurring after the effective date of the Plan, provided that no fractional Shares shall be subject to a right and each right shall be adjusted downward to the nearest full Share.  In the event of a proposed dissolution or liquidation of the Company, any Exercise Period and Offering Period then in progress will terminate immediately prior to the consummation of such action, unless otherwise provided by the Board.  In the event of a Corporate Transaction (as defined below), each option outstanding under the Plan shall be assumed or an equivalent option shall be substituted by the successor corporation or a parent or subsidiary of such successor corporation.  In the event that the successor corporation refuses to assume or substitute for outstanding options, each Exercise Period and Offering Period then in progress shall be shortened and a new Purchase Date shall be set (the “New Purchase Date”), as of which date any Exercise Period and Offering Period then in progress will terminate.  The New Purchase Date shall be on or before the date of consummation of the transaction and the Board shall notify each participating employee in writing, prior to the New Purchase Date, that the Purchase Date for his or her option has been changed to the New Purchase Date and that his or her option will be exercised automatically on the New Purchase Date, unless prior to such date he or she has withdrawn from the Offering Period as provided in Section 11.  For purposes of this Section 7, “Corporate Transaction” means a sale of all or substantially all of the Company’s assets, or a merger, consolidation, or other capital reorganization of the Company with or into another corporation, or any other transaction or series of related transactions in which the Company’s stockholders immediately prior thereto own less than 50% of the voting stock of the Company (or its successor or parent) immediately thereafter.  Either authorized and unissued Shares or issued Shares heretofore or hereafter reacquired by the Company may be made subject to rights under the Plan.  If for any reason any right under the Plan terminates in whole or in part, Shares subject to such terminated right may again be subjected to a right under the Plan.

 

(b)           Subject to the foregoing, if the Board of Directors determines that, on a given purchase date for an Offering (a “Purchase Date”), the number of Shares with respect to which rights are to be exercised may exceed (i) the number of Shares of Common Stock that were available for sale under the Plan on the Offering Date of the applicable Offering, or (ii) the number of Shares available for sale under the Plan on such Purchase Date, the Board of Directors may in its sole discretion provide that the Company shall make a pro rata allocation of the Shares of Common Stock available for purchase on such Offering Date or Purchase Date, as applicable, in as uniform a manner as shall be practicable and as it shall determine in its sole discretion to be equitable among all participant employees exercising rights to purchase Common Stock on such Purchase Date, and (x) continue all Offerings then in effect or (y) terminate any or all Offerings then in effect.  The Company may make pro rata allocation of the Shares available on the Purchase Date of any applicable Offering, notwithstanding any authorization of additional Shares for issuance under the Plan by the Company’s stockholders subsequent to the Offering Date for such Offering.  In the event of a pro-rata allocation, each participating employee’s right to purchase Shares shall be limited to such pro-rata amount of Shares and the remaining cash balance of the contributions shall be credited to his or her account, and the participating employees shall not have further rights against the Company or the Board of Directors.

 



 

8.             Limitations on Grants.

 

(a)           No employee shall be granted a right hereunder if such employee, immediately after the right is granted, would own stock or rights to purchase stock possessing five percent (5%) or more of the total combined voting power or value of all classes of stock of the Company, or of any subsidiary, computed in accordance with Section 423(b)(3) of the Code.

 

(b)           No employee shall be granted a right which permits the employee’s right to purchase shares under all employee stock purchase plans of the Company and its subsidiaries to accrue at a rate which exceeds twenty-five thousand dollars ($25,000) (or such other maximum as may be prescribed from time to time by the Code) of the fair market value of such Shares (determined at the time such right is granted) for each calendar year in which such right is outstanding at any time in accordance with the provisions of Section 423(b)(8) of the Code.

 

(c)           No right granted to any participating employee under an Offering, when aggregated with rights granted under any other Offering still exercisable by the participating employee, shall cover more shares than may be purchased at an exercise price not to exceed fifteen percent (15%) of the employee’s annual rate of compensation on the date the employee elects to participate in the Offering or such lesser percentage as the Board of Directors may determine.

 

9.             Limitation on Number of Shares Purchased.

 

The maximum number of Shares that an eligible participating employee may purchase during any Exercise Period shall not exceed the number of Shares that is equal to 875 Shares multiplied by the number of calendar quarters included in such Exercise Period, provided that such purchase shall be further subject to the limitations set forth in Sections 2, 7, and 8.

 

10.          Limit on Participation.

 

Participation in an Offering shall be limited to eligible employees who elect to participate in such Offering in the manner, and within the time limitations, established by the Board of Directors when it authorizes the Offering.

 

11.          Withdrawal.

 

(a)           An employee who has elected to participate in an Offering may cancel such election as to all (but not part) of the unexercised rights granted under such Offering by giving written notice of such cancellation to the Company before the date established by the Company for such purpose.  Upon such withdrawal, any amounts paid by the employee or withheld from the employee’s compensation through payroll deductions for the purpose of purchasing Shares shall be paid to the employee, without interest, unless otherwise determined by the Board of Directors.

 

(b)           A participating employee’s withdrawal from an Offering will not have any effect upon his or her eligibility to participate in a succeeding Offering which commences after the withdrawal or in any similar plan that may hereafter be adopted by the Company.  If a participating employee withdraws from an Offering, however, payroll deductions shall not

 



 

resume at the beginning of any succeeding Offering unless the employee makes a new election to participate in the Plan.

 

12.          Tax Withholding.

 

Each participating employee shall pay to the Company or the applicable subsidiary, or make provision satisfactory to the Administrator for payment of, any taxes required by law to be withheld in respect of the purchase or disposition of Shares no later than the date of the event creating the tax liability.  In the discretion of the Board of Directors and subject to applicable law, such tax obligations may be paid in whole or in part by delivery of Shares to the Company, including Shares purchased under the Plan, valued at fair market value (as determined by the Board of Directors) on the date of delivery.  The Company or the applicable subsidiary may, to the extent permitted by law, deduct any such tax obligations from any payment of any kind otherwise due to the employee or withhold Shares purchased hereunder, which shall be valued at fair market value (as determined by the Board of Directors) on the date of withholding.

 

13.          Termination of Employment.

 

Upon the termination of employment for any reason, including the death of the employee, before the date on which any rights granted under the Plan are exercisable, all such rights shall immediately terminate and amounts paid by the employee or withheld from the employee’s compensation through payroll deductions for the purpose of purchasing the Shares shall be paid to the employee or to the employee’s estate, without interest unless otherwise determined by the Board of Directors.

 

14.          Participants’ Rights as Shareholders and Employees.

 

(a)           No participating employee shall have any rights as a shareholder in the Shares covered by a right granted hereunder until such right has been exercised, full payment has been made for the corresponding Shares and the Share certificate is actually issued.

 

(b)           Each participating employee is an employee-at-will (that is to say that either the employee or the Company or any subsidiary may terminate the employment relationship at any time for any reason or no reason at all) unless and only to the extent provided in a written employment agreement for a specified term executed by the chief executive officer of the Company or his duly authorized designee or the authorized signatory of any subsidiary.  Neither the adoption, maintenance, nor operation of the Plan nor any grant of rights hereunder shall confer upon any employee any right with respect to the continuance of his/her employment with the Company or any subsidiary nor shall they interfere with the rights of the Company or subsidiary to terminate any employee at any time or otherwise change the terms of employment, including, without limitation, the right to promote, demote or otherwise re-assign any employee from one position to another within the Company or any subsidiary.

 

15.          Rights Not Transferable.

 

Rights under the Plan are not assignable or transferable by a participating employee and are exercisable only by the employee.

 



 

16.          Amendments to or Discontinuation of the Plan.

 

The Board of Directors of the Company shall have the right to amend, modify or terminate the Plan at any time without notice; provided, however, that the then existing rights of all participating employees shall not be adversely affected thereby, and provided further that, subject to the provisions of Section 7 above, no such amendment to the Plan shall, without the approval of the shareholders of the Company, increase the total number of Shares which may be offered under the Plan.

 

17.          Effective Date and Approvals.

 

(a)                           This Plan became effective on January 31, 1998, the date it was adopted by the Board of Directors, and it was approved by the shareholders of the Company within twelve (12) months before or after the date of adoption.

 

(b)                           The Company’s obligation to offer, sell and deliver the Shares under the Plan is subject to (i) the approval of any governmental authority required in connection with the authorization,  issuance or sale of such Shares, (ii) satisfaction of the listing requirements of any national securities exchange on which the Shares are then listed and (iii) compliance, in the opinion of the Company’s counsel with, all applicable federal and state securities and other laws.

 

18.          Term of Plan.

 

No rights shall be granted under the Plan after January 30, 2017.

 

19.          Administration of the Plan.

 

The Board of Directors or any committee or person(s) to whom it delegates its authority (the “Administrator”) shall administer, interpret and apply all provisions of the Plan as it deems necessary to meet special circumstances not anticipated or covered expressly by the Plan.  Nothing contained in this Section shall be deemed to authorize the Administrator to alter or administer the provisions of the Plan in a manner inconsistent with the provisions of Section 423 of the Code.  Determinations made by the Board of Directors with respect to any provision of the Plan or matter arising in connection therewith shall be final, conclusive and binding upon the Company and upon all participants, their heirs or legal representatives.

 

20.          Governing Law.

 

Subject to overriding federal law, the Plan shall be governed by and interpreted consistently with the laws of the State of Delaware.

 



EX-10.19 4 a2196756zex-10_19.htm EXHIBIT 10.19

Exhibit 10.19

 

LICENSE AGREEMENT

 

BY AND BETWEEN

 

DYAX CORP.

 

AND

 

FOVEA PHARMACEUTICALS SA

 



 

LICENSE AGREEMENT

 

This License Agreement (this “Agreement”) is made and effective as of August 21, 2008 (the “Effective Date”) by and between Dyax Corp., a Delaware corporation, with offices at 300 Technology Square, Cambridge, Massachusetts 02139, U.S.A. (“Dyax”) and Fovea Pharmaceuticals SA, a French corporation, with offices at 12 rue Jean-Antoine de Baif, 75013 Paris, France (“Fovea”).

 

INTRODUCTION

 

1.             Dyax owns or controls certain patents, know-how and other rights related to its proprietary novel kallikrein inhibitor known as DX-88 (ecallantide);

 

2.             Fovea has considerable knowledge and experience in developing and commercializing ophthalmic pharmaceutical products in the countries of the European Union;

 

3.             Dyax (as successor in interest to Dyax-Genzyme LLC) and Fovea entered into a Research and Option Agreement effective May 26, 2006 (the “Research and Option Agreement”), pursuant to which (a) Fovea conducted a non-clinical study of DX-88 for the treatment of macular edema associated with retinal vein occlusion and (b) Dyax granted Fovea an option to obtain a license to develop and commercialize DX-88 in ophthalmic indications in the European Union, which option was exercised by Fovea on April 2, 2007;

 

4.             Dyax believes that a license and collaboration arrangement with Fovea regarding the DX-88 in the ophthalmic field on the terms of this Agreement would be desirable;

 

5.             Fovea believes that Fovea’s participation in this arrangement with Dyax would be of economic benefit to Dyax and Fovea; and

 

6.             On and subject to the terms and conditions set forth herein, Dyax and Fovea therefore desire to provide for the development, manufacture and commercialization of DX-88 formulated for use in the ophthalmic field as described herein.

 

NOW, THEREFORE, for and in consideration of the mutual covenants contained herein, Dyax and Fovea hereby agree as follows:

 

ARTICLE I

DEFINITIONS

 

As used in this Agreement, the following terms shall have the meanings set forth below:

 

Section 1.1             “Affiliate”.  Affiliate shall mean with respect to any Party, any Person controlling, controlled by or under common control with such Party.  For purposes of this Section 1.1, “control” shall mean (a) in the case of a Person that is a corporate entity, direct or indirect ownership of more than fifty percent (50%) of the stock or shares having the right to vote for the election of directors of such Person and (b) in the case of a Person that is an entity, but is not a corporate entity, the possession,

 


* Confidential Treatment Requested.  Omitted portions filed with the Commission.

 



 

directly or indirectly, of the power to direct, or cause the direction of, the management or policies of such Person, whether through the ownership of voting securities, by contract or otherwise.

 

Section 1.2             “API Bulk Drug Substance”.  API Bulk Drug Substance shall mean the Compound in bulk form manufactured for use as an active pharmaceutical ingredient in the Product; provided [*****].

 

Section 1.3             “Blocking Third Party Patent Rights”.  Blocking Third Party Patent Rights shall mean, with respect to any country in the Territory, on a country-by-country basis, Patent Rights in such country owned or controlled by a Third Party that Cover the Product; provided, however, that any Patent Rights owned or controlled by [*****], shall not be deemed Blocking Third Party Patent Rights.   [*****]

 

Section 1.4             “Clinical Study”.  Clinical Study shall mean a Phase I Clinical Study, Phase II Clinical Study, Phase III Clinical Study, Post-Approval Study or other clinical study or trial of the Product in humans, as applicable.

 

Section 1.5             “Commercialization” or “Commercialize”.  Commercialization or Commercialize shall mean activities directed to obtaining pricing and reimbursement approvals, marketing, promoting, distributing, importing, exporting or selling a product.  Commercialization shall not include any activities related to Manufacturing.

 

Section 1.6             “Competing Product”.  Competing Product shall mean any prescription pharmaceutical product, other than the Product, that [*****].

 

Section 1.7             “Compound”.  Compound shall mean the novel kallikrein inhibitor known as DX-88 (ecallantide), with the amino acid sequence described in Exhibit A.

 

Section 1.8             “Control” or “Controlled”.  Control or Controlled shall mean, with respect to any intellectual property right or other intangible property, the possession (whether by license from a Third Party or ownership, or by control over an Affiliate having possession by license from a Third Party or ownership) by a Party of the ability to grant to the other Party access, ownership and/or a license or sublicense as provided herein without violating the terms of any agreement with any Third Party.  For purposes of clarification, a Party shall not be deemed or treated as Controlling or being in Control of any intellectual property right or other intangible property that any other Person owns or Controls solely because such other Person becomes an Affiliate of such Party at any time after the Effective Date pursuant to a transaction in which such other Person acquires, or becomes a controlling stockholder of, such Party.

 

Section 1.9             “Cover”, “Covering” or “Covered”.  Cover, Covering or Covered shall mean, with respect to the Product or with respect to technology, that, in the absence of a license granted under a Valid Claim, the making, use, offering for sale, sale, or importation of the Product or the practice of such technology would infringe such Valid Claim.

 

Section 1.10           “Development” or “Develop”.  Development or Develop shall mean non-clinical and clinical research and drug development activities, including without limitation toxicology, test

 


* Confidential Treatment Requested.  Omitted portions filed with the Commission.

 

2



 

method development and stability testing, process development, formulation development, delivery system development, quality assurance and quality control development, statistical analysis, Clinical Studies, regulatory affairs, and product approval and clinical study regulatory activities (excluding regulatory activities directed to obtaining pricing and reimbursement approvals). Development shall not include any activities related to Manufacturing.

 

Section 1.11           “Development Costs”.  Development Costs shall mean all internal and external costs incurred after the Effective Date in performing the Core Development Plan or the Supplemental Development Plan, as the case may be, in accordance with this Agreement.

 

Section 1.12           “Diligent Efforts”.  Diligent Efforts shall mean, with respect to the Product, the carrying out of obligations in a commercially reasonable, diligent and sustained manner using efforts not less than the efforts a Party devotes to a product of similar market potential, profit potential or strategic value, at a similar stage of its product life and based on conditions then prevailing, but excluding consideration of any obligation to the other Party under this Agreement.

 

Section 1.13           “Distributor”.  Distributor shall mean, with respect to a Party, a Third Party distributor of such Party with respect to the Product that is not a Related Party of such Party.

 

Section 1.14           “Dyax Intellectual Property”.  Dyax Intellectual Property shall mean Dyax Know-How and Dyax Patent Rights, collectively.

 

Section 1.15           “Dyax Know-How”.  Dyax Know-How shall mean any Know-How that (a) [*****] is Controlled by Dyax on the Effective Date [*****] and (b) is [*****] for the Development, Manufacture and/or Commercialization of the Product in the Field as contemplated by this Agreement.

 

Section 1.16           “Dyax Patent Rights”.  Dyax Patent Rights shall mean Patent Rights, including Dyax’s rights in Joint Patent Rights, that (a) Cover Dyax Know-How and (b) are Controlled by Dyax on the Effective Date or come within Dyax’s Control during the Term, including without limitation, the Existing Dyax Patent Rights and the Fovea-Assigned Patent Rights.

 

Section 1.17           “Dyax Territory”.  Dyax Territory shall mean all countries of the world other than the Fovea Territory.

 

Section 1.18           “EMEA”.  EMEA shall mean the European Medicines Agency or any successor agency thereto.

 

Section 1.19           “European Union” or “EU”.  European Union or EU shall mean the countries of the European Union, as it is constituted as of the Effective Date and as it may be expanded from time to time.

 

Section 1.20           “Executive Officers”.  Executive Officers shall mean the Chief Executive Officer of Dyax (or a senior executive officer of Dyax designated by Dyax’s Chief Executive Officer) and the Chief Executive Officer of Fovea (or a senior executive officer of Fovea designated by Fovea’s Chief Executive Officer).

 


* Confidential Treatment Requested.  Omitted portions filed with the Commission.

 

3



 

Section 1.21           “FDA”.  FDA shall mean the United States Food and Drug Administration or any successor agency thereto.

 

Section 1.22           “Field”.  Field shall mean the use in humans of a pharmaceutical product as a therapeutic for ophthalmic diseases or conditions.

 

Section 1.23           “Finished Product”.  Finished Product shall mean the finished Product formulation containing API Bulk Drug Substance filled into unit packages for final labeling and packaging.

 

Section 1.24           “First Commercial Sale”.  First Commercial Sale shall mean, with respect to the Product in a country, the first commercial sale of the Product in such country.  Sales for test marketing, Clinical Study purposes or compassionate, named patient or similar use shall not constitute a First Commercial Sale.

 

Section 1.25           “Fovea Intellectual Property”.  Fovea Intellectual Property shall mean Fovea Know-How and Fovea Patent Rights, collectively, and shall specifically exclude the Fovea-Assigned Intellectual Property.

 

Section 1.26           “Fovea Know-How”.  Fovea Know-How shall mean any Know-How that (a) either is Controlled by Fovea on the Effective Date [*****] and (b) is [*****] the Development, Manufacture and/or Commercialization of the Product in the Field as contemplated by this Agreement.  Fovea Know-How shall specifically exclude Know-How included in the Fovea-Assigned Intellectual Property.

 

Section 1.27           “Fovea New Outside IP”.  Fovea New Outside IP shall mean that portion of Fovea Know-How, Fovea Patent Rights and/or Fovea Product Intellectual Property that is not owned by Fovea but comes within Fovea’s Control at any time after the Effective Date during the Term.

 

Section 1.28           “Fovea Patent Rights”.  Fovea Patent Rights shall mean Patent Rights, including Fovea’s rights in Joint Patent Rights, that (a) Cover Fovea Know-How and (b) are Controlled by Fovea on the Effective Date or come within Fovea’s Control during the Term.   Fovea Patent Rights shall specifically exclude Fovea-Assigned Patent Rights.

 

Section 1.29           “Fovea Product Intellectual Property”.  Fovea Product Intellectual Property shall mean (a) any Know-How that (i) either is Controlled by Fovea on the Effective Date or comes within Fovea’s Control during the Term, including Fovea’s rights in Joint Know-How and Fovea Sole Inventions and (ii) that is produced, generated, conceived and/or reduced to practice as a result of Fovea’s Development, Manufacture, Commercialization of the Product or use of the Compound, or that is otherwise used by Fovea in the Development, Manufacture or Commercialization of the Product, and (b) Patent Rights, including Fovea’s rights in Joint Patent Rights, that Cover the Fovea Know-How described in the foregoing clause (a) and are Controlled by Fovea on the Effective Date or come within Fovea’s Control during the Term. Fovea Product Intellectual Property shall specifically exclude the Fovea-Assigned Intellectual Property.

 


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Section 1.30           “Fovea Territory”.  Fovea Territory shall mean (i) all member states of the European Union as constituted on the Effective Date, (ii) those countries listed on Exhibit H hereto and (iii) any country that is not within the scope of the foregoing clauses (i) and (ii) that becomes a member state of the European Union at any time after the Effective Date, provided that, at the time any such country referred to in this clause (iii) becomes a member state of the European Union, the inclusion of such country in the Fovea Territory would not violate or breach any contractual obligation of Dyax to any Third Party under any agreement that is in effect at the time such country becomes a member state of the European Union.

 

Section 1.31           “Fully Allocated Supply Cost”.  Fully Allocated Supply Cost shall mean with respect to API Bulk Drug Substance and/or Finished Product, as the case may be, the manufacturing Party’s internal and external costs, determined in accordance with GAAP, as consistently applied by such manufacturing Party in the ordinary course of its business, incurred in Manufacturing and/or acquiring such API Bulk Drug Substance and/or Finished Product (including but not limited to the following activities during the Term:  process development and validation, manufacturing scale-up and improvements, stability and other product testing and development activities relating to quality assurance and quality control, regulatory affairs activities and product liability insurance), which costs shall include, without limitation (a) the cost of goods produced, which cost shall include [*****] and/or (b) any other costs borne by the manufacturing Party for the [*****].

 

Section 1.32           “GAAP”.  GAAP shall mean United States generally accepted accounting principles.

 

Section 1.33           “Generic Competition”.  Generic Competition shall mean, with respect to a Product in a given country in a given calendar quarter, if, during such calendar quarter, one or more Generic Products shall be commercially available in such country and such Generic Products [*****].

 

Section 1.34           “Generic Product”.  Generic Product shall mean any pharmaceutical product sold by any Person for use in the Field (other than sales of the Product by either Party or its Related Parties in accordance with the terms of this Agreement, whether as a branded product or a generic product) that contains [*****].  For purposes of this Section 1.33, another compound will be considered to [*****].

 

Section 1.35           “IND”.  IND shall mean an Investigational New Drug Application filed with FDA or a similar application to conduct Clinical Studies filed with an applicable Regulatory Authority outside of the United States.

 

Section 1.36           “In-License”.  In-License shall mean an agreement between a Party and a Third Party pursuant to which such Party has (i) pursuant to Section 2.9, licensed Blocking Third Party Patent Rights with the approval of the JSC, or (ii) pursuant to Section 2.8, licensed with the approval of the JSC, Technology owned or controlled by a Collaborator that is to be used in the Development, Manufacture or Commercialization of the Initial Finished Product subject to, and in accordance with, the terms of this Agreement.   Without limiting the generality of the foregoing definition, the [*****] License Agreement shall not be treated for purposes of this Agreement as an In-License.

 

Section 1.37           “Invention”.  Invention shall mean any Know-How that is conceived, reduced to practice and/or developed in the course of performance of activities pursuant to this Agreement.

 


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Section 1.38           “Joint Intellectual Property”.  Joint Intellectual Property shall mean Joint Know-How and Joint Patent Rights, collectively.

 

Section 1.39           “Joint Know-How”.  Joint Know-How shall mean any Know-How that is developed or acquired jointly by the Parties in connection with their activities pursuant to this Agreement, including Joint Inventions.

 

Section 1.40           “Joint Patent Rights”.  Joint Patent Rights shall mean Patent Rights that Cover Joint Inventions.

 

Section 1.41           “Know-How”.  Know-How shall mean any information and materials, whether proprietary or not and whether patentable or not, including without limitation ideas, concepts, inventions, formulas, methods, protocols, procedures, knowledge, know-how, trade secrets, processes, assays, skills, experience, techniques, designs, compositions, plans, documents, results of experimentation and testing, including without limitation, pharmacological, toxicological, and pre-clinical and clinical test data and analytical and quality control data, improvements, discoveries, works of authorship, compounds and biological materials.

 

Section 1.42           “Major European Countries”.  Major European Countries shall mean the collective reference to the United Kingdom, France, Germany, Italy and Spain.

 

Section 1.43           “Manufacturing” or “Manufacture”.  Manufacturing or Manufacture shall mean activities directed to producing, manufacturing, processing, filling, finishing, packaging and labeling a product.

 

Section 1.44           “Net Sales”.  “Net Sales” shall mean, with respect to the Product, the gross invoiced sales of the Product by the Royalty Payor and its Related Parties to Third Parties that are not Related Parties of the Royalty Payor, less the following deductions to the extent included in the gross invoiced sales price for the Product or otherwise directly paid or incurred by such Royalty Payor or its Related Parties with respect to the sale of the Product:

 

[*****]

 

Notwithstanding the foregoing, in any case where the Product is sold or otherwise disposed of in a transaction that is not an arm’s length sale of the Product exclusively for cash that is separate from any sale or disposition of other products or of services, Net Sales shall mean the greatest of:

 

[*****]

 

With respect to sales of Product that is comprised of Compound combined with any other clinically active ingredient or a device (a “Combination Product”), Net Sales shall be calculated on the basis of [*****].   In the event that the Product is sold only as a Combination Product and not sold without other clinically active ingredients or a device, the Parties shall negotiate in good faith another basis on which to calculate Net Sales with respect to a Combination Product that fairly reflects the value of the Product relative to the other clinically active ingredients and/or device in the Combination Product, but in no event shall such calculation result in the [*****]. Notwithstanding anything express or implied in the provisions of the

 


* Confidential Treatment Requested.  Omitted portions filed with the Commission.

 

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foregoing two sentences, in no event shall such provisions be applicable in the event that the use of such other clinically active ingredient or device in any such Combination Product is pursuant to an In-License entered into by either Party pursuant to, and in accordance with, the provisions of Section 2.8 or Section 2.9 hereof.

 

A percentage of the deductions set forth in paragraphs (a) through (d) above equal to the ratio of the Net Sales for the Product to the Net Sales of the entire Combination Product will be applied in calculating Net Sales for a Combination Product.

 

Section 1.45           “Other Related Dyax Licensee”.  Other Related Dyax Licensee shall mean a Third Party to whom Dyax has granted a license or sublicense under the Dyax Intellectual Property, the Fovea Intellectual Property and/or Fovea Product Intellectual Property, as the case may be, to Develop, Manufacture and/or Commercialize the Compound or any product containing the Compound (but not, in any such case, the Product).  For clarity, any Third Party that is an Other Related Dyax Licensee may also be a Related Party of Dyax if such Third Party meets the definition of Related Party.

 

Section 1.46           “Parties”.  Parties shall mean Dyax and Fovea.

 

Section 1.47           “Party”.  Party shall mean either Dyax or Fovea.

 

Section 1.48           “Patent Rights”.  Patent Rights shall mean patents and patent applications and all substitutions, divisions, continuations, continuations-in-part, reissues, reexaminations and extensions thereof, and all counterparts thereof in any country.

 

Section 1.49           “Person”.  Person shall mean any natural person, corporation, firm, business trust, joint venture, association, organization, company, partnership or other business entity, or any government, or any agency or political subdivisions thereof.

 

Section 1.50           “Phase I Clinical Study”.  Phase I Clinical Study shall mean a clinical study of the Product in human volunteers or patients with the endpoint of determining initial tolerance, toxicity, safety and/or pharmacokinetic information, which shall be deemed commenced when the third volunteer or patient in such study has received his or her initial dose of the Product.

 

Section 1.51           “Phase II Clinical Study”.  Phase II Clinical Study shall mean a preliminary efficacy and safety or dose ranging human clinical study of the Product in the target patient population, which shall be deemed commenced when the third patient in such study has received his or her initial dose of the Product.

 

Section 1.52           “Phase III Clinical Study”.  Phase III Clinical Study shall mean a human clinical study to confirm with statistical significance the efficacy and safety of the Product performed to obtain Regulatory Approval for the Product in any country, which shall be deemed commenced when the third patient in such study has received his or her initial dose of the Product.

 

Section 1.53           “Post-Approval Study”.  Post-Approval Study shall mean a clinical study initiated in a country after receipt of Regulatory Approval for the Product in such country.

 


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Section 1.54           Product”.  Product shall mean a product containing or consisting of the Compound for use solely by intra-vitreous delivery via injection.  The definition of Product is subject to expansion pursuant to, and in accordance with, Section 3.1(g) hereof.

 

Section 1.55           Product Trademark(s)”.  Product Trademark(s) shall mean the trademark(s) and service mark(s) as may be proposed by Fovea and approved by the JSC for use in connection with the distribution, marketing, promotion and sale of the Product in the Fovea Territory, and/or accompanying logos, trade dress and/or indicia of origin.

 

Section 1.56           “[*****] License Agreement”.  [*****] License Agreement shall mean the License Agreement effective April 3, 1997 between [*****] and Dyax.

 

Section 1.57           “[*****] Patent Rights”.  [*****] Patent Rights shall mean the Patent Rights listed on Exhibit C-3, which have been licensed to Dyax under the [*****] License Agreement.

 

Section 1.58           Regulatory Approval”.  Regulatory Approval shall mean the approval of the applicable Regulatory Authority necessary for the marketing and sale of the Product for a particular indication in a country, excluding separate pricing and/or reimbursement approvals that may be required.

 

Section 1.59           Regulatory Authority”.  Regulatory Authority shall mean any federal, national, multinational, state, provincial or local regulatory agency, department, bureau or other governmental entity with authority over the marketing and sale of a pharmaceutical product in a country, including without limitation FDA in the United States and EMEA in the EU.

 

Section 1.60           Related Party”.  Related Party shall mean a Party’s Affiliates and permitted Sublicensees; provided that the term Related Party includes only those distributors whose obligations to such Party or Affiliate include responsibility for sales and/or marketing efforts for and on behalf of such Party in a country of the Territory with respect to the Product or sharing of costs and expenses with respect to sales and/or marketing of the Product on behalf of a Party or its Affiliates, and does not include distributors of such Party or its Affiliates who purchase Product from such Party or its Affiliates in an arm’s length transaction and who have no sales or marketing obligation for and on behalf of such Party or its Affiliates with respect to the Product.  For clarity, Fovea and its Affiliates shall not be deemed Related Parties of Dyax and Dyax and its Affiliates shall not be deemed Related Parties of Fovea.

 

Section 1.61           Royalty Payor”.  Royalty Payor shall mean the Party obligated to make royalty or other relevant payments under this Agreement to the other Party.

 

Section 1.62           Royalty Recipient”.  Royalty Recipient shall mean the Party entitled to receive royalty and other relevant payments under this Agreement from the other Party.

 

Section 1.63           Sublicensee”.  Sublicensee shall mean a Third Party to whom a license or sublicense under any Dyax Intellectual Property, Fovea Intellectual Property and/or Fovea Product Intellectual Property, as the case may be, has been granted pursuant to, and in full compliance with all applicable provisions of, this Agreement, to Develop, Manufacture and/or Commercialize the Product, or otherwise grants rights to distribute, promote or sell the Product.  For purposes of clarification, and without limiting the forgoing provisions of this definition, a Sublicensee shall include, for purposes of this

 


* Confidential Treatment Requested.  Omitted portions filed with the Commission.

 

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Agreement, (i) a Third Party to whom Dyax, in full compliance with all applicable provisions of this Agreement, grants a license or sublicense under Dyax Intellectual Property to Develop, Manufacture and/or Commercialize the Product and (ii) a Third Party to whom Fovea, in full compliance with all applicable provisions of this Agreement, grants a license or sublicense under Fovea Intellectual Property and/or Fovea Product Intellectual Property to Develop, Manufacture and/or Commercialize the Product.  Notwithstanding the foregoing, a Distributor shall not be deemed or treated, for purposes of this Agreement, as a Sublicensee.

 

Section 1.64           Territory”.  Territory shall mean with respect to (a) Fovea, the Fovea Territory and (b) Dyax, the Dyax Territory.

 

Section 1.65           Third Party”.  Third Party shall mean any Person other than a Party or any of its Affiliates.

 

Section 1.66           Transfer Price”. Transfer Price shall mean for (a) API Bulk Drug Substance supplied to Fovea for use in [*****]; (b) API Bulk Drug Substance supplied to Fovea for use in [*****]; (c) Finished Product supplied to Dyax for use in [*****]; and (d) Finished Product supplied to Dyax for [*****].  In the event that (i) either Party is not Manufacturing API Bulk Drug Substance or Finished Product, as the case may be, but a Related Party of such Party is acting on behalf of such Party, or an Other Related Dyax Licensee is acting on behalf of Dyax, under Article VI hereof to Manufacture and supply API Bulk Drug Substance or Finished Product, as the case may be, or (ii) either Party has granted to a Related Party any right of such Party to obtain supply of API Bulk Drug Substance or Finished Product, as the case may be, from the other Party pursuant to, and in accordance with, Article VI hereof, then any reference in this definition to such Party shall be deemed to be a reference to such Related Party or such Other Related Dyax Licensee, as the case may be.

 

Section 1.67           United States”.  United States shall mean the United States of America and its territories and possessions.

 

Section 1.68           Valid Claim”.  Valid Claim shall mean a claim (a) of any issued, unexpired patent that has not been revoked or held unenforceable or invalid by a decision of a court or governmental agency of competent jurisdiction from which no appeal can be taken, or with respect to which an appeal is not taken within the time allowed for appeal, and that has not been disclaimed or admitted to be invalid or unenforceable through reissue, disclaimer or otherwise or (b) of any patent application that has not been cancelled, withdrawn or abandoned or been pending for [*****].

 

Section 1.69           Additional Definitions.  Each of the following definitions is set forth in the Section of this Agreement indicated below:

 

Definition

 

Section

 

 

 

1974 Convention

 

13.1

AAA

 

12.3(a)

Agreement

 

Preamble

Alliance Manager

 

2.6

 


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Bankruptcy Code

 

11.2(e)

Breaching Party

 

11.2(b)

Challenging Party

 

11.2(d)

Collaborator

 

2.8

Competitive Infringement

 

8.4(a)

Confidential Information

 

9.1

Controlling Party

 

8.3(a)

Core Development Plan

 

4.2(a)

Core Dyax Patent Rights

 

8.3(a)

Dyax

 

Preamble

Dyax Indemnified Party

 

10.10(a)

Dyax Sole Inventions

 

8.2(a)

Dyax Supply Agreement

 

6.3(a)

Effective Date

 

Preamble

EU Commercialization Opportunity

 

3.1(f)

Existing Dyax Patent Rights

 

10.7(b)

Fovea

 

Preamble

Fovea-Assigned Intellectual Property

 

8.1

Fovea-Assigned Patent Rights

 

10.8(a)

Fovea Indemnified Party

 

10.10(b)

Fovea Sole Inventions

 

8.2(a)

Fovea Supply Agreement

 

6.3(a)

Fovea Trademarks

 

8.8(b)

Global Trademarks

 

8.8(b)

Indemnified Party

 

10.10(c)(i)

Indemnifying Party

 

10.10(c)(i)

Initial Enforcement Rights Party

 

8.4(c)

Initial Finished Product

 

2.8

Initial Notice

 

3.1(f)

Joint Inventions

 

8.2(b)

JSC

 

2.1(a)

Losses

 

10.10(a)

Non-Breaching Party

 

11.2(b)

Prosecuting Party

 

8.3(d)

[*****]

 

1.54

Royalty Term

 

7.1(d)

[*****]

 

4.2(a)

Promotional Materials

 

5.3

Research and Option Agreement

 

Introduction

Secondary Enforcement Rights Party

 

8.4(c)

Severed Clause

 

13.3

Sole Inventions

 

8.2(a)

Specifications

 

Exhibit E

Supplemental Development Plan

 

4.2(a)

Supply Agreement

 

6.3(a)

 


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Technology

 

2.8

Term

 

11.1

Third Party Collaboration Agreements

 

2.8

Working Group

 

2.2

 

ARTICLE II

MANAGEMENT OF AGREEMENT ACTIVITIES

 

Section 2.1            Joint Steering Committee.

 

(a)           Formation; Purposes and Principles.  Within ten days after the Effective Date, Dyax and Fovea shall establish a joint steering committee (the “JSC”), which shall have overall responsibility for the oversight of the Parties’ activities under this Agreement.

 

(b)           Specific Responsibilities.  In addition to its overall responsibility for such oversight as is established by this Agreement, the JSC shall in particular:

 

(i)            review and monitor the clinical and regulatory program of Fovea under the Core Development Plan;

 

(ii)           annually review and approve updates by Fovea to the Core Development Plan, including without limitation, the Clinical Study endpoints, clinical methodology and monitoring requirements for the Clinical Studies described in the Core Development Plan;

 

(iii)          review, discuss and comment on the Parties’ annual Commercialization plans pursuant to, and in accordance with, Section 5.2 hereof;

 

(iv)          review, discuss and comment on the clinical and regulatory program of Dyax under any Supplemental Development Plan provided by Dyax;

 

(v)           annually review, discuss and comment on updates by Dyax to any Supplemental Development Plan;

 

(vi)          review, discuss and comment on each Party’s strategy to seek and obtain Regulatory Approval of the Product, as well as, to the extent consistent with applicable law, related pricing and reimbursement approvals, in the Territory of such Party;

 

(vii)         review and monitor each Party’s progress in seeking and obtaining Regulatory Approval of the Product, as well as related pricing and reimbursement approvals, in the Territory of such Party;

 

(viii)        review, discuss and comment on each Party’s annual Commercialization plan and budget and the Commercialization program and activities of such Party; and

 


* Confidential Treatment Requested.  Omitted portions filed with the Commission.

 

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(ix)           perform such other functions as are expressly provided for elsewhere in this Agreement or as are appropriate to further the purposes of this Agreement as determined by the Parties, including periodic evaluations of performance against goals.

 

Section 2.2             Working Groups.  From time to time, the JSC may establish working groups (each, a “Working Group”) to oversee particular projects or activities, and each such Working Group shall be constituted and shall operate as the JSC determines.

 

Section 2.3             Membership.  Each of the JSC and any Working Groups shall be composed of an equal number of representatives appointed by each of Dyax and Fovea.  The JSC shall initially have three (3) representatives of each Party, but the JSC may change the size of the JSC from time to time by mutual consent of the members of the JSC.  Each Party may replace its JSC and Working Group representatives at any time upon written notice to the other Party. The JSC shall be chaired first by a representative of [*****] for the period from the Effective Date [*****], and thereafter the chairperson position shall rotate [*****] on every other [*****], with Fovea to appoint the chairpersons for the second two-year term, and so forth thereafter.  The chairperson shall be responsible for calling meetings, preparing and circulating an agenda in advance of each meeting, and preparing and issuing minutes of each meeting within [*****] thereafter.

 

Section 2.4             Decision-Making.  The JSC and any Working Group shall [*****].  With respect to decisions of the JSC and any Working Group, the representatives of each Party shall have collectively one vote on behalf of such Party.  Should the members of a Working Group maintain their disagreement on any matter [*****], the matter shall be referred to [*****] for resolution.  [*****]

 

Section 2.5             Meetings of the JSC and Working Groups.  The JSC and any Working Groups shall hold meetings at such times as the JSC shall determine, but in no event shall such meetings of the JSC be held less frequently than [*****].  The JSC and any Working Groups shall meet alternately at Dyax’s facilities in Cambridge, Massachusetts and Fovea’s facilities in Paris, France or at such locations as the Parties may otherwise agree.  Other representatives of each Party or, with approval of the JSC and subject to confidentiality and non-use provisions which are no less stringent than those set forth in Article IX of this Agreement, representatives of Third Parties involved in the Development, Manufacture or Commercialization of the Product in the Field, may attend meetings of the JSC or such Working Group as nonvoting observers.  Meetings of the JSC and any Working Groups may be held by audio or video teleconference with the consent of each Party.  Each Party shall be responsible for all of its own expenses of participating in the JSC and any Working Groups.  No action taken at a meeting of the JSC or a Working Group shall be effective unless a representative of each Party is present or participating.

 

Section 2.6             Alliance Managers.  Each Party shall designate a single alliance manager (“Alliance Manager”) for all of the activities contemplated under this Agreement.  Such alliance managers will be responsible for the day-to-day worldwide coordination of the activities contemplated by this Agreement and will serve to facilitate communication between the Parties.  Such alliance managers shall have experience and knowledge appropriate for managers with such project management responsibilities.  Each Party may change its designated alliance manager from time to time upon notice to the other Party.

 


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Section 2.7             Third Party Performance of Agreement Activities.   Fovea shall be entitled to utilize the services of Third Parties (including Third Party contract research organizations, Third Party contract manufacturing organizations (“CMOs”) and Third Party contract sales organizations (“CSOs”)) to perform its Development activities under the Core Development Plan or to Develop, Manufacture and Commercialize the Product in the Field subject to, and in accordance with, the provisions of this Agreement and the Supply Agreements; provided that (i) except for CMOs being used by Fovea as a result of a supply default of Dyax under Article VI hereof, Dyax shall have the right to approve, such approval to not be unreasonably withheld or delayed, any such CMOs or CSOs and (ii) Fovea shall remain at all times fully liable for its responsibilities under the Core Development Plan, this Agreement and the Supply Agreements.  Fovea shall not use Third Party contract resources to conduct part or all of its obligations under the Core Development Plan, this Agreement or any Supply Agreement unless Fovea’s rights under the agreement with the Third Party guarantee Dyax the same rights under this Agreement or the applicable Supply Agreement, as the case may be, as if Fovea had done the work itself, and any such Third Party agreement shall include confidentiality and non-use provisions which are no less stringent than those set forth in Article IX of this Agreement.  Dyax shall be entitled to utilize the services of Third Parties (including Third Party contract research organizations, Third Party contract manufacturing organizations and Third Party contract sales organizations) to Develop, Manufacture and Commercialize the Product subject to, and in accordance with, the provisions of this Agreement and the Supply Agreements; provided that Dyax shall remain at all times fully liable for its responsibilities under this Agreement and the Supply Agreements.  Dyax shall not use Third Party contract resources to conduct part or all of its obligations under this Agreement or any Supply Agreement unless Dyax’s rights under the agreement with the Third Party guarantee Fovea the same rights under this Agreement or the applicable Supply Agreement, as the case may be, as if Dyax had done the work itself, and any such Third Party agreement shall include confidentiality and non-use provisions which are no less stringent than those set forth in Article IX of this Agreement.

 

Section 2.8             Third Party Technology.  The Parties agree that it may be necessary or desirable to enter into agreements with Third Parties (“Collaborators”) to obtain technology, information, materials, data or know-how, patentable or otherwise, (“Technology”) in order to allow Fovea to manufacture, formulate and/or deliver the initial Finished Product for [*****] and/or to perform its obligations under the Core Development Plan with respect to the Initial Finished Product (such Third Party agreements being hereinafter referred to, collectively, as the “Third Party Collaboration Agreements”).  Such Third Party Collaboration Agreements shall not conflict with the terms and conditions of this Agreement or either Supply Agreement.  In the event that any such Third Party Collaboration Agreements are contemplated in connection with the activities described in the Core Development Plan, the JSC shall discuss, subject to Third Party confidentiality obligations, and agree upon whether or not to enter into such Third Party Collaboration Agreements, and the Core Development Plan and/or any and all applicable Supplemental Development Plans shall be amended to include actions required related to any such Technology, as relevant.  [*****]

 

Section 2.9             In-Licenses of Blocking Third Party Patent Right; Compliance with In-Licenses.

 

[*****]

 


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Section 2.10          Exchange of Information.  In accordance with and subject to the terms of Article IX, on an ongoing basis during the Term:

 

(a)           Dyax shall disclose to Fovea all Dyax Intellectual Property that has not been previously disclosed and shall update such disclosure [*****].

 

(b)           Fovea shall disclose to Dyax all Fovea Intellectual Property and all Fovea Product Intellectual Property that has not been previously disclosed and shall update such disclosure at least semi-annually.

 

(c)           Fovea shall make available its employees, consultants and subcontractors engaged in the performance of its Development, Manufacturing and Commercialization obligations under this Agreement as may be reasonably necessary to consult with Dyax with respect to such activities, upon reasonable notice during normal business hours as coordinated through the Alliance Managers and the JSC.

 

(d)           Dyax shall provide Fovea with such assistance and access to its employees, consultants and subcontractors as may be reasonably necessary to assist Fovea in the performance of Fovea’s Development, Manufacturing and Commercialization obligations under this Agreement, upon reasonable notice during normal business hours as coordinated through the Alliance Managers and the JSC.

 

ARTICLE III

LICENSE GRANTS

 

Section 3.1            Dyax Grants.

 

(a)           Subject to the terms and conditions of this Agreement, Dyax hereby grants to Fovea a co-exclusive (with Dyax) right and license, with the right to grant sublicenses solely as set forth in Section 3.1(e) below, under Dyax Intellectual Property, to Develop the Product in the Field as set forth in this Agreement.  Except pursuant to, and in accordance with, this Agreement, during the Term none of Dyax, its Related Parties or the Other Related Dyax Licensees shall Develop, or grant to any Third Party the right to Develop, the Product for Commercialization or use in the Field in any country of the Fovea Territory.

 

(b)           Subject to the terms and conditions of this Agreement, Dyax hereby grants to Fovea an exclusive right and license (including with respect to Dyax), with the right to grant sublicenses solely as set forth in Section 3.1(e) below, under Dyax Intellectual Property, to Commercialize the Product in the Field in the Fovea Territory.   Consistent with the license granted by Dyax to Fovea pursuant to this Section 3.1(b), during the Term none of Dyax, its Related Parties or the Other Related Dyax Licensees shall Commercialize, or grant to any Third Party the right to Commercialize, the Product in the Field in any country in the Fovea Territory.  Fovea shall have no rights hereunder to Develop or Commercialize, or to grant any Third Party the right to Develop or Commercialize, the Product outside the Field in any country.

 


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(c)           Subject to the terms and condition of this Agreement, Dyax hereby grants to Fovea a non-exclusive right and license, with the right to grant sublicenses solely as set forth in Section 3.1(e) below, under Dyax Intellectual Property, to Manufacture Product for use in the Field, provided that Fovea will not exercise any of its rights granted under this Section 3.1(c) except to the extent permitted pursuant to, and in accordance with, Article VI hereof.  During the Term, none of Dyax, its Related Parties or the Other Related Dyax Licensees shall Manufacture, or grant to any Third Party the right to Manufacture, the Product for use, sale or Commercialization in the Field in any country in the Fovea Territory, except if and to the extent otherwise expressly provided and permitted pursuant to, and in accordance with, Article VI hereof.

 

(d)           The licenses granted by Dyax to Fovea in Sections 3.1(a), (b) and (c), to the extent that they include any sublicense of any In-License of Dyax or of any other in-license of Third Party intellectual property entered into after the Effective Date, are, in all respects, subject to and limited by the terms of such In-License or other in-license, as the case may be.  Dyax hereby represents and warrants to Fovea that the rights and obligations of Fovea set forth in this Agreement do not contravene nor are they inconsistent with or in conflict with the terms of any in-license of Dyax that is in effect as of the Effective Date and that is being sublicensed to Fovea pursuant to any of the foregoing provisions of this Section 3.1.  During the Term, Dyax shall not enter into any In-License or other in-license of Third Party intellectual property having terms that would contravene or be inconsistent or in conflict with the rights of Fovea under this Agreement.  During the Term, Dyax shall not amend, modify or terminate any In-License or other in-license of Third Party intellectual property (including, without limitation, any such in-license that is in effect as of the Effective Date) without the prior written consent of Fovea (which may be granted or withheld by Fovea in its absolute discretion) if such amendment, modification or termination would materially adversely affect any of the rights that Fovea would have under this Agreement if such amendment, modification or termination were not effected.

 

(e)           Fovea shall be entitled to grant sublicenses under the licenses granted in Section 3.1(a), (b) and (c) to Affiliates and Third Parties (including, without limitation, the right to grant further sublicenses); provided, however, that any sublicense to a Third Party shall be subject to Dyax’s prior written approval, not to be unreasonably withheld or delayed.  Notwithstanding the foregoing provisions of this Section 3.1(e) expressed or implied to the contrary, (i) Dyax’s prior written approval shall not be required in connection with any grant to a Third Party of a sublicense under the license granted in Section 3.1(c) if and to the extent such sublicense without Dyax’s prior written approval is permitted pursuant to Article VI hereof, (ii) Dyax’s prior written consent shall not be required in connection with any grant to a Third Party of a sublicense under the license granted in Section 3.1(b) for the sole purpose of allowing such Third Party to act as a Distributor of the Product in the Field in the Fovea Territory and for no other purpose and (iii) in the event that the exercise by Fovea of any of its rights under Section 2.7 hereof in accordance with their respective terms as set forth thereunder shall require that Fovea grant to a Third Party a sublicense under the licenses granted under any of Section 3.1(a), (b) or (c), then Fovea shall be entitled to grant such sublicenses, solely to the extent so required, without the prior written approval of Dyax.

 

(f)            Each permitted sublicense under Section 3.1(e) shall be in writing, shall not contravene or be inconsistent or in conflict with the terms and conditions of this Agreement and shall include provisions (i) requiring the applicable Sublicensee to acknowledge and agree that such sublicense

 


* Confidential Treatment Requested.  Omitted portions filed with the Commission.

 

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is subject to the applicable license(s) granted hereunder and to the terms and conditions of this Agreement, (ii) requiring the applicable Sublicensee to perform all applicable obligations of Fovea hereunder, including, without limitation, any grant-back licenses, indemnification obligations and the obligation to make reports and keep and maintain records of sales to at least the same extent as required of Fovea under this Agreement, and (iii) allowing Dyax the same access and audit rights with respect to such records as permitted with respect to Fovea’s records hereunder.  Fovea shall at all times remain responsible for the performance of its Sublicensees.  Fovea shall provide, or cause to be provided, a copy of each such sublicense to Dyax promptly following execution, which may be reasonably redacted with respect to terms and conditions not relevant to determining compliance with this subsection (f), and with respect to financial terms.

 

(g)           Fovea shall have the right, exercisable at any time during the Term, to request that the definition of Product hereunder be expanded to include [*****]  Dyax shall negotiate reasonably and in good faith with Fovea with respect to any such request for a reasonable period of time not to exceed [*****] after receipt of written request from Fovea.  During the Term, none of Dyax, its Related Parties or the Other Related Dyax Licensees shall Develop or Commercialize, or grant to any Third Party the right to Develop or Commercialize, the Compound (or any product containing the Compound) for [*****].

 

Section 3.2            Fovea Grants.

 

(a)           Subject to the terms and conditions of this Agreement, Fovea hereby grants to Dyax a co-exclusive (with Fovea) right and license, with the right to grant sublicenses solely as set forth in Section 3.2(f) below, under Fovea Intellectual Property and Fovea Product Intellectual Property, to Develop the Product in the Field as set forth in this Agreement.  Except pursuant to, and in accordance with, this Agreement, during the Term none of Fovea or its Related Parties shall Develop, or grant to any Third Party the right to Develop, the Product for Commercialization or use in any field in any country in the Dyax Territory, or for Commercialization or use outside the Field in any country in the Fovea Territory.

 

(b)           Subject to the terms and conditions of this Agreement, Fovea hereby grants to Dyax (i) an exclusive right and license (including with respect to Fovea), with the right to grant sublicenses solely as set forth in Section 3.2(f) below, under Fovea Intellectual Property and Fovea Product Intellectual Property, to Commercialize the Product in the Field in the Dyax Territory and (ii) an exclusive right and license (including with respect to Fovea), with the right to grant sublicenses solely as set forth in Section 3.2(f) below, under Fovea Product Intellectual Property, to Commercialize the Product outside the Field in the Dyax Territory.  Consistent with the license granted by Fovea to Dyax pursuant to this Section 3.2(b), during the Term none of Fovea or its Related Parties shall Commercialize, or grant to any Third Party the right to Commercialize, the Product in any field in any country in the Dyax Territory, or outside the Field in any country in the Fovea Territory.

 

(c)           Subject to the terms and conditions of this Agreement, Fovea hereby grants to Dyax a non-exclusive right and license, with the right to grant sublicenses solely as set forth in Section 3.2(f) below, under Fovea Intellectual Property and Fovea Product Intellectual Property, to Manufacture

 


* Confidential Treatment Requested.  Omitted portions filed with the Commission.

 

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Finished Product, provided that Dyax will not exercise any of its rights granted under this Section 3.2(c) except to the extent permitted pursuant to, and in accordance with, Article VI.

 

(d)           Subject to the terms and conditions of this Agreement, Fovea hereby grants to Dyax a non-exclusive right and license, with the right to grant sublicenses solely as set forth in Section 3.2(f) below, under Fovea Product Intellectual Property to Develop, Manufacture and Commercialize products containing the Compound outside the Field in the Dyax Territory and/or the Fovea Territory.  The non-exclusive right and license granted to Dyax pursuant to this Section 3.2(d) shall be fully paid, except to the extent otherwise expressly provided elsewhere in this Agreement.

 

(e)           The licenses granted by Fovea to Dyax in Sections 3.2(a), (b), (c) and (d), to the extent that they include any sublicense of any In-License of Fovea or of any other in-license of Third Party intellectual property after the Effective Date, are, in all respects, subject to and limited by the terms of such In-License or other in-license.  Fovea hereby represents and warrants to Dyax that the rights and obligations of Dyax set forth in this Agreement do not contravene nor are they inconsistent with or in conflict with the terms of any in-license of Fovea that is in effect as of the Effective Date and that is being sublicensed to Dyax pursuant to any of the foregoing provisions of this Section 3.2.  During the Term, Fovea shall not enter into any In-License or other in-license of Third Party intellectual property having terms that would contravene or be inconsistent or in conflict with the rights of Dyax under this Agreement.  During the Term, Fovea shall not amend, modify or terminate any In-License or other in-license of Third Party intellectual property (including, without limitation, any such in-license that is in effect as of the Effective Date) without the prior written consent of Dyax (which may be granted or withheld by Dyax in its absolute discretion) if such amendment, modification or termination would materially adversely affect any of the rights that Dyax would have under this Agreement if such amendment, modification or termination were not effected.  In addition, notwithstanding anything expressed or implied in any of the foregoing provisions of this Section 3.2 or elsewhere in this Agreement to the contrary, no license is granted by Fovea under Section 3.2(a), (b), (c) or (d) or elsewhere in this Agreement to use any compound, molecule, pharmaceutical composition or development or product candidate developed without use of any Dyax Intellectual Property and owned or Controlled by Fovea as an active pharmaceutical ingredient in combination with the Compound unless such combination is the form of the Product being Developed by Fovea pursuant to the Core Development Plan.

 

(f)            Dyax shall be entitled to grant sublicenses under the licenses granted in Section 3.2(a), (b), (c) and (d) to Affiliates and Third Parties (including, without limitation, the right to grant further sublicenses) without having to obtain the consent or approval of Fovea; provided, however, that each such sublicense shall be in writing, shall not contravene or be inconsistent or in conflict with the terms and conditions of this Agreement and shall include provisions (i) requiring the applicable Sublicensee to acknowledge and agree that such sublicense is subject to the applicable license(s) granted hereunder and to the terms and conditions of this Agreement, (ii) requiring the applicable Sublicensee to perform all applicable obligations of Dyax hereunder, including, without limitation, any grant-back licenses, indemnification obligations and the obligation to make reports and keep and maintain records of sales to at least the same extent as required of Dyax under this Agreement, and (iii) allowing Fovea the same access and audit rights with respect to such records as permitted with respect to Dyax’s records hereunder.  Dyax shall at all times remain responsible for the performance of its Sublicensees.  Dyax shall provide, or cause to be provided, a copy of each such sublicense to Fovea promptly following execution,

 


* Confidential Treatment Requested.  Omitted portions filed with the Commission.

 

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which may be reasonably redacted with respect to terms and conditions not relevant to determining compliance with this subsection (f), and with respect to financial terms.

 

(g)           Notwithstanding anything express or implied in the foregoing provisions of this Section 3.2 or in any other provisions of this Agreement to the contrary,  any Fovea New Outside IP that Fovea Controls and has the right to sublicense to Dyax other than pursuant to an In-License [*****].

 

(h)           [*****]

 

Section 3.3             Dyax Retained Rights.  Any rights of Dyax not expressly granted to Fovea, or otherwise expressly restricted or limited, under the provisions of this Agreement shall be retained by Dyax.   Without limiting the generality of the immediately preceding sentence, Dyax shall retain the right, subject to the provisions of Article IX and Section 10.1 hereof, to (a) exploit and license Dyax Intellectual Property to Develop, Manufacture and Commercialize products containing the Compound within or outside the Field in the Dyax Territory, without any duty to obtain Fovea’s consent for such exploitation or license and, except as expressly provided in this Agreement, with respect to the Development, Manufacture or Commercialization by Dyax of Products in the Dyax Territory, without any duty to account to Fovea for such exploitation or license, (b) exploit and license Dyax Intellectual Property to Develop, Manufacture and Commercialize products containing the Compound outside the Field in the Fovea Territory, without any duty to account to Fovea or obtain Fovea’s consent for such exploitation, (c) exploit Dyax Intellectual Property for purposes unrelated to products containing the Compound, without any duty to account to Fovea or obtain Fovea’s consent for such exploitation, and (d) participate in the Development, Manufacture and Commercialization of the Product in accordance with this Agreement and any Supplemental Development Plan, and otherwise to exercise Dyax’s rights and perform Dyax’s obligations under this Agreement and/or the Supply Agreements, as applicable.

 

Section 3.4             Fovea Retained Rights.  Any rights of Fovea not expressly granted to Dyax, or otherwise expressly restricted or limited, under the provisions of this Agreement shall be retained by Fovea.   Without limiting the generality of the immediately preceding sentence, Fovea shall retain the right, subject to the provisions of Article IX and Section 10.1 hereof, to (a) exploit and license Fovea Intellectual Property and Fovea Product Intellectual Property for purposes unrelated to products containing the Compound, without any duty to account to Dyax or obtain Dyax’s consent for such exploitation or license, and (b) participate in the Development, Manufacture and Commercialization of the Product in accordance with this Agreement and the Core Development Plan, and otherwise to exercise Fovea’s rights and perform Fovea’s obligations under this Agreement and/or the Supply Agreements, as applicable.

 

ARTICLE IV

DEVELOPMENT

 

Section 4.1            Current Status; Certain Product Requirements.

 

(a)           Prior to the Effective Date, Dyax has independently completed one and initiated a second Phase III Clinical Study of the Compound for the treatment of hereditary angioedema, as well as

 


* Confidential Treatment Requested.  Omitted portions filed with the Commission.

 

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a Phase I/II Clinical Study of the Compound in patients undergoing on-pump cardiothoracic surgery.  As of the Effective Date, no clinical studies of the Compound in the Field have been initiated.

 

(b)           The Product formulation Commercialized by Fovea or its Related Parties under this Agreement shall be different from (i) the formulations of the Compound that have been developed prior to the Effective Date and (ii) any and all formulations of the Compound (or any product containing the Compound) that are Developed and/or Commercialized by Dyax and its Related Parties for use outside the Field.

 

Section 4.2            Development Plans; Amendments; Development Responsibilities.

 

(a)           The Development of the Product in the Field shall be governed by the “Core Development Plan” and the “Supplemental Development Plan.” The Core Development Plan, a copy of which shall be attached hereto as Exhibit B within sixty (60) days after the Effective Date, shall initially set forth a plan for Developing the Product for [*****], as well as strategies and timelines for completing such activities.

 

(i)            The Core Development Plan shall be updated and modified from time to time to cover all the Development activities reasonably necessary in order to develop a formulation and packaging of the Product meeting the requirements of Section 4.1(b).  [*****] Thereafter, the Core Development Plan shall also be updated and modified from time to time to reflect all Development activities planned by Fovea to obtain Regulatory Approval of such Product in the Field in the Fovea Territory, as well as to include any changes or modifications planned by Fovea to such Development activities and any changes or modifications that Fovea is required to implement pursuant to the provisions set forth below in this Section 4.2(a)(i).

 

Subject to the provisions of clauses (x) and (y) set forth below in this Section 4.2(a)(i), Fovea shall be obligated, based on applicable input from EMEA and FDA and Dyax, to update the design of the Development activities covered by the Core Development Plan so that, to the extent reasonably feasible from a regulatory and scientific perspective, the data generated in connection with such Development activities shall be sufficient to support Regulatory Approval in the United States of the Product [*****]. Notwithstanding anything expressed or implied in this Agreement to the contrary, (x) the Development activities of Fovea pursuant to this Agreement as set forth in the Core Development Plan shall be only with respect to the Product in the form (including, without limitation, the formulation) being Developed by Fovea for the purpose of applying for Regulatory Approval in the Fovea Territory and, in the event that the United States or any other country in the Dyax Territory requires a form of the Product (including, without limitation, the formulation thereof) that is different in any way from the form of the Product being developed by Fovea hereunder for the purpose of applying for Regulatory Approval in the Fovea Territory, Fovea shall have no obligation to make any change in the form of such Product being developed by Fovea or to perform any Development activities of any kind with any form of the Product that is different in any way from the form of such Product being developed by Fovea, and (y) Fovea shall have no obligation to conduct any Post-Approval Study required or requested by Dyax or by any Regulatory Authority in any country of the Dyax Territory or to change, modify or otherwise conduct any Post-Approval Study required or requested by any Regulatory Authority in any country of the Fovea Territory or that Fovea is otherwise conducting or planning to conduct for purposes of generating data

 


* Confidential Treatment Requested.  Omitted portions filed with the Commission.

 

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from such Post-Approval Study by Fovea that would satisfy the requirements or needs of Dyax or any Regulatory Authority in the Dyax Territory.

 

(ii)           The Supplemental Development Plan shall cover all the Development activities, including, without limitation, any new or additional Clinical Studies or any new or additional cohort of subjects or “arms” to be added to any Clinical Study, that Dyax plans to pursue at its sole discretion and that are conducted in connection with the Regulatory Approval of the Product in the Field in the United States and the other countries within the Dyax Territory.  For clarity, nothing in this Section 4.2(a)(ii) shall limit any of Fovea’s obligations under this Section 4.2(a) and nothing in this Agreement shall obligate Dyax to conduct any such Development activities.

 

(b)           Fovea shall be responsible for the Development activities set forth in the Core Development Plan.  The JSC shall review and monitor the clinical and regulatory program for the Product under the Core Development Plan.  Fovea shall review the Core Development Plan not less frequently than annually and shall develop detailed and specific Core Development Plan updates, which shall include annual budgets, for each calendar year until the completion of the Product Development activities covered by the Core Development Plan.  Fovea shall submit all such updates to the JSC for review and approval no later than [*****] and, upon the JSC’s approval, such updates shall be appended to the Core Development Plan. Each Party may also develop and submit to the JSC from time to time other proposed substantive amendments to the Core Development Plan.  The JSC shall review proposed amendments to the Core Development Plan presented by a Party at the next scheduled meeting of the JSC, or earlier if the JSC so agrees, and may approve such proposed amendments and/or any other proposed amendments that the JSC may consider from time to time in its discretion and, upon such approval by the JSC, the Core Development Plan shall be amended accordingly.

 

(c)           Dyax shall be responsible for the Development activities set forth in any Supplemental Development Plan proposed by Dyax.  The JSC shall review, discuss and comment on the clinical and regulatory programs for the Product under any Supplemental Development Plan but shall have no authority to approve or disapprove of the Supplemental Development Plan or the Development activities of Dyax under the Supplemental Development Plan and Dyax shall have no obligation to make any changes to the Supplemental Development Plan in response to any comments from the JSC. Dyax shall review any Supplemental Development Plan not less frequently than annually and shall develop Supplemental Development Plan updates for each calendar year until the completion of the Product Development activities covered by any such Supplemental Development Plan.

 

(d)           Neither Fovea nor its Related Parties shall, directly or through any Third Party, initiate, sponsor, fund, supply Product for, or otherwise conduct any Clinical Study of the Product not described in the then-effective Core Development Plan without the prior written approval of Dyax.

 

Section 4.3            Development Efforts; Manner of Performance; Reports.

 

(a)           Fovea shall use Diligent Efforts to execute and to perform, or cause to be performed, the activities for which it is responsible under the Core Development Plan and to cooperate with Dyax in carrying out the Core Development Plan, in good scientific manner and in compliance with all applicable laws and regulations and good clinical and laboratory practice.

 


* Confidential Treatment Requested.  Omitted portions filed with the Commission.

 

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(b)           Fovea will keep Dyax fully informed as to its progress, results (including the development of any technology or inventions), status and plans for performing and implementing the Core Development Plan.  In addition, within [*****], Fovea will provide to the JSC a written progress report, which will describe the Development activities that Fovea has performed or caused to be performed during [*****], evaluate the work performed in relation to the goals of the Core Development Plan, and provide such other information as may be required by the Core Development Plan or reasonably requested by the JSC with respect to such Development activities.

 

(c)   Dyax will keep Fovea reasonably informed as to its progress, results (including the development of any technology or inventions), status and plans for performing and implementing any Supplemental Development Plan.

 

Section 4.4            Regulatory Submissions and Regulatory Approvals.

 

(a)           Fovea shall own all regulatory submissions, including all applications, for Regulatory Approvals of the Product in the Field in the Fovea Territory, and shall be responsible for seeking and obtaining all Regulatory Approvals of the Product in the Field in the Fovea Territory as provided in the Core Development Plan.  Dyax shall own all regulatory submissions, including all applications, for Regulatory Approvals of the Product in the Dyax Territory and shall, at Dyax’s sole discretion, be solely responsible for seeking and obtaining all Regulatory Approvals for the Product in the Dyax Territory.  Each Party shall have access to all data contained or referenced in such submissions or applications for Regulatory Approvals of the Product, including without limitation all reports, correspondence and conversation logs, in each case as may be reasonably necessary to enable (i) Fovea to exercise its rights, and fulfill its obligations, under this Agreement to Develop, Manufacture and Commercialize the Product in the Field in the Fovea Territory and to perform its obligations under the Core Development Plan, and (ii) Dyax to Develop, Manufacture and Commercialize the Product outside the Fovea Territory and to exercise its retained rights with respect to all products containing the Compound.  Each Party shall provide appropriate notification of such right of the other Party to the Regulatory Authorities.

 

(b)           In the event that Fovea fails to use Diligent Efforts to seek any Regulatory Approval of the Product in any country of the Fovea Territory as provided in the Core Development Plan, Dyax shall have the right to seek such Regulatory Approval, in Dyax’s or Fovea’s name, upon [*****] prior notice to Fovea and in such case Fovea shall cooperate with Dyax’s efforts to obtain such Regulatory Approval in any such country and, if necessary, shall designate Dyax as its agent for such purpose; provided that, if Fovea provides Dyax with assurances reasonably satisfactory to Dyax of Fovea’s plan for immediately resuming Diligent Efforts to obtain such Regulatory Approval of the Product within such [*****] period, then Dyax shall not undertake such efforts to obtain such Regulatory Approval for so long as Fovea continues to use Diligent Efforts to obtain such Regulatory Approval.

 

(c)           Dyax will have the right to participate in all material meetings and other contact with Regulatory Authorities pertaining to Development or Regulatory Approval of the Product in the Fovea Territory.  To the extent reasonably possible and practicable, Fovea shall provide Dyax with reasonable advance notice of all such meetings and other contact and advance copies of all related documents and other relevant information relating to such meetings or other contact.  Fovea will have the

 


* Confidential Treatment Requested.  Omitted portions filed with the Commission.

 

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right to participate in all material meetings and other contact with Regulatory Authorities pertaining to Development or Regulatory Approval of the Product in the Field in the Dyax Territory but only if and to the extent such participation would be reasonably useful to the development of the Product in the Field in the Fovea Territory.  To the extent reasonably possible and practicable, Dyax shall provide Fovea with reasonable advance notice of all such meetings and other contact and advance copies of all related documents and other relevant information relating to such meetings or other contact.

 

(d)           Each Party shall provide the other Party with drafts (in English) of any material documents or other material correspondence pertaining to Regulatory Approvals of the Product in the Field in such Party’s Territory to be submitted by such Party to Regulatory Authorities, including without limitation any proposed labeling, sufficiently in advance of submission so that the other Party may review and comment on such documents and other correspondence and have a reasonable opportunity to influence the substance of such submissions in a manner consistent with the goal of obtaining Regulatory Approvals of the Product in the Field in the Territory of the submitting Party as quickly as reasonably practicable.  The non-submitting Party’s approval of such submissions shall not be unreasonably withheld or delayed.  Each Party shall promptly provide to the other Party copies (in English) of any material documents or other material correspondence pertaining to the Product in the Field, including without limitation all proposed labeling, received from Regulatory Authorities in the Territory of the submitting Party.  Each Party shall promptly provide the other Party with copies of all other material documents and correspondence pertaining to the Product in the Field after they have been submitted to, or received from, Regulatory Authorities in the Territory of the submitting Party.

 

(e)           Each Party shall have the right to make regulatory submissions and applications (including, without limitation, the filing of an IND) in the Territory of the other Party if and to the extent that such regulatory submissions and applications are required for purposes of such Party performing or carrying out its Development activities pursuant to, and in accordance with, the provisions of this Agreement.  Unless otherwise agreed by the Parties, each Party shall own all INDs filed by it for purposes of performing its Development responsibilities with respect to the Product as permitted under this Agreement.  Each Party shall have the right to cross-reference and make any other use of the other Party’s INDs for the Product that it would have if it were the owner, including without limitation access to all data contained or referenced in such INDs, in each case as may be reasonably necessary to enable such Party to Develop, Manufacture or Commercialize the Product in and for its Territory in accordance with the terms of this Agreement.

 

(f)            Fovea and its Affiliates shall take the lead in all pricing and reimbursement approval proceedings relating to the Product in the Fovea Territory.  Dyax and its Affiliates shall control all pricing and reimbursement approval proceedings relating to the Product in the Dyax Territory.  To the extent consistent with applicable law, Dyax shall have the right to attend all meetings between Fovea and Regulatory Authorities relating to pricing and reimbursement approvals relating to the Product in the Fovea Territory.  To the extent consistent with applicable law, Fovea shall provide Dyax with reasonable advance notice of all such meetings and advance copies of all related documents and other relevant information relating to such meetings or proceedings.  At a reasonable time prior to any meeting between a Party and Regulatory Authorities relating to the pricing and reimbursement approvals for the Product in such Party’s Territory, to the extent consistent with applicable law, such Party shall solicit the other Party’s input and feedback on the substantive issues to be discussed by such Party with the applicable

 


* Confidential Treatment Requested.  Omitted portions filed with the Commission.

 

22



 

Regulatory Authorities at such meeting with respect to pricing and reimbursement approvals in the Territory of such Party.  To the extent consistent with applicable law, each Party shall provide the other Party with drafts of all submissions relating to pricing and reimbursement approvals relating to the Product in the Territory of such Party (in English) for the other Party’s review and comment prior to their submission.  Furthermore, to the extent consistent with applicable law, Fovea shall provide Dyax with copies (in English) of any material documents or other material correspondence pertaining to pricing and reimbursement approvals relating to the Product in the Major European Countries, and upon request, the remaining countries of the Fovea Territory, and Dyax shall, to the extent consistent with applicable law, provide Fovea with copies (in English) of any material documents or other material correspondence pertaining to pricing and reimbursement approvals relating to the Product in the United States.

 

(g)           At each meeting of the JSC, each Party shall make a presentation regarding (i) such Party’s strategy relating to seeking and obtaining Regulatory Approval of the Product, and (ii) such Party’s progress in seeking and obtaining Regulatory Approval of the Product in such Party’s Territory.  At each meeting of the JSC, each Party shall also provide to the JSC an update of such Party’s past and future planned interactions with Regulatory Authorities with respect to matters relevant to Regulatory Approval of the Product in such Party’s Territory.  At each meeting of the JSC, the JSC shall discuss each Party’s strategy and progress in seeking and obtaining Regulatory Approval of the Product in such Party’s Territory, as well as such Party’s past and future planned interactions with Regulatory Authorities, and the JSC shall have the opportunity to comment on and provide substantive feedback to each Party on such matters.

 

Section 4.5             Complaints; Adverse Event Reporting Procedures; Notice of Adverse Events Affecting the Product.  Each Party will maintain a record of any and all complaints it receives with respect to the Product.  Each Party will notify the other Party in reasonable detail of any complaint received by the Party with respect to the Product within sufficient time to allow the other Party and its Related Parties to comply with any and all regulatory and other requirements imposed upon them in any jurisdiction in which the Product is being marketed or tested in Clinical Studies.  Each Party will (a) provide the other Party with all adverse event information and safety data relating to the Product in its control necessary or desirable for the other Party to comply with all applicable laws, rules and regulations with respect to the Product and (b) report and provide such information to the other Party in such a manner and time so as to enable the other Party to comply with all applicable laws, rules and regulations.  Dyax shall maintain a global adverse event database for the Compound and shall generate adverse event reports for Fovea’s use in the Fovea Territory.  Fovea shall have access to all data in the global adverse event database. Fovea shall have access to all data in the global adverse event database. Fovea shall reimburse Dyax for [*****] of Dyax’s internal and external costs and expenses of maintaining the global adverse event database, within thirty (30) days of receipt of an invoice from Dyax, which invoices shall be provided on an annual basis.  Each Party shall be responsible for submitting adverse event reports with respect to the Product to the applicable Regulatory Authorities in its own Territory. In addition, each Party shall promptly notify the other if such Party becomes aware of any information or circumstance that are likely to have a material adverse effect on the Development, Manufacture or Commercialization of the Product in the other Party’s Territory. Within six (6) months after the Effective Date the Parties will develop and agree in writing upon safety data exchange procedures governing the coordination of collection, investigation, reporting, and exchange of information concerning any adverse experiences, and

 


* Confidential Treatment Requested.  Omitted portions filed with the Commission.

 

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any product quality and product complaints involving adverse experiences, related to the Product, sufficient to enable each Party to comply with its legal and regulatory obligations.

 

Section 4.6            Development Costs.  Fovea shall bear 100% of the Development Costs incurred in the performance of the Core Development Plan.  Dyax shall bear 100% of the Development Costs incurred in the performance of the Supplemental Development Plan.

 

Section 4.7            Diligent Efforts; Compliance.

 

(a)           Fovea shall use Diligent Efforts to perform its Development activities under the Core Development Plan in accordance with this Agreement.

 

(b)           Fovea’s Diligent Efforts shall include the following minimum requirements:

 

(i)            at least one of the following shall occur in each calendar year during the Term and Fovea’s failure to achieve these requirements shall be deemed a material breach of this Agreement [*****]; and

 

(ii) subject to provisions of Section 4.7(c), Fovea’s Diligent Efforts shall include the achievement of the following Development milestones, and Fovea’s failure to achieve these milestones shall be deemed a material breach of this Agreement : [*****].

 

(c)           Notwithstanding the foregoing, Fovea may extend the period for completion of any Development milestone described in Section 4.7(b)(ii) above by up to [*****].

 

(d)           Each Party shall conduct the Development, Manufacture and Commercialization of the Product in accordance with all applicable laws, rules and regulations, including without limitation, current governmental regulations concerning good laboratory practices, good clinical practices and good manufacturing practices.

 

ARTICLE V

COMMERCIALIZATION

 

Section 5.1            [*****].  Fovea shall [*****] Commercialize the Product in the Field in the Fovea Territory and shall bear all costs and expenses of Commercializing the Product in the Field in the Fovea Territory.

 

Section 5.2            Commercialization Plans.  Upon filing by Fovea for Regulatory Approval for the Product in the Fovea Territory, Fovea shall develop an annual Commercialization plan (including a budget) for the Product in the Fovea Territory.  Such Commercialization plan shall include, without limitation, a strategy for obtaining Product pricing and reimbursement approvals in the Fovea Territory.  Fovea shall submit its Commercialization plan to the JSC for review, discussion and commentary.  The Commercialization plan of Fovea, and particularly the plans and budgets for the Major European Countries, shall contain sufficient detail with respect to Commercialization tactics and other matters to enable the JSC to conduct a meaningful review of such plan.  Upon filing by Dyax for Regulatory

 


* Confidential Treatment Requested.  Omitted portions filed with the Commission.

 

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Approval for the Product in the Dyax Territory, Dyax shall submit a Commercialization plan for the Dyax Territory to the JSC for review and discussion. Such Commercialization plan shall include, without limitation, a strategy for obtaining Product pricing and reimbursement approvals in the Dyax TerritoryThe JSC shall review, discuss and comment on the Commercialization plan of each Party and on each Party’s Commercialization program and activities for the Product under such Party’s Commercialization plan but the JSC shall have no authority to approve or disapprove of either Party’s Commercialization plan or the Commercialization program and activities of either Party under such Party’s Commercialization plan and neither Party shall have any obligation to make any changes to its Commercialization plan or to its Commercialization program or activities in response to any comments from the JSC.  Notwithstanding any other provision of this Agreement, Fovea shall be solely responsible for all decisions regarding the prices charged for the Product in the Fovea Territory, and Dyax shall be solely responsible for all decisions regarding the prices charged for the Product in the Dyax Territory.

 

Section 5.3             Advertising and Promotional Materials.  Fovea shall be responsible for the creation, preparation, production, reproduction and filing with the applicable Regulatory Authorities, of relevant written sales, promotion and advertising materials relating to the Product (“Promotional Materials”) for use in the Fovea Territory.  All such Promotional Materials shall be compliant with all applicable laws, rules and regulations, and any guidelines established by the pharmaceutical industry in the applicable country, and consistent with the Commercialization plan for the Fovea Territory.  [*****] Dyax shall be responsible for the creation, preparation, production, reproduction and filing with the applicable Regulatory Authorities of Promotional Materials for use in the Dyax Territory.  All such Promotional Materials of Dyax shall be compliant with all applicable laws, rules and regulations, and any guidelines established by the pharmaceutical industry in the applicable country, and consistent with the Commercialization plan for the Dyax Territory.  [*****] Neither Party shall make any medical or promotional claims for the Product other than as permitted by applicable laws, rules and regulations.  When distributing information related to the Product or its use (including information contained in scientific articles, reference publications and publicly available healthcare economic information), each Party shall comply with all applicable laws, rules and regulations and any guidelines established by the pharmaceutical industry in the applicable country in the Territory of such Party.

 

Section 5.4             Sales and Distribution.  Each Party and its Related Parties shall be responsible for booking sales and shall warehouse and distribute the Product in its own Territory.  If a Party receives any orders for the Product in the other Party’s Territory, it shall refer such orders to the other Party.  Moreover, each Party and its Related Parties shall be solely responsible handling all returns of the Product, as well as all aspects of Product order processing, invoicing and collection, distribution, inventory and receivables, in it own Territory.

 

Section 5.5             Recalls, Market Withdrawals or Corrective Actions.   In the event that any Regulatory Authority issues or requests a recall or takes a similar action in connection with the Product in a Territory, or in the event either Party determines that an event, incident or circumstance has occurred that may result in the need for a recall or market withdrawal in its own Territory, the Party notified of such recall or similar action, or the Party that desires such recall or similar action, shall within twenty-four (24) hours advise the other Party thereof by telephone or facsimile.  Each Party, in consultation with the other Party, shall decide whether to conduct a recall in its own Territory and the manner in which any such recall shall be conducted (except in the case of a government mandated recall, when such Party may

 


* Confidential Treatment Requested.  Omitted portions filed with the Commission.

 

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act without such advance notice but shall notify the other Party as soon as possible).  Each Party shall bear the expense of any such recall in its own Territory, provided that this will not limit any remedy that such Party may otherwise have against the other Party in connection with such recall.  Each Party will make available all of its pertinent records that may be reasonably requested in order to effect a recall in the other Party’s Territory.

 

ARTICLE VI

MANUFACTURE AND SUPPLY

 

Section 6.1            Supply by Dyax.

 

(a)           Development Stage.  At the written request of Fovea, which request may be made at any time and from time to time after the Effective Date and shall in any event be made by Fovea with sufficient advance notice to be commercially reasonable (or with such other period of advance notice as the Parties may otherwise agree), Dyax shall use Diligent Efforts to Manufacture and supply API Bulk Drug Substance to Fovea in sufficient quantities to satisfy the reasonable requirements of Fovea and its Related Parties (i) for use thereof in Development activities of the Product conducted in accordance with the Core Development Plan and (ii) for use in the Manufacture of Finished Product by Fovea pursuant to Section 6.2(a) below.  Dyax shall not be deemed or treated as being in breach of any of its obligations under this Section 6.1(a) to use Diligent Efforts to supply API Bulk Drug Substance to Fovea in the case of [*****].

 

(b)           Commercialization Stage.  At the written request of Fovea, which request shall be made at least [*****] prior to the reasonably expected date of First Commercial Sale of the Product in the Fovea Territory, Dyax shall use Diligent Efforts to Manufacture and supply API Bulk Drug Substance to Fovea in sufficient quantities to meet all of the requirements of Fovea and its Related Parties for use thereof in the Manufacture of Finished Product for (i) commercial sale in the Fovea Territory and (ii) supply to Dyax for commercial sale in the Dyax Territory, provided that the foregoing obligation of Dyax to use Diligent Efforts shall be subject to the provisions of Exhibit E hereto.  Any request as provided above that requires production of another batch of API Bulk Drug Substance shall in any event be made by Fovea with at least [*****] advance notice (or such other period of advance notice as may be set forth in the Dyax Supply Agreement or as the Parties may otherwise agree).

 

(c)           Price.  Fovea shall pay Dyax, or cause Dyax to be paid, the applicable Transfer Price for any such API Bulk Drug Substance ordered by Fovea.

 

(d)           Termination of Supply.  The obligations of Dyax under this Section 6.1 may be terminated by Dyax by giving written notice to Fovea that Dyax is terminating its supply obligations under this Section 6.1, in which case such obligations of Dyax shall terminate on the earlier of (i) the date on which Fovea and/or its Related Parties have established an alternative source of supply of API Bulk Drug Substance that can replace, without material interruption or delay, Dyax’ supply of API Bulk Drug Substance pursuant to this Section 6.1 and (ii) the [*****] that Dyax gives written notice of termination to Fovea pursuant to the foregoing provisions of this Section 6.1(d); provided, however, that, notwithstanding the foregoing, in no event shall Dyax’ obligations under this Section 6.1 terminate unless

 


* Confidential Treatment Requested.  Omitted portions filed with the Commission.

 

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and until Dyax and all of its Related Parties and the Other Related Dyax Licensees have discontinued all Manufacturing of API Bulk Drug Substance.   In the event that, at any time during the period in which Dyax has an obligation to supply API Bulk Drug Substance pursuant to this Section 6.1, Dyax is unable to supply sufficient quantities of API Bulk Drug Substance to meet the reasonable requirements of Fovea and its Related Parties for use thereof in connection with the purposes and activities set forth in Section 6.1(a) or (b) as indicated in any good faith forecasts to be provided pursuant to the Dyax Supply Agreement or this Section 6.1, then Fovea shall have the right (but not the obligation) to Manufacture API Bulk Drug Substance solely for such purposes and activities.  Fovea may exercise its rights under this Section 6.1(d) with respect to API Bulk Drug Substance by giving thirty (30) days prior written notice to Dyax.  Fovea may also exercise its rights under this Section 6.1(d) upon the effective date of any termination by Dyax of its supply obligations as provided above.  The exercise by Fovea of any of its rights under this Section 6.1(d) shall not relieve Dyax of its supply obligations under this Section 6.1.  Upon receipt by Dyax of written notice from Fovea to the effect that Fovea is exercising its rights under this Section 6.1(d), Dyax shall provide reasonable assistance, at Fovea’s expense, to enable Fovea to Manufacture or have Manufactured and supplied API Bulk Drug Substance.  [*****]

 

(e)           Limitations on Use.  Any API Bulk Drug Substance Manufactured by or on behalf of Fovea pursuant to Section 6.1(d) may be used solely in Development activities of the Product conducted in accordance with the Core Development Plan, in Commercialization activities for the Product conducted in accordance with the terms of this Agreement, or in the Manufacture and supply of Finished Product by Fovea pursuant to Section 6.2 below.  Upon exercise by Fovea of its rights under Section 6.1(d) with respect to API Bulk Drug Substance, Fovea may elect to satisfy some or all of the future requirements that it and its Related Parties may have with respect to API Bulk Drug Substance through its own Manufacturing efforts pursuant to Section 6.1(d) hereof.

 

Section 6.2            Supply by Fovea.

 

(a)           Development Stage.  From and after the time when the Development activities of the Parties under the Core Development Plan or any Supplemental Development Plan require the availability of Finished Product, Fovea shall use Diligent Efforts (x) to Manufacture Finished Product in sufficient quantities to meet the requirements of Fovea and its Related Parties for use thereof in Development activities of the Product conducted in accordance with the Core Development Plan and (y) to Manufacture and supply to Dyax Finished Product in sufficient quantities to meet the reasonable requirements of Dyax and its Related Parties for use thereof in Development activities of the Product conducted pursuant to any Supplemental Development Plan, provided that Dyax shall have made a written request for such quantities of Finished Product with sufficient advance notice to be commercially reasonable (or with such other period of advance notice as the Parties may otherwise agree).  Dyax shall provide Fovea with good faith written forecasts of such reasonable requirements at such time or times as Fovea may reasonably request or as required pursuant to the Fovea Supply Agreement.

 

(b)           Commercialization Stage.  As soon as practicable after Fovea requests that Dyax supply Fovea with API Bulk Drug Substance pursuant to Section 6.1(b) hereof, Fovea shall use Diligent Efforts (x) to Manufacture Finished Product in sufficient quantities to meet all of the requirements of Fovea and its Related Parties for commercial sale thereof in the Fovea Territory and (y) to Manufacture and supply Finished Product to Dyax in sufficient quantities to meet all of the requirements of Dyax and

 


* Confidential Treatment Requested.  Omitted portions filed with the Commission.

 

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its Related Parties for commercial sale thereof in the Dyax Territory, provided that Dyax shall have made a written request for such quantities of Finished Product with sufficient advance notice to be commercially reasonable (or with such other period of advance notice as the Parties may otherwise agree).  Dyax shall provide Fovea with good faith written forecasts of such reasonable requirements at such time or times as Fovea may reasonably request or as required pursuant to the Fovea Supply Agreement.

 

(c)           Price.  Dyax shall pay Fovea, or cause Fovea to be paid, the applicable Transfer Price for any Finished Product ordered by Dyax.

 

(d)           Conditions.  Notwithstanding anything express or implied in the foregoing provisions of this Section 6.2 or elsewhere in this Agreement to the contrary, (A) the Finished Product that Fovea is required to Manufacture and supply to Dyax pursuant to this Section 6.2 shall be the same as the Finished Product Manufactured by Fovea to meet the requirements of Fovea and/or its Related Parties for Finished Product at the relevant stage of Development or Commercialization, (B) Fovea’s obligations to Manufacture and supply units of Finished Product pursuant to this Section 6.2 is subject to the condition precedent that, if Dyax is supplying API Bulk Drug Substance to Fovea, Dyax shall have filled all orders for API Bulk Drug Substance placed under the Dyax Supply Agreement or Section 6.1 hereof to allow Manufacture and supply of such units of Finished Product (after giving effect to the provisions set forth above in Section 6.1(a) and Exhibit E, as relevant, with respect to shortages of API Bulk Drug Substance), and (C) Fovea shall not be deemed or treated as being in breach of any of its obligations under this Section 6.2 to use Diligent Efforts to Manufacture and/or supply Finished Product in the case of any failure or inability of Fovea to Manufacture and/or supply or cause to be Manufactured and/or supplied Finished Product pursuant to this Section 6.2 if (i) such failure or inability is due to a shortage of Finished Product and the available supply of Finished Product, if any, is allocated by Fovea between the Parties on a pro-rata basis based on good faith forecasts of the respective requirements of the Parties and their Related Parties, which, in the case of the requirements of Dyax and its Related Parties, shall have been provided by Dyax to Fovea in writing [*****] and (ii) Fovea uses Diligent Efforts to resolve all failure to Manufacture and/or supply issues as promptly as possible in consultation with Dyax.

 

(e)           Termination of Supply.  The obligations of Fovea under this Section 6.2 to supply Finished Product to Dyax may be terminated by Fovea by giving written notice to Dyax that Fovea is terminating such obligations under this Section 6.2, in which case such obligations of Fovea shall terminate on the earlier of (i) the date on which Dyax and/or its Related Parties have established an alternative source of supply of Finished Product that can replace, without material interruption or delay, Fovea’s supply of Finished Product pursuant to this Section 6.2 and (ii) the [*****] that Fovea gives written notice of termination to Dyax pursuant to the foregoing provisions of this Section 6.2(e); provided, however, that, notwithstanding the foregoing, in no event shall Fovea’s obligations under Section 6.2(a) or (b) to supply Finished Product to Dyax terminate unless and until Fovea and all of its Related Parties have discontinued all Manufacturing of Finished Product. In the event that, at any time during the period in which Fovea has an obligation to supply Finished Product to Dyax pursuant to Section 6.2(a) or (b) above, Fovea is unable to supply or have supplied sufficient quantities of Finished Product to meet the reasonable requirements of Dyax and its Related Parties for use thereof in connection with the purposes and activities set forth in Section 6.2(a) or (b), as applicable, as indicated in good faith forecasts to be provided by Dyax pursuant to the Fovea Supply Agreement or this Section 6.2, then Dyax

 


* Confidential Treatment Requested.  Omitted portions filed with the Commission.

 

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shall have the right (but not the obligation) to Manufacture Finished Product solely for such purposes and activities.  Dyax may exercise its rights under this Section 6.2(e) with respect to Finished Product by giving thirty (30) days prior written notice to Fovea.  Dyax may also exercise its rights under this Section 6.2(e) upon the effective date of any termination by Fovea of its supply obligations as provided above.  The exercise by Dyax of any of its rights under this Section 6.2(e) shall not relieve Fovea of its supply obligations under this Section 6.2.  Upon receipt by Fovea of written notice from Dyax to the effect that Dyax is exercising its rights under this Section 6.2(e), Fovea shall provide reasonable assistance, at Dyax’s expense, to enable Dyax to Manufacture or have Manufactured Finished Product.  [*****]

 

(f)            Limitations on Use.  Any Finished Product Manufactured by or on behalf of Dyax pursuant to Section 6.2(e) may be used solely in Commercialization of the Product by Dyax and its Related Parties in accordance with this Agreement.  Upon exercise by Dyax of its rights under Section 6.2(e) with respect to Finished Product, Dyax may elect to satisfy some or all of the future requirements that it and its Related Parties may have with respect to Finished Product through its own Manufacturing efforts pursuant to Section 6.2(e) hereof.

 

Section 6.3            Subcontractors.

 

(a)           Fovea may grant to one or more of its Related Parties or contract manufacturers any right that Fovea may have under Section 6.1 to Manufacture API Bulk Drug Substance, and may delegate to one or more of its Related Parties or contract manufacturers any obligation that Fovea may have under Section 6.2 to Manufacture and supply Finished Product, and, in either case, each of the Related Parties or contract manufacturers to whom such right has been granted or such obligation has been delegated, as the case may be, may exercise such right and/or shall perform such obligation, as the case may be, subject to and upon the same terms and conditions as would be applicable to Fovea under Section 6.1 or Section 6.2, as relevant, if Fovea were exercising such right and/or performing such obligation, as the case may be.

 

(b)           Dyax may grant to one or more of its Related Parties or contract manufacturers any right that Dyax may have under Section 6.2 to Manufacture Finished Product, and may delegate to one or more of its Related Parties, Other Related Dyax Licensees or contract manufacturers any obligation that Dyax may have under Section 6.1 to Manufacture and supply API Bulk Drug Substance, and, in either case, each of the Related Parties, Other Related Dyax Licensees or contract manufacturers to whom such right has been granted or such obligation has been delegated, as the case may be, may exercise such right and/or shall perform such obligation, as the case may be, subject to and upon the same terms and conditions as would be applicable to Dyax under Section 6.1 or Section 6.2, as relevant, if Dyax were exercising such right and/or performing such obligation, as the case may be.

 

(c)           Any delegation by either Party to any Related Party or contract manufacturer of such Party, or by Dyax to any Other Related Dyax Licensee, of any obligation that such Party may have under Section 6.1 or Section 6.2 to Manufacture and supply API Bulk Drug Substance or Finished Product, as the case may be, shall not release such Party from such obligation and such Party shall be responsible for the performance by such Related Party, contract manufacturer or Other Related Dyax Licensee, as the case may be, of such obligation and shall remain liable to the other Party if such

 


* Confidential Treatment Requested.  Omitted portions filed with the Commission.

 

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obligation is not performed by such Related Party,contract manufacturer or Other Related Dyax Licensee, as the case may be, on a timely basis in accordance with Section 6.1 or Section 6.2, as relevant.

 

Section 6.4            Supply Agreements.

 

(a)           [*****] the Parties shall negotiate in good faith and enter into a supply agreement pursuant to which Dyax will supply to Fovea API Bulk Drug Substance (the “Dyax Supply Agreement”). The Dyax Supply Agreement shall include the applicable terms set forth in Section 6.1, 6.3 and Exhibit E of this Agreement and shall contain such other provisions that the Parties mutually agree upon that are customary for supply agreements of this type.  Pending the execution and delivery of the Dyax Supply Agreement, Dyax shall perform its obligations under Section 6.1 in accordance with its terms.   Upon written request of Dyax made after execution of the Dyax Supply Agreement, the Parties shall negotiate in good faith and enter into a supply agreement pursuant to which Fovea will supply Finished Product to Dyax (the “Fovea Supply Agreement”; each of the Fovea Supply Agreement and the Dyax Supply Agreement is a “Supply Agreement” and collectively are referred to as the “Supply Agreements”).  The Fovea Supply Agreement shall include the applicable terms set forth in Section 6.2 and Section 6.3 hereof, shall, to the extent possible (unless the Parties otherwise agree), impose rights and obligations on Fovea that are consistent with the rights and obligations of Dyax under the Dyax Supply Agreement and the applicable provisions of Section 6.1 and shall contain such other provisions that the Parties mutually agree upon that are customary for supply agreements of this type.  Pending the execution and delivery of the Fovea Supply Agreement, Fovea shall perform its obligations under Section 6.2 in accordance with its terms.

 

(b)           Each Party will appoint at least one manufacturing logistics and quality assurance manager to support the Parties’ respective Product Manufacturing activities, and to function as a liaison with the other Party on matters relating to the Manufacture and supply of API Bulk Drug Substance and Finished Product.

 

ARTICLE VII

FINANCIAL PROVISIONS

 

Section 7.1            Royalties.

 

(a)           Royalty Rates.  Subject to Sections 7.1(b), (c) and (d), (i) Fovea shall pay to Dyax royalties on aggregate Net Sales in the Fovea Territory as follows:

 

Calendar Year Net Sales of the Product

 

Royalties (as a percentage of such Net Sales)

 

$[*****] - $[*****]

 

[*****]

%

$[*****] - $[*****]

 

[*****]

%

Greater than $[*****]

 

[*****]

%

 


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; and (ii) Dyax shall pay to Fovea royalties on aggregate Net Sales in the Dyax Territory as follows:

 

Calendar Year Net Sales of the Product

 

Royalties (as a percentage of such Net Sales)

 

$[*****] - $[*****]

 

[*****]

%

$[*****] - $[*****]

 

[*****]

%

Greater than $[*****]

 

[*****]

%

 

(b)           Applicability of Royalty Rates to Net Sales.  Royalties on aggregate Net Sales of the Product inside and outside the Fovea Territory in a calendar year shall be paid at the rate applicable to the portion of Net Sales within each of the Net Sales levels above during such calendar year.  For example, if during a calendar year, Net Sales of the Product in the Fovea Territory were equal to $[*****], the royalties payable by Fovea would be calculated by adding (i) the royalties with respect to the first $[*****] at the first level percentage of [*****] ($[*****] x [*****] = $[*****]), (ii) the royalties with respect to the next $[*****] at the second level percentage of [*****] ($[*****] x [*****] =  $[*****]), and (iii) the royalties with respect to the final $[*****] at the third level percentage of [*****] ($[*****] x [*****] = $[*****]), for a total royalty amount of $51,000,000.

 

(c)           In-Licenses.  If either Royalty Payor enters into an In-License at any time after the Effective Date and during the Term pursuant to, and in accordance with, the provisions of Section 2.8 or 2.9 hereof, then, other than royalties with respect to [*****], which shall be treated as specified below, (i) Fovea shall be responsible for paying any royalties under such In-License that are due as a result of the Development, Manufacture or Commercialization of the Product in the Field in the Fovea Territory by Fovea and its Related Parties, (ii) Dyax shall be responsible for paying any royalties under such In-License that are due as a result of the Development, Manufacture or Commercialization of the Product in the Field in the Dyax Territory by Dyax and its Related Parties, (iii) Dyax shall be responsible for paying any royalties under such In-License that are due as a result of the Development, Manufacture or Commercialization of the Product outside the Field in the Dyax Territory and/or Fovea Territory by Dyax and its Related Parties, and (iv) Dyax shall be responsible for paying any royalties under such In-License that are due as a result of the Development, Manufacture or Commercialization of the Compound or any product (other than the Product) containing the Compound in any field in the Dyax Territory and/or Fovea Territory by Dyax, its Related Parties and the Other Related Dyax Licensees.  [*****] the royalties actually paid by each Royalty Payor under any In-License of Blocking Third Party Patent Rights (but not any other In-License) signed by either Party in connection with any Net Sales of the Product shall offset any royalties otherwise payable by such Royalty Payor under Sections 7.1(a) or 7.1(b) hereof in connection with such Net Sales of the Product; provided, however, that in no event shall the royalties payable by either Royalty Payor for any calendar quarter under Sections 7.1(a) or 7.1(b) hereof be reduced in aggregate, through all applicable reductions set forth in this Section 7.1(c), by more than [*****].  In the event that any reduction is limited by the proviso at the end of the immediately preceding sentence, the applicable Royalty Payor shall be entitled to carry the unused portion of such reduction

 


* Confidential Treatment Requested.  Omitted portions filed with the Commission.

 

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forward to subsequent calendar quarters, subject to the application of the limitation set forth in such proviso to such subsequent calendar quarters.  [*****]

 

(d)           Reduction of Royalty Rates.

 

(i)            In the event that, at any time during the Term, Dyax or any of its Related Parties or any of the Other Related Dyax Licensees engages in Commercialization in the United States of any Competing Product delivered via the same method of delivery used to deliver the Product in any indication within the Field for which Regulatory Approval for such Product has been received in the United States, for so long as such Commercialization continues, the royalty rates that would otherwise be applicable to the royalties that Fovea is required to pay to Dyax under this Agreement shall automatically be reduced by [*****].

 

(ii)           If, during a given calendar quarter there is Generic Competition in a particular country of the Fovea Territory, then, for each such country in which there is Generic Competition, the royalties payable pursuant to Section 7.1 shall be reduced, on an indication-by-indication and country-by-country basis, for such calendar quarter as follows:

 

Share of Market Held by Generic Product (by unit)

 

Royalty Reduction

 

[*****]

 

[*****]

 

[*****]

 

[*****]

 

 

(e)           [*****] Royalty.  Notwithstanding any other provision hereof, in addition to the royalties due as set forth above, and without application of any offsets as provided in Section 7.1(c) above, each Party shall be responsible for any royalty due as a result of activities under the [*****] License Agreement or the [*****] Patent Rights as follows:

 

[*****]

 

(f)            Royalty Term. The royalty payment obligations of each Royalty Payor with respect to Section 7.1(e) shall continue for so long as payment are required under the relevant license under [*****] Patent Rights.  The royalty payment obligations of each Royalty Payor with respect to the Product pursuant to this Section 7.1 (other than Section 7.1(e)) shall commence in each country of the Territory on the first anniversary of the First Commercial Sale of the Product in such country and shall continue until the later of [*****] (each such period, a “Royalty Term”), subject to the following conditions:

 

(i)            no royalties shall be due upon the sale or other transfer among a Party or its Related Parties, but in such cases the royalty shall be due and calculated upon the Party’s or its Related Party’s Net Sales to the first independent Third Party;

 

(ii)           no royalties shall accrue on the sale or other disposition of the Product by the Parties or their Related Parties for use in a Clinical Study or any other Development activities permitted herein; and

 


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(iii)          no royalties shall accrue on the disposition of the Product in reasonable quantities by a Party or its Related Parties as samples (promotion or otherwise) or as donations (for example, to non-profit institutions or government agencies for a non-commercial purpose).

 

Section 7.2            Royalty Reports and Payments.  Within [*****] after the end of each calendar quarter for which royalties are payable by a Royalty Payor to a Royalty Recipient with respect to Net Sales pursuant to Section 7.1, such Royalty Payor shall submit to such Royalty Recipient a report, on a country-by-country basis, providing in reasonable detail an accounting of all Net Sales (including an accounting of all unit sales of the Product) made during such calendar quarter in its Territory and the calculation of the applicable royalties due to the other Party under Section 7.1, [*****] Concurrently with the submission of such report, such Royalty Payor shall pay to such Royalty Recipient all royalties payable by it under Section 7.1 [*****]

 

Section 7.3            Non-Royalty In-License Payments.

 

(a)           Subject to the provisions of Section 7.3(b) below, the non-royalty fees and payments due under any In-License that is entered into by either Party at any time after the Effective Date and during the Term shall be [*****].  Notwithstanding anything express or implied in the foregoing provisions of this Section 7.3(a) to the contrary, the provisions of this Section 7.3(a) shall not apply to any non-royalty fees and payments subject to the provisions of Section 7.3(b) below.

 

(b)           Any non-royalty fees and payments due with respect to the Initial Finished Product under any In-License that is entered into by Fovea pursuant to Section 2.8 at any time after the Effective Date shall be [*****]

 

(c)           For purposes of clarification, the provisions of this Section 7.3 shall not apply to any in-license that is in effect on the Effective Date and, except as expressly provided herein with respect to the [*****] License Agreement, each Party shall be responsible for any obligations under any such in-license to which it is a party on the Effective Date.

 

Section 7.4             Audits.  Each Party shall keep complete and accurate records of the underlying patent and trademark expenses, Net Sales and in-license royalties and non-royalty payments relating to the reports and payments required by Sections 7.1, 7.2 and 7.3,.  Each Party will have the right [*****]at its own expense to have an independent, certified public accountant, selected by such Party and reasonably acceptable to the other Party, review any such records of the other Party in the location(s) where such records are maintained by the other Party upon reasonable notice and during regular business hours and under obligations of confidentiality, for the sole purpose of verifying the basis and accuracy of payments made under Sections 7.1, 7.2 and7.3 within the prior [*****] period.  If the review of such records reveals that the other Party has failed to accurately report information pursuant to Section 7.1, 7.2 and 7.3, then the other Party shall promptly pay to the auditing Party any resulting amounts due under Section 7.1, 7.2 and 7.3, as the case may be, together with interest calculated in the manner provided in Section 7.9.  If any such under payments are greater than [*****] of the amounts actually due for a calendar quarter under Section 7.1, 7.2 and 7.3, [*****] the other Party shall pay all of the costs of such review.

 


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Section 7.5                                      Tax Matters.  If laws, rules or regulations require withholding of income taxes or other taxes imposed upon payments set forth in this Article VII, the Royalty Payor shall make such withholding payments as required and subtract such withholding payments from the payments set forth in this Article VII.  The Royalty Payor shall submit appropriate proof of payment of the withholding taxes to the Royalty Recipient within a reasonable period of time.  At the request of the Royalty Recipient, the Royalty Payor shall, at its cost, give the Royalty Recipient such reasonable assistance, which shall include the provision of appropriate certificates of such deductions made together with other supporting documentation as may be required by the relevant tax authority, to enable the Royalty Recipient to claim exemption from such withholding or other tax imposed or obtain a repayment thereof or reduction thereof and shall upon request provide such additional documentation from time to time as is reasonably required to confirm the payment of tax.

 

Section 7.6                                      United States Dollars.  All dollar ($) amounts specified in this Agreement are United States dollar amounts.

 

Section 7.7                                      Currency Exchange.  With respect to Net Sales invoiced or expenses incurred in U.S. dollars, the Net Sales or expense amounts and the amounts due to the receiving Party hereunder shall be expressed in U.S. dollars.  With respect to Net Sales invoiced or expenses incurred in a currency other than U.S. dollars, the Net Sales or expense shall be expressed in the currency in which such Net Sales were invoiced or such expense was incurred together with the U.S. dollar equivalent, calculated using the average of the spot rate on the first and last business days of the calendar quarter in which the Net Sales were made or the expense was incurred.  The “closing mid-point rates” found in the “dollar spot forward against the dollar” table published by The Financial Times or any other publication as agreed to by the Parties shall be used as the source of spot rates.  All payments shall be made in U.S. dollars.

 

Section 7.8                                      Blocked Payments.  In the event that, by reason of applicable laws, rules or regulations in any country, it becomes impossible or illegal for the Royalty Payor or its Related Parties, to transfer, or have transferred on its behalf, royalties or other payments to the Royalty Recipient, the Royalty Payor shall promptly notify the Royalty Recipient of the conditions preventing such transfer and such royalties or other payments shall be deposited in local currency in the relevant country to the credit of the Royalty Recipient in a recognized banking institution designated by the Royalty Recipient or, if none is designated by the Royalty Recipient within a period of thirty (30) days, in a recognized banking institution selected by the Royalty Payor or its Related Party, as the case may be, and identified in a notice given to the Royalty Recipient.

 

Section 7.9                                      Late Payments.  The Royalty Payor shall pay interest to the Royalty Recipient on the aggregate amount of any payments that are not paid on or before the date such payments are due under this Agreement at a rate per annum equal to the lesser of [*****] per month or the highest rate permitted by applicable law, calculated on the number of days such payments are paid after the date such payments are due and compounded monthly.

 


* Confidential Treatment Requested.  Omitted portions filed with the Commission.

 

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ARTICLE VIII

INTELLECTUAL PROPERTY OWNERSHIP, PROTECTION AND RELATED MATTERS

 

Section 8.1                                      Ownership of Product Intellectual Property.   All Know-How, Patent Rights and other intellectual property developed through direct or indirect use of the Compound, or that otherwise claims the Compound or any Product, and that was generated, developed, conceived or reduced to practice by or on behalf of Fovea or its Affiliates prior to the Effective Date (including, without limitation, in the performance of the Research and Option Agreement) (“Fovea-Assigned Intellectual Property”) shall be owned by Dyax.  Any and all rights that Fovea or its Related Parties have in or to any such Fovea-Assigned Intellectual Property shall be assigned to Dyax.  Fovea represents and warrants that it has taken all steps necessary to transfer and assign ownership in all such intellectual property to Dyax prior to the Effective Date.  Failure to effectuate such assignment shall be deemed a material breach of this Agreement.

 

Section 8.2                                      Ownership of Inventions.

 

(a)                                  Sole Inventions.  Each Party shall exclusively own all Inventions invented solely by such Party, its Affiliates and its and their employees, agents, consultants and contractors (“Sole Inventions”).  Sole Inventions invented solely by Fovea, its Affiliates, and its and their employees, agents, consultants and contractors are referred to herein as “Fovea Sole Inventions”.  Sole Inventions invented solely by Dyax, its Affiliates, and its and their employees, agents and consultants are referred to herein as “Dyax Sole Inventions”.

 

(b)                                 Joint Inventions and Joint Know-How.  The Parties shall jointly own all Inventions invented jointly by employees, agents, consultants, and contractors of Fovea and its Affiliates and employees, agents, consultants and contractors of Dyax and its Affiliates, on the basis of each Party having an undivided interest in the whole (“Joint Inventions”).  The Parties shall jointly own all Joint Know-How and Joint Patent Rights, subject to the rights and obligations expressly provided herein.

 

(c)                                  Inventorship.  For purposes of determining whether an Invention is a Fovea Sole Invention, a Dyax Sole Invention or a Joint Invention, questions of inventorship shall be resolved in accordance with United States patent laws.

 

Section 8.3                                      Prosecution and Maintenance of Patent Rights.

 

(a)                                  Solely-Controlled Patent Rights.  Each Party shall have the first right and option to prepare, file, prosecute, defend and maintain any Patent Rights Covering the Product or its use in the Territory that are solely Controlled by such Party, except that, subject to the provisions of any Third Party license agreement under which Fovea Controls Patent Rights, Dyax shall have the first right and option to prepare, file, prosecute and maintain in the name of Fovea and anywhere in the Territory any Patent Rights Covering a Fovea Sole Invention that Covers the Compound or that otherwise could, in Dyax’s reasonable judgment, be material to Dyax’s patent portfolio and strategy for the Compound.  The Party with such first right shall be referred to as the “Controlling Party”.  If the Controlling Party elects not to undertake the filing, prosecution, defense and/or maintenance (or, after commencement of such filing, prosecution, defense and/or maintenance, desires to cease the prosecution or the maintenance) of any Patent Rights that the Controlling Party has the right to prepare, file, prosecute, defend and maintain pursuant to the immediately preceding sentence, then the Controlling Party shall notify the non-Controlling Party of such election and, subject to the provisions of any Third Party license agreement

 


* Confidential Treatment Requested.  Omitted portions filed with the Commission.

 

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under which the Controlling Party Controls such Patent Rights, the non-Controlling Party shall be entitled (but not obligated), in the name of the Controlling Party, to file, prosecute, defend and/or maintain such Patent Rights in the non-Controlling Party’s Territory; provided, however, that Fovea shall have no such rights with respect to any Core Dyax Patent Rights (as defined below) in any country.  For purposes of this Agreement, the term “Core Dyax Patent Rights” shall mean Dyax Patent Rights or Joint Patent Rights that Cover the Compound or its use or that otherwise could, in Dyax’s reasonable judgment, be material to Dyax’s patent portfolio and strategy for the Compound.

 

(b)                                 Joint Patent Rights.  Dyax shall have the first right and option to prepare, file, prosecute, defend and maintain the Joint Patent Rights.  If Dyax elects not to undertake (or, after commencement of such filing, prosecution and/or maintenance, desires to cease the prosecution or the maintenance of) any Joint Patent Rights in the Fovea Territory, then Dyax shall notify Fovea of such election and Fovea shall be entitled (but not obligated) to prepare, file, prosecute, defend and/or maintain such Joint Patent Rights in the names of both Parties; provided, however, that Fovea shall have no such rights with respect to any Core Dyax Patent Rights in any country.

 

(c)                                  Costs and Expenses.

 

(i)                                     Fovea. Fovea shall bear its own costs and expenses incurred in preparing, filing, prosecuting, defending and/or maintaining those Dyax Patent Rights and Fovea Patent Rights (but not Joint Patent Rights) that Fovea actually prepares, files, prosecutes, defends and/or maintains after implementing and giving full effect to the provisions of Section 8.3(a) above.

 

(ii)                                  Dyax. Dyax shall bear its own costs and expenses incurred in preparing, filing, prosecuting, defending and/or maintaining those Dyax Patent Rights and Fovea Patent Rights (but not Joint Patent Rights) that Dyax actually prepares, files, prosecutes, defends and/or maintains after implementing and giving full effect to the provisions of Section 8.3(a) above.

 

(iii)                               Joint Patent Rights. Dyax and Fovea shall share all reasonable, documented external and out-of-pocket costs and expenses actually incurred by either Party in connection with preparing, reviewing, commenting, filing, prosecuting, defending and/or maintaining the Joint Patent Rights.  Each Party shall provide to the other Party copies of invoices or other documentation reasonably evidencing such external and out-of-pocket expenses and the Party that is responsible for preparing, filing, prosecuting, defending and/or maintaining the applicable Joint Patent Rights pursuant to Section 8.3(b) shall notify the other Party of the amount that either Party needs to reimburse the other Party in order for both Parties to share such external and out-of-pocket costs and expenses as contemplated in this Section 8.3(c)(iii).  Either Party required to reimburse the other Party as contemplated under this Section 8.3(c)(iii) shall be obligated to do so within [*****] after the notification contemplated in the immediately preceding sentence is given.

 

(d)                                 Cooperation. The Party having the right to prosecute and maintain patents under this Section 8.3 shall be referred to as the “Prosecuting Party”. Each Party agrees to cooperate with the other with respect to the preparation, filing, prosecution, defense and maintenance of patents and patent applications pursuant to this Section 8.3, and will perform such lawful acts and execute such documents in order to reasonably assist the Prosecuting Party in connection therewith.  Dyax, as the Prosecuting

 


* Confidential Treatment Requested.  Omitted portions filed with the Commission.

 

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Party, shall (i) keep Fovea fully informed as to the filing, prosecution, maintenance, defense and enforcement of (1) Fovea Patent Rights as to which Dyax is the Controlling Party pursuant to Section 8.3(a), (2) Joint Patent Rights and (3) Dyax Patent Rights claiming the Product or the use of the Compound or Product in the Field that are being or will be filed, prosecuted, defended or maintained by Dyax pursuant to Section 8.3 in the Fovea Territory, (ii) furnish to Fovea copies of all material filings as well as copies of all material correspondence from the relevant patent office, in each case relating to any such filing, prosecution, defense, maintenance and enforcement, and (iii) allow Fovea [*****] to review and comment upon, and to consider and incorporate in good faith its reasonable comments into, any such document filed with any patent office prior to filing such documents.  This provision shall apply mutatis mutandis to Fovea as the Prosecuting Party with respect to (1) Fovea Patent Rights subject to the provisions of Section 8.3(a) and as to which Dyax is not the Controlling Party, (2) Joint Patent Rights, and (3) Dyax Patent Rights claiming the Product or the use of the Compound or Product in the Field that are being or will be filed, prosecuted, defended or maintained by Fovea in the Fovea Territory pursuant to Section 8.3(a) or (b).

 

(e)                                  Core Dyax Patent Rights.   In addition to its obligations under Section 8.3(d), Dyax shall use Diligent Efforts to prepare, file, prosecute and maintain the Core Dyax Patent Rights so as to provide commercially reasonable protection for Products in the Field in the Fovea Territory and the Dyax Territory and shall confer with and keep Fovea reasonably informed regarding the status of such activities.

 

Section 8.4                                      Third Party Infringement.

 

(a)                                  Notice.  Each Party shall promptly report in writing to the other Party during the Term any known or suspected (i) infringement of any of the Dyax Patent Rights, Fovea Patent Rights or Joint Patent Rights or (ii) unauthorized use of any of the Dyax Know-How, Fovea Know-How or Joint Know-How of which such Party becomes aware, in the case of either clause (i) or clause (ii) involving the Development, Manufacture or Commercialization by a Third Party of a competing product in the Field (a “Competitive Infringement”) in the other Party’s Territory, and shall provide the other Party with all available evidence supporting such known or suspected infringement or unauthorized use.

 

(b)                                 Initial Right to Enforce.  Subject to Section 8.4(c) below and the provisions of any Third Party license agreement under which Dyax’s rights in Dyax Patent Rights or Fovea’s rights in Fovea Patent Rights are granted, (i) Dyax shall have the first right to initiate a suit or take other appropriate action that it believes is reasonably required to protect (i.e., prevent or abate actual or threatened infringement or misappropriation of) or otherwise enforce the Dyax Intellectual Property and the Joint Intellectual Property in the Territory and (ii) Fovea shall have the first right to initiate a suit or take other appropriate action that it believes is reasonably required to protect (i.e., prevent or abate actual or threatened infringement or misappropriation of) or otherwise enforce the Fovea Intellectual Property in the Territory.

 

(c)                                  Step-In Right.  Subject to the provisions of any Third Party license agreement under which Dyax’s rights in Dyax Patent Rights are granted or Fovea’s rights in Fovea Patent Rights are granted, if the Party with the first right to enforce (the “Initial Enforcement Rights Party”) the Dyax Intellectual Property, the Fovea Intellectual Property or the Joint Intellectual Property fails to initiate a

 


* Confidential Treatment Requested.  Omitted portions filed with the Commission.

 

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suit or take other appropriate action that it has the initial right to initiate or take pursuant to Section 8.4(b) above with respect to a Competitive Infringement in the other Party’s Territory within [*****] after becoming aware of the basis for such suit or action, then the other Party (the “Secondary Enforcement Rights Party”) may, in its discretion, provide the Initial Enforcement Rights Party with written notice of such Secondary Enforcement Rights Party’s intent to initiate a suit or take other appropriate action with respect to such Competitive Infringement in the Secondary Enforcement Rights Party’s Territory.  If the Secondary Enforcement Rights Party provides such notice and the Initial Enforcement Rights Party fails to initiate a suit or take such other appropriate action within thirty (30) days after receipt of such notice from the Secondary Enforcement Rights Party, then the Secondary Enforcement Rights Party shall have the right to initiate a suit or take other appropriate action that it believes is reasonably required to protect the applicable Dyax Intellectual Property, the applicable Fovea Intellectual Property or the Joint Intellectual Property from such Competitive Infringement in the Secondary Enforcement Rights Party’s Territory.  Notwithstanding anything to the contrary contained in this Section 8.4(c) or elsewhere, if Dyax fails to initiate a suit or take other appropriate action that it has the initial right to initiate or take pursuant to Section 8.4(b) above with respect to any Competitive Infringement involving the Core Dyax Patent Rights, then, with respect to such Core Dyax Patent Rights, (i) Fovea shall have no rights to initiate a suit or take other action with respect to such Competitive Infringement in any country and (ii) each country of the Fovea Territory in which such Core Dyax Patent Rights have been filed or issued and in which such Competitive Infringement exists shall be treated, for purposes of Section 7.1(d)(ii), as if there is Generic Competition in such country.

 

(d)                                 Conduct of Certain Actions; Costs.  The Party initiating suit shall have the sole and exclusive right to select counsel for any suit initiated by it pursuant to Section 8.4(b) or 8.4(c).  If required under applicable law in order for the initiating Party to initiate and/or maintain such suit, the other Party shall join as a party to the suit.  Such other Party shall offer reasonable assistance to the initiating Party in connection therewith at no charge to the initiating Party except for reimbursement of reasonable out-of-pocket expenses incurred in rendering such assistance.  The initiating Party shall assume and pay all of its own out-of-pocket costs incurred in connection with any litigation or proceedings initiated by it pursuant to Sections 8.4(b) and 8.4(c), including without limitation the fees and expenses of the counsel selected by it.  The other Party shall have the right to participate and be represented in any such suit that is based on a Competitive Infringement by its own counsel at its own expense.

 

(e)                                  Recoveries.  With respect to any suit or action referred to in Sections 8.4(b) and 8.4(c) that is based on a Competitive Infringement in the Territory, any recovery obtained as a result of any such proceeding, by settlement or otherwise, shall be applied in the following order of priority:

 

(i)                                     first, [*****]; and

 

(ii)                                  second, [*****].

 

Section 8.5                                      Claimed Infringement.  In the event that a Party becomes aware of any claim that the practice by either Party of Dyax Intellectual Property, Fovea Intellectual Property or Joint Intellectual Property in the Development, Manufacture or Commercialization of the Product infringes the intellectual property rights of any Third Party, such Party shall promptly notify the other Party.  In any such instance,

 


* Confidential Treatment Requested.  Omitted portions filed with the Commission.

 

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the Parties shall cooperate and shall mutually agree upon an appropriate course of action.  Each Party shall provide to the other Party copies of any notices it receives from Third Parties regarding any patent nullity actions, any declaratory judgment actions and any alleged infringement or misappropriation of Third Party intellectual property relating to the Development, Manufacture or Commercialization of the Product.  Such notices shall be provided promptly, but in no event after more than [*****] following receipt thereof.

 

Section 8.6                                      Patent Term Extensions.  The Parties shall cooperate, if necessary and appropriate, with each other in gaining patent term extensions wherever applicable in the Territory to Patent Rights Controlled by either Party that Cover the Product.  The Parties shall, if necessary and appropriate, [*****].

 

Section 8.7                                      Patent Marking.  Each Party agrees to comply with the patent marking statutes in each country in its Territory in which the Product is sold by such Party and/or its Related Parties.

 

Section 8.8                                      Trademarks.

 

(a)                                  Each Party and its Affiliates shall retain all right, title and interest in and to its and their respective corporate names and logos.

 

(b)                                 The Parties shall develop and propose, and the JSC shall consider and approve, one or more Product Trademark(s) for use throughout the Territory (“Global Trademarks”).  The Product shall be promoted and sold, in accordance with the provisions of this Agreement, in the Fovea Territory under a Global Trademark unless such Global Trademark cannot be legally used to promote and sell the Product in the Fovea Territory, in which case an alternative Product Trademark proposed by Fovea and approved by Dyax (which approval shall not be unreasonably withheld or delayed) (a “Fovea Trademark”), shall be used in the Fovea Territory.  The Product shall be promoted and sold, in accordance with the provisions of this Agreement, in the Dyax Territory using the Global Trademark. Any and all Global Trademarks and Fovea Trademark(s) shall be different from the trademark(s) and servicemark(s) used by Dyax or its Affiliates or sublicensees to promote and sell products containing the Compound other than the Product in or outside the Territory.  Dyax (or its local Affiliates, as appropriate) shall own all rights to Global Trademarks, and all goodwill associated therewith throughout the Territory and Fovea shall own all rights to Fovea Trademarks and associated goodwill in the Fovea Territory.  Dyax shall also own rights to any Internet domain names incorporating the applicable Global Trademarks, or any variation or part of such Global Trademarks, as its URL address or any part of such address; and Fovea shall also own rights to any Internet domain names incorporating the applicable Fovea Trademarks or any variation or part of such Fovea Trademarks as its URL address or any part of such address.

 

(c)                                  If Global Trademarks are used by Fovea to promote and sell the Product in the Fovea Territory, then the following provisions shall apply:  Dyax shall grant Fovea an exclusive license (including the right to grant sublicenses) to use the Global Trademarks to Commercialize the Product in the Fovea Territory.  Fovea agrees that the quality of the Product and the Manufacture and Commercialization thereof shall be consistent with customary standards of quality in the biopharmaceuticals industry.  In addition, Fovea shall comply strictly with Dyax’s trademark style and usage standards that Dyax communicates to Fovea from time to time with respect to the Global

 


* Confidential Treatment Requested.  Omitted portions filed with the Commission.

 

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Trademarks.  Fovea shall at its own expense, at the request of Dyax from time to time, submit to Dyax for approval a reasonable number of production samples of the Product and related packaging materials.  In the event that Dyax reasonably objects to the usage of the Global Trademarks owned by it in connection with any sample, it shall give written notice of such objection to Fovea within [*****] of receipt by Dyax of the sample, specifying the way in which such usage of its Global Trademarks fails to meet the style, usage or quality standards for the Product set forth in the first two sentences of this Section 8.8(c), and, if and to the extent so requested by Dyax, Fovea shall immediately cease sale and distribution of the Product.  If Fovea has ceased sale and distribution of the Product pursuant to the immediately preceding sentence and wishes to continue to distribute and sell the Product, it must remedy the failure and submit further samples to Dyax for approval.

 

(d)                                 Dyax will use Diligent Efforts to establish, maintain and enforce the Global Trademarks during the Term, provided that, at the election of Fovea, Fovea shall have the right to enforce the Global Trademarks (if being used by Fovea) against an infringer thereof in the Fovea Territory if such infringement is limited only to the Fovea Territory and if Dyax reasonably agrees that such action would not jeopardize the Global Trademark in any jurisdiction outside the Fovea Territory.  [*****]

 

(e)                                  In the event either Party becomes aware of any infringement of any Product Trademark by a Third Party, such Party shall promptly notify the other Party and the Parties shall consult with each other and jointly determine the best way to prevent such infringement, including, without limitation, by the institution of legal proceedings against such Third Party.

 

ARTICLE IX

CONFIDENTIALITY AND PUBLICITY

 

Section 9.1                                      Confidential Information.  During the Term and for [*****] after any termination or expiration thereof, each Party agrees to keep in confidence and not to disclose to any Third Party, or use for any purpose, except pursuant to, and in order to carry out, the terms and objectives of this Agreement, any Confidential Information of the other Party.  As used herein, “Confidential Information” shall mean all trade secrets or confidential or proprietary information designated as such in writing by the disclosing Party, whether by letter or by the use of an appropriate stamp or legend, prior to or at the time any such trade secret or confidential or proprietary information is disclosed by the disclosing Party to the receiving Party.  Notwithstanding the foregoing, information which is orally or visually disclosed to the receiving Party by the disclosing Party, or is disclosed in writing without an appropriate letter, stamp or legend, shall constitute Confidential Information if (x) it would be apparent to a reasonable person, familiar with the disclosing Party’s business and the industry in which it operates, that such information is of a confidential or proprietary nature, the maintenance of which is important to the disclosing Party, or if (y) the disclosing Party, within [*****] after such disclosure, delivers to the receiving Party a written document or documents describing such information and referencing the place and date of such oral, visual or written disclosure and the names of the employees or officers of the receiving Party to whom such disclosure was made.  The restrictions on the disclosure and use of Confidential Information set forth in the first sentence of this Section 9.1 shall not apply to any Confidential Information that:

 


* Confidential Treatment Requested.  Omitted portions filed with the Commission.

 

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(a)                                  was known by the receiving Party prior to disclosure by the disclosing Party hereunder (as evidenced by the receiving Party’s written records);

 

(b)                                 is or becomes part of the public domain through no fault of the receiving Party;

 

(c)                                  is disclosed to the receiving Party by a Third Party having a legal right to make such a disclosure without violating any confidentiality or non-use obligation that such Third Party has to the disclosing Party; or

 

(d)                                 is independently developed by the receiving Party (as evidenced by the receiving Party’s written records).

 

Notwithstanding the obligations of confidentiality and non-use set forth above, a receiving Party may provide Confidential Information disclosed to it to (i) governmental or other Regulatory Authorities in order to obtain patents or to gain or maintain approval to conduct Clinical Studies or to otherwise Develop, Manufacture or Commercialize the Product in accordance with this Agreement; provided, that such disclosure shall be subject to the prior written consent of the Party whose Confidential Information is intended to be disclosed (which consent shall not be unreasonably withheld or delayed), and such Confidential Information shall be disclosed only to the extent reasonably necessary to obtain patents or authorizations in a manner consistent with the rights and obligations hereunder, (ii) the extent required by applicable law, including without limitation by the rules or regulations of the United States Securities and Exchange Commission or similar regulatory agency in a country other than the United States or of any stock exchange or listing entity, (iii) any bona fide actual or prospective underwriters, investors, lenders or other financing sources or bona fide actual or prospective collaborators, strategic partners or acquirors who are obligated to keep such information confidential, to the extent reasonably necessary to enable such actual or prospective underwriters, investors, lenders or other financing sources, collaborators, strategic partners or acquirors to determine their interest in underwriting or making an investment in, or otherwise providing financing to, collaborating or partnering with, or acquiring, the receiving Party.  In addition, if either Party is required to disclose Confidential Information of the other Party by regulation, law or legal process, including without limitation by the rules or regulations of the United States Securities and Exchange Commission or similar regulatory agency in a country other than the United States or of any stock exchange or listing entity, such Party shall provide prior notice of such intended disclosure to such other Party if practicable under the circumstances and shall disclose only such Confidential Information of such other Party as is required to be disclosed.

 

Section 9.2                                      Related Party, Employee, Consultant and Advisor Obligations.  Each Party agrees that it and its Affiliates shall provide or permit access to Confidential Information received from the other Party only to the receiving Party’s Related Parties, employees, consultants, advisors and permitted subcontractors, and to the employees, consultants, advisors and permitted subcontractors of the receiving Party’s Related Parties, who have a need to know such Confidential Information to assist the receiving Party with the Development, Manufacturing and Commercialization of the Product in accordance with this Agreement and the activities contemplated by this Agreement and who are subject to obligations of confidentiality and non-use with respect to such Confidential Information similar to the obligations of confidentiality and non-use of the receiving Party pursuant to Section 9.1; provided, that Dyax and Fovea shall each remain responsible for any failure by its Affiliates, and its and its Affiliates’

 


* Confidential Treatment Requested.  Omitted portions filed with the Commission.

 

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respective employees, consultants, advisors and permitted subcontractors, sublicensees and sub-distributors, to treat such Confidential Information as required under Section 9.1 (as if such Affiliates, employees, consultants, advisors and permitted subcontractors, sublicensees and sub-distributors were Parties directly bound to the requirements of Section 9.1).

 

Section 9.3                                      Publicity.  Following the execution of this Agreement, the Parties shall at a mutually agreeable time issue a mutually agreeable joint press release regarding the subject matter of this Agreement.  After such initial joint press release, neither Party shall issue a press release or public announcement relating to the Product or this Agreement without the prior written approval of the other Party, which approval shall not be unreasonably withheld, except that a Party may (a) issue such a press release or public announcement if the contents of such press release or public announcement have previously been made public other than through a breach of this Agreement by the issuing Party; and (b) issue such a press release or public announcement if required by applicable regulation or law, including without limitation by the rules or regulations of the United States Securities and Exchange Commission or similar regulatory agency in a country other than the United States or of any stock exchange or listing entity; provided that the other Party has received prior notice of such intended press release or public announcement if practicable under the circumstances and, with respect to press releases and public announcements made pursuant to the foregoing clause (b), the Party subject to the requirement includes in such press release or public announcement only such information relating to the Product or this Agreement as is required by such applicable regulation or law.

 

Section 9.4                                      Publications.  Subject to the restrictions provided below, either Party may publish or present the results of Development carried out on the Product in accordance with this Agreement, subject to the prior review by the other Party for patentability and protection of such other Party’s Confidential Information.  Each Party shall provide to the other Party the opportunity to review and approve any proposed abstracts, manuscripts or summaries of presentations that cover the results of Development of the Product.  Each Party shall designate a Person or Persons who shall be responsible for approving such publications.  Such designated person shall respond in writing promptly and in no event later than [*****] after receipt of the proposed material with either approval of the proposed material or a specific statement of concern, based upon either the need to seek patent protection or concern regarding competitive disadvantage arising from the proposal.  In the event of concern, the submitting Party agrees not to submit such publication or to make such presentation that contains such information until the other Party is given a reasonable period of time (not to exceed [*****]) to seek patent protection for any material in such publication or presentation that it believes is patentable or to resolve any other issues, and the submitting Party shall remove from such proposed publication any Confidential Information of the other Party as requested by such other Party.  With respect to any proposed abstracts, manuscripts or summaries of presentations by investigators or other Third Parties, such materials shall be subject to review under this Section 9.4 to the extent that Dyax or Fovea, as the case may be, has the right to do so.

 

ARTICLE X

REPRESENTATIONS AND WARRANTIES; CERTAIN COVENANTS; INDEMNIFICATION

 

Section 10.1                                Exclusivity Covenant. During the Term, Fovea and its Related Parties shall refrain from engaging in clinical Development or Commercialization of a Competing Product in the Field

 


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or outside the Field anywhere in the world, subject to the provisions set forth below in this Section 10.1.    During the Term, Dyax and its Related Parties and the Other Related Dyax Licensees shall refrain from engaging in clinical Development or Commercialization of a Competing Product for use in the Field in the Fovea Territory.  Notwithstanding anything express or implied in the foregoing provisions of this Section 10.1 to the contrary, this Section 10.1 shall not restrict or limit Fovea from Developing or Commercializing, and Fovea shall have the right to Develop and Commercialize, any product for use as a therapeutic for ophthalmic diseases or conditions in humans that [*****].

 

Section 10.2                                Representations of Authority.  Dyax and Fovea each represents and warrants to the other Party that, as of the Effective Date, it has full corporate right, power and authority to enter into this Agreement and to perform its respective obligations under this Agreement and that it has the right to grant to the other the licenses and sublicenses granted pursuant to this Agreement.

 

Section 10.3                                Consents.  Dyax and Fovea each represents and warrants to the other Party that, except for any Regulatory Approvals, pricing and/or reimbursement approvals, manufacturing approvals and/or similar approvals necessary for the Development, Manufacture or Commercialization of the Product, all necessary consents, approvals and authorizations of all government authorities and other persons required to be obtained by it as of the Effective Date in connection with the execution, delivery and performance of this Agreement have been obtained by the Effective Date.

 

Section 10.4                                No Conflict.  Dyax and Fovea each represents and warrants to the other Party that, notwithstanding anything to the contrary in this Agreement, the execution and delivery of this Agreement by such Party, the performance of such Party’s obligations hereunder and the licenses and sublicenses to be granted by such Party pursuant to this Agreement (a) do not conflict with or violate any requirement of any laws, rules or regulations existing as of the Effective Date and applicable to such Party and (b) do not conflict with, violate, breach or constitute a default under any contractual obligations of such Party or any of its Affiliates existing as of the Effective Date.

 

Section 10.5                                Enforceability.  Dyax and Fovea each represents and warrants to the other Party that, as of the Effective Date, this Agreement is a legal and valid obligation binding upon it and is enforceable against it in accordance with its terms, except as such enforceability may be limited by applicable insolvency and other applicable laws affecting creditors’ rights generally or by the availability of equitable remedies.

 

Section 10.6                                No Debarment.  Dyax and Fovea each represents and warrants to the other Party that, as of the Effective Date, neither Party nor any of its Affiliates has been debarred or is subject to debarment and that neither Party nor any of its Affiliates has used or will use in any capacity, in connection with the Development, Manufacture or Commercialization of the Product, any Person who has been debarred pursuant to Section 306 of the United States Federal Food, Drug, and Cosmetic Act, or who is the subject of a conviction described in such section.  Each Party agrees to inform the other Party in writing immediately if it or any Person who is performing the activities under this Agreement is debarred or is the subject of a conviction described in Section 306, or if any action, suit, claim, investigation or legal or administrative proceeding is pending or, to the best of the notifying Party’s knowledge, is threatened, relating to the debarment or conviction of the notifying Party or any Person

 


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used in any capacity by the notifying Party or any of its Affiliates in connection with the Development, Manufacture or Commercialization of the Product.

 

Section 10.7                                Additional Representations and Warranties of Dyax.  Dyax represents and warrants to Fovea that, as of the Effective Date:

 

(a)                                  Dyax has not granted any license to any Third Party under any of the Dyax Intellectual Property to Develop, Manufacture or Commercialize the Product in the Field.

 

(b)                                 Except for non-exclusive licenses granted by Dyax to its Affiliates and to Third Parties, which grants do not conflict with the license grants to Fovea hereunder, to the best of its knowledge, (i) Dyax is the sole and exclusive owner of all right, title and interest in and to the Patent Rights listed on Exhibit C-1 (the “Existing Dyax Patent Rights”) and (ii) other than the Existing Dyax Patent Rights and the Fovea-Assigned Patent Rights, there are no other Dyax Patent Rights as of the Effective Date.

 

(c)                                  Neither Dyax nor any of its Affiliates is or has been a party to any agreement with the U.S. federal government or an agency thereof pursuant to which the U.S. federal government or such agency provided funding for the Development of the Compound or the Product.

 

(d)                                 No claim of infringement of the Patent Rights of any Third Party has been made, nor to Dyax’s knowledge threatened, against Dyax or any of its Affiliates or, to the best of Dyax’s knowledge, any of its Related Parties or any of the Other Related Dyax Licensees with respect to the Development, Manufacture or Commercialization of the Compound or the Product, and there are no other claims, judgments or settlements against or owed by Dyax or any of its Affiliates or, to the best of Dyax’s knowledge, any of its Related Parties or any of the Other Related Dyax Licensees or to which Dyax or any of its Affiliates or, to the best of Dyax’s knowledge, any of its Related Parties or any of the Other Related Dyax Licensees is a party or, to the best of Dyax’s knowledge, pending or threatened claims or litigation, in either case relating to the Compound or Product.

 

(e)                                  Prior to the Effective Date Dyax has provided Fovea with a complete and correct copy of the [*****] License Agreement.  To the best of Dyax’s knowledge, such agreement remains in full force and effect as of the Effective Date and such agreement is the only agreement as of the Effective Date between Dyax and any Third Party that imposes an obligation to pay royalties to a Third Party based on sales of the Product.

 

Section 10.8                                Additional Representations and Warranties of Fovea.  Fovea represents and warrants to Dyax that, as of the Effective Date:

 

(a)                                  It has transferred and assigned all rights that it or its Affiliates may have in the Fovea-Assigned Intellectual Property, including without limitation, the Patent Rights listed on Exhibit C-2 (the “Fovea-Assigned Patent Rights”), to Dyax, in each case free and clear of all liens, charges and encumbrances, and is not aware of any claim made against it asserting the invalidity, misuse, unregisterability, unenforceability or non-infringement of any of such Fovea-Assigned Intellectual Property or challenging Fovea’s sole Control of such Fovea-Assigned Intellectual Property, or the

 


* Confidential Treatment Requested.  Omitted portions filed with the Commission.

 

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assignment to Dyax of such Fovea-Assigned Intellectual Property, or making any adverse claim of ownership or misappropriation thereof.

 

(b)                                 Neither Fovea nor any of its Affiliates is or has been a party to any agreement with the U.S. federal government or an agency thereof pursuant to which the U.S. federal government or such agency provided funding for the Development of the Compound or the Product.

 

(c)                                  To the best of Fovea’s knowledge, the Development, Manufacture and Commercialization of the Compound as conducted by Fovea on or prior to the Effective Date did not infringe, interfere with or result in the misappropriation of any intellectual property rights of any Third Party existing as of the Effective Date.

 

(d)                                 No claim of infringement of the Patent Rights of any Third Party has been made, nor to Fovea’s knowledge threatened, against Fovea or any of its Affiliates with respect to the Development, Manufacture or Commercialization of the Compound or the Product, and there are no other claims, judgments or settlements against or owed by Fovea or any of its Affiliates or to which Fovea or any of its Affiliates is a party or, to the best of Fovea’s knowledge, pending or threatened claims or litigation, in either case relating to the Compound or Product.

 

(e)                                  Fovea has made available to Dyax all information in its Control relating to the Compound and the Development, Manufacture and Commercialization of the Compound as conducted by Fovea to date.

 

(f)                                    All of the studies, tests and pre-clinical and clinical trials of the Compound conducted prior to, or being conducted as of, the Effective Date by Fovea have been and are being conducted in accordance with applicable laws, rules and regulations.

 

(g)                                 There are no agreements between Fovea and any Third Party that impose an obligation to pay royalties to a Third Party based on sales of the Product.

 

Section 10.9                                No Warranties.  EXCEPT AS OTHERWISE EXPRESSLY SET FORTH HEREIN, NEITHER PARTY MAKES ANY REPRESENTATION OR EXTENDS ANY WARRANTIES OF ANY KIND, EITHER EXPRESS OR IMPLIED, TO THE OTHER PARTY, AND EACH PARTY HEREBY DISCLAIMS ALL IMPLIED WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE AND NONINFRINGEMENT WITH RESPECT TO THE COMPOUND AND THE PRODUCT.  EACH PARTY HEREBY DISCLAIMS ANY REPRESENTATION OR WARRANTY THAT THE DEVELOPMENT, MANUFACTURE AND COMMERCIALIZATION OF THE PRODUCT PURSUANT TO THIS AGREEMENT WILL BE SUCCESSFUL.

 

Section 10.10                          Indemnification.

 

(a)                                  By Fovea. Fovea will defend, indemnify and hold harmless Dyax, its Related Parties, and their respective directors, officers, employees and agents (the “Dyax Indemnified Parties”) from and against all claims, demands, liabilities, damages, penalties, fines, costs and expenses, including reasonable attorneys’ and expert fees and costs, and costs or amounts paid to settle (collectively,

 


* Confidential Treatment Requested.  Omitted portions filed with the Commission.

 

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Losses”), arising from or occurring as a result of a Third Party’s claim (including any Third Party product liability or infringement claim), action, suit, judgment or settlement to the extent such Losses are due to or based upon:

 

(i)                                     the gross negligence, recklessness, bad faith, intentional wrongful acts or omissions or violations of applicable law or regulation by or of Fovea, its Related Parties, wholesale distributors, contractors or their respective directors, officers, employees or agents, including, without limitation, in connection with the Development, Manufacture or Commercialization of the Product by Fovea, its Related Parties, wholesale distributors or contractors; or

 

(ii)                                  the material breach by Fovea of the terms of, or the material inaccuracy of any representation or warranty made by it in, this Agreement or any Supply Agreement; or

 

(iii)                               any manufacturing defect in any Finished Product supplied to Dyax or its Related Parties by or on behalf of Fovea; or

 

(iv)                              the Development, Manufacture and Commercialization of the Product in the Field by Fovea or its Related Parties, wholesale distributors or contractors, except to the extent that such Losses arise out of, and are allocable to, (x) the negligence, recklessness, bad faith, intentional wrongful acts, omissions or violations of law or breach of this Agreement committed by the Dyax Indemnified Parties, (y) any manufacturing defect in any API Bulk Drug Substance supplied to Fovea or its Related Parties by or on behalf of Dyax, (z) any actual or alleged infringement or misappropriation by Fovea or its Related Parties, wholesale distributors or contractors of the Patent Rights or Know How of any Third Party to the extent arising from the composition of matter or use of the Compound itself in actions undertaken pursuant to, and in accordance with, the provisions of this Agreement (and not, for clarity, to the extent such actual or alleged infringement or misappropriation arises from the delivery method or formulation of the Product that is Developed by Fovea for use in the Field pursuant to this Agreement or from any combination of the Compound with any other materials or components that is made by Fovea in the course of Developing the Product for use in the Field pursuant to this Agreement) or (zz) any liability for which Dyax is to indemnify Fovea pursuant to Section 10.10(b)(v) below.

 

(b)                                 Dyax will defend, indemnify and hold harmless Fovea, its Related Parties, and their respective directors, officers, employees and agents (the “Fovea Indemnified Parties”) from and against all Losses arising from or occurring as a result of a Third Party’s claim (including any Third Party product liability or infringement claim), action, suit, judgment or settlement that is due to or based upon:

 

(i)                                     the gross negligence, recklessness, bad faith, intentional wrongful acts or omissions or violations of applicable law or regulation by or of Dyax, its Related Parties, Other Related Dyax Licensees, wholesale distributors, contractors or their respective directors, officers, employees or agents, including, without limitation, in connection with the Development, Manufacture or Commercialization of the Product, the Compound or any other product containing the Compound by Dyax, its Related Parties, Other Related Dyax Licensees, wholesale distributors or contractors; or

 

(ii)                                  material breach by Dyax of the terms of, or the material inaccuracy of any representation or warranty made by it in, this Agreement; or

 


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(iii)                               any manufacturing defect in any API Bulk Drug Substance supplied to Fovea or its Related Parties by or on behalf of Dyax ; or

 

(iv)                              the Development, Manufacture and Commercialization of the Product, the Compound or any product containing the Compound by Dyax or its Related Parties, Other Related Dyax Licensees, wholesale distributors or contractors, except to the extent that such Losses arise out of, and are allocable to, (x) the negligence, recklessness, bad faith, intentional wrongful acts, omissions or violations of law or breach of this Agreement committed by the Fovea Indemnified Parties, or (y) any manufacturing defect in any Finished Product supplied to Dyax or its Related Parties by or on behalf of Fovea, (z) any actual or alleged infringement or misappropriation by Dyax or its Related Parties or the Other Related Dyax Licensees of the Patent Rights or Know How of any Third Party to the extent arising from the use of the Fovea Intellectual Property itself pursuant to this Agreement (and not to the extent such actual or alleged infringement or misappropriation arises from the composition of matter or use of the Compound itself); or

 

(v)                                 any actual or alleged infringement (including contributory infringement) or misappropriation of the Patent Rights or Know-How of any Third Party to the extent arising from the use or practice by Dyax or its Related Parties, Other Related Dyax Licensees, wholesale distributors or contractors of any Fovea New Outside IP that is offered to Dyax pursuant to Section 3.2(g) but that is not sublicensed by Fovea to Dyax by virtue of the provisions of Section 3.2(g) hereof to Develop, Manufacture or Commercialize the Product, the Compound or any product containing the Compound.

 

(c)                                  Claims for Indemnification.

 

(i)                                     A person entitled to indemnification under this Section 10.10 (an “Indemnified Party”) shall give prompt written notification to the person from whom indemnification is sought (the “Indemnifying Party”) of the commencement of any action, suit or proceeding relating to a Third Party claim for which indemnification may be sought or, if earlier, upon the assertion of any such claim by a Third Party (it being understood and agreed, however, that the failure by an Indemnified Party to give notice of a Third-Party claim as provided in this Section 10.10 shall not relieve the Indemnifying Party of its indemnification obligation under this Agreement except and only to the extent that such Indemnifying Party is actually prejudiced as a result of such failure to give notice).

 

(ii)                                  Within [*****] after delivery of such notification, the Indemnifying Party may, upon written notice thereof to the Indemnified Party, assume control of the defense of such action, suit, proceeding or claim with counsel reasonably satisfactory to the Indemnified Party.  If the Indemnifying Party does not assume control of such defense, the Indemnified Party shall control such defense.

 

(iii)                               The Party not controlling such defense may participate therein at its own expense; provided, that if the Indemnifying Party assumes control of such defense and the Indemnified Party reasonably concludes, based on advice from counsel, that the Indemnifying Party and the Indemnified Party have conflicting interests with respect to such action, suit, proceeding or claim, the Indemnifying Party shall be responsible for the reasonable fees and expenses of counsel to the Indemnified Party solely in connection therewith; provided further, however, that in no event shall the

 


* Confidential Treatment Requested.  Omitted portions filed with the Commission.

 

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Indemnifying Party be responsible for the fees and expenses of more than one counsel in any one jurisdiction for all Indemnified Parties.

 

(iv)                              The Party controlling such defense shall keep the other Party advised of the status of such action, suit, proceeding or claim and the defense thereof and shall consider recommendations made by the other Party with respect thereto.

 

(v)                                 The Indemnified Party shall not agree to any settlement of such action, suit, proceeding or claim without the prior written consent of the Indemnifying Party, which shall not be unreasonably withheld or delayed.  The Indemnifying Party shall not agree to any settlement of such action, suit, proceeding or claim or consent to any judgment in respect thereof that does not include a complete and unconditional release of the Indemnified Party from all liability with respect thereto or that imposes any liability or obligation on the Indemnified Party without the prior written consent of the Indemnified Party.

 

Section 10.11                          No Consequential or Punitive Damages.  NEITHER PARTY HERETO WILL BE LIABLE FOR INDIRECT, INCIDENTAL, CONSEQUENTIAL, SPECIAL, EXEMPLARY, PUNITIVE OR MULTIPLE DAMAGES ARISING OUT OF THIS AGREEMENT OR THE EXERCISE OF ITS RIGHTS HEREUNDER, OR FOR LOST PROFITS ARISING FROM OR RELATING TO ANY BREACH OF THIS AGREEMENT, REGARDLESS OF ANY NOTICE OF SUCH DAMAGES.  NOTHING IN THIS SECTION 10.11 IS INTENDED TO LIMIT OR RESTRICT THE INDEMNIFICATION RIGHTS OR OBLIGATIONS OF EITHER PARTY WITH RESPECT TO THIRD PARTY CLAIMS OR WITH RESPECT TO A BREACH OF A PARTY’S OBLIGATIONS OF CONFIDENTIALITY OR NON-USE IN ARTICLE IX.  For clarity, except as expressly set forth in Section 5.5, neither Party shall have any liability to the other Party for any Losses resulting from any clinical hold imposed by a Regulatory Authority, any withdrawal or suspension by any Regulatory Authority of marketing authorization or other Regulatory Approval, or any recall required by any Regulatory Authority, in each case with respect to the Product, or with respect to the Compound outside the Field, as a result of any safety or efficacy data obtained in connection with the Development of the Product or any product containing the Compound by either Party or its Related Parties in accordance with the terms of this Agreement, provided, however, that the foregoing clause shall not limit liability with respect to any event that has been caused by, or is the direct result of,  the negligence, recklessness, bad faith, intentional wrongful acts, omissions or violations of law or breach of this Agreement committed by the potentially liable Party.

 

ARTICLE XI

TERM AND TERMINATION

 

Section 11.1                                Term.  Unless terminated earlier in accordance with this Article XI, this Agreement shall remain in force for the period commencing on the Effective Date and ending on the expiration of the last Royalty Term to expire under this Agreement. (the “Term”).

 


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Section 11.2                                Termination Rights.

 

(a)                                  Termination for Convenience.  Fovea shall have the right to terminate this Agreement at any time after the Effective Date on [*****] prior written notice to Dyax.

 

(b)                                 Termination For Material Breach.  Upon any material breach of this Agreement or any Supply Agreement by a Party (the “Breaching Party”), the other Party (the “Non-Breaching Party”) may terminate this Agreement by providing [*****] prior written notice to the Breaching Party in the case of a breach of a payment obligation and [*****] written notice to the Breaching Party in the case of any other material breach.  The termination shall become effective at the end of the notice period unless the Breaching Party cures such breach during such notice period; provided that the Non-Breaching Party may, by notice to the Breaching Party, designate a later date for such termination in order to facilitate an orderly transition of activities relating to the Product and such later date shall be the effective date of such termination if the Breaching Party does not object to such later date by prompt written notice to the Non-Breaching Party.  Notwithstanding the foregoing, (i) if such breach, by its nature, is incurable, the Non-Breaching Party may terminate this Agreement immediately upon written notice to the Breaching Party and (ii) if such breach (other than a payment breach), by its nature, is curable, but not within the foregoing cure period, then such cure period shall be extended if the Breaching Party provides a written plan for curing such breach to the Non-Breaching Party and uses Diligent Efforts to cure such breach in accordance with such written plan; provided that no such extension shall exceed ninety (90) days without the written consent of the Non-Breaching Party.

 

(c)                                  Termination for Bankruptcy. A Party may terminate this Agreement should the other Party commit an act of bankruptcy, be declared bankrupt, voluntarily file or have filed against it a petition for bankruptcy or reorganization unless such petition is dismissed within [*****] of filing or such petition is for a reorganization under Chapter 11 of the Bankruptcy Code (as defined below) or any relevant foreign equivalent thereof and such Party is not in default at the time of the filing of such petition or at any time during such reorganization of any of its obligations under this Agreement or any Supply Agreement, enter into a procedure of winding up to dissolution, or should a trustee or receiver be appointed for its business assets or operations. All rights and licenses granted under or pursuant to this Agreement are, and shall otherwise be deemed to be, for the purposes of Section 365(n) of Title 11, U.S. Code (“Bankruptcy Code”) license rights to “intellectual property” as defined under Section 101(60) of the Bankruptcy Code. The Parties agree that any Party, as a licensee hereunder, shall retain and may fully exercise all of its rights and elections under the Bankruptcy Code or any relevant foreign equivalent thereof.

 

(d)                                 Challenges of Patent Rights.  In the event that a Party or any of its Related Parties (the “Challenging Party”) shall (i) commence or participate in any action or proceeding (including, without limitation, any patent opposition or re-examination proceeding), or otherwise assert in writing any claim, challenging or denying the validity of any of the Patent Rights licensed to the Challenging Party hereunder, or any claim thereof or (ii) actively assist any other Person in bringing or prosecuting any action or proceeding (including, without limitation, any patent opposition or re-examination proceeding) challenging or denying the validity of any of such Patent Rights or any claim thereof, the other Party will have the right to give notice to the Challenging Party (which notice must be given, if at all, within [*****] after the other Party first learns of the foregoing) that the licenses granted to the Challenging Party to such Patent Rights will terminate in [*****] following such notice, and, unless the

 


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Challenging Party withdraws or causes to be withdrawn all such challenge(s) within such [*****] period, such licenses will so terminate.

 

Section 11.3                                Consequences of Termination.

 

(a)                                  Termination by Dyax for Cause.   Without limiting any other legal or equitable remedies that Dyax may have (but subject to the provisions set forth below in this Section 11.3(a)), if Dyax terminates this Agreement in accordance with Sections 11.2(b) or (c), then (i) Fovea’s obligations under Section 10.1 shall survive for a period of one (1) year after termination, (ii) Fovea shall as promptly as practicable transfer to Dyax or Dyax’s designee (A) possession and ownership of all governmental or regulatory correspondence, conversation logs, filings and approvals (including all Regulatory Approvals and pricing and reimbursement approvals) in Fovea’s possession or Control relating to the Development, Manufacture or Commercialization of the Product and all Fovea Trademarks then being used or planned for use in connection with the Commercialization of the Product, (B) copies of all data, reports, records and materials in Fovea’s possession or Control relating to the Development, Manufacture or Commercialization of the Product, including all non-clinical and clinical data relating to the Product, and (C) all records and materials in Fovea’s possession or Control containing Confidential Information of Dyax, (iii) appoint Dyax as Fovea’s and/or Fovea’s Related Parties’ agent for all Product-related matters involving Regulatory Authorities in the Fovea Territory until all Regulatory Approvals and other regulatory filings have been transferred to Dyax or its designee, (iv) if the effective date of termination is after First Commercial Sale, then Fovea shall appoint Dyax as its exclusive distributor of the Product in the Fovea Territory and grant Dyax the right to appoint sub-distributors, until such time as all Regulatory Approvals in the Fovea Territory have been transferred to Dyax or its designee, (v) if Fovea or its Related Parties are obligated to Manufacture Finished Product for Dyax on the effective date of such termination, then, at Dyax’s option, supply the Finished Product to Dyax in the Fovea Territory on terms no less favorable than those on which Fovea supplied the Finished Product prior to such termination to its most favored distributor in the Fovea Territory, until such time as all Regulatory Approvals in the Fovea Territory have been transferred to Dyax or its designee, Dyax has obtained all necessary manufacturing approvals and Dyax has procured or developed its own source of Finished Product supply, provided, however, that such time shall in no event exceed [*****] unless Fovea or the applicable Related Party otherwise agrees in its sole and absolute discretion, (vi) if Dyax so requests, Fovea shall transfer to Dyax any Third Party agreements relating to the Development, Manufacture or Commercialization of the Product to which Fovea is a party, to the extent that such transfer is not expressly prohibited by the terms of such Third Party agreements and (vii) Fovea shall (x) assign ownership of all Fovea Product Intellectual Property that relates solely to the Product to Dyax, free and clear of any liens or encumbrances and (y) grant Dyax a non-exclusive right and license, with the right to grant sublicenses (subject to restrictions and limitations similar to those set forth in Section 3.2(f) that are applicable to sublicenses of licenses granted by Fovea to Dyax pursuant to Section 3.2 hereof), under all Fovea Product Intellectual Property to Develop, Manufacture and Commercialize products containing the Compound inside and outside the Field and throughout the world. The license granted pursuant to this Section 11.3(a) shall be royalty-free, fully-paid and perpetual; provided, however, that if and to the extent that any such license includes any sublicense of Third Party intellectual property licensed by Fovea, then (1) such sublicense shall be subject to the terms and conditions of the license between Fovea and such Third Party and (2) Dyax shall be responsible for the payment to such Third Party of any and all fees, payments and royalties due under the license between Fovea and such Third Party as a result of the practice by Dyax

 


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and its Related Parties and the Other Related Dyax Licensees of such sublicensed Third Party intellectual property. Fovea shall execute all documents and take all such further actions as may be reasonably requested by Dyax in order to give effect to the foregoing clauses (i) through (vii).  Notwithstanding anything express or implied in this Section 11.3(a) to the contrary, (x) any sublicense to a Third Party of any of the rights licensed to Fovea pursuant to this Agreement that is in effect at the time of the effective date of the termination of this Agreement by Dyax in accordance with Sections 11.2(b) or (c) shall survive any such termination of this Agreement and shall continue in full force and effect in accordance with the respective terms thereof, provided that the terms of such sublicense permit Dyax to replace Fovea as a party under such sublicense upon any such termination of this Agreement and that such sublicense and its terms conform with all of the requirements therefor set forth in this Agreement, (y) Dyax’s rights under this Section 11.3(a) shall be subject to, limited by, and may not be exercisable by virtue of, the terms of any sublicense that survives, pursuant to the foregoing clause (x), such termination of this Agreement, (z) no license is granted by Fovea under this Section 11.3(a) to use any compound, molecule, pharmaceutical composition or development or product candidate developed without use of any Dyax Intellectual Property and owned or Controlled by Fovea as an active pharmaceutical ingredient in combination with the Compound unless such combination was the form of the Product being Developed by Fovea pursuant to the Core Development Plan.

 

(b)                                 Termination by Fovea for Convenience. Without limiting any other legal or equitable remedies that Dyax may have (but subject to the provisions set forth below in this Section 11.3(b)), if Fovea terminates this Agreement in accordance with Section 11.2(a), then (i) if Fovea has exercised its termination right at any time prior to [*****], Fovea shall pay Dyax a one-time termination fee of [*****], (ii) Fovea’s obligations under Section 10.1 shall survive for a period of one (1) year after termination, (iii) the provisions of Section 11.3(a)(ii)-(v) shall apply, and (iv) Fovea shall grant to Dyax (x) an exclusive right and license, with the right to grant sublicenses (subject to restrictions and limitations similar to those set forth in Section 3.2(f) that are applicable to sublicenses of licenses granted by Fovea to Dyax pursuant to Section 3.2 hereof), under Fovea Product Intellectual Property that relates solely to the Product, to Develop, Manufacture and Commercialize the Product for the treatment of indications that are inside and outside the Field and throughout the world and (y) a non-exclusive right and license, with the right to grant sublicenses (subject to restrictions and limitations similar to those set forth in Section 3.2(f) that are applicable to sublicenses of licenses granted by Fovea to Dyax pursuant to Section 3.2 hereof), under Fovea Product Intellectual Property to Develop, Manufacture and Commercialize products containing the Compound inside and outside the Field and throughout the world.  The licenses granted pursuant to this Section 11.3(b) shall be royalty-free, fully-paid and perpetual; provided, however, that (1) if the effective date of termination occurs at any time after the Regulatory Approval of the Product has been obtained in the Fovea Territory, then Dyax will be obligated to pay Fovea royalties with respect to Net Sales in the Fovea Territory and the Dyax Territory calculated pursuant to Section 7.1 at fifty percent (50%) of the royalty rates specified in Section 7.1(a)(ii), but, in the case of Net Sales in the Dyax Territory, only if Regulatory Approval of the Product in the Dyax Territory was materially based on data generated by Fovea or its Related Parties in support of Regulatory Approval in the Fovea Territory, and (2) if and to the extent that any such license includes any sublicense of Third Party intellectual property licensed by Fovea, then (A) such sublicense shall be subject to the terms and conditions of the license between Fovea and such Third Party and (B) Dyax shall be responsible for the payment to such Third Party of any and all fees, payments and royalties due under the license between Fovea and such Third Party as a result of the practice by Dyax and its Related Parties and the Other

 


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Related Dyax Licensees of such sublicensed Third Party intellectual property.  Fovea shall execute all documents and take all such further actions as may be reasonably requested by Dyax in order to give effect to the foregoing clauses (i) through (iv).  Notwithstanding anything express or implied in this Section 11.3(b) to the contrary, no license is granted by Fovea under this Section 11.3(b) to use any compound, molecule, pharmaceutical composition or development or product candidate developed without use of any Dyax Intellectual Property and owned or Controlled by Fovea as an active pharmaceutical ingredient in combination with the Compound unless such combination was the form of the Product being Developed by Fovea pursuant to the Core Development Plan.

 

(c)                                  Termination by Fovea for Cause.  Without limiting any other legal or equitable remedies that Fovea may have, if Fovea terminates this Agreement in accordance with Sections 11.2(b) or (c), (i) the provisions of Section 11.3(a)(ii)-(v) shall apply, and (ii) Fovea shall grant to Dyax a non-exclusive right and license, with the right to grant sublicenses (subject to restrictions and limitations similar to those set forth in Section 3.2(f) that are applicable to sublicenses of licenses granted by Fovea to Dyax pursuant to Section 3.2 hereof), under Fovea Product Intellectual Property to Develop, Manufacture and Commercialize products containing the Compound inside and outside the Field and throughout the world. The license granted pursuant to this Section 11.3(c) shall be royalty-free, fully-paid and perpetual; provided, however, that (1) if the effective date of termination occurs at any time prior to the Regulatory Approval of the Product has been obtained in the Fovea Territory, then Dyax shall be obligated to pay Fovea [*****], (2) if the effective date of termination occurs at any time after the Regulatory Approval of the Product has been obtained in the Fovea Territory, then Dyax will be obligated to pay Fovea royalties with respect to Net Sales in the Fovea Territory and the Dyax Territory calculated pursuant to Section 7.1 at the royalty rates specified in Section 7.1(a)(ii), but, in the case of Net Sales in the Dyax Territory, only if Regulatory Approval of the Product in the Dyax Territory was materially based on data generated in support of Regulatory Approval in the Fovea Territory, and (3) if and to the extent that any such license includes any sublicense of Third Party intellectual property licensed by Fovea, then (A) such sublicense shall be subject to the terms and conditions of the license between Fovea and such Third Party and (B) Dyax shall be responsible for the payment to such Third Party of any and all fees, payments and royalties due under the license between Fovea and such Third Party as a result of the practice by Dyax and its Related Parties and the Other Related Dyax Licensees of such sublicensed Third Party intellectual property.  Fovea shall execute all documents and take all such further actions as may be reasonably requested by Dyax in order to give effect to the foregoing clauses (i) and (ii).  Notwithstanding anything express or implied in this Section 11.3(c) to the contrary, (x) any sublicense to a Third Party of the rights licensed to Fovea pursuant to this Agreement that is in effect at the time of the effective date of the termination of this Agreement by Fovea in accordance with Sections 11.2(b) or (c) shall survive such termination and shall continue in full force and effect in accordance with the respective terms thereof, provided that the terms of such sublicense permit Dyax to replace Fovea as a party under such sublicense upon any such termination of this Agreement and that such sublicense and its terms conform with all of the requirements therefor set forth in this Agreement, (y) Dyax’s rights under this Section 11.3(c) shall be subject to, limited by, and may not be exercisable by virtue of, the terms of any sublicense that survives, pursuant to the foregoing clause (x), such termination of this Agreement, and (z) no license is granted by Fovea under this Section 11.3(c) to use any compound, molecule, pharmaceutical composition or development or product candidate developed without use of any Dyax Intellectual Property and owned or Controlled by Fovea as an active pharmaceutical ingredient in combination with the Compound unless

 


* Confidential Treatment Requested.  Omitted portions filed with the Commission.

 

52



 

such combination was the form of the Product being Developed by Fovea pursuant to the Core Development Plan.

 

Section 11.4                                Survival.  In the event of any expiration or termination of this Agreement, (a) all financial obligations under Article VII owed as of the effective date of such expiration or termination shall remain in effect, (b) all obligations to pay damages in connection with any material breach of this Agreement that has not been cured or otherwise resolved or settled as of the effective date of such expiration or termination shall remain in effect, and (c) the provisions set forth in Article XIII and in Sections 7.4-7.9, 8.1, 8.2, 8.8(a), 9.1, 9.2, 10.1 (last sentence), 10.9 10.10, 10.11, 11.3, 11.4 and 12.3, and all other provisions contained in this Agreement that by their terms survive expiration or termination of this Agreement, shall survive.  In addition, in the event of an expiration of this Agreement (but not in the event of any termination of this Agreement pursuant to Section 11.2), the licenses granted in Sections 3.1 and 3.2 shall survive as perpetual, fully paid-up, non-royalty-bearing licenses, and any co-exclusive or exclusive license in such Sections shall convert to a nonexclusive license.

 

ARTICLE XII

FINAL DECISION-MAKING; DISPUTE RESOLUTION

 

Section 12.1                                Referral to Executive Officers.  If for any reason the JSC cannot resolve any matter properly referred to it, either Party may refer the matter to the Executive Officers for resolution.  If after discussing the matter in good faith and attempting to find a mutually satisfactory resolution to the issue, the Executive Officers fail to come to consensus within [*****] after the date on which the matter is referred to the Executive Officers, the provisions of Sections 12.2 and 12.3 shall apply and resolutions reached through such provisions shall be binding on the Parties.

 

Section 12.2                                Final Decision-Making Authority Allocated to a Single Party.  If the Executive Officers fail to come to consensus on any matter referred to the Executive Officers within the period for resolution set forth in Section 12.1, then

 

(a)                                  on matters solely relating to the Development, Regulatory Approval, and Commercialization of the Product in the Field in the Fovea Territory, including without limitation the setting of the prices charged by Fovea and its Related Parties for the Product in the Fovea Territory, Fovea shall have the final decision-making authority;

 

(b)                                 on matters solely relating to the Development, Regulatory Approval and Commercialization of the Product in the Dyax Territory, including without limitation the setting of the prices charged by Dyax and its Related Parties for the Product in the Dyax Territory, or the selection of Global Trademarks, Dyax shall have the final decision-making authority;

 

(c)                                  on matters relating to the Manufacture of the Product, the Party with the applicable Manufacturing responsibility under this Agreement shall have the final decision-making authority;

 

(d)                                 on any matter that is reasonably likely to materially and adversely impact (I) the Development, Regulatory Approval or Commercialization of the Product in the Field in the Dyax

 


* Confidential Treatment Requested.  Omitted portions filed with the Commission.

 

53


 

 

Territory or (II) the Development, Regulatory Approval, Manufacture or Commercialization of products containing the Compound in indications outside the Field or within the Field (to the extent permitted under this Agreement), Dyax shall have the final decision-making authority; provided, that if the Parties maintain their good faith disagreement on whether such matter is reasonably likely to cause or result in any such material and adverse impact, then either Party may refer the matter to arbitration pursuant to Section 12.3 as modified by Exhibit D; and, provided, further, that Dyax shall not exercise its final decision-making authority over any matter under or subject to this Section 12.2(d) to:

 

(i)                                     require Fovea to perform Development activities (including, without limitation, regulatory activities) that Fovea is not otherwise required to conduct under this Agreement; or

 

(ii)                                  increase the budgeted Development Costs (including, without limitation, the costs of regulatory activities) set forth in the Core Development Plan for any calendar year, except that, in the case of the Development Costs of the Product for [*****], such Development Costs may exceed the budgeted Development Costs set forth in the Core Development Plan by [*****];

 

(e)                                  notwithstanding the foregoing provisions of this Section 12.2, (I) neither Party shall have final decision-making authority pursuant to this Section 12.2 with respect to (A) any decision by the JSC to treat any license entered or to be entered into by a Party pursuant to Section 2.8 or Section 2.9 hereof as an In-License and (B) matters (i) over which one or the other of the Parties is expressly allocated final decision-making authority elsewhere in this Agreement, (ii) for which this Agreement expressly provides that a decision shall not be made without the approval or consent of one or both of the Parties, or (iii) relating to a breach or alleged breach of this Agreement by a Party, and (II) neither Party may exercise its final decision-making authority pursuant to this Section 12.2 so as to change, modify or alter any express provision of this Agreement; and

 

(f)                                    with respect to matters over which neither Party is allocated final-decision making authority (other than matters for which this Agreement expressly provides that a decision shall not be made without the approval or consent of one or both of the Parties), the provisions of Section 12.3 shall apply.

 

Section 12.3                                Arbitration.  Any dispute arising out of or relating to this Agreement that is not finally resolved through the provisions of Section 12.1 or 12.2, including without limitation the interpretation of this Agreement and any breach or alleged breach of this Agreement, shall be resolved through binding arbitration as follows; provided, that specific matters for which this Agreement expressly provides that a decision shall not be made without the approval or consent of one or both of the Parties shall not be subject to resolution under this Section 12.3:

 

(a)                                  A Party may submit such dispute to arbitration by notifying the other Party, in writing, of such dispute.  Within [*****] after receipt of such notice, the Parties shall designate in writing a single arbitrator to resolve the dispute; provided, however, that if the Parties cannot agree on an arbitrator within such [*****]period, the arbitrator shall be selected by the Boston, Massachusetts office of the American Arbitration Association (the “AAA”).  The arbitrator shall be a lawyer knowledgeable and experienced in the law concerning the subject matter of the dispute, and shall not be an Affiliate,

 


* Confidential Treatment Requested.  Omitted portions filed with the Commission.

 

54



 

employee, consultant, officer, director or stockholder of either Party or of a Related Party of either Party or of an Other Related Dyax Licensee.

 

(b)                                 Within [*****] after the designation of the arbitrator, the arbitrator and the Parties shall meet, at which time the Parties shall be required to set forth in writing all disputed issues and a proposed ruling on the merits of each such issue.

 

(c)                                  The arbitrator shall set a date for a hearing, which shall be no later than forty-five (45) days after the submission of written proposals pursuant to Section 12.3(b), to discuss each of the issues identified by the Parties.  The Parties shall have the right to be represented by counsel.  Except as provided herein, the arbitration shall be governed by the Commercial Arbitration Rules of the AAA; provided, however, that the Federal Rules of Evidence shall apply with regard to the admissibility of evidence and the arbitration shall be conducted by a single arbitrator.

 

(d)                                 The arbitrator shall use his or her best efforts to rule on each disputed issue within [*****] after the completion of the hearings described in this Section 12.3.  The determination of the arbitrator as to the resolution of any dispute shall be binding and conclusive upon all Parties.  All rulings of the arbitrator shall be in writing and shall be delivered to the Parties.

 

(e)                                  The (i) attorneys’ fees of the Parties in any arbitration, (ii) fees of the arbitrator and (iii) costs and expenses of the arbitration shall be borne by the Parties as determined by the arbitrator.

 

(f)                                    Any arbitration pursuant to this Section 12.3 shall be conducted in Boston, Massachusetts.  Any arbitration award may be entered in and enforced by a court in accordance with Section 13.7.

 

(g)                                 Nothing in this Section 12.3 shall be construed as limiting in any way the right of a Party to seek injunctive relief with respect to any actual or threatened breach of this Agreement from, or to bring an action in aid of arbitration in, a court in accordance with Section 13.7.  Should any Party seek injunctive relief, then for purposes of determining whether to grant such injunctive relief, the dispute underlying the request for such injunctive relief may be heard by a court in accordance with Section 13.7.

 

(h)                                 The arbitrator shall not award damages excluded pursuant to Section 10.11.

 

ARTICLE XIII

MISCELLANEOUS

 

Section 13.1                                Choice of Law.  This Agreement shall be governed by and interpreted under, and any court action in accordance with Section 13.7 shall apply, the laws of the Commonwealth of Massachusetts excluding: (a) its conflicts of laws principles; (b) the United Nations Conventions on Contracts for the International Sale of Goods; (c) the 1974 Convention on the Limitation Period in the International Sale of Goods (the “1974 Convention”); and (d) the Protocol amending the 1974 Convention, done at Vienna April 11, 1980.

 


* Confidential Treatment Requested.  Omitted portions filed with the Commission.

 

55



 

Section 13.2                                Notices.  Any notice or report required or permitted to be given or made under this Agreement by one of the Parties to the other shall be in writing and shall be deemed to have been delivered upon personal delivery or (a) four days after deposit in the mail or the business day next following deposit with a reputable overnight courier and (b) in the case of notices provided by facsimile (which notice shall be followed immediately by an additional notice pursuant to clause (a) above if the notice is of a default hereunder), upon completion of transmissions to the addressee’s facsimile number, as follows (or at such other addresses or facsimile numbers as may have been furnished in writing by one of the Parties to the other as provided in this Section 13.2):

 

If to Dyax:

Dyax Corp.

 

300 Technology Square

 

Cambridge, Massachusetts 02139

 

U.S.A.

 

 

 

[*****]

 

 

With a copy to:

Dyax Corp.

 

300 Technology Square

 

Cambridge, Massachusetts 02139

 

U.S.A.

 

 

 

[*****]

 

 

And to:

[*****]

 

 

 

[*****]

 

 

If to Fovea:

Fovea Pharmaceuticals SA

 

12 rue Jean-Antoine de Baîf

 

75013 Paris, France

 

 

 

[*****]

 

 

With a copy to:

Fovea Pharmaceuticals SA

 

12 rue Jean-Antoine de Baîf

 

75013 Paris, France

 

 

 

[*****]

 

Section 13.3                                Severability.  If, under applicable law or regulation, any provision of this Agreement is invalid or unenforceable, or otherwise directly or indirectly affects the validity of any other material provision(s) of this Agreement (such invalid or unenforceable provision, a “Severed Clause”), it is mutually agreed that this Agreement shall endure except for the Severed Clause.  The Parties shall

 


* Confidential Treatment Requested.  Omitted portions filed with the Commission.

 

56



 

consult one another and use their commercially reasonable efforts to agree upon a valid and enforceable provision that is a reasonable substitute for the Severed Clause in view of the intent of this Agreement.

 

Section 13.4                                Captions.  All captions herein are for convenience only and shall not be interpreted as having any substantive meaning.

 

Section 13.5                                Integration.  This Agreement (together with all Exhibits), the Supply Agreements and the safety data exchange procedures referred to in Section 4.5, constitute the entire agreement between the Parties hereto with respect to the within subject matter and supersedes all previous agreements, whether written or oral, including but not limited to the Research and Option Agreement.  This Agreement may be amended only in writing signed by properly authorized representatives of each of Dyax and Fovea.

 

Section 13.6                                Independent Contractors; No Agency.  Neither Party shall have any responsibility for the hiring, firing or compensation of the other Party’s employees or for any employee benefits.  No employee or representative of a Party shall have any authority to bind or obligate the other Party to this Agreement for any sum or in any manner whatsoever, or to create or impose any contractual or other liability on the other Party without said Party’s written approval.  For all purposes, and notwithstanding any other provision of this Agreement to the contrary, Fovea’s legal relationship under this Agreement to Dyax shall be that of independent contractor.

 

Section 13.7                                Submission to Jurisdiction.  Each Party (a) submits to the exclusive jurisdiction of the state and federal courts sitting in Boston, Massachusetts, with respect to actions or proceedings arising out of or relating to this Agreement in which a Party brings an action in aid of arbitration, (b) agrees that all claims in respect of such action or proceeding may be heard and determined only in any such court, and (c) agrees not to bring any action or proceeding arising out of or relating to this Agreement in any other court, other than an action or proceeding seeking injunctive relief or brought to enforce an arbitration ruling issued pursuant to Section 12.3.  Each Party waives any defense of inconvenient forum to the maintenance of any action or proceeding so brought and waives any bond, surety or other security that might be required of the other Party with respect thereto.  Each Party may make service on the other Party by sending or delivering a copy of the process to the Party to be served at the address and in the manner provided for the giving of notices in Section 13.2.  Nothing in this Section 13.7, however, shall affect the right of any Party to serve legal process in any other manner permitted by law.

 

Section 13.8                                Assignment; Successors.  Neither Dyax nor Fovea may assign this Agreement in whole or in part, nor any rights hereunder, without the prior written consent of the other Party; provided that (a) either Party may assign this Agreement to an Affiliate, (b) this Agreement may be assigned by Fovea to a Third Party that is not a Product Competitor (defined below) in connection with a sale or transfer of all or substantially all of Fovea’s business or assets to which this Agreement relates, and (c) this Agreement may be assigned by Dyax to a Third Party in connection with a sale or transfer of all or substantially all of Dyax’s business or assets to which this Agreement relates. A “Product Competitor” shall mean any Person (x) that is pursuing clinical Development or Commercialization of a Competing Product for the treatment of any ophthalmic indication in humans in the Fovea Territory if and to the extent that the Product either is in clinical Development pursuant to the Core Development Plan for the

 


* Confidential Treatment Requested.  Omitted portions filed with the Commission.

 

57



 

treatment of such ophthalmic indication or has received Regulatory Approval and is being Commercialized in the Fovea Territory for the treatment of such ophthalmic indication or (y) that is pursuing clinical Development or Commercialization of a Competing Product for the treatment of any ophthalmic indication in humans in the United States if and to the extent that the Product either is in clinical Development pursuant to the Supplemental Development Plan for the treatment of such ophthalmic indication in the United States or has received Regulatory Approval and is being Commercialized in the United States for the treatment of such ophthalmic indication.  Exhibit F sets forth a list of Third Parties that, as of the Effective Date, meet the definition of Product Competitor.  Exhibit F may be amended from time to time by written notice of Dyax to Fovea to add and/or delete the names of Third Parties that meet or no longer meet, as applicable, the definition of Product Competitor. As a condition to any such assignment otherwise permitted pursuant to the foregoing provisions of this Section 13.8, the assignee shall agree in writing to assume and perform all of the obligations of the assigning Party under this Agreement, and the assigning Party shall remain primarily liable under this Agreement for the prompt and punctual payment and performance of all obligations of the assignee.  Any assignment made other than in accordance with the immediately preceding sentence shall be wholly void and invalid, and the assignee in any such assignment shall acquire no rights whatsoever, and the non-assigning Party shall not recognize, nor shall it be required to recognize, such assignment.  This Section 13.8 limits both the right and the power to assign this Agreement and/or rights under this Agreement.  This Agreement shall be binding upon, and shall inure to the benefit of, all permitted successors and assigns.

 

Section 13.9                                Execution in Counterparts; Facsimile Signatures.  This Agreement may be executed in counterparts, each of which counterparts, when so executed and delivered, shall be deemed to be an original, and all of which counterparts, taken together, shall constitute one and the same instrument even if both Parties have not executed the same counterpart.  Signatures provided by facsimile transmission shall be deemed to be original signatures.

 

Section 13.10                          Waiver.  The waiver by either Party hereto of any right hereunder, or of the failure of the other Party to perform, or of a breach by the other Party, shall not be deemed a waiver of any other right hereunder or of any other breach or failure by such other Party whether of a similar nature or otherwise

 

Section 13.11                          Performance by Affiliates.  To the extent that this Agreement imposes obligations on Affiliates of a Party, such Party agrees to cause its Affiliates to perform such obligations

 

Section 13.12                          Force Majeure.  Neither Party shall be held liable to the other Party nor be deemed to have defaulted under or breached the Agreement for failure or delay in performing any obligation under this Agreement when such failure or delay is caused by or results from causes beyond the reasonable control of the affected Party including, but not limited to, embargoes, war, acts of war (whether war be declared or not), insurrections, riots, civil commotions, strikes, lockouts or other labor disturbances, fire, floods, or other acts of God, or acts, omissions or delays in acting by any governmental authority or the other Party.  The affected Party shall notify the other Party of such force majeure circumstances as soon as reasonably practical, and shall promptly undertake all reasonable efforts necessary to cure such force majeure circumstances.

 


* Confidential Treatment Requested.  Omitted portions filed with the Commission.

 

58



 

Section 13.13                          Further Assurances.  Each Party agrees to do and perform all such further acts and things and shall execute and deliver such other agreements, certificates, instruments and documents necessary or that the other Party may deem advisable in order to carry out the intent and accomplish the purposes of this Agreement and to evidence, perfect or otherwise confirm its rights hereunder.

 


* Confidential Treatment Requested.  Omitted portions filed with the Commission.

 

59



 

IN WITNESS WHEREOF, Dyax and Fovea have caused this Agreement to be duly executed by their authorized representatives under seal, effective as of the date first above written.

 

 

DYAX CORP.

 

 

 

 

 

 

 

By:

/s/ Gustav Christensen

 

 

Name: Gustav Christensen

 

 

Title: EVP & CBO

 

 

 

 

 

FOVEA PHARMACEUTICALS SA

 

 

 

 

 

 

By:

/s/ Bernard Gilly

 

 

Name: Bernard Gilly

 

 

Title: Chairman & Chief Operating Officer

 


* Confidential Treatment Requested.  Omitted portions filed with the Commission.

 

60


 

EXHIBIT A

 

Amino Acid Sequence of DX-88

 

[*****]

 

[*****]

 

[*****]

 

[*****]

 

A-1



 

EXHIBIT B

 

Development Plan

 

[*****]

 

B-1



 

EXHIBIT C-1

 

Existing Dyax Patent Rights

 

MATTER

 

SERIAL

 

PATENT

 

PUBL

 

TITLE

 

STATUS

 

ISSUE

10280-096AT1

 

95909223.0

 

E 275 583

 

739355

 

KALLIKREIN-BINDING “KUNITZ DOMAIN” PROTEINS AND ANALOGUES THEREOF

 

ISSUED

 

9 /8 /2004

10280-096BE1

 

95909223.0

 

0739355

 

 

 

KALLIKREIN-BINDING “KUNITZ DOMAIN” PROTEINS AND ANALOGUES THEREOF

 

ISSUED

 

9 /8 /2004

10280-096CA1

 

2180950

 

2180950

 

 

 

KALLIKREIN-INHIBITING “KUNITZ DOMAIN” PROTEINS AND ANALOGUES THEREOF

 

ISSUED

 

3 /29/2005

10280-096CH1

 

95909223.0

 

0739355

 

 

 

KALLIKREIN-BINDING “KUNITZ DOMAIN” PROTEINS AND ANALOGUES THEREOF

 

ISSUED

 

9 /8 /2004

10280-096DE1

 

95909223.0

 

69533472.7

 

 

 

KALLIKREIN-BINDING “KUNITZ DOMAIN” PROTEINS AND ANALOGUES THEREOF

 

ISSUED

 

9 /8 /2004

10280-096DK1

 

95909223.0

 

0739355

 

739355

 

KALLIKREIN-BINDING “KUNITZ DOMAIN” PROTEINS AND ANALOGUES THEREOF

 

ISSUED

 

9 /8 /2004

10280-096EP1

 

95909223.0

 

0739355

 

EP0739355

 

KALLIKREIN-BINDING “KUNITZ DOMAIN” PROTEINS AND ANALOGUES THEREOF

 

ISSUED

 

9 /8 /2004

10280-096EP2

 

04019920.0

 

 

 

EP1484339

 

KALLIKREIN-BINDING “KUNITZ DOMAIN” PROTEINS AND ANALOGUES THEREOF

 

PUBLISHED

 

 

10280-096ES1

 

95909223.0

 

0739355

 

 

 

KALLIKREIN-BINDING “KUNITZ DOMAIN” PROTEINS AND ANALOGUES THEREOF

 

ISSUED

 

9 /8 /2004

10280-096FR1

 

95909223.0

 

0739355

 

 

 

KALLIKREIN-BINDING “KUNITZ DOMAIN” PROTEINS AND ANALOGUES THEREOF

 

ISSUED

 

9 /8 /2004

10280-096GB1

 

95909223.0

 

0739355

 

 

 

KALLIKREIN-BINDING “KUNITZ DOMAIN” PROTEINS AND ANALOGUES THEREOF

 

ISSUED

 

9 /8 /2004

10280-096GR1

 

95909223.0

 

0739355

 

 

 

KALLIKREIN-BINDING “KUNITZ DOMAIN” PROTEINS AND ANALOGUES THEREOF

 

ISSUED

 

9 /8 /2004

10280-096HK2

 

05104679.5

 

 

 

1071899A

 

KALLIKREIN-BINDING “KUNITZ DOMAIN” PROTEINS AND ANALOGUES THEREOF

 

PUBLISHED

 

 

 

C-1



 

MATTER

 

SERIAL

 

PATENT

 

PUBL

 

TITLE

 

STATUS

 

ISSUE

10280-096IE1

 

95909223.0

 

0739355

 

 

 

KALLIKREIN-BINDING “KUNITZ DOMAIN” PROTEINS AND ANALOGUES THEREOF

 

ISSUED

 

9 /8 /2004

10280-096IT1

 

95909223.0

 

0739355

 

WO95/21601

 

KALLIKREIN-BINDING “KUNITZ DOMAIN” PROTEINS AND ANALOGUES THEREOF

 

ISSUED

 

9 /8 /2004

10280-096JP1

 

7-518726

 

3805785

 

9511131

 

KALLIKREIN-BINDING “KUNITZ DOMAIN” PROTEINS AND ANALOGUES THEREOF

 

ISSUED

 

5 /19/2006

[*****]

 

[*****]

 

[*****]

 

 

 

[*****]

 

[*****]

 

[*****]

10280-096LU1

 

95909223.0

 

0739355

 

 

 

KALLIKREIN-BINDING “KUNITZ DOMAIN” PROTEINS AND ANALOGUES THEREOF

 

ISSUED

 

9 /8 /2004

10280-096MC1

 

95909223.0

 

0739355

 

 

 

KALLIKREIN-BINDING “KUNITZ DOMAIN” PROTEINS AND ANALOGUES THEREOF

 

ISSUED

 

9 /8 /2004

10280-096NL1

 

95909223.0

 

0739355

 

 

 

KALLIKREIN-BINDING “KUNITZ DOMAIN” PROTEINS AND ANALOGUES THEREOF

 

ISSUED

 

9 /8 /2004

10280-096PT1

 

95909223.0

 

0739355

 

739355

 

KALLIKREIN-BINDING “KUNITZ DOMAIN” PROTEINS AND ANALOGUES THEREOF

 

ISSUED

 

9 /8 /2004

10280-096SE1

 

95909223.0

 

0739355

 

 

 

KALLIKREIN-BINDING “KUNITZ DOMAIN” PROTEINS AND ANALOGUES THEREOF

 

ISSUED

 

9 /8 /2004

10280-096US1

 

08/676,125

 

5,795,865

 

 

 

KALLIKREIN-INHIBITING “KUNITZ DOMAIN” PROTEINS AND ANALOGUES THEREOF

 

ISSUED

 

8 /18/1998

10280-096001

 

08/208,264

 

6,057,287

 

 

 

KALLIKREIN-BINDING “KUNITZ DOMAIN” PROTEINS AND ANALOGUES THEREOF

 

ISSUED

 

5 /2 /2000

10280-096002

 

09/421,097

 

6,333,402

 

 

 

KALLIKREIN-BINDING “KUNITZ DOMAIN” PROTEINS AND ANALOGUES THEROF

 

ISSUED

 

12/25/2001

[*****]

 

[*****]

 

 

 

 

 

[*****]

 

[*****]

 

 

10280-096004

 

09/136,012

 

5,994,125

 

 

 

KALLIKREIN-INHIBITING “KUNITZ DOMAIN” PROTEINS AND ANALOGUES THEREOF

 

ISSUED

 

11/30/1999

10280-096005

 

11/365,438

 

 

 

US 2006-

 

KALLIKREIN-BINDING “KUNITZ

 

PUBLISHED

 

 

 

C-2



 

MATTER

 

SERIAL

 

PATENT

 

PUBL

 

TITLE

 

STATUS

 

ISSUE

 

 

 

 

 

 

0264603 A1

 

DOMAIN” PROTEINS AND ANALOGUES THEREOF

 

 

 

 

10280-096WO1

 

PCT/US95/00299

 

 

 

WO95/21601

 

KALLIKREIN-BINDING “KUNITZ DOMAIN” PROTEINS AND ANALOGUES THEREOF

 

PUBLISHED

 

 

10280-094003

 

11/323,261

 

7,276,480

 

US 2007-0249807 A1

 

PREVENTION AND REDUCTION OF BLOOD LOSS

 

ISSUED

 

10/2 /2007

[*****]

 

[*****]

 

 

 

 

 

[*****]

 

[*****]

 

 

10280-143001

 

11/716,278

 

 

 

US 2007-0213275 A1

 

FORMULATIONS FOR ECALLANTIDE

 

PUBLISHED

 

 

10280-143WO1

 

PCT/US07/63703

 

 

 

WO2007106746 A2

 

FORMULATIONS FOR ECALLANTIDE

 

PUBLISHED

 

 

 

C-3


 

EXHIBIT C-2

 

Fovea —Assigned Dyax Patent Rights

 

[*****]

 

[*****]

 

 

 

[*****]

 

[*****]

 

 

 

 

[*****]

 

[*****]

 

 

 

 

 

[*****]

 

[*****]

 

 

[*****]

 

[*****]

 

 

 

 

 

[*****]

 

[*****]

 

 

[*****]

 

[*****]

 

 

 

 

 

[*****]

 

[*****]

 

 

 

C-4



 

EXHIBIT C-3

 

[*****] Patent Rights

 

[*****]

 

C-5



 

EXHIBIT D

 

Arbitration Procedures for Certain Collaboration Governance Issues

 

1.  General.  In the event that the JSC is unable to reach consensus on a decision-making matter other than (a) a matter with respect to which one of the Parties is expressly allocated decision-making authority in this Agreement or (b) a matter for which this Agreement expressly provides that a decision shall not be made without the approval or consent of one or both of the Parties, the decision shall be made through binding arbitration in accordance with the provisions of Article XII as modified by this Exhibit D.

 

2.  Designation of Arbitrator.  In the event of any dispute subject to this Exhibit D, the Parties shall designate an arbitrator in accordance with Section 12.3(a); provided that (a) the Parties shall make such designation (or referral to the AAA) within [*****] and (b) the arbitrator shall be a former pharmaceutical or biotechnology industry executive with experience in the subject matter of the dispute.

 

3.  Exchange of Proposed Resolutions; Advocacy.  Within [*****] after the designation of the arbitrator, the Parties shall exchange their proposed resolutions of the dispute together with a brief or other written memorandum supporting the merits of their final proposed resolutions.  The arbitrator and the Parties shall then meet within [*****], at which time each Party shall have one hour to argue in support of its final proposed resolution.  The provisions of the foregoing sentence may be modified at the discretion of the arbitrator.  The Parties shall not call any witnesses in support of their arguments unless the arbitrator otherwise determines in his or her discretion.

 

4.  Selection of Proposed Resolution.  The arbitrator shall select as the binding resolution the proposed resolution that reflects the more commercially reasonable resolution consistent with the goals and obligations of the Parties set forth in the Agreement within [*****] (or such longer period of time as the arbitrator determines in his or her discretion) after the meeting with the arbitrator referred to in the immediately preceding paragraph.

 

D-1



 

EXHIBIT E

 

Dyax Supply Agreement Terms

 

1.             The provisions set forth in this Exhibit E shall apply to the obligation of Dyax to supply API Bulk Drug Substance to Fovea for use in the Manufacture and supply by Fovea of Finished Product for commercial sale in the Fovea Territory by Fovea and its Related Parties and for commercial sale in the Dyax Territory by Dyax and its Related Parties.

 

2.             Dyax and Fovea shall mutually agree upon the specifications, including the necessary documentation, certificates of analysis and test results, for the API Bulk Drug Substance to be supplied under the Dyax Supply Agreement (the “Specifications”).  Fovea shall use the API Bulk Drug Substance supplied by Dyax solely for such purposes permitted under this Agreement and shall not transfer any such API Bulk Drug Substance to any Third Party for any other purpose.

 

3.             Unless agreed otherwise in writing by the Parties or as otherwise set forth in the Dyax Supply Agreement, [*****] before the commencement of each calendar quarter, Fovea will give to Dyax a forecast of Fovea’s estimated quarterly requirements of API Bulk Drug Substance for the [*****] commencing with such calendar quarter.  Such forecast will include quantity and unit requirements for API Bulk Drug Substance on a country-by-country basis.  [*****] of Fovea’s forecasted requirements of API Bulk Drug Substance during the [*****] of such forecast, and [*****] of Fovea’s forecasted requirements of API Bulk Drug Substance during the [*****] of such forecast, shall be considered binding.  Fovea’s forecasted requirements of API Bulk Drug Substance during the last four quarters of such forecast will be non-binding. Fovea will provide Dyax with binding purchase orders for API Bulk Drug Substance at least [*****] in advance of the delivery date for such API Bulk Drug Substance.  The Parties agree that they will revisit the provisions of this paragraph 3 at the time of the negotiation of the Dyax Supply Agreement to ensure that they are appropriate considering the interests of both Parties.

 

4.             In the event of a shortage of supply of API Bulk Drug Substance, Dyax shall promptly notify Fovea and, unless otherwise agreed by the Parties, (a) prior to such time as Dyax (whether directly or through a Related Party) and Fovea (whether directly or through a Related Party) shall have each been selling Product for a period of [*****], available supply shall be allocated between the respective Parties on a pro-rata basis based on good faith forecasts of requirements and (b) once Dyax (whether directly or through a Related Party) and Fovea (whether directly or through a Related Party) shall have been selling Product for a period [*****], available supply shall be allocated between the respective Parties on a pro-rata basis based on quantities purchased during the prior [*****].  In addition, Dyax will use Diligent Efforts to resolve all failure to supply issues as promptly as possible in consultation with Fovea.

 

5.             Dyax agrees that all API Bulk Drug Substance supplied to Fovea will, at the time of delivery to Fovea, have been Manufactured in accordance with the Specifications.

 

6.             In addition to more detailed terms regarding the matters specified above in this Exhibit E, the Dyax Supply Agreement shall contain other customary supply agreement provisions.

 

E-1



 

EXHIBIT F

 

Product Competitors

 

[*****]

 

F-1



 

EXHIBIT G

 

[*****] Payments

 

[*****]

 

[*****]

 

[*****]

 

[*****]

 

[*****]

 

 

[*****]

 

[*****]

 

[*****]

 

[*****]

 

G-1



 

EXHIBIT H

 

Non-European Union Countries within the Fovea Territory

 

Russia

 

Turkey

 

Switzerland

 

H-1



EX-10.20 5 a2196756zex-10_20.htm EXHIBIT 10.20

Exhibit 10.20

 

SERVICES AGREEMENT

(Specialty Pharmacy and Hub Services)

 

This SERVICES AGREEMENT (“Agreement”), dated as of November 19, 2009 (the “Effective Date”), is entered into by and between DYAX CORP., a Delaware corporation with offices located at 300 Technology Square, Cambridge, Massachusetts 02139 (“Dyax”), and US BIOSERVICES CORPORATION, a Delaware corporation, on behalf of itself and its subsidiaries IHS Acquisition XXX, Inc., Pharm Plus Acquisition, Inc., Ambulatory Pharmacy Services, Inc. and Specialty Pharmacy, Inc., all of which do business as US Bioservices, with its primary offices located at 3101 Gaylord Parkway, Frisco, Texas 75034 (collectively, “US Bio”).

 

WHEREAS, Dyax has developed the Product (as defined below);

 

WHEREAS, in the United States, Dyax intends to secure the regulatory approvals required in order to promote, market and sell the Product in the United States as a treatment for patients suffering acute attacks associated with the disease known as hereditary angioedema (“HAE”);

 

WHEREAS, US Bio is in the business of providing specialty pharmacy and retail distribution services for pharmaceutical products; and

 

WHEREAS, Dyax wishes to engage US Bio to provide Dyax with specialty pharmacy and retail distribution services for the Product throughout the United States, and US Bio wishes to accept such engagement, all upon the terms and subject to the conditions set forth in this Agreement.

 

NOW, THEREFORE, for good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the parties agree as follows:

 

1.             Definitions.

 

As used in this Agreement, the following capitalized terms shall have the following meanings:

 

1.1                                 Affiliate” shall mean any individual, corporation, partnership, association, or business that directly or indirectly through intermediaries, controls, is controlled by or is under common control with, a party. An ownership, voting or similar interest (including any right or option to obtain such an interest) representing more than 50% of the total interests then outstanding of the pertinent entity shall constitute “control” for the purposes of this definition.

 

1.2                                 Applicable Laws” shall mean all applicable laws, rules, regulations in the Territory, including guidelines and guidances promulgated by governmental entities.

 

1.3                                 Competing Product” shall mean any pharmaceutical product, other than the Product, that is being developed, manufactured or commercialized for use as a therapeutic or prophylactic treatment for Patients.

 

1.4                                 FDA” shall mean the United States Food and Drug Administration or any successor agency thereto.

 


*Confidential Treatment Requested.  Omitted portions filed with the Commission.

 



 

1.5                                 Field” shall mean all uses in the therapeutic treatment of HAE.

 

1.6                                 HIPAA” shall mean the Health Insurance Portability and Accountability Act of 1996, as amended, 42 U.S.C. § 1320d, et seq., and the implementing regulations promulgated thereunder.

 

1.7                                 Hub Services” shall have the meaning set forth in Section 8.1 below.

 

1.8                                 Patient” shall mean any person diagnosed with HAE.

 

1.9                                 Product” shall mean Dyax’s proprietary plasma kallikrein inhibitor, known as internally as DX-88 and generically as ecallantide, as more formally described on Exhibit A.

 

1.10                           REMS Program” shall mean the Risk Evaluation and Mitigation Program required to be implemented under Section 505-1 of the Federal Food, Drug and Cosmetic Act in connection with the regulatory approval of the Product by the FDA.

 

1.11                           SOPs” shall have the meaning set forth in Section 8.4.

 

1.12                           Specialty Pharmacy Customers” shall mean health-care providers (generally physicians and physician-operated clinics) who receive Product on behalf of specific Patients pursuant to a physician-issued prescription in accordance with the terms and conditions set forth in this Agreement.  For the avoidance of doubt, Specialty Pharmacy Customer shall not include specialty pharmacies, distributors, wholesalers or hospital, institutional or other pharmacies.

 

1.13                           Statement of Work” shall have the meaning set forth in Section 8.1.

 

1.14                           Term” shall have the meaning set forth in Section 15.1.

 

1.15                           Territory” shall mean the 50 states of the United States of America, the District of Columbia and Puerto Rico.

 

2.                                      Engagement of US Bio.

 

2.1                                 Engagement.  Upon the terms and conditions set forth herein, Dyax hereby engages US Bio, on an exclusive basis during the Term (subject to Section 15.4), to (i) dispense and distribute Product to Specialty Pharmacy Customers for the Field in the Territory, and (ii) provide the Hub Services.  US Bio hereby accepts such engagement and shall dispense and distribute Product to Specialty Pharmacy Customers in the Territory and provide the Hub Services in a professional and responsible manner and in accordance with the terms of this Agreement and all Applicable Laws.

 

2.2                                 Authorized Distributor.  In connection with US Bio’s engagement under Section 2.1 above, and solely for the limited purpose of compliance with the pedigree requirements of the Prescription Drug Marketing Act and any similar state laws, Dyax hereby designates US Bio as an Authorized Distributor of Record (“ADR”) of the Product during the Term.

 

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2.3                                 Exclusivity.

 

(a)                                  The parties acknowledge and agree that as a result of the exclusive nature of the US Bio engagement, (i) subject to Section 15.4, during the Term, Dyax shall not engage any party other than US Bio or its Affiliates to dispense and distribute Product to Specialty Pharmacy Customers for the Field in the Territory or perform the Hub Services, (ii) during the Term and for [*****] thereafter, US Bio shall not, and shall cause its Affiliates providing specialty pharmacy services not to, provide services substantially similar to the Hub Services for any Competing Product, and (iii) during the Term and for [*****] thereafter, US Bio shall not promote any Competing Product.  To the extent that a non-specialty pharmacy Affiliate of US Bio provides services for a Competing Product, US Bio acknowledges that it will maintain the confidentiality and security of all Dyax Confidential Information in accordance with Article 11 and that US Bio will not disclose any Confidential Information of Dyax, or any acquired knowledge or learnings that US Bio may obtain in connection with the performance of the Hub Services, to any such Affiliate.

 

(b)                                 The parties acknowledge and agree that the restriction set forth in Section 2.3(a)(iii) shall not preclude US Bio from (i) dispensing a Competing Product, (ii) providing clinically appropriate information to healthcare providers, patients and others in connection with dispensing a Competing Product, or (iii) providing general information on US Bio’s specialty pharmacy services; provided that, in each case US Bio does not violate the terms of this Agreement or otherwise Disadvantage the Product in any way in the Territory.  For purpose of the foregoing sentence, “Disadvantage” shall mean any activities that (X) are intended to encourage, or could reasonably be foreseen to encourage, the utilization of a Competing Product, such as advertising the Product in a manner that suggests that a Competitive Product is superior to the Product in terms of acquisition price, reimbursement rates, or efficacy, or (Y) otherwise operate to the disadvantage of the Product.

 

2.4                                 Reserved Rights.

 

(a)                                  Except as expressly provided in this Agreement, no right, title or interest in or to Product or any patent, trade secret, trademark or any other intellectual property right of Dyax or its Affiliates is granted, whether express or implied, by Dyax to US Bio.  In furtherance of the foregoing and not in limitation thereof, nothing herein shall in any way limit Dyax’s ability to (i) dispense or distribute Product to Specialty Pharmacy Customers outside of the Territory, (ii) dispense or distribute Product to Specialty Pharmacy Customers in the Territory for uses outside the Field or (iii) dispense or distribute Product to any person or entity other than a Specialty Pharmacy Customer, including specialty pharmacies, distributors, wholesalers or hospital pharmacies or health-care providers that purchase Product on a wholesale basis (e.g., buy-and-bill or consignment).

 

(b)                                 Except as expressly provided in this Agreement, no right, title or interest in or to any patent, trade secret, trademark or any other intellectual property right of US Bio or its Affiliates is granted, whether express or implied, by US Bio to Dyax.  By way of clarification, all proprietary systems, databases and web-based applications, and any

 

3



 

standard operating procedures, work rules, programming, software, routines, analytic tools, embedded logic or table structures associated therewith, that have been developed, maintained, utilized and improved by US Bio (or its Affiliates) in connection with this Agreement or the Hub Services are and will remain the property of US Bio (or its Affiliates).

 

2.5                                 Service Level Commitments.  The parties to this Agreement desire to define a mutually beneficial relationship between Dyax and US Bio in order to achieve Dyax’s goals of high patient level product availability, high levels of consumer and pharmacy confidence in the integrity and quality of the Product, and achievement of a collaborative, transparent, and cost-effective distribution system.  In order to achieve the stated goals, US Bio agrees to dispense and distribute the Product and perform the Hub Services hereunder in accordance with the key performance indicators described in the Statement of Work attached hereto as Exhibit B and incorporated herein by this reference.

 

3.                                      Purchase and Sale of Product.

 

3.1                                 Purchase of Product.  US Bio shall (i) purchase Product only from Dyax (or its third party logistics provider acting on Dyax’s behalf) and no other supplier, (ii) dispense and distribute Product that it has purchased from Dyax, and (iii) dispense and distribute Product only to Specialty Pharmacy Customers for the Field in the Territory.  US Bio shall fill orders for Product only with Product and shall not substitute other products.

 

3.2           Purchase Price; Payment Terms.

 

(a)                                  The price payable by US Bio to Dyax for all Product purchased by US Bio hereunder (the “Purchase Price”) shall be [*****].

 

(b)                                 Dyax promptly shall invoice US Bio for the Purchase Price for all Product purchased hereunder.  All Dyax invoices for Product shall be due and payable by US Bio within [*****] after receipt by US Bio [*****].  On all undisputed balances exceeding [*****] from invoice receipt, US Bio shall pay interest equal to the lesser of (i) [*****] per month and (ii) the maximum allowed by law.

 

4.                                      Delivery of Product to US Bio.

 

4.1                                 Product Orders.  US Bio shall submit all Product orders electronically in the industry standard format in accordance with such procedures as may be mutually agreed upon by the parties.  Unless otherwise agreed between the parties, all Product orders shall be submitted in quantities of 20 units (or multiples of 20 units).

 

4.2                                 Delivery Times.  Dyax shall make commercially reasonable efforts to ship all US Bio orders completely and to have Product from such orders shipped to US Bio within a mutually agreeable schedule of up to [*****] of order placement.  US Bio acknowledges and agrees that Dyax may not be able to fill all orders completely or within a specified time due to shortages or other causes and such inability shall not constitute a breach of this Agreement.

 

4



 

4.3                                 Product Dating.  Dyax shall ship Product to US Bio with at least [*****] shelf life remaining, unless otherwise agreed in writing (including via email or other electronic communication) by US Bio[*****]

 

4.4                                 Product Delivery; Risk of Loss.  Dyax shall deliver all Product Free On Board to US Bio’s facility in the Territory designated in the applicable order.  For purposes of this Section, the term “Free On Board” means that Dyax shall (i) bear all costs associated with shipping Product to the US Bio designated facility, and (ii) bear all risk of loss for Product until its delivery to the designated US Bio facility.  Title to, and risk of loss of, all Product shall pass to US Bio on delivery.

 

4.5                                 Inspection of Product.  US Bio shall examine the Product upon delivery at US Bio’s designated facility and shall notify Dyax in writing (including via email or other electronic communication) within one (1) business day of any problems relating to the quantity of Product delivered or any defect in any of the Product that is reasonably discoverable upon visual inspection of the Product without unpacking of pallets.

 

4.6                                 No Alteration.  US Bio shall not alter the Product in any way, including the packaging thereof, without Dyax’s written consent (except to remove the Product from the shipping containers) and shall not alter the Product labeling, except to add a prescription label to the Product upon dispensing or shipment, as required by Applicable Laws.

 

4.7                                 Storage Conditions.  US Bio will maintain Product stored at, and shipped from, its facilities under (i) the Product storage, shipment and handling requirements set forth in the FDA-approved labeling and (ii) any additional requirements mutually agreed upon between US Bio and Dyax.  US Bio shall notify Dyax within one (1) business day of any deviation from such requirements so that Dyax can determine whether any further action must be taken with respect to such Product.  Failure of US Bio to notify Dyax promptly of such deviation shall constitute a breach of this Agreement by US Bio.

 

5.                                      Product Inventories.

 

5.1                                 Inventory Levels.  During the Term, unless otherwise agreed to by Dyax in writing (including via email or other electronic communication) and subject to Section 5.2, US Bio shall maintain at all times an inventory of Product in an amount equal to not less than [*****] nor more than [*****] of [*****].

 

5.2                                 Supply Shortages.  US Bio shall have no obligation to maintain the minimum inventory levels described in Section 5.1 if Product is unavailable from Dyax.

 

6.                                      Product Returns.

 

Dyax (or Dyax’s third party logistics provider acting on Dyax’s behalf) shall accept and process returns of Product purchased by US Bio hereunder in accordance with Dyax’s Product Returns Policy, as it may be amended from time to time by Dyax.  A copy of the Product Returns Policy in effect as of the Effective Date is attached to this Agreement as Exhibit D.

 

5



 

7.                                      Suspension, Recalls and Government Notices.

 

7.1                                 Suspension.  Upon written notification by Dyax to suspend distribution of Product, US Bio immediately shall suspend its distribution of Product.  If the suspension continues for more than [*****], Dyax will repurchase Product in saleable condition held in inventory by US Bio at the price paid for such Product by US Bio.  All repurchased Product shall be returned to Dyax (or Dyax’s third party logistics provider) at Dyax’s expense.

 

7.2                                 Recalls.

 

(a)                                  Recalls Procedures.  Dyax shall promptly notify US Bio of any recalls or market withdrawals initiated by Dyax or required by the FDA or any other governmental agency.  US Bio shall notify Dyax immediately of any event or circumstance that US Bio reasonably believes may necessitate a recall or market withdrawal.  Upon receipt of notice of a recall or market withdrawal from Dyax, US Bio shall administer such recall or market withdrawal under the direction of Dyax, including promptly notifying the affected Specialty Pharmacy Customers of US Bio in accordance with Dyax’s instructions.  Dyax shall provide US Bio with a form letter to be used in connection with notice of any recall or market withdrawal, and shall, to the extent practicable, provide US Bio the opportunity to review and comment on such letter.  Dyax shall be responsible for the mailing, shipping, and reasonable administrative expenses incurred by US Bio in connection with the recall or market withdrawal, plus a reasonable service fee as mutually agreed upon in advance by the parties as well as the cost of replacement Product for US Bio’s Specialty Pharmacy Customers.  Notwithstanding the foregoing, to the extent that such recall or market withdrawal arises or results from (i) the negligence or intentional misconduct of US Bio or any of its permitted agents or employees or (ii) the breach by US Bio of this Agreement, US Bio shall bear and be responsible for all such costs as well as the reasonable, documented, out-of-pocket expenses of Dyax incurred in connection with such recall or market withdrawal.

 

(b)                                 Investigations; Cooperation.  US Bio shall reasonably cooperate with Dyax in investigating any Product failure that resulted in the need for a recall or market withdrawal and any reasonable, documented, out-of-pocket cost involved with such investigation shall be reimbursed by Dyax, except to the extent that such recall or market withdrawal arises or results from (i) the negligence or intentional misconduct of US Bio or any of its permitted agents or employees or (ii) the breach by US Bio of this Agreement, in which event US Bio shall bear and be responsible for such costs as well as the reasonable, documented, out-of-pocket expenses of Dyax incurred in connection with such investigation.

 

7.3                                 Government Notices.  Each party shall provide the other with a copy of any correspondence or notices it receives from the FDA, or other governmental entity specifically relating to activities conducted under this Agreement, no later than one (1) business day following such receipt.  In addition, US Bio shall provide Dyax with any notice it receives from the FDA or other governmental entity relating to Product no later than one (1) business day following such receipt.  Each party shall also provide the other with concurrent copies of any responses to any such correspondence or notices (e.g., a response to an FDA 483 notice, warning letter, or untitled regulatory letter);

 

6



 

provided that Dyax shall review and approve all such responses by US Bio to the extent related to the Product and to the extent reasonably feasible.  Where reasonably possible, US Bio shall give prior notice to Dyax of any scheduled FDA or other governmental inspection of US Bio’s facilities specifically relating to the Product, and, if reasonably possible, will afford Dyax the opportunity to be present at such inspection.

 

8.                                      Hub Services and Related US Bio Obligations.

 

8.1                                 Hub Services; Statement of Work.   US Bio shall provide certain support services relating to (i) the sale and use of the Product in the Field in the Territory and (ii) the REMS Program (collectively, the “Hub Services”).  The specific nature of such Hub Services, and any additional terms and conditions applicable to such Hub Services, shall be set forth in writing (each such writing, a “Statement of Work”).  The initial Statement of Work that has been agreed upon by the parties is attached hereto as Exhibit B.  Any changes to the initial Statement of Work or any new Statement of Work must be in writing and approved by both parties, and thereafter shall be considered an addendum to this Agreement.  All Services performed under any Statement of Work shall be subject to all the terms and conditions set forth herein.

 

8.2                                 REMS ProgramUS Bio shall distribute Product, perform the Hub Services, and otherwise conduct all activities under this Agreement in accordance with the REMS Program and any additional policies Dyax implements and provides in writing to US Bio.  Without limiting the scope of the foregoing, US Bio agrees that any promotional, educational or other materials delivered to Specialty Pharmacy Customers and/or Patients in connection with this Agreement shall be preceded or accompanied by the medication guide, the healthcare provider letter and/or any other materials required by the REMS Program, as applicable, and in accordance with the provisions of the REMS Program.

 

8.3                                 Adverse Event Reporting.  In the event that an adverse experience, as that term is defined at 21 C.F.R. § 600.80 (as such provision may be amended from time to time), with regard to the Product is reported to US Bio, US Bio shall ensure that all applicable safety and other relevant information relating to the Product that is obtained during the course of any interaction with patients, healthcare providers, or other individual, is communicated and maintained in accordance with Applicable Laws.  US Bio shall notify Dyax of any adverse drug experiences with regard to the Product within three (3) business days after its first receipt; provided however, that any information relating to a serious adverse experience (SAE), as that term is defined at 21 C.F.R. § 600.80 (as such provision may be amended from time to time), shall be provided to Dyax within one (1) business day after its first receipt.  US Bio shall also make all reasonable efforts to assist Dyax with any follow-up investigation necessary to comply with Applicable Laws with respect the reporting of adverse drug experiences relating to the Product; provided, that US Bio will not be responsible for reporting of any adverse events to the FDA.  Dyax and US Bio will ensure that appropriate SOPs (as defined in Section 8.4) regarding adverse experiences are established, maintained and regularly reviewed to ensure compliance in accordance with the terms of this Agreement and Applicable Laws.  Dyax and US Bio will ensure that all staff involved in these activities are appropriately trained and records of such training are maintained.

 

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8.4                                 Standard Operating Procedures; Other Work Instructions.  US Bio shall conduct all Hub Services under this Agreement in accordance with Standard Operating Procedures (“SOPs”) and other Dyax-specific work instructions (“Dyax Instructions”) applicable to such activities, as established and approved in writing by the parties from time to time.  The preliminary SOPs and Dyax Instructions that have been approved by the parties are attached hereto as Exhibit C.  [*****]  The parties acknowledge and agree that the Hub Services SOPs and Dyax Instructions are the property of Dyax and to the extent that such Hub Services SOPs and Dyax Instructions are maintained by US Bio, then, upon termination or expiration of this Agreement or otherwise upon Dyax’s request, US Bio will deliver such SOPs and Dyax Instructions to Dyax.  Notwithstanding anything to the contrary contained in this Agreement or elsewhere, during the Term of this Agreement, the SOPs shall not include any of US Bio’s internal standard operating procedures or work instructions that are non-specific to Dyax and the Product, which are the confidential and proprietary property of US Bio and shall not be disclosed by Dyax to any third party without the consent of US Bio.  Dyax shall be permitted, upon its reasonable request, to review any of US Bio’s internal standard operating procedures or work instructions at US Bio’s facility.  Upon termination of this Agreement, any of US Bio’s internal standard operating procedures or work instructions in Dyax’s possession will be returned to US Bio or (at US Bio’s election) destroyed by Dyax, with Dyax providing US Bio with a written certification of destruction.

 

8.5                                 No Subcontracting or Subdistribution.  All obligations and services to be performed by US Bio under this Agreement shall be solely performed by US Bio and US Bio shall not outsource or subcontract any of its obligations hereunder without Dyax’s prior written consent.

 

8.6                                 Applicable Laws and RegulationsUS Bio shall conduct all activities under this Agreement in compliance with all Applicable Laws, including federal and state pharmacy or pedigree laws, laws relating to the promotion of prescription medicines including the prohibition of off-label promotion, federal and state laws protecting the privacy of patient or prescriber identifiable information (including HIPAA), federal and state anti-kickback laws and regulations, laws relating to the disposal of pharmaceutical products and hazardous wastes, and all applicable professional and industry standards and good business practices.  If Dyax reasonably determines that US Bio has conducted activities under this Agreement in a manner that could potentially compromise public health or safety, then Dyax may terminate this Agreement immediately, and whether or not Dyax terminates this Agreement, may pursue all other legal remedies available to it.

 

8.7                                 Product Promotion.  US Bio will not provide any information regarding the safety, effectiveness, or use of Product to Specialty Pharmacy Customers or other persons or entities except as approved in advance in writing by Dyax or required by Applicable Laws.  US Bio may provide information on its own specialty pharmacy and distribution services to its Specialty Pharmacy Customers in accordance with US Bio standard business practices, including informing its Specialty Pharmacy Customers of pricing available for the Product and other products distributed by US Bio.  US Bio warrants that any information it provides to its Specialty Pharmacy Customers regarding Product or its services will be truthful and non-misleading and will comply with all Applicable Laws.

 

8.8                                 Discounts.  To the extent required by Applicable Laws, including 42 U.S.C. §§ 1320a-7b(b) and in conformance with the standards set forth in 42 C.F.R. § 1001.952(h) for safe harbor protection, US Bio shall advise and inform each of its Specialty Pharmacy Customers to fully report, as required by

 

8



 

law or contract, any discounts, rebates, or reductions in prices on Product and provide the discount information supplied by US Bio to the Department of Health and Human Services or a state agency upon request, consistent with the requirements of 42 U.S.C. § 1320a-7b(b) and 42 C.F.R. § 1001.952(h).

 

8.9                                 Diversion.  US Bio shall notify Dyax in writing (including via email or other electronic communication) promptly within one (1) business day of learning of information to suggest that any person or entity is diverting or attempting to divert Product.  For the purposes of this Section 8.9, “diverting” means the unauthorized sale, distribution, purchase, receipt, or handling of Product.  Dyax may immediately terminate this Agreement upon written notice if it is determined by Dyax that US Bio has purchased Product from sources other than Dyax or its designated third party logistics provider.

 

9.                                      Compensation for Hub Services.

 

Dyax will compensate US Bio for the Hub Services in accordance with the Statement of Work.  For clarity, the fees on Statement of Work shall be and remain in effect for the duration of the Term, provided that if Dyax terminates its agreement with either of US Bio’s Affiliates, Integrated Commercialization Solutions, Inc. or ASD Specialty Healthcare, Inc., such fees may be subject to adjustment.  Within [*****] following the end of each calendar month during the term of this Agreement, US Bio shall provide a detailed invoice that specifically identifies the Hub Services conducted by US Bio during that calendar month.  Dyax shall notify US Bio of any disputed charges in writing within [*****] following receipt of the invoice covering such charges.  In the absence of any such notice of dispute, all invoices shall be deemed to be correct and due in full within [*****] following receipt of the invoice.  On all undisputed invoice balances exceeding [*****], Dyax shall pay interest equal to the lesser of (i) [*****] per month and (ii) the maximum allowed by law.

 

10.                               Reports and Records.

 

10.1                           Product ReportsUS Bio shall generate and furnish to Dyax (or its designee) the Product reports specified in the Statement of Work attached as Exhibit B (collectively, the “Product Reports”).

 

10.2                           Activity Reports.  In addition to any specific reports that US Bio may be required to deliver to Dyax under this Agreement, US Bio shall provide to Dyax (or its designee) all information and reports related to its activities with respect to the Product that are reasonably requested by Dyax and can be prepared by US Bio without undue burden; provided, that US Bio shall be compensated and fully reimbursed by Dyax for any additional time and expense incurred in connection with the preparation and delivery of such information and/or reports.

 

10.3                           Compliance.  The parties intend that all reports provided to Dyax under Sections 10.1, 10.2 and 13.3 shall comply with Applicable Laws, including HIPAA and any laws relating to the identity of the Patient or prescriber.  Accordingly, the parties agree that US Bio shall only provide Dyax with patient information that is de-identified in accordance with HIPAA’s de-identification provision, 45 C.F.R. § 164.514(b), unless: (i) Dyax or US Bio has on file a valid, HIPAA-compliant written authorization for each patient whose protected health information (“PHI”) is sought to be disclosed; or (ii) written authorization is not required under Applicable Laws in order to disclose the PHI sought.  To the extent they may be required by HIPAA, US Bio shall obtain any Business

 

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Associate Agreements (as described in 45 C.F.R. § 164.504) that are necessary to fulfill its obligations under this Agreement.  In the event of any inconsistency between the data file layouts described for the Product Reports in the Statement of Work attached as Exhibit B and this Section 10.3, the terms of this Section 10.3 shall control.  In the event of any amendment to any Applicable Laws, US Bio shall be entitled to unilaterally modify the data reports, without consent from Dyax, as required to comply with such amendments; provided that US Bio shall provide Dyax with notice of such modification and a description of the amendment requiring such modification prior to submitting a modified data report.  In addition to the foregoing, the parties acknowledge that existing contractual relationships with third party payors may restrict US Bio’s ability to collect, use, and/or disclose certain Patient-, payor-, or physician-specific data.

 

10.4                           Ownership and Use of Data.  Subject to Applicable Laws, Dyax shall have the following rights with respect to information and data relating to Product, the sale of Product to Specialty Pharmacy Customers and the use by Product of Patients obtained, maintained, generated or furnished by US Bio to Dyax in connection with performing US Bio’s obligations hereunder, including such data and information contained in the reports delivered pursuant to Sections 10.1 and 10.2:

 

(a)                                  With respect to the activity and other data generated in connection with the Hub Services (which shall be captured in the Hub Services database and may be reported to Dyax pursuant to this Agreement), Dyax shall own and have the exclusive right to use all such information and data (provided, that US Bio may use any and all information and data to the extent required in its performance of the Hub Services or as otherwise necessary in connection with its dispensing of Product and related services to Patients) and all such information shall be deemed to be Dyax Confidential Information; and

 

(b)                                 The parties acknowledge and agree that US Bio shall own product dispensing data and any other clinical data related to such dispensing activities.  With respect to all information and data not covered by Section 10.4(a) but which is provided by US Bio to Dyax in accordance with this Agreement, Dyax shall have a right to use any and all information and data, for any purpose as permitted by law or, to the extent such data contain PHI, as permitted by the applicable patient’s written authorization or as otherwise allowed under the law.

 

10.5                           Records.  US Bio shall keep complete and accurate books and records pertaining to US Bio’s activities under this Agreement.  Such books and records shall be retained for at least [*****] after the expiration or termination of this Agreement or for such longer period as may be required by Applicable Laws.

 

10.6                           Audits.  Dyax, at its expense, from time to time may perform, or have an independent third party auditor (subject to execution of a mutually agreeable nondisclosure agreement) perform, audits of the records maintained pursuant to Section 10.5 and may observe, or have an independent third party auditor observe, the performance by US Bio of its activities hereunder to verify the status of Product and ensure compliance with the terms of this Agreement.  Dyax shall provide US Bio with at least ten (10) business days advance written notice of such audits or observations, and shall conduct any audit or observation during normal business hours in a manner that does not interfere with US Bio’s normal business operations.  US Bio shall make available relevant records that do not

 

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contain information pertaining to US Bio’s other clients or products and permit such observations.  Dyax and US Bio shall discuss the results of any such audits or observations and US Bio shall implement all corrective measures reasonably requested by Dyax.  All audits shall be reasonable in time and scope.

 

11.                               Confidentiality.

 

11.1                           Confidential Information.  All confidential, non-public documents and other information disclosed to a party by or on behalf of the other party pursuant to this Agreement, which includes but is not limited to information concerns prices and quantities purchased by any customer, Product information, pricing, fees and proposals, operating and sales data, information about processes, systems, strategic plans, business plans, financial information, processes (including SOPs), customer information, information concerning patients or physicians, methods, databases, technology (including software and all source code), and any analysis, compilation, or study, and any other information or materials prepared or derived from such information (collectively, “Confidential Information”), shall, subject to Sections 11.2 and 11.3, be held by the receiving party in strict confidence and not disclosed either directly or indirectly to any third party (other than Affiliates, advisors and consultants who have a need to know such information and who are subject to obligations of confidentiality at least as onerous as those set forth herein) and shall only be used for purposes of fulfilling the receiving party’s obligations, or exercising its rights, under this Agreement.   Notwithstanding the foregoing, all data and information owned by Dyax pursuant to Section 10.4 shall be the Confidential Information of Dyax and not US Bio, and regardless of the party that discloses such Confidential Information hereunder, Dyax shall be deemed the disclosing party, and US Bio shall be deemed the receiving party, with respect to such Confidential Information.  The terms and conditions of this Agreement and any amendments or addenda thereto shall be deemed the Confidential Information of each party.

 

11.2                           Exclusions from Confidentiality.  Notwithstanding anything to the contrary in this Agreement, the receiving party shall have no liability to the disclosing party for the use or disclosure of any Confidential Information that the receiving party can establish by written documentation to:

 

(a)                                  have been publicly known prior to disclosure by the disclosing party of such information to the receiving party;

 

(b)                                 have become publicly known without fault on the part of the receiving party, subsequent to disclosure to the receiving party;

 

(c)                                  have been received by the receiving party at any time from a source, other than the disclosing party, lawfully having possession of and the right to disclose such information;

 

(d)                                 have been otherwise known by the receiving party prior to disclosure by the disclosing party to the receiving party of such information; or

 

(e)                                  have been independently developed by the receiving party without use of information disclosed by the Disclosing Party.

 

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11.3                           Required Disclosure.  A party receiving Confidential Information may disclose such Confidential Information if required to do so by a court (or other governmental agency or stock exchange of competent jurisdiction), any governmental body or as required under any Applicable Laws; provided that (i) the party required to disclose such Confidential Information provides prompt notice of such pending disclosure to the disclosing party so that the disclosing party can seek a protective order or to prevent such disclosure, and (ii) the party required to disclose such Confidential Information shall exercise reasonable efforts to ensure that the information is accorded confidential treatment by the court or other governmental agency or stock exchange.

 

11.4                           Survival of Confidentiality Obligations.  The provisions of this Section 11 shall survive for a period of [*****] following the expiration or termination of this Agreement.

 

11.5                           Injunctive ReliefEach party acknowledges that the failure by the Receiving Party to comply with any of the provisions of this Section 11 will result in irreparable injury and continuing damage to the disclosing party for which there will be no adequate remedy at law and that, in the event of a failure of the receiving party so to comply, the disclosing party shall be entitled to seek such preliminary and permanent injunctive relief as may be necessary to ensure compliance with all the provisions of this Section without having to prove actual damages or to post a bond.

 

12.                               Use of Marks.

 

For the purposes of this Agreement, Dyax hereby grants to US Bio a non-exclusive, non-transferable, revocable license to use Dyax’s trademarks, trade names and service marks used and/or owned by Dyax with respect to the Product (collectively, the “Marks”).  The Marks shall be used by US Bio solely in connection with its sale, distribution and/or delivery of Product, and other activities conducted under this Agreement, in each case solely in accordance with the terms hereof.  The ownership of and goodwill in all Marks shall remain the sole and exclusive property of Dyax and inure exclusively to Dyax’s sole benefit, both during the Term and thereafter.  US Bio agrees that nothing in this Agreement shall give US Bio any right, title or interest in or to the Marks other than the right to use the same in the manner contemplated by this Agreement and only for so long as this Agreement is in force.

 

13.                               Additional Representations, Warranties and Covenants.

 

13.1                           Authorization.  Each party represents and warrants to the other party that it has the legal right and power to enter into this Agreement, to extend the rights and licenses granted to the other in this Agreement, and to fully perform its obligations hereunder, and that the performance of such obligations will not conflict with its charter documents or any agreements, contracts, or other arrangements to which it is a party.  Furthermore, no approvals, consents, orders or authorizations of or designation, registration, declaration or filing with any governmental authority (within the Field in the Territory) is required for either party’s performance of its obligations under this Agreement, other than any approvals that have been obtained already or will be obtained in the ordinary course of the performance of such obligations.

 

13.2                           No Other Agreements.  Each party represents and warrants to the other that this Agreement is not dependent on, and does not operate in conjunction with (either explicitly or implicitly), any other arrangement between Dyax and US Bio.

 

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13.3                           Product PricingUS Bio represents, warrants and covenants that:

 

(a)                                  it will refrain from doing anything that would impede Dyax from meeting any reporting obligations with respect to Product pricing that Dyax may have under Applicable Laws;

 

(b)                                 it will report the Product sales price offered to Specialty Pharmacy Customers on the invoices or statements submitted by US Bio to Dyax; and

 

(c)                                  no discount provided or other payment made pursuant to this Agreement is intended in any way as a discount related to a drug formulary and has not been negotiated or discussed between the parties in connection with any drug formulary.

 

To the extent required under Applicable Laws, US Bio will report the discounts to appropriate Federal health care programs, and in any event, will promptly disclose such discounts if requested by a government agency.

 

13.4                           Hub Services; Service Fees.  The parties mutually represent and warrant to each other that:

 

(a)                                  the service fees paid to US Bio in connection with the Hub Services (i) are not intended in any way as remuneration for US Bio to use, purchase, or recommend any Dyax product or service, except as provided for in this Agreement,  (ii) represent the fair market value for the Hub Services based upon arms length negotiations, (iii) are bona fide service fees that do not constitute a discount or other form of compensation that must be included in Dyax’s reporting of pricing information for Product to the Centers for Medicare and Medicaid Services;

 

(b)                                 the service fees paid to US Bio in connection with the Hub Services are not intended in any way as payment related to a drug formulary or drug formulary activities and have not been negotiated or discussed between the parties in connection with any such drug formulary or formulary activities; and

 

(c)                                  the Hub Services do not involve the counseling or promotion of a business arrangement or other activity that violates any state or federal law.

 

13.5                           Federal Programs.  US Bio represents, warrants and covenants to Dyax that (a) neither US Bio nor any of its Affiliates that perform activities under this Agreement has been debarred or is subject to debarment pursuant to Section 306 of the Act or listed on either Excluded List (as defined herein), and (b) neither US Bio nor any of its Affiliates that perform activities under this Agreement will  knowingly (after reasonable investigation) use in any capacity, in connection with the services to be performed under this Agreement, any person who has been debarred pursuant to Section 306 of the Act, or who is the subject of a conviction described in such section, or listed on either Excluded List.  US Bio shall inform Dyax in writing immediately if it or any person who is performing services hereunder is debarred or is the subject of a conviction described in Section 306 of the Act or listed on either Excluded List, or if any action, suit, claim, investigation or legal or administrative proceeding is pending or, to the best of US Bio’s knowledge, is threatened, relating

 

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to the debarment or conviction Section 306 of the Act, or listing on either Excluded List, of US Bio or any person performing services hereunder.  “Excluded Lists” means the Department of Health and Human Service’s List of Excluded Individuals/Entities and the General Services Administration’s Lists of Parties Excluded from Federal Procurement and Non-Procurement Programs.

 

13.6                           Licensure.  US Bio represents and warrants that it now has and shall maintain in full force during the Term all applicable federal and state pharmacy and other licenses or approvals required under Applicable Laws and regulations to fulfill its obligations under this Agreement in each state in the Territory, the District of Columbia and Puerto Rico.  US Bio promptly shall notify Dyax of any denials, revocations or suspension of license or registrations by any state or federal agency or any other regulatory authority in the Territory, or any written notice from a governmental body proposing such a denial, revocation or suspension of a license or registration.  US Bio shall promptly provide Dyax with notice of any material communications with pharmacy licensing boards which relate to potential problems with facilities, operations, contractors or procedures used by US Bio in distribution of the Product, including notices of inquiries, investigations or inspections and resulting findings, except that  in no event shall US Bio be required to disclose information concerning its other clients or the products of such clients.

 

13.7                           Dyax Representations and Warranties.  Dyax hereby represents and warrants to US Bio that, at the time of delivery of Product by Dyax to US Bio hereunder: (a) such Product shall not in any material respect be adulterated, misbranded or otherwise prohibited within the meaning of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. §§ 301 et. seq., as amended and in effect at the time of delivery (the “Act”), or within the meaning of any applicable state or local law; (b) such Product will be merchandise that may be introduced and delivered into interstate commerce under the provisions of Section 301 of the Act or Section 351 of the Public Health Service Act; (c) Dyax (or as applicable its designated third-party logistics provider) has and will maintain, in full force and effect, all licenses and permits required under Applicable Laws for Dyax to sell and distribute such Product under this Agreement; (d) such Product will be the subject of a duly approved Biologics License Application and may be legally transported or sold under Applicable Laws; (e) such Product will have been approved by each applicable governmental authority for commercial sale and shipment of such Product within the Territory; and (f) Dyax either (i) owns or holds the duly approved Biologics License Application, as such term is used in the Public Health Service Act, Title 21, United States Code, as amended for such Product, or (ii) is otherwise considered the “manufacturer” of such Product within the meaning of any applicable federal, state or local law relating to pedigrees.

 

13.8                           No Other Warranties.  Except as expressly provided herein, neither party hereto makes any representations or warranties to the other party, express or implied, either in fact or by operation of law, by statute or otherwise, and each party specifically disclaims any express or implied representations and warranties of merchantability or fitness for a particular purpose.

 

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14.                               Liability, Indemnification and Insurance.

 

14.1                           Remedies.

 

(a)                                  Generally.  Rights and remedies under this Agreement are cumulative and in addition to any other available rights or remedies under any other agreement, at law or in equity.

 

(b)                                 Equitable Relief.  If either party violates or threatens to violate any provision of this Agreement, the other party may suffer irreparable harm and its remedies at law may be inadequate.  Accordingly, the other party may seek equitable relief.

 

14.2                           Indemnification.

 

(a)                                  Indemnification by US Bio.  US Bio shall indemnify, defend, and hold harmless Dyax and its Affiliates and its and their respective directors, officers, employees, representatives and agents and their respective successors, heirs and assigns (the “Dyax Indemnitees”) against any liability, damage, loss, penalty, fine or expense (including reasonable attorneys fees and expenses of litigation) (collectively, “Losses”) incurred by or imposed upon the Dyax Indemnitees or any of them in connection with any claims, suits, demands, investigations, enforcement actions, or judgments, in each case initiated by a third party (including any governmental or regulatory agency) (collectively, “Third Party Claims”) which arise out of: (a) the gross negligence or willful misconduct of US Bio in connection with this Agreement; or (b) the breach of this Agreement by US Bio, in each case except for those Losses for which Dyax has an obligation to indemnify US Bio pursuant to Section 14.2(b), as to which Losses each party shall indemnify the other to the extent of its respective liability for such Losses.

 

(b)                                 Indemnification by Dyax.  Dyax shall indemnify, defend, and hold harmless US Bio and its Affiliates and its and their respective directors, officers, employees, representatives and agents and their respective successors, heirs and assigns (the “US Bio Indemnitees”) against any Losses incurred by or imposed upon US Bio Indemnitees or any of them in connection with any Third Party Claims which arise out of: (a) the negligence or willful misconduct of Dyax in connection with this Agreement; (b) the breach of this Agreement by Dyax, in each case except for those Losses for which US Bio has an obligation to indemnify Dyax pursuant to Section 14.2(a); (c) any claims of patent, trademark, copyright or other infringement related to Products; or (d) the storage, handling, use, non-use, demonstration, consumption, ingestion, digestion, manufacture, production and assembly of Products and their transportation to US Bio (except to the extent that such activities are conducted on Dyax’s behalf by an Affiliate of US Bio), as to which Losses each party shall indemnify the other to the extent of its respective liability for such Losses.

 

(c)                                  Indemnification Procedure.  A party that intends to claim indemnification under this Section 14.2 (the “Indemnitee”) shall:  (i) promptly notify the indemnifying party (the “Indemnitor”) in writing of any Third Party Claim in respect of which the Indemnitee or any of its Affiliates or any of their respective directors, officers, employees, representatives, agents or their respective successors, heirs or assigns intend to claim such indemnification hereunder; (ii) provide the Indemnitor sole control of the defense and/or settlement thereof with counsel reasonably satisfactory to the Indemnitee; provided, however, that the Indemnitee reserves the right to retain its own counsel to defend itself in, but not control the defense of, such suit, at its own expense, unless (a) 

 

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the interests of the Indemnitee and the Indemnitor in the suit conflict in such a manner and to such extent as to require, consistent with applicable standards of professional responsibility, the retention of separate counsel for the Indemnitee, in which case, the Indemnitor shall pay for one separate counsel chosen by the Indemnitee or (b) the Indemnitor shall not have employed attorneys reasonably satisfactory to the Indemnitee to defend any action within a reasonable time after notice of commencement of such action and (iii) provide the Indemnitor, at the Indemnitor’s request and expense, with reasonable assistance and full information with respect thereto.  Neither the Indemnitor nor the Indemnitee shall be responsible to or bound by any settlement made by the other without its prior written consent, which shall not be unreasonably withheld or delayed.  Without limiting the foregoing provisions of this Section 14.2(c), the Indemnitor shall keep the Indemnitee reasonably informed of the progress of any claim, suit or action under this Section 14.2 and the Indemnitee shall have the right to participate in any such claim, suit or proceeding with counsel of its choosing at its own expense, but the Indemnitor shall have the sole right to control the defense or settlement thereof in accordance with the terms of this Section 14.2(c).

 

14.3                           Limitation of Liability.

 

(a)                                  Neither party shall be liable to the other for special, exemplary, consequential, incidental (including lost or anticipated revenues or profits), indirect or punitive damages arising from the performance or nonperformance of such party under this Agreement whether such claim is based on contract, tort (including negligence) or otherwise, even if an authorized representative of such party is advised of the possibility or likelihood of same.

 

(b)                                 Notwithstanding the exclusions and limitations of liability set forth in Section 14.3(a) above, such exclusions and limitations shall not apply to: (i) either party’s indemnification obligations pursuant to Section 14.2; or (ii) either party’s breach of the party’s confidentiality obligations pursuant to Article 11.

 

14.4                           US Bio Insurance Obligations.  During the Term, US Bio shall maintain the following minimum levels of insurance:

 

(a)                                  Employer’s liability insurance with a limit of [*****] for bodily injury by accident per person, [*****] for bodily injury by accident, all persons and [*****] bodily injury by disease policy limit;

 

(b)                                 Commercial general liability insurance, including personal injury blanket contractual liability and broad form property damage, with a [*****] combined single limit;

 

(c)                                  Umbrella liability insurance in the amount of [*****] per occurrence and aggregate; and

 

(d)                                 Property insurance covering the business property of US Bio and others while at any unnamed location in the amount of [*****].

 

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The insurance required by this Section 14.4 may be made up through a combination of self-insured retention and traditional insurance.  Throughout the Term, US Bio shall (a) provide prompt written notice to Dyax in the event US Bio becomes aware or is notified that the insurance described in this Section 14.4 will be materially adversely modified or cancelled in such a manner that US Bio is no longer in compliance with the requirements of this Section 14.4 and (b) provide Dyax with proof of such insurance on or before the date such insurance is renewed for each year.

 

14.5                           Dyax Insurance Obligations.  During the Term, Dyax will maintain products liability and commercial general liability insurance having a limit of not less than [*****] per occurrence, Combined Single Limit (Bodily Injury and Property Damage), pursuant to one or more insurance policies with reputable insurance carriers having a Best’s Rating of A VII or otherwise as reasonably approved by US Bio.  Dyax will designate US Bio as an “additional insured” under such insurance policy and will obtain a broad form vendor’s endorsement for products liability for US Bio.  Within thirty (30) days after the Effective Date, Dyax will provide to US Bio a certificate of insurance indicating that such obligations have been satisfied.  As a condition precedent to the effectiveness of this Agreement, Dyax will execute the form of Continuing Guaranty and Indemnification Agreement (the “Continuing Guaranty”) with AmerisourceBergen Corporation attached hereto as Exhibit E.

 

15.                               Term and Termination.

 

15.1                           Term. Unless earlier terminated in accordance with the terms hereof, the term of this Agreement (the “Term”) shall (i) commence as of the Effective Date and will continue in effect for an initial period of three (3) years (the “Initial Term”), and (ii) automatically renew for subsequent periods of [*****] (each, a “Renewal Term”), unless either party provides written notice to the other at least [*****] prior to the end of the Initial Term or then-current Renewal Term that it  does not wish to renew.  The parties will work together in good faith to discuss and agree upon any appropriate fee adjustments at least [*****] prior to expiration of the Initial Term (or any subsequent Renewal Terms).

 

15.2                           Termination.  In addition to any other provision of this Agreement providing for termination hereof, this Agreement may be terminated as follows:

 

(a)                                  Termination by Dyax For Convenience.  Dyax may terminate this Agreement for convenience, without cause, upon [*****] prior written notice of termination to US Bio; provided, that, upon any such termination that occurs prior to the second anniversary of the Effective Date, Dyax shall pay US Bio the following amount within [*****] following the effective date of termination: (i) [*****] if prior to the first anniversary of the Effective Date; (ii) [*****] if after the first anniversary of the Effective Date but prior to the second anniversary of the Effective Date; and (iii) [*****] if after the second anniversary of the Effective Date but prior to the third anniversary of the Effective Date.

 

(b)                                 Termination For Cause.

 

(i)                                     This Agreement may be terminated by either party on written termination notice to the other party in the event of any material breach of this Agreement by the other party (other than a breach by US Bio of Section 8.2, which is governed by

 

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clause (ii) below), which breach is not cured within [*****] days after delivery of written notice by the non-breaching party specifying such breach and requiring cure.  Notwithstanding the right to cure provided by the foregoing sentence, US Bio shall have the right to cure only two (2) material breaches of any particular obligation hereunder, and this Agreement may be terminated by Dyax immediately on written notice to US Bio in the event of any additional material breach of such obligation by US Bio.

 

(ii)                                  This Agreement may be terminated by Dyax immediately on written notice to US Bio in the event of any material breach by US Bio of Section 8.2.

 

(c)                                  Insolvency.  This Agreement may be terminated by either party immediately upon written notice to the other party in the event of any of the following events:

 

(i)                                     the institution by the other party of insolvency, receivership or bankruptcy proceedings or any other material proceedings for the settlement of the other party’s debts, or the institution against the other party of any such proceedings that remain undismissed for [*****];

 

(ii)                                  the other party’s making an assignment for the benefit of its creditors; or

 

(iii)                               the other party’s dissolution.

 

(d)                                 Other AgreementsIn the event that any of (a) the Distribution Services Agreement of even date herewith between Dyax and ASD Specialty Healthcare, Inc. or (b) the Distribution Services Agreement of even date herewith between Dyax and Integrated Commercialization Solutions, Inc. is terminated for any reason, then (i) this Agreement may be terminated by Dyax immediately upon ninety (90) days written notice to US Bio; and (ii) if not terminated by Dyax, US Bio will notify Dyax of any applicable adjustment to the fees based on such termination.

 

(e)           Supervening Illegality.

 

(i)                                     This Agreement shall terminate if both:  (A) as a result of the enactment of any new applicable federal or state law or regulation, or any change in any existing applicable federal or state law or regulation or any new interpretation of any applicable federal or state law or regulation by any legislative body, court or regulatory agency, the performance by a party of any material obligation under the Agreement would be rendered illegal or any material provision of the Agreement would be rendered invalid or unenforceable, and (B) the parties are unable to negotiate a mutually acceptable amendment to the Agreement pursuant to Section 15.2(e)(iii) below.  If any immaterial provision of this Agreement is held to be illegal, invalid or unenforceable for any reason, the Agreement shall be deemed amended to delete such provision, such amendment to apply only with respect to the operation of the Agreement in the particular jurisdiction in which such provision is held to be illegal, invalid or unenforceable,

 

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and the remainder of the Agreement shall remain in full force and effect and enforceable in accordance with its terms.

 

(ii)                                  The parties agree that the party affected by the new law or regulation or the change in law or regulation or the interpretation of a law or regulation shall use reasonable efforts to give the other party at least [*****] prior written notice of the effective date of such new law, change, or interpretation.

 

(iii)                               The parties agree that, notwithstanding the foregoing provisions of this Section, either party may, within ten (10) business days of giving or receiving notice of the new law, change or interpretation, notify the other party of its wish to renegotiate the applicable terms of the Agreement (“Renegotiation Notice”), in which event the parties shall negotiate in good faith, for a period of sixty (60) days from delivery of the Renegotiation Notice, an amendment to the Agreement that addresses the portion of the Agreement rendered illegal, invalid or unenforceable by the new law, change or interpretation while preserving to the greatest extent possible the original intent of the Agreement.  If the parties successfully conclude such negotiations prior to the effective date of the new law, change or interpretation, the Agreement shall not terminate and shall be amended to reflect the negotiated terms.  If the parties are unable to successfully conclude such negotiations prior to the effective date of the new law, change or interpretation and such effective date is within the sixty (60) day negotiation period, the Agreement shall be deemed amended to delete such portion rendered illegal, invalid, or unenforceable, such amendment to apply only with respect to the operation of the Agreement in the particular jurisdiction in which such portion is held to be illegal, invalid or unenforceable, and the remainder shall remain in full force and effect and enforceable in accordance with its terms.  In the event the parties are unable to successfully conclude such negotiations within the sixty (60) day negotiation period, the Agreement shall terminate at the end of the sixty (60) day negotiation period.

 

15.3         Effect of TerminationUpon the expiration or earlier termination of this Agreement:

 

(a)                                  all Confidential Information received hereunder shall be returned to the disclosing party, or destroyed, at the disclosing party’s election (provided that the receiving party may retain one copy to the extent necessary to comply with any contractual or other legal obligations applicable thereto);

 

(b)                                 all rights granted to US Bio with respect to the Product shall terminate and US Bio shall cease in a timely and orderly manner all activities with respect to the selling and distribution of Product; and

 

(c)                                  unless terminated by US Bio pursuant to Section 15.2(b), for a period of [*****] following such expiration or early termination, US Bio and its Affiliates shall provide commercially reasonable assistance in connection with Dyax’s transition of Product distribution and Hub Services to Dyax, its Affiliates or any third party selected by Dyax. 

 

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Dyax shall reimburse US Bio for its reasonable, documented out-of-pocket costs and expenses incurred with in connection with providing such transition services; provided that, in the event of a termination due to US Bio’s breach, neither the existence of this provision nor the fact of Dyax’s agreement to pay for such transition services shall in any way effect or limit Dyax’s rights or remedies with respect to such breach.

 

Termination of this Agreement shall not relieve either party of obligations incurred prior to termination.  The provisions of Sections 2.3(a)(ii), 2.3(a)(iii), 10.4, 10.5, 10.6, 15.3, 17.10 and 17.11 and Articles 11, 14 and 16, together with and any other provisions which by their express terms extend beyond the expiration or termination of this Agreement, shall survive any termination of this Agreement.

 

15.4                           Termination of Exclusivity.  In the event that Dyax has the right to terminate this Agreement for any reason (except pursuant to Section 15.2(a) (Termination for Convenience), Dyax, on immediate written notice to US Bio, may terminate Section 2.3(a)(i), which shall have no further force or effect from and after the delivery of such notice by Dyax.  In the event that Dyax terminates this Agreement for convenience pursuant to Section 15.2(a), then US Bio’s obligations under Sections 2.3(a)(ii) and 2.3(a)(iii) shall expire one (1) year after the effective date of termination and thereafter have no further force or effect.

 

16.                               Dispute Resolution.

 

16.1                           Resolution by Executives.  Any dispute, controversy or claim initiated by either party arising out of, or resulting from the breach or alleged breach by either party of its obligations under this Agreement (other than bona fide third party actions or proceedings filed or instituted in an action or proceeding by a third party against a party to this Agreement), whether before or after termination of this Agreement, shall be in the first instance referred to the respective chief executive officers of the parties unless such dispute or claim must be filed to preserve a legal interest or injunctive relief is required.

 

16.2                           Arbitration.  If chief executive officers (or their representatives, it being agreed that the chief executive officer of either party may designate a representative, provided such representative is empowered with decision making in the dispute)  of the parties fail to resolve any dispute as provided in Section 16.1 within [*****], then such dispute shall be finally resolved by binding arbitration as follows:

 

(a)                                  Any dispute that might arise between the parties relating to or arising from this Agreement shall be settled by binding arbitration in accordance with the then-prevailing Commercial Arbitration Rules of the American Arbitration Association (“AAA”), except where those rules conflict with this provision, in which case this provision controls. Arbitration shall be conducted before a single arbitrator selected from the AAA’s National Roster of Arbitrators, each of whom shall be a lawyer with at least 15 years experience with a law firm or corporate law department of over 25 lawyers or who was a judge of a court of general jurisdiction.  Each party shall have the right to meet and interview the potential arbitrator for no more than one hour each prior to the selection of an arbitrator.  The arbitration shall be held, and Dyax and US Bio irrevocably consent to arbitrate, in a

 

20


 

mutually agreeable location.  The arbitration shall be conducted in English.  In rendering the award the arbitrator must apply the substantive law of the State of Delaware (except where that law conflicts with this clause); however, the interpretation and enforcement of this arbitration provision shall be governed by the Federal Arbitration Act.  The arbitrator shall render a written opinion setting forth findings of fact and conclusions of law with the reasons therefor stated.  Under no circumstances shall the arbitrator award damages in excess of or inconsistent with any limitations of liability contained in this Agreement.  Any court with jurisdiction shall enforce this clause and enter judgment on any award.  US Bio and Dyax will agree upon, within [*****] after the arbitrator is selected or, if they fail to agree, the AAA will design, procedures that they will follow to assure that the arbitration will be concluded and the award rendered within no more than eight months from selection of the arbitrator.

 

(b)                                 The arbitration proceedings shall be confidential, and neither party shall publicize the nature of any dispute or the outcome of any arbitration proceedings except to the extent required by law, provided in such case the party required to make any disclosure informs the other party of such requirement to allow the other party to seek a protective order.  The arbitrator shall issue appropriate protective orders to safeguard each party’s Confidential Information.

 

(c)                                  Each party has the right before or during the arbitration to seek and obtain from the appropriate court provisional remedies such as attachment, an injunction, replevin, etc., to avoid irreparable harm, maintain the status quo or preserve the subject matter of the arbitration.

 

17.                               Miscellaneous.

 

17.1                           Relationship of Parties.  US Bio’s relationship with Dyax hereunder shall be that of independent contractor, and neither party shall be considered the agent of, partner of, employee or other member of the workforce of, or participant in a joint venture with, the other party.  Neither party shall have authority to bind the other party unless otherwise agreed to in writing by such parties.

 

17.2                           Notices.  All notices, requests, demands and other communications required or permitted to be given pursuant to this Agreement shall be in writing and shall be deemed to have been duly given upon the date of receipt if delivered by hand, recognized international overnight courier, confirmed facsimile transmission, or registered or certified mail, return receipt requested, postage prepaid to the following addresses or facsimile numbers:

 

If to Dyax:

 

Dyax Corp.

 

 

300 Technology Square

 

 

Cambridge, MA 02139

 

 

[*****]

 

 

 

If to US Bio:

 

US Bioservices Corporation

 

 

3101 Gaylord Parkway

 

 

Frisco, TX 75034

 

21



 

 

 

[*****]

 

 

 

 

 

with a copy to:

 

 

 

 

 

AmerisourceBergen Specialty Group

 

 

3101 Gaylord Parkway

 

 

Frisco, TX 75034

 

 

[*****]

 

Either party may change its designated address, contact person and facsimile number by notice to the other party in the manner provided in this Section.

 

17.3                           Assignment.  Neither party may assign its rights or delegate its obligations under this Agreement without the prior written consent of the other party, except that either party may assign this Agreement to any of its Affiliates or to a successor in connection with the merger, consolidation, or sale of all or substantially all of its assets or that portion of its business pertaining to the subject matter of this Agreement, with prompt written notice to the other party of any such assignment; provided that: (i) if such assignee is an Affiliate, the assignor shall responsible for and liable with respect to all assigned obligations and (ii) if such assignee is not an Affiliate, (A) the assignee assumes the assignor’s obligations under the Continuing Guaranty and Indemnification Agreement, and (B) the assignee has net assets as of the end of its most recently completed fiscal year equal to or in excess of the net assets of the assignor as of the end of its most recently completed fiscal year, in each case as set forth in the audited balance sheet of the assignor and assignee, and (iii) in the case of an assignment by Dyax, the assignee is not a Competitor to US Bio.  For the purposes of this Section 17.3, a “Competitor” means any organization, entity or person that competes with US Bio including but not limited to the following companies and their affiliated entities: [*****]  Notwithstanding the foregoing, US Bio acknowledges and agrees that Dyax may perform its obligations and exercise its rights hereunder through a third party logistics provider.

 

17.4                           Force Majeure. Each party’s obligation under this Agreement will be excused to the extent any delay or nonperformance is caused by strikes or other labor disturbance, acts of God, war, or other conditions beyond the reasonable control of that party, but only during the duration of such condition.

 

17.5                           Amendment and Waiver.  This Agreement may be amended, supplemented, or otherwise modified only by means of a written instrument signed by both parties.  Any waiver of any rights or failure to act in a specific instance shall relate only to such instance and shall not be construed as an agreement to waive any rights or fail to act in any other instance, whether or not similar.  To be valid, any waiver must be in writing.

 

17.6                           Severability.  In the event any provision of this Agreement should be held invalid, illegal or unenforceable, the remaining provisions shall not be affected or impaired and the parties shall use all reasonable efforts to replace the applicable provision with a valid, legal and enforceable provision which insofar as practical implements the original intent of such invalid, illegal or unenforceable provision, provided, however, that if the parties fail to reach such agreement within

 

22



 

sixty (60) days, a party whose rights or obligations are materially adversely affected as a result of a provision being held invalid, illegal or unenforceable may terminate this Agreement.

 

17.7                           Headings.  All headings used in this Agreement are inserted for convenience only and are not intended to affect the meaning or interpretation of this Agreement or any Article or Section hereof.

 

17.8                           Successors and Assigns.  This Agreement shall be binding on and shall benefit any and all successors, trustees, permitted assigns and other successors in interest of the parties.

 

17.9                           Applicable Law; Disclaimer of Puerto Rico Law 75.

 

(a)                                  This Agreement shall be construed and enforced in accordance with the laws of the State of Delaware (excluding the choice of law provisions thereof).

 

(b)                                 The parties expressly disclaim, to the fullest extent allowed by Applicable Laws, any application of the Puerto Rico Dealers Act, Law No. 75 of June 1964 (the “Dealers Act”) as amended, and the parties acknowledge that the Dealers Act shall not apply in the interpretation or enforcement of any of the rights and obligations of the parties hereto.

 

17.10                     Contract Interpretation.  The parties have jointly negotiated this Agreement and, thus, neither this Agreement nor any provision will be interpreted for or against any party on the basis that it or its attorney drafted the Agreement or the provision at issue.   When this Agreement requires approval of one or more parties, such approval may not be unreasonably withheld or delayed.  Words, regardless of the number and gender specifically used, will be construed to include any other number, singular or plural, and any gender, masculine, feminine, or neuter, as the context requires.  “And” includes “or.”  “Or” is disjunctive but not necessarily exclusive.  “Including” means “including but not limited to.” Unless other specifically stated, the term “days” means calendar days.

 

17.11                     Entire Agreement; No Reliance.  Each of the parties agrees and acknowledges that this Agreement, including the Continuing Guaranty and the attachments referred to herein, (i) constitutes the entire agreement and supersedes all prior and contemporaneous agreements, understandings, negotiations and discussions, whether oral or written, between the parties with respect to the subject matter of this Agreement, and (ii) is not intended to confer any rights or remedies, or impose any obligations, on any person other than the parties hereto.  Each of the parties expressly agrees and acknowledges that, other than those statements expressly set forth in this Agreement, it is not relying on any statement, whether oral or written, of any person or entity with respect to its entry into this Agreement or to the consummation of the transactions contemplated by this Agreement.

 

17.12                     Counterparts.  This Agreement may be executed in multiple counterparts, each of which shall be deemed an original but all of which together shall constitute one and the same instrument.  Facsimile execution and delivery of this Agreement are legal, valid and binding execution and delivery for all purposes.

 

[signature page to follow]

 

23



 

IN WITNESS WHEREOF, the parties hereto have caused this Agreement to be executed by their duly authorized respective officers as of the Effective Date.

 

 

US Bioservices Corporation

Dyax Corp.

 

 

 

 

 

 

By:

/s/ Mark O. Johnson

 

By:

/s/ Ivana Magovcevic-Liebisch

 

 

 

 

 

Name:

Mark O. Johnson

Name:

Ivana Magovcevic-Liebisch

 

 

 

 

Title:

President

Title:

Executive Vice President Corporate Development and General Counsel

 

 

AmerisourceBergen Specialty Group, Inc., a Delaware corporation, agrees that it shall be financially responsible for any unsatisfied liabilities of US Bioservices Corporation under this Agreement; provided that any defense or privilege that may be asserted by US Bioservices Corporation may also be asserted by AmerisourceBergen Specialty Group, Inc.

 

 

AmerisourceBergen Specialty Group, Inc.

 

 

 

 

 

By:

/s/ Mike Mullen

 

 

 

 

Name:

Mike Mullen

 

 

 

 

Title:

President

 

24



 

LIST OF EXHIBITS

 

EXHIBIT A — Product Description

EXHIBIT B — Initial Statement of Work for Hub Services

EXHIBIT C — Standard Operating Procedures for Hub Services

EXHIBIT D — Product Returns Policy

EXHIBIT E — Continuing Guaranty

 

25



 

EXHIBIT A

Product Description

 

Product Trade Name:

 

Kalbitor®

Generic Name:

 

ecallantide

NDC Number:

 

47783-101-01

 

Kalbitor is a recombinant protein with high affinity and high specificity for human plasma kallikrein and is used in the treatment of Hereditary Angioedema (HAE).

 

Kalbitor is temperature sensitive and must be stored and shipped at 2-8°C (36-42°F).

 

Kalbitor is packaged in a single carton containing three 1 mL vials and is administered through three subcutaneous injections.

 

26



 

EXHIBIT B

Initial Statement of Work for Hub Services

 

[*****]

 

27



 

EXHIBIT C

Standard Operating Procedures for Hub Services

 

[*****]

 

28



 

EXHIBIT D

Product Returns Policy

 

[*****]

 

29



 

EXHIBIT E

Continuing Guaranty

 

[attached hereto]

 

30



EX-10.21 6 a2196756zex-10_21.htm EXHIBIT 10.21

Exhibit 10.21

 

DISTRIBUTION SERVICES AGREEMENT

(Wholesale Distribution)

 

This DISTRIBUTION SERVICES AGREEMENT (“Agreement”), dated as of November 19, 2009 (the “Effective Date”), is entered into by and between DYAX CORP., a Delaware corporation with offices located at 300 Technology Square, Cambridge, Massachusetts 02139 (“Dyax”), and ASD SPECIALTY HEALTHCARE INC., a California corporation with its primary offices located at 3101 Gaylord Parkway, Frisco, Texas 75034 (“ASD”).

 

WHEREAS, Dyax has developed the Product (as defined below);

 

WHEREAS, in the United States, Dyax intends to secure the regulatory approvals required in order to promote, market and sell the Product in the United States as a treatment for patients suffering acute attacks associated with the disease known as hereditary angioedema (“HAE”);

 

WHEREAS, ASD is a distributor of therapeutic products and vaccines to health system pharmacies and alternate-site practitioners throughout the United States; and

 

WHEREAS, Dyax wishes to engage ASD to distribute the Product to Wholesale Customers (as defined below) throughout the United States, and ASD wishes to accept such engagement, all upon the terms and subject to the conditions set forth in this Agreement.

 

NOW, THEREFORE, for good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the parties agree as follows:

 

1.                                      Definitions.

 

As used in this Agreement, the following capitalized terms shall have the following meanings:

 

1.1                                 Affiliate” shall mean any individual, corporation, partnership, association, or business that directly or indirectly through intermediaries, controls, is controlled by or is under common control with, a party. An ownership, voting or similar interest (including any right or option to obtain such an interest) representing more than 50% of the total interests then outstanding of the pertinent entity shall constitute “control” for the purposes of this definition.

 

1.2                                 Applicable Laws” shall mean all applicable laws, rules, regulations in the Territory, including guidelines and guidances promulgated by governmental entities.

 

1.3                                 Consenting Facility” shall mean each health care facility designated by Dyax that [*****].

 

1.4                                 FDA” shall mean the United States Food and Drug Administration or any successor agency thereto.

 

1.5                                 Field” shall mean all uses in the therapeutic treatment of HAE.

 

1.6                                 Patient” shall mean any person diagnosed with HAE.

 


* Confidential Treatment Requested.  Omitted portions filed with the Commission.

 



 

CONFIDENTIAL DOCUMENT

EXECUTION COPY

 

1.7                                 Product” shall mean Dyax’s proprietary plasma kallikrein inhibitor, known as internally as DX-88 and generically as ecallantide, as more formally described on Exhibit A.

 

1.8                                 REMS Program” shall mean the Risk Evaluation and Mitigation Program required to be implemented under Section 505-1 of the Federal Food, Drug and Cosmetic Act in connection with the regulatory approval of the Product by the FDA.

 

1.9                                 SOPs” shall have the meaning set forth in Section 8.3.

 

1.10                           Term” shall have the meaning set forth in Section 13.1.

 

1.11                           Territory” shall mean the 50 states of the United States of America, the District of Columbia and Puerto Rico.

 

1.12                           Wholesale Customersshall mean hospital, institutional and other pharmacies that purchase Product for their own account for later resale to Patients.  For the purpose of this Agreement, “Wholesale Customer” shall also include physicians who purchase Product on a “buy and bill” basis.  For the avoidance of doubt, (a) all Wholesale Customers must be enrolled in the REMS Program at the time of sale or distribution of Product thereto by ASD and (b) Wholesale Customer shall not include specialty pharmacies, distributors, or other wholesalers.

 

2.                                      Engagement of ASD.

 

2.1                                 Engagement.  Upon the terms and conditions set forth herein, Dyax hereby engages ASD, on an exclusive basis during the Term (subject to Section 13.4), to offer for sale, sell and distribute Product to Wholesale Customers in the Field in the Territory.  ASD hereby accepts such engagement and shall offer for sale, sell and distribute Product to Wholesale Customers in the Territory in a professional and responsible manner and in accordance with the terms of this Agreement and all Applicable Laws.

 

2.2                                 Authorized Distributor.  In connection with ASD’s engagement under Section 2.1 above, and solely for the limited purpose of compliance with the pedigree requirements of the Prescription Drug Marketing Act and any similar state laws, Dyax hereby designates ASD as an Authorized Distributor of Record (“ADR”) of the Product during the Term.

 

2.3                                 Exclusivity; Agreement Not to Disadvantage Products.  The parties acknowledge and agree that as a result of the exclusive nature of the ASD engagement, subject to Section 13.4, during the Term:

 

(a)                                  Dyax shall not engage any party other than ASD or its Affiliates to distribute Product to Wholesale Customers for the Field in the Territory; and

 

(b)                                 ASD shall not promote any Competing Product in a way that Disadvantages the Product. For the purpose of the foregoing sentence, “Disadvantage” shall mean any activities that (X) are intended to encourage, or could reasonably be foreseen to encourage, the utilization of a Competing Product, such as advertising the Product in a manner that suggests that a Competitive Product is superior to the Product in terms of acquisition

 

2



 

price, reimbursement rates, or efficacy, or (Y) otherwise operate to the disadvantage of the Product.  For purposes of clarification, announcing a Competing Product on ASD’s web site, listing product changes for a Competing Product (such as indication additions or packaging changes) on ASD’s web site, and providing answers for ASD customers who contact ASD regarding a Competing Product (including responding to questions including (i) what products ASD stocks for a particular disease state, (ii) what are the prices of such products, (iii)  what are the indications for such products, and (iv) what are the differences among storage requirements, physical state and administration of the products) are normal promotional activities of a distributor that shall not be considered to Disadvantage the Product.

 

2.4                                 Reserved Rights. Except as expressly provided in this Agreement, no right, title or interest in or to Product or any patent, trade secret, trademark or any other intellectual property right of Dyax or its Affiliates is granted, whether express or implied, by Dyax to ASD.  In furtherance of the foregoing and not in limitation thereof, nothing herein shall in any way limit Dyax’s ability to (i) offer for sale, sell or distribute Product to Wholesale Customers outside of the Territory, (ii) offer for sale, sell or distribute Product to Wholesale Customers in the Territory for uses outside of the Field or (iii) offer for sale, sell or distribute Product to any person or entity other than a Wholesale Customer, including specialty pharmacies, either directly or through a third party, anywhere in the world. Except as expressly provided in this Agreement, no right, title or interest in or to any patent, trade secret, trademark or any other intellectual property right of ASD or its Affiliates is granted, whether express or implied, by ASD to Dyax.  By way of clarification, all proprietary systems, databases and web-based applications, and any standard operating procedures, work rules, programming, software, routines, analytic tools, embedded logic or table structures associated therewith, that have been developed, maintained, utilized and improved by ASD (or its Affiliates) in connection with this Agreement are and will remain the property of ASD (or its Affiliates).

 

2.5                                 Service Level Commitments.  The parties to this Agreement desire to define a mutually beneficial relationship between Dyax and ASD in order to achieve Dyax’s goals of high patient level product availability, high levels of consumer and pharmacy confidence in the integrity and quality of the Product, and achievement of a collaborative, transparent, and cost-effective distribution system.  In order to achieve the stated goals, ASD agrees to offer for sale, sell and distribute the Product hereunder in accordance with the key performance indicators / service level commitments attached hereto as Exhibit B and incorporated herein by this reference.

 

3.                                      Purchase and Sale of Product.

 

3.1                                 Purchase of Product.  ASD shall (i) purchase Product only from Dyax and no other supplier, (ii) distribute Product that it has purchased from Dyax, and (iii) offer for sale, sell and distribute Product only to Wholesale Customers for the Field in the Territory.   ASD shall fill orders for Product only with Product and shall not substitute other products.

 

3



 

3.2                                 Purchase Price; Payment Terms.

 

(a)                                  The price payable by ASD to Dyax for all Product purchased by ASD hereunder (the “Purchase Price”) shall be [*****].

 

(b)                                 Dyax promptly shall invoice ASD for the Purchase Price for all Product purchased hereunder.  All Dyax invoices for Product shall be due and payable by ASD within [*****] after receipt by ASD provided, however, [*****].  On all undisputed balances exceeding [*****] from invoice receipt, ASD shall pay interest equal to the lesser of (i) [*****] per month and (ii) the maximum allowed by law.

 

3.3                                 Product Pricing.

 

(a)                                  With the exception of sales to certain government Wholesale Customers, ASD shall have sole discretion to establish the prices and terms on which ASD sells Product to Wholesale Customers, provided however, that ASD shall not charge Wholesale Customers more than [*****], excluding reasonable upcharges associated with the consignment of Product with such Wholesale Customer and charges for payment by credit card, shipping, sales tax and other transaction based taxes.

 

(b)                                 Sales to Government Wholesale Customers.  ASD shall make Product available for purchase by 340B covered entities and government entities entitled to purchase off the Federal Supply Schedule (“FSS”) at prices below WAC.  Dyax shall communicate these discounted prices to ASD quarterly, and shall accept chargeback requests from ASD in accordance with the procedures set forth in Exhibit C.  ASD shall use commercially reasonable efforts to ensure that Wholesale Customers claiming the right to purchase at 340B or FSS prices are eligible to do so prior to making the discounted sale.  If periods of shortage occur, ASD shall not disproportionately disadvantage either 340B covered entities nor government organizations entitled to purchase off the FSS in order management.

 

3.4                                 Chargeback and Deduction Policies.  ASD shall abide by Dyax’s policies regarding chargebacks (“Chargeback and Deduction Policies”) attached hereto as Exhibit C and incorporated by reference herein.  Such policies may be altered from time to time by Dyax upon written notice to ASD, provided that if any such change is not acceptable, ASD may terminate this Agreement on [*****] written notice to Dyax.

 

3.5                                 Compliance with Safe Harbor.  To the extent the safe harbors under 42 C.F.R. § 1001.952 are applicable to payments made under this Agreement, the parties agree to comply with the safe harbors with regard to such payments.

 

4.                                      Delivery of Product to ASD.

 

4.1                                 Product Orders.  ASD shall submit all Product orders electronically in the industry standard format in accordance with such procedures as may be mutually agreed upon by the parties.  Unless

 

4



 

otherwise agreed between the parties, all Product orders shall be submitted in quantities of 20 units (or multiples of 20 units).

 

4.2                                 Delivery Times.  Dyax shall make commercially reasonable efforts to ship all ASD orders completely and to have Product from such orders shipped to ASD within a mutually agreeable schedule of up to five (5) business days of order placement.  ASD acknowledges and agrees that Dyax may not be able to fill all orders completely or within a specified time due to shortages or other causes and such inability shall not constitute a breach of this Agreement.

 

4.3                                 Product Dating.  Dyax shall ship Product to ASD with at least [*****] shelf life remaining, unless otherwise agreed in writing by ASD[*****]

 

4.4                                 Product Delivery; Risk of Loss.  Dyax shall deliver all Product Free On Board to ASD’s facility in the Territory designated in the applicable order.  For purposes of this Section, the term “Free On Board” means that Dyax shall bear (i) all costs associated with shipping Product to the ASD designated facility, and (ii) all risk of loss for Product until its delivery to the designated ASD facility.  Title to, and risk of loss of, all Product shall pass to ASD on delivery.

 

4.5                                 Inspection of Product.  ASD shall examine the Product upon delivery at ASD’s designated facility and shall notify Dyax in writing within one (1) business day of any problems relating to the quantity of Product delivered or any defect in any of the Product that is reasonably discoverable upon visual inspection of the Product without unpacking of pallets.

 

4.6                                 No Alteration.  ASD shall not alter the Product in any way, including the packaging thereof, without Dyax’s written consent (except to remove the Product from the shipping containers) and shall not alter the Product labeling.

 

4.7                                 Storage Conditions.  ASD will maintain Product stored at, and shipped from, its facilities under (i) the Product storage, shipment and handling requirements set forth in the FDA approved labeling and (ii) any additional requirements mutually agreed upon between ASD and Dyax.  ASD shall notify Dyax within one (1) business day of any known deviation from such requirements so that Dyax can determine whether any further action must be taken with respect to such Product.  Failure of ASD to notify Dyax promptly of such known deviation shall constitute a breach of this Agreement by ASD.

 

5.                                      Product Inventories.

 

5.1                                 Inventory Levels.   During the Term, unless otherwise agreed to by Dyax in writing and subject to Section 5.2, ASD shall maintain at all times a Warehouse Inventory of Product in an amount equal to not less than [*****] nor more than [*****] of ASD’s Expected Sales (as defined herein) to Wholesale Customers.  [*****]

 

5.2                                 Supply Shortages.  ASD shall have no obligation to maintain the minimum inventory levels described in Section 5.1 if Product is unavailable from Dyax.

 

5



 

5.3                                 Consignment Arrangements.  Subject to the additional terms set forth in Exhibit D, ASD shall install Product in each Consenting Facility designated by Dyax that has an existing Cubixx® refrigerated cabinet.  Furthermore, upon payment by Dyax of the applicable fee specified in Exhibit D, ASD shall install in each Consenting Facility designated by Dyax a Cubixx refrigerated cabinet (a “Dyax Consignment Unit”).  As between Dyax and ASD, ASD shall be solely responsible for the maintenance of all Cubixx refrigerated cabinets and Dyax Consignment Units.  ASD shall use commercially reasonable efforts to ensure that no product other than Product is kept or stored in any Dyax Consignment Unit.  Furthermore, ASD shall use commercially reasonable efforts to ensure that each Consignment Unit and Cubixx refrigerated cabinet is stocked at all times with reasonably sufficient amounts of Product to satisfy demand for product in the applicable Consenting Facility.  ASD shall reasonably assist Dyax to obtain the consent of each health care facility designated by Dyax to the installation of a Dyax Consignment Unit or Cubixx refrigerated cabinet.

 

6.                                      Product Returns.

 

Dyax (or its third party logistics provider acting on behalf of Dyax) shall accept and process returns of Product purchased by ASD hereunder in accordance with Dyax’s Product Returns Policy, as it may be amended from time to time by Dyax.  A copy of the Product Returns Policy in effect as of the Effective Date is attached to this Agreement as Exhibit E.

 

7.                                      Suspension, Recalls and Government Notices.

 

7.1                                 Suspension.  Upon written notification by Dyax to suspend distribution of Product, ASD immediately shall suspend its distribution of Product.  If the suspension continues for more than [*****], Dyax will repurchase the Product in saleable condition held in inventory by ASD at the price paid for such Product by ASD.  All repurchased Product shall be returned to Dyax at Dyax’s expense.

 

7.2                                 Recalls.

 

(a)                                  Recalls Procedures.  Dyax shall promptly notify ASD of any recalls or market withdrawals initiated by Dyax or required by the FDA or any other governmental agency.  ASD shall notify Dyax immediately of any event or circumstance that ASD reasonably believes may necessitate a recall or market withdrawal.  Upon receipt of notice of a recall or market withdrawal from Dyax, ASD shall administer such recall or market withdrawal under the direction of Dyax, including promptly notifying the affected Wholesale Customers of ASD in accordance with Dyax’s instructions.  Dyax shall provide ASD with a form letter to be used in connection with notice of any recall or market withdrawal, and shall, to the extent practicable, provide ASD the opportunity to review and comment on such letter.  Dyax shall be responsible for the mailing, shipping, and reasonable administrative expenses incurred by ASD in connection with the recall or market withdrawal, plus a reasonable service fee as mutually agreed upon in advance by the parties as well as the cost of replacement Product for ASD’s Wholesale Customers, except to the extent that such recall or market withdrawal arises or results from (i) the negligence or intentional misconduct of ASD or any of its permitted agents or employees or (ii) the breach by ASD of this Agreement, in which event ASD shall bear and be responsible for such costs as well as the

 

6



 

reasonable, documented, out-of-pocket expenses of Dyax incurred in connection with such recall or market withdrawal.

 

(b)                                 Investigations; Cooperation.  ASD shall fully cooperate with Dyax in investigating any Product failure that resulted in the need for a recall or market withdrawal and any reasonable, documented, out-of-pocket cost involved with such investigation shall be reimbursed by Dyax, except to the extent that such recall or market withdrawal arises or results from (i) the negligence or intentional misconduct of ASD or any of its permitted agents or employees or (ii) the breach by ASD of this Agreement, in which event ASD shall bear and be responsible for such costs as well as the reasonable, documented, out-of-pocket expenses of Dyax incurred in connection with such investigation.

 

7.3                                 Government Notices.  Each party shall provide the other with a copy of any correspondence or notices it receives from the FDA, or other governmental entity specifically relating to the Product or activities conducted under this Agreement, no later than one (1) business day following such receipt.  Each party shall also provide the other with concurrent copies of any responses to any such correspondence or notices (e.g., a response to an FDA 483 notice, warning letter, or untitled regulatory letter); provided that Dyax shall review and approve all such responses by ASD to the extent related to the Product and to the extent reasonably feasible.  Where reasonably possible, ASD shall give prior notice to Dyax of any scheduled FDA or other governmental inspection of ASD’s facilities specifically relating to the Product, and, if reasonably possible, will afford Dyax the opportunity to be present at such inspection.

 

8.                                      Additional ASD Obligations and Services.

 

8.1                                 REMS ProgramASD shall distribute Product and otherwise conduct all activities under this Agreement in accordance with the REMS Program and any additional policies Dyax implements and provides in writing to ASD.

 

8.2                                 Adverse Event Reporting.  In the event that an adverse experience, as that term is defined at 21 C.F.R. § 600.80 (as such provision may be amended from time to time), with regard to the Product is reported to ASD, ASD shall ensure that all applicable safety and other relevant information relating to the Product that is obtained during the course of any interaction with patients, healthcare providers, or other individual, is communicated and maintained in accordance with Applicable Laws.  ASD shall notify Dyax of any adverse drug experiences with regard to the Product within three (3) business days after its first receipt; provided however, that any information relating to a serious adverse experience (SAE), as that term is defined at 21 C.F.R. § 600.80 (as such provision may be amended from time to time), shall be provided to Dyax within one (1) business day after its first receipt.  ASD shall also make all reasonable efforts to assist Dyax with any follow-up investigation necessary to comply with Applicable Laws with respect the reporting of adverse drug experiences relating to the Product; provided, that ASD will not be responsible for reporting of any adverse events to the FDA.  Dyax and ASD will ensure that appropriate SOPs (as defined in Section 8.3) regarding adverse experiences are established and/or maintained and regularly reviewed to ensure compliance in accordance with the terms of this Agreement and Applicable Laws.  Dyax and ASD will ensure that all staff involved in these activities is appropriately trained and records of such training are maintained.

 

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8.3                                 Standard Operating Procedures.  ASD shall conduct all activities under this Agreement in accordance with all Standard Operating Procedures (“SOPs”) applicable to such activities, as established and approved in writing by the parties from time to time.    Any material changes to such SOPs or any new SOPs, to the extent that they specifically relate exclusively to Dyax or the Product (and not the general processes of ASD or products of other ASD clients), shall be subject to the prior written consent of Dyax.  Notwithstanding anything to the contrary contained in this Agreement or elsewhere, during the Term of this Agreement, Dyax shall be permitted, upon its reasonable request, to review all SOPs at ASD’s facility.  Except for SOPs that are specific and exclusive to Dyax Product (“Dyax SOPs”), the SOPs are confidential and proprietary to ASD and shall not be disclosed by Dyax to any third party.  The parties acknowledge and agree that the Dyax SOPs are the property of Dyax and, upon termination or expiration of this Agreement, ASD will deliver such SOPs to Dyax.  Upon termination of this Agreement, any of ASD’s internal standard operating procedures (excluding Dyax SOPs) in Dyax’s possession will be returned to ASD or (at ASD’s election) destroyed by Dyax, with Dyax providing ASD with a written certification of destruction.

 

8.4                                 No Subcontracting or Subdistribution. All obligations and services to be performed by ASD under this Agreement shall be solely performed by ASD and ASD shall not outsource or subcontract any of its obligations hereunder without Dyax’s prior written consent, except to an affiliate of ASD.

 

8.5                                 Applicable Laws and RegulationsASD shall conduct all activities under this Agreement in compliance with all Applicable Laws, including federal and state wholesale and pedigree laws, laws relating to the promotion of prescription medicines including the prohibition of off-label promotion, federal and state laws protecting the privacy of patient medical information (including HIPAA if applicable), federal and state anti-kickback laws and regulations, laws relating to the disposal of pharmaceutical products and hazardous wastes, and all applicable professional and industry standards and good business practices.  If Dyax reasonably determines that ASD has conducted activities under this Agreement in a manner that could potentially compromise public health or safety, then Dyax may terminate this Agreement immediately, and whether or not Dyax terminates this Agreement, may pursue all other legal remedies available to it.

 

ASD shall provide Dyax a copy of its state and local registrations and provide copies of new registrations to Dyax prior to expirations. ASD promptly shall report to Dyax any written notice it receives in connection with an administrative, civil, criminal or other actions by local, state or federal authorities against ASD and its employees regarding alleged violations of Applicable Laws that relate to the services under this Agreement or to the Product.  ASD shall comply with the guidelines for distributing to Disproportionate Share Hospitals, as defined in the Veteran’s Health Care Act of 1992 (also known as Public Law 102-585), Section 602.

 

8.6                                 Product Promotion.  ASD will not provide any information regarding the safety, effectiveness, or use of Product to Wholesale Customers or other persons or entities except as approved in advance in writing by Dyax.  ASD may provide information on its own distribution services to its Wholesale Customers in accordance with ASD standard business practices, including informing its Wholesale Customers of pricing available for the Product and other products distributed by ASD.  ASD

 

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warrants that any information it provides to its Wholesale Customers regarding Product or its services will be truthful and non-misleading and will comply with all Applicable Laws.

 

8.7                                 Discounts.  To the extent required by Applicable Laws, including 42 U.S.C. §§ 1320a-7b(b) and in conformance with the standards set forth in 42 C.F.R. § 1001.952(h) for safe harbor protection, ASD shall advise and inform each of its Wholesale Customers to fully report, as required by law or contract, any discounts, rebates, or reductions in prices on Product and provide the discount information supplied by ASD to the Department of Health and Human Services or a state agency upon request, consistent with the requirements of 42 U.S.C. § 1320a-7b(b) and 42 C.F.R. § 1001.952(h).

 

8.8                                 Diversion.  ASD shall notify Dyax in writing promptly within one (1) business day of learning of information to suggest that any person or entity is diverting or attempting to divert Product.  For the purposes of this Section 8.8, “diverting” means the unauthorized sale, distribution, purchase, receipt, or handling of Product.  Dyax may immediately terminate this Agreement upon written notice if ASD has purchased Product from sources other than Dyax.

 

9.                                      Reports and Records.

 

9.1                                 EDI Reports.  ASD shall prepare and deliver to Dyax the following reports utilizing (i) the reporting and parameters recognized by the American National Standards Institute (“ANSI”), (ii) the Electronic Data Interchange (“EDI”) guidelines established by the Healthcare Distribution Management Association (“HDMA”), and (iii) any required specifications from Dyax, which may change from time to time with reasonable notice to ASD:

 

(a)                                  EDI 844.  The HDMA Product Transfer Account Adjustment (“EDI 844”) shall be submitted to Dyax in accordance with Chargeback and Deduction Policies listed in Exhibit C;

 

(b)                                 EDI 850.  The HDMA Product Purchase Order (“EDI 850”) shall be submitted to Dyax in accordance with such procedures as may be mutually agreed upon by the parties;

 

(c)                                  EDI 852.  Inventory Level and Status Report (“EDI 852”) shall be submitted to Dyax on a daily basis.  ASD shall provide Dyax the EDI 852 information in a readable format such as MS Excel;

 

(d)                                 EDI 867.  The HDMA Product Transfer and Resale Report (“EDI 867”) shall be submitted to Dyax on a weekly basis, by no later than 11:59 p.m. on Monday for the previous business week.  ASD shall provide Dyax the EDI 867 information in a readable format such as MS Excel; and

 

(e)                                  Other Data Reports. Additional HDMA reports submitted and/or received, as applicable, shall include but are not limited to the following:  Invoices (“EDI 810”), Electronic Funds Transfer (“EDI 820”), Electronic Chargeback (“EDI 844”), Price Authorizations (“EDI 845”) Chargeback Reconciliations (“EDI 849”), Purchase Order Acknowledgements (“EDI 855”),

 

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Advance Shipment Notices (“EDI 856”), Return Merchandise Authorizations (“EDI 180”) and the Debit/Adjustment Memo (“EDI 812”).  The foregoing Data Reports shall be provided to Dyax on a weekly basis.

 

In the event that critical internal support systems and electronic communication links, including EDI, are not available for three (3) consecutive business days, the parties will cooperate to promptly implement substitute procedures to document the information customarily sent by EDI and prevent interruptions to each other’s business.  ASD shall include sufficient data in the inventory and sales reports so that Dyax can determine and evaluate the on-hand and on-order inventory, purchases, returns and chargebacks made by government customers.

 

9.2                                 Activity Reports.  In addition to any specific reports that ASD may be required to deliver to Dyax under this Agreement, ASD shall provide to Dyax all information and reports related to its activities with respect to the Product that are reasonably requested by Dyax; provided that ASD shall be fully reimbursed by Dyax for any additional expense incurred in connection with the preparation and delivery of such information and/or reports.

 

9.3                                 Ownership and Use of Data.  Subject to Applicable Laws, Dyax shall have the following rights with respect to information and data relating to Product, the sale of Product to Wholesale Customers and the use by Product of Patients obtained, maintained, generated or furnished by ASD to Dyax in connection with performing ASD’s obligations hereunder, including such data and information contained in the reports delivered pursuant to Sections 9.1 and 9.2:

 

(a)                                  With respect to all reports provided by ASD to Dyax under this Agreement (including this Section 9), Dyax shall own and have the right to use all such reports and all such information shall be deemed to be Dyax Confidential Information; and

 

(b)                                 ASD shall own all sales and distribution data generated through its performance of this Agreement and grants Dyax a non-exclusive, perpetual right to use such data for its internal purposes.

 

(c)                                  With respect to all information and data not covered by Section 9.3(a) and (b), Dyax shall have a right to use any and all information and data, for any purpose as permitted by law or, to the extent such data contain PHI, as permitted by the applicable patient’s written authorization.

 

9.4                                 Records.  ASD shall keep complete and accurate books and records pertaining to ASD’s activities under this Agreement.  Such books and records shall be retained for at least [*****] after the expiration or termination of this Agreement or for such longer period as may be required by Applicable Law.

 

9.5                                 Audits.  Dyax, at its expense, from time to time may perform, or have an independent third party auditor (subject to execution of a mutually agreeable nondisclosure agreement) perform, audits of the records maintained pursuant to Section 9.4 and may observe, or have an independent third party auditor observe, the performance by ASD of its activities hereunder to verify the status of Product and ensure compliance with the terms of this Agreement.  Dyax shall provide ASD with at

 

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least ten (10) business days advance notice of such audits or observations, and shall conduct any audit or observation during normal business hours in a manner that does not interfere with ICS’s normal business operations. ASD shall make available relevant records that do not contain information pertaining to ASD’s other suppliers, customers or products and permit such observations.  Dyax and ASD shall discuss the results of any such audits or observations and ASD shall implement all corrective measures reasonably requested by Dyax.  All audits shall be reasonable in time and scope.

 

10.                               Confidentiality.

 

10.1                           Confidential Information.  All confidential, non-public documents and other information disclosed to a party by or on behalf of the other party pursuant to this Agreement, which includes but is not limited to information concerning prices, fees and proposals, operating and sales data, quantities purchased by any customer, information about processes (including SOPs), systems, strategic plans, business plans, financial information, customer information, information concerning patients or physicians, methods, databases, technology (including software and all source code), and any other information or materials prepared or derived from such information (collectively, “Confidential Information”), shall, subject to Sections 10.2 and 10.3, be held by the receiving party in strict confidence and not disclosed either directly or indirectly to any third party (other than affiliates, advisors and consultants who have a need to know such information and who are subject to obligations of confidentiality at least as onerous as those set forth herein) and shall only be used for purposes of fulfilling the receiving party’s obligations, or exercising its rights, under this Agreement.   Notwithstanding the foregoing, all data and information owned by Dyax pursuant to Section 9.3 shall be the Confidential Information of Dyax and not ASD, and regardless of the party that discloses such Confidential Information hereunder, Dyax shall be deemed the disclosing party, and ASD shall be deemed the receiving party, with respect to such Confidential Information.  The terms and conditions of this Agreement and any amendments or addenda thereto shall be deemed the Confidential Information of each party.

 

10.2                           Exclusions from Confidentiality.  Notwithstanding anything to the contrary in this Agreement, the receiving party shall have no liability to the disclosing party for the use or disclosure of any Confidential Information that the receiving party can establish by written documentation to:

 

(a)                                  have been publicly known prior to disclosure by the disclosing party of such information to the receiving party;

 

(b)                                 have become publicly known without fault on the part of the receiving party, subsequent to disclosure to the receiving party;

 

(c)                                  have been received by the receiving party at any time from a source, other than the disclosing party, lawfully having possession of and the right to disclose such information;

 

(d)                                 have been otherwise known by the receiving party prior to disclosure by the disclosing party to the receiving party of such information; or

 

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(e)                                  have been independently developed by the receiving party without use of information disclosed by the Disclosing Party.

 

10.3                           Required Disclosure.  A party receiving Confidential Information may disclose such Confidential Information if required to do so by a court (or other governmental agency or stock exchange of competent jurisdiction), any governmental body or as required under any Applicable Laws; provided that (i) the party required to disclose such Confidential Information provides prompt notice of such pending disclosure to the disclosing party so that the disclosing party can seek a protective order or to prevent such disclosure, and (ii) the party required to disclose such Confidential Information shall exercise reasonable efforts to ensure that the information is accorded confidential treatment by the court or other governmental agency or stock exchange.

 

10.4                           Survival of Confidentiality Obligations.  The provisions of this Section 10 shall survive for a period of [*****] following the expiration or termination of this Agreement.

 

10.5                           Injunctive ReliefEach party acknowledges that the failure by the Receiving Party to comply with any of the provisions of this Section 10 will result in irreparable injury and continuing damage to the disclosing party for which there will be no adequate remedy at law and that, in the event of a failure of the receiving party so to comply, the disclosing party shall be entitled to such preliminary and permanent injunctive relief as may be necessary to ensure compliance with all the provisions of this Section 10 without having to prove actual damages or to post a bond.

 

11.                               Additional Representations, Warranties and Covenants.

 

11.1                           Authorization.  Each party represents and warrants to the other party that it has the legal right and power to enter into this Agreement, to extend the rights and licenses granted to the other in this Agreement, and to fully perform its obligations hereunder, and that the performance of such obligations will not conflict with its charter documents or any agreements, contracts, or other arrangements to which it is a party. Furthermore, no approvals, consents, orders or authorizations of or designation, registration, declaration or filing with any governmental authority (within the Field in the Territory) is required for either party’s performance of its obligations under this Agreement, other than any approvals that have been obtained already or will be obtained in the ordinary course of the performance of such obligations.

 

11.2                           No Other Agreements.  Each party represents and warrants to the other that this Agreement is not dependent on, and does not operate in conjunction with (either explicitly or implicitly), any other arrangement between Dyax and ASD.

 

11.3                           Dyax Representations and Warranties.  Dyax hereby represents and warrants to ASD that, at the time of delivery of Product by Dyax to ASD hereunder: (a) such Product shall not in any material respect be adulterated, misbranded or otherwise prohibited within the meaning of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. §§ 301 et. seq., as amended and in effect at the time of delivery (the “Act”), or within the meaning of any applicable state or local law; (b) such Product will be merchandise that may be introduced and delivered into interstate commerce under the provisions of Section 301 of the Act or Section 351 of the Public Health Service Act; (c) Dyax (or as applicable its designated third-party logistics provider) has and will maintain, in full force and

 

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effect, all licenses and permits required under Applicable Laws for Dyax to sell and distribute such Product under this Agreement; (d) such Product will be the subject of a duly approved Biologics License Application and may be legally transported or sold under Applicable Laws; (e) such Product will have been approved by each applicable governmental authority for commercial sale and shipment of such Product within the Territory; and (f) Dyax either (i) owns or holds the duly approved Biologics License Application, as such term is used in the Public Health Service Act, Title 21, United States Code, as amended for such Product, or (ii) is otherwise considered the “manufacturer” of such Product within the meaning of any applicable federal, state or local law relating to pedigrees.

 

11.4                           Product PricingASD represents and warrants that:

 

(a)                                  it will refrain from doing anything that would impede Dyax from meeting any reporting obligations with respect to Product pricing that Dyax may have under Applicable Laws;

 

(b)                                 ASD will properly report the Product sales price to the customer on the invoices or statements submitted by ASD to Dyax; and

 

(c)                                  no discount provided or other payment made pursuant to this Agreement is intended in any way as a discount related to a drug formulary and has not been negotiated or discussed between the parties in connection with any drug formulary.

 

To the extent required under Applicable Laws, ASD will report the discounts to appropriate Federal health care programs, and in any event, will promptly disclose such discounts if requested by a government agency.

 

11.5                           Federal Programs.  ASD represents, warrants and covenants to Dyax that (a) neither ASD nor any of its Affiliates that perform activities under this Agreement has been debarred or is subject to debarment pursuant to Section 306 of the Act or listed on either Excluded List (as defined herein), and (b) neither ASD nor any of its Affiliates that perform activities under this Agreement will knowingly (after reasonable investigation) use in any capacity, in connection with the services to be performed under this Agreement, any person who has been debarred pursuant to Section 306 of the Act, or who is the subject of a conviction described in such section, or listed on either Excluded List.  ASD shall inform Dyax in writing immediately if it or any person who is performing services hereunder is debarred or is the subject of a conviction described in Section 306 of the Act or listed on either Excluded List, or if any action, suit, claim, investigation or legal or administrative proceeding is pending or, to the best of ASD’s knowledge, is threatened, relating to the debarment or conviction Section 306 of the Act, or listing on either Excluded List, of ASD or any person performing services hereunder.  “Excluded Lists” means the Department of Health and Human Service’s List of Excluded Individuals/Entities and the General Services Administration’s Lists of Parties Excluded from Federal Procurement and Non-Procurement Programs.

 

11.6                           Prescriber Identifiable LawsDyax warrants that it will not use or disclose any information provided by ASD in a manner inconsistent with any Applicable Laws, including any laws relating to the identity of any prescriber.  ASD warrants that it will not disclose any information to Dyax in contravention of any Applicable Laws, including any laws relating to the identity of any prescriber.

 

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11.7                           ASD/Licensure.  ASD represents and warrants that it now has and shall maintain in full force during the Term all applicable federal and state wholesaler and other licenses or approvals required under Applicable Laws and regulations to fulfill its obligations under this Agreement in each state in the Territory, the District of Columbia and Puerto Rico.  ASD promptly shall notify Dyax of any denials, revocations or suspension of license or registrations by any state or federal agency or any other regulatory authority in the Territory, or any written notice from a governmental body proposing such a denial, revocation or suspension of a license or registration.  ASD shall promptly provide Dyax with notice of any material communications with pharmacy and/or wholesaler licensing boards which relate to potential problems with facilities, operations, contractors or procedures used by ASD in distribution of the Product, including notices of inquiries, investigations or inspections and resulting findings, except that in no event shall ASD be required to disclose information concerning its other suppliers or customers or the products of such other suppliers.

 

11.8                           No Other Warranties.  Except as expressly provided herein and in the Continuing Guaranty, neither party hereto makes any representations or warranties to the other party, express or implied, either in fact or by operation of law, by statute or otherwise, and each party specifically disclaims any express or implied representations and warranties of merchantability or fitness for a particular purpose.

 

12.                               Liability, Indemnification and Insurance.

 

12.1                           Remedies.

 

(a)                                  Generally.  Rights and remedies under this Agreement are cumulative and in addition to any other available rights or remedies under any other agreement, at law or in equity.

 

(b)                                 Equitable Relief.  If either party violates or threatens to violate any provision of this Agreement, the other party may suffer irreparable harm and its remedies at law may be inadequate.  Accordingly, the other party may seek equitable relief.

 

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12.2                           Indemnification.

 

(a)                                  Indemnification by ASD.  ASD shall indemnify, defend, and hold harmless Dyax and its Affiliates and its and their respective directors, officers, employees, representatives and agents and their respective successors, heirs and assigns (the “Dyax Indemnitees”) against any liability, damage, loss, penalty, fine or expense (including reasonable attorneys fees and expenses of litigation) (collectively, “Losses”) incurred by or imposed upon the Dyax Indemnitees or any of them in connection with any claims, suits, demands, investigations, enforcement actions, or judgments, in each case initiated by a third party (including any governmental or regulatory agency) (collectively, “Third Party Claims”) which arise out of: (a) the gross negligence or willful misconduct of ASD in connection with this Agreement; or (b) the breach of this Agreement by ASD, in each case except for those Losses for which Dyax has an obligation to indemnify ASD pursuant to Section 12.2(b), as to which Losses each party shall indemnify the other to the extent of its respective liability for such Losses.

 

(b)                                 Indemnification by Dyax.  Dyax shall indemnify, defend, and hold harmless ASD and its Affiliates and its and their respective directors, officers, employees, representatives and agents and their respective successors, heirs and assigns (the “ASD Indemnitees”) against any Losses incurred by or imposed upon ASD Indemnitees or any of them in connection with any Third Party Claims which arise out of: (a) the negligence or willful misconduct of Dyax in connection with this Agreement; (b) the breach of this Agreement by Dyax, (c) any claims of patent, trademark, copyright or other infringement related to Products, or (d) the storage, handling, use, non-use, demonstration, consumption, ingestion, digestion, manufacture, production and assembly of Products and their transportation to ASD (except to the extent that such activities are conducted on Dyax’s behalf by an Affiliate of ASD), in each case except for those Losses for which ASD has an obligation to indemnify Dyax pursuant to Section 12.2(a), as to which Losses each party shall indemnify the other to the extent of its respective liability for such Losses.

 

(c)                                  Indemnification Procedure.  A party that intends to claim indemnification under this Section 12.2 (the “Indemnitee”) shall:  (i) promptly notify the indemnifying party (the “Indemnitor”) in writing of any Third Party Claim in respect of which the Indemnitee or any of its Affiliates or any of their respective directors, officers, employees, representatives, agents or their respective successors, heirs or assigns intend to claim such indemnification hereunder; (ii) provide the Indemnitor sole control of the defense and/or settlement thereof with counsel reasonably satisfactory to the Indemnitee; provided, however, that the Indemnitee reserves the right to retain its own counsel to defend itself in, but not control the defense of, such suit, at its own expense, unless (a) the interests of the Indemnitee and the Indemnitor in the suit conflict in such a manner and to such extent as to require, consistent with applicable standards of professional responsibility, the retention of separate counsel for the Indemnitee, in which case, the Indemnitor shall pay for one separate counsel chosen by the Indemnitee or (b) the Indemnitor shall not have employed attorneys reasonably satisfactory to the Indemnitee to defend any action within a reasonable time after notice of commencement of such action and (iii) provide the Indemnitor, at the Indemnitor’s request and expense, with

 

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reasonable assistance and full information with respect thereto.  Neither the Indemnitor nor the Indemnitee shall be responsible to or bound by any settlement made by the other without its prior written consent, which shall not be unreasonably withheld or delayed.  Without limiting the foregoing provisions of this Section 12.2(c), the Indemnitor shall keep the Indemnitee reasonably informed of the progress of any claim, suit or action under this Section 12.2 and the Indemnitee shall have the right to participate in any such claim, suit or proceeding with counsel of its choosing at its own expense, but the Indemnitor shall have the sole right to control the defense or settlement thereof in accordance with the terms of this Section 12.2(c).

 

12.3                           Limitation of Liability.

 

(a)                                  Neither party shall be liable to the other for special, exemplary, consequential, incidental (including lost or anticipated revenues or profits), indirect or punitive damages arising from the performance or nonperformance of such party under this Agreement whether such claim is based on contract, tort (including negligence) or otherwise, even if an authorized representative of such party is advised of the possibility or likelihood of same.

 

(b)                                 Notwithstanding the exclusions and limitations of liability set forth in Section 12.3(a) above, such exclusions and limitations shall not apply to: (i) either party’s indemnification obligations pursuant to Section 12.2; or (ii) either party’s breach of the party’s confidentiality obligations pursuant to Article 10.

 

12.4                           ASD Insurance Obligations.  During the Term, ASD shall maintain the following minimum levels of insurance:

 

(a)                                  Employer’s liability insurance with a limit of $[*****] for bodily injury by accident per person, $[*****] for bodily injury by accident, all persons and $[*****] bodily injury by disease policy limit;

 

(b)                                 Commercial general liability insurance, including personal injury blanket contractual liability and broad form property damage, with a $[*****] combined single limit;

 

(c)                                  Umbrella liability insurance in the amount of $[*****] per occurrence and aggregate; and

 

(d)                                 Property insurance covering the business property of ASD and others while at any unnamed location in the amount of $[*****].

 

The insurance required by this Section 12.4 may be made up through a combination of self-insured retention and traditional insurance.  Throughout the Term, ASD shall (a) provide prompt written notice to Dyax in the event ASD becomes aware or is notified that the insurance described in this Section 12.4 will be materially adversely modified or cancelled in such a manner that ICS is no longer in compliance with the requirements of Section 12.4, and (b) provide Dyax with proof of such insurance on or before the date such insurance is renewed for each year.

 

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12.5                           Dyax Insurance Obligation; Continuing Guaranty.  During the Term, Dyax will maintain products liability and commercial general liability insurance having a limit of not less than [*****] per occurrence, Combined Single Limit (Bodily Injury and Property Damage), pursuant to one or more insurance policies with reputable insurance carriers having a Best’s Rating of A VII or otherwise as reasonably approved by ASD.  Dyax will designate ASD and its Affiliates as an “additional insured” under such insurance policy and will obtain a broad form vendor’s endorsement for products liability for ASD.  Within thirty (30) days after the Effective Date, Dyax will provide to ASD a certificate of insurance indicating that such obligations have been satisfied.  As a condition precedent to the effectiveness of this Agreement, Dyax will execute the form of Continuing Guaranty and Indemnification Agreement (the “Continuing Guaranty”) with AmerisourceBergen Corporation attached hereto as Exhibit F.

 

13.                               Term and Termination.

 

13.1                           Term. Unless earlier terminated in accordance with the terms hereof, the term of this Agreement (the “Term”) shall (i) commence as of the Effective Date and will continue in effect for an initial period of three (3) years (the “Initial Term”), and (ii) automatically renew for subsequent periods of [*****] (each, a “Renewal Term”), unless either party provides written notice to the other at least [*****] prior to the end of the Initial Term or then-current Renewal Term that it does not wish to renew.  The parties will work together in good faith to discuss and agree upon any appropriate fee adjustments at least three months prior to expiration of the Initial Term.

 

13.2                           Termination.  In addition to any other provision of this Agreement providing for termination hereof, this Agreement may be terminated as follows:

 

(a)                                  Termination by Dyax For Convenience.  Dyax may terminate this Agreement for convenience, without cause, upon [*****] prior written notice of termination to ASD.

 

(b)                                 Termination For Cause.

 

(i)                                     This Agreement may be terminated by either party on written termination notice to the other party in the event of any material breach of this Agreement by the other party (other than a breach by ASD Section 8.1, which is governed by clause (ii) below), which breach is not cured within [*****] after delivery of written notice by the non-breaching party specifying such breach and requiring cure.  Notwithstanding the right to cure provided by the foregoing sentence, ASD shall have the right to cure only two (2) material breaches of any particular obligation hereunder, and this Agreement may be terminated by Dyax immediately on written notice to ASD in the event of any additional material breach of such obligation by ASD.

 

(ii)                                  This Agreement may be terminated by Dyax immediately on written notice to ASD in the event of any material breach by ASD of Section 8.1.

 

(c)                                  Insolvency.  This Agreement may be terminated by either party immediately upon written notice to the other party in the event of any of the following events:

 

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(i)                                     the institution by the other party of insolvency, receivership or bankruptcy proceedings or any other material proceedings for the settlement of the other party’s debts, or the institution against the other party of any such proceedings that remain undismissed for [*****];

 

(ii)                                  the other party’s making an assignment for the benefit of its creditors; or

 

(iii)                               the other party’s dissolution.

 

(d)                                 Other AgreementsIn the event that any of (a) the Distribution Services Agreement of even date herewith between Dyax and US BIOSERVICES CORPORATION, or (b) the Distribution Services Agreement of even date herewith between Dyax and Integrated Commercialization Solutions, Inc. is terminated for any reason, then (i) this Agreement may be terminated by Dyax immediately upon written notice to ASD; and (ii) if not terminated, ICS will notify Dyax of any applicable adjustment to Fees based upon such termination.

 

(e)                                  Supervening Illegality.

 

(i)                                     This Agreement shall terminate if both:  (A) as a result of the enactment of any new applicable federal or state law or regulation, or any change in any existing applicable federal or state law or regulation or any new interpretation of any applicable federal or state law or regulation by any legislative body, court or regulatory agency, the performance by a party of any material obligation under the Agreement would be rendered illegal or any material provision of the Agreement would be rendered invalid or unenforceable, and (B) the parties are unable to negotiate a mutually acceptable amendment to the Agreement pursuant to Section 13.2(e)(iii) below.  If any immaterial provision of this Agreement is held to be illegal, invalid or unenforceable for any reason, the Agreement shall be deemed amended to delete such provision, such amendment to apply only with respect to the operation of the Agreement in the particular jurisdiction in which such provision is held to be illegal, invalid or unenforceable, and the remainder of the Agreement shall remain in full force and effect and enforceable in accordance with its terms.

 

(ii)                                  The parties agree that the party affected by the new law or regulation or the change in law or regulation or the interpretation of a law or regulation shall use reasonable efforts to give the other party at least [*****] prior written notice of the effective date of such new law, change, or interpretation.

 

(iii)                               The parties agree that, notwithstanding the foregoing provisions of this Section, either party may, within ten (10) business days of giving or receiving notice of the new law, change or interpretation, notify the other party of its wish to renegotiate the applicable terms of the Agreement (“Renegotiation Notice”), in which event the parties shall negotiate in good faith, for a period of sixty (60)

 

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days from delivery of the Renegotiation Notice, an amendment to the Agreement that addresses the portion of the Agreement rendered illegal, invalid or unenforceable by the new law, change or interpretation while preserving to the greatest extent possible the original intent of the Agreement.  If the parties successfully conclude such negotiations prior to the effective date of the new law, change or interpretation, the Agreement shall not terminate and shall be amended to reflect the negotiated terms.  If the parties are unable to successfully conclude such negotiations prior to the effective date of the new law, change or interpretation and such effective date is within the sixty (60) day negotiation period, the Agreement shall be deemed amended to delete such portion rendered illegal, invalid, or unenforceable, such amendment to apply only with respect to the operation of the Agreement in the particular jurisdiction in which such portion is held to be illegal, invalid or unenforceable, and the remainder shall remain in full force and effect and enforceable in accordance with its terms.  In the event the parties are unable to successfully conclude such negotiations within the sixty (60) day negotiation period, the Agreement shall terminate at the end of the sixty (60) day negotiation period.

 

13.3                           Effect of TerminationUpon the expiration or earlier termination of this Agreement:

 

(a)                                  all Confidential Information received hereunder shall be returned to the disclosing party, or destroyed, at the disclosing party’s election (provided that the receiving party may retain one copy to the extent necessary to comply with any contractual or other legal obligations applicable thereto);

 

(b)                                 all rights granted to ASD with respect to the Product shall terminate and ASD shall cease in a timely and orderly manner all activities with respect to the selling and distribution of Product; and

 

(c)                                  unless terminated by ASD pursuant to Section 13.2(b) above (Material Breach), for a period of [*****] following such expiration or early termination, ASD and its Affiliates shall provide commercially reasonable assistance in connection with Dyax’s transition of Product distribution to Dyax, its Affiliates or any third party selected by Dyax.  Dyax shall reimburse ASD for its reasonable, documented out-of-pocket costs and expenses incurred with in connection with providing such transition services; provided that, in the event of a termination due to ASD’s breach, neither the existence of this provision nor the fact of Dyax’s agreement to pay for such transition services shall in any way effect or limit Dyax’s rights or remedies with respect to such breach.

 

Termination of this Agreement shall not relieve either party of obligations incurred prior to termination.  The provisions of Sections 9.3, 9.4, 9.5, 13.3, 15.10 and 15.11 and Articles 10, 12 and 14, together with and any other provisions which by their express terms extend beyond the expiration or termination of this Agreement, shall survive any termination of this Agreement.

 

13.4                           Termination of Exclusivity.  In the event that (i) Dyax has the right to terminate this Agreement for any reason (except pursuant to Section 13.2(a) (Termination for Convenience), Dyax, on

 

19


 

immediate written notice to ASD, may terminate Section 2.3(a), which shall have no further force or effect from and after the delivery of such notice by Dyax.

 

14.                               Dispute Resolution.

 

14.1                           Resolution by Executives.  Any dispute, controversy or claim initiated by either party arising out of, or resulting from the breach or alleged breach by either party of its obligations under this Agreement (other than bona fide third party actions or proceedings filed or instituted in an action or proceeding by a third party against a party to this Agreement), whether before or after termination of this Agreement, shall be in the first instance referred to the respective chief executive officers of the parties unless such dispute or claim must be filed to preserve a legal interest or injunctive relief is required.

 

14.2                           Arbitration.  If chief executive officers (or their representatives, it being agreed that the chief executive officer of either party may designate a representative, provided such representative is empowered with decision making in the dispute)  of the parties fail to resolve any dispute as provided in Section 14.1 within [*****], then such dispute shall be finally resolved by binding arbitration as follows:

 

(a)                                  Any dispute that might arise between the parties relating to or arising from this Agreement shall be settled by binding arbitration in accordance with the then-prevailing Commercial Arbitration Rules of the American Arbitration Association (“AAA”), except where those rules conflict with this provision, in which case this provision controls. Arbitration shall be conducted before a single arbitrator selected from the AAA’s National Roster of Arbitrators, each of whom shall be a lawyer with at least 15 years experience with a law firm or corporate law department of over 25 lawyers or who was a judge of a court of general jurisdiction.  Each party shall have the right to meet and interview the potential arbitrator for no more than one hour each prior to the selection of an arbitrator.  The arbitration shall be held, and Dyax and ASD irrevocably consent to arbitrate, in New York, NY, unless they mutually agree upon an alternative location. The arbitration shall be conducted in English. In rendering the award the arbitrator must apply the substantive law of the State of Delaware (except where that law conflicts with this clause); however, the interpretation and enforcement of this arbitration provision shall be governed by the Federal Arbitration Act.  The arbitrator shall render a written opinion setting forth findings of fact and conclusions of law with the reasons therefor stated.  Under no circumstances shall the arbitrator award damages in excess of or inconsistent with any limitations of liability contained in this Agreement.  Any court with jurisdiction shall enforce this clause and enter judgment on any award.  ASD and Dyax will agree upon, within [*****] after the arbitrator is selected or, if they fail to agree, the AAA will design, procedures that they will follow to assure that the arbitration will be concluded and the award rendered within no more than eight months from selection of the arbitrator.

 

(b)                                 The arbitration proceedings shall be confidential, and neither party shall publicize the nature of any dispute or the outcome of any mediation or arbitration proceedings except to the extent required by law, provided in such case the party required to make any disclosure informs the other party of such requirement to allow the other party to seek a

 

20



 

protective order.  The mediator or arbitrator, as the case may be, shall issue appropriate protective orders to safeguard each party’s confidential information.

 

(c)                                  Each party has the right before or during the mediation or arbitration to seek and obtain from the appropriate court provisional remedies such as attachment, an injunction, replevin, etc., to avoid irreparable harm, maintain the status quo or preserve the subject matter of the arbitration.

 

15.                               Miscellaneous.

 

15.1                           Relationship of Parties.  ASD’s relationship with Dyax hereunder shall be that of independent contractor, and neither party shall be considered the agent of, partner of, employee or other member of the workforce of, or participant in a joint venture with, the other party.  Neither party shall have authority to bind the other party unless otherwise agreed to in writing by such parties.

 

15.2                           Notices.  All notices, requests, demands and other communications required or permitted to be given pursuant to this Agreement shall be in writing and shall be deemed to have been duly given upon the date of receipt if delivered by hand, recognized international overnight courier, confirmed facsimile transmission, or registered or certified mail, return receipt requested, postage prepaid to the following addresses or facsimile numbers:

 

If to Dyax:

Dyax Corp.

 

300 Technology Square

 

Cambridge, MA 02139

 

[*****]

 

 

If to ASD:

AmerisourceBergen Specialty Group

 

3101 Gaylord Parkway

 

Frisco, TX 75034

 

[*****]

 

Either party may change its designated address, contact person and facsimile number by notice to the other party in the manner provided in this Section.

 

15.3                           Assignment.  Neither party may assign its rights or delegate its obligations under this Agreement without the prior written consent of the other party, except that either party may assign this Agreement to any of its Affiliates or to a successor in connection with the merger, consolidation, or sale of all or substantially all of its assets or that portion of its business pertaining to the subject matter of this Agreement, with prompt written notice to the other party of any such assignment; provided that: (i) if such assignee is an Affiliate, the assignor shall responsible for and liable with respect to all assigned obligations and (ii) if such assignee is not an Affiliate, (A) the assignee assumes the assignor’s obligations under the Continuing Guaranty and Indemnification Agreement, and (B) the assignee has net assets as of the end of its most recently completed fiscal year equal to or in excess of the net assets of the assignor as of the end of its most recently completed fiscal year, in each case as set forth in the audited balance sheet of the assignor and assignee, and (iii) in the case of an assignment by Dyax, the assignee is not a Competitor to ASD.  For the purposes

 

21



 

of this Section 15.3, a “Competitor” means any organization, entity or person that competes with ASD including but not limited to the following companies and their affiliated entities: [*****].  Notwithstanding the foregoing, ASD acknowledges and agrees that Dyax may perform its obligations and exercise its rights hereunder through a third party logistics provider.

 

15.4                           Force Majeure. Each party’s obligation under this Agreement will be excused to the extent any delay or nonperformance is caused by strikes or other labor disturbance, acts of God, war, or other conditions beyond the reasonable control of that party, but only during the duration of such condition.

 

15.5                           Amendment and Waiver.  This Agreement may be amended, supplemented, or otherwise modified only by means of a written instrument signed by both parties.  Any waiver of any rights or failure to act in a specific instance shall relate only to such instance and shall not be construed as an agreement to waive any rights or fail to act in any other instance, whether or not similar.  To be valid, any waiver must be in writing.

 

15.6                           Severability.  In the event any provision of this Agreement should be held invalid, illegal or unenforceable, the remaining provisions shall not be affected or impaired and the parties shall use all reasonable efforts to replace the applicable provision with a valid, legal and enforceable provision which insofar as practical implements the original intent of such invalid, illegal or unenforceable provision, provided, however, that if the parties fail to reach such agreement within sixty (60) days, a party whose rights or obligations are materially adversely affected as a result of a provision being held invalid, illegal or unenforceable may terminate this Agreement.

 

15.7                           Headings.  All headings used in this Agreement are inserted for convenience only and are not intended to affect the meaning or interpretation of this Agreement or any Article or Section hereof.

 

15.8                           Successors and Assigns.  This Agreement shall be binding on and shall benefit any and all successors, trustees, permitted assigns and other successors in interest of the parties.

 

15.9                           Applicable Law; Disclaimer of Puerto Rico Law 75.

 

(a)                                  This Agreement shall be construed and enforced in accordance with the laws of the State of Delaware (excluding the choice of law provisions thereof).

 

(b)                                 The parties expressly disclaim, to the fullest extent allowed by Applicable Law, any application of the Puerto Rico Dealers Act, Law No. 75 of June 1964 (the “Dealers Act”) as amended, and the parties acknowledge that the Dealers Act shall not apply in the interpretation or enforcement of any of the rights and obligations of the parties hereto.

 

15.10                     Contract Interpretation.  The parties have jointly negotiated this Agreement and, thus, neither this Agreement nor any provision will be interpreted for or against any party on the basis that it or its attorney drafted the Agreement or the provision at issue.   When this Agreement requires approval of one or more parties, such approval may not be unreasonably withheld or delayed.  Words, regardless of the number and gender specifically used, will be construed to include any other number, singular or plural, and any gender, masculine, feminine, or neuter, as the context

 

22



 

requires.  “And” includes “or.”  “Or” is disjunctive but not necessarily exclusive.  “Including” means “including but not limited to.” Unless other specifically stated, the term “days” means calendar days.

 

15.11                     Entire Agreement; No Reliance.  Each of the parties agrees and acknowledges that this Agreement, including the Continuing Guaranty and the attachments referred to herein, (i) constitutes the entire agreement and supersedes all prior and contemporaneous agreements, understandings, negotiations and discussions, whether oral or written, between the parties with respect to the subject matter of this Agreement, and (ii) is not intended to confer any rights or remedies, or impose any obligations, on any person other than the parties hereto.  Each of the parties expressly agrees and acknowledges that, other than those statements expressly set forth in this Agreement, it is not relying on any statement, whether oral or written, of any person or entity with respect to its entry into this Agreement or to the consummation of the transactions contemplated by this Agreement.

 

15.12                     Counterparts.  This Agreement may be executed in multiple counterparts, each of which shall be deemed an original but all of which together shall constitute one and the same instrument.  Facsimile execution and delivery of this Agreement are legal, valid and binding execution and delivery for all purposes.

 

[signature page to follow]

 

23



 

IN WITNESS WHEREOF, the parties hereto have caused this Agreement to be executed by their duly authorized respective officers as of the Effective Date.

 

 

ASD Specialty Healthcare, Inc.

 

Dyax Corp.

 

 

 

 

 

 

 

By:

/s/ Chris B. Myers

 

By:

/s/ Ivana Magovcevic-Liesbisch

 

 

 

 

 

Name:

Chris B. Myers

 

Name:

Ivana Magovcevic-Liesbisch

 

 

 

 

 

Title:

COO

 

Title:

Executive Vice President Corporate
Development and General Counsel

 

 

AmerisourceBergen Specialty Group, Inc., a Delaware corporation, agrees that is shall be financially responsible for any unsatisfied liabilities of ASD Specialty Healthcare, Inc. under this Agreement, provided that any defense or privilege that may be asserted by ASD Specialty Healthcare, Inc. may also be asserted by AmerisourceBergen Specialty Group, Inc.

 

 

 

AmerisourceBergen Specialty Group, Inc.

 

 

 

 

 

 

 

By:

/s/ Mike Mullen

 

 

 

 

Name:

Mike Mullen

 

 

 

 

Title:

President

 

24



 

LIST OF EXHIBITS

 

EXHIBIT A — Product Description

EXHIBIT B — Service Level Commitments

EXHIBIT C — Chargeback Policies

EXHIBIT D — Consignment

EXHIBIT E — Product Returns Policy

EXHIBIT F — Continuing Guaranty

 

25



 

EXHIBIT A

Product Description

 

Product Trade Name:

 

Kalbitor®

Generic Name:

 

ecallantide

NDC Number:

 

47783-101-01

 

Kalbitor is a recombinant protein with high affinity and high specificity for human plasma kallikrein and is used in the treatment of Hereditary Angioedema (HAE).

 

Kalbitor is temperature sensitive and must be stored and shipped at 2-8°C (36-42°F).

 

Kalbitor is packaged in a single carton containing three 1 mL vials and is administered through three subcutaneous injections.

 

26



 

EXHIBIT B

Service Level Commitments

 

[*****]

 

27



 

EXHIBIT C

Chargeback Policies

 

[*****]

 

28



 

EXHIBIT D

Consignment

 

[*****]

 

29



 

EXHIBIT E

Product Returns Policy

 

[*****]

 

30



 

EXHIBIT F

Continuing Guaranty

 

[attached hereto]

 

31



EX-10.22 7 a2196756zex-10_22.htm EXHIBIT 10.22

Exhibit 10.22

 

DISTRIBUTION SERVICES AGREEMENT

(3PL Services)

 

This DISTRIBUTION SERVICES AGREEMENT (“Agreement”), dated as of November 19, 2009 (the “Effective Date”), is entered into by and between DYAX CORP., a Delaware corporation with offices located at 300 Technology Square, Cambridge, Massachusetts 02139 (“Dyax”), and INTEGRATED COMMERCIALIZATION SOLUTIONS, INC., a California corporation with its primary offices located at 3101 Gaylord Parkway, Frisco, Texas 75034 (“ICS”).

 

WHEREAS, Dyax has developed the Product (as defined below);

 

WHEREAS, in the United States, Dyax intends to secure the regulatory approvals required in order to promote, market and sell the Product in the United States as a treatment for patients suffering acute attacks associated with the disease known as hereditary angioedema (“HAE”);

 

WHEREAS, ICS is in the business of providing commercialization services for pharmaceutical products; and

 

WHEREAS, Dyax wishes to engage ICS to provide Dyax with certain third-party logistic services for the Product throughout the United States, and ICS wishes to accept such engagement, all upon the terms and subject to the conditions set forth in this Agreement.

 

NOW, THEREFORE, for good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the parties agree as follows:

 

1.                                      Definitions.

 

As used in this Agreement, the following capitalized terms shall have the following meanings:

 

1.1                                 3PL Services” shall have the meaning set forth in Section 3.1.

 

1.2                                 Affiliate” shall mean any individual, corporation, partnership, association, or business that directly or indirectly through intermediaries, controls, is controlled by or is under common control with, a party. An ownership, voting or similar interest (including any right or option to obtain such an interest) representing more than 50% of the total interests then outstanding of the pertinent entity shall constitute “control” for the purposes of this definition.

 

1.3                                 Applicable Laws” shall mean all applicable laws, rules, regulations in the Territory, including guidelines and guidances promulgated by governmental entities.

 

1.4                                 FDA” shall mean the United States Food and Drug Administration or any successor agency thereto.

 

1.5                                 Field” shall mean all uses in the therapeutic treatment of HAE.

 

1.6                                 Product” shall mean Dyax’s proprietary plasma kallikrein inhibitor, known as internally as DX-88 and generically as ecallantide, as more formally described on Exhibit A.

 


* Confidential Treatment Requested.  Omitted portions filed with the Commission.

 



 

1.7                                 REMS Program” shall mean the Risk Evaluation and Mitigation Program required to be implemented under Section 505-1 of the Federal Food, Drug and Cosmetic Act in connection with the regulatory approval of the Product by the FDA.

 

1.8                                 SOPs” shall have the meaning set forth in Section 3.2.

 

1.9                                 Statement of Work” shall have the meaning set forth in Section 3.1

 

1.10                           Term” shall have the meaning set forth in Section 11.1.

 

1.11                           Territory” shall mean the 50 states of the United States of America, the District of Columbia and Puerto Rico.

 

2.                                      Engagement of ICS.

 

2.1                                 Engagement.  Upon the terms and conditions set forth herein, Dyax hereby engages ICS, on an exclusive basis during the Term (subject to Section 11.4), to provide 3PL Services in connection with the promotion, offer for sale, sale and distribution of Product in the Field in the Territory.  ICS hereby accepts such engagement and shall provide the 3PL Services in a professional and responsible manner and in accordance with the terms of this Agreement and all Applicable Laws.

 

2.2                                 Authorized Distributor.  In connection with ICS’s engagement under Section 2.1 above, and solely for the limited purpose of compliance with the pedigree requirements of the Prescription Drug Marketing Act and any similar state laws, Dyax hereby designates ICS as an Authorized Distributor of Record (“ADR”) of the Product during the Term and a third party logistics provider who does not take title to Product or have general responsibility to direct the sale or disposition of Product.  The foregoing shall not be construed in a manner that results in ICS being considered a distributor or wholesaler for any other purpose or under any Applicable Laws.

 

2.3                                 Exclusivity.  The parties acknowledge and agree that as a result of the exclusive nature of the ICS engagement, subject to Section 11.4, during the Term, Dyax shall not engage any party other than ICS or its Affiliates to serve as Dyax’s third-party logistic service provider for Product for the Field in the Territory.

 

2.4                                 Reserved Rights. Except as expressly provided in this Agreement, no right, title or interest in or to Product or any patent, trade secret, trademark or any other intellectual property right of Dyax or its Affiliates is granted, whether express or implied, by Dyax to ICS.  Except as expressly provided in this Agreement, no right, title or interest in or to any patent, trade secret, trademark or any other intellectual property right of ICS or its Affiliates is granted, whether express or implied, by ICS to Dyax.  By way of clarification, all proprietary systems, databases and web-based applications, and any standard operating procedures, work rules, programming, software, routines, analytic tools, embedded logic or table structures associated therewith, that have been developed, maintained, utilized and improved by ICS (or its Affiliates) in connection with this Agreement or the Hub Services are and will remain the property of ICS (or its Affiliates).

 

2



 

3.                                      3PL Services and Related ICS Obligations.

 

3.1                                 3PL Services; Statement of Work.  ICS shall provide certain third party logistics services with respect to the Product (“3PL Services”). The specific nature of such 3PL Services, and any additional terms and conditions applicable to such 3PL Services, shall be set forth in writing (each such writing a “Statement of Work”).  The initial Statement of Work that has been agreed upon by the parties is attached hereto as Exhibit B.  Any changes to the initial Statements of Work or any new Statement of Work must be in writing and approved by both parties, and thereafter shall be considered an addendum to this Agreement.  All services performed under any Statement of Work shall be subject to all the terms and conditions set forth herein.

 

3.2                                 Standard Operating Procedures.  ICS shall conduct all activities under this Agreement in accordance with all Standard Operating Procedures (“SOPs”) applicable to such activities, as established and approved in writing by the parties from time to time.   Any SOPs specific to Dyax will be discussed and agreed upon by the parties and material changes will be implemented by ICS only at Dyax’s direction.    Notwithstanding anything to the contrary contained in this Agreement or elsewhere, during the Term of this Agreement, Dyax shall be permitted, upon its reasonable request, to review all such SOPs at the ICS facility.  The SOPs are confidential and proprietary to ICS and shall not be disclosed by Dyax to any third party without the consent of ICS.  Upon termination of this Agreement, any SOPs in Dyax’s possession will be returned to ICS or (at ICS’s election) destroyed by Dyax with certification of destruction.

 

3.3                                 No Subcontracting or Subdistribution. All obligations and services to be performed by ICS under this Agreement shall be solely performed by ICS and ICS shall not outsource or subcontract any of its obligations hereunder without Dyax’s prior written consent, except to an Affiliate of ICS.

 

3.4                                 Applicable Laws and RegulationsICS shall conduct all activities under this Agreement in compliance with all Applicable Laws, including federal and state pharmacy, wholesaler and pedigree laws, federal and state laws protecting the privacy of patient medical information (including HIPAA if applicable), laws relating to the disposal of pharmaceutical products and hazardous wastes, and all applicable professional and industry standards and good business practices.  If Dyax reasonably determines that ICS has conducted activities under this Agreement in a manner that could potentially compromise public health or safety, then Dyax may terminate this Agreement immediately, and whether or not Dyax terminates this Agreement, may pursue all other legal remedies available to it.

 

3.5                                 Storage Conditions.  ICS will maintain Product stored at, and shipped from, its facilities under (i) the Product storage, shipment and handling requirements set forth in the Statement of Work included in Exhibit B, (ii) any applicable SOPs and (iii) any other conditions required by the FDA approved labeling.  ICS shall notify Dyax within one (1) business day of any known deviation from such requirements so that Dyax can determine whether any further action must be taken with respect to such Product.  Failure of ICS to notify Dyax promptly of such known deviation shall constitute a breach of this Agreement by ICS.

 

3



 

3.6                                 Title to Product.  All right, title and interest in and to all Product at ICS’s facility or otherwise in the possession of ICS shall at all times remain the sole property of Dyax.  At no time and under no circumstance shall ICS have title to, or any right or interest in or to, any Product at ICS’s facility or otherwise in ICS’s possession or control.  ICS hereby expressly waives and releases any and all liens and claims it may have in respect of any Product arising under any statute, common law or otherwise.  ICS from time to time during the Term shall execute such forms, documents and instruments evidencing Dyax’s ownership of Product as Dyax reasonably shall request.  ICS shall take no action that is inconsistent with the right, title and interest of Dyax in and to the Product and any attempt by ICS to sell, or to grant or create a lien on or security interest in, any Product shall be void ab initio.  ICS shall have no authority to store any Product with any other warehouseman or in any place other than ICS’s facility.  At any time during the Term and for any reason, Dyax may take all or any portion of any Product into its possession by giving ICS notice of such intent, and upon the giving of such notice ICS shall deliver such Product to Dyax in accordance with instructions provided by Dyax, subject to Dyax promptly reimbursing ICS’s reasonable actual costs of return and removal.

 

3.7                                 Risk of Loss.  ICS shall have no risk of loss for all Product at ICS’s facility or otherwise in the possession of ICS, except to the extent that ICS’s gross negligence or willful misconduct caused such loss.    In such case, any loss due to damage or loss of products will be based upon Dyax’s cost of manufacturing or acquiring products, not it’s selling cost.

 

3.8                                 Diversion.  ICS shall notify Dyax in writing within one (1) business day of learning of information to suggest that any person or entity is diverting or attempting to divert Product.  For the purposes of this Section 3.8, “diverting” means the unauthorized sale, distribution, purchase, receipt, or handling of Product.

 

3.9                                 Product Promotion.  ICS shall not provide any information regarding the safety, effectiveness, or use of Product to any persons or entities except as approved in advance in writing by Dyax.

 

4.                                      Compensation for 3PL Services.

 

Dyax will compensate ICS for the 3PL Services in accordance with the fee schedule attached as Exhibit C.  For clarity, the fees on Exhibit C shall be and remain in effect for the duration of the Term, provided that if Dyax terminates its agreement with either of ICS’s Affiliates, US Bioservices Corporation or ASD Specialty Healthcare, Inc., fees may be subject to adjustment.  Within [*****] following the end of each [*****] during the Term, ICS shall provide a detailed invoice that specifically identifies the 3PL Services conducted by ICS during [*****].  Dyax shall notify ICS of any disputed charges in writing within [*****] following receipt of the invoice covering such charges.  In the absence of any such notice of dispute, all invoices shall be deemed to be correct and due in full within [*****] following receipt of the invoice.  On all undisputed invoice balances exceeding [*****], Dyax shall pay interest equal to the lesser of (i) [*****] per month and (ii) the maximum allowed by law.

 

4



 

5.                                      Suspension, Recalls and Government Notices.

 

5.1                                 Suspension.  Upon written notification by Dyax to suspend distribution of Product, ICS immediately shall suspend its distribution of Product.

 

5.2                                 Recalls.

 

(a)                                  Recall Procedures.  Dyax shall promptly notify ICS of any recalls or market withdrawals initiated by Dyax or required by the FDA or any other governmental agency.  ICS shall notify Dyax immediately of any event or circumstance that ICS reasonably believes may necessitate a recall or market withdrawal.  Any recall or market withdrawal initiated by Dyax or required by the Untied States Food and Drug Administration shall be conducted in accordance with the Recall Statement of Work, included in the Statements of Work attached as Exhibit B hereto.  Any changes to the Recall Statement of Work shall be subject to the terms and conditions set forth in Section 3.1.  Dyax shall be responsible for the mailing, shipping, and reasonable administrative expenses incurred by ICS in connection with the recall or market withdrawal, plus a reasonable service fee as mutually agreed upon in advance by the parties.  Notwithstanding the foreging, to the extent that such recall or market withdrawal arises or results from (i) the negligence or intentional misconduct of ICS or any of its permitted agents or employees or (ii) the breach by ICS of this Agreement, ICS shall bear and be responsible for such costs as well as the reasonable, documented, out-of-pocket expenses of Dyax incurred in connection with such recall or market withdrawal.

 

(b)                                 Investigations; Cooperation.  ICS shall fully cooperate with Dyax in investigating any Product failure that resulted in the need for a recall or market withdrawal and any reasonable, documented, out-of-pocket cost involved with such investigation shall be reimbursed by Dyax, except to the extent that such recall or market withdrawal arises or results from (i) the negligence or intentional misconduct of ICS or any of its permitted agents or employees or (ii) the breach by ICS of this Agreement, in which event ICS shall bear and be responsible for such costs as well as the reasonable, documented, out-of-pocket expenses of Dyax incurred in connection with such investigation.

 

5.3                                 Government Notices.  Each party shall provide the other with a copy of any correspondence or notices it receives from the FDA, or other governmental entity specifically relating to the Product or activities conducted under this Agreement, no later than one (1) business day following such receipt.    Each party shall also provide the other with concurrent copies of any responses to any such correspondence or notices (e.g., a response to an FDA 483 notice, warning letter, or untitled regulatory letter); provided that Dyax shall review and approve all such responses by ICS to the extent related to the Product and to the extent reasonably feasible.  Where reasonably possible, ICS shall give prior notice to Dyax of any scheduled FDA or other governmental inspection of ICS’s facilities specifically relating to the Product, and, if reasonably possible, will afford Dyax the opportunity to be present at such inspection.

 

5



 

6.                                      Reports and Records.

 

6.1                                 Activity Reports.  In addition to any specific reports that ICS may be required to deliver to Dyax under this Agreement or any Statement of Work, ICS shall provide to Dyax all information and reports related to its activities with respect to the Product that are reasonably requested by Dyax and can be prepared by ICS without undue burden; provided that ICS shall be compensated and fully reimbursed by Dyax for any additional time and expense incurred in connection with the preparation and delivery of such information and/or reports.

 

6.2                                 Ownership of Data.  Dyax exclusively shall own all information and data relating to Product, the distribution of Product and the use of Product obtained, maintained, generated or furnished by ICS in connection with performing its obligations hereunder and all data and information contained in the reports delivered pursuant to Section 6.1, except any data, materials or information not specific to the Product or which relate to the general processes, services and reports developed by ICS or which contains ICS’s Confidential Information (the “ICS Information”), and ICS hereby assigns to Dyax all of its right, title and interest in and to such information and data (excluding ICS Information) without additional consideration.

 

6.3                                 Records.  ICS shall keep complete and accurate books and records pertaining to ICS’s activities under this Agreement.  Such books and records shall be retained for at least [*****] after the expiration or termination of this Agreement or for such longer period as may be required by Applicable Law.

 

6.4                                 Audits.  Dyax, at its expense, from time to time may perform, or have an independent third party auditor (subject to execution of a mutually agreeable nondisclosure agreement) perform, audits of the records maintained pursuant to Section 6.3 and may observe, or have an independent third party auditor observe, the performance by ICS of its activities hereunder to verify the status of Product and ensure compliance with the terms of this Agreement.  Dyax shall provide ICS with at least ten (10) business days advance notice of such audits or observations, and shall conduct any audit or observation during normal business hours in a manner that does not interfere with ICS’s normal business operations.  ICS shall make available relevant records that do not contain information pertaining to ICS’s other clients or products and permit such observations.  Dyax and ICS shall discuss the results of any such audits or observations and ICS shall implement all corrective measures reasonably requested by Dyax.  All audits shall be reasonable in time and scope.

 

7.                                      Confidentiality.

 

7.1                                 Confidential Information.  All confidential, non-public documents and other information disclosed to a party by or on behalf of the other party pursuant to this Agreement which includes but is not limited to information concerns prices and quantities purchased by any customer, Product information, operating and sales data, information about systems, strategic plans, business plans, financial information, processes (including SOPs), customer information, information concerning patients or physicians, methods, databases, technology (including software and all source code) and any other information or material prepared or derived from such information (collectively, “Confidential Information”), shall, subject to Sections 7.2 and 7.3, be held by the receiving party in

 

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strict confidence and not disclosed either directly or indirectly to any third party (other than Affiliates, advisors and consultants who have a need to know such information and who are subject to obligations of confidentiality at least as onerous as those set forth herein) and shall only be used for purposes of fulfilling the receiving party’s obligations, or exercising its rights, under this Agreement.   Notwithstanding the foregoing, all data and information owned by Dyax pursuant to Section 6.2 shall be the Confidential Information of Dyax and not ICS, and regardless of the party that discloses such Confidential Information hereunder, Dyax shall be deemed the disclosing party, and ICS shall be deemed the receiving party, with respect to such Confidential Information.  The terms and conditions of this Agreement and any amendments or addenda thereto shall be deemed the Confidential Information of each party.

 

7.2                                 Exclusions from Confidentiality.  Notwithstanding anything to the contrary in this Agreement, the receiving party shall have no liability to the disclosing party for the use or disclosure of any Confidential Information that the receiving party can establish by written documentation to:

 

(a)                                  have been publicly known prior to disclosure by the disclosing party of such information to the receiving party;

 

(b)                                 have become publicly known without fault on the part of the receiving party, subsequent to disclosure to the receiving party;

 

(c)                                  have been received by the receiving party at any time from a source, other than the disclosing party, lawfully having possession of and the right to disclose such information;

 

(d)                                 have been otherwise known by the receiving party prior to disclosure by the disclosing party to the receiving party of such information; or

 

(e)                                  have been independently developed by the receiving party without use of information disclosed by the disclosing party.

 

7.3                                 Required Disclosure.  A party receiving Confidential Information may disclose such Confidential Information if required to do so by a court (or other governmental agency or stock exchange of competent jurisdiction), any governmental body or as required under any Applicable Laws; provided that (i) the party required to disclose such Confidential Information provides prompt notice of such pending disclosure to the disclosing party so that the disclosing party can seek a protective order or to prevent such disclosure, and (ii) the party required to disclose such Confidential Information shall exercise reasonable efforts to ensure that the information is accorded confidential treatment by the court or other governmental agency or stock exchange.

 

7.4                                 Survival of Confidentiality Obligations.  The provisions of this Article 7 shall survive for a period of seven (7) years following the expiration or termination of this Agreement.

 

7.5                                 Injunctive ReliefEach party acknowledges that the failure by the Receiving Party to comply with any of the provisions of this Article 7 will result in irreparable injury and continuing damage to the disclosing party for which there will be no adequate remedy at law and that, in the event of a failure of the receiving party so to comply, the disclosing party shall be entitled to such preliminary

 

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and permanent injunctive relief as may be necessary to ensure compliance with all the provisions of this Article 7 without having to prove actual damages or to post a bond.

 

7.6                                 HIPAA Compliance.  Notwithstanding anything to the contrary herein (including the Exhibits hereto), ICS shall only provide information to Dyax under this Agreement in a manner consistent with HIPAA, to the extent applicable.  Accordingly, the parties agree that ICS shall only provide Dyax information that is de-identified in accordance with HIPAA’s de-identification provision, 45 C.F.R. § 164.514(b)(2), unless Dyax: (i) has on file a valid, HIPAA-compliant authorization for each patient whose protected health information (“PHI”) is sought to be disclosed; or (ii) authorization is not required under Applicable Laws in order to disclose the information sought.

 

8.                                      Use of Marks.

 

For the purposes of this Agreement, Dyax hereby grants to ICS a non-exclusive, non-transferable, revocable license to use Dyax’s trademarks, trade names and service marks used and/or owned by Dyax with respect to the Product (collectively, the “Marks”).  The Marks shall be used by ICS solely in connection with its distribution and/or delivery of Product, and other activities conducted under this Agreement, in each case solely in accordance with the terms hereof.  The ownership of and goodwill in all Marks shall remain the sole and exclusive property of Dyax and inure exclusively to Dyax’s sole benefit, both during the Term and thereafter.  ICS agrees that nothing in this Agreement shall give ICS any right, title or interest in or to the Marks other than the right to use the same in the manner contemplated by this Agreement and only for so long as this Agreement is in force.

 

9.                                      Additional Representations, Warranties and Covenants.

 

9.1                                 Authorization.  Each party represents and warrants to the other party that it has the legal right and power to enter into this Agreement, to extend the rights and licenses granted to the other in this Agreement, and to fully perform its obligations hereunder, and that the performance of such obligations will not conflict with its charter documents or any agreements, contracts, or other arrangements to which it is a party. Furthermore, no approvals, consents, orders or authorizations of or designation, registration, declaration or filing with any governmental authority (within the Field in the Territory) is required for either party’s performance of its obligations under this Agreement, other than any approvals that have been obtained already or will be obtained in the ordinary course of the performance of such obligations.

 

9.2                                 Federal Programs.  ICS represents, warrants and covenants to Dyax that (a) neither ICS nor any of its Affiliates that perform activities under this Agreement has been debarred or is subject to debarment pursuant to Section 306 of the Act or listed on either Excluded List (as defined herein), and (b) neither ICS nor any of its Affiliates that perform activities under this Agreement will knowingly (after reasonable investigation) use in any capacity, in connection with the services to be performed under this Agreement, any person who has been debarred pursuant to Section 306 of the Act, or who is the subject of a conviction described in such section, or listed on either Excluded List.  ICS shall inform Dyax in writing immediately if it or any person who is performing services hereunder is debarred or is the subject of a conviction described in Section 306 of the Act or listed on either Excluded List, or if any action, suit, claim, investigation or legal or administrative proceeding is pending or, to the best of ICS’s knowledge, is threatened, relating to the debarment

 

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or conviction Section 306 of the Act, or listing on either Excluded List, of ICS or any person performing services hereunder.  “Excluded Lists” means the Department of Health and Human Service’s List of Excluded Individuals/Entities and the General Services Administration’s Lists of Parties Excluded from Federal Procurement and Non-Procurement Programs.

 

9.3                                 ICS/Licensure.  ICS represents and warrants that it now has and shall maintain in full force during the Term all applicable federal and state wholesaler and other licenses or approvals required under Applicable Laws and regulations to fulfill its obligations under this Agreement in each state in the Territory, the District of Columbia and Puerto Rico.  ICS promptly shall notify Dyax of any denials, revocations or suspension of license or registrations by any state or federal agency or any other regulatory authority in the Territory, or any written notice from a governmental body proposing such a denial, revocation or suspension of a license or registration.  ICS shall promptly provide Dyax with notice of any material communications with wholesaler licensing boards which relate to potential problems with facilities, operations, contractors or procedures used by ICS in distribution of the Product, including notices of inquiries, investigations or inspections and resulting findings, except that in no event shall ICS be required to disclose information concerning its other clients or the products of such clients.

 

9.4                                 Dyax Representations and Warranties.  Dyax hereby represents and warrants to ICS that, at the time of delivery of Product by Dyax to ICS hereunder: (a) such Product shall not in any material respect be adulterated, misbranded or otherwise prohibited within the meaning of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. §§ 301 et. seq., as amended and in effect at the time of delivery (the “Act”), or within the meaning of any applicable state or local law; (b) such Product will be merchandise that may be introduced and delivered into interstate commerce under the provisions of Section 301 of the Act or Section 351 of the Public Health Service Act; (c) Dyax has and will maintain, in full force and effect, all licenses and permits required under Applicable Laws for Dyax to sell and distribute such Product under this Agreement; (d) such Product will be the subject of a duly approved Biologics License Application and may be legally transported or sold under Applicable Laws; (e) such Product will have been approved by each applicable governmental authority for commercial sale and shipment of such Product within the Territory; and (f) Dyax either (i) owns or holds the duly approved Biologics License Application, as such term is used in the Public Health Service Act, Title 21, United States Code, as amended for such Product, or (ii) is otherwise considered the “manufacturer” of such Product within the meaning of any applicable federal, state or local law relating to pedigrees.

 

9.5                                 No Other Warranties.  Except as expressly provided herein and in the Continuing Guaranty, neither party hereto makes any representations or warranties to the other party, express or implied, either in fact or by operation of law, by statute or otherwise, and each party specifically disclaims any express or implied representations and warranties of merchantability or fitness for a particular purpose.

 

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10.                               Liability, Indemnification and Insurance.

 

10.1                           Remedies.

 

(a)                                  Generally.  Rights and remedies under this Agreement are cumulative and in addition to any other available rights or remedies under any other agreement, at law or in equity.

 

(b)                                 Equitable Relief.  If either party violates or threatens to violate any provision of this Agreement, the other party may suffer irreparable harm and its remedies at law may be inadequate.  Accordingly, the other party may seek equitable relief.

 

10.2                           Indemnification.

 

(a)                                  Indemnification by ICS.  ICS shall indemnify, defend, and hold harmless Dyax and its Affiliates and its and their respective directors, officers, employees, representatives and agents and their respective successors, heirs and assigns (the “Dyax Indemnitees”) against any liability, damage, loss, penalty, fine or expense (including reasonable attorneys fees and expenses of litigation) (collectively, “Losses”) incurred by or imposed upon Dyax Indemnitees or any of them in connection with any claims, suits, demands, investigations, enforcement actions, or judgments, in each case initiated by a third party (including any governmental or regulatory agency) (collectively, “Third Party Claims”) which arise out of: (a) the gross negligence or willful misconduct of ICS in connection with this Agreement; or (b) the breach of this Agreement by ICS, in each case except for those Losses for which Dyax has an obligation to indemnify ICS pursuant to Section 10.2(b), as to which Losses each party shall indemnify the other to the extent of its respective liability for such Losses.

 

(b)                                 Indemnification by Dyax.  Dyax shall indemnify, defend, and hold harmless ICS and its Affiliates and its and their respective directors, officers, employees, representatives and agents and their respective successors, heirs and assigns (the “ICS Indemnitees”) against any Losses incurred by or imposed upon ICS Indemnitees or any of them in connection with any Third Party Claims which arise out of: (a) the negligence or willful misconduct of Dyax in connection with this Agreement; (b) the breach of this Agreement by Dyax, (c) claims of patent, trademark, copyright or other infringement related to Products, or (d) storage, handling, use, non-use, demonstration, consumption, ingestion, digestion, manufacture, production and assembly of Products and their transportation to ICS (except to the extent that such activities are actually conducted by ICS), in each case except for those Losses for which ICS has an obligation to indemnify Dyax pursuant to Section 10.2(a), as to which Losses each party shall indemnify the other to the extent of its respective liability for such Losses.

 

(c)                                  Indemnification Procedure.  A party that intends to claim indemnification under this Section 10.2 (the “Indemnitee”) shall:  (i) promptly notify the indemnifying party (the “Indemnitor”) in writing of any Third Party Claim in respect of which the Indemnitee or any of its Affiliates or any of their respective directors, officers, employees, representatives, agents or their respective successors, heirs or assigns intend to claim

 

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such indemnification hereunder; (ii) provide the Indemnitor sole control of the defense and/or settlement thereof with counsel reasonably satisfactory to the Indemnitee; provided, however, that the Indemnitee reserves the right to retain its own counsel to defend itself in, but not control the defense of, such suit, at its own expense, unless (a) the interests of the Indemnitee and the Indemnitor in the suit conflict in such a manner and to such extent as to require, consistent with applicable standards of professional responsibility, the retention of separate counsel for the Indemnitee, in which case, the Indemnitor shall pay for one separate counsel chosen by the Indemnitee or (b) the Indemnitor shall not have employed attorneys reasonably satisfactory to the Indemnitee to defend any action within a reasonable time after notice of commencement of such action and (iii) provide the Indemnitor, at the Indemnitor’s request and expense, with reasonable assistance and full information with respect thereto.  Neither the Indemnitor nor the Indemnitee shall be responsible to or bound by any settlement made by the other without its prior written consent, which shall not be unreasonably withheld or delayed.  Without limiting the foregoing provisions of this Section 10.2(c), the Indemnitor shall keep the Indemnitee reasonably informed of the progress of any claim, suit or action under this Section 10.2 and the Indemnitee shall have the right to participate in any such claim, suit or proceeding with counsel of its choosing at its own expense, but the Indemnitor shall have the sole right to control the defense or settlement thereof in accordance with the terms of this Section 10.2(c).

 

10.3                           Limitation of Liability.

 

(a)                                  Neither party shall be liable to the other for special, exemplary, consequential, incidental (including lost or anticipated revenues or profits), indirect or punitive damages arising from the performance or nonperformance of such party under this Agreement whether such claim is based on contract, tort (including negligence) or otherwise, even if an authorized representative of such party is advised of the possibility or likelihood of same.

 

(b)                                 Notwithstanding the exclusions and limitations of liability set forth in Section 10.3(a) above, such exclusions and limitations shall not apply to: (i) either party’s indemnification obligations pursuant to Section 10.2; or (ii) either party’s breach of the party’s confidentiality obligations pursuant to Article 7.

 

(c)                                  Any loss due to damage or loss of Products will be based upon Dyax’s cost of manufacturing or acquiring products, not it’s selling cost.

 

10.4                           ICS Insurance Obligations.  During the Term, ICS shall maintain appropriate levels of insurance for the risks assumed under this Agreement, including the following minimum levels of insurance:

 

(a)                                  Employer’s liability insurance with a limit of [*****] for bodily injury by accident per person, [*****] for bodily injury by accident, all persons and [*****] bodily injury by disease policy limit;

 

(b)                                 Commercial general liability insurance, including personal injury blanket contractual liability and broad form property damage, with a [*****] combined single limit;

 

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(c)                                  Umbrella liability insurance in the amount of [*****] per occurrence and aggregate; and

 

ICS will not be obligated to insure Products against loss or damage arising from the storage of Products at the ICS Facility.  The insurance required by this Section 10.4 may be made up through a combination of self-insured retention and traditional insurance.  Throughout the Term, ICS shall (a) provide prompt written notice to Dyax in the event ICS becomes aware or is notified that the insurance described in this Section 10.4 will be materially adversely modified or cancelled in such a manner that ICS is no longer in compliance with the requirements of Section 10.4 and (b) provide Dyax with proof of such insurance on or before the date such insurance is renewed for each year.

 

10.5                           Dyax Insurance Obligations.  During the Term, Dyax will maintain property, products liability and commercial general liability insurance having a limit of not less than [*****] per occurrence, Combined Single Limit (Bodily Injury and Property Damage), pursuant to one or more insurance policies with reputable insurance carriers having a Best’s Rating of A VII or otherwise as reasonably approved by ICS.  Dyax will designate ICS as an “additional insured” under such insurance policy and will obtain a broad form vendor’s endorsement for products liability for ICS.  Within thirty (30) days after the Effective Date, Dyax will provide to ICS a certificate of insurance indicating that such obligations have been satisfied.  As a condition precedent to the effectiveness of this Agreement, Dyax will execute the form of Continuing Guaranty and Indemnification Agreement (the “Continuing Guaranty”) with AmerisourceBergen Corporation attached hereto as Exhibit D.

 

11.                               Terms and Termination.

 

11.1                           Term. Unless earlier terminated in accordance with the terms hereof, the term of this Agreement (the “Term”) shall (i) commence as of the Effective Date and will continue in effect for an initial period of t three (3) years (the “Initial Term”), and (ii) automatically renew for subsequent periods of [*****] (each, a “Renewal Term”), unless either party provides written notice to the other at least [*****] prior to the end of the Initial Term or then-current Renewal Term that it does not wish to renew. The parties will work together in good faith to discuss and agree upon any appropriate fee adjustments at least [*****] prior to expiration of the Initial Term.

 

11.2                           Termination.  In addition to any other provision of this Agreement providing for termination hereof, this Agreement may be terminated as follows:

 

(a)                                  Termination by Dyax For Convenience.  Dyax may terminate this Agreement for convenience, without cause, upon [*****] prior written notice of termination to ICS.

 

(b)                                 Termination For CauseThis Agreement may be terminated by either party on written termination notice to the other party in the event of any material breach of this Agreement by the other party (other than a breach by ICS of Section 3.2, which is governed by clause (ii) below), which breach is not cured within [*****] (or [*****] for any breach relating to payment obligations under this Agreement) after delivery of written notice by the non-breaching party specifying such breach and requiring cure.  Notwithstanding the right to cure provided by the foregoing sentence, ICS shall have the right to cure only two (2) material breaches of any particular obligation hereunder, and

 

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this Agreement may be terminated by Dyax immediately on written notice to ICS in the event of any additional material breach of such obligation by ICS.

 

(c)                                  Insolvency.  This Agreement may be terminated by either party immediately upon written notice to the other party in the event of any of the following events:

 

(i)                                     the institution by the other party of insolvency, receivership or bankruptcy proceedings or any other material proceedings for the settlement of the other party’s debts, or the institution against the other party of any such proceedings that remain undismissed for ninety (90) days;

 

(ii)                                  the other party’s making an assignment for the benefit of its creditors; or

 

(iii)                               the other party’s dissolution.

 

(d)                                 Other AgreementsIn the event that any of (a) the Distribution Services Agreement of even date herewith between Dyax and ASD Specialty Healthcare, Inc. or (b) the Distribution Services Agreement of even date herewith between Dyax and US Bioservices Corporation is terminated for any reason, then (i) this Agreement may be terminated by Dyax upon [*****] written notice to ICS; and (ii) if not terminated, ICS will notify Dyax of any applicable adjustment to Fees based upon such termination.

 

(e)                                  Supervening Illegality.

 

(i)                                     This Agreement shall terminate if both:  (A) as a result of the enactment of any new applicable federal or state law or regulation, or any change in any existing applicable federal or state law or regulation or any new interpretation of any applicable federal or state law or regulation by any legislative body, court or regulatory agency, the performance by a party of any material obligation under the Agreement would be rendered illegal or any material provision of the Agreement would be rendered invalid or unenforceable, and (B) the parties are unable to negotiate a mutually acceptable amendment to the Agreement pursuant to Section 11.2(e)(iii) below.  If any immaterial provision of this Agreement is held to be illegal, invalid or unenforceable for any reason, the Agreement shall be deemed amended to delete such provision, such amendment to apply only with respect to the operation of the Agreement in the particular jurisdiction in which such provision is held to be illegal, invalid or unenforceable, and the remainder of the Agreement shall remain in full force and effect and enforceable in accordance with its terms.

 

(ii)                                  The parties agree that the party affected by the new law or regulation or the change in law or regulation or the interpretation of a law or regulation shall use reasonable efforts to give the other party at least [*****] prior written notice of the effective date of such new law, change, or interpretation.

 

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(iii)                               The parties agree that, notwithstanding the foregoing provisions of this Section, either party may, within ten (10) business days of giving or receiving notice of the new law, change or interpretation, notify the other party of its wish to renegotiate the applicable terms of the Agreement (“Renegotiation Notice”), in which event the parties shall negotiate in good faith, for a period of sixty (60) days from delivery of the Renegotiation Notice, an amendment to the Agreement that addresses the portion of the Agreement rendered illegal, invalid or unenforceable by the new law, change or interpretation while preserving to the greatest extent possible the original intent of the Agreement.  If the parties successfully conclude such negotiations prior to the effective date of the new law, change or interpretation, the Agreement shall not terminate and shall be amended to reflect the negotiated terms.  If the parties are unable to successfully conclude such negotiations prior to the effective date of the new law, change or interpretation and such effective date is within the sixty (60) day negotiation period, the Agreement shall be deemed amended to delete such portion rendered illegal, invalid, or unenforceable, such amendment to apply only with respect to the operation of the Agreement in the particular jurisdiction in which such portion is held to be illegal, invalid or unenforceable, and the remainder shall remain in full force and effect and enforceable in accordance with its terms.  In the event the parties are unable to successfully conclude such negotiations within the sixty (60) day negotiation period, the Agreement shall terminate at the end of the sixty (60) day negotiation period.

 

11.3                           Effect of TerminationUpon the expiration or earlier termination of this Agreement:

 

(a)                                  all Confidential Information received hereunder shall be returned to the disclosing party, or destroyed, at the disclosing party’s election (provided that the receiving party may retain one copy to the extent necessary to comply with any contractual or other legal obligations applicable thereto);

 

(b)                                 all rights granted to ICS with respect to the Product shall terminate and ICS shall follow Dyax’s reasonable instructions to cease in a timely and orderly manner all activities with respect to the selling and distribution of Product; and

 

(c)                                  unless terminated by ICS pursuant to Section 11.2 above (Material Breach) for a period of [*****] following such expiration or early termination, ICS and its Affiliates shall provide commercially reasonable assistance in connection with Dyax’s transition of Product distribution and Hub Services to Dyax, its Affiliates or any third party selected by Dyax.  Dyax shall reimburse ICS for its reasonable, documented out-of-pocket costs and expenses incurred with in connection with providing such transition services; provided that, in the event of a termination due to ICS’s breach, neither the existence of this provision nor the fact of Dyax’s agreement to pay for such transition services shall in any way effect or limit Dyax’s rights or remedies with respect to such breach.

 

(d)                                 If Dyax terminates this Agreement pursuant to Section 11.2(a) or ICS terminates this Agreement pursuant to Section 11.2(b) prior to the first anniversary of the Effective Date,

 

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Dyax shall pay ICS an early termination fee, with the amount being equal to $110,000.  The Early Termination Fee is intended to compensate ICS for development costs related to the Services hereunder and is in addition to, not in lieu of, any other amounts it is entitled to under this Agreement or at law.

 

Termination of this Agreement shall not relieve either party of obligations incurred prior to termination.  The provisions of Sections 6.2, 6.3, 6.4, 11.3, 13.10 and 13.11 and Articles 7, 10 and 12, together with and any other provisions which by their express terms extend beyond the expiration or termination of this Agreement, shall survive any termination of this Agreement.

 

11.4                           Termination of Exclusivity.  In the event that Dyax has the right to terminate this Agreement, Dyax, on immediate written notice to ICS, may terminate Section 2.3, which shall have no further force or effect from and after the delivery of such notice by Dyax.

 

12.                               Dispute Resolution.

 

12.1                           Resolution by Executives.  Any dispute, controversy or claim initiated by either party arising out of, or resulting from the breach or alleged breach by either party of its obligations under this Agreement (other than bona fide third party actions or proceedings filed or instituted in an action or proceeding by a third party against a party to this Agreement), whether before or after termination of this Agreement, shall be in the first instance referred to the respective chief executive officers of the parties unless such dispute or claim must be filed to preserve a legal interest or injunctive relief is required.

 

12.2                           Arbitration.  If chief executive officers (or their representatives, it being agreed that the chief executive officer of either party may designate a representative, provided such representative is empowered with decision making in the dispute)  of the parties fail to resolve any dispute as provided in Section 12.1 within [*****], then such dispute shall be finally resolved by binding arbitration as follows:

 

(a)                                  Any dispute that might arise between the parties relating to or arising from this Any dispute that might arise between the parties relating to or arising from this Agreement shall be settled by binding arbitration in accordance with the then-prevailing Commercial Arbitration Rules of the American Arbitration Association (“AAA”), except where those rules conflict with this provision, in which case this provision controls. Arbitration shall be conducted before a single arbitrator selected from the AAA’s National Roster of Arbitrators, each of whom shall be a lawyer with at least 15 years experience with a law firm or corporate law department of over 25 lawyers or who was a judge of a court of general jurisdiction.  Each party shall have the right to meet and interview the potential arbitrator for no more than one hour each prior to the selection of an arbitrator.  The arbitration shall be held, and Dyax and ICS irrevocably consent to arbitrate, in New York, NY, unless they mutually agree upon an alternative location. The arbitration shall be conducted in English. In rendering the award the arbitrator must apply the substantive law of the State of Delaware (except where that law conflicts with this clause); however, the interpretation and enforcement of this arbitration provision shall be governed by the Federal Arbitration Act.  The arbitrator shall render a written opinion setting forth findings

 

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of fact and conclusions of law with the reasons therefor stated.  Under no circumstances shall the arbitrator award damages in excess of or inconsistent with any limitations of liability contained in this Agreement.  Any court with jurisdiction shall enforce this clause and enter judgment on any award.  ICS and Dyax will agree upon, within [*****] days after the arbitrator is selected or, if they fail to agree, the AAA will design, procedures that they will follow to assure that the arbitration will be concluded and the award rendered within no more than eight months from selection of the arbitrator.

 

(b)                                 The arbitration proceedings shall be confidential, and neither party shall publicize the nature of any dispute or the outcome of any mediation or arbitration proceedings except to the extent required by law, provided in such case the party required to make any disclosure informs the other party of such requirement to allow the other party to seek a protective order.  The mediator or arbitrator, as the case may be, shall issue appropriate protective orders to safeguard each party’s confidential information.

 

(c)                                  Each party has the right before or during the mediation or arbitration to seek and obtain from the appropriate court provisional remedies such as attachment, an injunction, replevin, etc., to avoid irreparable harm, maintain the status quo or preserve the subject matter of the arbitration.

 

13.                               Miscellaneous.

 

13.1                           Relationship of Parties.  ICS’s relationship with Dyax hereunder shall be that of independent contractor, and neither party shall be considered the agent of, partner of, employee or other member of the workforce of, or participant in a joint venture with, the other party.  Neither party shall have authority to bind the other party unless otherwise agreed to in writing by such parties.

 

13.2                           Notices.  All notices, requests, demands and other communications required or permitted to be given pursuant to this Agreement shall be in writing and shall be deemed to have been duly given upon the date of receipt if delivered by hand, recognized international overnight courier, confirmed facsimile transmission, or registered or certified mail, return receipt requested, postage prepaid to the following addresses or facsimile numbers:

 

If to Dyax:

Dyax Corp.

 

300 Technology Square

 

Cambridge, MA 02139

 

[*****]

 

 

If to ICS:

AmerisourceBergen Specialty Group

 

3101 Gaylord Parkway

 

Frisco, TX 75034

 

[*****]

 

Either party may change its designated address, contact person and facsimile number by notice to the other party in the manner provided in this Section.

 

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13.3                           Assignment.  Neither party may assign its rights or delegate its obligations under this Agreement without the prior written consent of the other party, except that either party may assign this Agreement to any of its Affiliates or to a successor in connection with the merger, consolidation, or sale of all or substantially all of its assets or that portion of its business pertaining to the subject matter of this Agreement, with prompt written notice to the other party of any such assignment; provided that: (i) if such assignee is an Affiliate, the assignor shall be responsible for and liable with respect to all assigned obligations and (ii) if such assignee is not an Affiliate, (A) the assignee assumes the assignor’s obligations under the Continuing Guaranty and Indemnification Agreement, and (B) the assignee has net assets as of the end of its most recently completed fiscal year equal to or in excess of the net assets of the assignor as of the end of its most recently completed fiscal year, in each case as set forth in the audited balance sheet of the assignor and assignee, and (iii) in the case of an assignment by Dyax, the assignee is not a Competitor to ICS.  For the purposes of this Section 13.3, a “Competitor” means any organization, entity or person that competes with ICS including but not limited to the following companies and their affiliated entities: [*****].

 

13.4                           Force Majeure. Each party’s obligation under this Agreement will be excused to the extent any delay or nonperformance is caused by strikes or other labor disturbance, acts of God, war, or other conditions beyond the reasonable control of that party, but only during the duration of such condition.

 

13.5                           Amendment and Waiver.  This Agreement may be amended, supplemented, or otherwise modified only by means of a written instrument signed by both parties.  Any waiver of any rights or failure to act in a specific instance shall relate only to such instance and shall not be construed as an agreement to waive any rights or fail to act in any other instance, whether or not similar.  To be valid, any waiver must be in writing.

 

13.6                           Severability.  In the event any provision of this Agreement should be held invalid, illegal or unenforceable, the remaining provisions shall not be affected or impaired and the parties shall use all reasonable efforts to replace the applicable provision with a valid, legal and enforceable provision which insofar as practical implements the original intent of such invalid, illegal or unenforceable provision, provided, however, that if the parties fail to reach such agreement within sixty (60) days, a party whose rights or obligations are materially adversely affected as a result of a provision being held invalid, illegal or unenforceable may terminate this Agreement.

 

13.7                           Headings.  All headings used in this Agreement are inserted for convenience only and are not intended to affect the meaning or interpretation of this Agreement or any Article or Section hereof.

 

13.8                           Successors and Assigns.  This Agreement shall be binding on and shall benefit any and all successors, trustees, permitted assigns and other successors in interest of the parties.

 

13.9                           Applicable Law; Disclaimer of Puerto Rico Law 75.

 

(a)                                  This Agreement shall be construed and enforced in accordance with the laws of the State of Delaware (excluding the choice of law provisions thereof).

 

17



 

(b)                                 The parties expressly disclaim, to the fullest extent allowed by Applicable Law, any application of the Puerto Rico Dealers Act, Law No. 75 of June 1964 (the “Dealers Act”) as amended, and the parties acknowledge that the Dealers Act shall not apply in the interpretation or enforcement of any of the rights and obligations of the parties hereto.

 

13.10                     Contract Interpretation.  The parties have jointly negotiated this Agreement and, thus, neither this Agreement nor any provision will be interpreted for or against any party on the basis that it or its attorney drafted the Agreement or the provision at issue.   When this Agreement requires approval of one or more parties, such approval may not be unreasonably withheld or delayed.  Words, regardless of the number and gender specifically used, will be construed to include any other number, singular or plural, and any gender, masculine, feminine, or neuter, as the context requires.  “And” includes “or.”  “Or” is disjunctive but not necessarily exclusive.  “Including” means “including but not limited to.” Unless other specifically stated, the term “days” means calendar days.

 

13.11                     Entire Agreement; No Reliance.  Each of the parties agrees and acknowledges that this Agreement, including the Continuing Guaranty and attachments referred to herein, (i) constitutes the entire agreement and supersedes all prior and contemporaneous agreements, understandings, negotiations and discussions, whether oral or written, between the parties with respect to the subject matter of this Agreement, and (ii) is not intended to confer any rights or remedies, or impose any obligations, on any person other than the parties hereto.  Each of the parties expressly agrees and acknowledges that, other than those statements expressly set forth in this Agreement, it is not relying on any statement, whether oral or written, of any person or entity with respect to its entry into this Agreement or to the consummation of the transactions contemplated by this Agreement.

 

13.12                     Counterparts.  This Agreement may be executed in multiple counterparts, each of which shall be deemed an original but all of which together shall constitute one and the same instrument.  Facsimile execution and delivery of this Agreement are legal, valid and binding execution and delivery for all purposes.

 

[signature page to follow]

 

18



 

IN WITNESS WHEREOF, the parties hereto have caused this Agreement to be executed by their duly authorized respective officers as of the Effective Date.

 

 

Integrated Commercialization Solutions, Inc.

 

Dyax Corp.

 

 

 

 

 

 

 

By:

/s/ Douglas Cook

 

By:

/s/ Ivana Magovcevic-Liebisch

 

 

 

 

 

Name:

Douglas Cook

 

Name:

Ivana Magovcevic-Liebisch

 

 

 

 

 

Title:

VP, Distribution Services

 

Title:

Executive Vice President Corporate
Development and General Counsel

 

 

AmerisourceBergen Specialty Group, Inc., a Delaware corporation, agrees that is shall be financially responsible for any unsatisfied liabilities of Integrated Commercialization Solutions, Inc.  under this Agreement, provided that any defense or privilege that may be asserted by Integrated Commercialization Solutions, Inc. may also be asserted by AmerisourceBergen Specialty Group, Inc.

 

 

AmerisourceBergen Specialty Group, Inc.

 

 

 

 

 

By:

/s/ Mike Mullen

 

 

 

 

Name:

Mike Mullen

 

 

 

 

Title:

President

 

19



 

LIST OF EXHIBITS

 

EXHIBIT A — Product Description

EXHIBIT B — Initial Statement of Work

EXHIBIT C — Fee Schedule

EXHIBIT D — Continuing Guaranty

 

20


 

EXHIBIT A

Product Description

 

Product Trade Name:

Kalbitor®

Generic Name:

ecallantide

NDC Number:

47783-101-01

 

Kalbitor is a recombinant protein with high affinity and high specificity for human plasma kallikrein and is used in the treatment of Hereditary Angioedema (HAE).

 

Kalbitor is temperature sensitive and must be stored and shipped at 2-8°C (36-42°F).

 

Kalbitor is packaged in a single carton containing three 1 mL vials and is administered through three subcutaneous injections.

 

21



 

EXHIBIT B

Initial Statement of Work

 

[*****]

 

22



 

EXHIBIT C

Fee Schedule

 

[*****]

 

23



 

EXHIBIT D

Continuing Guaranty

 

[attached hereto]

 

24


 


EX-21.1 8 a2196756zex-21_1.htm EXHIBIT 21.1
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Exhibit 21.1


Dyax Corp.
Subsidiaries of the Company

NAME
  PARENT   STATE OR COUNTRY OF
INCORPORATION

Dyax Holdings B.V. 

 

Dyax Corp.

 

Netherlands

Dyax B.V. 

 

Dyax Holdings B.V.

 

Netherlands

Dyax S.A. 

 

Dyax Corp.

 

Belgium




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Dyax Corp. Subsidiaries of the Company
EX-23.1 9 a2196756zex-23_1.htm EXHIBIT 23.1
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Exhibit 23.1


CONSENT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM

        We hereby consent to the incorporation by reference in the Registration Statements on Form S-3 (Nos. 333-142325 and 333-148317) and Form S-8 (Nos. 333-146155, 333-146154, 333-119607, 333-105842, 333-131416, 333-49852, 333-49856, 333-97523, and 333-97527) of Dyax Corp. of our report dated March 12, 2010 relating to the financial statements, financial statement schedule and the effectiveness of internal control over financial reporting, which appears in this Form 10-K.

/s/ PricewaterhouseCoopers LLP

Boston, Massachusetts
March 12, 2010




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CONSENT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
EX-31.1 10 a2196756zex-31_1.htm EXHIBIT 31.1
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Exhibit 31.1


Certification Pursuant to Section 240.13a-14 or 240.15d-14
of the Securities Exchange Act of 1934, as amended

I, Gustav A. Christensen, certify that:

1.
I have reviewed this annual report on Form 10-K of Dyax Corp.;

2.
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

3.
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

4.
The registrant's other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

(a)
Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

(b)
Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

(c)
Evaluated the effectiveness of the registrant's disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

(d)
Disclosed in this report any change in the registrant's internal control over financial reporting that occurred during the registrant's most recent fiscal quarter (the registrant's fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant's internal control over financial reporting; and

5.
The registrant's other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant's auditors and the audit committee of the registrant's board of directors (or persons performing the equivalent functions):

(a)
All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant's ability to record, process, summarize and report financial information; and

(b)
Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant's internal control over financial reporting.

Date: March 12, 2010

   

  /s/ GUSTAV A. CHRISTENSEN

Gustav A. Christensen
Chief Executive Officer



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Certification Pursuant to Section 240.13a-14 or 240.15d-14 of the Securities Exchange Act of 1934, as amended
EX-31.2 11 a2196756zex-31_2.htm EXHIBIT 31.2
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Exhibit 31.2


Certification Pursuant to Section 240.13a-14 or 240.15d-14
of the Securities Exchange Act of 1934, as amended

I, George Migausky, certify that:

1.
I have reviewed this annual report on Form 10-K of Dyax Corp.;

2.
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

3.
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

4.
The registrant's other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

(a)
Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

(b)
Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

(c)
Evaluated the effectiveness of the registrant's disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

(d)
Disclosed in this report any change in the registrant's internal control over financial reporting that occurred during the registrant's most recent fiscal quarter (the registrant's fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant's internal control over financial reporting; and

5.
The registrant's other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant's auditors and the audit committee of the registrant's board of directors (or persons performing the equivalent functions):

(a)
All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant's ability to record, process, summarize and report financial information; and

(b)
Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant's internal control over financial reporting.

Date: March 12, 2010

   

  /s/ GEORGE MIGAUSKY

George Migausky
Chief Financial Officer



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Certification Pursuant to Section 240.13a-14 or 240.15d-14 of the Securities Exchange Act of 1934, as amended
EX-32.1 12 a2196756zex-32_1.htm EXHIBIT 32.1
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Exhibit 32.1


Certification of Periodic Financial Report
Pursuant to 18 U.S.C. Section 1350

        Each of the undersigned officers of Dyax Corp. (the "Company") certifies, under the standards set forth in and solely for the purposes of 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that the Annual Report on Form 10-K of the Company for the year ended December 31, 2009 fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934 and information contained in that Form 10-K fairly presents, in all material respects, the financial condition and results of operations of the Company.

Dated: March 12, 2010

 

/s/ GUSTAV A. CHRISTENSEN


Gustav A. Christensen
Chief Executive Officer

Dated: March 12, 2010

 

/s/ GEORGE MIGAUSKY


George Migausky
Chief Financial Officer



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Certification of Periodic Financial Report Pursuant to 18 U.S.C. Section 1350
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