-----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, IAD5lUc+Tdduxug91dH1gGo5iQ5NSVfBuRzlYp3RLvvyM5igxznojTJZUzg30aIk wqlgTO7/SoA/9/+iX6e4oA== 0000912057-02-032396.txt : 20021120 0000912057-02-032396.hdr.sgml : 20021120 20020814215625 ACCESSION NUMBER: 0000912057-02-032396 CONFORMED SUBMISSION TYPE: 10-Q PUBLIC DOCUMENT COUNT: 4 CONFORMED PERIOD OF REPORT: 20020630 FILED AS OF DATE: 20020814 DATE AS OF CHANGE: 20021120 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-Q SEC ACT: 1934 Act SEC FILE NUMBER: 000-24537 FILM NUMBER: 02738833 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-Q 1 a2086278z10-q.txt 10-Q SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q /X/ Quarterly Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the period ended June 30, 2002 or / / Transition Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the transition period from to . Commission File No. 000-24537 DYAX CORP. (Exact Name of Registrant as Specified in its Charter) DELAWARE 04-3053198 (State of Incorporation) (I.R.S. Employer Identification Number) 300 TECHNOLOGY SQUARE, CAMBRIDGE, MA 02139 (Address of Principal Executive Offices) (617) 225-2500 (Registrant's Telephone Number, including Area Code) Indicate by check mark whether the registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. YES /X/ NO / / Number of shares outstanding of Dyax Corp.'s Common Stock, par value $0.01, as of August 12, 2002: 19,702,323. DYAX CORP. TABLE OF CONTENTS
PAGE PART I - FINANCIAL INFORMATION Item 1 - Financial Statements Consolidated Balance Sheets (Unaudited) June 30, 2002 and December 31, 2001..............................3 Consolidated Statements of Operations and Comprehensive Loss (Unaudited) For the three months ended June 30, 2002 and 2001 and for the six months ended June 30, 2002 and 2001.........4 Consolidated Statements of Cash Flows (Unaudited) For the six months ended June 30, 2002 and 2001..................5 Notes to Unaudited Consolidated Financial Statements....................6 Item 2 - Management's Discussion and Analysis of Financial Condition and Results of Operations..................................................11 Item 3 - Quantitative and Qualitative Disclosures About Market Risk.............17 PART II- OTHER INFORMATION Item 1 - Legal Proceedings......................................................17 Item 2 - Use of Proceeds from Registered Securities.............................17 Item 4 - Submission of Matters to a Vote of Security Shareholders...............18 Item 6 - Exhibits and Reports on Form 8-K.......................................18 Signature.......................................................................19 Exhibit Index...................................................................20
2 PART I - FINANCIAL INFORMATION Item 1 - Financial Statements DYAX CORP. CONSOLIDATED BALANCE SHEETS (UNAUDITED)
June 30, December 31, 2002 2001 ------------- ------------- ASSETS Current assets: Cash and cash equivalents....................................................... $ 39,429,000 $ 51,034,000 Accounts receivable, net........................................................ 5,901,000 7,128,000 Inventories..................................................................... 3,737,000 3,267,000 Current portion of notes receivable, employees.................................. 95,000 159,000 Other current assets............................................................ 591,000 541,000 ------------- ------------- Total current assets....................................................... 49,753,000 62,129,000 Fixed assets, net of accumulated depreciaton of $6,372,000 and $4,982,000 at June 30, 2002 and December 31, 2001, respectively............................ 19,815,000 12,915,000 Notes receivable, employees........................................................ 1,284,000 1,346,000 Goodwill and other intangible assets, net.......................................... 146,000 157,000 Restricted cash.................................................................... 4,713,000 4,365,000 Other assets....................................................................... 1,238,000 529,000 ------------- ------------- Total assets............................................................... $ 76,949,000 $ 81,441,000 ============= ============= LIABILITIES AND STOCKHOLDERS' EQUITY Current liabilities: Accounts payable and accrued expenses........................................... $ 9,864,000 $ 10,104,000 Current portion of deferred revenue............................................. 8,165,000 5,821,000 Current portion of long-term obligations........................................ 2,760,000 2,194,000 ------------- ------------- Total current liabilities.................................................. 20,789,000 18,119,000 Deferred revenue................................................................... 288,000 3,618,000 Long-term obligations.............................................................. 13,623,000 4,240,000 ------------- ------------- Total liabilities.......................................................... 34,700,000 25,977,000 Commitments and contingencies (Note 9) Stockholders' equity: Common stock, $0.01 par value; 50,000,000 shares authorized at June 30, 2002 and December 31, 2001; 19,661,236 and 19,433,928 shares issued and outstanding at June 30, 2002 and December 31, 2001, respectively................ 197,000 194,000 Additional paid-in capital...................................................... 141,761,000 141,384,000 Accumulated deficit............................................................. (98,775,000) (84,009,000) Deferred compensation........................................................... (1,489,000) (2,199,000) Accumulated other comprehensive income.......................................... 555,000 94,000 ------------- ------------- Total stockholders' equity................................................. 42,249,000 55,464,000 ------------- ------------- Total liabilities and stockholders' equity................................. $ 76,949,000 $ 81,441,000 ============= =============
THE ACCOMPANYING NOTES ARE AN INTEGRAL PART OF THE UNAUDITED CONSOLIDATED FINANCIAL STATEMENTS. 3 DYAX CORP. CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (UNAUDITED)
Three Months Ended Six Months Ended June 30, June 30, ---------------------------- ---------------------------- 2002 2001 2002 2001 ------------ ------------ ------------ ------------ Revenues: Product revenues.......................................... $ 5,845,000 $ 4,628,000 $ 10,827,000 $ 8,474,000 Product development and license fee revenues.............. 4,777,000 3,581,000 8,681,000 6,803,000 ------------ ------------ ------------ ------------ Total revenues....................................... 10,622,000 8,209,000 19,508,000 15,277,000 Costs and expenses: Cost of products sold..................................... 2,607,000 2,078,000 4,779,000 3,846,000 Research and development: Research and development............................. 8,006,000 5,083,000 15,473,000 9,045,000 Other - noncash compensation......................... 133,000 168,000 256,000 339,000 Selling, general and administrative: Selling, general and administrative.................. 7,376,000 5,072,000 13,371,000 10,322,000 Other - noncash compensation......................... 157,000 206,000 313,000 415,000 ------------ ------------ ------------ ------------ Total costs and expenses..................................... 18,279,000 12,607,000 34,192,000 23,967,000 ------------ ------------ ------------ ------------ Loss from operations......................................... (7,657,000) (4,398,000) (14,684,000) (8,690,000) Other (expense) income, net............................... (45,000) 609,000 (82,000) 1,475,000 ------------ ------------ ------------ ------------ Net loss..................................................... (7,702,000) (3,789,000) (14,766,000) (7,215,000) Other comprehensive income (loss): Foreign currency translation adjustments.................. 610,000 (72,000) 461,000 (229,000) ------------ ------------ ------------ ------------ Comprehensive loss........................................... $ (7,092,000) $ (3,861,000) $(14,305,000) $ (7,444,000) ============ ============ ============ ============ Basic and diluted net loss per share......................... $ (0.39) $ (0.20) $ (0.75) $ (0.38) ============ ============ ============ ============ Shares used in computing basic and diluted net loss per share 19,643,659 19,220,875 19,602,238 19,161,082 ============ ============ ============ ============
THE ACCOMPANYING NOTES ARE AN INTEGRAL PART OF THE UNAUDITED CONSOLIDATED FINANCIAL STATEMENTS. 4 DYAX CORP. CONSOLIDATED STATEMENTS OF CASH FLOWS (UNAUDITED)
Six Months Ended June 30, ---------------------------- 2002 2001 ------------ ------------ Cash flows from operating activities: Net loss.................................................................... $(14,766,000) $ (7,215,000) Adjustments to reconcile net loss to net cash used in operating activities: Depreciation and amortization of fixed assets........................... 1,604,000 619,000 Amortization of goodwill and other intangibles.......................... 57,000 445,000 Provision for doubtful accounts......................................... 83,000 - Inventory valuation adjustment.......................................... (279,000) 82,000 Compensation expense associated with stock options...................... 570,000 754,000 Changes in operating assets and liabilities: Accounts receivable..................................................... 1,246,000 (1,794,000) Inventories............................................................. (158,000) (437,000) Notes receivable, employees............................................. 126,000 112,000 Other assets............................................................ (750,000) (231,000) Accounts payable and accrued expenses................................... (307,000) (1,222,000) Deferred revenue........................................................ (995,000) (108,000) ------------ ------------ Net cash used in operating activities....................................... (13,569,000) (8,995,000) ------------ ------------ Cash flows from investing activities: Purchase of fixed assets................................................ (10,723,000) (2,142,000) ------------ ------------ Cash flows from financing activities: Proceeds from the issuance of common stock and the exercise of stock options 520,000 205,000 Proceeds from landlord for leasehold improvements........................... 2,352,000 - Proceeds from long-term obligations......................................... 10,754,000 291,000 Increase in restricted cash................................................. (348,000) - Repayment of long-term obligations.......................................... (871,000) (362,000) ------------ ------------ Net cash provided by financing activities................................... 12,407,000 134,000 Effect of foreign currency translation on cash balances..................... 280,000 (66,000) ------------ ------------ Net decrease in cash and cash equivalents................................... (11,605,000) (11,069,000) Cash and cash equivalents at beginning of the period........................ 51,034,000 74,205,000 ------------ ------------ Cash and cash equivalents at end of the period.............................. $ 39,429,000 $ 63,136,000 ============ ============ Supplemental disclosure of cash flow information: Interest paid........................................................... $ 443,000 $ 69,000 ============ ============ Supplemental disclosure of non-cash investing and financing activities: Acquisition of property and equipment under capital lease agreements (note: these amounts are also included in purchase of fixed assets and in proceeds from long-term obligations)............................. $ 2,506,000 $ 291,000 ============ ============
THE ACCOMPANYING NOTES ARE AN INTEGRAL PART OF THE UNAUDITED CONSOLIDATED FINANCIAL STATEMENTS. 5 DYAX CORP. NOTES TO UNAUDITED CONSOLIDATED FINANCIAL STATEMENTS 1. NATURE OF BUSINESS AND BASIS OF PRESENTATION Dyax Corp. (Dyax or the Company) is a biopharmaceutical company principally focused on the discovery, development and commercialization of therapeutic products. The Company has two product candidates in clinical trials, DX-890 and DX-88, and has collaborative agreements for the development of both of these product candidates. The Company's collaborator for DX-890 recently completed a Phase IIa trial for cystic fibrosis. The Company is currently conducting a Phase II trial of DX-88 in hereditary angioedema (HAE) in Europe and expects to initiate a second Phase II study of DX-88 in HAE and a Phase I/II study of DX-88 in cardiopulmonary bypass in 2002. The Company uses a proprietary, patented method, known as phage display, to identify a broad range of compounds with the potential for the treatment of various diseases. The Company is using phage display technology to build a broad portfolio of product candidates that it plans to develop and commercialize on its own or with others. On behalf of collaborators, the Company also uses phage display technology to identify compounds that can be used in therapeutics, diagnostic imaging, the development of research reagents, and in purifying and manufacturing biopharmaceuticals. The Company is further leveraging its phage display technology through collaborations and licenses that are structured to generate revenues through research funding, license fees, technical and clinical milestone payments, and royalties. The Company, through its Biotage subsidiary, develops, manufactures and sells chromatography separations systems and products and is a leading supplier of chromatography separations systems that use disposable cartridges to separate and purify pharmaceuticals being produced for research and clinical development. The accompanying unaudited interim consolidated financial statements have been prepared by the Company in accordance with accounting principles generally accepted in the United States of America (GAAP) for interim financial information and with the instructions to Form 10-Q. The consolidated financial statements include the accounts of the Company and its subsidiaries. All material intercompany balances and transactions have been eliminated. Certain amounts from prior years have been reclassified in the accompanying unaudited consolidated financial statements in order to be consistent with current year classifications. The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect (i) the reported amounts of assets and liabilities, (ii) disclosure of contingent assets and liabilities at the dates of the financial statements and (iii) the reported amounts of revenues and expenses during the reporting periods. Actual results could differ from those estimates. The results of operations for the three and six-month periods ended June 30, 2002 are not necessarily indicative of the results that may be expected for the year ending December 31, 2002. It is management's opinion that the accompanying unaudited interim consolidated financial statements reflect all adjustments (which are normal and recurring) necessary for a fair presentation of the results for the interim periods. The financial statements should be read in conjunction with the consolidated financial statements included in the Company's Annual Report on Form 10-K for the year ended December 31, 2001. 2. INVENTORY Inventories consist of the following:
June 30, December 31, 2002 2001 ------------ ------------ Raw materials....... $ 2,551,000 $ 2,396,000 Work in process..... 640,000 237,000 Finished products... 546,000 634,000 ------------ ------------ $ 3,737,000 $ 3,267,000 ============ ============
6 3. ACCOUNTS PAYABLE AND ACCRUED EXPENSES Accounts payable and accrued expenses consist of the following:
June 30, December 31, 2002 2001 ------------ ------------ Accounts payable........................ $ 4,423,000 $ 5,833,000 Accrued compensation and related taxes.. 2,325,000 2,357,000 Accrued external R&D contracts.......... 1,028,000 550,000 Accrued legal fees...................... 670,000 565,000 Accrued building improvement costs...... 494,000 121,000 Accrued warranty costs.................. 296,000 296,000 Other accrued liabilities............... 628,000 382,000 ------------ ------------ $ 9,864,000 $ 10,104,000 ============ ============
4. NET LOSS PER SHARE Net loss per share is computed under Statement of Financial Accounting Standards (SFAS) No. 128, Earnings Per Share. 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 are antidilutive for all periods presented and therefore are excluded from the calculation of diluted net loss per share. Stock options totaling 3,544,850 and 3,040,873 were outstanding at June 30, 2002 and 2001, respectively. 5. COMPREHENSIVE LOSS Accumulated other comprehensive income (loss) is calculated as follows:
Three Months Ended Six Months Ended June 30, June 30, ---------------------------- --------------------------- 2002 2001 2002 2001 ------------ ------------ ------------ ------------ Accumulated other comprehensive income (loss): Foreign currency translation adjustment: Balance at beginning of period.......... $ (55,000) $ (184,000) $ 94,000 $ (27,000) Change during period.................... 610,000 (72,000) 461,000 (229,000) ------------ ------------ ------------ ------------ Balance at end of period................ $ 555,000 $ (256,000) $ 555,000 $ (256,000) ============ ============ ============ ============
6. BUSINESS SEGMENTS The Company discloses business segments under SFAS No. 131, Disclosures about Segments of an Enterprise and Related Information. Segment data does not include allocations of corporate administrative costs to each operating segment. The Company evaluates the performance of its segments and allocates resources to them based on losses before corporate administrative costs, interest and taxes. The Company has two reportable segments: (i) Separations and (ii) Biopharmaceuticals (In previous filings, the Biopharmaceuticals segment was named Therapeutics/Diagnostics). The Separations segment develops, manufactures and sells chromatography separations systems and products through the Company's Biotage subsidiary. The Biopharmaceuticals segment is principally focused on the discovery, development and commercialization of therapeutic products. It also licenses its proprietary technology to third parties and licenses affinity ligands developed using the Company's phage display technology to third parties for separations applications. The Company's reportable segments are strategic business units that offer different products and services. They are managed separately because each business requires different technologies and marketing strategies. 7 The following table presents certain segment financial information and the reconciliation of segment loss from operations to consolidated totals.
Separations Biopharmaceuticals Total --------------- ------------------ --------------- THREE MONTHS ENDED JUNE 30, 2002 Revenue from external customers and collaborators........................... $ 5,845,000 $ 4,777,000 $ 10,622,000 Segment loss from operations............ $ (125,000) $ (2,866,000) $ (2,991,000) Segment assets.......................... $ 18,556,000 $ 7,479,000 $ 26,035,000 THREE MONTHS ENDED JUNE 30, 2001 Revenue from external customers and collaborators........................... $ 4,628,000 $ 3,581,000 $ 8,209,000 Segment loss from operations............ $ (585,000) $ (1,985,000) $ (2,570,000) Segment assets.......................... $ 10,034,000 $ 4,533,000 $ 14,567,000 SIX MONTHS ENDED JUNE 30, 2002 Revenue from external customers and collaborators........................... $ 10,827,000 $ 8,681,000 $ 19,508,000 Segment loss from operations............ $ (483,000) $ (6,071,000) $ (6,554,000) Segment assets.......................... $ 18,556,000 $ 7,479,000 $ 26,035,000 SIX MONTHS ENDED JUNE 30, 2001 Revenue from external customers and collaborators........................... $ 8,474,000 $ 6,803,000 $ 15,277,000 Segment loss from operations............ $ (1,347,000) $ (3,125,000) $ (4,472,000) Segment assets.......................... $ 10,034,000 $ 4,533,000 $ 14,567,000
Three Months Ended Six Months Ended June 30, June 30, ---------------------------- ---------------------------- 2002 2001 2002 2001 ------------ ------------ ------------ ------------ RECONCILIATIONS: Loss from operations: Loss from operations from reportable segments............................. $ (2,991,000) $ (2,570,000) $ (6,554,000) $ (4,472,000) Unallocated amounts: Corporate expenses................ (4,666,000) (1,828,000) (8,130,000) (4,218,000) Other (expense) income, net....... (45,000) 609,000 (82,000) 1,475,000 ------------ ------------ ------------ ------------ Consolidated net loss.................. $ (7,702,000) $ (3,789,000) $(14,766,000) $ (7,215,000) ============ ============ ============ ============
7. GOODWILL AND OTHER INTANGIBLE ASSETS In June 2001, The Financial Accounting Standards Board (FASB) issued SFAS No. 142, Goodwill and Other Intangible Assets. SFAS 142 requires that ratable amortization of goodwill be replaced with periodic tests of the goodwill's impairment and that intangible assets other than goodwill be amortized over their useful lives. The provisions of SFAS 142 are effective for fiscal years beginning after December 15, 2001. Pursuant to SFAS 142, the Company ceased amortizing goodwill on January 1, 2002 and completed a test for goodwill impairment as of June 30, 2002. No impairment charge was required. The Company's goodwill amortization expense was approximately $217,000 for the quarter ended June 30, 2001 and $434,000 for the six months ended June 30, 2001. Adjusted net loss excluding goodwill amortization expense for the quarter ended June 30, 2001 was $3.6 million and was $6.8 million for the six months ended June 30, 2001. Adjusted basic and diluted net loss per share for the quarter ended June 30, 2001 was $0.19 and for the six months ended June 30, 2001 was $0.35. Intangible assets other than goodwill continue to be amortized over their remaining estimated useful lives. Patents are amortized on a straight-line basis over a period of 15 years. The covenant not to compete is amortized on a straight-line basis over five years. Amortization expense is not expected to be material to the Company's financial position or operating results in future periods. 8 Goodwill and other intangible assets consist of the following:
June 30, December 31, 2002 2001 --------------------------- --------------------------- Gross Gross Carrying Accumulated Carrying Accumulated Amount Amortization Amount Amortization ------------ ------------ ------------ ------------ Goodwill................. $ 2,452,000 $ 2,341,000 $ 2,452,000 $ 2,341,000 Patent................... 100,000 80,000 100,000 76,000 Covenant not to compete.. 75,000 60,000 75,000 53,000 ------------ ------------ ------------ ------------ $ 2,627,000 $ 2,481,000 $ 2,627,000 $ 2,470,000 ============ ============ ============ ============
Capitalized software development costs were $275,000 and $141,000 at June 30, 2002 and December 31, 2001, respectively. These costs are amortized over the estimated useful lives of the related software products, currently five years. Accumulated amortization of these assets totaled $57,000 and $10,000 as of June 30, 2002 and December 31, 2001, respectively. The unamortized portion of these costs is included in other assets on the Company's consolidated balance sheets. 8. RECENTLY ISSUED ACCOUNTING STANDARDS In August 2001, the FASB issued SFAS No. 143, Accounting for Obligations Associated with the Retirement of Long-Lived Assets. The provisions of SFAS 143 apply to all entities that incur obligations associated with the retirement of tangible long-lived assets. SFAS 143 is effective for fiscal years beginning after June 15, 2002 and will be adopted by the Company in fiscal year 2003. The Company does not expect the adoption of SFAS 143 to have a material impact on its financial position or operating results. In August 2001, the FASB issued SFAS No. 144, Accounting for the Impairment or Disposal of Long-Lived Assets. SFAS 144 supersedes SFAS No. 121, Accounting for the Impairment of Long-Lived Assets and for Long-Lived Assets to Be Disposed Of and provides a single accounting model for long-lived assets to be disposed of. SFAS 144 is effective for fiscal years beginning after December 15, 2001. The Company adopted SFAS 144 on January 1, 2002. The adoption of this statement did not have any effect on the Company's financial position or operating results. 9. COMMITMENTS AND CONTINGENCIES On May 31, 2002, the Company and Genzyme Corporation amended their collaboration agreement for the development and commercialization of DX-88 (the Amended Collaboration Agreement). The Company and Genzyme also executed a senior secured promissory note and security agreement under which Genzyme agreed to loan the Company up to $7.0 million and the Company pledged certain tangible and intangible personal property of or arising out of the DX-88 program. The security agreement provides for additional collateral should the Company, under the Amended Collaboration Agreement, exercise its option to purchase Genzyme's interest in the application of DX-88 in cardiopulmonary bypass and other surgery, or should the Company fail to meet certain financial covenants. The financial covenants state that the Company must maintain at least $20.0 million in cash or cash equivalents based on the Company's quarterly consolidated financial statements and that the Company maintains at least one continued listing standard for the Nasdaq National Market. Advances under the promissory note may be made once each calendar quarter, beginning on May 31, 2002 and ending upon completion of the first Phase II clinical trial for the treatment of HAE, and may not exceed $4.0 million during the second quarter of 2002 and $1.5 million during any subsequent calendar quarter. The loan bears interest at a rate of prime plus two percent, 6.75% at June 30, 2002. Interest is payable quarterly. The principal and all unpaid interest are due on May 31, 2005 (the Maturity Date). The Company may extend the Maturity Date to May 31, 2007 if the Amended Collaboration Agreement is in effect, no default or event of default exists and the Company satisfies the financial covenants as of the Maturity Date. As of June 30, 2002, the Company had received $4.0 million under this note, which is included in long-term obligations on the Company's balance sheet. The Company anticipates receiving the remaining $3.0 million prior to the end of 2002. In connection with the construction of Biotage's new facility in Charlottesville, Virginia, Biotage executed a loan agreement for approximately $4.3 million from a commercial bank on April 24, 2002. Under the terms of the loan agreement, interest is payable monthly on the amount outstanding until completion of construction, limited to a maximum of 16 months. On the earlier of completion of 9 construction or 16 months, the loan will convert to a term loan and will be repaid over 20 years with interest at between 5.83% and 7.00%. Interest will be fixed at 5.83% for the first five years and will be adjusted once every five years thereafter, but may be adjusted earlier if Biotage fails to maintain an average non-interest bearing compensating balance of $750,000 at the lending bank. The Company expects construction to be completed by the fourth quarter of 2002. As of June 30, 2002, there was $1.6 million outstanding under the loan, which is included in long-term obligations on the Company's balance sheet. During 2001, the Company signed a capital lease and debt agreement for the purchase of qualified fixed assets. In the first half of 2002, the Company sold to and leased back from the lender $2.0 million of laboratory, production and office equipment. Interest pursuant to this agreement ranges between 10.01% and 10.14%. Principal and interest are payable over 36 months or 42 months based on the underlying fixed assets. Capital lease obligations are collateralized by the assets under lease. Other debt obligations are collateralized by a stand-by letter of credit for the amount financed. If at the end of any quarter the Company's unrestricted cash is less than the greater of $25.0 million or the Company's annualized cash needs, the Company must provide an irrevocable letter of credit in the amount equal to the amount of debt financed, which was $2.9 million at June 30, 2002. Annualized cash needs are determined by multiplying cash used in operations for the most recently ended quarter by four. The lender has no obligation to fund any further amounts. In June 2001, the Company entered into an agreement to lease approximately 67,000 square feet of laboratory and office space in Cambridge, Massachusetts. The lease term commenced in the first quarter of 2002 and has an initial term of ten years, expiring at the end of February 2012. Under the terms of the agreement, the Company is obligated to lease an additional 24,122 square feet of space by August 2007 and has the option to extend the entire lease for two additional five-year terms. The Company was required to provide a cash-collateralized letter of credit in the amount of $4.3 million, which may be reduced after the fifth year of the lease term. The cash collateral is included in restricted cash on the Company's balance sheet. Under the terms of the agreement, the landlord loaned the Company approximately $2.4 million to be used towards the cost of leasehold improvements, which is included in long-term obligations on the Company's balance sheet. The loan bears interest at a rate of 12.00% and is payable in 116 equal monthly installments through February 2012. 10. COLLABORATIVE AGREEMENTS On May 31, 2002, the Company and Genzyme Corporation amended their collaboration agreement for the development and commercialization of DX-88 (the Amended Collaboration Agreement). Under the Amended Collaboration Agreement, the Company is responsible for funding the development of DX-88 for the treatment of HAE until the later of incurring $8.0 million of development costs or completion of the first Phase II clinical trial for HAE (the Initial Program). Genzyme has an option to acquire a 50 percent interest in the DX-88 program upon the Company's completion of the first Phase II clinical trial in HAE, and will have a period of 60 days after review of the data to exercise its option. If Genzyme exercises its option, it will be responsible for 50% of the development costs incurred subsequent to completion of the Initial Program, and upon dosing the first patient in a pivotal clinical trial of DX-88 for HAE, Genzyme will be obligated to pay the Company one-half of the development costs in excess of $6.0 million that were incurred by the Company through completion of the Initial Program. As of June 30, 2002, the Company had incurred approximately $8.3 million of costs under this program. Under the Amended Collaboration Agreement, the Company has an option until March 31, 2003 to purchase Genzyme's interest in the application of DX-88 for the prevention of blood loss and other systemic inflammatory responses in cardiopulmonary bypass and other surgery. 11. LITIGATION The Company reported in its Annual Report on Form 10-K for the year ended December 31, 2001 that the Company's first phage display patent in Europe, Patent 10 436,597 (the 597 Patent) was opposed by two parties in late 1997. The oppositions primarily related to whether the written description of the inventions in the Company's European patent was sufficient under European patent law. A hearing on these oppositions was held on April 6, 2000 and the patent was revoked. The Company appealed this decision to the Technical Board of Appeals of the European Patent Office (the Technical Board). In July 2002, the Company announced that at a hearing on July 2, 2002, the Technical Board affirmed the April 6, 2000 revocation of the Company's 597 Patent ruling that the patent was not valid on the grounds that it failed to provide verification of the claimed display of a proteinaceous binding domain. The decision of the Technical Board is final and cannot be appealed. The Company has two divisional patent applications of the 597 Patent pending in the European Patent Office. The Company will not be able to prevent other parties from using its phage display technology in Europe if the European Patent Office does not grant it another patent. The Company cannot assure that it will prevail in the prosecution of these patent applications. The Company believes that the outcome of these proceedings will not have a material adverse effect on its financial position and operating results. Item 2 - MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS The discussion in this item and elsewhere in this report contains forward-looking statements involving risks and uncertainties that could cause actual results to differ materially from those expressed in the forward-looking statements. These risks and uncertainties include those described under "Important Factors That May Affect Future Operations and Results" below. OVERVIEW We are a biopharmaceutical company principally focused on the discovery, development and commercialization of therapeutic products. We have two product candidates in clinical trials, DX-890 and DX-88, and have collaborative agreements for the development of both of these product candidates. Our collaborator for DX-890 recently completed a Phase IIa trial for cystic fibrosis. We are currently conducting a Phase II trial of DX-88 in hereditary angioedema (HAE) in Europe and expect to initiate a second Phase II study of DX-88 in HAE and a Phase I/II study of DX-88 in cardiopulmonary bypass in 2002. We use a proprietary, patented method, known as phage display, to identify a broad range of compounds with the potential for the treatment of various diseases. We are using phage display technology to build a broad portfolio of product candidates that we plan to develop and commercialize on our own or with others. On behalf of collaborators, we also use phage display technology to identify compounds that can be used in therapeutics, diagnostic imaging, the development of research reagents, and in purifying and manufacturing biopharmaceuticals. We are further leveraging our phage display technology through collaborations and licenses that are structured to generate revenues through research funding, license fees, technical and clinical milestone payments, and royalties. We, through our Biotage subsidiary, develop, manufacture and sell chromatography separations systems and products and are a leading supplier of chromatography separations systems that use disposable cartridges to separate and purify pharmaceuticals being produced for research and clinical development. RESULTS OF OPERATIONS THREE MONTHS ENDED JUNE 30, 2002 AND 2001 Total revenues for the three month period ended June 30, 2002 (the 2002 Quarter) were $10.6 million, compared with $8.2 million for the three month period ended June 30, 2001 (the 2001 Quarter), an increase of $2.4 million or 29%. Product revenues and product development and license fee revenues accounted for 55% and 45%, 11 respectively, of our total revenues in the 2002 Quarter, as compared with 56% and 44% in the 2001 Quarter. Product revenues increased to $5.8 million in the 2002 Quarter from $4.6 million in the 2001 Quarter, an increase of $1.2 million or 26%. The increase in product revenues was primarily due to increased unit sales in Biotage's drug discovery purification consumables business, significant sales of the Horizon product that was launched last year and increased shipments of large production scale equipment. Product development and license fee revenues increased to $4.8 million for the 2002 Quarter from $3.6 million for the 2001 Quarter, an increase of $1.2 million or 33%. This increase was primarily due to higher revenue from Debiopharm S.A. under our DX-890 collaboration representing reimbursement of our costs of drug manufacture, and higher revenue under a funded research agreement. These increases were partly offset by the absence in 2002 of government-funded programs, which were completed in 2001. Cost of products sold for the 2002 Quarter was $2.6 million compared to $2.1 million for the 2001 Quarter, an increase of $529,000 or 25%, which was consistent with the increase in product revenues. The gross margin on product revenues for the 2002 Quarter was 55.4% compared to 55.1% for the 2001 Quarter. Research and development expenses for the 2002 Quarter were $8.1 million, compared with $5.3 million for the 2001 Quarter, an increase of $2.9 million or 55%. The increase resulted primarily from higher external manufacture and development costs associated with our DX-890 and DX-88 product candidates, higher facility and depreciation costs related to our new premises in Cambridge and increased headcount. Research and development expense for the 2002 Quarter was approximately $740,000 less than the amount that was reported in our press release on July 30, 2002, due to a corrective reclassification that also resulted in a corresponding increase in Selling, General and Administrative expense in the 2002 Quarter. The reclassification did not change our previously announced net loss for the six months ended June 30, 2002. Selling, general and administrative expenses increased to $7.5 million for the 2002 Quarter compared to $5.3 million for the 2001 Quarter, an increase of $2.3 million or 43%. The increase was primarily due to higher costs in the following areas: professional fees related to expanding and protecting our intellectual property, sales and marketing expenses as we expand our chromatography product sales capabilities and facility costs related to our new premises in Cambridge. Other expense/income was a net expense of $45,000 for the 2002 Quarter compared to income of $609,000 for the 2001 Quarter. Interest income decreased due to lower cash and cash equivalent balances and lower interest rates. Interest expense increased due to additional long-term debt obligations. Our net loss for the 2002 Quarter was $7.7 million compared to $3.8 million for the 2001 Quarter. SIX MONTHS ENDED JUNE 30, 2002 AND 2001 Total revenues for the six month period ended June 30, 2002 (the 2002 Period) were $19.5 million, compared with $15.3 million for the six month period ended June 30, 2001 (the 2001 Period), an increase of $4.2 million or 28%. Product revenues and product development and license fee revenues accounted for 56% and 44%, respectively, of our total revenues in the 2002 Period, as compared with 55% and 45% in the 2001 Period. Product revenues increased to $10.8 million in the 2002 Period from $8.5 million in the 2001 Period, an increase of $2.4 million or 28%. The increase in product revenues was primarily due to increased unit sales in Biotage's drug discovery purification consumables business, significant sales of the Horizon product that was launched last year and increased shipments of large production scale equipment. Product development and license fee revenues increased to $8.7 million for the 2002 Period from $6.8 million for the 2001 Period, an increase of $1.9 million or 28%. This increase was primarily due to higher revenue from Debiopharm S.A. under our DX-890 collaboration representing reimbursements of our costs of drug manufacture, and higher revenue under a funded research collaboration. These 12 increases were partly offset by an absence of government-funded programs, which were completed in 2001. Deferred revenue as of June 30, 2002 decreased by $986,000 from December 31, 2001. This decrease was primarily due to revenue recognized on research collaborations and patent and other license fee agreements partly offset by cash received under a funded research agreement. Deferred revenue is recognized as revenue over future periods and in accordance with Staff Accounting Bulletin No. 101, "Revenue Recognition in Financial Statements." Cost of products sold for the 2002 Period was $4.8 million compared to $3.8 million for the 2001 Period, an increase of $933,000 or 24%. The gross margin on product revenues for the 2002 Period was 55.9% compared to 54.6% for the 2001 Period. This was mainly due to a favorable product mix in the 2002 Period compared with the 2001 Period, operating efficiencies and spreading relatively fixed manufacturing overhead costs over an increased revenue base. Research and development expenses for the 2002 Period were $15.7 million, compared with $9.4 million for the 2001 Period, an increase of $6.3 million or 68%. The increase resulted primarily from higher external manufacture and development costs associated with our DX-890 and DX-88 product candidates, higher facility and depreciation costs related to our new premises in Cambridge and higher headcount. Selling, general and administrative expenses increased to $13.7 million for the 2002 Period compared to $10.7 million for the 2001 Period, an increase of $2.9 million or 27%. The increase was primarily due to higher costs in the following areas: professional fees related to expanding and protecting our intellectual property, sales and marketing expenses as we expand our chromatography product sales capabilities and facility costs related to our new premises in Cambridge. Other expense/income was a net expense of $82,000 for the 2002 Period compared to income of $1.5 million for the 2001 Period. Interest income decreased due to lower cash and cash equivalent balances and lower interest rates. Interest expense increased due to additional long-term debt obligations. Our net loss for the 2002 Period was $14.8 million compared to $7.2 million for the 2001 Period. LIQUIDITY AND CAPITAL RESOURCES Through June 30, 2002, we have funded our operations principally through the sale of equity securities, which have provided aggregate net cash proceeds since inception of approximately $132.2 million, including net proceeds of $62.4 million from our August 2000 initial public offering. We have also generated funds from product sales, product development, license fee revenues, interest income, long-term obligations and other sources. As of June 30, 2002, we had cash and cash equivalents of approximately $39.4 million, a decrease of approximately $11.6 million from December 31, 2001. We invest excess cash in U.S. Treasury obligations. Our operating activities used cash of $13.6 million and $9.0 million for the 2002 and 2001 Periods, respectively. The use of cash in both periods resulted primarily from losses from operations and changes in our working capital accounts, net of depreciation, amortization, provision for doubtful accounts, inventory valuation adjustments and noncash compensation expense. Our investing activities used cash of $10.7 million and $2.1 million for the 2002 and 2001 Periods, respectively. Our investing activities consisted of purchases of fixed assets funded primarily through long-term obligations. Our financing activities provided cash of $12.4 million and $134,000 for the 2002 and 2001 Periods, respectively. Our financing activities for the 2002 Period consisted primarily of borrowings under long-term obligations, proceeds from landlord's financing of leasehold improvements, the exercise of stock options and the sale of common stock under our employee stock purchase plan. These proceeds were partly offset by repayments of long-term obligations. Our financing activities 13 for the 2001 Period consisted primarily of proceeds from additional debt and the exercise of stock options partly offset by repayments of long-term obligations. In the second quarter of 2002, we completed a build-out of our new Cambridge, Massachusetts premises. The cost of the build-out was $10.1 million. We funded this project with $4.8 million in proceeds from our landlord ($2.4 million in loans, $2.4 million in cost reimbursement), $2.8 million in loans from a commercial lender and $2.5 million of internal funds. As of June 30, 2002, accrued building improvement costs totaled approximately $500,000 and were included in accounts payable and accrued expenses on the balance sheet. We have financed fixed asset purchases through capital leases and debt. Capital lease obligations are collateralized by the assets under lease. Certain debt obligations are collateralized by a stand-by letter of credit for the amount financed. If at the end of any quarter our unrestricted cash is less than the greater of $25.0 million or annualized cash needs, we must provide to our principal lender an irrevocable letter of credit in an amount equal to the amount financed by that lender, which was $2.9 million at June 30, 2002. Annualized cash needs are determined by multiplying cash used in operations for the most recently ended quarter by four. We believe that we will be able to obtain funding for our future fixed asset purchases through existing or alternative lenders. If we cannot obtain additional funding we will have to use our existing cash and cash equivalents to fund future fixed asset purchases. On May 31, 2002, we and Genzyme Corporation amended our collaboration agreement for the development and commercialization of DX-88 (the Amended Collaboration Agreement). Under the Amended Collaboration Agreement, we are responsible for funding the development of DX-88 for the treatment of HAE until the later of incurring $8.0 million of development costs or completion of the first Phase II clinical trial for HAE (the Initial Program). Genzyme has an option to acquire a 50 percent interest in the DX-88 program upon our completion of the first Phase II clinical trial in HAE, and will have a period of 60 days after review of the data to exercise its option. If Genzyme exercises its option, it will be responsible for 50% of the development costs incurred subsequent to completion of the Initial Program, and upon dosing the first patient in a pivotal clinical trial of DX-88 for HAE, Genzyme will be obligated to pay us one-half of the development costs in excess of $6.0 million that were incurred by us through completion of the Initial Program. As of June 30, 2002, we had incurred approximately $8.3 million of costs under this program. Under the Amended Collaboration Agreement, we have an option until March 31, 2003 to purchase Genzyme's interest in the application of DX-88 for the prevention of blood loss and other systemic inflammatory responses in cardiopulmonary bypass and other surgery. We also executed a senior secured promissory note and security agreement under which Genzyme agreed to loan us up to $7.0 million and we pledged certain tangible and intangible personal property of or arising out of the DX-88 program. The security agreement provides for additional collateral should we, under the Amended Collaboration Agreement, exercise our option to purchase Genzyme's interest in the application of DX-88 in cardiopulmonary bypass and other surgery, or should we fail to meet certain financial covenants. The financial covenants state that we must maintain at least $20.0 million in cash or cash equivalents based on our quarterly consolidated financial statements and that we maintain at least one continued listing standard for the Nasdaq National Market. Advances under the promissory note may be made once each calendar quarter, beginning on May 31, 2002 and ending upon completion of the first Phase II clinical trial for the treatment of HAE, and may not exceed $4.0 million during the second quarter of 2002 and $1.5 million during any subsequent calendar quarter. The loan bears interest at a rate of prime plus two percent, 6.75% at June 30, 2002. Interest is payable quarterly. The principal and all unpaid interest are due on May 31, 2005 (the Maturity Date). We may extend the Maturity Date to May 31, 2007 if the Amended Collaboration Agreement is in effect, no default or event of default exists and we satisfy the financial covenants as of the Maturity Date. As of June 30, 2002, we had received $4.0 million under this note, which is included in long-term obligations on our balance sheet. We anticipate receiving the remaining $3.0 million prior to the end of 2002. 14 OUTLOOK For the year ending December 31, 2002, we anticipate that total revenues should be approximately $38 million to $40 million. We expect cost of products sold as a percentage of product revenues to be consistent with those in the first half of 2002. As of June 30, 2002, we had two product candidates in clinical trials, DX-890 and DX-88. Our collaborator for DX-890 recently completed a Phase IIa trial for the treatment of cystic fibrosis. We are currently conducting a Phase II trial of DX-88 in hereditary angioedema in Europe and expect to initiate a second Phase II study of DX-88 in HAE and a Phase I/II study of DX-88 in cardiopulmonary bypass in 2002. Research and development expenses are expected to be approximately $34 million to $39 million for the year ending December 31, 2002, an increase of approximately 75% to 100% from the year ended December 31, 2001, due to continued progress of our clinical trials, expanded development of our preclinical pipeline, facility costs associated with our Cambridge premises and higher headcount. Selling, general and administrative expenses are expected to be approximately $26 million to $28 million for the year ending December 31, 2002, an increase of approximately 10% to 15% from the year ended December 31, 2001. We estimate that our Biotage subsidiary will invest approximately $2.6 million in the remaining six months of 2002 to complete construction of its 51,000 square foot facility in Charlottesville, Virginia. This investment is being funded through a loan with a commercial bank. We expect to spend approximately $2.5 million on other fixed asset purchases during the remaining six months of 2002. We expect net cash outflows to be approximately $12 million during the remaining six months of 2002. We believe that existing cash and cash equivalents plus anticipated cash flow from product revenues and collaborations will be sufficient to support our current operating plans through 2003. We anticipate that we will need to raise additional cash to fund our operations and we may raise such capital through the sale of equity or through debt financing. The sale of equity or issuance of debt may result in dilution to our stockholders, and we cannot be certain that additional financing will be available in amounts or on terms acceptable to us, if at all. In light of the current condition of the capital markets, we will also have to consider other alternatives, including reducing the scope of our planned research, development and commercialization activities, which could negatively impact our business. CRITICAL ACCOUNTING POLICIES In our Form 10-K for the year ended December 31, 2001, our most critical accounting policies and estimates upon which our financial status depends upon were identified as those relating to inventories, allowance for doubtful accounts, valuation of long-lived and intangible assets, revenue recognition and litigation claims. We reviewed our policies and determined that those policies remain our most critical accounting policies for the quarter and six months ended June 30, 2002. We did not make any changes in those policies during the six months ended June 30, 2002. IMPORTANT FACTORS THAT MAY AFFECT FUTURE OPERATIONS AND RESULTS This Quarterly Report on Form 10-Q contains forward-looking statements. These forward-looking statements appear principally in the section entitled "Management's Discussion and Analysis of Financial Conditions and Results of Operations." Forward-looking statements may appear in other sections of this report as well. Generally, the forward-looking statements in this report use words like "expect," "believe," "continue," "anticipate," "estimate," "may," "will," "could," "should," "opportunity," "future," "project," and similar expressions. The forward-looking statements include statements about our: - clinical trials; 15 - results of operations; - research and development programs; and - collaborations. 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. The forward-looking statements contained in this report are not guarantees of future performance and involve certain risks, uncertainties and assumptions that are difficult to predict. Therefore, actual outcomes and results may differ materially from what is expressed in such forward-looking statements. We caution investors not to place undue reliance on the forward-looking statements contained in this report. These statements speak only as of the date of this report, and we do not undertake any obligation to update or revise them, except as required by law. The following factors, among others, create risks and uncertainties that could affect our future or other performance: - our history of operating losses and our expectation that we will incur significant additional operating losses; - any inability to raise the capital that we will need to sustain our operations; - any inability to successfully and expeditiously complete the rigorous clinical trials and regulatory approvals that any biopharmaceutical that we develop must undergo, which could substantially delay or prevent their development or marketing; - our dependence on third parties to manufacture biopharmaceuticals, which may adversely affect our ability to commercialize any biopharmaceuticals we may develop; - our lack of experience in conducting clinical trials, regulatory processes, and conducting sales and marketing activities, any or all of which may adversely impact our ability to commercialize any biopharmaceuticals we may develop; - our dependence on the expertise, effort, priorities and contractual obligations of our collaborators, any changes in our collaborators' business direction or priorities or defaults in their obligations may have an adverse impact on our research revenues and ultimately our license revenues and expenses; - any failure by us or our collaborators to gain market acceptance of our biopharmaceuticals; - competition and technological change that may make our potential products and technologies less attractive or obsolete; - any inability to obtain and maintain intellectual property protection for our products and technologies; - time consuming and expensive proceedings to obtain, enforce or defend patents and to defend against charges of infringement that may result in unfavorable outcomes and could limit our patent rights and our activities; - significant fluctuations in our revenues and operating results, which have occurred in the past and which we expect to continue to fluctuate in the future; - any loss or inability to hire and retain qualified personnel; - difficulties in managing our growth; - our dependence on one supplier for a key component in our separations products; - risks associated with international sales and operations and collaborations; - failure to acquire technology and integrate complementary businesses; - our common stock may continue to have a volatile public trading price and low trading volume; and - anti-takeover provisions in our governing documents and under Delaware law and our shareholder rights plan that may make an acquisition of us more difficult. As a result of the foregoing and other factors, we may experience material fluctuations in our future operating results, which could materially affect our 16 business, financial position, and stock price. These risks and uncertainties are discussed in more detail in Exhibit 99.1 entitled, "Important Factors Affecting Future Operations and Results" filed with our Annual Report on Form 10-K for the year ended December 31, 2001. Item 3 - QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK Our exposure to market risk is confined to our cash and cash equivalents. We place our investments in high-quality financial instruments, primarily U.S. Treasury funds, which we believe are subject to limited credit risk. We currently do not hedge interest rate exposure. As of June 30, 2002, we had cash and cash equivalents of $39.4 million consisting of cash and highly liquid, short-term investments. Our short-term investments will decline by an immaterial amount if market interest rates increase, and therefore, our exposure to interest rate changes is immaterial. Declines of interest rates over time will, however, reduce our interest income from our short-term investments. Our outstanding capital lease obligations are all at fixed interest rates and therefore have minimal exposure to changes in interest rates. Most of our transactions are conducted in U.S. dollars. We have collaboration and technology license agreements, and product sales with parties located outside the United States. Transactions under certain of these and other agreements are conducted in local foreign currency. If exchange rates undergo a change of up to 10%, we do not believe that it would have a material impact on our results of operations or cash flows. PART II - OTHER INFORMATION Item 1 - Legal Proceedings The Company reported in its Annual Report on Form 10-K for the year ended December 31, 2001 that the Company's first phage display patent in Europe, Patent 436,597 (the 597 Patent) was opposed by two parties in late 1997. The oppositions primarily related to whether the written description of the inventions in the Company's European patent was sufficient under European patent law. A hearing on these oppositions was held on April 6, 2000 and the patent was revoked. The Company appealed this decision to the Technical Board of Appeals of the European Patent Office (the Technical Board). In July 2002, the Company announced that at a hearing on July 2, 2002, the Technical Board affirmed the April 6, 2000 revocation of the Company's 597 Patent ruling that the patent was not valid on the grounds that it failed to provide verification of the claimed display of a proteinaceous binding domain. The decision of the Technical Board is final and cannot be appealed. The Company has two divisional patent applications of the 597 Patent pending in the European Patent Office. The Company will not be able to prevent other parties from using its phage display technology in Europe if the European Patent Office does not grant it another patent. The Company cannot assure that it will prevail in the prosecution of these patent applications. The Company believes that the outcome of these proceedings will not have a material adverse effect on its financial position and operating results. Item 2 - Use of Proceeds from Registered Securities On August 18, 2000, we sold 4,600,000 shares of common stock (including 600,000 shares pursuant to the exercise by the underwriters of their overallotment option) at a price of $15.00 per share in our initial public offering and received proceeds of approximately $62.4 million, net of underwriter commissions. From August 18, 2000 through June 30, 2002, we used approximately $30.0 million to fund operating activities and $22.0 million for the purchase of fixed assets. The remaining proceeds were held in cash and cash equivalents at June 30, 2002. 17 Item 4 - Submission of Matters to a Vote of Security Shareholders We held our Annual Meeting of Stockholders on May 16, 2002. The following represents the results of the voting on proposals submitted to the stockholders at the Annual Meeting: (a) Proposal to elect James W. Fordyce, Thomas L. Kempner and Alix Marduel to the Board of Directors, each to serve a three-year term.
NOMINEE VOTES FOR VOTES WITHHELD ------- --------- -------------- James W. Fordyce 15,833,251 569,250 Thomas L. Kempner 15,828,471 574,030 Alix Marduel 15,450,197 952,304
There were no broker non-votes or abstentions with respect to this matter. Each nominee received a plurality of the votes cast, and therefore has been duly elected a director of Dyax. The terms in office of directors Constantine E. Anagnostopoulos, Henry R. Lewis, David J. McLachlan, Henry E. Blair, Gregory D. Phelps and John W. Littlechild continued after the meeting. (b) Proposal to amend Dyax's Amended and Restated 1995 Equity Incentive Plan to, among other things, increase the number of shares reserved for issuance under the plan from 4.5 million to 6.5 million shares and to provide for automatic annual increases up to an aggregate amount of not more than 10.25 million shares. The proposal received a majority of the shares represented in person or by proxy and therefore has been adopted.
VOTES FOR VOTES AGAINST VOTES ABSTAINING BROKER NON-VOTES --------- ------------- ---------------- ---------------- 9,611,515 2,734,854 126,458 3,929,674
(c) Proposal to amend Dyax's 1998 Employee Stock Purchase Plan to increase the number of shares of Common Stock issued and issuable under the plan from 98,000 to 200,000 shares. The proposal received a majority of the shares represented in person or by proxy and therefore has been adopted.
VOTES FOR VOTES AGAINST VOTES ABSTAINING BROKER NON-VOTES ---------- ------------- ---------------- ---------------- 11,566,092 775,901 130,834 3,929,674
Item 6 - Exhibits and Reports on Form 8-K (a) - Exhibits See the Exhibit Index immediately following the signature page to this report, which Exhibit Index is incorporated herein by reference. (b) - Reports on Form 8-K No reports on Form 8-K were filed during the quarter for which this report is filed. 18 DYAX CORP. SIGNATURE Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized. DYAX CORP. Date: August 14, 2002 /s/ STEPHEN S. GALLIKER ---------------------------------- Executive Vice President, Finance and Administration, and Chief Financial Officer 19 DYAX CORP. EXHIBIT INDEX
EXHIBIT NO. DESCRIPTION 3.1 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, 2000 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, 2000 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) and incorporated herein by reference. 3.4 Certificate of Correction to the Restated Certificate of Incorporation of the Company. Filed as Exhibit 3.4 to the Company's Amendment No. 1 to the Annual Report on Form 10-K/A (File No. 000-24537) and incorporated herein by reference. 10.1 Amended and Restated Collaboration Agreement Between Genzyme Corporation and Dyax Corp dated May 31, 2002. Filed herewith. 10.2 Senior Secured Promissory Note Between Genzyme Corporation and Dyax Corp dated May 31, 2002. Filed herewith. 10.3 Security Agreement Between Genzyme Corporation and Dyax Corp dated May 31, 2002. Filed herewith.
20 EX-10.1 3 a2086278zex-10_1.txt EXHIBIT 10.1 Exhibit 10.1 AMENDED AND RESTATED COLLABORATION AGREEMENT between GENZYME CORPORATION and DYAX CORP. dated as of May 31, 2002 AMENDED AND RESTATED COLLABORATION AGREEMENT THIS AMENDED AND RESTATED COLLABORATION AGREEMENT dated as of May 31, 2002 (the "AGREEMENT") is made between Genzyme Corporation, a Massachusetts corporation having its principal place of business at One Kendall Square, Cambridge, Massachusetts 02139 ("GENZYME") and Dyax Corp., a Delaware corporation having its principal place of business at 300 Technology Square, Cambridge, Massachusetts 02139 ("DYAX"). Genzyme and Dyax are sometimes referred to herein individually as a "PARTY" and collectively as the "PARTIES." R E C I T A L S A. Dyax is developing DX-88 (formerly known as "EPI-KAL 2"), a 58-amino acid polypeptide human plasma Kallikrein inhibitor. Kallikrein inhibition may have therapeutic benefit in the prevention and/or treatment of hereditary angioedema ("HAE"), complications of cardiopulmonary bypass surgery ("CPB") and other inflammatory diseases. Dyax is currently developing DX-88 for the treatment of HAE, CPB and other inflammatory diseases. B. Genzyme has expertise in the areas of development, manufacturing and marketing of bio-pharmaceutical products. C. Dyax and Genzyme entered into a Collaboration Agreement dated as of October 1, 1998 (the "Original Collaboration Agreement") pursuant to which the parties agreed to collaborate in developing DX-88 for the treatment of HAE and other inflammatory diseases. D. The Parties desire to modify the terms of their collaboration and amend the Original Collaboration Agreement as provided herein. NOW THEREFORE, in consideration of the premises and of the covenants herein contained, the Parties mutually agree to amend and restate the Original Collaboration Agreement as follows: ARTICLE 1 DEFINITIONS For purposes of this Agreement, the terms defined in this Article shall have the meanings specified below. Certain other capitalized terms are defined elsewhere in this Agreement. 1.1 "AFFILIATE" shall mean any corporation or other entity which controls, is controlled by, or is under common control with a Party. A corporation or other entity shall be regarded as in control of another corporation or entity if it owns or directly or indirectly controls more than fifty percent (50%) of the voting stock or other ownership interest of the other corporation or entity, or if it possesses, directly or indirectly, the power to direct or cause the direction of the management and policies of the corporation or other entity or the power to elect or appoint more than fifty percent (50%) of the members of the governing body of the corporation or other entity. 1.2 "BUY-IN OPTION" shall have the meaning set forth in Section 4.2 hereof. 1.3 "COLLABORATION PRODUCT" shall mean DX-88 and any protein/peptide analogs, derivatives or improvements thereof (other than "small molecule" drugs) that inhibit the activity of human plasma Kallikrein or any combination products, delivery systems and dosage forms related thereto, together with any process developed for use in the Field by a Party utilizing, based upon or arising out of the Genzyme Patent Rights, the Dyax Patent Rights, the Joint Patent Rights, the Genzyme Technology, the Dyax Technology, the Joint Technology or the Manufacturing Know-How owned or controlled by either Party. For purposes of this Agreement, "small molecule" drugs shall mean compounds that have a molecular weight of less than one thousand (1,000) daltons and which have activity as inhibitors of human plasma kallikrein. 1.4 "COMMERCIALIZATION COSTS" with respect to a Collaboration Product shall mean the variable costs and fixed costs incurred by the Parties or by Kallikrein LLC with respect to work performed by the Parties and their Affiliates and subcontractors in connection with the performance of the Commercialization Plan for such Collaboration Product, including without limitation, sales and marketing costs related to performing market research, post-marketing studies, advertising, producing promotional literature, sponsoring seminars and symposia, sales training meetings and seminars, originating sales, providing reimbursement and other patient support services and such other expenses described in Section 6.4 hereof. For purposes of this Section 1.4, "VARIABLE COSTS" shall be deemed to be the cost of labor, raw materials, supplies and other resources directly consumed in the conduct of the Commercialization Plan and manufacture of Collaboration Product for use in commercialization activities, as well as royalties payable to Third Parties. For purposes of Section 1.4, "FIXED COSTS" shall be deemed to be the cost of facilities, utilities, insurance, equipment depreciation and other fixed costs directly related to the conduct of the Commercialization Plan and the manufacture of Collaboration Product for use in commercialization activities, allocated based upon the proportion of such costs directly attributable to the support or performance of the Commercialization Plan and the manufacture of Collaboration Product for use in commercialization activities or by such other method of cost allocation as may be approved by the Steering Committee. Commercialization Costs shall exclude all costs otherwise reimbursed pursuant to this Agreement. All cost determinations made hereunder shall be made in accordance with GAAP. 1.5 "COMMERCIALIZATION PLAN" shall mean, with respect to a particular Collaboration Product, the comprehensive plan for the commercialization of such Collaboration Product, as more specifically described in Section 6.1 hereof. 1.6 "COMMERCIALLY REASONABLE AND DILIGENT EFFORTS" shall have the meaning ascribed to it in Section 5.1.1. 1.7 "DEVELOPMENT COSTS" with respect to a Collaboration Product shall mean the variable costs and fixed costs incurred by the Parties or by Kallikrein LLC with respect to work performed by the Parties and their Affiliates and subcontractors in connection with the conduct of the Development Plan for such Collaboration Product, including without limitation (a) direct, out-of-pocket external costs, including clinical grants, clinical laboratory fees, positive controls and the cost of studies conducted and services provided by contract research organizations and individuals, consultants, toxicology contractors, and manufacturers necessary or useful for the purpose of obtaining Regulatory Approvals for such Collaboration Product, (b) amounts paid to Genzyme by Dyax prior to satisfaction by Dyax of the Initial 2 Funding Commitment (as defined herein), or to Genzyme and Dyax by Kallikrein LLC after satisfaction by Dyax of the Initial Funding Commitment, with respect to research and development and pre-commercialization sales and marketing efforts as set forth in the Development Plan for such Collaboration Product, including without limitation the efforts of the Parties to develop and document process methods and procedures for the manufacture, characterization and release of such Collaboration Product and the Fully Absorbed Cost of Goods for batches of such Collaboration Product manufactured and supplied for use in preclinical and clinical trials and pre-commercialization activities, including quality control and quality assurance, (c) costs related to data management, statistical designs and studies, document preparation and other expenses associated with the clinical testing program for such Collaboration Product, (d) costs for preparing, submitting, reviewing or developing data or information for the purpose of submission of applications to obtain Regulatory Approvals for such Collaboration Product and (e) the PRO RATA share of license fees and other amounts payable to Third Party licensors and costs relating to the prosecution and maintenance of Patent Rights, allocated based on the proportion of such costs directly attributable to such Collaboration Product. For purposes of this Section 1.6, "VARIABLE COSTS" shall be deemed to be the cost of labor, raw materials, supplies and other resources directly consumed in the conduct of the Development Program and the manufacture of the Collaboration Product for use in preclinical and clinical trials and pre-commercialization activities. For purposes of this Section 1.7, "FIXED COSTS" shall be deemed to be the cost of facilities, utilities, insurance, facility and equipment depreciation and other fixed costs directly related to the conduct of the Development Program and the manufacture of the Collaboration Product for use in preclinical and clinical trials and pre-commercialization activities, allocated based upon the proportion of such costs directly attributable to support of the Development Program and the manufacture of the Collaboration Product for use in preclinical and clinical trials and pre-commercialization activities or by such other method of cost allocation as may be approved by the Steering Committee. Development Costs shall exclude all costs otherwise reimbursed pursuant to this Agreement. All cost determinations made hereunder shall be made in accordance with GAAP. 1.8 "DEVELOPMENT PLAN" shall mean, with respect to a particular Collaboration Product, the comprehensive plan and budget for the development of such Collaboration Product under the Development Program, as more specifically described in Section 5.1 hereof. 1.9 "DEVELOPMENT PROGRAM" shall mean, with respect to a particular Collaboration Product, the preclinical and clinical development of such Collaboration Product including the preparation and filing of all applications for Regulatory Approvals for such Collaboration Product. 1.10 "DYAX COMPANIES" shall mean Dyax and a wholly-owned subsidiary of Dyax ("Subsidiary") to be formed prior to the LLC Formation Date for the purpose of holding a one percent (1%) interest in Kallikrein LLC. 1.11 "DYAX PATENT RIGHTS" shall mean all Patent Rights owned or controlled by, or licensed (to the extent licensed and if there is the right to sublicense) to, Dyax, to the extent that such Patent Rights claim Collaboration Products or are necessary for the research, development, manufacture or commercialization of Collaboration Products in the Field. The Dyax Patent Rights in existence on the Effective Date are set forth on SCHEDULE 1.10. This schedule will be updated by Dyax on the LLC Formation Date to include all Dyax Patent Rights owned or controlled by Dyax as of such date. 3 1.12 "DYAX TECHNOLOGY" shall mean all Technology owned or controlled by, or licensed (to the extent licensed and if there is the right to sublicense) to, Dyax that is necessary for, or specifically relates or is specifically useful to, the research, development, manufacture or commercialization of Collaboration Products for use in the Field. 1.13 "EFFECTIVE DATE" shall mean the date first above written. 1.14 "FDA" shall mean the United States Food and Drug Administration, any successor agency, or the regulatory authority of any country other than the United States with responsibilities comparable to those of the United States Food and Drug Administration. 1.15 "FIELD" shall mean any and all therapeutic uses of a Collaboration Product. 1.16 "FULLY ABSORBED COST OF GOODS" with respect to a Collaboration Product shall mean (a) the variable costs and fixed costs incurred by a Party associated with the manufacture (inclusive of finishing processes) of batches of such Collaboration Product or (b) if such Collaboration Product is not manufactured by the Parties, the transfer price for batches of such Collaboration Product purchased from Third Party manufacturers. For purposes of this Section 1.15, "VARIABLE COSTS" shall be deemed to be the cost of labor, raw materials, supplies and other resources directly consumed in the manufacture of batches of such Collaboration Product, including quality control and quality assurance. For purposes of this Section 1.16, "FIXED COSTS" shall be deemed to be the cost of facilities, utilities, insurance, facility and equipment depreciation and other fixed costs directly related to the manufacture of batches of such Collaboration Product, as well as royalties payable to Third Parties in connection with the manufacture, use or sale of a Collaboration Product. Fixed costs shall be allocated to such Collaboration Product based upon the proportion of such costs directly attributable to support of the manufacturing process for such Collaboration Product. If a facility is used to manufacture Collaboration Products and products for other programs of either Genzyme or Dyax, fixed costs shall be allocated in proportion to the use of such facility for the manufacture of Collaboration Products and products for such other programs. Fully Absorbed Cost of Goods shall exclude all costs otherwise reimbursed pursuant to this Agreement. In the event that either Dyax or Genzyme subcontracts with the other Party to perform any work on its behalf in connection with the manufacturing responsibilities assigned to Dyax or Genzyme, respectively, pursuant to Section 7.3.1 hereof, Dyax and Genzyme (i) shall each directly charge Kallikrein LLC their respective Fully Absorbed Cost of Goods and (ii) shall not include any part of the other Party's Fully Absorbed Cost of Goods in the amount so charged to Kallikrein LLC. Except as otherwise provided in this Agreement, all cost determinations made hereunder shall be made in accordance with GAAP. 1.17 "GAAP" shall mean United States generally accepted accounting principles, consistently applied, except when different accounting principles are required under the terms of the Operating Agreement, in which case the accounting principles mandated under the Operating Agreement shall control. 1.18 "GENZYME PATENT RIGHTS" shall mean all Patent Rights owned or controlled by, or licensed (to the extent licensed and if there is the right to sublicense) to, Genzyme, to the extent that such Patent Rights claim Collaboration Products or are necessary for the research, development, manufacture or commercialization of Collaboration Products in the Field. The Genzyme Patent Rights in existence on the Effective Date are set forth on SCHEDULE 1.17. If 4 Genzyme exercises its Buy-In Option, this schedule will be updated by Genzyme upon execution and delivery of the Purchase Agreement to include all Genzyme Patent Rights owned or controlled by Genzyme as of such date. 1.19 "GENZYME TECHNOLOGY" shall mean all Technology owned or controlled by, or licensed (to the extent licensed and if there is the right to sublicense) to, Genzyme that is necessary for or specifically relates or is specifically useful to, the research, development, manufacture or commercialization of Collaboration Products for use in the Field. 1.20 "JOINT PATENT RIGHTS" shall mean the Patent Rights that claim Joint Inventions (as such term is defined in Section 9.1.1 hereof) that are jointly discovered, made or conceived during and in connection with the Program to the extent that such Patent Rights relate to or are useful for the research, development, manufacture or commercialization of Collaboration Products for use in the Field. 1.21 "JOINT TECHNOLOGY" shall mean all Technology discovered, made or conceived during and in connection with the Program, and future Technology owned or controlled by, or licensed (with the right to sublicense where possible) to, either Genzyme or Dyax relating to or useful for the research, development, manufacture or commercialization of Collaboration Products for use in the Field. 1.22 "KALLIKREIN LLC" shall mean the Delaware limited liability company to be organized by Dyax in accordance with Section 2.1 hereof for the purpose of developing and commercializing Collaboration Products in the Territory and in the Field. 1.23 "LLC FORMATION DATE" shall mean the date the Certificate of Formation of Kallikrein LLC is filed with the Secretary of State of Delaware. 1.24 "MANUFACTURING KNOW-HOW" shall mean all information, techniques, inventions, discoveries, improvements, practices, methods, knowledge, skill, experience and other technology, whether or not patentable or copyrightable, and any copyrights based thereon, relating to or necessary or useful for the production, purification, packaging, storage and transportation of Collaboration Products, including without limitation specifications, acceptance criteria, manufacturing batch records, standard operating procedures, engineering plans, installation, operation and process qualification protocols for equipment, validation records, master files submitted to the FDA, process validation reports, environmental monitoring processes, test data including pharmacological, toxicological and clinical test data, cost data and employee training materials. 1.25 "MANUFACTURING PARTY" shall have the meaning set forth in Section 7.3. 1.26 "MEMBER" shall have the meaning set forth in the Operating Agreement. 1.27 "NDA" shall mean a New Drug Application, Biologics License Application, or similar application filed with the FDA after completion of human clinical trials to obtain marketing approval for a Collaboration Product. 1.28 "NET PROFIT" of Kallikrein LLC for any period shall be equal to (a) the sum during such period of all revenues recognized and recorded by Kallikrein LLC during such period, including without limitation (i) revenues from sales of all Collaboration Products sold by 5 Kallikrein LLC and (ii) all revenues received by Kallikrein LLC from Third Parties as consideration for sublicensing the manufacture, use, distribution or sale of Collaboration Products, LESS (b) all expenses incurred by Kallikrein LLC during such period, including without limitation expenses incurred in respect of Development Costs and Commercialization Costs and facility and equipment depreciation costs not otherwise accounted for. All determinations made hereunder shall be made in accordance with GAAP. 1.29 "OPERATING AGREEMENT" shall mean the Operating Agreement of Kallikrein LLC in substantially the form attached hereto as SCHEDULE 1.28 to be entered into by Dyax and Subsidiary on the LLC Formation Date, and Genzyme if Genzyme exercises its Buy-In Option. 1.30 "PATENT RIGHTS" shall mean any patents, patent applications, certificates of invention, or applications for certificates of invention, together with any extensions, registrations, confirmations, reissues, divisions, continuations or continuations-in-part, re-examinations or renewals thereof, that may be sought throughout the world. 1.31 "PERCENTAGE INTEREST" shall have the meaning set forth in the Operating Agreement. If Genzyme exercises its Buy-In Option pursuant to Section 4.2 hereof, the Percentage Interests of the Parties shall be adjusted such that the Percentage Interests of Dyax and Genzyme shall each be fifty percent (50%), and the Operating Agreement shall be amended accordingly. 1.32 "PROGRAM" shall mean the collaboration described in this Agreement. 1.33 "PROGRAM COSTS" shall mean all Program-related costs, including without limitation Development Costs and Commercialization Costs, in each case as such costs are incurred or accrued by the Parties or by Kallikrein LLC on or after the Effective Date. 1.34 "PROGRAM MANAGEMENT TEAM" shall mean the joint team composed of representatives of Genzyme and Dyax described in Section 8.1.1 hereof. 1.35 "PURCHASE AGREEMENT" shall mean the Purchase Agreement in substantially the form attached hereto as SCHEDULE 1.34 to be entered into by Dyax and Genzyme if Genzyme exercises its Buy-In Option. 1.36 "REGULATORY APPROVALS" shall mean all approvals from regulatory authorities in any country required lawfully to manufacture and market Collaboration Products in any such country, including without limitation any NDA, any establishment license application filed with the FDA to obtain approval of the facilities and equipment to be used to manufacture a Collaboration Product, and any product pricing approvals where applicable. Regulatory Approvals shall also include "orphan drug" designations granted by the FDA for a Collaboration Product. 1.37 "REGULATORY SCHEME" shall mean the United States Public Health Service Act, the United States Food, Drug and Cosmetics Act, and the regulations, interpretations and guidelines promulgated thereunder by the FDA or the regulatory scheme applicable to the Collaboration Products in any country other than the United States, as such statutes, regulations, interpretations and guidelines or regulatory schemes may be amended from time to time. 6 1.38 "SPECIFICATIONS" with respect to a Collaboration Product shall mean the written specifications for such Collaboration Product determined by the Program Management Team and approved by the Steering Committee; PROVIDED that such specifications shall at all times comply with the relevant Regulatory Scheme in the country of sale and in the country of use. The Specifications may be amended from time to time by the Program Management Team provided that such amendments are approved by the Steering Committee or the written agreement of the Parties, as the case may be. Copies of such Specifications shall be maintained by both Dyax and Genzyme and shall become a part of this Agreement as if incorporated herein. 1.39 "STEERING COMMITTEE" shall mean the joint team composed of representatives of Dyax and Genzyme appointed as described in Section 8.2.1 hereof. The Steering Committee shall also be the governing body of Kallikrein LLC following the LLC Formation Date. 1.40 "SURGICAL PRODUCT" shall mean the use of the Collaboration Product for the reduction of blood loss and other effects of systemic inflammatory responses in surgery. 1.41 "TECHNOLOGY" shall mean inventions, trade secrets, copyrights, know-how, data and other intellectual property of any kind (including without limitation any proprietary biological or other materials, compounds or reagents, but not including Patent Rights). 1.42 "TERRITORY" shall mean all of the countries in the world. 1.43 "THIRD PARTY" shall mean any entity other than Kallikrein LLC, Dyax or Genzyme and their respective Affiliates. ARTICLE 2 SCOPE AND STRUCTURE OF THE COLLABORATION 2.1 GENERAL. Genzyme and Dyax desire to collaborate in developing Collaboration Products in the Field and in the Territory, with the initial focus of the Program to be on the development of a Collaboration Product for the treatment of HAE. Dyax shall initially be responsible for undertaking the Development Program as described in the Development Plan. Because the Program is at an early stage, the Parties intend to defer creating a third party vehicle for the further development and commercialization of Collaboration Products until the later of (i) Dyax incurring eight million dollars ($8,000,000) in Program Costs or (ii) completion of the first Phase II clinical trial of a Collaboration Product in HAE, either in the United States or Europe. Accordingly, at that time, Dyax will form Kallikrein LLC and Dyax will be the sole initial member of Kallikrein LLC. Immediately following the formation of Kallikrein LLC, Kallikrein LLC will execute and become a Party to this Agreement. Immediately following the execution and delivery of this Agreement by Kallikrein LLC, Dyax will transfer and assign one percent (1%) of its interest to Subsidiary, and Subsidiary will be admitted as a member of Kallikrein LLC. Immediately thereafter, Genzyme shall determine whether to exercise its Buy-In Option pursuant to Section 4.2 hereof. If Genzyme so elects, Dyax will sell and assign to Genzyme a fifty percent (50%) interest in Kallikrein LLC (subject to adjustment pursuant to Section 4.3.1 hereof and pursuant to the Operating Agreement) pursuant to the Purchase Agreement and Article 4 hereof and, upon execution and delivery of an amendment to the Operating Agreement, Genzyme will be admitted as a member of Kallikrein LLC. Kallikrein LLC will then undertake the Development Program for each Collaboration Product, with each of the Parties assuming responsibility for those portions of the Development Program allocated to it under this Agreement. Upon completion of the Development Program, the Manufacturing Party or Parties 7 will manufacture the Collaboration Products on behalf of Kallikrein LLC and Genzyme will market and sell the Collaboration Products in the Field and in the Territory as exclusive agent for Kallikrein LLC all on the terms and conditions set forth in this Agreement or such other terms and conditions as the Parties may agree upon. If Genzyme does not exercise its Buy-In Option, either Party may terminate this Agreement in accordance with Section 13.2.5. For the avoidance of doubt, the parties acknowledge and agree that any and all obligations attributable to Genzyme hereunder with respect to Kallikrein LLC shall take effect only if Genzyme exercises its Buy-In Option in accordance with Section 4.2. 2.2 EXCLUSIVE RELATIONSHIP. Subject to Section 3.2, neither Kallikrein LLC, Genzyme, Dyax nor any of their respective Affiliates shall independently, or with a Third Party, conduct research or development activities regarding, or engage in the manufacture, marketing, sale or distribution of, DX-88 and any other protein/peptide product that inhibits the activity of human plasma kallikrein during the term of this Agreement other than as part of the Program. In addition, during the two-year period following termination of this Agreement, neither (a) the breaching Party and its Affiliates in the case of termination pursuant to Section 13.2.1 hereof, (b) the terminating Party and its Affiliates in the case of termination pursuant to Section 13.2.2 hereof, (c) the non-terminating Party and its Affiliates in the case of termination pursuant to Sections 13.2.3 and 13.2.4 hereof nor (d) Genzyme in the case of termination pursuant to Section 13.2.5 hereof shall independently, or with a Third Party, conduct research regarding, or engage in the manufacture, marketing, sale or distribution of, protein/peptide products that inhibit the activity of human plasma kallikrein; PROVIDED, HOWEVER, that in the event that this Agreement is terminated pursuant to Sections 13.2.2 or 13.2.5 hereof and the non-terminating Party, or Dyax in the case of termination pursuant to Section 13.2.5 hereof, does not exercise its option under Sections 13.3.2(a) or 13.3.5(a) hereof, then the restrictions set forth in this sentence shall not apply. Notwithstanding the foregoing, nothing herein is intended to restrict Genzyme, Dyax or their respective Affiliates from conducting research or development activities regarding, or engaging in the manufacture, marketing, sale or distribution of, "small molecule" drugs (as defined in Section 1.3). ARTICLE 3 GRANTS AND RESERVATIONS OF RIGHTS 3.1 LICENSES OF RIGHTS TO KALLIKREIN LLC. 3.1.1 GRANTS FROM DYAX. Except as otherwise expressly provided herein, Dyax will grant to Kallikrein LLC on the LLC Formation Date a worldwide, exclusive, royalty-free right and sublicense during the term of this Agreement, with the right to grant further sublicenses, under Dyax Patent Rights, Dyax Technology, the Joint Patent Rights and the Joint Technology and any Manufacturing Know-How owned or held by Dyax to develop, make, have made, use, offer for sale, sell, have sold, import and export Collaboration Products in the Field. 3.1.2 GRANTS FROM GENZYME. Except as otherwise expressly provided herein, Genzyme will grant to Kallikrein LLC on the LLC Formation Date a worldwide, exclusive, royalty-free right and sublicense during the term of this Agreement, with the right to grant further sublicenses, under the Genzyme Patent Rights, Genzyme Technology, Joint Patent Rights and the Joint Technology and any Manufacturing Know-How owned or held by Genzyme to develop, make, have made, use, offer for sale, sell, have sold, import and export Collaboration Products in the Field. 8 3.1.3 KALLIKREIN LLC UNDERTAKINGS; SUBLICENSES. In consideration of the licenses to be granted under this Section 3.1, Kallikrein LLC will undertake to pay all royalties, sublicense fees and other costs or expenses payable to Third Parties associated with the acquisition or use of such licenses by Kallikrein LLC for use in connection with the Program. Except as provided in Section 3.2 below, all sublicenses granted by Kallikrein LLC shall be subject to prior approval by the Steering Committee. 3.1.4 RIGHTS OF KALLIKREIN LLC TO PATENT RIGHTS OR TECHNOLOGY DEVELOPED OUTSIDE THE PROGRAM. In the event that either Dyax or Genzyme develops, acquires or otherwise comes to own or control or receives a license with respect to Patent Rights, Technology or Manufacturing Know-How after the LLC Formation Date other than in connection with the Program and such Patent Rights, Technology or Manufacturing Know-How are useful in the Field and licensable or sublicensable by Dyax or Genzyme ("ADDITIONAL TECHNOLOGY"), as the case may be, the Party owning or controlling such Additional Technology will grant to Kallikrein LLC an option exercisable at the discretion of the Steering Committee to obtain an exclusive right and license during the term of this Agreement, with the right to grant sublicenses, to such Additional Technology to the extent necessary or appropriate to enable Kallikrein LLC to develop, make, have made, use, offer for sale, sell, have sold, import and export Collaboration Products in the Field and in the Territory, in each case subject only to Kallikrein LLC's undertaking to pay (a) a commercially reasonable portion of all costs incurred by Dyax or Genzyme, as the case may be, to acquire or develop such Additional Technology, (b) a commercially reasonable portion of any and all development costs relating to the Additional Technology incurred by Dyax or Genzyme, as the case may be, since the date such Party acquired or developed such Additional Technology and (c) all royalties, sublicense fees and other costs or expenses payable to Third Parties associated with the acquisition or use of such license by Kallikrein LLC; PROVIDED, HOWEVER, that if Dyax or Genzyme, as the case may be, has more limited rights to such Additional Technology than those described above, the license subject to Kallikrein LLC's option hereunder shall be consistent with the rights held by Dyax or Genzyme, as the case may be, with respect to such Additional Technology. 3.2 PROPOSALS FOR ADDITIONAL INDICATIONS. Genzyme and Dyax acknowledge and agree that the initial focus of the Program shall be the use of a Collaboration Product for the treatment of HAE. At any time during the term of this Agreement, either Genzyme or Dyax (the "PROPOSING PARTY") may make a proposal to the Steering Committee to develop a Collaboration Product for an additional disease indication. If the Steering Committee accepts such proposal within sixty (60) days of receipt thereof, the then-current Development Plan or Commercialization Plan, as applicable, shall be amended accordingly. If the Steering Committee fails or affirmatively declines to accept such proposal within sixty (60) days of receipt thereof, the Proposing Party and/or its Affiliates will be free to develop, manufacture and/or commercialize a Collaboration Product for such disease indication (an "EXTERNAL PRODUCT") independently of the other Party or Kallikrein LLC, either by itself or with a Third Party, within or outside the Field, and such activities shall no longer be considered to be part of the Program. An External Product shall not be considered to be a Collaboration Product for purposes of this Agreement. All up-front payments received by the Proposing Party and/or its Affiliates from a Third Party with respect to the licensing of the Proposing Party's Patent Rights, Technology or Manufacturing Know-How for use in developing, manufacturing and/or commercializing such External Product will be shared by the Parties in accordance with their Percentage Interests. All subsequent license fees, milestones and royalty payments relating to, or revenues generated from the sale of, such External Product, and any proceeds from the sale of all of the rights to such 9 External Product, will be distributed in accordance with the formula set forth on SCHEDULE 3.2 hereto. The Parties shall negotiate in good faith any license and royalty agreements necessary to permit the Proposing Party to develop and commercialize an External Product in accordance with this Section 3.2. Genzyme and Dyax acknowledge and agree that the Surgical Product shall be considered an External Product. Genzyme hereby grants Dyax an option to purchase all of Genzyme's rights in the Surgical Product that it would otherwise have under this Section 3.2 for one million dollars ($1,000,000), (the "Surgical Product Option"). The Surgical Product Option shall expire on March 31, 2003. 3.3 SUBLICENSES OF RIGHTS FROM KALLIKREIN LLC TO DYAX AND GENZYME. Kallikrein LLC will grant to each of Dyax and Genzyme a worldwide, non-exclusive, royalty-free right and sublicense during the term of this Agreement under the Patent Rights, Technology and Manufacturing Know-How licenses granted to it pursuant to Section 3.1 solely to the extent required to permit such Party to perform its duties under this Agreement. Kallikrein LLC will also grant to each of Dyax and Genzyme a worldwide, non-exclusive, royalty-free right and license during the term of this Agreement under any Additional Technology as to which Kallikrein LLC elects to obtain a license pursuant to Section 3.1.4 above solely to the extent required to permit such Party to perform its obligations under this Agreement. Kallikrein LLC will further grant to Genzyme a worldwide, non-exclusive, royalty-free right and license during the term of this Agreement to use any and all trademarks owned or licensed (with the right to sublicense) by Kallikrein LLC in connection with the commercialization of Collaboration Products in the Field and in the Territory to the extent required to permit Genzyme to perform its duties under this Agreement. 3.4 RESERVATION OF RIGHTS. 3.4.1 RESERVATION BY DYAX. Notwithstanding the license grants set forth in Section 3.1, Dyax will at all times reserve the rights under the Dyax Patent Rights, the Dyax Technology, the Joint Patent Rights, the Joint Technology and the Manufacturing Know-How owned or controlled by Dyax (a) to make, have made and use Collaboration Products for research and development purposes only, (b) to develop, make, have made, use, offer for sale, sell, have sold, import and export products outside the Field and (c) to grant licenses to Third Parties for the foregoing purposes. 3.4.2 RESERVATION BY GENZYME. Notwithstanding the license grants set forth in Section 3.1, Genzyme will at all times reserve the rights under the Genzyme Patent Rights, the Genzyme Technology, the Joint Patent Rights, the Joint Technology and Manufacturing Know-How owned or controlled by Genzyme (a) to make, have made and use Collaboration Products for research and development purposes only, (b) to develop, make, have made, use, offer for sale, sell, have sold, import and export products outside the Field and (c) to grant licenses to Third Parties for the foregoing purposes. 3.5 ASSIGNMENT OF ORPHAN DRUG DESIGNATION. Except to the extent prohibited by the Regulatory Scheme, the Parties agree to assign to Kallikrein LLC on the LLC Formation Date any "Orphan Drug" designations for any Collaboration Product which Dyax or Genzyme may receive during the term of this Agreement. 10 ARTICLE 4 PROGRAM FUNDING; LLC INTEREST 4.1 INITIAL FUNDING COMMITMENT. Dyax hereby undertakes to fund the greater of (i) eight million dollars ($8,000,000) in Program Costs or (ii) the total Program Costs incurred through the completion of the first Phase II clinical trial of a Collaboration Product for use in HAE, either in the United States or Europe (the "INITIAL FUNDING COMMITMENT"). 4.2 BUY-IN OPTION. Following satisfaction of the Initial Funding Commitment, Genzyme and its Affiliates shall have the option to purchase a fifty percent (50%) interest in Kallikrein LLC in accordance with Section 4.5 hereof ("Buy-In Option"). Genzyme shall provide Dyax with written notice of its exercise of the Buy-In Option no later than sixty (60) days after Genzyme has reviewed and discussed with Dyax the data from the first completed Phase II clinical trial of a Collaboration Product for use in HAE. 4.3 PROGRAM FUNDING; CAPITAL CONTRIBUTIONS. 4.3.1 GENERAL. If Genzyme elects to exercise its Buy-In Option, Genzyme and Dyax shall each make capital contributions to Kallikrein LLC in an amount equal to fifty percent (50%) of all Program Costs incurred or accrued after satisfaction of the Initial Funding Commitment, as further set forth in this Section 4.3. In the event that either Dyax or Genzyme fails to make a capital contribution to Kallikrein LLC as required by this Section 4.3.1, and the other Party does not elect to terminate this Agreement pursuant to Section 13.2.1 hereof, then the Percentage Interests in Kallikrein LLC and the future funding responsibility of the Members shall be adjusted as provided in Section 4.1(b) of the Operating Agreement. 4.3.2 INITIAL CAPITAL CONTRIBUTIONS. If Genzyme elects to exercise its Buy-In Option, within five (5) working days after the execution and delivery of the Purchase Agreement, Dyax and Genzyme shall each make a capital contribution to Kallikrein LLC in an amount equal to one-half of the Program Costs budgeted to be incurred by Kallikrein LLC from the LLC Formation Date through and including the end of the next calendar month after the LLC Formation Date. 4.3.3 MONTHLY CAPITAL CONTRIBUTIONS. With respect to each calendar month thereafter, Genzyme and Dyax shall each make capital contributions to Kallikrein LLC, monthly in advance, not later than the fifteenth (15th) day of the prior calendar month, in an aggregate amount equal to one-third of the Program Costs budgeted to be incurred by Kallikrein LLC in any then-current Development Plan or Commercialization Plan for the calendar quarter in which such calendar month occurs, allocated between such Parties in accordance with the funding responsibility assumed by Genzyme and Dyax, on behalf of the Dyax Companies, pursuant to Section 4.3.1 above. Upon receipt of each such capital contribution from Genzyme or Dyax, as the case may be, Kallikrein LLC shall promptly pay each of the Parties an amount equal to that portion of the budgeted Program Costs to which they are respectively entitled. 4.3.4 QUARTERLY STATEMENTS; QUARTERLY RECONCILIATION. Within thirty (30) days after the end of each of the first three (3) calendar quarters of each year and within sixty (60) days after the end of each calendar year, each of Dyax and Genzyme shall provide Kallikrein LLC with a detailed itemization of its Program Costs actually incurred during the previous quarter. Each of Dyax and Genzyme shall provide the other Party with estimates of such costs upon the reasonable request of the other Party prior to the dates such statements are due. Within thirty (30) days following receipt of the quarterly statement of actual Program Costs provided by each of Dyax and Genzyme, Dyax and Genzyme shall each make an additional capital 11 contribution to Kallikrein LLC in the amount of any actual Program Costs shown thereon and not yet paid for which such Party has assumed funding responsibility pursuant to this Section 4.3 but only to the extent that such amount, together with all prior capital contributions to date during such year, does not exceed one hundred ten percent (110%) of the total Program Costs budgeted year-to-date through the end of the quarter to which such statement relates (except to the extent such excess is approved by the Steering Committee pursuant to Section 5.1.3 hereof). If the aggregate amount stated to be due from Kallikrein LLC in such quarterly statements for actual Program Costs is less than the amount already contributed by the Parties to the capital of Kallikrein LLC with respect to budgeted Program Costs for such calendar quarter, such excess shall be credited pro rata against the next successive monthly capital contribution due from Genzyme or Dyax hereunder. 4.4 DISTRIBUTIONS. Distributions shall be made quarterly to each Member in amounts determined in accordance with the Operating Agreement. Amounts available for distribution shall be calculated for each calendar quarter after the date of the first sale of a Collaboration Product following Regulatory Approval of such Collaboration Product and shall be reported to each of Dyax and Genzyme within ninety (90) days following the end of each such quarter. All distributions to the Parties will be accompanied by a report setting forth the basis for such distribution. Such reports shall be subject to audit rights as set forth in Section 4.6 below, MUTATIS MUTANDIS. 4.5 SALE AND PURCHASE OF LLC INTEREST. If Genzyme elects to exercise its Buy-In Option, Dyax shall sell, assign and transfer to Genzyme, and Genzyme shall purchase from Dyax, a fifty percent (50%) interest in Kallikrein LLC (subject to adjustment pursuant to Section 4.3.1 hereof and pursuant to the Operating Agreement) for an aggregate amount of not more than twenty-five million ten dollars ($25,000,010), exclusive of Section 4.5(b) below, payable as set forth in Sections 4.5(a), 4.5(c) and 4.5(d) below: (a) Genzyme shall pay to Dyax an amount of ten dollars ($10) upon execution of the Purchase Agreement; (b) Upon dosing the first patient in a pivotal clinical trial of a Collaboration Product for use in HAE, Genzyme shall pay to Dyax an amount equal to fifty percent (50%) of the difference between the total Program Costs incurred by Dyax prior to the satisfaction of the Initial Funding Commitment and six million dollars ($6,000,000). (c) Genzyme shall pay to Dyax an amount of ten million dollars ($10,000,000) on the first full approval by the U.S. FDA of an NDA for the use of a Collaboration Product for any therapeutic indication; and (d) Genzyme shall pay to Dyax an amount of five million dollars ($5,000,000) on the full approval by the U.S. FDA of each subsequent NDA for the use of a Collaboration Product for a new indication, up to a maximum of three (3) such payments. Each of the aforementioned payments shall be made in United States dollars by certified or bank check or by wire transfer within thirty (30) days following the occurrence and confirmation of each event. 12 4.6 BOOKS OF ACCOUNT; AUDIT. Genzyme shall keep and maintain proper and complete books of account, and shall maintain a bank account, on behalf of Kallikrein LLC following Genzyme's exercise of its Buy-In Option. Prior to Genzyme's exercise of its Buy-In Option or if Genzyme declines to exercise its Buy-In Option, Dyax shall keep and maintain proper and complete books of account, and shall maintain a bank account, on behalf of Kallikrein LLC. Each Party shall have reasonable access to such books of account and bank records upon reasonable prior notice to the other Party. In the event that either Dyax or Genzyme reasonably deems the Program to be material to Dyax or Genzyme, as the case may be, for financial accounting purposes, then, upon such Party's request, audited financial statements of Kallikrein LLC shall be prepared by an independent accounting firm to be selected by the Steering Committee. Each of Dyax and Genzyme shall keep and maintain proper and complete records and books of account documenting all Program Costs incurred by it. Each of Kallikrein LLC, Dyax and Genzyme shall permit independent accountants retained by the other Parties to have access to its records and books for the sole purpose of determining the appropriateness of Program Costs charged by the non-auditing Party hereunder. Such examination shall be conducted during regular business hours and upon reasonable notice, at the auditing Party's own expense and no more than once in each calendar year during the term of this Agreement and once during the three (3) calendar years following the termination hereof. If such examination reveals that such Program Costs have been misstated, any adjustment shall be promptly refunded or paid, as appropriate. The auditing Party shall pay the fees and expenses of the accountant engaged to perform the audit, unless such audit reveals an overcharge of ten percent (10%) or more for the period examined, in which case the Party who received such overpayment shall pay all reasonable costs and expenses incurred by the auditing Party in the course of making such determination, including the fees and expenses of the accountant. 4.7 ENFORCEABILITY OF SECTIONS 4.1 AND 4.3. The agreements regarding funding commitments and capital contributions set forth in Sections 4.1 and 4.3 hereof are by and between, and for the benefit of, Genzyme and Dyax only, are not enforceable by Kallikrein LLC or any Third Party, and shall take effect only if Genzyme exercises its Buy-In Option pursuant to Section 4.2 hereof. ARTICLE 5 THE DEVELOPMENT PROGRAM 5.1 CONDUCT OF THE DEVELOPMENT PROGRAM. 5.1.1 GENERAL. The Parties each agree to collaborate diligently in the development of Collaboration Products in the Field and to use commercially reasonable and diligent efforts to develop, obtain Regulatory Approvals for and bring to market Collaboration Products in the Field and in the Territory as soon as practicable, all in accordance with the Development Plan and the Commercialization Plan for such Collaboration Products. The Parties agree to execute and substantially perform and to cooperate with each other in carrying out the Development Plan and the Commercialization Plan for each Collaboration Product. Neither Dyax nor Genzyme shall be required to undertake activities in furtherance of the Development Plan or Commercialization Plan in the absence of funding pursuant to the provisions of this Agreement. As used in this Agreement, the term "COMMERCIALLY REASONABLE AND DILIGENT EFFORTS" will mean that level of effort which, consistent with the exercise of prudent scientific and 13 business judgment, is applied by the Party in question to its other therapeutic products at a similar stage of development and with similar commercial potential. 5.1.2 DEVELOPMENT PLAN. Prior to exercise of the Buy-In Option by Genzyme, the Development Program shall be conducted by Dyax under a Development Plan which shall describe the proposed overall program of development for each Collaboration Product, including preclinical studies, toxicology, formulation, clinical trials and regulatory plans and other key elements necessary to obtain Regulatory Approvals for such Collaboration Product. Following the exercise of the Buy-In Option by Genzyme, the Development Program shall be conducted by Genzyme and Dyax on behalf of Kallikrein LLC under the Development Plan in effect as of such date. Pursuant to the applicable Development Plan, development work may be subcontracted by Dyax to Genzyme, or by Kallikrein LLC to Genzyme and Dyax, as applicable, at fully absorbed costs determined by GAAP. The respective charges to Dyax or Kallikrein LLC, as the case may be, shall be invoiced following completion of the work, and shall be payable by Dyax or Kallikrein LLC, as applicable, within a commercially reasonable time thereafter (but in no event later than forty-five (45) days of the date of invoice therefor). The Development Plan shall include a summary of estimated Development Costs expected during the development process through obtaining such Regulatory Approvals and a detailed description of and budget for all development activities proposed for each calendar year for each Collaboration Product. 5.1.3 INITIAL AND UPDATED DEVELOPMENT PLAN. The Development Plan shall be updated annually by the Program Management Team and submitted to the Steering Committee for review and approval not later than sixty (60) days prior to January 1 of each year during the Development Program. Each such updated Development Plan shall include (a) an overall development plan for each Collaboration Product which sets forth all major development tasks remaining to be accomplished prior to submission of filings for Regulatory Approvals and (b) a detailed description and budget for the development and pre-commercialization activities proposed for the forthcoming calendar year. The Project Management Team shall be primarily responsible for preparing the annual updates to the Development Plan and, in connection with the preparation of such updates, shall consult with Genzyme and Dyax regarding the identification, timing and execution of and budget for the major tasks and detailed activities required to perform the updated Development Plan. Each such updated Development Plan approved by the Steering Committee shall be signed by an authorized representative of each of Dyax and Genzyme. The members of the Program Management Team shall actively consult with one another throughout the term of the Development Plan so as to adjust the specific work performed under the Development Plan to conform to evolving developments in technology and the results of the development work performed. While minor adjustments to the Development Plan may be made from time to time upon approval of the Program Management Team, significant changes in the scope or direction of the work and any changes in funding exceeding one hundred ten percent (110%) of the total amount budgeted in any calendar year for the Development Program must be approved by the Steering Committee, in the absence of which approval the most recently approved Development Plan shall remain in effect. 5.1.4 EXECUTION AND PERFORMANCE. The Development Program shall allocate among the Parties responsibility for each of the activities described therein. The Parties shall use commercially reasonable and diligent efforts to conduct the activities described in the Development Plan. The Development Plan shall be supervised by the Program Management Team. The Program Management Team will coordinate preclinical and clinical testing of the 14 Collaboration Products and work with designated individuals at Dyax and Genzyme in the preparation of Regulatory Approval filings for the Collaboration Products. 5.1.5 ATTENDANCE AT REGULATORY MEETINGS. Each Party shall provide the others with prior notice of all meetings and teleconferences between representatives of the notifying Party and regulatory authorities regarding any Collaboration Product. Except as otherwise provided herein, the Party receiving such notice shall have the right to have representatives participate in all such meetings and teleconferences. Each Party shall keep a reasonably detailed record of each contact between such Party and all regulatory authorities regarding any Collaboration Product and deliver a copy of such record to the other Party within three (3) business days of such contact. 5.2 DEVELOPMENT INFORMATION. 5.2.1 OWNERSHIP OF PRE-CLINICAL AND CLINICAL DATA. The Parties shall jointly own all pre-clinical and clinical trial data generated as part of the Program or otherwise funded or partially funded by the Parties. Upon the formation of Kallikrein LLC, the Parties shall assign their respective interests in such data to Kallikrein LLC and Kallikrein LLC shall thereafter own such data. 5.2.2 REPORTS AND INFORMATION EXCHANGE. Each of Dyax and Genzyme shall use commercially reasonable and diligent efforts to disclose to the other Party and, if applicable, Kallikrein LLC, all material information relating to any Collaboration Product promptly after it is learned or its materiality is appreciated. The Party performing or supervising clinical trials of Collaboration Products in accordance with the Development Plan shall, on behalf and in the name of the owner of the clinical trial data accumulated from all clinical trials of Collaboration Products, maintain the database of such data and of adverse reaction information for all such Collaboration Products. Each Party shall also keep the Program Management Team informed as to its progress in the Development Plan. Within sixty (60) days following the end of each calendar quarter during the Development Program, each of Dyax and Genzyme shall provide the other Parties with a reasonably detailed written report describing the progress to date of all activities for which such Party was allocated responsibility during such quarter under the Development Plan. 5.2.3 ADVERSE REACTION REPORTING. Each of Dyax and Genzyme shall notify the other Parties of any adverse reaction information relating to any Collaboration Product within twenty-four (24) hours of the receipt of such information and as necessary for compliance with regulatory requirements. "ADVERSE REACTION INFORMATION" includes without limitation information relating to any experience that (a) suggests a significant hazard, contraindication, side effect or precaution, (b) is fatal or life threatening, (c) is permanently disabling, (d) requires or prolongs inpatient hospitalization, (e) involves a congenital anomaly, cancer or overdose or (f) is one not identified in nature, specificity, severity or frequency in the current investigator brochure or the United States labeling for the Collaboration Product. 5.2.4 CLINICAL AND REGULATORY AUDITS. Each of Dyax and Genzyme shall permit Kallikrein LLC and the other Party, or the representatives of Kallikrein LLC or the other Party, to have access during regular business hours and upon reasonable advance notice, at the auditing Party's own expense and no more than once in each calendar year during the term of this Agreement, to the non-auditing Party's records and facilities relating to the Development 15 Program for the purpose of monitoring compliance with Good Clinical Practice and other applicable requirements of the Regulatory Scheme. 5.3 REGULATORY APPROVAL FILINGS. Regulatory Approval filings in the Territory for the Collaboration Products and for the facilities used to manufacture such Collaboration Products shall be filed in the name of an entity determined by the Steering Committee. The entity in whose name such Regulatory Approval filings are filed shall give each of the Parties a right of reference in such filings if such right is not prohibited under the applicable Regulatory Scheme. Prior to submission to the FDA, the Parties, through the Program Management Team, shall consult, cooperate in preparing and mutually agree on the content and scope of the Regulatory Approval filings. In the event that Regulatory Approvals are required to be filed in the name of an entity other than Dyax, Genzyme or Kallikrein LLC, the Steering Committee shall ensure that a duly authorized officer of such entity agrees in writing that (a) such entity shall hold the licenses issued in respect of such Regulatory Approval filings, maintain control over the manufacturing facilities, equipment and personnel, and engage in pharmacovigilence to the extent required by the Regulatory Scheme, (b) such entity shall maintain compliance with applicable Regulatory Schemes, (c) such entity shall provide manufacturing and supply services at the Fully Absorbed Cost of Goods of Collaboration Products so manufactured and supplied, (d) the Parties shall have an irrevocable right of access and reference to such Regulatory Approval filings, licenses and facilities and (e) such entity agrees to comply with the provisions of Article 13 hereof with respect to the ownership and/or disposition of such Regulatory Approvals in the event this Agreement is terminated and to provide the level of cooperation described in Section 14.1 hereof in connection therewith. 5.4 FACILITIES VISITS. Representatives of Dyax and Genzyme may visit all manufacturing sites and the sites of any clinical trials or other experiments being conducted by the other Party, Kallikrein LLC or a Third Party in connection with the Development Program. If requested by the other Party, Dyax and Genzyme shall cause appropriate individuals working on the Development Program to be available for meetings at the location of the facilities where such individuals are employed at times reasonably convenient to the Party responding to such request. ARTICLE 6 SALES, MARKETING AND ADMINISTRATIVE SERVICES 6.1 COMMERCIALIZATION PLANS. 6.1.1 GENERAL. The commercialization of each Collaboration Product shall be governed by a Commercialization Plan which shall describe the overall plan for commercializing such Collaboration Product, including without limitation (a) a comprehensive marketing, sales, pricing, manufacturing, distribution and licensing strategy for such Collaboration Product in all applicable countries, including the identification of any Third Parties engaged or to be engaged in connection with such activities and the arrangements with them that have been or are proposed to be agreed upon (including policies and procedures for adjustments, rebates, bundling and the like), (b) estimated launch date, market and sales forecasts, in numbers of patients and local currency, and competitive analysis for such Collaboration Product, (c) a detailed budget for the Commercialization Costs to be incurred in connection with performing such Commercialization Plan, (d) reasonable due diligence obligations to be met by Genzyme with respect to commercialization objectives to be achieved during the calendar year to which the 16 Commercialization Plan relates (such as minimum annual sales objectives) and (e) a detailed manufacturing plan. 6.1.2 INITIAL AND UPDATED COMMERCIALIZATION PLANS. No later than immediately prior to the completion of the submission of all Regulatory Approval filings for a Collaboration Product in any given country, Genzyme shall develop and submit to the Steering Committee for review and approval an initial Commercialization Plan in accordance with its customary standard for a product of comparable market potential, taking into consideration factors such as market conditions, regulatory factors, competition and the costs and profits of such Collaboration Product. Genzyme shall be primarily responsible for developing each Commercialization Plan and, in connection therewith, shall consult with Dyax regarding the identification, timing and execution of and budget for the major commercialization tasks required to perform the Commercialization Plan. Each Commercialization Plan shall be updated annually by Genzyme, in consultation with Dyax below as herein provided, and shall be submitted to the Steering Committee for approval not later than sixty (60) days prior to January 1 of each year. Each Commercialization Plan approved by the Steering Committee shall be signed by an authorized representative of each of Dyax and Genzyme. While minor adjustments to the Commercialization Plan may be made from time to time without Steering Committee approval, significant changes in the scope or direction of the work and any changes in funding exceeding one hundred ten percent (110%) of the total amount budgeted in any calendar year for the Commercialization Plan must be approved by the Steering Committee, and in the absence of such approval, the provisions of the most recently approved Commercialization Plan shall remain in effect. Within sixty (60) days following the end of each calendar quarter after the filing of the first application for a Regulatory Approval (other than an application for "orphan drug" designation of a Collaboration Product), each of Dyax and Genzyme shall provide the other Parties with a reasonably detailed written report describing the progress to date of all activities for which such Party was allocated responsibility during such quarter under the Commercialization Plan, including, if reasonably available, sales information for each Collaboration Product on a country-by-country basis. 6.2 EXCLUSIVE ENGAGEMENT. Kallikrein LLC will engage Genzyme on an exclusive basis to market and sell Collaboration Products within the Territory for use within the Field. Genzyme will (by itself or through its Affiliates) use commercially reasonable and diligent efforts to establish each Collaboration Product in the markets, fulfill market demand and meet the marketing and distribution goals set forth in the Commercialization Plan for such Collaboration Product. 6.3 ORDERS. Genzyme shall provide written notice to Kallikrein LLC of its requirements for the Collaboration Products, setting forth the quantity of Collaboration Products required, any specifications therefor and the date required. Kallikrein LLC, on the date set forth in the applicable requirements notice, shall deliver the Collaboration Products to Genzyme for sale within the Territory. All freight, insurance, duties and all other charges associated with shipment of the Collaboration Products shall be considered Commercialization Costs for such Collaboration Products only to the extent such costs are not charged to Genzyme's customers. 6.4 MARKETING AND DISTRIBUTION EXPENSES. Genzyme's ordinary expenses incurred in the course of performing its marketing and distribution obligations hereunder shall constitute Commercialization Costs budgeted as part of the then-effective Commercialization Plan and, as such, shall be reimbursed by Dyax prior to the satisfaction by Dyax of the Initial Funding 17 Commitment and by Kallikrein LLC after the satisfaction by Dyax of the Initial Funding Commitment, but only to the extent that such amounts, together with all other Commercialization Costs to date during such calendar year, do not exceed one hundred ten percent (110%) of the Commercialization Costs budgeted in the Commercialization Plan then in effect for such calendar year (except to the extent such excess is approved by the Steering Committee pursuant to Section 6.1.2 above). Ordinary marketing and distribution expenses include, but are not limited to, recruitment costs and salaries and associated expenses for sales and marketing personnel and support staff, advertising and promotion costs, transportation expenses including insurance (but only to the extent not charged to customers and only such proportion of all such costs directly attributable to support of the Commercialization Plan), duties and taxes, bad debt expense, and costs associated with cash and other trade discounts and allowances and other marketing concessions to customers actually allowed and taken. 6.5 RESPONSIBILITIES OF GENZYME. Genzyme shall be solely responsible for all aspects of the marketing of the Collaboration Products in accordance with the strategy, policies and procedures established in the Commercialization Plan, including without limitation the responsibilities described in this Section 6.5. (a) Genzyme shall be primarily responsible for the implementation of each Commercialization Plan, including without limitation setting all terms of sale, including establishing pricing policies, credit terms and cash discounts and allowances, formulating marketing plans, negotiating agreements with Third Party distributors (if any), providing patient information, providing customer support services, providing reimbursement counseling services and sales force training. (b) Genzyme shall employ sufficiently trained and experienced individuals in numbers adequate to carry out its responsibilities under this Article 6. Sales and support personnel shall be familiar with the Collaboration Products and with competitive products and shall respond promptly to customer requests for support. (c) Genzyme shall provide instructions and appropriate training to customers in the proper use and handling of the Collaboration Products and shall monitor performance of the Collaboration Products. (d) Genzyme shall have sole responsibility for responding to all requests for medical information regarding Collaboration Products. (e) Genzyme shall comply with all laws and government regulations applicable to the sale of Collaboration Products within the Territory. (f) The Collaboration Products shall be sold under trademarks selected by the Steering Committee and owned by or licensed to Kallikrein LLC in accordance with Section 9.1.2 hereof. (g) Genzyme shall maintain complete and accurate records of all movements and transactions involving Collaboration Products by an appropriate identifier and by customer so that all such movements and transactions can be traced quickly and effectively. Upon written request, Genzyme will provide copies of such records to the other Parties, with access to facilities used by Genzyme in performing its duties under this Article 6 during normal 18 business hours and upon reasonable advance notice for the purpose of inspecting such facilities for compliance with the terms of this Agreement. The records maintained by Genzyme pursuant to this clause (g) shall be subject to the other Parties' audit rights under Section 4.6 hereof. (h) Genzyme shall report to the Steering Committee in writing the occurrence of each material incident of Collaboration Product performance required to be reported to regulatory authorities, including without limitation adverse reaction information in accordance with Section 5.2.3 hereof, within three (3) business days of the happening of such occurrence. 6.6 RESPONSIBILITIES OF KALLIKREIN LLC AND DYAX. Kallikrein LLC shall supply Collaboration Products to Genzyme in accordance with notices of requirements pursuant to Section 6.3 above. Neither Kallikrein LLC nor Dyax shall actively solicit for its own account sales of Collaboration Products in the Territory. Any solicitations or requests to purchase Collaboration Products received by Kallikrein LLC or Dyax from any customer or prospective customer with its principal address or place of business located in the Territory or who Kallikrein LLC or Dyax, as the case may be, knows intends to use the Collaboration Products in the Territory or ship such Collaboration Products into the Territory shall be immediately referred to Genzyme. 6.7 GENERAL AND ADMINISTRATIVE SERVICES. General and administrative services required by Kallikrein LLC shall be provided at cost by either or both of Dyax and Genzyme as determined by the Steering Committee. All such costs, in addition to general and administrative costs payable to Third Parties (such as accountants) and general and administrative costs incurred by Dyax and Genzyme in satisfying their respective obligations under this Agreement, shall be considered to be Program Costs. ARTICLE 7 MANUFACTURE AND SUPPLY Subject to the terms and conditions of this Agreement, Collaboration Products shall be manufactured and supplied for preclinical and clinical testing and for commercial sale upon the following terms and conditions: 7.1 PROCESS DEVELOPMENT. The Parties will use commercially reasonable and diligent efforts to develop a process for the manufacture of each Collaboration Product and to scale up that process to a scale sufficient to manufacture and supply (a) the anticipated demand for preclinical studies and clinical trials of such Collaboration Product in accordance with the projections set forth in the Development Plan and (b) the anticipated market demand for such Collaboration Product at the time Regulatory Approval is obtained for such Collaboration Product in accordance with the projections set forth in the Commercialization Plan for such Collaboration Product. The development of the process for the manufacture of Collaboration Products as well as the scale up of such process and all material issues incident to the development of the ability to produce Collaboration Products for commercial purposes in sufficient quantity and in a timely manner will be within the purview of the Program Management Team. The Parties will use commercially reasonable and diligent efforts, and will cause any approved Third Party supplier, to make filings necessary to obtain approval of any license application for a manufacturing facility which may be required as part of any Regulatory Approval for the first Collaboration Product. 19 7.2 MANUFACTURE AND SUPPLY OF COLLABORATION PRODUCTS FOR CLINICAL TRIALS. Dyax will use commercially reasonable and diligent efforts to manufacture and supply, or to have manufactured and supplied, Collaboration Products for preclinical studies and clinical trials in quantities and within a time period sufficient to conduct the activities set forth in the Development Plan. The Fully Absorbed Cost of Goods for such Collaboration Products shall be deemed Development Costs and reimbursed in accordance with the terms of this Agreement. 7.3 MANUFACTURE AND SUPPLY OF COLLABORATION PRODUCTS FOR COMMERCIAL SALE. Kallikrein LLC shall, as determined by the Steering Committee, designate one of the Parties (the "MANUFACTURING PARTY") to manufacture and supply Collaboration Products (or cause Collaboration Products to be manufactured or supplied) for commercial sale pursuant to a supply agreement entered into by Kallikrein LLC and the Manufacturing Party (a "SUPPLY AGREEMENT"). The terms of each Supply Agreement shall include, without limitation, the terms and conditions set forth below. 7.3.1 GENERAL. Kallikrein LLC shall use commercially reasonable and diligent efforts to manufacture and supply Collaboration Products to meet market demand for Collaboration Products ordered in accordance with the terms hereof. The Manufacturing Party shall be entitled to charge Kallikrein LLC an amount equal to its Fully Absorbed Cost of Goods for such Collaboration Products. The costs of any failed or discarded lots shall be borne by the Manufacturing Party and shall not be considered Program Costs. The Manufacturing Party may subcontract with Genzyme, Dyax or Third Parties for the manufacture or packaging of Collaboration Products, as determined by the Steering Committee. Notwithstanding the foregoing provisions of this Section 7.3.1, to the extent required by the Regulatory Scheme, any entity selected by the Steering Committee pursuant to Section 5.3 above may be engaged by Kallikrein LLC to manufacture Collaboration Products. The respective charges to Kallikrein LLC shall be invoiced following completion of the work, and shall be payable by Kallikrein LLC within a commercially reasonable time thereafter (but in no event later than forty-five (45) days of the date of invoice therefor). 7.3.2 FORECASTS. The Program Management Team shall establish a procedure for providing forecasts of customer orders for Collaboration Products pursuant to Section 6.3 above, updating such forecasts and ordering Collaboration Product, in each case within time periods sufficient to enable Kallikrein LLC to manufacture such Collaboration Products to meet such forecasts in a commercially reasonable and diligent manner. 7.4 CERTIFICATES OF ANALYSIS. The Manufacturing Party selected pursuant to Section 7.3 above shall perform, or cause its contract manufacturer(s) to perform, quality assurance and control tests on each lot of Collaboration Products before delivery and shall prepare, or cause its contract manufacturer(s) to prepare and deliver, a written report of the results of such tests (for purposes of Sections 7.4, 7.5 and 7.6, such contract manufacturer(s) shall be included in the definition of the term "Manufacturing Party"). Each test report shall set forth for each lot delivered the items tested, specifications and results in a certificate of analysis containing the types of information which shall have been approved by the Program Management Team or required by the FDA or other applicable regulatory authority. The Manufacturing Party shall maintain such certificates for a period of not less than five (5) years from the date of manufacture and for so long as required under applicable requirements of the FDA or other applicable regulatory authority. 20 7.5 CERTIFICATES OF MANUFACTURING COMPLIANCE. The Manufacturing Party shall prepare, or cause its contract manufacturer(s) to prepare and deliver, and maintain for a period of not less than five (5) years and for so long as required under applicable requirements of the FDA or other applicable regulatory authority for each lot of Collaboration Products manufactured a certificate of manufacturing compliance containing the types of information which shall have been approved by the Program Management Team or required by the FDA or other applicable regulatory authority, which certificate will certify that the lot of Collaboration Products was manufactured in accordance with the Specifications and the Good Manufacturing Practices of the FDA or other applicable regulatory authority as the same may be amended from time to time. The Manufacturing Party shall advise the other Parties immediately if an authorized agent of the FDA or other regulatory authority visits any of the Manufacturing Party's manufacturing facilities, or the facilities where the Collaboration Products are being manufactured, for an inspection with respect to the Collaboration Products. The Manufacturing Party shall furnish to the other Parties the report by such agency of such visit, to the extent that such report relates to Collaboration Products, within ten (10) business days of the Manufacturing Party's receipt of such report, and the other Parties shall have the right to comment on any response by the Manufacturing Party to such inspecting agency. 7.6 ACCESS TO FACILITIES. Each Party shall have the right to inspect those portions of the manufacturing, finish processing or storage facilities and testing labs of the Manufacturing Party where Collaboration Products are being manufactured, finished, stored or tested, or any subcontractor who is manufacturing, finishing, storing or testing Collaboration Products for the Manufacturing Party, at any time during regular business hours and upon reasonable advance notice to ascertain compliance with the Good Manufacturing Practices of the FDA or other applicable regulatory authority, as the same may be amended from time to time. Any confidential information disclosed to or otherwise gathered by the Party conducting such inspection during any such inspection shall be deemed "Information" as defined in Section 10.1 below. ARTICLE 8 MANAGEMENT 8.1 PROGRAM MANAGEMENT TEAM. 8.1.1 GENERAL. The Parties have established a Program Management Team to oversee and control development of Collaboration Products and to prepare for and oversee the launch of Collaboration Products. The Program Management Team shall be composed of not more than three (3) representatives appointed by Dyax and three (3) representatives appointed by Genzyme. Such representatives will include individuals with expertise and responsibilities in such areas as preclinical development, clinical development, manufacturing, regulatory affairs, marketing, sales management and reimbursement. The Program Management Team shall meet as needed, but not less than monthly unless the Parties mutually agree otherwise. The Program Management Team shall appoint one of its members to act as Secretary. Such meetings shall be at times and places or in such form (e.g., telephone or video conference) as the members of the Program Management Team shall agree. A Party may change one or more of its representatives to the Program Management Team at any time. Members of the Program Management Team may be represented at any meeting by another member of the Program Management Team or by a deputy. Any approval, determination or other action agreed to by a majority of the members of the Program Management Team appointed by each of Dyax and Genzyme or their deputies present at the relevant Team meeting shall be the approval, determination or other action of the 21 Program Management Team, provided at least two (2) representatives of each of Dyax and Genzyme are present at such meeting. Representatives of either Dyax and Genzyme who are not members of the Program Management Team may attend meetings of the Program Management Team as agreed to by the representative members of the other Party. The Program Management Team may designate project leaders to the extent it deems it necessary or advisable. 8.1.2 DEVELOPMENT PROGRAM FUNCTIONS. During the term of the Development Program, the Program Management Team shall coordinate, expedite and control the development of Collaboration Products to obtain Regulatory Approvals. The Program Management Team will (a) develop and recommend to the Steering Committee Development Plans (including annual development budgets), (b) facilitate the flow of information with respect to development work being conducted for each Collaboration Product throughout the Territory and (c) discuss and cooperate regarding the conduct of such development work. 8.1.3 COMMERCIALIZATION FUNCTIONS. Following submission of filings for Regulatory Approvals for the first Collaboration Product, the functions of the Program Management Team shall be expanded to include: (a) monitoring the commercialization of Collaboration Products pursuant to the Commercialization Plan, including oversight of planning, annual budgeting, manufacturing, marketing, sales and distribution, and licensing of Collaboration Products; (b) monitoring actual expenses incurred in the manufacture, marketing, sale and distribution of Collaboration Products; (c) overseeing any post-marketing studies of a Collaboration Product and (d) facilitating cooperation regarding the commercialization and marketing activities of the Parties. In addition, following the formation of Kallikrein LLC, the Program Management Team shall function as the operational staff of Kallikrein LLC. 8.1.4 MINUTES. The Program Management Team shall keep accurate minutes of its deliberations which shall record all proposed decisions and all actions recommended or taken. The Secretary shall be responsible for the preparation of draft minutes. Draft minutes shall be sent to all members of the Program Management Team within five (5) working days after each meeting and shall be approved, if appropriate, at the next meeting. All records of the Program Management Team shall at all times be available to all of the Parties. 8.2 STEERING COMMITTEE. 8.2.1 GENERAL. The Parties have established a Steering Committee to oversee and manage the collaboration contemplated by this Agreement. The Steering Committee is and shall continue to be composed of three (3) representatives appointed by Dyax and three (3) representatives appointed by Genzyme. Such representatives will be senior officers and/or managers of their respective companies. Genzyme and Dyax shall each designate one (1) of their respective representatives on the Steering Committee to act as Co-Chairman. The Steering Committee shall appoint one (1) of its members to act as Secretary. The Steering Committee will meet as needed but not less than once each calendar quarter. Such meetings shall be at times and places or in such form (e.g., telephone or video conference) as the members of the Steering Committee shall agree. A Party may change one or more of its representatives to the Steering Committee at any time. Members of the Steering Committee may be represented at any meeting by another member of the Steering Committee or by a deputy. Any approval, determination or other action agreed to by unanimous consent of the members of the Steering Committee or their deputies present at the relevant Steering Committee meeting shall be the approval, determination or other action of the Steering Committee, provided at least two (2) representatives of each of 22 Dyax and Genzyme are present at such meeting. Representatives of either Dyax and Genzyme who are not members of the Steering Committee may attend meetings of the Steering Committee as agreed to by the representative members of the other Party. 8.2.2 FUNCTIONS. The Steering Committee shall perform the following functions: (a) determine the overall strategy for the Program in the manner contemplated by this Agreement; (b) coordinate the activities of the Parties hereunder; (c) settle disputes or disagreements that are unresolved by the Program Management Team; (d) approve any agreements with Third Parties regarding a Collaboration Product or which involve the grant of any rights related to the development, manufacture or marketing of a Collaboration Product; (e) review and approve each Development Plan, including each significant change and annual update thereto, submitted to it pursuant to Section 5.1.3 hereof; (f) review and approve each Commercialization Plan, including each significant change and annual update thereto, submitted to it for approval pursuant to Section 6.1.2 hereof; (g) following the formation of Kallikrein LLC, serve as the governing body of Kallikrein LLC; and (h) perform such other functions as appropriate to further the purposes of this Agreement as determined by the Parties. 8.2.3 MINUTES. The Steering Committee shall keep accurate minutes of its deliberations which shall record all proposed decisions and all actions recommended or taken. The Secretary shall be responsible for the preparation of draft minutes. Draft minutes shall be sent to all members of the Steering Committee within ten (10) working days after each meeting and shall be approved, if appropriate, at the next meeting. All records of the Steering Committee shall at all times be available to both Dyax and Genzyme. 8.3 GENERAL DISAGREEMENTS. All disagreements within the Program Management Team and the Steering Committee shall be subject to the following: (a) The representatives to the Program Management Team or Steering Committee will negotiate in good faith for a period of not less than thirty (30) days to attempt to resolve the dispute. In the case of the Program Management Team, any unresolved dispute shall be referred to the Steering Committee for good faith negotiations for an additional period of not less than thirty (30) days to attempt to resolve the dispute. (b) In the event that the dispute is not resolved after the period specified in clause (a), the representatives shall promptly present the disagreement to the Chief Executive Officers of Dyax and Genzyme or a designee of such Chief Executive Officer reasonably acceptable to the other Party. (c) Such executives shall meet or discuss in a telephone or video conference each of Dyax and Genzyme's views and explain the basis for such dispute. (d) If such executives cannot resolve such disagreement within sixty (60) days after such issue has been referred to them, then such dispute shall be referred to arbitration as described in Section 14.10 hereof. ARTICLE 9 INTELLECTUAL PROPERTY RIGHTS 9.1 OWNERSHIP. The Parties acknowledge that the ownership rights set forth herein (a) shall not be affected by the participation in the discovery or development of an Invention (as defined below) by the Program Management Team or the Steering Committee in the course of 23 discharging their duties hereunder and (b) are subject to the license grants set forth in Article 3 above. 9.1.1 OWNERSHIP AND ASSIGNMENT OF DISCOVERIES AND IMPROVEMENTS. All right, title and interest in all writings, inventions, discoveries, improvements and other technology, whether or not patentable or copyrightable, and any patent applications, patents or copyrights based thereon (collectively, the "INVENTIONS") that are discovered, made or conceived during and in connection with the Program solely by employees of Dyax or others acting on behalf of Dyax ("DYAX INVENTIONS") shall be owned by Dyax. All right, title and interest in all Inventions that are discovered, made or conceived during and in connection with the Program solely by employees of Genzyme or others acting on behalf of Genzyme ("GENZYME INVENTIONS") shall be owned by Genzyme. All right, title and interest in all Inventions that are discovered, made or conceived during and in connection with the Program jointly by employees of Dyax and Genzyme ("JOINT INVENTIONS") shall be jointly owned by Genzyme and Dyax. Each of Dyax and Genzyme shall promptly disclose to Kallikrein LLC and the other Party the making, conception or reduction to practice of Inventions by employees or others acting on behalf of such Party. All Dyax Inventions, Genzyme Inventions and Joint Inventions shall be automatically licensed to Kallikrein LLC in accordance with the provisions of Section 3.1 hereof. 9.1.2 OWNERSHIP OF TRADEMARKS. The Steering Committee shall select and Kallikrein LLC shall own all trademarks for the sale and use of Collaboration Products in the Territory, and all expenses thereof shall be considered Program Costs. All such trademarks shall be registered in the name of Kallikrein LLC if and when registered. In the event that the applicable laws and regulations of any country in which the Steering Committee elects to register any such trademark require that such trademark be registered in the name of an entity other than Kallikrein LLC, or if the Steering Committee determines that it is in the best interests of the parties, then the Steering Committee shall select such entity and ensure that a duly authorized officer of such entity agrees in writing that such entity shall (a) grant Kallikrein LLC a worldwide, exclusive, fully-paid, royalty-free, irrevocable (during the term of this Agreement) right and license (with the right to grant sublicenses) to use such trademark and (b) comply with the provisions of Article 13 hereof with respect to the ownership and/or disposition of such trademark in the event this Agreement is terminated and provide the level of cooperation described in Section 14.1 hereof in connection therewith. 9.1.3 COOPERATION OF EMPLOYEES. Each of Dyax and Genzyme represents and agrees that all employees or others acting on its behalf in performing its obligations under this Agreement shall be obligated under a binding written agreement to assign to such Party, or as such Party shall direct, all Inventions made or conceived by such employee or other person. In the case of non-employees working for other companies or institutions on behalf of Dyax or Genzyme, Dyax or Genzyme, as applicable, shall have the right to obtain licenses for all Inventions made by such non-employees on behalf of Dyax or Genzyme, as applicable, in accordance with the policies of said company or institution. Dyax and Genzyme agree to undertake to enforce such agreements (including, where appropriate, by legal action) considering, among other things, the commercial value of such Inventions. 9.2 FILING, PROSECUTION AND MAINTENANCE OF PATENT RIGHTS. 9.2.1 FILING, PROSECUTION AND MAINTENANCE. Each of Dyax and Genzyme shall be responsible for the filing, prosecution and maintenance of all patent applications and patents 24 which make up its Patent Rights. The Steering Committee shall designate either Dyax or Genzyme as the Party responsible for the filing, prosecution and maintenance of all patent applications and patents which make up the Joint Patent Rights. For so long as any of the license grants set forth in Article 3 hereof remain in effect and upon request of the other Party, each of Dyax and Genzyme agrees to file and prosecute patent applications and maintain the patents covering the Patent Rights for which it is responsible in all countries in the Territory selected by the Steering Committee. Each of Dyax and Genzyme shall consult with and keep the other fully informed of important issues relating to the preparation and filing (if time permits), prosecution and maintenance of such patent applications and patents, and shall furnish to the other Party copies of documents relevant to such preparation, filing, prosecution or maintenance in sufficient time prior to filing such document or making any payment due thereunder to allow for review and comment by the other Party and, to the extent possible in the reasonable exercise of its discretion, the filing Party shall incorporate all such comments. 9.2.2 PATENT FILING COSTS. All costs associated with filing, prosecuting and maintaining patent applications and patents covering each of Dyax and Genzyme's Patent Rights and the Joint Patent Rights specific to the Field in the Territory (including costs relating to patent oppositions, interferences, reexaminations and reissues) shall be deemed Development Costs; PROVIDED, HOWEVER, that if the subject matter of any such Patent Rights would include claims outside the Field, one-half (1/2) of such costs shall be deemed Development Costs. 9.3 COOPERATION. Each of Dyax and Genzyme shall make available to the other Party (or to the other Party's authorized attorneys, agents or representatives) its employees, agents or consultants to the extent necessary or appropriate to enable the appropriate Party to file, prosecute and maintain patent applications and resulting patents with respect to inventions owned by a Party and for periods of time sufficient for such Party to obtain the assistance it needs from such personnel. Where appropriate, each of Dyax and Genzyme shall sign or cause to have signed all documents relating to said patent applications or patents at no charge to the other Party. 9.4 NOTIFICATION OF PATENT TERM RESTORATION. Each of Dyax and Genzyme shall notify the other Party of (a) the issuance of each United States patent included within the Patent Rights for which the notifying Party is responsible, giving the date of issue and patent number for each such patent, and (b) each notice pertaining to any patent included within the Patent Rights for which the notifying Party is responsible which it receives as patent owner pursuant to the Drug Price Competition and Patent Term Restoration Act of 1984, including notices pursuant to Sections 101 and 103 of such Act from persons who have filed an abbreviated NDA. Such notices shall be given promptly, but in any event within ten (10) business days after receipt of each such notice pursuant to such Act. Each of Dyax and Genzyme shall notify the other Party of each filing for patent term restoration under such Act, any allegations of failure to show due diligence and all awards of patent term restoration (extensions) with respect to the Patent Rights for which the notifying Party is responsible. 9.5 NO OTHER TECHNOLOGY RIGHTS. Except as otherwise expressly provided in this Agreement, under no circumstances shall a Party hereto, as a result of this Agreement, obtain any ownership interest in or other right to the Patent Rights, Technology or Manufacturing Know-How of the other Party, including items owned, controlled or developed by the other Party, or transferred by the other Party to said Party at any time pursuant to this Agreement. It is understood and agreed that this Agreement does not grant either Party any license or other right 25 in the Patent Rights of the other Party for uses other than as specified in Article 3 hereof and this Article 9. 9.6 ENFORCEMENT OF PATENT RIGHTS; DEFENSE OF INFRINGEMENT ACTIONS. Dyax and Genzyme shall each promptly notify the other in writing of any alleged or threatened infringement of any patents or patent applications for which it is responsible pursuant to Section 9.2 above or if either Party, or any of their respective Affiliates, shall be individually named as a defendant in a legal proceeding by a Third Party for infringement of a patent because of the manufacture, use or sale of a Collaboration Product or because of attempts to invalidate Patent Rights. 9.6.1 FIRST RIGHT TO RESPOND. Each of Dyax and Genzyme shall have the first right to respond to or defend (in consultation with the Steering Committee) against such challenge or infringement of the Patent Rights for which it is responsible pursuant to Section 9.2 above or charge of infringement. Such right shall be exercised in a diligent and timely manner in order to protect the rights of the Parties in the Patent Rights. In the event such Party elects to so respond or defend, the other Party will cooperate with the responding Party's legal counsel, join in such suits as may be brought by the responding Party to enforce its Patent Rights, and be available at the responding Party's reasonable request to be an expert witness or otherwise to assist in such proceedings. 9.6.2 SHARING OF LITIGATION AND SETTLEMENT EXPENSES. The costs incurred (a) in responding to or defending against a challenge to or infringement of a Party's Patent Rights specific to the Field or a charge that the manufacture, use or sale of Collaboration Products infringe upon the Patent Rights of Third Parties, (b) in settling any such actions, which may not be done without the prior written consent of the Steering Committee, which consent shall not be unreasonably withheld or delayed, and (c) as damages paid as a result of such actions shall be deemed Program Costs. 9.6.3 SECOND RIGHT TO RESPOND. If a Party does not exercise its right to respond to or defend against challenges or infringements of its Patent Rights as provided in Section 9.6.1 above within thirty (30) days of becoming aware of or being notified of such challenges or infringements, then the other Party shall have the option to do so at its sole cost; PROVIDED that in such case all amounts so recovered from such Third Party shall be retained by the Party undertaking such response or defense and the Party so responding shall have no further obligations to the other Party with respect to the response or defense thereof. ARTICLE 10 CONFIDENTIALITY 10.1 NONDISCLOSURE OBLIGATIONS. Except as otherwise provided in this Article 10, during the term of this Agreement and for a period of five (5) years thereafter, the Parties shall maintain in confidence and use only for purposes specifically authorized under this Agreement (a) confidential information and data resulting from or related to the development, commercialization or marketing of Collaboration Products and (b) all information and data not described in clause (a) but supplied by one Party to the other under this Agreement or in the course of the Parties' due diligence investigations prior to the execution of this Agreement and marked or identified as "Confidential." 26 For purposes of this Article 10, information and data described in clause (a) or (b) of the preceding paragraph shall be referred to as "INFORMATION." To the extent it is reasonably necessary or appropriate to fulfill its obligations or exercise its rights under this Agreement, a Party may disclose Information it is otherwise obligated under this Section not to disclose to its Affiliates, sublicensees, employees, consultants, outside contractors and clinical investigators, on a need-to-know basis and on the condition that such entities or persons agree to keep the Information confidential for the same time periods and to substantially the same extent as such Party is required to keep the Information confidential; and a Party or its sublicensees may disclose such Information to government or other regulatory authorities to the extent that such disclosure is reasonably necessary to obtain patents or authorizations to conduct clinical trials with and to market commercially Collaboration Products. The obligation not to disclose Information shall not apply to any part of such Information that: (i) is or becomes patented, published or otherwise becomes publicly known other than by acts of the Party obligated not to disclose such Information or its Affiliates or sublicensees in contravention of this Agreement; (ii) can be shown by written documents to have been disclosed to the receiving Party or its Affiliates or sublicensees by a Third Party, PROVIDED that such Information was not obtained by such Third Party directly or indirectly from the other Party under this Agreement; (iii) prior to disclosure under this Agreement, was already in the possession of the receiving Party or its Affiliates or sublicensees, PROVIDED that such Information was not obtained directly or indirectly from the other Party under this Agreement; (iv) can be shown by written documents to have been independently developed by the receiving Party or its Affiliates without use of the other Party's Information or breach of any of the provisions of this Agreement; or (v) is disclosed by the receiving Party pursuant to a subpoena lawfully issued by a court or governmental agency, PROVIDED that the receiving Party notifies the other Party immediately upon receipt of any such subpoena. 10.2 TERMS OF THIS AGREEMENT; PRESS RELEASES. The Parties agree to seek confidential treatment for any filing of this Agreement with the Securities and Exchange Commission and shall agree upon the content of the request for confidential treatment made by each Party in respect of such filing. Except as permitted by the foregoing provisions or as otherwise required by law, Dyax and Genzyme each agree not to disclose any terms or conditions of this Agreement to any Third Party without the prior consent of the other Party. The Parties agree that all press releases related to the Program shall be issued jointly by Dyax and Genzyme and that the Party preparing any such press release shall provide the other Party with a draft thereof reasonably in advance of disclosure so as to permit the other Party to review and comment on such press release. 10.3 PUBLICATIONS. Each Party recognizes the mutual interest in obtaining valid patent protection. Consequently, any Party, its employees or consultants wishing to make a publication (including any oral disclosure made without obligation of confidentiality) relating to work performed by such Party as part of the Program (the "PUBLISHING PARTY") shall transmit to a representative of the other Party (the "REVIEWING PARTY") on the Program Management Team a copy of the proposed written publication at least thirty (30) days prior to submission for publication, or an abstract of such oral disclosure at least ten (10) days prior to submission of the abstract or the oral disclosure, whichever is earlier. The Reviewing Party shall have the right to (a) request a delay in publication or presentation in order to protect patentable information, (b) propose modifications to the publication for patent reasons or (c) request that the information be maintained as a trade secret. 27 If the Reviewing Party requests a delay as described in clause (a) above, the Publishing Party shall delay submission or presentation of the publication for a period of ninety (90) days to enable patent applications protecting each Party's rights in such information to be filed. Upon the expiration of thirty (30) days, in the case of proposed written disclosures, or ten (10) days, in the case of an abstract of proposed oral disclosures, from transmission of such proposed disclosures to the Reviewing Party, the Publishing Party shall be free to proceed with the written publication or the oral presentation, respectively, unless the Reviewing Party has requested the delay described above. To the extent possible in the reasonable exercise of its discretion, the Publishing Party shall incorporate all modifications proposed under clause (b) above. If a trade secret that is the subject of a request made under clause (c) above cannot be otherwise protected without unreasonable expense to the Reviewing Party, such information shall be omitted from the publication. ARTICLE 11 REPRESENTATIONS AND WARRANTIES 11.1 AUTHORIZATION. Each Party warrants and represents to the other Parties that (a) 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 perform fully its obligations hereunder, (b) this Agreement has been duly executed and delivered and is a valid and binding agreement of such Party, enforceable in accordance with its terms, (c) such Party has obtained all necessary approvals to the transactions contemplated hereby and (d) such Party has not made and will not make any commitments to others in conflict with or in derogation of such rights or this Agreement. 11.2 INTELLECTUAL PROPERTY RIGHTS. On the LLC Formation Date, and prior to granting the licenses set forth in Article 3 hereof, the Parties will represent and warrant to each other as follows: 11.2.1 Dyax will represent and warrant that, as of the LLC Formation Date, (a) the Dyax Patent Rights and the Dyax Technology are free and clear of any lien or other encumbrance and (b) it has the right to (i) enter into the obligations set forth in this Agreement and (ii) grant the rights and licenses set forth in Article 3 hereof. 11.2.2 Genzyme will represent and warrant that, as of the LLC Formation Date, (a) the Genzyme Patent Rights and the Genzyme Technology are free and clear of any lien or other encumbrance and (b) it has the right to (i) enter into the obligations set forth in this Agreement and (ii) grant the rights and licenses set forth in Article 3 hereof. 11.3 WARRANTIES. 11.3.1 GENZYME WARRANTIES. Genzyme warrants that (i) any Collaboration Products delivered by Genzyme pursuant to Section 7.3 hereof, if any, will conform in all material respects to the Specifications, the conditions of any applicable Regulatory Approvals regarding the manufacturing process and any applicable requirements of the Regulatory Scheme regarding the manufacturing process and (ii) the Collaboration Products sold pursuant to Section 6.2 hereof will be marketed and sold in all material respects in accordance with the conditions of 28 all applicable laws and regulations, including any applicable Regulatory Approvals and any applicable labeling claims. 11.3.2 DYAX WARRANTIES. Dyax warrants that any Collaboration Products delivered by Dyax pursuant to Sections 7.2 or 7.3 hereof will conform in all material respects to the Specifications, the conditions of any applicable Regulatory Approvals regarding the manufacturing process and any applicable requirements of the Regulatory Scheme regarding the manufacturing process. 11.4 DISCLAIMER OF REPRESENTATIONS AND WARRANTIES. EXCEPT AS OTHERWISE EXPRESSLY SET FORTH IN THIS AGREEMENT, NONE OF DYAX, GENZYME OR KALLIKREIN LLC MAKES ANY REPRESENTATIONS OR EXTENDS ANY WARRANTIES OF ANY KIND, EITHER EXPRESS OR IMPLIED, INCLUDING WITHOUT LIMITATION WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, AND THE NON-INFRINGEMENT OF ANY THIRD-PARTY PATENTS OR PROPRIETARY RIGHTS. ALL UNIFORM COMMERCIAL CODE WARRANTIES ARE EXPRESSLY DISCLAIMED BY THE PARTIES. 11.5 LIMITATION OF LIABILITY. It is agreed by the Parties that no Party shall have a right to or shall claim special, indirect or consequential damages, including lost profits, for breach of this Agreement. Remedies shall be limited to claims for amounts due hereunder or as otherwise provided in this Agreement, including claims for indemnification as provided in Section 12.1 hereof. ARTICLE 12 INDEMNITY 12.1 INDEMNITY OBLIGATIONS PRIOR TO GENZYME'S EXERCISE OF BUY-IN OPTION. Each Party (the "INDEMNIFYING Party") shall defend, indemnify and hold harmless the other Party (the "INDEMNIFIED PARTY") and its directors, officers, employees and agents from and against any and all claims, liabilities, losses and expenses, including attorney's fees, incurred by or asserted against the Indemnified Party or any of the foregoing prior to Genzyme's exercise of its Buy-In Option arising out of the development, testing, manufacture, handling or storage by the Indemnifying Party of any Collaboration Product in accordance with the Development Plan or Commercialization Plan, as the case may be, except to the extent such claims, liabilities, losses and expenses result from the negligent, reckless or intentional acts or omissions of the Indemnified Party, in which case the Indemnified Party shall indemnify and hold harmless the Indemnifying Party and its directors, officers, employees and agents. 12.2 KALLIKREIN LLC INDEMNITY OBLIGATIONS. The Operating Agreement shall provide that Kallikrein LLC shall indemnify each of the Members and its Affiliates, employees and agents (each an "INDEMNIFIED PERSON") for any act performed by such Indemnified Person within the scope of the authority conferred upon such Indemnified Person under this Agreement; PROVIDED that it shall be a condition to such indemnity that (a) the Indemnified Person seeking indemnification acted in good faith and in a manner reasonably believed to be in, or not opposed to, the best interests of Kallikrein LLC, (b) the act for which indemnification is sought did not constitute gross negligence or willful misconduct by such Indemnified Person and (c) payment and indemnification of any matter disposed of by a compromise payment by such Indemnified 29 Person, pursuant to consent decree or otherwise, shall have been approved by the Members, which approval shall not be unreasonably withheld or delayed, or by a court of competent jurisdiction. 12.3 INSURANCE. 12.3.1 Kallikrein LLC shall obtain and maintain product liability insurance with respect to the design, development, manufacture, modification, distribution and sale of Collaboration Products and comprehensive general liability insurance, each in amounts reasonably believed by Genzyme and Dyax to be adequate and customary for the development, manufacture and sale of novel therapeutic products and for the property of Kallikrein LLC. Each such insurance policy shall be for an amount determined by the Steering Committee. The insurance will contain a deductible to be determined by the Steering Committee. Genzyme shall obtain and maintain such insurance on behalf of Kallikrein LLC. The aforementioned product liability and comprehensive general liability insurance shall be obtained as soon as practicable after the LLC Formation Date, but in no event later than ninety (90) days thereafter, from an insurance carrier approved by the Steering Committee. The costs of all such insurance shall be included in the Program Costs. 12.3.2 Genzyme and Dyax shall each maintain at their own cost similar product liability and comprehensive general liability insurance coverage in amounts reasonably determined by the Steering Committee from time to time. Genzyme and Dyax shall each also provide coverage for Kallikrein LLC after Genzyme's exercise of its Buy-In Option in excess of any valid and collectible insurance available from Kallikrein LLC by including their respective Percentage Interests under their respective product liability insurance policies to the extent their respective interests appear and to the extent such Parties are legally obligated to pay. Genzyme shall also provide coverage for Kallikrein LLC under its property and transit insurance policies, with the costs of the associated insurance premiums to be included in the Program Costs subject to reimbursement by Kallikrein LLC within thirty (30) days after receipt of an invoice therefor. 12.3.3 Each Party will furnish the other Parties a certificate(s) from an insurance carrier (having a minimum AM Best rating of B) showing all insurance set forth above. 12.3.4 The insurance certificate(s) showing Kallikrein LLC's insurance will include the following statement: "The insurance certified hereunder is applicable to all contracts between Genzyme Corporation, Dyax Corp. and the Insured. This insurance may be canceled or altered only after ten (10) days' written notice to Genzyme Corporation and Dyax Corp." The insurance, and the certificate(s), will (a) name each of Genzyme and Dyax (including their respective officers, directors, employees, Affiliates, agents, successors and assigns) as additional insureds with respect to matters arising from this Agreement, (b) provide that such insurance is primary to any liability insurance carried by Genzyme and Dyax and (c) provide that underwriters and insurance companies of Kallikrein LLC may not have any right of subrogation against Genzyme or Dyax (including their respective officers, directors, employees, servants, Affiliates, agents, successors and assigns) except in the event a claim results from Genzyme's or Dyax's respective gross negligence or willful misconduct. Such certificate(s) shall be made available to each Party upon reasonable advance request. 30 12.3.5 The Steering Committee shall review the adequacy of the insurance described above on a quarterly basis and the Steering Committee shall have the power to reasonably direct the modification of such insurance. ARTICLE 13 TERM AND TERMINATION 13.1 TERM. The term of this Agreement shall be perpetual unless terminated pursuant to Section 13.2 below. 13.2 TERMINATION. This Agreement may be terminated in the following circumstances: 13.2.1 FOR CERTAIN MATERIAL BREACHES. If either Dyax or Genzyme (a) fails to use commercially reasonable and diligent efforts to perform any material duty imposed upon such Party under this Agreement or a Development Plan or Commercialization Plan or (b) following the formation of Kallikrein LLC, fails to make two (2) or more capital contributions in accordance with Article 4 hereof, and such failure to perform is not cured within ninety (90) days of written notice thereof from the non-breaching Party, the non-breaching Party may elect, in its sole discretion, to (i) in the case of clause (b) above, waive the terms of Article 4 hereof with respect to any one or more required capital contributions and cause the respective Percentage Interests and future funding responsibilities of the Parties to be adjusted in accordance with Section 4.3.1 hereof or (ii) terminate this Agreement with the consequences set forth in Section 13.3.1 below. Such 90-day period shall be extended to one hundred eighty (180) days if the breaching Party has engaged in good faith efforts to remedy such default within such 90-day period and indicated in writing to the non-breaching Party prior to the expiration of such 90-day period that it believes that it will be able to remedy the default within such 180-day period, but such extension shall apply only so long as the breaching Party is engaging in good faith efforts to remedy such default. 13.2.2 FOR CONVENIENCE. Either Dyax or Genzyme may elect to terminate this Agreement for any reason at any time after the satisfaction by Dyax of the Initial Funding Commitment upon one (1) year prior written notice to the other Party (during which one year period the obligations of the Parties, including without limitation obligations with respect to the funding of Program Costs, shall continue in full force and effect) with the consequences set forth in Section 13.3.2 below. 13.2.3 UPON CHANGE OF CONTROL. Either Dyax or Genzyme may terminate this Agreement with the consequences set forth in Section 13.3.3 in the event that the other Party is a party to a transaction involving (a) a merger or consolidation in which such party is not the surviving entity or (b) the sale of all or substantially all of the assets of such Party to a Third Party. Termination of this Agreement pursuant to this Section 13.2.3 shall be effective as of the effective date of such transaction. 13.2.4 UPON BANKRUPTCY. Either Dyax or Genzyme may terminate this Agreement with the consequences set forth in Section 13.3.4 below upon the bankruptcy, insolvency, dissolution or winding-up of the other Party, except in the case of a petition in bankruptcy filed involuntarily against a Party, if such petition is dismissed within sixty (60) days of the date of its filing. 31 13.2.5 UPON GENZYME'S FAILURE TO EXERCISE ITS BUY-IN OPTION. Either Dyax or Genzyme may terminate this Agreement with the consequences set forth in Section 13.3.5 below in the event that Genzyme declines to exercise its Buy-In Option pursuant to Section 4.2 hereof. 13.3 EFFECTS OF TERMINATION. 13.3.1 FOR CERTAIN MATERIAL BREACHES. In addition to the rights and duties set forth in Sections 13.4 and 13.5 below, Dyax and Genzyme shall have the following rights and duties upon termination of this Agreement pursuant to Section 13.2.1(ii) above: (a) the non-breaching Party shall obtain from the breaching Party the worldwide, exclusive, irrevocable right and license, with the right to grant sublicenses, under the breaching Party's Patent Rights, Technology, rights in Joint Technology and Joint Patent Rights, and Manufacturing Know-How to develop, make, have made, use, offer for sale, sell, have sold, import and export Collaboration Products in the Field and in the Territory, and the breaching Party shall execute such documents and take all action as may be necessary or desirable to effect the foregoing; PROVIDED that such license shall be for the same level of exclusivity as the rights that had been or would be granted with respect thereto under Section 3.1 hereof; and PROVIDED, FURTHER, that any license granted hereunder shall be subject to the obligation of the non-breaching Party to use commercially reasonable and diligent efforts to develop and market Collaboration Products pursuant to such license; (b) if applicable, the breaching Party shall assign and transfer all of its interest in Kallikrein LLC to the non-breaching Party, and the non-breaching Party may dissolve Kallikrein LLC in its sole discretion; provided that in the event that Dyax is the breaching party, it shall also cause Subsidiary to assign and transfer all of its interest in Kallikrein LLC to Genzyme. (c) (i) any licenses granted pursuant to Article 3 shall be revoked, (ii) if Kallikrein LLC does not yet exist or is dissolved, any applicable Regulatory Approvals (other than any Regulatory Approvals filed in the name of an entity other than Kallikrein LLC or the non-breaching Party pursuant to Section 5.3 hereof), pre-clinical and clinical data owned or licensed by Kallikrein LLC or the breaching Party and any trademarks owned or licensed by Kallikrein LLC (other than any trademarks registered in the name of an entity other than Kallikrein LLC or the non-breaching Party pursuant to Section 9.1.2 hereof) shall be assigned or licensed to the non-breaching Party and (iii) any Regulatory Approvals filed and any trademarks registered in the name of an entity other than Kallikrein LLC or the non-breaching Party shall be (A) exclusively licensed to Kallikrein LLC, the non-breaching Party or any Third Party or Affiliate designated by such Party until such time as Kallikrein LLC, the non-breaching Party or its designee is qualified to hold such Regulatory Approvals or trademarks under the applicable provisions of the Regulatory Scheme and (B) transferred or assigned to Kallikrein LLC, the non-breaching Party or its designee, as appropriate, as soon as practicable thereafter; and (d) the non-breaching Party shall become obligated to pay the breaching Party an amount equal to (i) eighty percent (80%) of the Fair Value (as defined in Section 13.3.6 below) of the breaching Party's interest in the Collaboration Products as of the date of termination, PLUS (ii) if applicable, the non-terminating Party's Percentage Interest of the net asset value of Kallikrein LLC as of the date of termination after deduction of net assets included in the Fair Value of Collaboration Products, PLUS (iii) interest thereon at the Base Rate 32 of interest declared from time to time by BankBoston, N.A. in Boston, Massachusetts from the date of termination to the date payment is made (the "BREACH BUYOUT AMOUNT"), payable as follows: (1) if the non-breaching Party elects to sell or otherwise dispose of all or any portion of its or its Affiliates' right, title and interest in the Collaboration Products, then the non-breaching Party shall, upon any such sale or other disposition, pay the breaching Party an amount equal to seventy-five percent (75%) of the net proceeds of such sale or other disposition when such payments are actually paid; (2) for as long as the non-breaching Party (together, in the case of Dyax with Subsidiary) has not sold or otherwise disposed of all or a portion of its (together in the case of Dyax, with Subsidiaries) right, title and interest in the Collaboration Products which is equal to or greater than the breaching Party's (together in the case of Dyax, with Subsidiaries) Percentage Interest as of the date of termination, the non-breaching Party shall pay the breaching Party (and, in the event that Dyax is the breaching Party, Subsidiary) a percentage of Net Profits, which percentage shall equal (i) the breaching Party's (and, in the event that Dyax is the breaching Party, Subsidiaries) Percentage Interest as of the date of termination minus (ii) a percentage equal to the portion of the right, title and interest in the Collaboration Products sold or otherwise disposed of by the non-breaching Party (and in the event that Dyax is the non-breaching Party, Subsidiary) as described in the preceding paragraph; and (3) on the fourth anniversary of the date of termination, the non-breaching Party shall pay the breaching Party (and, in the event that Dyax is the breaching Party, Subsidiary) the difference between the aggregate amounts paid pursuant to clauses (1) and (2) above and the Breach Buyout Amount; PROVIDED, that the aggregate amount of all payments made under clauses (1), (2) and (3) shall not exceed the Breach Buyout Amount. 13.3.2 FOR CONVENIENCE. In addition to the rights and duties set forth in Sections 13.4 and 13.5 below, Subsidiary shall have the following rights and Dyax and Genzyme shall have the following rights and duties upon termination of this Agreement pursuant to Section 13.2.2 above: (a) the non-terminating Party shall have an option exercisable upon written notice to the terminating Party within the one-year period provided in Section 13.2.2 hereof to obtain from the terminating Party the worldwide, exclusive, irrevocable right and license, with the right to grant sublicenses, under the terminating Party's Patent Rights, Technology, rights in Joint Technology and Joint Patent Rights, and Manufacturing Know-How to develop, make, have made, use, offer for sale, sell, have sold, import and export Collaboration Products in the Field and in the Territory, and the terminating Party shall execute such documents and take all action as may be necessary or desirable to affect the foregoing; PROVIDED that such license shall be for the same level of exclusivity as the rights that had been or would be granted with respect thereto under Section 3.1; and PROVIDED, FURTHER, that any license granted hereunder shall be subject to the obligation of the non-terminating Party to use commercially reasonable and diligent efforts to develop and market Collaboration Products pursuant to such license; 33 (b) if applicable, upon exercise of its license option provided in paragraph (a) of this Section 13.3.2, the terminating Party shall assign and transfer all of its interest in Kallikrein LLC to the non-terminating Party, and the non-terminating Party may dissolve Kallikrein LLC in its sole discretion; (c) upon exercise of its license option provided in paragraph (a) of this Section 13.3.2, (i) any licenses granted pursuant to Article 3 shall be revoked, (ii) if Kallikrein LLC does not yet exist or is dissolved, any applicable Regulatory Approvals (other than any Regulatory Approvals filed in the name of an entity other than Kallikrein LLC or the non-terminating Party pursuant to Section 5.3 hereof), pre-clinical and clinical data owned or licensed by Kallikrein LLC or the terminating Party and any trademarks owned or licensed by Kallikrein LLC (other than any trademarks registered in the name of an entity other than Kallikrein LLC or the non-terminating Party pursuant to Section 9.1.2 hereof) shall be assigned to the non-terminating Party and (iii) any Regulatory Approvals filed and any trademarks registered in the name of an entity other than Kallikrein LLC or the non-terminating Party shall be (A) exclusively licensed to Kallikrein LLC, the non-terminating Party or any Third Party or Affiliate designated by such Party until such time as Kallikrein LLC, the non-terminating Party or its designee is qualified to hold such Regulatory Approvals or trademarks under the applicable provisions of the Regulatory Scheme and (B) transferred or assigned to Kallikrein LLC, the non-terminating Party or its designee, as appropriate, as soon as practicable thereafter; (d) upon the exercise of its license option provided in paragraph (a) of this Section 13.3.2, the non-terminating Party shall become obligated to pay to the terminating Party an amount equal to (i) one hundred percent (100%) of the Fair Value (as defined in Section 13.3.6 below) of the terminating Party's interest in the Collaboration Products as of the date of termination (or, in the event that Dyax is the non-terminating Party, Genzyme shall pay the Dyax Companies an amount equal to one hundred percent (100%) of the Fair Value of the Dyax Companies' aggregate interest in the Collaboration Products as of the date of termination) PLUS (ii) if applicable, the non-terminating Party's Percentage Interest of the net asset value of Kallikrein LLC as of the date of termination after deduction of net assets included in the Fair Value of Collaboration Products, PLUS (iii) interest thereon at the Base Rate of interest declared from time to time by BankBoston, N.A. in Boston, Massachusetts from the date of termination to the date payment is made (the "CONVENIENCE BUYOUT AMOUNT"), payable on the terms and conditions and in accordance with the schedule of payments set forth in Section 13.3.1(d), MUTATIS MUTANDIS; PROVIDED, HOWEVER, that if Genzyme is the terminating Party and Dyax has not paid the outstanding balance under the Convenience Buyout Amount on the fourth anniversary of the date of termination, Genzyme shall make available to Dyax a line of credit for such outstanding balance, such line of credit to have a five (5) year term and to bear interest at a rate equal to two percent (2%) above the Base Rate of interest declared from time to time by BankBoston, N.A. in Boston, Massachusetts, and (e) if the license option provided in paragraph (a) of this Section 13.3.2 is not exercised, then all right, title and interest in the Collaboration Products shall be sold to the highest bidder within eighteen (18) months from the date of termination and the proceeds shall be allocated between the Members in proportion to their Percentage Interests as of the date of termination and if applicable, Kallikrein LLC shall be dissolved. 34 13.3.3 UPON A CHANGE OF CONTROL. In addition to the rights and duties set forth in Sections 13.4 and 13.5 below, Dyax and Genzyme shall have the following rights and duties upon termination of this Agreement pursuant to Section 13.2.3: (a) the terminating Party shall have the worldwide, exclusive, irrevocable and, except as provided in Section 13.3.3(d), royalty-free right and license, with the right to grant sublicenses, under the non-terminating Party's Patent Rights, Technology, rights in Joint Technology and Joint Patent Rights, and Manufacturing Know-How to develop, make, have made, use, offer for sale, sell, have sold, import and export Collaboration Products in the Territory and in the Field, and the non-terminating Party shall execute such documents and take all action as may be necessary or desirable to effect the foregoing; PROVIDED that such license shall be for the same level of exclusivity as the rights that had been or would be granted with respect thereto under Section 3.1; and PROVIDED, FURTHER, that any license granted hereunder shall be subject to the obligation of the terminating Party to use commercially reasonable and diligent efforts to develop and market Collaboration Products pursuant to such license; (b) if applicable, the non-terminating Party shall assign and transfer all of its interest in Kallikrein LLC to the terminating Party, and the terminating Party may dissolve Kallikrein LLC in its sole discretion; PROVIDED that in the event that Dyax is the non-terminating party, it shall also cause Subsidiary to assign and transfer all of its interest in Kallikrein LLC to Genzyme; (c) (i) any licenses granted to Article 3 shall be revoked, (ii) if Kallikrein LLC does not yet exist or is dissolved, any applicable Regulatory Approvals (other than any Regulatory Approvals filed in the name of an entity other than Kallikrein LLC or the terminating Party pursuant to Section 5.3 hereof), pre-clinical and clinical data owned or licensed by Kallikrein LLC or the non-terminating Party and any trademarks owned or licensed by Kallikrein LLC (other than any trademarks registered in the name of an entity other than Kallikrein LLC or the terminating Party pursuant to Section 9.1.2 hereof) shall be assigned or licensed to the terminating Party and (iii) any Regulatory Approvals filed and any trademarks registered in the name of an entity other than Kallikrein LLC or the terminating Party shall be (A) exclusively licensed to Kallikrein LLC, the terminating Party or any Third Party or Affiliate designated by such Party until such time as Kallikrein LLC, the terminating Party or its designee is qualified to hold such Regulatory Approvals or trademarks under the applicable provisions of the Regulatory Scheme and (B) transferred or assigned to Kallikrein LLC, the terminating Party or its designee, as appropriate, as soon as practicable thereafter; and (d) the terminating Party (the "OFFEROR") shall, pursuant to the conditions set forth in this Section 13.3(d), give the other Party (Genzyme in the case Dyax is terminating or the Dyax Companies in the case Genzyme is terminating, in either case the "OFFEREE") at the time of termination written notice of the Offeror's intention to purchase Offeree's entire interest in and to (i) the Collaboration Products as of the date of termination and (ii) if applicable, the Percentage Interest of the net asset value of Kallikrein LLC as of the date of termination (the "NOTICE OF OFFER"). The Notice of Offer shall state therein the specific price, terms and conditions under which the Offeror agrees to purchase Offeree's entire interest in and to (i) the Collaboration Products as of the date of termination and (ii) if applicable, the Percentage Interest of the net asset value of Kallikrein LLC as of the date of termination; PROVIDED, HOWEVER, that the purchase price shall be paid in cash, publicly-traded and registered securities or as the Parties otherwise agree. The Offeree shall then have ninety (90) days (the 35 "ACCEPTANCE PERIOD") from the receipt of the Notice of Offer to give notice (the "NOTICE OF ACCEPTANCE") of the Offeree's intention to accept the offer of the Offeror and shall sell Offeree's entire interest in and to (i) the Collaboration Products as of the date of termination and (ii) if applicable, the Percentage Interest of the net asset value of Kallikrein LLC as of the date of termination to Offeror for the price and upon such terms and conditions as set forth in the Notice of Offer. In the event the Offeree gives such Notice of Acceptance, a closing shall be held within ninety (90) days of the receipt of the Notice of Acceptance by the Offeror. In the event the Offeree elects not to accept the Offeror's offer to purchase, by giving the Offeror written notice thereof, or by failing to give the appropriate Notice of Acceptance within the Acceptance Period, the Offeree shall thereby automatically be bound to purchase Offeror's entire interest in and to (i) the Collaboration Products as of the date of termination and (ii) if applicable, the Percentage Interest of the net asset value of Kallikrein LLC as of the date of termination for the same price (as adjusted for Percentage Interest, if necessary) and upon such terms and conditions as specified in the Notice of Offer. In such event, a closing shall be held within ninety (90) days of the earlier to occur of the expiration of the Acceptance Period and the date of receipt of the written rejection, whichever is the first to occur. In addition to any other remedies provided by this Agreement, in the event the Offeree rejects the offer contained in the Notice of Offer, but thereafter fails for any reason to timely close as provided herein above, the Offeree shall, by such failure to close, be deemed to have accepted the original offer contained in the Notice of Offer, and shall thereafter sell Offeree's entire interest in and to (i) the Collaboration Products as of the date of termination and (ii) if applicable, the Percentage Interest of the net asset value of Kallikrein LLC as of the date of termination to the Offeror pursuant to the terms of the Notice of Offer. For purposes of Sections 13.3.3 (a)-(c) above, the Party purchasing the other Party's interest in (i) the Collaboration Products and (ii) if applicable, the Percentage Interest of the net asset value of Kallikrein LLC shall be deemed to be the terminating Party and the other Party shall be deemed to be the non-terminating Party. 13.3.4 UPON BANKRUPTCY. In addition to the rights and duties set forth in Sections 13.4 and 13.5 below, Dyax and Genzyme shall have the following rights and duties upon termination of this Agreement pursuant to Section 13.2.4 above: (a) the terminating Party shall obtain from the non-terminating Party the worldwide, exclusive, irrevocable right and license, with the right to grant sublicenses, under the non-terminating Party's Patent Rights, Technology, rights in Joint Technology and Joint Patent Rights, and Manufacturing Know-How to develop, make, have made, use, offer for sale, sell, have sold, import and export Collaboration Products in the Field and in the Territory, and the non-terminating Party shall execute such documents and take all action as may be necessary or desirable to affect the foregoing; PROVIDED that such license shall be for the same level of exclusivity as the rights that had been or would be granted with respect thereto under Section 3.1 hereof; and PROVIDED, FURTHER, that any license granted hereunder shall be subject to the obligation of the terminating Party to use commercially reasonable and diligent efforts to develop and market Collaboration Products pursuant to such license; (b) if applicable, the non-terminating Party shall assign and transfer all of its interest in Kallikrein LLC to the terminating Party, and the terminating Party may dissolve Kallikrein LLC in its sole discretion;, PROVIDED that in the event that Dyax is the non-terminating Party, it shall also cause Subsidiary to assign and transfer all of its interest in Kallikrein LLC to Genzyme. 36 (c) (i) any licenses granted to Article 3 shall be revoked, (ii) if Kallikrein LLC does not yet exist or is dissolved, any applicable Regulatory Approvals (other than any Regulatory Approvals filed in the name of an entity other than Kallikrein LLC or the terminating Party pursuant to Section 5.3 hereof), pre-clinical and clinical data owned or licensed by Kallikrein LLC or the non-terminating Party and any trademarks owned or licensed by Kallikrein LLC (other than any trademarks registered in the name of an entity other than Kallikrein LLC or the terminating Party pursuant to Section 9.1.2 hereof) shall be assigned or licensed to the terminating Party and (iii) any Regulatory Approvals filed and any trademarks registered in the name of an entity other than Kallikrein LLC or the terminating Party shall be (A) exclusively licensed to Kallikrein LLC, the terminating Party or any Third Party or Affiliate designated by such Party until such time as Kallikrein LLC, the terminating Party or its designee is qualified to hold such Regulatory Approvals or trademarks under the applicable provisions of the Regulatory Scheme and (B) transferred or assigned to Kallikrein LLC, the terminating Party or its designee, as appropriate, as soon as practicable thereafter; and (d) the terminating Party shall become obligated to pay to the non-terminating Party an amount equal to (i) one hundred percent (100%) of the Fair Value (as defined in Section 13.3.6 below) of the non-terminating Party's interest in the Collaboration Products as of the date of termination (or, in the event that Dyax is the non-terminating Party, Genzyme shall pay the Dyax Companies an amount equal to one hundred percent (100%) of the Fair Value of the Dyax Companies' aggregate interest in the Collaboration Products as of the date of termination), PLUS (ii) if applicable, the non-terminating Party's Percentage Interest of the net asset value of Kallikrein LLC as of the date of termination after deduction of net assets included in the Fair Value of Collaboration Products, PLUS (iii) interest thereon at the Base Rate of interest declared from time to time by BankBoston, N.A. in Boston, Massachusetts from the date of termination to the date payment is made (the "BANKRUPTCY BUYOUT AMOUNT"), payable on the terms and conditions and in accordance with the schedule of payments set forth in Section 13.3.1(d), MUTATIS MUTANDIS. 13.3.5 UPON GENZYME'S REFUSAL TO EXERCISE ITS BUY-IN OPTION. In addition to the rights and duties set forth in Sections 13.4 and 13.5 below, Dyax and Genzyme shall have the following rights and duties upon termination of this Agreement pursuant to Section 13.2.5 above: (a) Dyax shall have an option exercisable upon written notice to Genzyme within sixty (60) days after termination pursuant to Section 13.2.5 to obtain from Genzyme the worldwide, exclusive irrevocable right and license, with the right to grant sublicenses, under the Genzyme's Patent Rights, Genzyme Technology, Genzyme rights in Joint Technology and Joint Patent Rights, and Manufacturing Know-How to develop, make, have made, use, offer for sale, sell, have sold, import and export Collaboration Products in the Field and in the Territory, and Genzyme shall execute such documents and take all action as may be necessary or desirable to affect the foregoing; PROVIDED that such license shall be for the same level of exclusivity as the rights that had been or would be granted with respect thereto under Section 3.1; and PROVIDED, FURTHER, that any license granted hereunder shall be subject to the obligation of Dyax to use commercially reasonable and diligent efforts to develop and market Collaboration Products pursuant to such license; (b) if applicable, upon exercise of its license option provided in paragraph (a) of this Section 13.3.5, Dyax may dissolve Kallikrein LLC in its sole discretion; 37 (c) upon exercise of its license option provided in paragraph (a) of this Section 13.3.5, (i) any licenses granted pursuant to Article 3 shall be revoked, (ii) if Kallikrein LLC does not yet exist or is dissolved, any applicable Regulatory Approvals (other than any Regulatory Approvals filed in the name of an entity other than Kallikrein LLC or Dyax pursuant to Section 5.3 hereof), pre-clinical and clinical data owned or licensed by Kallikrein LLC or Genzyme and any trademarks owned or licensed by Kallikrein LLC (other than any trademarks registered in the name of an entity other than Kallikrein LLC or Dyax pursuant to Section 9.1.2 hereof) shall be assigned to Dyax and (iii) any Regulatory Approvals filed and any trademarks registered in the name of an entity other than Kallikrein LLC or Dyax shall be (A) exclusively licensed to Kallikrein LLC, Dyax or any Third Party or Affiliate designated by Dyax until such time as Kallikrein LLC, Dyax or its designee is qualified to hold such Regulatory Approvals or trademarks under the applicable provisions of the Regulatory Scheme and (B) transferred or assigned to Kallikrein LLC, Dyax or its designee, as appropriate, as soon as practicable thereafter; (d) upon the exercise of its license option provided in paragraph (a) of this Section 13.3.5, Dyax shall become obligated to pay to Genzyme an amount equal to the lesser of (i) one hundred percent (100%) of the Fair Value (as defined in Section 13.3.6 below) of Genzyme's interest in the Collaboration Products as of the date of termination) or (ii), three million dollars ($3,000,000). 13.3.6 FAIR VALUE. For purposes of this Section 13.3, the "FAIR VALUE" of a Party's interest in the Collaboration Products shall be the amount an informed and willing buyer under no compulsion to buy would be willing to pay and an informed and willing seller under no compulsion to sell would be willing to accept for all right, title and interest in such Party's interest in the Collaboration Products, determined as of the date of termination, which determination shall be made by the mutual agreement of Dyax and Genzyme. In the event that Dyax and Genzyme are unable to agree upon the Fair Value within one hundred and twenty (120) days of the date of termination, the Fair Value shall be determined by an investment banking firm selected by mutual agreement of Dyax and Genzyme, and the costs and expenses incurred in connection with the engagement of such investment banking firm shall be shared equally by Dyax and Genzyme. 13.4 INVENTORY. Upon the termination of this Agreement, if Genzyme does not obtain a license pursuant to Section 13.3 hereof, Dyax shall have the option to repurchase Genzyme's inventory of Collaboration Products acquired by Genzyme pursuant to Article 6 hereof. Within ten (10) days after such termination, Dyax shall elect in writing to either (a) permit Genzyme to sell off its remaining inventory of Collaboration Products, PROVIDED that Genzyme shall comply with all of the terms and conditions of this Agreement restricting such selling activities as in effect immediately prior to such termination, or (b) repurchase Genzyme's inventory of Collaboration Products. If Dyax fails to make such an election, Genzyme shall be permitted to sell-off its remaining inventory of Collaboration Products in accordance with clause (a) of this Section 13.4. Any repurchase of Genzyme's inventory of Collaboration Products shall be at the price as stated in Genzyme's then-current price list, LESS a handling charge to be reasonably determined by the Parties in good faith. 13.5 SURVIVAL OF RIGHTS AND DUTIES. No termination of this Agreement shall eliminate any rights or duties of the Parties accrued prior to such termination. The provisions of Article 1, Sections 2.2, 3.4, 4.4, 4.6, 9.1.1, 9.1.2, 9.1.3, 9.3, 9.5, Article 10, Sections 11.3, 11.4, 11.5, 38 Sections 12.1, 12.2, 13.2, 13.3, 13.4, 13.5, 14.1, 14.3, 14.4, 14.8, 14.9, 14.10, 14.11, and 14.12 hereof shall survive any termination of this Agreement. ARTICLE 14 MISCELLANEOUS 14.1 COOPERATION. If either Dyax or Genzyme (the "ASSUMING PARTY") shall assume the Program rights from the other Party (the "RESPONSIBLE PARTY") in accordance with the provisions of Article 13 hereof, the Responsible Party shall promptly provide to the Assuming Party (or any Third Party or Affiliate designated by the Assuming Party) all Technology, Manufacturing Know-How and access to regulatory filings sufficient to allow the Assuming Party to perform the duties assumed. The Responsible Party shall further use its best efforts to provide all assistance required by the Assuming Party with respect to such transfer so as to permit the Assuming Party to begin to perform such duties as soon as possible to minimize any disruption in the continuity of supply or marketing of Collaboration Products. If the Responsible Party is the Manufacturing Party for a Collaboration Product, the Responsible Party shall, at the option of the Assuming Party, supply such Collaboration Product to the Assuming Party, at a mutually agreeable price not to exceed the Fully Allocated Cost of Goods for such Collaboration Product, until the earlier of: (i) twenty-four (24) months from the effective date of termination and (ii) six (6) months after the Assuming Party delivers notice to the Responsible Party that the Assuming Party is able to manufacture such Collaboration Product. In addition, if upon the date this Agreement is terminated Collaboration Products are being manufactured in facilities owned or leased by the Responsible Party (including facilities subleased by Kallikrein LLC from the Responsible Party), the Responsible Party agrees to lease such facilities to the Assuming Party on commercially reasonable terms for a period of up to twenty-four (24) months. 14.2 EXCHANGE CONTROLS. All payments due hereunder shall be paid in United States dollars. If at any time legal restrictions prevent the prompt remittance of part or all payments with respect to any country in which Collaboration Products are sold, payment shall be made through such lawful means or methods as the Parties may determine in good faith. 14.3 WITHHOLDING TAXES. If applicable laws or regulations require that taxes be withheld from payments made hereunder, the Party paying such taxes will (a) deduct such taxes, (b) timely pay such taxes to the proper authority and (c) send written evidence of payment to the Party from whom such taxes were withheld within sixty (60) days after payment. Each Party will assist the other Party or Parties in claiming tax refunds, deductions or credits at such other Party's request and will cooperate to minimize the withholding tax, if available, under various treaties applicable to any payment made hereunder. 14.4 INTEREST ON LATE PAYMENTS. Any payments to be made hereunder that are not paid on or before the date such payments are due under this Agreement shall bear interest, to the extent permitted by applicable law, at the Base Rate of interest declared from time to time by BankBoston, N.A. in Boston, Massachusetts, calculated on the number of days payment is delinquent. 14.5 FORCE MAJEURE. Neither Party shall be held liable or responsible to the other Party nor be deemed to have defaulted under or breached this Agreement for failure or delay in fulfilling or performing any term of this Agreement when such failure or delay is caused by or results from causes beyond the reasonable control of the affected Party, including without limitation fire, floods, embargoes, war, acts of war (whether war is declared or not), 39 insurrections, riots, civil commotions, strikes, lockouts or other labor disturbances, acts of God or acts, omissions or delays in acting by any governmental authority or the other Party; PROVIDED, HOWEVER, that the Party so affected shall use commercially reasonable and diligent efforts to avoid or remove such causes of non-performance, and shall continue performance hereunder with reasonable dispatch wherever such causes are removed. Each Party shall provide the other Parties with prompt written notice of any delay or failure to perform that occurs by reason of FORCE MAJEURE. The Parties shall mutually seek a resolution of the delay or the failure to perform in good faith. 14.6 ASSIGNMENT. This Agreement may not be assigned or otherwise transferred by any Party without the consent of the other Parties; PROVIDED, HOWEVER, that either Dyax or Genzyme may, without such consent, assign its rights and obligations under this Agreement (a) in connection with a corporate reorganization, to any member of an affiliated group, all or substantially all of the equity interest of which is owned and controlled by such Party or its direct or indirect parent corporation or (b) in connection with a merger, consolidation or sale of substantially all of such Party's assets to an unrelated Third Party; PROVIDED, HOWEVER, that such Party's rights and obligations under this Agreement shall be assumed by its successor in interest in any such transaction and shall not be transferred separate from all or substantially all of its other business assets, including without limitation those business assets that are the subject of this Agreement. Any permitted assignee shall assume all obligations of its assignor under this Agreement. Any purported assignment in violation of this Section 14.6 shall be void. 14.7 SEVERABILITY. Each Party hereby agrees that it does not intend to violate any public policy, statutory or common laws, rules, regulations, treaty or decision of any government agency or executive body thereof of any country or community or association of countries. Should one or more provisions of this Agreement be or become invalid, the Parties hereto shall substitute, by mutual consent, valid provisions for such invalid provisions which valid provisions in their economic effect are sufficiently similar to the invalid provisions that it can be reasonably assumed that the Parties would have entered into this Agreement with such valid provisions. In case such valid provisions cannot be agreed upon, the invalidity of one or several provisions of this Agreement shall not affect the validity of this Agreement as a whole, unless the invalid provisions are of such essential importance to this Agreement that it is to be reasonably assumed that the Parties would not have entered into this Agreement without the invalid provisions. 14.8 NOTICES. Any consent, notice or report required or permitted to be given or made under this Agreement by one of the Parties hereto to the other shall be in writing, delivered personally or by facsimile (and promptly confirmed by personal delivery or courier), by a next business day delivery service of a nationally recognized overnight courier service or by courier, postage prepaid (where applicable), addressed to such other Party at its address indicated below, or to such other address as the addressee shall have last furnished in writing to the addressor in accordance with this Section 14.8 and shall be effective upon receipt by the addressee. If to Dyax: Dyax Corp. or Subsidiary 300 Technology Square Cambridge, Massachusetts 02139 Attention: President Facsimile: (617) 225-2501 40 with a copy to: Palmer & Dodge LLP 111 Huntington Avenue Boston, Massachusetts 02199-7613 Attention: Nathaniel S. Gardiner Facsimile: (617) 227-4420 If to Genzyme: Genzyme Corporation One Kendall Square Cambridge, Massachusetts 02139 Attention: President Facsimile: (617) 374-7423 with a copy to: Genzyme Corporation One Kendall Square Cambridge, Massachusetts 02139 Attention: Chief Legal Officer Facsimile: (617) 252-7553 If to Kallikrein Kallikrein LLC LLC (if such c/o Genzyme Corporation notice is sent One Kendall Square by Dyax): Cambridge, Massachusetts 02139 Attention: President Facsimile: (617) 374-7423 with a copy to: Genzyme Corporation One Kendall Square Cambridge, Massachusetts 02139 Attention: Chief Legal Officer Facsimile: (617) 252-7553 If to Kallikrein Kallikrein LLC LLC (if such c/o Dyax Corp. notice is sent 300 Technology Square by Genzyme): Cambridge, Massachusetts 02139 Attention: President Facsimile: (617) 225-2501 with a copy to: Palmer & Dodge LLP 111 Huntington Avenue Boston, Massachusetts 02199-7613 Attention: Nathaniel S. Gardiner Facsimile: (617) 227-4420 14.9 APPLICABLE LAW. This Agreement shall be governed by and construed in accordance with the laws of the Commonwealth of Massachusetts without regard to any choice of law principle that would dictate the application of the laws of another jurisdiction. 14.10 ARBITRATION. Any disputes arising between the Parties relating to, arising out of or in any way connected with this Agreement or any term or condition hereof, or the performance 41 by either Party of its obligations hereunder, whether before or after termination of this Agreement (a "DISPUTE"), which has not resolved in accordance with the provisions of Section 8.3 hereof, shall be finally resolved by binding arbitration as herein provided. 14.10.1 GENERAL. Except as otherwise provided in this Section 14.10, any arbitration hereunder shall be conducted under the commercial rules of the American Arbitration Association. Each such arbitration shall be conducted in the English language by a panel of three (3) arbitrators (the "ARBITRATION Panel"). Each of Dyax and Genzyme shall appoint one (1) arbitrator to the Arbitration Panel and the third arbitrator shall be appointed by the two (2) arbitrators appointed by Dyax and Genzyme. The Arbitration Panel shall be convened upon delivery of the Notice of Arbitration (as herein defined). Any such arbitration shall be held in Boston, Massachusetts. The Arbitration Panel shall have the authority to grant specific performance, and to allocate between the Parties the costs of arbitration in such equitable manner as it shall determine. Judgment upon the award so rendered may be entered in any court having jurisdiction or application may be made to such court for judicial acceptance of any award and an order of enforcement, as the case may be. 14.10.2 PROCEDURE. (a) Whenever a Party (the "CLAIMANT") shall decide to institute arbitration proceedings, it shall give written notice to that effect (the "NOTICE OF ARBITRATION") to the other Party (the "RESPONDENT"). The Notice of Arbitration shall set forth in detail the nature of the Dispute, the facts upon which the Claimant relies and the issues to be arbitrated (collectively, the "ARBITRATION ISSUES"). Within fifteen (15) days of its receipt of the Notice of Arbitration, the Respondent shall send the Claimant and the Arbitration Panel a written Response (the "RESPONSE"). The Response shall set forth in detail the facts upon which the Respondent relies. In addition, the Response shall contain all counterclaims which the Respondent may have against the Claimant which are within the Arbitration Issues, whether or not such claims have previously been identified. If the Response sets forth a counterclaim, the Claimant may, within fifteen (15) days of the receipt of the Response, deliver to the Respondent and the Arbitration Panel a rejoinder answering such counterclaim. (b) Within fifteen (15) days after the later of (i) the expiration of the period provided in Section 14.10.2(a) above for the Claimant to deliver a rejoinder or (ii) the completion of any discovery proceedings authorized by the Arbitration Panel: (A) the Claimant shall send to the Arbitration Panel a proposed resolution of the Arbitration Issues and a proposed resolution of any counterclaims set forth in the Response, including without limitation the amount of monetary damages, if any, or other relief sought (the "CLAIMANT'S PROPOSAL"); and (B) the Respondent shall send to the Arbitration Panel a proposed resolution of the Arbitration Issues, a proposed resolution of any counterclaims set forth in the Response and a proposed resolution of any rejoinder submitted by the Claimant, including without limitation the amount of monetary damages, if any, or other relief sought (the "RESPONDENT'S PROPOSAL"). Once both the Claimant's Proposal and the Respondent's Proposal have been submitted, the Arbitration Panel shall deliver to each Party a copy of the other Party's proposal. (c) The Arbitration Panel shall issue an opinion with respect to any Dispute, which opinion shall explicitly accept either the Claimant's Proposal or the Respondent's Proposal in its entirety (the "FINAL DECISION"). The Arbitration Panel shall not have the authority to reach a Final Decision that provides remedies or requires payments other than those set forth 42 in the Claimant's Proposal or the Respondent's Proposal. The concurrence of two (2) arbitrators shall be sufficient for the entry of a Final Decision. The arbitrators shall issue a Final Decision within one (1) month from the later of (i) the last day for submission of proposals under Section 14.10.2(b) above or (ii) the date of the final hearing on any Dispute held by the Arbitration Panel. A Final Decision shall be binding on both Parties. 14.11 INJUNCTIVE RELIEF. The Parties hereby acknowledge that a breach of their respective obligations under Article 10 hereof may cause irreparable harm and that the remedy or remedies at law for any such breach may be inadequate. The Parties hereby agree that, in the event of any such breach, in addition to all other available remedies hereunder, the non-breaching Party or Parties shall have the right to obtain equitable relief to enforce Article 10 hereof. 14.12 ENTIRE AGREEMENT. This Agreement, the Operating Agreement and the Purchase Agreement contain the entire understanding of the Parties with respect to the subject matter hereof. All express or implied agreements and understandings, either oral or written, heretofore made are expressly merged in and made a part of this Agreement including, but not limited to, the Confidential Disclosure Agreement and modifications thereof dated October 1, 1997 and the Original Collaboration Agreement. This Agreement may be amended, or any term hereof modified, only by a written instrument duly executed by both Parties hereto. Each of the Parties hereby acknowledges that this Agreement is, and the Operating Agreement and Purchase Agreement will be, the result of mutual negotiation and therefore any ambiguity in their respective terms shall not be construed against the drafting Party. 14.13 HEADINGS. The captions to the several Articles and Sections hereof are not a part of this Agreement, but are merely guides or labels to assist in locating and reading the several Articles and Sections hereof. 14.14 INDEPENDENT CONTRACTORS. It is expressly agreed that Dyax and Genzyme shall be independent contractors and that, except as Members of Kallikrein LLC, the relationship between the two Parties shall not constitute a partnership, joint venture or agency. Neither Dyax nor Genzyme shall have the authority to make any statements, representations or commitments of any kind, or to take any action, which shall be binding on the other, without the prior consent of the other Party to do so. 14.15 WAIVER. Except as expressly provided herein, the waiver by either Party hereto of any right hereunder or of any failure to perform or any breach by the other Party shall not be deemed a waiver of any other right hereunder or of any other failure to perform or breach by said other Party, whether of a similar nature or otherwise, nor shall any singular or partial exercise of such right preclude any further exercise thereof or the exercise of any other such right. 14.16 COUNTERPARTS. This Agreement may be executed in two or more counterparts, each of which shall be deemed an original, but all of which together shall constitute one and the same instrument. 43 IN WITNESS WHEREOF, the parties have executed this Agreement as of the date first set forth above. GENZYME CORPORATION By: /s/ G. Jan Van Heek --------------------------- Title: Executive Vice President ------------------------ DYAX CORP. By: /s/ Jack Morgan --------------------------- Title: Senior Vice President ------------------------ 44 EX-10.2 4 a2086278zex-10_2.txt EXHIBIT 10.2 Exhibit 10.2 SENIOR SECURED PROMISSORY NOTE Cambridge, Massachusetts $7,000,000 May 31, 2002 FOR VALUE RECEIVED, DYAX CORP., a Delaware corporation (the "Debtor"), hereby promises to pay to the order of GENZYME CORPORATION, a Massachusetts corporation (the "Lender"), the principal balance of SEVEN MILLION DOLLARS ($7,000,000) or such lesser amount as shall have been advanced to the Debtor hereunder, together with interest on the unpaid principal balance of this Note from time to time outstanding at a variable rate per annum equal to the sum of: (a) the Prime Rate in effect from time to time and (b) two percent (2%) (the "Basic Rate"). Each change in such interest rate shall take effect simultaneously with the corresponding change in such Prime Rate. "Prime Rate" shall mean the rate of interest published in the WALL STREET JOURNAL as the prime rate from time to time. All interest accrued hereunder shall be due and payable quarterly in arrears on the first business day of each calendar quarter, commencing on the first such date to occur at least thirty (30) days after the date of the first advance. The outstanding principal sum hereunder, together with any accrued but unpaid interest and all other charges payable hereunder, shall be due and payable in full on May 31, 2005 (the "Maturity Date"), unless accelerated or subject to mandatory prepayment as provided below. Notwithstanding the foregoing Maturity Date, unless accelerated or subject to mandatory prepayment as provided below, the term of this Note may be extended by the Debtor until May 31, 2007 (the "New Maturity Date") if on the Maturity Date, Debtor has met the conditions described in Schedule A attached hereto. Upon the occurrence of an Event of Default (as defined below), the entire unpaid principal balance of this Note, together with any interest accrued thereon and all other sums due or owed by the Debtor hereunder or under the terms of that certain Security Agreement dated as of even date with this Note between the Debtor and the Lender (the "Security Agreement"), shall at the option of the Lender, upon notice from Lender (except for an Event of Default under of Section 4(f) or Section 4(g) hereof which will be without notice) to the Debtor become immediately due and payable with interest (after such Event of Default and until the Debtor's indebtedness to the Lender is paid in full) at a rate per annum equal to the sum of: (a) the sum of the Basic Rate and (b) three percent (3%). All payments of principal, interest and other amounts payable on or in respect of this Note shall be made to the Lender at its office at One Kendall Square, Cambridge, Massachusetts 02139, or to such other place as the Lender may from time to time direct, in lawful money of the United States of America, in funds immediately available. Interest shall be computed on the basis of a 360-day year and a 30-day month. It is the intent of the Lender and the Debtor that in no event shall interest be payable at a rate in excess of the maximum rate permitted by applicable law (the "Maximum Legal Rate"). Solely to the extent necessary to prevent interest under this Note from exceeding the Maximum Legal Rate, any amount that would be treated as excessive under a final judicial interpretation of applicable law shall be deemed to have been a mistake and automatically cancelled and, if received by the Lender, shall be applied to the principal balance of this Note or, if no principal balance remains outstanding, then such amount shall be refunded to the Debtor. Notwithstanding any provision of this Note to the contrary, if the Debtor at any time has $100,000,000 or more in cash or cash equivalents as reported in the Debtor's consolidated financial statements filed with the Securities and Exchange Commission, then the Lender shall be entitled at its option to require the Debtor to prepay in full all amounts due hereunder, by providing the Debtor with thirty (30) days' prior written notice of such mandatory prepayment, in which case, all outstanding principal, any accrued but unpaid interest and all other charges due hereunder shall become due and payable on the thirtieth (30th) day following such notice. 1. DESCRIPTION OF NOTE; ADVANCES This Note is secured by the Collateral granted pursuant to the Security Agreement and incorporates by reference the provisions thereof. Neither the foregoing reference to the Security Agreement nor any provisions thereof shall affect or impair the absolute and unconditional obligation of the Debtor to pay the principal, interest and all other charges payable hereunder on this Note as provided herein. Subject to the terms and conditions set forth herein and at any time prior to the Maturity Date (except as provided below), the Debtor may, by delivering written notice to the Lender prior to the date of the requested advance, request an advance hereunder in a minimum principal amount of not less than two hundred fifty thousand dollars ($250,000). The Lender shall make such advance on or before the twentieth business day following receipt of such notice. Advances may be made once each calendar quarter, beginning on the date hereof and ending upon completion of the first Phase II clinical trial, either in the United States or Europe, of a Collaboration Product for the treatment of HAE, as such terms are defined in that certain Amended and Restated Collaboration Agreement dated as of the date hereof between the Debtor and the Lender (the "Collaboration Agreement"). The Lender shall not be obligated to make advances in excess of $4,000,000 during the second quarter of 2002 and $1,500,000 during any subsequent calendar quarter. Notwithstanding any provision of this Note to the contrary, the Lender shall have no obligation to make any advances hereunder if a Default (as defined below) or an Event of Default exists. For purposes of this Note, a "Default" means an event or circumstance which, with the giving of notice, the passage of time, or both, would constitute an Event of Default. Notwithstanding any provision of this Note or the Collaboration Agreement to the contrary, upon the effective date of any termination of the Collaboration Agreement by (i) the Lender in accordance with Section 13.2.2, (ii) the Debtor in accordance with Section 13.2.1 or (iii) either party in accordance with Section 13.2.5 thereof AND Dyax exercises its license option pursuant to Section 13.3.5(a) of the Collaboration Agreement, the Lender shall have no further obligation to make any further advances under this Note. Additionally, notwithstanding any 2 provision of this Note or the Collaboration Agreement to the contrary, upon the effective date of any termination of the Collaboration Agreement by (i) either party pursuant to Sections 13.2.3 or 13.2.4, (ii) the Debtor pursuant to Section 13.2.2, (iii) the Lender pursuant to Section 13.2.1 or (iv) either party pursuant to Section 13.2.5 AND Dyax does NOT exercise its license option pursuant to Section 13.3.5(a) of the Collaboration Agreement, all amounts outstanding hereunder on the effective date of such termination shall become immediately due and payable without notice or further action by the Lender. The date and amount of all advances made by the Lender to the Debtor hereunder and each payment made by the Debtor on account of the principal balance hereof, shall be recorded by the Lender on its books and, prior to any transfer of this Note, recorded by the Lender on the schedule attached hereto or any continuation thereof; PROVIDED that the failure of the Lender to make any such recordation shall not affect the obligations of the Debtor to make a payment when due of any amount owing hereunder with respect to any advances made by the Lender. 2. [Intentionally omitted.] 3. PREPAYMENT OF PRINCIPAL The Debtor may, at its option, prepay from time to time all or any part of this Note without premium or penalty but together with interest on the principal amount so prepaid accrued to the date of prepayment. 4. EVENTS OF DEFAULT Upon the occurrence of any one or more of the following events (each, an "Event of Default"), the Lender at its option may declare all amounts due hereunder, including, without limitation, the entire unpaid principal balance of this Note and any accrued, unpaid interest thereon, to be immediately due and payable without notice or protest (both of which are hereby waived): (a) The failure to make any payment of interest within 5 business days of the due date thereof (without reference to Section 6.3 below), or failure to make payment of principal or other amounts due pursuant to the terms of this Note or the Security Agreement on or before the due date; (b) A judgment, decree, writ, warrant of attachment or similar process in an amount equal to or exceeding $1,000,000 is entered against the Debtor or any of its assets, if such judgment, decree, writ, warrant of attachment or similar process is not adequately covered by insurance or has not been vacated, discharged, appealed from (with execution or similar process continuously stayed) within thirty (30) days of such judgment's entry; (c) The occurrence of any event that causes any indebtedness (including a capitalized lease obligation) of the Debtor equal to or exceeding $100,000 which is owed to a person or entity other than the Lender to be accelerated, notwithstanding that such acceleration has not taken place; (d) The occurrence of an Event of Default under the Security Agreement; 3 (e) A termination of the Collaboration Agreement by (i) either party pursuant to Sections 13.2.3 or 13.2.4, (ii) the Debtor pursuant to Section 13.2.2, (iii) the Lender pursuant to Section 13.2.1 or (iv) either party pursuant to Section 13.2.5 AND Dyax does NOT exercise its license option pursuant to Section 13.3.5(a) of the Collaboration Agreement; (f) A proceeding is instituted in a court having jurisdiction in the premises seeking a decree or order for relief in respect to the Debtor in an involuntary case under any applicable bankruptcy, insolvency or other similar law nor or hereafter in effect, or for the appointment of a receiver, liquidator, assignee, custodian, trustee, sequestrator (or other similar official) of the Debtor, or for a substantial part of its property, or for the winding-up or liquidation of it affairs, and such proceeding remains undismissed or unstayed and in effect for a period of sixty (60) days or such court enters a decree or order granting the relief sought in such proceeding; or (g) The Debtor voluntarily suspends transaction of its business, dissolves or is liquidated, commences a voluntary case under any applicable bankruptcy, insolvency or other similar law now or hereafter in effect, consents to the entry of an order for relief in an involuntary case under any such law, or consents to the appointment of or taking possession by a receiver, liquidator, assignee, trustee, custodian, sequestrator (or similar official) of the Debtor, as the case may be, or for any substantial part of its property, or makes a general assignment for the benefit of creditors. Upon the occurrence of any Event of Default hereunder, (i) the Lender may declare the principal balance of this Note to be immediately due and payable by written notice to the Debtor, PROVIDED, however, in the case of an Event of Default described in paragraphs (f) or (g) above, all amounts payable by the Debtor hereunder, including, without limitation, the principal balance and all accrued interest on this Note, shall automatically become immediately due and payable, without notice, action or election by the Lender, and (ii) the Lender may enforce all other rights and remedies granted pursuant to this Note, the Security Agreement, any other document, or by applicable law. All of the rights of the Lender hereunder shall be cumulative and not exclusive, and each of which may be exercised singly, repetitively, in any combination, and in any order. The Lender's rights and remedies hereunder may be exercised without resort or regard to any other source of satisfaction of any liabilities owing by the Debtor to the Lender. No inconsistency between the default provisions of this Note and any other agreement shall be deemed to create any additional notice, cure or grace period or derogate from the express terms of such provisions. Upon the occurrence of an Event of Default, the Debtor agrees to pay on demand all costs and expenses (including, without limitation, reasonable attorneys' fees) incurred or paid by the Lender in collecting or enforcing this Note. 5. WAIVER No delay or omission on the part of the Lender in exercising any right under this Note shall operate as a waiver of such right or of any other right of the Lender, nor shall any delay, omission or waiver on any one occasion be deemed a bar to or waiver of the same or any other right on any future occasion. No course of dealing or other conduct, no oral agreement or 4 representation made by the Lender or usage of trade shall operate as a waiver remedy of the Lender. The Debtor, by executing this Note, and any other makers, sureties, guarantors or endorsers, by endorsing this Note or by entering into or executing any agreement to pay any of the indebtedness evidenced hereby, waives (to the fullest extent allowed by law) all requirements of diligence in collection, demand, presentment, notice of non-payment, protest, notice of protest, suit and all other conditions precedent in connection with the collection and enforcement of this Note or any security for this Note or any guarantee of the indebtedness evidenced hereby (other than demand for payment if expressly required by this Note). This Note shall be binding upon the successors and assigns of the Debtor. 6. GENERAL 6.1 GOVERNING LAW. This Note shall be governed by and construed in accordance with the laws of the Commonwealth of Massachusetts. 6.2 ASSIGNMENT. Neither the Lender nor the Debtor may assign its rights or obligations hereunder without the prior written consent of the other party. 6.3 SATURDAYS, SUNDAYS, HOLIDAYS. If any date that may at any time be specified in this Note as a date for the making of any payment on this Note shall fall on Saturday, Sunday or on a day which in the Commonwealth of Massachusetts shall be a legal holiday, then the date for the making of that payment shall be the next subsequent day which is not a Saturday, Sunday or legal holiday. 6.4 NOTICES. All notices hereunder shall be made in accordance with Section 20 of the Security Agreement. 6.5 ENTIRE AGREEMENT. This Note, together with the Security Agreement and the Collaboration Agreement, contains the entire agreement between the parties with respect to the subject matter hereof, and supersedes every course of dealing, other conduct, oral agreement or representation previously made by the Lender. All prior agreements between the Debtor and the Lender concerning the lending and borrowing of money are hereby terminated. 6.6 SEVERABILITY. In the event that any court of competent jurisdiction shall determine that any provision, or portion thereof, contained in this Note shall be unenforceable in any respect, then such provision shall be deemed limited to the extent that such court deems it enforceable, and the remaining provisions of this Note shall nevertheless remain in full force and effect. 6.7 AMENDMENTS. None of the terms or provisions of this Note may be excluded, modified, or amended except by a written instrument duly executed on behalf of both the Debtor and the Lender expressly referring hereto and setting forth the provision so excluded, modified or amended. No waiver or forbearance of any of the rights and remedies of the Lender hereunder shall be effective unless made specifically in a writing signed by the Lender, and any such waiver or forbearance shall be effective only in the specific instance and for the specific purpose for which given. 5 6.8 HEADINGS. The headings in this Note are for convenience only and shall not affect the interpretation hereof. IN WITNESS WHEREOF, the undersigned has executed this Note under seal as of the date first above written. DYAX CORP. By /s/ Jack Morgan --------------------------------- Name: Jack Morgan Title: Senior Vice President By its signature below, the Lender agrees to make advances under this Note in accordance with the provisions herein: GENZYME CORPORATION By /s/ G. Jan Van Heek ------------------------------ Name: G. Jan Van Heek Title: Executive Vice President 6 SCHEDULE OF LOANS This Note evidences loans made on the dates and in the principal amounts set forth below, subject to the payments or prepayments set forth below:
----------------------------------------------------------------------------------------------------------------- Principal Amount Paid or Unpaid Principal Date Made Amount of Loan Prepaid Amount Notation Made By ----------------------------------------------------------------------------------------------------------------- $ $ $ ----------------------------------------------------------------------------------------------------------------- ----------------------------------------------------------------------------------------------------------------- ----------------------------------------------------------------------------------------------------------------- ----------------------------------------------------------------------------------------------------------------- ----------------------------------------------------------------------------------------------------------------- ----------------------------------------------------------------------------------------------------------------- ----------------------------------------------------------------------------------------------------------------- ----------------------------------------------------------------------------------------------------------------- -----------------------------------------------------------------------------------------------------------------
7 SCHEDULE A EXTENSION CONDITIONS 1. The Collaboration Agreement shall be in full force and effect. 2. The Debtor satisfies the financial covenants set forth in Section 7A of the Security Agreement as of the Maturity Date. 3. No Default or Event of Default exists. 8 EX-10.3 5 a2086278zex-10_3.txt EXHIBIT 10.3 Exhibit 10.3 SECURITY AGREEMENT This Security Agreement (this "AGREEMENT") dated as of May 31, 2002 is between DYAX CORP., a Delaware corporation with its principal place of business at 300 Technology Square, Cambridge, Massachusetts 02139 (the "DEBTOR") and GENZYME CORPORATION, a Massachusetts corporation with its principal place of business at One Kendall Square, Cambridge, Massachusetts 02139 (THE "SECURED PARTY"). RECITALS WHEREAS, the Secured Party has agreed to loan Debtor the principal sum of up to seven million dollars ($7,000,000), the repayment of which, together with interest and other charges, shall be evidenced by that Senior Secured Promissory Note dated the date hereof (the "NOTE"); and WHEREAS, the Secured Party's agreement to advance funds pursuant to the Note is conditioned upon, among other things, the Debtor providing security for the payment of the Note; NOW, THEREFORE, in consideration of the loan and for other good and valuable consideration, receipt and sufficiency of which are hereby acknowledged, the parties agree as follows: 1. DEFINITIONS. As used in this Agreement, the following terms have the following meanings: "Default" means an event or circumstance which, with the giving of notice, the passage of time, or both, could constitute an Event of Default. "GAAP" means generally accepted accounting principles as in effect in the United States of America from time to time, consistently applied. "Indebtedness" means (a) all obligations for borrowed money or the deferred price of property or services, such as reimbursement and other obligations for surety bonds and letters of credit, (b) obligations evidenced by notes, bonds, debentures or similar instruments, (c) capital lease obligations, (d) all obligations or liabilities of others that are guaranteed and (e) any other obligations or liabilities which are required by GAAP to be shown as debt on a balance sheet. "Intellectual Property" means all of the Debtor's right, title and interest in and to patents, patent rights, trademark licenses, trademarks, service marks and copyrights (and applications and registrations therefore including all reissues, divisions, continuations, extensions and continuations-in-part thereof), inventions, improvements, discoveries, data, know-how, methods, processes, whether or not patentable, including but not limited to formulations, techniques and materials, analytical data, clinical data, manufacturing know-how and processing, purification and fill-finish know-how, master file, control information, all regulatory information, permits, licenses, trade names, trade styles, bioinformatics, trade secrets, drawings, specifications, descriptions, and all memoranda, notes, and records with respect to any research and development, all whether now owned or subsequently acquired or developed by the Debtor and whether in tangible or intangible form or contained on magnetic media readable by machine together with all such magnetic media. "Letter of Credit" shall mean a letter of credit (a) issued by a bank satisfactory in all respects to the Secured Party, (b) in an amount equal to (i) the amount of the then-outstanding balance under the Note, if the principal amount of the Note has been fully advanced or (ii) the amount of the then-outstanding balance under the Note, plus the amount of remaining advances to be made, if the Note has not yet been fully advanced, (c) that has an expiration date not earlier than 30 days after the Maturity Date or New Maturity Date, both as applicable and as defined in the Note, and (d) that otherwise contains terms in all respects satisfactory to the Secured Party including, without limitation, the right of Secured Party to draw down thereon immediately upon an Event of Default. "Lien" is a mortgage, lien, deed of trust, charge, pledge, security interest or other encumbrance. "Program" means the Debtor's research, development, production and sales relating to human plasma Kallikrein inhibitors, including that certain 58-amino acid polypeptide human plasma Kallikrein inhibitor known as "DX-88" (formerly known as EPI-KAL-2) together with all analogs, homologs, derivatives and improvements related thereto. "Permitted Indebtedness" is: (1) Debtor's Indebtedness to the Secured Party under the Note or this Agreement; (2) Indebtedness existing as of the date hereof and shown on Schedule B attached hereto; (3) Indebtedness to trade creditors incurred in the ordinary course of business; and (4) other Indebtedness of the Debtor and its subsidiaries consisting of capital lease obligations or purchase money security obligations secured only by Liens permitted under clause (d) of the definition of "Permitted Liens," in an aggregate principal amount not in excess of $15,000,000 at any one time outstanding; (5) Indebtedness that is subordinated to Debtor's Indebtedness to the Secured Party, pursuant to subordination provisions satisfactory to the Secured Party. 2 "Permitted Liens" are: (a) Liens existing as of the date hereof and shown on Schedule B attached hereto or arising under this Agreement; (b) Liens in favor of the Lender arising under this Agreement; and (c) Liens for taxes, fees, assessments or other government charges or levies, either not delinquent or being contested in good faith and for which the Debtor maintains adequate reserves on its books, IF they have no priority over any of Secured Party's security interests. (d) Liens on fixed or capital assets, including personal property, acquired, constructed or improved by any of the Debtor and its subsidiaries, provided that (A) such Liens secure Indebtedness (including capital lease obligations) permitted by clause (4) of the definition of "Permitted Indebtedness," (B) such Liens and the Indebtedness secured thereby are incurred prior to or within 90 days after such acquisition or the completion of such construction or improvement, (C) the Indebtedness secured thereby does not exceed the cost of acquiring, constructing or improving such fixed or capital assets, and (D) such security interests shall not apply to any other property or assets of any of the Debtor or its subsidiaries; and "UCC" means the Uniform Commercial Code as in effect from time to time in any applicable jurisdiction, as the same may be amended from time to time. 2. GRANT. (a) COLLATERAL. To secure the full and prompt payment and performance of the Obligations (as defined below), the Debtor grants the Secured Party a continuing security interest in all of the Debtor's right, title and interest in and to the following property of or arising from the Program, whether now owned or existing or hereafter acquired or arising: all tangible and intangible personal property of or arising from the Program, including, but not limited to, the following (i): all goods, accounts, and general intangibles (as those terms are defined in the UCC), (ii) all Intellectual Property of or arising from the Program including, but not limited to, the patents issued or assigned to and all patent applications made by the Debtor relating to human plasma Kallikrein inhibitors, including that certain 58-amino acid polypeptide human plasma Kallikrein inhibitor known as "DX-88" (formerly known as EPI-KAL-2), including, without limitation, the patents, patent applications and exclusive licenses listed on SCHEDULE A hereto; (iii) all infringement claims with regard to such Intellectual Property; (iv) all rights to income, profits, royalties, damages, licenses or other rights related to such Intellectual Property; and (v) all proceeds (as defined by the UCC) and products of the foregoing (collectively, the "COLLATERAL"). Notwithstanding anything to the contrary, Debtor does not pledge any assets that are not specific to or that do not arise from the Program; nor does the Collateral include any equipment. Upon Debtor's exercise of the Surgical Product Option in Section 3.2 of the Amended and Restated Collaboration Agreement dated as of May 31, 2002 by and between the parties hereto (the "Collaboration Agreement"), so long as no Default or Event of Default exists, Secured Party shall release its security interest in that portion of the Collateral that relates to the Surgical Products indication and add as collateral the Additional Collateral as set forth below in Section 2(b). 3 (b) ADDITIONAL COLLATERAL. Upon (i) Debtor's exercise of the Surgical Product Option in Section 3.2 of the Collaboration Agreement, (ii) Debtor's breach of the financial covenant set forth in Section 7A(a) hereof, or (iii) Debtor's breach of the financial covenant set forth in Section 7A(b) hereof, Debtor shall add as additional collateral (i) the Applicable Percentage (as hereafter defined) of all of Debtor's right, title and interest in Debtor's ownership interest in Biotage, Inc. (the "Shares"); (ii) all products, proceeds, substitutions, additions, interest, dividends and other distributions (including, without limitation, stock splits) relating to the shares and (iii) all books and records relating to the property described in (i) and (ii) (collectively, the "Additional Collateral"). Thereafter, all references in this Agreement to the "Collateral" shall be deemed to include the Additional Collateral. Effective upon the occurrence of any of the events set forth in this Section 2(b) above, to further secure the full and prompt payment and performance of the Obligations, the Debtor grants the Secured Party a continuing security interest in all of the Debtor's right, title and interest in and to the Additional Collateral. No later than five days after the occurrence of any of the events set forth in this Section 2(b) above, the Debtor shall execute a stock pledge agreement in form and substance reasonably satisfactory to the Secured Party and deliver to the Secured Party related stock certificates and stock powers and failure to do so shall constitute an Event of Default. The Secured Party agrees that the Debtor shall no longer be obligated to grant the Secured Party the Additional Collateral or, if such Additional Collateral has already been granted, shall release such Additional Collateral, after the Secured Party confirms that it has been provided with a Letter of Credit. "Applicable Percentage" shall mean (a) forty-nine percent (49%) in the event of (i) Debtor's exercise of the Surgical Product Option in Section 3.2 of the Collaboration Agreement or (ii) Debtor's breach of the financial covenant set forth in Section 7A(a) hereof and (b) sixty-seven percent (67%) in the event of Debtor's breach of the financial covenant set forth in Section 7A(b) hereof. 3. OBLIGATIONS. The security interest granted in Section 2 above secures all payment and performance obligations of the Debtor to the Secured Party under the terms of the Note and this Agreement (collectively, the "OBLIGATIONS"). 4. REPRESENTATIONS, WARRANTIES AND COVENANTS. The Debtor hereby represents, warrants, covenants and agrees as follows: (a) the Debtor is a corporation duly organized, validly existing and in good standing under the laws of the State of Delaware. The Debtor's exact legal name is that indicated on page 1 and on the signature page of this Agreement. The Debtor's tax identification number is 04-3053198. Biotage, Inc. is a corporation duly organized, validly existing and in good standing under the laws of Delaware and is a wholly-owned subsidiary of the Debtor. The execution, delivery and performance of this Agreement by the Debtor has been duly authorized by all necessary corporate action and does not contravene the Debtor's Certificate of Incorporation or By-Laws as currently in effect; (b) neither the execution, delivery or performance by the Debtor of this Agreement or the consummation by the Debtor of the transactions contemplated hereby or thereby will result in a violation or breach of (or give rise to any right of termination, revocation, cancellation or acceleration under or increased payments under), or constitute a default (with or 4 without due notice or lapse of time or both) under, or result in the creation of any Lien, upon any of the properties or assets of the Debtor under, any of the terms, conditions or provisions of any note, bond, mortgage, indenture, contract, agreement, obligation, instrument, offer, commitment, understanding or other arrangement or of any license, waiver, exemption, order, franchise, permit or concession to which the Debtor is a party or by which any of its properties or assets is bound; (c) the security interest granted to the Secured Party in the Collateral shall constitute a first lien, and that the Debtor is the lawful owner of such Collateral free from any right or claim of any person or any Lien, and has good right to pledge, sell, consign, assign, transfer and create a security interest in the same. The patents, patent applications and exclusive licenses listed on SCHEDULE A hereto constitute all such property included in the Program that the Debtor owns or has an interest in as of the date hereof; (d) the Collateral is and will be used primarily for business purposes and will not be held for sale or leased to others, or otherwise disposed of by the Debtor without the prior written consent of the Secured Party. Additionally, unless and until Debtor exercises the Surgical Product Option in Section 3.2 of the Collaboration Agreement as described in Section 2 (a) above, the Debtor shall not be entitled to grant any licenses of any of its Intellectual Property related to the Program to third parties; (e) the tangible Collateral is located at 300 Technology Square, Cambridge, MA 02139. Other than in the ordinary course of business, the Collateral will not be removed from this location without prior written notice to the Secured Party. (f) without the prior written consent of the Secured Party, the Debtor will not grant or permit to exist any security interest in, or any lien, attachment, levy or encumbrance upon, any of the Collateral or the Additional Collateral, except for Permitted Liens; (g) the Debtor will not, without the prior written consent of the Secured Party, execute (or authorize the filing of) any financing statements or other documents evidencing a lien in connection with the Collateral other than those in favor of the Secured Party; (h) no claim, litigation or proceeding is threatened or pending which would have a material adverse effect on the Debtor or ownership or value of the Collateral; (i) all Indebtedness of Debtor existing as of the date hereof is accurately described in Schedule B attached hereto; and (j) as of the date hereof, there are no Liens on any of the Debtor's personal property, except as set forth in Schedule B attached hereto. 5. COVENANTS CONCERNING DEBTOR'S LEGAL STATUS. The Debtor covenants with the Secured Party as follows: (a) without providing at least thirty (30) days' prior written notice to the Secured Party, the Debtor will not change its name, its chief executive office, its mailing address, tax identification number or organizational identification number, if it has one, (b) if the Debtor does not have an organizational identification number and later obtains one, the Debtor will forthwith notify the Secured Party of such organizational identification number, and (c) 5 without providing at least thirty (30) days' prior written notice to Secured Party, the Debtor will not change its type of organization, jurisdiction of organization or other legal structure. 6. PROTECTION OF COLLATERAL. For so long as this Agreement is in effect, the Debtor will: (a) comply with all laws, ordinances and regulations to which it is subject and use the Collateral in a lawful manner and not in contravention of the requirements of any policy of insurance; (b) keep all property insured with such insurance companies and in such amounts and coverages as are reasonably satisfactory to the Secured Party. The Secured Party shall be named as a loss payee and an additional insured as its interest may appear on all insurance applicable to the Collateral. The Debtor shall furnish the Secured Party with certificates or other evidence of insurance satisfactory to the Secured Party within thirty (30) days of the date of this Agreement. All evidence of insurance shall also provide for at least thirty (30) days' prior notice to the Secured Party of any cancellation, modification, or change in coverage. Any insurance proceeds received by the Secured Party may be, at its option, applied to the Obligations. (c) pay all taxes, liens, and assessments when due, except for the lien of property taxes not yet due and payable and except for the payment of any taxes which are being contested in good faith by the Debtor and for which adequate reserves have been set aside; (d) maintain the collateral in good order and repair (reasonable wear and tear excepted) at the Debtor's addresses set forth in Section 4(e). The Collateral and the Additional Collateral will not be encumbered, sold, assigned, or otherwise transferred, whether voluntarily or by operation of law, except for the sale of inventory in the ordinary course of business, without the prior written consent of the Secured Party; (e) keep and maintain the Collateral in accordance with all applicable laws, rules and regulations (governmental and otherwise); (f) keep complete and accurate records of all Collateral. The Secured Party may inspect and copy such records and inspect the Collateral at any time, without prior notice, during normal business hours; (g) execute, at the Secured Party's request, such documents which the Secured Party deems necessary to protect and perfect its security interest and other rights in the Collateral. Debtor also grants the Secured Party an irrevocable power of attorney to execute all such documents on Debtor's behalf. 7. ADDITIONAL COVENANTS. For so long as this Agreement is in effect, the Debtor: (a) will not, and will not permit any of its subsidiaries to, without the Secured Party's prior written consent, create, incur, assume or be liable for any Indebtedness, other than Permitted Indebtedness; 6 (b) will not, without the Secured Party's prior written consent, create, incur or allow any Lien on any of the Collateral or the Additional Collateral, except for Permitted Liens listed in clauses (b) and (c) in the definition of "Permitted Liens"; (c) will not, without the Secured Party's prior written consent, merge or consolidate with any person or entity or acquire all or substantially all of the capital stock or assets of any person or entity; (d) will deliver to the Secured Party (i) as soon as available, but no later than one hundred twenty (120) days after the last day of the Debtor's fiscal year, audited consolidated financial statements prepared under GAAP, together with an unqualified opinion on the financial statements from an independent certified public accounting firm reasonably acceptable to the Secured Party, and (ii) within five (5) days of the filing, copies of all statements, reports and notices made available to Debtor's security holders and all reports on Form 10-K, 10-Q and 8-K filed with the Securities and Exchange Commission; and (e) will not, without the Secured Party's prior written consent, directly or indirectly transfer any of its interest in Biotage, Inc. or permit Biotage, Inc. to transfer any of its assets, except in the ordinary course of business, unless the Secured Party confirms that it has been provided with a Letter of Credit. 7A. FINANCIAL COVENANTS. (a) The Debtor (and its subsidiaries) shall not at any time have less than $20,000,000 in cash or cash equivalents which shall be determined quarterly based on its consolidated balance sheet filed with the Securities and Exchange Commission. (b) The Debtor shall maintain at least one continued listing standard for the Nasdaq National Market. (c) The Debtor shall immediately notify the Secured Party of the Debtor's failure to comply with Section 7A(a) or Section 7A(b) above. 8. REIMBURSEMENT. In the event Debtor fails to obtain any insurance or pay any tax, lien or assessment which it is required to obtain or pay (except to the extent such nonpayment is permitted under Section 6(c) above) or otherwise perform any obligation under this Agreement, the Secured Party may, at its option, obtain, pay or otherwise perform the same on the Debtor's behalf. In such event, the cost together with interest from the date of payment by the Secured Party at the rate of ten percent (10%) per annum shall be included as an Obligation and shall be due and payable upon demand by the Secured Party. The Secured Party shall have no obligation to make any such expenditures, nor shall the making thereof be construed as a waiver or cure of any Event of Default. 9. AUTHORIZATION TO FILE FINANCING STATEMENTS. The Debtor hereby irrevocably authorizes the Secured Party at any time and from time to time to file in any filing office in any UCC jurisdiction any initial financing statements and amendments thereto that (a) indicate the Collateral and (b) provide any other information required by part 5 of Article 9 of the UCC for the sufficiency or filing office acceptance of any financing statement or amendment, including 7 whether the Debtor is an organization, the type of organization and any organization identification number issued to the Debtor. The Debtor agrees to furnish any such information to the Secured Party promptly upon the Secured Party's request. 10. EVENTS OF DEFAULT. The happening of any of the following shall be an Event of Default under this Agreement (each an "EVENT OF DEFAULT"): (a) the occurrence of an Event of Default under the Note; (b) the Debtor otherwise fails to perform or breaches any material obligation under this Agreement; (c) any material representation or warranty made herein by the Debtor is untrue; (d) there occurs a material adverse change to the value of the Collateral as determined by Secured Party in its reasonable discretion; or (e) the Debtor fails to maintain its corporate existence in good standing. 11. REMEDIES. Upon the occurrence of an Event of Default, Secured Party shall be entitled to take one or more of the following actions: (a) all Obligations shall become due and payable as provided in the Note; (b) the Secured Party shall have all the rights and remedies of a secured party upon default, including but not limited to those provided under the Uniform Commercial Code as in effect in the Commonwealth of Massachusetts or any applicable jurisdiction; (c) the Debtor shall, upon the Secured Party's request, assemble the Collateral and make it available to the Secured Party at a place to be named by the Secured Party which is reasonably convenient to both parties; (d) the Secured Party shall have the right, without notice or legal process but without a breach of the peace, to enter any place where the Collateral is located for the purpose of taking possession and removing it; (e) unless the Collateral is perishable or threatens to decline speedily in value or is of a type customarily sold on a recognized market, the Secured Party shall give to the Debtor at least ten (10) days prior written notice of the time and place of any public sale of Collateral or of the time after which any private sale or any other intended disposition is to be made. The Debtor hereby acknowledges that ten (10) days' prior written notice of such sale or sales shall be reasonable notice. In addition, the Debtor waives any and all rights that it may have to a judicial hearing in advance of the enforcement of any of the Secured Party's rights and remedies hereunder, including, without limitation, its right following an Event of Default to take immediate possession of the Collateral and to exercise its rights and remedies with respect thereto; and 8 (f) Secured Party may declare the entire right, title, and interest of the Debtor in any of the Intellectual Property that constitutes Collateral vested in the Secured Party, in which event such right, title, and interest shall immediately vest in the Secured Party and in which case the Secured Party shall be entitled to exercise the power of attorney referred to in Section 14 hereof to execute, cause to be acknowledged and notarized and to record said absolute assignment with the applicable agency; (g) take and practice or sell any of the Intellectual Property that constitutes Collateral; (h) direct the Debtor to refrain, in which event the Debtor shall refrain, from practicing any of the Intellectual Property that constitutes Collateral directly or indirectly, and the Debtor shall execute such other and further documents as the Secured Party may request further to confirm this and to transfer ownership of the Collateral to the Secured Party; (i) the Debtor shall, in connection with any disposition of Collateral, execute and deliver to the Secured Party an Assignment of Patents and Patent Applications substantially in the form attached as Exhibit A hereto. If the Debtor fails to provide such document within (10) ten days after it has been requested by the Secured Party, then the Secured Party may complete such document by exercise of a power of attorney hereby granted by the Debtor. Such power of attorney is coupled with an interest and is irrevocable; and (j) the Debtor shall remain liable for any deficiency remaining after any sale. The Secured Party's reasonable attorney's fees shall be included in the costs of sales preparation. 12. [Intentionally omitted] 13. SECURED PARTY'S OBLIGATIONS AND DUTIES. Anything herein to the contrary notwithstanding, the Debtor shall remain obligated and liable under each contract or agreement comprised in the Collateral to be observed or performed by the Debtor thereunder. The Secured Party shall not have any obligation or liability under any such contract or agreement by reason of or arising out of this Agreement or the receipt by the Secured Party of any payment relating to any of the Collateral, nor shall the Secured Party be obligated in any manner to perform any of the obligations of the Debtor under or pursuant to any such contract or agreement, to make inquiry as to the nature or sufficiency of any payment received by the Secured Party in respect of the Collateral or as to the sufficiency of any performance by any party under any such contract or agreement, to present or file any claim, to take any action to enforce any performance or to collect the payment of any amounts which may have been assigned to the Secured Party or to which the Secured Party may be entitled at any time or times. The Secured Party's sole duty with respect to the custody, safe keeping and physical preservation of the Collateral in its possession, under the UCC or otherwise, shall be to deal with such Collateral in the same manner as the Secured Party deals with similar property for its own account. 9 14. POWER OF ATTORNEY. (a) The Debtor hereby irrevocably constitutes and appoints the Secured Party and any officer or agent thereof, with full power of substitution, as its true and lawful attorneys-in-fact with full irrevocable power and authority in the place and stead of the Debtor or in the Secured Party's own name, for the purpose of carrying out the terms of this Agreement, to take any and all appropriate action and to execute any and all documents and instruments that may be necessary or useful to accomplish the purposes of this Agreement and, without limiting the generality of the foregoing, hereby gives said attorneys the power and right, on behalf of the Debtor, without notice to or assent by the Debtor, to do the following upon the occurrence of an Event of Default, generally to sell, transfer, pledge, make any agreement with respect to or otherwise dispose of or deal with any of the Collateral in such manner as is consistent with the UCC and as fully and completely as though the Secured Party were the absolute owner thereof for all purposes, and to do, at the Debtor's expense, at any time, or from time to time, all acts and things which the Secured Party deems necessary or useful to protect, preserve or realize upon the Collateral and the Secured Party's security interest therein, in order to effect the intent of this Agreement, all no less fully and effectively as the Debtor might do, including, without limitation, (i) the filing and prosecuting of registration and transfer applications with the appropriate federal, state or local agencies or authorities with respect to trademarks, copyrights and patentable inventions and processes, (ii) upon written notice to the Debtor, the exercise of voting rights with respect to voting securities, which rights may be exercised, if the Secured Party so elects, with a view to causing the liquidation of assets of the issuer of any such securities and (iii) the execution, delivery and recording, in connection with any sale or other disposition of any Collateral, of the endorsements, assignments or other instruments of conveyance or transfer with respect to such Collateral. (b) To the extent permitted by law, the Debtor hereby ratifies all that said attorneys shall lawfully do or cause to be done by virtue hereof. This power of attorney is a power coupled with an interest and is irrevocable. The powers conferred on the Secured Party hereunder are solely to protect its interests in the Collateral and shall not impose any duty upon it to exercise any such powers. The Secured Party shall be accountable only for the amounts that it actually receives as a result of the exercise of such powers, and neither it nor any of its officers, directors, employees or agents shall be responsible to the Debtor for any act or failure to act, except for the Secured Party's own gross negligence or willful misconduct. 15. NO WAIVER BY SECURED PARTY, ETC. The Secured Party shall not be deemed to have waived any of its rights and remedies in respect of the Obligations or the Collateral unless such waiver shall be in writing and signed by the Secured Party. No delay or omission on the part of the Secured Party in exercising any right or remedy shall operate as a waiver of such right or remedy or any other right or remedy. A waiver on any one occasion shall not be construed as a bar to or waiver of any right or remedy on any future occasion. All rights and remedies of the Secured Party with respect to the Obligations or the Collateral, whether evidenced hereby or by any other instrument or papers, shall be cumulative and may be exercised singularly, alternatively, successively or concurrently at such time or at such times as the Secured Party deems expedient. 16. SURETYSHIP WAIVERS BY DEBTOR. The Debtor waives demand, notice, protest, notice of acceptance of this Agreement, notice of loans made, credit extended, Collateral received or delivered or other action taken in reliance hereon and all other demands and notices 10 of any description. With respect to both the Obligations and the Collateral, the Debtor assents to any extension or postponement of the time of payment or any other indulgence, to any substitution, exchange or release of or failure to perfect any security interest in any Collateral, to the addition or release of any party or person primarily or secondarily liable, to the acceptance of partial payment thereon and the settlement, compromising or adjusting of any thereof, all in such manner and at such time or times as the Secured Party may deem advisable. Except as required by applicable law, the Secured Party shall have no duty as to the collection or protection of the Collateral or any income therefrom, the preservation of rights against prior parties, or the preservation of any rights pertaining thereto beyond the safe custody thereof as set forth in Section 13 above. The Debtor further waives any and all other suretyship defenses. 17. MARSHALLING. The Secured Party shall not be required to marshal any present or future collateral security (including but not limited to the Collateral) for, or other assurances of payment of, the Obligations or any of them or to resort to such collateral security or other assurances of payment in any particular order, and all of its rights and remedies hereunder and in respect of such collateral security and other assurances of payment shall be cumulative and in addition to all other rights and remedies, however existing or arising. To the extent that it lawfully may, the Debtor hereby agrees that it will not invoke any law relating to the marshalling of collateral which might cause delay in or impede the enforcement of the Secured Party's rights and remedies under this Agreement or under any other instrument creating or evidencing any of the Obligations or under which any of the Obligations is outstanding or by which any of the Obligations is secured or payment thereof is otherwise assured, and, to the extent that it lawfully may, the Debtor hereby irrevocably waives the benefits of all such laws. 18. PROCEEDS OF DISPOSITIONS; EXPENSES. The Debtor shall pay to the Secured Party on demand any and all expenses, including reasonable attorneys' fees and disbursements, incurred or paid by the Secured Party in protecting, preserving or enforcing the Secured Party's rights and remedies under or in respect of any of the Obligations or any of the Collateral. After deducting all of said expenses, the residue of any proceeds of collection or sale or other disposition of Collateral shall, to the extent actually received in cash, be applied to the payment of the Obligations in such order or preference as the Secured Party may determine, proper allowance and provision being made for any Obligations not then due. Upon the final payment and satisfaction in full of all of the Obligations and after making any payments required by Sections 9-608(a)(1)(c) or 9-615(a)(3) of the UCC, any excess shall be returned to the Debtor. In the absence of final payment and satisfaction in full of all of the Obligations, the Debtor shall remain liable for any deficiency. 19. GENERAL. The following general provisions apply: (a) except to the extent specifically referenced, this Agreement, together with the Note and the Collaboration Agreement are the only agreements between the parties regarding its subject matter. They supersede all prior or contemporaneous agreements, whether oral or written; (b) no modification or waiver of this Agreement shall be effective unless contained in a writing signed by the modifying or waiving party. The waiver of any default shall not be deemed a waiver of any other or subsequent default; 11 (c) all remedies shall be cumulative; (d) section headings and other titles are for convenience only and shall not be used in construing or interpreting this Agreement. Any provision of this Agreement which is unenforceable shall be severed and the remainder of this Agreement enforced to the fullest extent permitted by law. This Agreement shall be governed by and construed under the laws of the Commonwealth of Massachusetts, including its choice of law rules; and (e) this Agreement shall be binding on the parties and their respective successors and assigns. 20. NOTICES. Except in the case of notices and other communications expressly permitted to be given by telephone, all notices and other communications provided for herein shall be in writing and shall be delivered by hand or overnight courier service, mailed by certified or registered mail or sent by telecopy, as follows: (a) if to the Secured Party, to Genzyme Corporation, One Kendall Square, Cambridge, Massachusetts 02139-1562, Attn: Mr. Michael Wyzga, Telephone: (617) 252-7500, Facsimile: (617) 252-7802; with a copy to: Genzyme Corporation, One Kendall Square, Cambridge, Massachusetts 02139-1562, Attn: Chief Legal Officer, Telephone: (617) 252-7500, Facsimile: (617) 252-7553; and (b) if to the Debtor, to Dyax Corp., 300 Technology Square, Cambridge, Massachusetts 02139, Attention: President, Telephone: (617) 225-2500, Facsimile: (617) 225-2501), with a copy to: Dyax Corp., 300 Technology Square, Cambridge, Massachusetts 02139, Attention: Vice President, Legal Affairs, Telephone: (617) 225-2500, Facsimile: (617) 225-2501). IN WITNESS WHEREOF, the parties have executed this Agreement under seal as of the date first above written. GENZYME CORPORATION DYAX CORP. By: /s/ G. Jan Van Heek By: /s/ Jack Morgan -------------------------------- --------------------------------- Name: G. Jan Van Heek Name: Jack Morgan Title: Executive Vice President Title: Senior Vice President 12 SCHEDULE A DYAX PATENT RIGHTS
- -------------------------------------------------------------------------------------------------------------------------- APPLICATION COUNTRY NUMBER FILING DATE STATUS - -------------------------------------------------------------------------------------------------------------------------- U.S. (Markland 1) 08/179,964 1/11/94 Abandoned in favor of US 08/208,264 - -------------------------------------------------------------------------------------------------------------------------- U.S. CIP (Markland 1A) 08/208,264 3/10/94 U.S. Patent 6,057,287 issued 5/02/00 - -------------------------------------------------------------------------------------------------------------------------- U.S. CIP (Markland 1A Div) 09/421,097 10/19/99 U.S. Patent 6,333,402 issued 12/25/01 - -------------------------------------------------------------------------------------------------------------------------- U.S. CIP (Markland 1B) 08/676,125 9/25/96 U.S. Patent 5,795,865 issued 8/18/98 - -------------------------------------------------------------------------------------------------------------------------- U.S. Div. (Markland 1B Div) 09/136,012 8/17/98 U.S. Patent 5,994,125 issued 11/30/99 - -------------------------------------------------------------------------------------------------------------------------- Canada (Markland 1B) 2,180,950 1/11/95 Pending - -------------------------------------------------------------------------------------------------------------------------- EPO (Markland 1B) 95/909223.0 1/11/95 Pending pub 0739355 10/30/96 - -------------------------------------------------------------------------------------------------------------------------- Japan (Markland 1B) 7-518726 1/11/95 Published - -------------------------------------------------------------------------------------------------------------------------- PCT (Markland 1B) US95/00299 1/11/95 WO95/21601 - --------------------------------------------------------------------------------------------------------------------------
13 SCHEDULE B EXISTING INDEBTEDNESS: CAPITAL LEASE OBLIGATIONS Master Lease Agreement between General Electric Capital Corporation and Dyax Corp. (indebtedness under lease line as of March 31, 2002 of $4,846,221 with commitment to extend additional line of $5,000,000) Master Lease Agreement between Transamerica Business Credit Corporation and Dyax Corp. (indebtedness under lease line of March 31, 2002 of $1,417,844) Master Lease Agreement between Dyax SA and Locabel (current indebtedness of Euro 553,295,14 with ability to extend to Euro 1,250,000) OTHER DEBT Loan obligation of Massachusetts Institute of Technology to Dyax Corp. under Lease Agreement to loan up to $35 per rentable square foot to fund portion of Tenant's Work (total debt not to exceed $2,400,000) Virginia National Bank as holder of promissory note in amount of $4,250,000 given by Biotage Real Estate LLC to Industrial Development Authority of Albemarle County, Virginia to fund land acquisition and construction of new facility for Biotage, Inc. EXISTING LIENS: Letter of Credit for benefit of Massachusetts Institute of Technology ($4,279,932) to secure obligations under Lease Agreement for 300 Technology Square All Equipment acquired pursuant to Master Lease Agreements under 3 Existing Capital Lease Obligations listed above Real Estate located in Albemarle County, Virginia to secure obligations under Promissory Note held by Virginia National Bank 14 EXHIBIT A ASSIGNMENT OF PATENTS AND PATENT APPLICATIONS In consideration of good and valuable consideration, the sufficiency and receipt of which are hereby acknowledged, _______________________(the "Company"), a corporation organized under the laws of the state of ________________, having an office at ____________________________________, hereby sells, assigns, transfers and sets over unto _______________________________________________a corporation organized under the laws of the State of __________, having an office at __________________________, (the "Assignee"), the entire right, title, and interest in and to the Patents and Patent Applications listed on Schedule A attached hereto, in and for the United States, the same to be held and enjoyed by said Assignee, its successors, assigns, or other legal representatives, to the full ends of the terms for which all Patents therefor may be granted, as fully and entirely as the same would have been held and enjoyed by the Company if this assignment had not been made. And by this covenant the Company will execute or procure any further necessary assurance of title to said Patents and Patent Applications in said Assignee, its successors, assigns or other legal representatives, and, upon the request of said Assignee, will make all rightful oaths and do all lawful acts requisite for procuring the same or for aiding therein, without further compensation, its successors, assigns, or other legal representatives. And the Commissioner of Patents and Trademarks is hereby authorized and requested to issue any and all Patents, and Patents emanating from the Patent Applications, to said Assignee. DYAX CORP. By: ---------------------------- Name: Title: State of _______________ ) ) ss County of _____________ ) 15 Before me this ___ day of _______ 20__, personally appeared _______________________ to me personally known to be the person described in and who executed the above instrument, and acknowledged to me that he executed the same of his own free will for the purposes therein set forth. ------------------------ Notary Public AFFIX SEAL 16 -----END PRIVACY-ENHANCED MESSAGE-----