-----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, WCapP1g6XfPARKuFawyhFYU3/Ss7h+trODegx2W5n8TGKYqxLmku9+vjhZ7TBchO HKWv7/KPtL9dHkJz5nxUKQ== 0000912057-96-027711.txt : 19961202 0000912057-96-027711.hdr.sgml : 19961202 ACCESSION NUMBER: 0000912057-96-027711 CONFORMED SUBMISSION TYPE: S-1/A PUBLIC DOCUMENT COUNT: 5 FILED AS OF DATE: 19961126 SROS: NASD FILER: COMPANY DATA: COMPANY CONFORMED NAME: PROGENICS PHARMACEUTICALS INC CENTRAL INDEX KEY: 0000835887 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 133379479 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: S-1/A SEC ACT: 1933 Act SEC FILE NUMBER: 333-13627 FILM NUMBER: 96672942 BUSINESS ADDRESS: STREET 1: 777 OLD SAW MILL RIVER ROAD CITY: TARRYTOWN STATE: NY ZIP: 10591 BUSINESS PHONE: 9147892800 MAIL ADDRESS: STREET 1: 777 OLD SAW MILL RIVER ROAD CITY: TARRYTOWN STATE: NY ZIP: 10591 S-1/A 1 FORM S-1/A AS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION ON NOVEMBER 26, 1996 REGISTRATION NO. 333-13627 - -------------------------------------------------------------------------------- - -------------------------------------------------------------------------------- SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 --------------------- AMENDMENT NO. 5 TO FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 PROGENICS PHARMACEUTICALS, INC. (Exact name of registrant as specified in its charter) DELAWARE 2834 13-3379479 (State or other jurisdiction (Primary Standard Industrial (I.R.S. Employer of Classification Code Number) Identification incorporation or organization) No.)
777 OLD SAW MILL RIVER ROAD TARRYTOWN, NEW YORK 10591 (914) 789-2800 (Address, including zip code and telephone number, including area code, of registrant's principal executive offices) PAUL J. MADDON, M.D., PH.D. CHAIRMAN OF THE BOARD, CHIEF EXECUTIVE OFFICER AND PRESIDENT PROGENICS PHARMACEUTICALS, INC. 777 OLD SAW MILL RIVER ROAD TARRYTOWN, NEW YORK 10591 (914) 789-2800 (Name, address, including zip code, and telephone number, including area code, of agent for service) -------------------------- COPIES OF ALL COMMUNICATIONS, INCLUDING ALL COMMUNICATIONS SENT TO THE AGENT FOR SERVICE, SHOULD BE SENT TO: MARK R. BAKER, ESQ. DAVID E. REDLICK, ESQ. DEWEY BALLANTINE HALE AND DORR 1301 AVENUE OF THE AMERICAS 60 STATE STREET NEW YORK, NEW YORK 10019 BOSTON, MASSACHUSETTS 02109 (212) 259-8000 (617) 526-6000 -------------------------- APPROXIMATE DATE OF COMMENCEMENT OF PROPOSED SALE TO THE PUBLIC: As soon as practicable after the effective date of this Registration Statement. -------------------------- If any of the securities being registered on this Form are to be offered on a delayed or continuous basis pursuant to Rule 415 under the Securities Act of 1933, check the following box: / / If this Form is filed to register additional securities for an offering pursuant to Rule 462(b) under the Securities Act, please check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering: / / If this Form is a post-effective amendment filed pursuant to Rule 462(c) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering: / / If delivery of the prospectus is expected to be made pursuant to Rule 434, please check the following box: / / -------------------------- THE REGISTRANT HEREBY AMENDS THIS REGISTRATION STATEMENT ON SUCH DATE OR DATES AS MAY BE NECESSARY TO DELAY ITS EFFECTIVE DATE UNTIL THE REGISTRANT SHALL FILE A FURTHER AMENDMENT WHICH SPECIFICALLY STATES THAT THIS REGISTRATION STATEMENT SHALL THEREAFTER BECOME EFFECTIVE IN ACCORDANCE WITH SECTION 8(A) OF THE SECURITIES ACT OF 1933 OR UNTIL THE REGISTRATION STATEMENT SHALL BECOME EFFECTIVE ON SUCH DATE AS THE COMMISSION, ACTING PURSUANT TO SAID SECTION 8(A), MAY DETERMINE. - -------------------------------------------------------------------------------- - -------------------------------------------------------------------------------- PART II INFORMATION NOT REQUIRED IN PROSPECTUS ITEM 13. OTHER EXPENSES OF ISSUANCE AND DISTRIBUTION The following is an itemized statement of the estimated amounts of all expenses payable by the Registrant in connection with the registration of the Common Stock offered hereby, other than underwriting discounts and commissions: Registration Fee--Securities and Exchange Commission............ $ 9,061 NASD Filing Fee................................................. 3,490 Blue Sky fees and expenses...................................... 20,000 Accountants' fees and expenses.................................. 350,000 Legal fees and expenses......................................... 500,000 Printing and engraving expenses................................. 250,000 Transfer agent and registrar fees............................... 5,000 Miscellaneous................................................... 2,449 --------- Total............................................... $1,140,000 --------- ---------
ITEM 14. INDEMNIFICATION OF DIRECTORS AND OFFICERS Section 145(a) of the General Corporation Law of the State of Delaware (the "DGCL") provides that a Delaware corporation may indemnify any person who was or is a party or is threatened to be made a party to any threatened, pending or completed action, suit or proceeding, whether civil, criminal, administrative or investigative (other than an action by or in the right of the corporation) by reason of the fact that he is or was a director, officer, employee or agent of the corporation or is or was serving at the request of the corporation as a director, officer, employee or agent of another corporation or enterprise, against expenses, judgments, fines and amounts paid in settlement actually and reasonably incurred by him in connection with such action, suit or proceeding if he acted in good faith and in a manner he reasonably believed to be in or not opposed to the best interests of the corporation, and, with respect to any criminal action or proceeding, had no cause to believe his conduct was unlawful. Section 145(b) of the DGCL provides that a Delaware corporation may indemnify any person who was or is a party or is threatened to be made a party to any threatened, pending or completed action or suit by or in the right of the corporation to procure a judgment in its favor by reason of the fact that such person acted in any of the capacities set forth above, against expenses actually and reasonably incurred by him in connection with the defense or settlement of such action or suit if he acted under similar standards, except that no indemnification may be made in respect of any claim, issue or matter as to which such person shall have been adjudged to be liable to the corporation unless and only to the extent that the court in which such action or suit was brought shall determine that despite the adjudication of liability, such person is fairly and reasonably entitled to be indemnified for such expenses which the court shall deem proper. Section 145 of the DGCL further provides that to the extent a director or officer of a corporation has been successful in the defense of any action, suit or proceeding referred to in subsections (a) and (b) or in the defense of any claim, issue, or matter therein, he shall be indemnified against expenses actually and reasonably incurred by him in connection therewith; that indemnification provided for by Section 145 shall not be deemed exclusive of any other rights to which the indemnified party may be entitled; and that the corporation may purchase and maintain insurance on behalf of a director or officer of the corporation against any liability asserted against him or incurred by him in any such capacity or arising out of his status as such whether or not the corporation would have the power to indemnify him against such liabilities under such Section 145. II-1 Section 102(b)(7) of the DGCL provides that a corporation in its original certificate of incorporation or an amendment thereto validly approved by stockholders may eliminate or limit personal liability of members of its board of directors or governing body for breach of a director's fiduciary duty. However, no such provision may eliminate or limit the liability of a director for breaching his duty of loyalty, failing to act in good faith, engaging in intentional misconduct or knowingly violating a law, paying a dividend or approving a stock repurchase which was illegal, or obtaining an improper personal benefit. A provision of this type has no effect on the availability of equitable remedies, such as injunction or rescission, for breach of fiduciary duty. The Company's Restated Certificate of Incorporation contains such a provision. The Company's Certificate of Incorporation and By-Laws provide that the Company shall indemnify officers and directors, and to the extent authorized by the Board of Directors, employees and agents of the Company, to the full extent permitted by and in the manner permissible under the laws of the State of Delaware. In addition, the By-Laws permit the Board of Directors to authorize the Company to purchase and maintain insurance against any liability asserted against any director, officer, employee or agent of the Company arising out of his capacity as such. The Company has entered into Indemnification Agreements with each of its officers and directors, pursuant to which the Company has agreed to indemnify and advance expenses to such officers and directors to the fullest extent permitted by applicable law. The Company has obtained an insurance policy providing coverage for certain liabilities of its officers and directors. ITEM 15. RECENT SALES OF UNREGISTERED SECURITIES During the past three years, the Registrant has issued securities to a limited number of persons, as described below. No underwriter or underwriting discounts or commissions were involved. There was no public offering in any such transaction and the Company believes that each transaction was exempt from the registration requirements of the Securities Act of 1933 (the "Securities Act") by reason of Section 4(2) thereof based on the private nature of the transactions and the sophistication of the purchasers, all of whom had access to information concerning the Registrant and acquired the securities for investment and not with a view to the distribution thereof. From January 1993 through August 1993, the registrant issued a total of 272,270 shares of Series B Preferred Stock, $.001 par value per share, and warrants to purchase 272,270 shares of Series B Preferred Stock, to 33 individuals and entities of whom two entities are affiliates of the Company, one individual is a director and the rest are accredited investors for an aggregate purchase price of $1,089,080 in cash. In September 1993 and October 1993, the registrant issued a total of 562,500 shares of Series B Preferred Stock, and warrants to purchase 562,500 shares of Series B Preferred Stock, to three entities of whom two entities are affiliates of the Company and the remaining entity is an accredited investor for an aggregate purchase price of $2,250,000. In February 1994, the registrant issued a total of 719,310 shares of Series B Preferred Stock to 22 individuals and entities of whom one entity is an affiliate of the Company, one individual is a director and the remaining individuals and entities are accredited investors for an aggregate purchase price of $3,596,550 in cash. In November 1995 and December 1995, the registrant issued a total of 424,184 shares of Series C Preferred Stock, $.001 par value per share, and warrants to purchase 106,046 shares of Series C Preferred Stock, to seven individuals and entities of whom one individual is a director, two entities are affiliated with a director of the Company and the remaining individuals and entities are accredited investors for an aggregate purchase price of $897,249 in cash and conversion of a note payable in the principal amount of $1,200,000 plus accrued interest thereon of $23,671. II-2 In December 1995, the registrant issued 45,000 shares of Common Stock, $.0013 par value per share, to one entity which is a licensor as partial consideration for a license agreement. In January 1996 and February 1996, the registrant issued a total of 964,812 shares of Series C Preferred Stock, and warrants to purchase 241,203 shares of Series C Preferred Stock, to 52 individuals and entities of whom two entities are affiliates of the Company, two individuals are directors and the remaining individuals and entities are accredited investors for an aggregate purchase price of $4,824,060 in cash. From January 1, 1993 to September 30, 1996, the Company issued options to purchase 1,549,163 shares of Common Stock (of which options to purchase 57,750 shares of Common Stock subsequently have been cancelled) to employees and consultants of the Company pursuant to the 1989 Option Plan, the 1993 Option Plan and the 1993 Executive Option Plan. None of such options has been exercised. ITEM 16. EXHIBITS AND FINANCIAL STATEMENT SCHEDULES (a) Exhibits **1.1 --Form of Underwriting Agreement **3.1 --Certificate of Incorporation, as amended, of the Registrant **3.2 --By-Laws of the Registrant **4.1 --Specimen Certificate for Common Stock, $0.0013 par value per share, of the Registrant **5.1 --Opinion of Dewey Ballantine **10.1 --Form of Registration Rights Agreement **10.2 --1989 Non-Qualified Stock Option Plan **10.3 --1993 Stock Option Plan, as amended **10.4 --1993 Executive Stock Option Plan **10.5 --Amended 1996 Stock Incentive Plan **10.6 --Form of Indemnification Agreement **10.7 --Employment Agreement dated December 15, 1993 between the Registrant and Dr. Paul J. Maddon **10.8 --Letter dated August 25, 1994 between the Registrant and Dr. Robert J. Israel **10.9 --Sublease dated July 13, 1988 between the Registrant and Union Carbide Corporation +10.10 --gp120 Supply Agreement dated July 19, 1995 between the Registrant and E. I. DuPont De Nemours and Company, as amended October 27, 1995 +10.11 --sCD4 Supply Agreement dated June 27, 1995 between the Registrant and E. I. DuPont De Nemours and Company **+10.12 --Supply Agreement dated February 8, 1996 between the Registrant and Intracel Corporation **+10.13 --License Agreement dated November 17, 1994 between the Registrant and Sloan-Kettering Institute for Cancer Research +10.14 --Clinical Trial Agreement dated December 12, 1994 between the Registrant and Sloan-Kettering Institute for Cancer Research **+10.15 --QS-21 License and Supply Agreement dated August 31, 1995 between the Registrant and Aquila Biopharmaceuticals Inc. **+10.16 --gp120 Sublicense Agreement dated March 17, 1995 between the Registrant and Aquila Biopharmaceuticals Inc. **+10.17 --Cooperative Research and Development Agreement dated February 25, 1993 between the Registrant and the Centers for Disease Control and Prevention **+10.18 --License Agreement dated March 1, 1989, as amended by a Letter Agreement dated March 1, 1989 and as amended by a Letter Agreement dated October 22, 1996 between the Registrant and the Trustees of Columbia University **+10.19 --License Agreement dated June 25, 1996 between the Registrant and The Regents of the University of California +10.20 --KLH Supply Agreement dated July 1, 1996 between the Registrant and PerImmune, Inc.
II-3 **+10.21 --sCD4 Supply Agreement dated November 3, 1993 between the Registrant and E.I. DuPont De Nemours and Company **10.22 --Lease dated June 30, 1994 between the Registrant and Keren Limited Partnership **11.1 --Statement of computation of loss per share for the years ended December 31, 1993, 1994 and 1995 **11.2 --Statement of computation of loss per share for the nine months ended September 30, 1995 and 1996 **11.3 --Pro forma statement of computation of loss per share **23.1 --Consent of Coopers & Lybrand L.L.P. **23.2 --Consent of Dewey Ballantine (contained in Exhibit 5.1) **24.1 --Power of Attorney (included on page II-5) **27.1 --Financial Data Schedule
- ------------------------ ** Previously filed. + Confidential treatment requested as to certain portions, which portions are omitted and filed separately with the Commission. (b) Financial Statement Schedules All schedules have been omitted because they are not required or because the required information is given in the Financial Statements or Notes thereto. ITEM 17. UNDERTAKINGS The undersigned Registrant hereby undertakes to provide to the underwriters, at the closing specified in the underwriting agreement, certificates in such denominations and registered in such names as required by the underwriters to permit prompt delivery to each purchaser. Insofar as indemnification for liabilities arising under the Securities Act of 1933 may be permitted to directors, officers and controlling persons of the Registrant pursuant to the foregoing provisions, or otherwise, the Registrant has been advised that in the opinion of the Securities and Exchange Commission such indemnification is against public policy as expressed in the Act and is, therefore, unenforceable. In the event that a claim for indemnification against such liabilities (other than the payment by the Registrant of expenses incurred or paid by a director, officer or controlling person of the Registrant in the successful defense of any action, suit or proceeding) is asserted by such director, officer or controlling person in connection with the securities being registered, the Registrant will, unless in the opinion of its counsel the matter has been settled by controlling precedent, submit to a court of appropriate jurisdiction the question whether such indemnification by it is against public policy as expressed in the Act and will be governed by the final adjudication of such issue. The undersigned Registrant hereby undertakes that: (1) For purposes of determining any liability under the Securities Act of 1933, the information omitted from the form of prospectus filed as part of this registration statement in reliance upon Rule 430A and contained in a form of prospectus filed by the Registrant pursuant to Rule 424(b)(1) or (4) or 497(h) under the Securities Act shall be deemed to be part of this registration statement as of the time it was declared effective. (2) For the purpose of determining any liability under the Securities Act of 1933, each post-effective amendment that contains a form of prospectus shall be deemed to be a new registration statement relating to the securities offered therein, and the offering of such securities at that time shall be deemed to be the initial bona fide offering thereof. II-4 SIGNATURES Pursuant to the requirements of the Securities Act of 1933, the Registrant has duly caused this Amendment to the Registration Statement to be signed on its behalf by the undersigned, thereunto duly authorized, in the City of Tarrytown, State of New York, on November 26, 1996. PROGENICS PHARMACEUTICALS, INC. BY: /s/ PAUL J. MADDON, M.D., PH.D ----------------------------------------- Paul J. Maddon, M.D., Ph.D. Chairman of the Board, Chief Executive Officer and President POWER OF ATTORNEY Pursuant to the requirements of the Securities Act of 1933, as amended, this Amendment to the Registration Statement has been signed by the following persons on November 26, 1996 in the capacities indicated: SIGNATURE TITLE DATE - ------------------------------ --------------------------- ------------------- Chairman of the Board, * Chief Executive Officer - ------------------------------ and President (principal November 26, 1996 Paul J. Maddon, M.D., Ph.D. executive officer) Vice President, Finance and * Operations, Treasurer - ------------------------------ (principal accounting and November 26, 1996 Robert A. McKinney financial officer) * Director - ------------------------------ November 26, 1996 Charles A. Baker * Director - ------------------------------ November 26, 1996 Mark F. Dalton * Director - ------------------------------ November 26, 1996 Stephen P. Goff, Ph.D. * Director - ------------------------------ November 26, 1996 Elizabeth M. Greetham II-5 SIGNATURE TITLE DATE - ------------------------------ --------------------------- ------------------- * Director - ------------------------------ November 26, 1996 Paul F. Jacobson * Director - ------------------------------ David A. Scheinberg, M.D., November 26, 1996 Ph.D. *By: /s/ ROBERT A. MCKINNEY ------------------------------------------ Robert A. McKinney (As Attorney-in-Fact) II-6 INDEX TO EXHIBITS
EXHIBITS DESCRIPTION PAGE - ----------- ------------------------------------------------------------------------------------------------- --------- **1.1 --Form of Underwriting Agreement **3.1 --Certificate of Incorporation, as amended, of the Registrant **3.2 --By-Laws of the Registrant **4.1 --Specimen Certificate for Common Stock, $.0013 par value per share, of the Registrant **5.1 --Opinion of Dewey Ballantine **10.1 --Form of Registration Rights Agreement **10.2 --1989 Non-Qualified Stock Option Plan **10.3 --1993 Stock Option Plan as amended **10.4 --1993 Executive Stock Option Plan **10.5 --Amended 1996 Stock Incentive Plan **10.6 --Form of Indemnification Agreement **10.7 --Employment Agreement dated December 15, 1993 between the Registrant and Dr. Paul J. Maddon **10.8 --Letter dated August 25, 1994 between the Registrant and Dr. Robert J. Israel **10.9 --Sublease dated July 13, 1988 between the Registrant and Union Carbide Corporation +10.10 --gp120 Supply Agreement dated July 19, 1995 between the Registrant and E. I. DuPont De Nemours and Company, as amended, October 27, 1995 +10.11 --sCD4 Supply Agreement dated June 27, 1995 between the Registrant and E. I. DuPont De Nemours and Company **+10.12 --Supply Agreement dated February 8, 1996 between the Registrant and Intracel Corporation **+10.13 --License Agreement dated November 17, 1994 between the Registrant and Sloan-Kettering Institute for Cancer Research +10.14 --Clinical Trial Agreement dated December 12, 1994 between the Registrant and Sloan-Kettering Institute for Cancer Research **+10.15 --QS-21 License and Supply Agreement dated August 31, 1995 between the Registrant and Cambridge Biotech Corporation **+10.16 --gp120 Sublicense Agreement dated March 17, 1995 between the Registrant and Cambridge Biotech Corporation **+10.17 --Cooperative Research and Development Agreement dated February 25, 1993 between the Registrant and the Centers for Disease Control and Prevention **+10.18 --License Agreement dated March 1, 1989, as amended by a Letter Agreement dated March 1, 1989 and as amended by a Letter Agreement dated October 22, 1996 between the Registrant and the Trustees of Columbia University **+10.19 --License Agreement dated June 25, 1996 between the Registrant and The Regents of the University of California +10.20 --KLH Supply Agreement dated July 1, 1996 between the Registrant and PerImmune, Inc. **+10.21 --sCD4 Supply Agreement dated November 3, 1993 between the Registrant and E.I. DuPont De Nemours and Company **10.22 --Lease dated June 30, 1994 between the Registrant and Keren Limited Partnership **11.1 --Statement of computation of loss per share for the years ended December 31, 1993, 1994 and 1995
**11.2 --Statement of computation of loss per share for the nine months ended September 30, 1995 and 1996 **11.3 --Pro forma statement of computation of loss per share **23.1 --Consent of Coopers & Lybrand L.L.P. **23.2 --Consent of Dewey Ballantine (contained in Exhibit 5.1) **24.1 --Power of Attorney (included on page II-5) **27.1 --Financial Data Schedule
- ------------------------ ** Previously filed. + Confidential treatment requested as to certain portions, which portions are omitted and filed separately with the Commission. EX-10.10 2 EXHIBIT 10.10 Exhibit 10.10 gp120 SUPPLY AGREEMENT This Agreement, dated as of the 19th day of July, 1995, is between E. I. DU PONT DE NEMOURS AND COMPANY, a Delaware corporation with a place of business at 549 Albany St., Boston, MA 02118 ("DUPONT"), and PROGENICS PHARMACEUTICALS, INC., a Delaware corporation with its principal place of business at Old Saw Mill River Road, Tarrytown, New York 10591 ("PROGENICS"). 1. PURPOSE AND SCOPE OF THIS AGREEMENT A. During the term hereof, PROGENICS will manufacture and sell to DUPONT, and DUPONT shall purchase from PROGENICS, all of DUPONT's requirements for resale of recombinant HIV-1LAI gp120 (full length) produced in a CHO expression system (the "Product") for DUPONT's marketing, distribution and resale throughout the world. DUPONT will limit sales to customers who intend to use the Product only for research purposes and not for other purposes such as clinical diagnostics or vaccine development. B. DUPONT will resell the Product as packaged by PROGENICS, and DUPONT will not modify the Product or combine it with other components prior to resale. C. PROGENICS has developed Product specifications for the Product which are attached as Exhibit A. All PROGENICS manufacturing of Product will comply with the Product processing standards and specifications. PROGENICS may revise the processing standards and specifications as it deems necessary and will advise DUPONT as far in advance of any changes as is reasonably possible. If any change affects customer use or perceived performance of the Product, PROGENICS will give DUPONT at least 90 days advance notice of such change. D. PROGENICS will package the Product under specifications established by DUPONT with PROGENICS' consent. Both DUPONT's and PROGENICS' names shall appear on the Product label and promotional material, with the statement "Manufactured by Progenics Pharmaceuticals, Inc. for E. I. du Pont de Nemours and Company." All Product labeling and literature shall contain the phrase "For laboratory use only--not for vaccine or diagnostic use." Any labeling changes will require the prior approval of DUPONT. 2. IMPROVED PRODUCTS A. If during the term hereof PROGENICS develops an improved Product and the commercialization of the improved Product reaches the market evaluation stage, PROGENICS will give DUPONT written notice of its plans to commercialize the improved Product and offer to make available, at DUPONT's cost, sample of the improved Product for DUPONT's evaluation, but as testing materials only and not under circumstances that would commit PROGENICS or DUPONT to supply the improved Product or give customers an expectation that the improved Product will be commercialized. DUPONT may elect to add the improved Product to this Agreement at any time, subject to provisions of Paragraph 2-B below. The parties intend that DUPONT will have advance notice of the introduction of improved Product to enable DUPONT to sell remaining inventory of Product that may be replaced by the improved Product. B. PROGENICS may discontinue a Product that has, in PROGENICS' sole opinion, been replaced by an improved Product. If PROGENICS decides to discontinue a Product, PROGENICS will give DUPONT notice at least 90 days in advance of the discontinuance. 3. PRICE AND FORECASTING A. DUPONT will pay PROGENICS for Product as follows: 1. RAW MATERIALS COST DUPONT will pay PROGENICS for the Product raw material cost at [***] 2. REVENUE SHARING [***] to DUPONT on resale of Product will be paid to PROGENICS, 1) reduced by [***] and 2) increased by [***]. An example of Revenue Sharing is attached hereto as Exhibit B for purposes of illustration. DUPONT will provide worldwide Product sales reports each April and October during the term hereof. PROGENICS shall, on the basis of such reports, calculate the revenue sharing for such six-month period and invoice DUPONT for the amount owing. Such invoices shall include documentation of the method of establishing the amount owning. For purposes of revenue sharing, [***] 3. LARGE VOLUME PURCHASERS DUPONT may negotiate special pricing with large volume purchasers, in which event the parties shall negotiate in good faith a discounted raw materials cost. In no event shall the PROGENICS price to DUPONT be less than [***] 2 [***] Confidential Treatment Requested All prices are F.O.B. PROGENICS' plant. PROGENICS assumes all risks and costs of freight, insurance and similar shipping costs. B. The raw material prices stated in Paragraph 3-A may be revised by PROGENICS from time to time during the term hereof on at least 90 days' advance written notice to DUPONT. C. On execution of this Agreement and then on a semi-annual basis during the term of this Agreement, DUPONT will provide to PROGENICS a written non-binding forecast by month for purchases of Product by DUPONT during each month of the succeeding twelve months. 4. ORDERS FOR PRODUCT AND PAYMENT A. At least once each year during the term of this Agreement, DUPONT will issue a Blanket Purchase Order for anticipated Product purchases. DUPONT will then issue releases against the Blanket Purchase Order, on at least a monthly basis, at least 30 days in advance of the requested ship date. Releases will be firm orders. B. PROGENICS will manufacture and ship the Product to DUPONT within ten days of DUPONT's requested ship date. On shipment of an Order, PROGENICS will invoice DUPONT for the raw material cost of the Product. C. DUPONT will pay PROGENICS within 30 days of DUPONT's receipt of a correct PROGENICS invoice. D. DUPONT may request manufacture of Product using its standard purchase order forms or other written means (an "Order"). Purchases under this Agreement will be governed by the provisions of this Agreement, rather than the standard terms and conditions of DUPONT's purchase order form or any PROGENICS form. 5. QUALITY CONTROL, REJECTION OF NONCONFORMING PRODUCTS AND NOTICE OF CUSTOMER COMPLAINTS A. PROGENICS and DUPONT agree to exchange sufficient quality and Product release information to avoid duplication of testing of Product. PROGENICS and DUPONT will mutually agree on the types and amounts of information needed to reach this goal. B. PROGENICS will manufacture Product in accordance with the specification attached in Exhibit A and any amendments to Exhibit A. DUPONT may return any defective or nonconforming Product to PROGENICS. Nonconformance will mean any failure to meet specification or other manufacturing defect that renders the 3 Product unsuitable for sale or use. Risk of loss and expenses incurred in shipping any defective or nonconforming Product to PROGENICS will be borne by PROGENICS with a direct reimbursement to DUPONT or, at DUPONT's option, credit on subsequent purchases. C. DUPONT will notify PROGENICS of any customer complaint about a Product or Improved Product defect within ten days of confirmation of the defect. The notice will specify the Product and type of defect. 6. LIMITED WARRANTY AND LIMITATION OF REMEDIES A. PROGENICS warrants to DUPONT that all Product meets the specifications stated in Exhibit A and is free of defects in Material and manufacture at the time of shipment. If any Product is proven to be defective in material or manufacture, PROGENICS' entire liability and DUPONT's exclusive remedy will be, at PROGENICS' option, either replacement of the Product, or refund of the purchase price paid by DUPONT for the defective Product, within a reasonable time after written notification of the defect and return of the defective Product to PROGENICS. Notices of defect must be received by PROGENICS within 60 days of DUPONT's receipt of notice of a defect from the customer. B. THE WARRANTY STATED IN PARAGRAPH 6-A IS MADE IN LIEU OF ALL OTHER WARRANTIES, EXPRESS OR IMPLIED, INCLUDING BUT NOT LIMITED TO THE IMPLIED WARRANTY OF MERCHANTABILITY, THE IMPLIED WARRANTY OF FITNESS FOR A PARTICULAR PURPOSE, ANY IMPLIED WARRANTY ARISING OUT OF A COURSE OF DEALING OR OF PERFORMANCE, CUSTOM OR USAGE OF TRADE, EXCEPT OF TITLE AND AGAINST PATENT INFRINGEMENT. C. PROGENICS has no obligations under this warranty with respect to Products that have been modified or damaged through misuse, abuse, accident, neglect, improper storage or mishandling by DUPONT, or if DUPONT holds Product in storage beyond the natural age of the Product. D. PROGENICS warrants and represents that (i) Product does not constitute the subject matter of any currently pending litigation and PROGENICS is not aware as of the effective date of this Agreement of any litigation contemplated by PROGENICS or any other third party with respect to the subject matter of this Agreement and (ii) sale and use of Product will not infringe any third party patents and that any patent rights necessary for DUPONT and its customers to use and sell Product have been acquired by PROGENICS. No warranty or representation is made with respect to use of Product for purposes other than research or for use in combination with other products. 4 7. LIMITATION OF LIABILITIES: TIME LIMIT FOR FILING ACTION A. Subject to the indemnity provisions set forth below, NEITHER PARTY WILL UNDER ANY CIRCUMSTANCES BE LIABLE TO THE OTHER FOR INDIRECT, INCIDENTAL, SPECIAL OR CONSEQUENTIAL DAMAGES (INCLUDING, BUT NOT LIMITED TO, LOSS OF PROFITS, REVENUE OR BUSINESS) RESULTING FROM OR IN ANY WAY RELATED TO THE PRODUCTS, ANY OF DUPONT'S PURCHASE ORDERS, THIS AGREEMENT, OR, THE TERMINATION OR NONRENEWAL OF THIS AGREEMENT. This limitation applies regardless of whether the damages are sought based on breach of warranty, breach of contract, negligence, strict liability in tort, or any other legal theory. B. Any action for breach of warranty or any other obligation under this Agreement must be commenced within one year after the breach occurs. 8. INDEMNIFICATION A. PROGENICS agrees to indemnify, defend and hold harmless DUPONT from any cost, loss, claim, liability and expense (including reasonable attorney's fees and expenses of litigation) by third parties for property damage, personal injury or death to the extent based on PROGENICS' breach of this Agreement or on PROGENICS' negligence with respect to manufacture of the Product. B. PROGENICS will defend DUPONT at PROGENICS' cost and expense, including reasonable attorney's fees, against any claim or suit for infringement of patent brought against DUPONT to the extent the claim concerns the Product. In addition, PROGENICS will indemnify DUPONT against any judgment awarded in such a suit, provided that DUPONT gives PROGENICS prompt written notice of the claim, the right to maintain sole control of the defense and all negotiations for settlement of the claim or suit, and cooperates with PROGENICS if requested in the defense of the claim of suit. C. DUPONT agrees to indemnify, defend and hold harmless PROGENICS from any cost, loss, claim, liability and expense (including reasonable attorney's fees and expenses of litigation) by third parties for property damage, personal injury or death to the extent based on DUPONT's breach of this Agreement or on DUPONT's negligence with respect to sale or distribution of the Product. D. (i) DUPONT will promptly advise PROGENICS in writing of any claim of infringement and of the commencement against it of any claim for infringement of a patent issued to a third party based upon the sale of any Product. PROGENICS will, if promptly requested in writing to do so, and subject to the other conditions and limitations of this Section, defend any such lawsuit. 5 (ii) PROGENICS shall have the control of the defense of such lawsuit. DUPONT agrees to assist PROGENICS in the defense of such suit or action by providing information and, if need be, fact witnesses. DUPONT shall have the right to be represented by its own attorneys at DUPONT's own expense, which attorneys will act only in an advisory capacity. (iii) If PROGENICS is requested to defend a lawsuit as described above, PROGENICS will defend DUPONT for any damages and costs that may become payable under a final judgment or decree by any court in such lawsuit. (iv) Nothing herein shall authorize PROGENICS to settle any lawsuit without the consent of Licensee, if by such settlement DUPONT is obligated to make any monetary payment, to transfer any property or any interest in property, to become subject to an injunction, or to grant any license or other rights under its intellectual property rights. (v) If DUPONT is unable to dispose of any inventory due to infringement of third party patent, then PROGENICS shall provide DUPONT with a credit equal to the amount of inventory which DUPONT cannot dispose of due to infringement of a third party patent. 9. CONFIDENTIALITY AND PATENT RIGHTS A. DUPONT will treat as confidential information and not disclose to third persons or use for its own benefit or the benefit of others, any of PROGENICS' developments, business knowledge, know-how, discoveries (including PROGENICS' Product formula, processing standards, specification, test procedures and other information concerning the design, composition and method of manufacture of the Product) and other confidential or proprietary information which may be disclosed to DUPONT in writing or confirmed in writing and specifically designated as "confidential". B. The obligation of nondisclosure and non-use set forth above shall not apply to any items which: 1. Are available to the public or become available to the public through no fault of the recipient; 2. are known by the recipient at the time of disclosure, as shown by prior written records; 3. are rightfully received by the recipient from a third party without a duty of nondisclosure; or 4. are developed by or for the recipient independent of the disclosure hereunder, as evidenced by the recipient's written records relating thereto. The obligation of nondisclosure and non-use set forth above shall continue for a period of five years from disclosure, notwithstanding any earlier termination of this Agreement. 6 E. Neither party acquires any intellectual property rights or licenses under this Agreement, or rights to use confidential information disclosed to it hereunder for purposes other than complying with its obligations hereunder. 10. TERM AND TERMINATION A. This Agreement commences on the date first above written and continues unless and until either party gives the other at least 120 days advance written notice of termination. B. Either party may terminate this Agreement if the other party breaches this Agreement by giving 30 days prior written notice, subject, however, to the other party's right to cure the breach within the notice period. C. Even after termination, the provisions of this Agreement still apply to all Product ordered, purchased and manufactured, all obligations created or arising, and all transactions and events occurring before the date of termination. 11. NOTICES A. All notices required by this Agreement must be in writing and sent by certified mail, with return receipt requested, Federal Express or other overnight service. The date of a notice is the date it is received. A facsimile copy of any notice shall be sent in addition to the written notice herein specified. B. DUPONT will send all notices under this Agreement to: Attn.: CEO Progenics Pharmaceuticals, Inc. Old Saw Mill River Road Tarrytown, NY 10591 Telex (914) 789-2817 C. PROGENICS will send all notices under this Agreement to: Attn.: Product Manager DuPont Medical Products 549 Albany Street Boston, MA 02118 Telex (617) 542-8463 D. A party may designate in writing other individuals or locations to receive notice. 7 12. DISPUTE RESOLUTION A. The parties agree to attempt in good faith to resolve any dispute arising out of or relating to this Agreement promptly by negotiations. 1. Either party may give the other party written notice of any dispute not resolved in the normal course of business. Executives of both parties at levels one step above the project personnel who have previously been involved in the dispute will meet at a mutually acceptable time and place within ten days after delivery of the notice, and thereafter as often as they reasonably deem necessary. The purpose of this meeting is for the executives to exchange relevant information and to attempt to resolve the dispute. 2. If the matter has not been resolved by the executives within 30 days of the notice, or if the parties fail to meet within the ten day period, the dispute will be referred to senior executives of both parties who have authority to settle the dispute to attempt to resolve the dispute. If the matter has not been resolved within 30 days from the referral of the dispute to the senior executives, or if no meeting has taken place within 15 days after referral to the senior executives, either party may initiate mediation or other mutually agreed to alternate dispute resolution mechanism. 3. If the dispute has not been resolved by negotiation as stated above, the parties agree to attempt to settle the dispute by mediation using a third party neutral; provided however, that if the dispute has not been resolved within ninety (90) days of the initial notice of dispute for whatever reason, either party may pursue such judicial relief as it deems appropriate. B. The procedures stated in Paragraph 12-A will be the sole and exclusive procedures for the resolution of disputes between the parties arising out of or relating to this Agreement. A party, however, may seek a preliminary injunction or other provisional judicial relief if in its judgment such action is necessary to avoid irreparable damage or to preserve the status quo. Despite such action the parties will continue to participate in good faith in the procedures specified in this Paragraph 12. C. Any questions, claims, disputes or litigation arising from or related to this Agreement are governed by the law of the state of New York, without regard to the principles of conflicts of law. 7 13. GENERAL TERMS A. No liability shall result from delay in performance, or nonperformance, caused by circumstances beyond the control of the party affected, including without limitation Act of God, fire, flood, war, government action, riot, civil disturbance, accident, inability to obtain labor, material, equipment or transportation. Quantities so affected by force majeure may be eliminated without liability, but the Agreement shall remain otherwise unaffected. B. The relationship of the parties under this Agreement is that of independent contractors. Nothing in this Agreement authorizes either party to act for the other as an agent. C. Neither party may assign any of its rights or delegate or subcontract any of its duties under this Agreement without first getting the other party's permission in writing. Notwithstanding the foregoing, assignment and delegation may be made by either party hereto without such prior permission in connection with the transfer by such party of the business to which this Agreement relates. D. This Agreement represents the entire agreement of the parties, and supersedes any and all prior agreements, conversations and understandings between the parties hereto with respect to the subject matter hereof. No modification of its provisions shall be valid unless it is in writing and signed by both parties. The provisions of this Agreement are severable. If any provision herein violates or anywhere contravenes any applicable law, it shall not be deemed a part of this Agreement. C. This Agreement shall be interpreted in accordance with the laws of New York. ACCEPTED AND AGREED TO: PROGENICS PHARMACEUTICALS, INC. E.I. DU PONT DE NEMOURS AND COMPANY By: Paul J. Maddon By: Janet J. Seal - --------------------------- ---------------------------- Title: Chairman & CEO Title: Non Business District 8 PROGENICS Sheet 1 [***] Page 1 [***] Confidential Treatment Requested PROGENICS [LOGO] [LETTERHEAD] PRODUCT SPECIFICATION SHEET PRODUCT: Recombinant HIV-1LAI gp120 PRODUCT HIV- 1LAI gp120 (full-Length) DESCRIPTION: produced in a CHO expression system. STORAGE BUFFER: 20 mM Imidazole, pH 7.1; 200 mM NaCl CONCENTRATION: 1 mg/ml SHIP: DRY ICE STORE: -80DEG. C STABILITY: 6 months at -80DEG. C QUALITY CONTROL - --------------- CONCENTRATION Determined by BCA and AND PURITY: SDS-PAGE/Silver stain (Purity > 95%) AUTHENTICITY: Reactive with recombinant human soluble CD4 and anti-gp120 antibodies Mammalian cell glycosylation pattern. ACTIVITY: Binds recombinant human soluble CD4 with an affinity of 1.7 nM. FOR LABORATORY USE ONLY NOT FOR VACCINE OR DIAGNOSTIC USE [LOGO] [LETTERHEAD] E.I. DU PONT DE NEMOURS & CO. (INC.) MEDICAL PRODUCTS DEPARTMENT Reference is made to the Agreement entered into the 19th day of July, 1995, as amended between E.I. DuPont de Nemours and Company (DuPont) and Progenics Pharmaceuticals, Inc. (Progenics) relative to the purchase of HIV-1 (LAI) gp120 by DuPont. It is hereby mutually agreed to further amend the aforesaid Agreement in the following manner effective August 24, 1995. This amendment is being made to update specifications, extending stability from 6 months at -80DEG. C to 12 months from date of purification/repurification. Hence a new Product specification Exhibit A is attached, dated and effective August, 1995. This amendment is also being made to update the "Orders for Product and Payment" clause, to include Progenics' agreement to supply DuPont Product with at least nine (9) months shelf life upon receipt by DuPont. All other terms and conditions of the current Agreement, except as modified in the above manner, shall continue in full force and effect. Please indicate your acceptance of this amendment by signing both copies in the space provided below and return the copy marked "DuPont M&L Copy" to Robert Hand, DuPont Merck Pharmaceutical Co., Purchasing Department, 331 Treble Cove Road, Billerica, MA 01862. Very truly yours, PROGENICS PHARMACEUTICALS, INC. E.I. DUPONT de NEMOURS & CO. BY: /s/ Paul J. Maddon BY: /s/ R.M. Hand - -------------------------------- ---------------------------- TITLE: Chief Executive Officer TITLE: Sr. Purchasing Agent - -------------------------------- ---------------------------- DATE: October 27, 1995 DATE: September 10, 1995 - -------------------------------- ---------------------------- Attach. MATERIALS SPECIFICATION SHEET (PURCHASED MATERIALS) DESCRIPTION: Recombinant HIV-1 LAI gp 120 DUPONT PART#: NEA201001EA - ------------------------------------------------------------------------------- SPECIFICATIONS TEST/APPROVAL CRITERIA - ------------------------------------------------------------------------------- PRODUCT DESCRIPTION: HIV-1 LAI gp120 (full-length) produced in a mammalian (CHO) express system STORAGE BUFFER: 10mM Sodium Phosphate, 4mM Potassium Chloride, 140mM Sodium Chloride, pH 7.1 CONCENTRATION: 1.0 + or - 0.1 mg/mL AMOUNT: 100 ug per vial SHIP: Dry ice STORE: - 80DEG. C STABILITY: 12 months at -80DEG. C from date of Purification/Repurification - ------------------------------------------------------------------------------- QUALITY CONTROL TEST/APPROVAL CRITERIA - ------------------------------------------------------------------------------- CONCENTRATION AND PURITY: Determine by BCA and SDS-PAGE/Silver stain (Purity > 95%) AUTHENTICITY: Reactive with recombinant human soluble CD4 and anti-gp 120 antibodies; Mammalian cell glycosylation pattern ACTIVITY: Binds to recombinant human soluble CD4 (Kd < 10nM) NEA201-0995 SUPERCEDES: 081895 EX-10.11 3 EXHIBIT 10.11 Exhibit 10.11 [LOGO] E.I. DU PONT DE NEMOURS & CO. (INC.) MEDICAL PRODUCTS DEPARTMENT This document, when properly executed, shall constitute a Supply Agreement between Progenics Pharmaceuticals, Inc. with offices at Old Saw Mill River Road, Tarrytown, NY, (Progenics) and E.I. DuPont de Nemours and Company (DuPont), with offices at 549 Albany Street, Boston, MA. 1. PERIOD OF AGREEMENT: May 1, 1995 through April 30, 1998. After the original term, this Agreement will renew automatically for successive 12 month periods unless either party gives notice to the other of its intention not to renew at least 120 days prior to the expiration of the then current term. 2. MATERIAL: Recombinant Soluble sCD4, referred to hereafter as sCD4 or Product. 3. MATERIAL SPECIFICATIONS: Material shall be suppled in the form and manner, and must conform in all material respects to the specifications set out in Attachment A. Alterations to these specifications require the express written consent of each party. 4. INABILITY TO SUPPLY: Progenics recognizes the importance of its obligation to meet DuPont's material requirements in a timely and reliable manner. To enable such continuity of supply, Progenics will use its best efforts to arrange for sCD4 to be manufactured on Progenics' behalf if some unusual event causes Progenics' inability to supply. If at any time, Progenics for a continuous period of ten (10) days due to a force majeure event, or non-force majeure event, shall be unable or unwilling to deliver any Product subject to this Agreement and attachments hereto, then Progenics shall notify DuPont of the situation and use its best efforts to arrange for sCD4 to be manufactured to DuPont's material requirements hereunder. In the event that the failure to deliver sCD4 shall be as a result of the fault of Progenics, then Progenics shall bear all costs necessary to cause the sCD4 to be manufactured by another party ("Alternate Manufacturing Cost"). MEDICAL PRODUCTS DEPARTMENT 549 Albany Street, Boston, Massachusetts 02118 Telephone 617-482-9595 Fax (617) 542-8468 2 INABILITY TO SUPPLY (Cont'd): In the event that the failure to deliver sCD4 shall be as a result of the fault of DuPont, then DuPont shall bear all Alternate Manufacturing Costs. In all other events, Progenics shall arrange for the alternate manufacturer and each party shall bear its own costs. If Progenics corrects the cause for alternate manufacture, then Progenics may resume production of affected Product at any time. 5. PRICE AND ROYALTIES Cost/mg Royalty Rate ------- ------------ [***] [***] 6. PAYMENT TERMS: Net 30 days, following the receipt of a properly prepared and correct invoice. 7. QUANTITY: DuPont commits to purchase 100% of its purchase requirements for sCD4 during the term of this order from Progenics, and Progenics agrees to supply 100% of DuPont's purchase requirements. 8. DELIVERY TERMS: F.O.B. Destination, freight pre-paid and added. 9. RELEASE: DuPont will advise Progenics of its purchase requirements at least quarterly, or as may otherwise suit the parties by agreement. Progenics shall ship product as required by DuPont according to a mutually agreed upon schedule. Progenics shall advise DuPont at its earliest opportunity if it is unable to ship Product at an agreed upon time. Progenics will, on a best effort basis, attempt to fulfill any unscheduled, or spot requirements of DuPont. 10. LABELLING AND SHIPPING: Progenics' name and logo will appear on the main kit label (not on components) on manual and on promotional literature, along with DuPont's. All labels to be approved by both parties. Product will be shipped Federal Express Priority I on dry ice. In parallel, Progenics will perform stability studies on lyophilized product. Shelf life of the sCD4 will be no less than 6 months upon receipt by DuPont. [***] Confidential Treatment Requested 3 11. CONFIDENTIALITY: The parties hereto shall keep confidential all confidential technical information, supplied by one party to the other, shall not disclose or make known to any individual, firm, or corporation, except when authorized in writing to do so by the other party, and shall not use such information for any purpose other than the performance of the obligations provided in this Agreement. The provisions of this clause shall remain binding for five (5) years after the termination of this Agreement. Each party shall use the same degree of care to avoid disclosure of confidential technical information as the party employs with similar information of its own which it does not desire to publish or disclose. Any confidential information shared between the parties must be identified and labeled in writing as confide ntial. The confidentiality of and information disclosed verbally must be identified in writing as confidential no more than 14 days after disclosure. This obligation shall not apply to information and/or documents which: A) Are or come within the public domain otherwise than as a consequence of a breach of the obligations hereunder; B) Are known to the receiving party prior to disclosure by the other party as shown by the receiving party's records; C) Are lawfully disclosed to the receiving party by third parties; or D) Are subsequently independently developed by the receiving party through no reference whatsoever to disclosure hereunder. 12. WARRANTY: Progenics warrants and guarantees that DuPont will not be subject to any patent infringement with respect to sDC4 supplied by Progenics as set forth in paragraph 14. In addition, Progenics warrants and represents that it shall convey good and valid title to material(s) supplied 4 WARRANTY (Cont'd): hereunder and that material(s) supplied hereunder shall meet all of the specifications set forth in Attachment A and shall be free from defects except those caused by misuse or mishandling occurring after such delivery. Progenics shall notify DuPont prior to making any formulation changes in the Product. Progenics further warrants that packaged product will meet the warranty of merchantability and fitness for intended use. In the event of a recall of Product, Progenics agrees to reimburse DuPont for all reasonable costs incurred in the recall. 13. USE OF MATERIAL: Progenics as a co-exclusive licensee to a family of patents owned by Columbia University covering the CD4 gene and protein, will supply DuPont with quantities of sCD4 necessary to meet market demands. DuPont shall be entitled to use such sCD4 supplied by Progenics for the manufacturing of drug screening kits to be sold by DuPont to third parties. 14. PATENTS: Progenics, Biogen, Inc. and Genentech, Inc. each hold a worldwide co-exclusive license from Columbia University to make, have made, use and sell sCD4 gene and protein under [***] and all divisional, continuation, continuation-in-part applications thereof, any patent granted on any aforesaid patent application, and any extension, reissue, or reexamination of any patents that may issue thereon as well as any foreign counterparts thereof. Progenics also holds a [***] Progenics shall defend any suit or proceeding brought against DuPont based on a claim that materials or services purchased hereunder, or any part thereof, furnished by Progenics under this Agreement constitutes an infringement of any patent, copyright, or other proprietary right of any third party provided Progenics is notified promptly in writing and given authority, information, and assistance by DuPont to defend such suits or proceedings. *** Confidential Treatment Requested 5 PATENTS (Cont'd): Progenics shall assume the responsibility to pay all costs, to include such reasonable attorney fees of defending such suits or proceeding and any damages that may be awarded therein against DuPont, to settle any such claim on such terms and conditions it deems advisable. In case the materials purchased hereunder, or any part thereof, is in such suit or proceeding held to constitute infringement or any patent, copyright, or other proprietary right of any third party, and the use thereof is enjoined, or the settlement made requires the use of services or materials purchased hereunder to be discontinued, Progenics shall, at its own expense, and its option, either procure for DuPont the right to continue using such materials or services, replace the same with non-infringing materials which conform to the available specifications, modify such materials or services in a manner acceptable to DuPont so it becomes non-infringing, or terminate this Agreement. 15. RELATIONSHIP OF THE PARTIES: Nothing contained herein shall be construed to empower either party to act as agent for the other. The parties agree that each of them shall, in relation to its obligations hereunder, be acting as an independent contractor. RELATIONSHIP OF THE PARTIES (Cont'd) Notwithstanding, neither party shall, during the period of this Agreement, enter into discussions nor create an alternative arrangement with any third party concerning the subject matter herein, without first advising the other party of its intent. 16. ASSIGNMENT AND SUBCONTRACTING: Neither party shall assign or transfer this Agreement, in whole or in part, or any interest arising under this Agreement or subcontract any work hereunder without the prior written consent of the other party. Subject to the provisions of this clause, this Agreement shall insure the benefit of and be binding upon the successors and assigns of the parties. 17. DOCUMENTS/COMMUNICATIONS: Purchase Order Number(s), Line Number(s), and Release Number(s) are to appear on all paper work such as packing lists, invoices and correspondence. Also, Certificates of Analysis (C.O.A.) shall be submitted to DuPont by Progenics for each lot shipped by Progenics. 6 18. NOTICES: Any notices to be given hereunder shall be given in writing and shall be deemed to have been validly given when deposited in the United States mail, properly stamped and addressed to DuPont or Progenics, whichever the case may be, at the addresses shown below or at such other address as may from time to time be designated by such party in a notice to the other party. Progenics: Progenics Pharmaceutical, Inc. Old Saw Mill River Road Tarrytown, NY 10591 Attn: Joel Sendek DuPont: E.I. DuPont de Nemours and Company Medical Products Department 549 Albany Street Boston, MA 02118 Attn: Judith Lima-Ziegler Materials/Inventory Supervisor 19. NONDISCRIMINATION: Progenics warrants that it has complied with all applicable laws, rules, orders and regulations of governmental authority covering the production, sale and delivery of the Product specified herein, including, but not limited to, Executive Order 11246, and the rules and regulations promulgated thereunder, the Rehabilitation Act of 1973 and the Vietnam Era Veterans Readjustment Act of 1974. Further, Progenics warrants that in the performance of the services hereunder, it will comply with all applicable provisions of the Fair Labor Standards Act of 1938, as amended. 20. AUDITS: Progenics shall permit no less frequently than once per year, and upon reasonable notice by DuPont, inspections and audits by DuPont during regular business hours of all records and aspects of sCD4 manufacture, testing, packaging, labelling and shipping. 21. CANCELLATION: This Agreement may be cancelled by either party upon 120 days written notice to the other party. 7 22. ENTIRETY: This Agreement, together with the Attachments specifically referenced and attached hereto, embodies the entire understanding between DuPont and Progenics, and there are no contracts, warranties, or representations, oral or written, express or implied, with reference to the subject matter hereof which are not merged herein. Except as otherwise specifically stated, no modification hereto shall be of any force or effect unless reduced to writing and signed by both parties and expressly referred to as being modifications of this Agreement. AGREED & APPROVED: FOR PROGENICS: FOR DUPONT: Name: Paul J. Maddon, M.D., Ph.D. Name: Robert M. Hand Title: CEO and Scientific Dir. Title: Sr. Purchasing Agent Signature: /s/ Paul J. Maddon Signature: /s/ Robert M. Hand Date: June 27, 1995 Date: June 8, 1995 EX-10.14 4 EXHIBIT 10.14 Exhibit 10.14 CLINICAL TRIAL AGREEMENT THIS AGREEMENT is made and entered into as of the 12th day of December, 1994 (hereinafter "Effective Date") by and between SLOAN-KETTERING INSTITUTE FOR CANCER RESEARCH and its affiliate, MEMORIAL HOSPITAL FOR CANCER AND ALLIED DISEASES, both having a principal place of business at 1275 York Avenue, New York, New York 10021, membership corporations of the State of New York (hereinafter "SKI/MEMORIAL") and ACTIVE BIOTHERAPIES, INC., a corporation of the State of Delaware having its principal place of business at 777 Old Saw Mill River Road, Tarrytown, New York 10591, (hereinafter "ABI"). WITNESSETH WHEREAS, SKI/MEMORIAL has established and maintains a Clinical Immunology Service, a Division of Hematologic Oncology, in the Department of Medicine and has acquired expertise in conducting research investigations, clinical trials and laboratory test evaluations; and WHEREAS, ABI conducts business in the development, manufacture and sale of therapeutic products; and WHEREAS, ABI desires SKI/MEMORIAL to conduct a clinical trial to determine the safety and efficacy of GM2 covalently attached to KLH plus the immunological adjuvant QS-21 in patients with melanoma (hereinafter "GM2-KLH conjugate"), said trial entitled VACCINATION OF MELANOMA PATIENTS WITH GM2 COVALENTLY ATTACHED TO KLH (GM2-KLH) PLUS THE IMMUNOLOGICAL ADJUVANT QS-21: TRIAL COMPARING DOSES OF GM2-KLH (hereinafter the "Study"). NOW, THEREFORE intending to be legally bound and upon the terms, conditions and covenants hereinafter set forth, SKI/MEMORIAL and ABI agree as follows: ARTICLE I - THE STUDY 1.1 The Study under this Agreement will be conducted under the protocol approved by SKI/MEMORIAL's Human Subject Institutional Review Board (hereinafter "IRB"), based on the protocol annexed hereto as Exhibit A (hereinafter "Protocol"). SKI/MEMORIAL shall submit the Protocol for approval to the IRB. ABI shall supply Study drug after ABI has: 1 a. received a mutually executed copy of this Agreement; b. received documentation from the Office of Industrial Affairs that SKI/MEMORIAL's IRB has approved the Protocol; Promptly after SKI/MEMORIAL's IRB has approved the final Protocol, the Principal Investigator shall forward a copy to the Office of Industrial Affairs, and the Office of Industrial Affairs shall forward a copy to ABI. The Principal Investigator shall also forward to the Office of Industrial Affairs any subsequent change to the Protocol, and the Office of Industrial Affairs shall forward the change to ABI. 1.2 As part of this Agreement, SKI/MEMORIAL shall appoint Dr. Paul B. Chapman and/or such other physicians as it may deem appropriate as investigators (hereinafter "Investigators") to oversee the Study. If Dr. Chapman should become unable to complete the Study, SKI/MEMORIAL shall consult with ABI regarding the appointment of a new principal investigator. SKI/MEMORIAL will negotiate in good faith to select a new principal investigator so that the Study can continue. 1.3 The Investigators on behalf of SKI/MEMORIAL shall prepare and maintain records and case histories with all pertinent data documented as required by the Protocol on case report forms supplied by ABI. All patient data shall be kept confidential. Information provided to ABI shall not disclose patient names, except to the extent that the patient consent form permits. 1.4 The Investigators shall also immediately notify ABI of any adverse reaction in the course of the Study of which they become aware. 1.5 All applicable government laws, rules, regulations and guidelines, including those of the United States Food and Drug Administration (hereinafter the "FDA"), shall be adhered to by SKI/MEMORIAL and ABI in the performance and documentation of the Study. 1.6 ABI shall provide SKI/MEMORIAL with any investigational protocols, pre-clinical or background information which are germane to the Study. 1.7 ABI shall provide, without cost to SKI/MEMORIAL, sufficient amounts of its GM2-KLH conjugate to SKI/MEMORIAL to conduct the Study. SKI/MEMORIAL may not use this GM2-KLH conjugate in any way other than as specified in the Protocol. 2 1.8 SKI/MEMORIAL shall use reasonable efforts to obtain an institutional IND for purposes of conducting the Study. At ABI's request any time in the three years after the Effective Date, SKI/MEMORIAL will assign the IND to ABI at no additional charge and write a letter to the FDA to inform them of the assignment of the IND to ABI. ABI shall indemnify SKI/MEMORIAL for any use ABI makes of the IND after SKI/MEMORIAL has assigned it to ABI, including attorney fees. ARTICLE II - SKI/MEMORIAL STAFF AND FACILITIES 2.1 The Study shall be carried out at SKI/MEMORIAL under the supervision of SKI/MEMORIAL's IRB and the Investigators indicated above. 2.2 SKI/MEMORIAL shall provide the physician, laboratory, statistical, and clinical support staff levels of effort required to complete the Study. ARTICLE III- REPORTS 3.1 SKI/MEMORIAL shall keep ABI advised of the status of the Study via periodic reports. The frequency of such reports shall be mutually agreed to by both parties. There shall also be a final report of the Study presented to ABI. 3.2 All reports submitted to ABI shall become the property of ABI and may be used by ABI without, however, making any reference to Memorial Sloan-Kettering Cancer Center, Memorial Hospital for Cancer and Allied Diseases or Sloan-Kettering Institute for Cancer Research, unless such reference appears in a communication with the FDA or as otherwise required by law. If ABI desires to make reference to any of the foregoing in utilizing the results of the Study, ABI must first obtain written consent from SKI/MEMORIAL. SKI/MEMORIAL shall respond to any such ABI's request for release of information within thirty (30) days after receiving ABI's request. ARTICLE IV - PUBLICATION 4.1 Notwithstanding anything contained herein to the contrary including without limitation Articles 5.1 and 9.6, SKI/MEMORIAL may freely publish the results of its investigative findings hereunder. The authorship and contents (including scientific conclusions and professional judgments) of any paper submitted shall be determined by SKI/MEMORIAL. SKI/MEMORIAL shall provide ABI with a copy of the papers prepared for publication prior to their submission to a scientific journal or presentation at scientific meetings. ABI shall have thirty (30) days to review the papers. ABI shall not make any editorial changes in the papers, but may delete any of its Confidential Information (as defined below) contained therein. ABI personnel shall be acknowledged with customary scientific practice. 3 ARTICLE V - CONFIDENTIAL INFORMATION 5.1 In order to effectively complete the Study, it may be necessary or desirable for the parties to disclose proprietary, trade secret and/or other confidential information (herein "Confidential Information") to one another. Each party agrees that any such Confidential Information disclosed to it or to its employees shall be used only in connection with the legitimate purposes of this Agreement; shall be disclosed only to those who have a need to know it, and shall be safeguarded with the same care normally afforded such Confidential Information in the possession, custody or control of the party receiving the Confidential Information provided, however, that the disclosing party specifies in writing the nature and identity of the Confidential Information and the manner and time of disclosure. The foregoing shall not apply when, after and to the extent the Confidential Information disclosed becomes generally available to the public through no fault of the receiving party, was already known to the receiving party at the time of disclosure as evidenced by written records in the possession of the receiving party prior to such time, or is subsequently received by the receiving party in good faith from a third party without breaching any confidential obligation between the third party and the disclosing party. ARTICLE VI - COMPENSATION 6.1 In consideration for SKI/MEMORIAL's participation and to cover the costs associated with the Study, ABI shall pay SKI/MEMORIAL a total of [***] 6.2 SKI/MEMORIAL shall discuss, if ABI so requests, budgetary matters with ABI, but reserves the right to be the final control on budgetary categories and expenditures. SKI/MEMORIAL shall not be obligated to provide expenditure reports, or to submit to audits by ABI. 4 [***] Confidential Treatment Requested 6.3 The checks shall be made payable to SLOAN-KETTERING INSTITUTE FOR CANCER RESEARCH (Sloan-Kettering Institute Tax I.D. No. 13-1624182) and shall be forwarded to: Memorial Sloan-Kettering Cancer Center Office of Industrial Affairs 1275 York Avenue New York, New York 10021 ABI should note on its check stub or in its transmittal letter that the payment relates to a Clinical Trial Agreement, SK#1267, under the direction of Dr. Paul B. Chapman. ARTICLE VII - INDEPENDENT CONTRACTOR 7.1 Both parties shall, at all times during the performance of this Agreement, remain as independent contractors and the Agreement shall not make the parties partners, joint venturers, or agents of one another. No party to this Agreement shall have the power to bind or obligate the other party. ARTICLE VIII - TERM AND TERMINATION 8.1 This Agreement shall commence on the Effective Date of this Agreement and shall continue until completion as provided in the Protocol, which is estimated at about twelve (12) months from the date hereof. 8.2 This Agreement can be terminated by either SKI/MEMORIAL or ABI with or without cause upon thirty (30) days prior written notice without penalty to either party. 8.3 In the event that a.) SKI/MEMORIAL terminates this Agreement prior to completion of the Study, the amount due to SKI/MEMORIAL from ABI shall be [***] any time between the Effective Date and the date of termination of this Agreement and then completes the Protocol; or b.) ABI terminates this Agreement then in addition to [***] 8.4 If ABI terminates the Agreement prior to completion of the Study, ABI shall, if permitted by law and requested by SKI/MEMORIAL, supply SKI/MEMORIAL, free of charge, with sufficient GM2-KLH conjugate to allow SKI/MEMORIAL to complete the treatment of those patients participating in the Study on the date of SKI/MEMORIAL's receipt of ABI's termination notice. 5 *** Confidential Treatment Requested 8.5 Sections 3.2, 4.1, 5.1, 8.3, 8.4, 8.5, 9.1, 9.6 and 9.7 shall all survive the termination of this Agreement. ARTICLE IX - GENERAL 9.1 ABI shall indemnify, defend and hold SKI/MEMORIAL, and its affiliate corporation, Memorial Sloan-Kettering Cancer Center harmless from and against all claims, causes of action, suits, damages and costs arising out of, resulting from, or otherwise in respect of, the manufacture, sale and/or use of GM2-KLH conjugate except where such claims, causes of action, suits, damages and costs are the result of negligence on behalf of SKI/MEMORIAL, its staff or agents. ABI shall have no obligation to indemnify, defend or hold SKI/MEMORIAL harmless against liability, loss or damage arising from a failure by SKI/MEMORIAL, its staff or agents to; (i) comply with any applicable FDA or other governmental requirement or; (ii) adhere to the terms of the Protocol. SKI/MEMORIAL shall indemnify, defend and hold ABI harmless from and against all claims, causes of action, suits, damages and costs arising out of, resulting from, or otherwise in respect of, the manufacture, sale and/or use of GM2-KLH conjugate except where such claims, causes of action, suits, damages and costs are the result of negligence on behalf of ABI, its staff or agents. SKI/MEMORIAL shall have no obligation to indemnify, defend or hold ABI harmless against liability, loss or damage arising from a failure by ABI, its staff or agents to; (i) comply with any applicable FDA or other governmental requirement or; (ii) adhere to the terms of the Protocol. 9.2 No right or license is granted under this Agreement by either party to the other either expressly or by implication, except those specifically set forth herein. 9.3 Nothing contained within this Agreement shall impose an obligation of exclusivity on one party by the other. Both parties reserve the right to enter into and participate in other activities (either alone or with a third party) including, but not limited to, clinical trials and sponsored research projects. 9.4 All matters affecting the interpretation, validity and performance of this Agreement shall be governed by the laws of the State of New York applicable to agreements made and to be performed wholly within the State of New York. This Agreement, including the Protocol, sets forth the entire understanding between the parties 6 herein, and cannot be changed or amended except by written agreement executed by the parties. In the event of any inconsistency in this Agreement, the inconsistency shall be resolved by giving precedence first, to the Articles of this Agreement, and then, to the Protocol. This Agreement may not be assigned by either party without the prior written consent of the other party. 9.5 All notices to be given by either party to the other shall be made in writing by hand delivery or by registered or certified mail, return receipt requested and addressed to the parties at the following addresses respectively: Sloan-Kettering Institute for Cancer Research 1275 York Avenue New York, New York 10021 (Attention: Director, Office of Industrial Affairs) (Copy: James S. Quirk, Senior Vice President) Active Biotherapies, Inc. 777 Old Saw Mill River Road Tarrytown, New York 10591 (Attention: Paul J. Madddon, M.D., Ph.D. President and CEO) Any notice shall be effective as of its date of receipt. 9.6 Except as set forth in articles 5.1 and 4.1, as required by law and/or as may be required in order to maintain a party's status as an exempt organization under Section 501(c) (3) of the Internal Revenue Code and regulations thereunder, neither SKI/MEMORIAL nor ABI shall release any information, publicity, news releases or other public announcement, written or oral, with regard to the Agreement or any amendment thereto or to performance hereunder, to newspapers or any other mass communication media without the prior written approval of the other party. SKI/MEMORIAL shall respond to any such ABI's request for release of information within thirty (30) days after receiving ABI's request. ABI shall not use the name of Memorial Sloan-Kettering Cancer Center, Memorial Hospital for Cancer and Allied Diseases or Sloan-Kettering Institute for Cancer Research, or a variant of any of the foregoing in any advertising, packaging or other promotional material in connection with the GM2-KLH conjugate except as may be required by law. 7 IN WITNESS THEREOF, SKI/MEMORIAL and ABI have caused this Agreement to be executed in duplicate by their respective duly authorized officers. ACTIVE BIOTHERAPIES, INC. SLOAN-KETTERING INSTITUTE FOR CANCER RESEARCH, AND By: /s/ Paul J. Maddon MEMORIAL HOSPITAL FOR AND --------------------------- ALLIED DISEASES Paul J. Maddon, M.D., Ph.D. President and CEO Date: Dec. 23, 1994 By: /s/ James S. Quirk ---------- ------------------------------- James S. Quirk Senior Vice President Research Resources Management Date: Dec. 12, 1994 ------- By: /s/ Paul B. Chapman ------------------------------- Paul B. Chapman, M.D. Principal Investigator Date: Dec 4, 1994 ------- 8 EX-10.20 5 EXHIBIT 10.20 Exhibit 10.20 SUPPLY AGREEMENT This supply agreement is entered into as of July 1, 1996 (the "Effective Date") between PerImmune, Inc. ("PerImmune") and Progenics Pharmaceuticals, Inc. (each singularly a "Party" and collectively the "Parties") with reference to the following: RECITALS WHEREAS, PerImmune, Inc. manufactures purified keyhole limpet hemocyanin ("KLH"); and WHEREAS, Progenics Pharmaceuticals, Inc. is performing research and development in the field of vaccines for human cancers and is interested in purchasing KLH from PerImmune, Inc. for use as a carrier protein for such vaccines; THEREFORE, the parties agree as follows: 1. DEFINITIONS. The following terms shall have the following meanings for purposes of this Agreement: 1.1 "AFFILIATE" means any corporation, firm, partnership or other entity, whether de jure or de facto, which directly or indirectly owns, is owned by, or is under common ownership with a party to this Agreement to the extent of at least fifty percent (50%) of the equity (or such lesser percentage which is the maximum allowed to be owned by a foreign corporation in a particular jurisdiction) having the power to vote on or direct the affairs of the entity and any person, firm, partnership, corporation or other entity actually controlled by, controlling, or under common control with a party to this Agreement. For example, Akzo, N.Y. is an Affiliate of PerImmune pursuant to this definition. 1.2 "AGREEMENT" means this Supply Agreement, including any exhibits, schedules or other attachments thereto, as any of the foregoing may be validly amended and agreed to in writing by the Parties from time to time. 1.3 "COMMERCIAL INTRODUCTION" means the date of first commercial sale (other than for purposes of obtaining regulatory approval) of a Ganglioside Vaccine by Progenies Pharmaceuticals, Inc. 1.4 "EFFECTIVE DATE" is defined in the introductory paragraph. 1.5 "FULLY BURDENED MANUFACTURING COST" means the actual cost of Manufacture by PerImmune of KLH under a Manufacturing Process in compliance with Page 2 cGMPs, which actual cost shall be comprised of the cost of goods produced as determined in accordance with United States generally accepted accounting principles, [***] 1.6 "cGLPs" means the current Good Laboratory Practices for Finished Pharmaceuticals pursuant to 21 C.F.R. 58 et sea., as amended from time to time. 1.7 "cGMPs" means the current Good Manufacturing Practices for Finished Pharmaceuticals pursuant to 21 C.F.R. 210 et seci., as amended from time to time. 1.8 "KLH" means keyhole limpet hemocyanin. 1.9 "KLH REQUIREMENTS" means the amount of KLH in bulk which Progenics Pharmaceuticals, Inc. may require for all research and development, pre-clinical and human clinical testing of Ganglioside Vaccines and, after Commercial Introduction, production of Ganglioside Vaccines for commercial sales. 1.10 "KNOW-HOW" means materials, data, results, formulae, designs, specifications, methods, processes, improvements, techniques, ideas, discoveries, technical information, process information, clinical information and any other information, whether or not any of the foregoing is patentable, which is confidential (in accordance with Section 5 hereof and proprietary to PerImmune now or hereafter during the Term of this Agreement, to the extent that any of the foregoing relates to the development, manufacture, use or sale of KLH in connection with the development, manufacture, use or sale of any Gangiloside Vaccine, provided however, that the term "Know-how" shall not include any of the foregoing that is subject to proprietary rights of third parties. 1.11 "GANGLIOSIDE VACCINE" means any vaccine or vaccines comprising purified gangliosides (whether alone or in combination) conjugated to KLH for the prevention or treatment of human cancers. A ganglioside is a neuraminic acid containing glycolipids. 1.12 "MANUFACTURE" OR "MANUFACTURING PROCESS" means the aseptic-storage, handling, production, processing and packaging of KLH in accordance with this Agreement. 1.13 ."MANUFACTURING YEAR" means each calendar year commencing on or after January 1, 1995. 1.14 "PARTY" and "PARTIES" are defined in the introductory paragraph. 1.15 "PERIMMUNE" means PERIMMUNE, INC., (formerly Organon Teknika Corporation Biotechnology Research Institute) , a Delaware corporation, its Affiliates and its successors and permitted assigns. [***] Confidential Treatment Requested Page 3 1.16 "SPECIFICATIONS" is defined in Exhibit A 1.17 "TERM" is defined in Section 4.1. 1.18 "PROGENICS" means Progenics Pharmaceuticals, Inc., a Delaware corporation, its Affiliates and its permitted successors and assigns. 2. MANUFACTURE AND SUPPLY. 2.1 GENERAL. Progenics agrees that PerImmune shall have the exclusive right and obligation during the Term to Manufacture and supply to Progenics one hundred percent (100%) of its KLH Requirements for purposes of research and development, pre-clinical studies and human clinical trials and commercial sales of all Ganglioside Vaccines throughout the world. PerImmune agrees that, for the purposes of Ganglioside Vaccines, it will provide KLH exclusively to Progenics and PerImmune will not knowingly supply KLH to third party manufacturers of Ganglioside Vaccines. PerImmune hereby agrees, at its sole expense, to commit all reasonably necessary facilities, appropriately trained personnel, machinery, equipment, utilities and other PerImmune resources required to satisfy its obligations under this Agreement. 2.2 PERIMMUNE TRANSFER PRICE OF KLH. With respect to each and every Ganglioside Vaccine, PerImmune shall Manufacture and supply one hundred percent (100%) of KLH Requirements of such Ganglioside Vaccine, including for purposes of all research and development, preclinical studies and human clinical trials, and the Commercial sales of such Ganglioside Vaccine. [***] In addition, in order to verify the production cost of KLH, Progenics will have the right to pay for an independent certified public accountant, ("CPA") to inspect the records of PerImmune once per year during regular business hours, provided that such accountant has entered into a confidentiality agreement with PerImmune which is satisfactory to PerImmune. The CPA shall then compile a report which states only PerImmune's Fully Burdened manufacturing Cost for KLH which may be used by the Parties for negotiating the transfer price. 2.3 PERlMMUNE'S REPRESENTATIONS, WARRANTIES AND COVENANTS. PerImmune hereby represents and warrants to Progenics as follows: (a) PRE-CLINICAL STUDY AND HUMAN CLINICAL TRIAL USE, PerImmune shall Manufacture all KLH Requirements for use in any vaccine used in connection with any pre-clinical study or human clinical trial of any Ganglioside Vaccine (i) strictly in compliance with (A) this Agreement, (B) all Specifications, and (C) all applicable laws [***] Confidential Treatment Requested Page 4 and regulations, including but not limited to cGMPs to the extent applicable, and (ii) in a PerImmune facility holding all applicable licenses in the jurisdiction of Manufacture. (b) COMMERCIAL USE. PerImmune shall Manufacture all KLH Requirements for use in the commercialization of any Ganglioside Vaccine (i) strictly in compliance with (A) this Agreement, (B) all Specifications, and (C) all applicable laws and regulations, including but not limited to cGMPs to the extent applicable, and (ii) in a PerImmune facility holding all applicable licenses in the jurisdiction of Manufacture. (c) CERTIFICATE OF ANALYSIS: NON-COMPLYING KLH. Before, during and after Manufacture of KLH Requirements, PerImmune shall obtain samples, monitor the Manufacturing Process and the environment of such Manufacture, and keep such technical books and records of all of the foregoing as are required under the Specifications and Procedures and all applicable laws and regulations, including but not limited to cGLPs or cGMPs (as appropriate and applicable). PerImmune shall test each lot of KLH requirements Manufactured for Progenics or as required under the Specifications. Together with each such lot of KLH Requirements, PerImmune shall provide a written certificate of analysis which shall set forth the results of such testing by PerImmune and PerImmune's quality control approval of such lot of KLH Requirements. PerImmune's obligations under this section 2.3(c) shall be performed at PerImmune's sole expense. Progenics shall be entitled to test any such KLH Requirements in accordance with the Specifications, at Progenics' sole expense. Without limiting any of Progenics' other rights or remedies under this Agreement with respect to any KLH Requirements supplied hereunder that do not comply with applicable representations and warranties under this Section 2.3, and provided PerImmune reasonably confirms Progenics' test results, the Parties agree that; (i) Progenics shall not be obligated to pay PerImmune the transfer price applicable to such non-complying KLH Requirements; (ii) if Progenics has already paid for such non-complying KLH Requirements, Progenics shall be entitled to a credit against future purchases for the amount paid to PerImmune therefor; (iii) PerImmune shall, on a priority basis, Manufacture and supply to Progenics, as applicable, replacement KLH Requirements in full compliance with this Section 2.3; and (iv) PerImmune shall bear the full cost of returning or destroying the non-complying KLH Requirements. 2.4 Procedures for Estimating, Ordering and Supplying - KLH REQUIREMENTS. Subject to the other terms of this Agreement: (a) ANNUAL DEMAND FORECAST FOR EACH MANUFACTURING YEAR. During the Term, commencing on July 1 , 1996 and on an on-going quarterly basis as described below, Progenics will provide PerImmune with a written rolling annual demand forecast of KLH Requirements for each manufacturing Year which shall be binding as to the first quarter and non-binding as to the remaining three (3) quarters. Thereafter, Progenics shall provide an updated annual demand forecast on a quarterly Page 5 basis no later than ninety (90) days in advance of the commencement of the first (and binding) quarter covered by such annual demand forecast. The Parties also agree that the variance, if any, between the binding forecast of a given quarter and the last nonbinding forecast for such quarter shall be between [***] and [***] meaning that Progenics' binding forecast for such quarter must be at least [***] but not more than [***] of such last non-binding forecasted amount for such quarter. (b) PURCHASE ORDERS. Progenics shall place a firm purchase order or purchase orders with PerImmune setting forth (i) the quantities of KLH Requirements to be Manufactured and supplied hereunder, (ii) the schedule for receipt from PerImmune of such batch(es) of KLH Requirements, and (iii) instructions for shipping and packaging. Each such firm purchase order shall be submitted no later than thirty (30) days in advance of the first scheduled date of receipt thereof. Subject to the other terms of this Agreement, Progenics shall be obligated to place firm purchase orders with PerImmune for, and PerImmune hereby commits to Manufacture and supply hereunder pursuant to such firm purchase orders, [***] of the amount of KLH Requirements in the then-binding quarter of each annual demand forecast under Section 2.4(b); provided, however, that: (A) the Parties may mutually agree in writing to amend any such firm purchase order; (B) PerImmune in its discretion may agree to Manufacture and supply hereunder additional amounts of KLH Requirements in excess of the then-binding amount, provided that Progenics places firm purchase order(s) for such excess KLH Requirements on a timely basis; and (C) PerImmune agrees to provide Progenics with as much advance written notice as possible (and in any case at least thirty (30) days' written advance notice) if PerImmune determines that any scheduled delivery of KLH Requirements pursuant to any purchase order will be delayed by more than fifteen (15) days for any reason of which PerImmune becomes aware. 2.5 PRIORITY. a) PRIORITY AMONG CUSTOMERS. PerImmune hereby agrees and acknowledges that, in the event that PerImmune is unable to satisfy in full its obligations under this Agreement to Manufacture and supply [***] of KLH Requirements as well as PerImmune's obligations to third parties with respect to Manufacture and supply of KLH, PerImmune shall use reasonable efforts to satisfy its obligations under this Agreement and, in the event of any shortage of KLH available to meet all such obligations, PerImmune shall allocate proportionately all available KLH among Progenics and such third parties with highest priority for the Manufacture and supply of KLH for purposes of outstanding firm purchase orders for comparable delivery time frames. In such event PerImmune, shall be permitted to invoice, and Progenics agrees to pay, the additional expenses of PerImmune for such efforts. [***] Confidential Treatment Requested Page 6 (b) INABILITY TO SUPPLY. In the event that PerImmune is unable to supply [***] of Progenics' purchase orders for two consecutive quarters, then PerImmune agrees to provide Progenics the right and license to use the relevant Know-how to manufacture or have manufactured KLH for use in producing Ganglioside Vaccine, and to fully cooperate with regulatory authorities to qualify Progenics and/or its designee as a manufacturer of KLH. In such event, at Progenics' request, PerImmune shall promptly disclose to Progenics all Know-how and information reasonably necessary to manufacture KLH and the parties shall mutually agree upon a reasonable schedule for gradually reducing the amount of KLH purchased by Progenics from PerImmune, until such time PerImmune is able to reasonably demonstrate the ability to supply Progenics with its requirements. (c) ASSURANCE OF SUPPLY. Progenics and PerImmune will cooperate to anticipate Progenics' long-term requirements for KLH Requirements supply, and PerImmune will take reasonable measures to assure that Progenics' and its Partners' KLH Requirements can be met, which measures may include the maintenance of adequate safety stocks of KLH. 2.6. REGULATORY APPROVAL OF MANUFACTURING. PerImmune shall be solely responsible, at its sole cost and expense, for obtaining all necessary regulatory approvals particular to KLH for Manufacture and supply of KLH Requirements. Progenics shall advise PerImmune of any new Specifications required by the United States Food and Drug Administration or the Federal Food, Drug and Cosmetic Act (or the equivalent regulatory authority or law In other countries) with respect to any Ganglioside Vaccine. PerImmune shall not modify in any manner any Specifications without Progenics prior written consent (which consent shall not be unreasonably withheld). 2.7 REGULATORY FILINGS. Without limiting the generality of the foregoing, for purposes of supporting all preclinical studies and human clinical trials and all regulatory filings, applications and approvals on the part of Progenics with respect to any Ganglioside Vaccine, PerImmune hereby agrees that on an on-going basis during the Term: (1) PerImmune shall permit Progenics to reference PerImmune's drug master file and/or Investigational New Drug Applications (IND's) for KLH with the United States Food and Drug Administration; (ii) to the extent not subject to the proprietary rights of third parties, PerImmune shall provide Progenics with all pre-clinical and clinical data, results and other relevant information with respect to KLH (including but not limited to information regarding the toxicity, safety and stability of KLH) that is (A) submitted by PerImmune in connection with any Investigational New Drug application or other regulatory filing with respect to KLH from time to time during the Term or (B) otherwise in PerImmune's possession from time to time during the Term; and (iii) a PerImmune representative, at Progenics' request, shall attend periodic meetings to discuss the progress of clinical trials of any Ganglioside Vaccines. Progenics will reimburse [***] Confidential Treatment Requested Page 7 PerImmune for the foregoing assistance only (i) for its reasonable out-of pocket expenses, including but not limited to travel, and (ii) PerImmune's fully burdened costs of performing technical studies or engaging outside services subject to the prior approval of Progenics. a) ADVERSE EVENTS REPORTING. On an on-going basis during the Term and for at least ten (10) years after the expiration or termination of this Agreement, each Party agrees to provide the other Party with any written information in its possession which indicates adverse effects in humans associated with KLH or any products using KLH. 2.8 PERIMMUNE RECORDKEEPING AND INSPECTION. (a) TECHNICAL RECORDS. With respect to any Manufacture and supply of KLH Requirements, PerImmune shall, at its expense, keep properly completed technical books and records, test data and reports as required under the Specifications and all applicable laws and regulations, including but not limited to cGLPs or cGMPs (as appropriate), and in any case shall maintain such technical Information for at least two (2) years from the expiration date of the relevant Ganglioside Vaccine or longer if required under applicable laws and regulations (including but not limited to cGLPs and cGMPs, as applicable). During regular business hours and upon reasonable advance written request, PerImmune shall make any such technical information available to Progenics for inspection. (b) FINANCIAL RECORDS. During the Term, PerImmune shall keep for at least three (3) years records of its Fully Burdened Manufacturing Costs, and the calculations thereof in sufficient detail to permit Progenics designee, reasonably acceptable to PerImmune, to confirm the accuracy thereof. At the request of Progenics, and not more frequently than once per year, upon at least five (5) business days' prior written notice, and at the expense of Progenics (except as otherwise provided below), PerImmune shall permit a nationally recognized, independent, certified public accountant selected by Progenics and acceptable to PerImmune to inspect (during regular business hours) any such PerImmune records for the then-preceding three (3) years solely to the extent necessary to verify such costs, margins and calculations, provided that such accountant in advance has entered into a confidentiality agreement with PerImmune and Progenics substantially similar to the confidentiality provisions of this Agreement, limiting the use and disclosure of such information to authorized representatives of the Parties. Results of any such inspection shall be made available to both Parties. If such inspection reveals a deficiency in the calculation of PerImmune's Fully Burdened Manufacturing Cost to PerImmune resulting in an overpayment to PerImmune of the transfer price by [***] , PerImmune shall pay all costs and expenses of such inspection. [***] Confidential Treatment Requested Page 8 (c) QUALITY AUDIT. Upon submission of a proposal by Progenics which is approved by PerImmune, PerImmune shall permit Progenics to audit, in cooperation with PerImmune's personnel, production, packaging, and quality control facilities of PerImmune and any of its significant suppliers as they relate to production of KLH to allow Progenics to verify PerImmune's compliance with its responsibilities under this Agreement. 2.9 LIABILITY. (a) INDEMNIFICATION BY PROGENICS. Except as otherwise provided in Sections 2.9(b) or (c), Progenics will defend, indemnify and hold harmless PerImmune against any and all claims, actions, liabilities, damages, losses, costs or expenses, including reasonable attorney's fees, based upon or arising out of the sales or use of any Ganglioside Vaccine by Progenics, provided that PerImmune gives Progenics prompt notice thereof in writing, permits Progenics to control the investigation, preparation and defense thereof (including any compromise or settlement thereof and any appeal) and provides reasonable assistance to Progenics, at Progenics expense, in that regard. (b) LIABILITY. Each Party assumes full responsibility and liability for any injury, damage or expense which it or its employees, agents and invitees incur and which arise from its manufacture, handling and use of KLH or Ganglioside Vaccines, except to the extent such injury, damage or expense arises from the negligence or willful misconduct of the other Party. (c) INDEMNIFICATION BY PERIMMUNE. PerImmune will defend, indemnify and hold harmless Progenics against any and all claims, actions, liabilities, damages, losses, costs or expense (including reasonable attorneys' fees) including without limitation expenses of total or partial product recalls in connection with the manufacture, use or sale of Ganglioside Vaccines (i) based upon the gross negligence or willful misconduct of PerImmune or its employees arising out of the Manufacture or shipment of KLH Requirements by PerImmune or based upon a manufacturing defect in KLH Requirements manufactured by PerImmune; or (ii) the failure of PerImmune to comply with governmental regulations with respect to KLH, provided that Progenics or its Partners give PerImmune prompt notice thereof in writing, permits PerImmune to control the investigation, preparation and defense thereof (including any compromise or settlement thereof and any appeal) and provides reasonable assistance to PerImmune, at PerImmune's expense, in that regard. 3. CONFIDENTIALITY. 3.1. Each party agrees to take such steps and, when necessary to protect the rights of the other, shall cause its employees and agents and its Affiliates employees and agents, to take such steps as are reasonably required to protect and keep Page 9 confidential, and shall not use, publicize or otherwise disclose to third parties other than Affiliates, Confidential Information (as defined below) of the other party, which was acquired from the other party pursuant to this Agreement, including, without limitation, following procedures designed to limit access of such information to those persons having a need to know it. The parties agree not to disclose or use such Confidential Information except as they may be entitled to do so or if necessary pursuant to or in the performance of this Agreement. 3.2 The obligation of confidentiality and restriction on use imposed by the foregoing Subsection 3.1 shall not apply to any particular item of Confidential Information that: 3. 2.1 is known or generally available, or subsequently becomes known or generally available, to the public, or is otherwise at the time of disclosure or subsequently becomes part of the public domain, whether by printed publication or otherwise through no fault of the receiving parties; 3.2.2 the receiving party can demonstrate by competent evidence, based in substance upon writings and/or physical evidence, (i) was known to the receiving party at the time of receipt or (ii) is furnished to the receiving party without obligation of confidentiality or non-use by a third party, either before or after the time of its disclosure by the disclosing party, which third party is not restricted by a confidential undertaking to the disclosing party at the time of the disclosure; 3.2.3 the receiving party can demonstrate by competent evidence, based in substance upon writings and/or physical evidence, has been developed independently for the receiving party by persons not having access to the Confidential information; or 3.2.4 is the Confidential Information of the disclosing party and that the disclosing party discloses to a non-Affiliate party without restriction. 3.3 The obligations of confidentiality and restriction on use under this Section 3 shall continue to be binding upon the parties for a period of five years following termination of this Agreement. 3.4 Either party may also disclose Confidential Information disclosed to it by the other party to the extent, and only to the extent, such disclosure is necessary for such party to comply with applicable governmental laws or regulations. The party that desires to so disclose Information shall give the other party reasonable advance notice of any such proposed disclosure pursuant to such compliance with law or regulation, shall use its best efforts to secure confidential treatment of the Information thus disclosed, and shall advise the other party in writing of the manner in which that was done. Page Page 10 3.5 For purposes of this Agreement, Confidential Information shall mean: (a) data, inventions, Information, processes, know-how, patent applications, trade secrets and similar intellectual property rights of a party, including, without limitation, the original and copies of all documents, inventions, laboratory notebooks, drawings, specifications, devices, equipment, prototype models and tangible manifestations embodying any technology disclosed hereunder, (b) a party's customer lists and marketing, sales, costs, royalty and similar information related to the manufacture or sale of KLH or other part of the Parties' business, and (c) any other information disclosed in writing and marked as "Confidential Information" or, if disclosed orally, reduced to writing and marked as "Confidential Information" and submitted within thirty (30) days of the original oral disclosure. 3.6 PERMITTED DISCLOSURES. Each Party may disclose the other Party's information to the extent such disclosure is reasonably necessary in prosecuting or defending litigation, filing, prosecuting or maintaining patent applications or patents, complying with applicable laws or regulations, or, in the case of Progenics, conducting preclinical or clinical trials or preparing or filing regulatory filings with respect to Ganglioside Vaccines; provided, however, that if a Party is required to make any disclosure of the other Party's information furnished pursuant to this Agreement, it will give reasonable advance notice of such disclosure requirements to the other Party and, except to the extent inappropriate in the case of patent applications, will use its best efforts to secure confidential treatment of such information required to be disclosed. 4. TERM: TERMINATION. 4.1 TERM. The term of this Agreement shall be for three years from the Effective Date and will renew automatically for successive 12 month periods unless sooner terminated as provided in this Section 4. 4.2 MATERIAL BREACH. Subject to Section 8.6, failure by either Party to comply with any of the material obligations contained in this Agreement shall entitle the other Party to give to the Party in default notice specifying the nature of the default and requiring it to make good such default. If such default is not cured within sixty (60) days after the receipt of such notice, the notifying Party shall be entitled, without prejudice to any of its other rights conferred on it by this Agreement and in addition to any other remedies available to it by law or in equity, to terminate this Agreement effective upon written notice to the other Party. The right of a Party to terminate this Agreement, as herein above provided, shall not be affected in any way by its waiver or failure to take action with respect to any previous default. 4.3 INSOLVENCY OR BANKRuPTCY. Either Party may, in addition to any other remedies available to it by law or in equity, terminate this Agreement, in whole or in part as the terminating Party may determine, effective upon written notice to the other Party, in the event the other party shall have become insolvent or bankrupt, or shall have Page 11 made an assignment for the benefit of its creditors, or there shall have been appointed a trustee or receiver of the other Party for all or a substantial part of its property, or any case or proceeding shall have been commenced seeking reorganization, liquidation, dissolution, winding-up, arrangement, composition or readjustment of its debts or any other relief under any bankruptcy, insolvency, reorganization or other similar act or law of any jurisdiction now or hereafter in effect, or there shall have been issued a warrant of attachment, execution, disdain or similar process against, any substantial part of the property of the other Party, and any such event shall have continued for sixty (60) days undismissed, unbounded and undischarged. 4.4 ACCRUED RIGHTS, SURVIVING OBLIGATIONS: PARTNERS. Expiration or any termination of this Agreement for any reason shall be without prejudice to any rights which shall have accrued to the benefit of either Party prior to such expiration or termination. Such expiration or termination shall not relieve either Party from obligations which are expressly indicated to survive expiration or termination of this Agreement, which obligations include, without limitation, those under Sections 2.8, 2.9, 3, 5, 6 and 7. 5. PERIMMUNE PATENT RIGHTS. PerImmune shall not assert against Progenics or its customers any patents now or hereinafter owned or controlled by PerImmune which concern KLH or any Ganglioside Vaccine of Progenics which incorporates KLH. This Section shall continue to apply to any Affiliate of PerImmune which ceases to be an Affiliate of PerImmune as defined by this Agreement. 6. PERiMMUNE REPRESENTATIONS AND WARRANTIES. PerImmune represents and warrants that: (a) the execution and delivery of this Agreement and the performance of the transactions contemplated hereby have been duly authorized by PerImmune; (b) the performance by PerImmune of any of the terms and conditions of this Agreement on its part to be performed does not and will not constitute a breach or violation of any other agreement or understanding, written or oral, to which it is a party; (c) To the best of PerImmune's knowledge, there are no adverse proceedings, claims or actions pending, or threatened, relating to KLH and at the time of disclosure and delivery thereof to Progenics and PerImmune shall have the full right Page 12 and legal capacity to disclose and deliver KLH without violating the rights of third parties. 7. ARBITRATION. Any dispute, controversy or claim between the Parties, arising out of or relating to this Agreement or the Parties' respective rights and obligations hereunder either during or after the Term (including the question as to whether any such matter is arbitrable) shall be subject to binding arbitration in accordance with then-existing commercial arbitration rules of the American Arbitration Association. The Parties agree that, in the course of any such arbitration, service of any notice at their respective addresses in accordance with Section 8.11 of this Agreement shall be valid and sufficient, and any arbitration hereunder shall be in the jurisdiction of the defendant Party, which in the case of Progenics shall be New York and in the case of PerImmune shall be Maryland. In any such arbitration, an award shall be rendered by a majority of the members of a board of arbitration consisting of three (3) members, one (1) of whom shall be chosen by each of Progenics and PerImmune and the third of whom shall be appointed by mutual agreement of such two (2) arbitrators. In the event of failure of such two (2) arbitrators to agree within sixty (60) days after the commencement of arbitration (as defined below) upon appointment of the third arbitrator, or, in the event that either Party shall fail to appoint an arbitrator within thirty (30) days after the commencement of the arbitration proceedings, the third arbitrator or (upon request of the other Party) the second arbitrator and the third arbitrator, as the case may be, shall be appointed by the American Arbitration Association in accordance with its then existing commercial arbitration rules. For purposes of this Section, the "commencement of the arbitration proceeding" shall mean the date upon which the defendant Party receives from the American Arbitration Association a copy of the request for arbitration filed by the party desiring to have recourse to arbitration. The decision of the arbitrators shall be in writing and shall set forth the basis therefor. The Parties shall abide by all awards rendered in arbitration proceedings, and such awards may be enforced and executed upon in any court having jurisdiction over the Party against whom enforcement of such award is to be sought. The Parties shall divide equally the administrative charges, arbitrators' fees, and related expenses of arbitration, but each Party shall pay its own legal fees incurred in connection with any such arbitration; provided, however, if the arbitrators determine that one Party prevailed clearly and substantially over the other Party, then the non-prevailing Party shall also pay the reasonable attorneys' fees and expert witness costs and other arbitration costs of the prevailing Party. Page 13 8. MISCELLANEOUS PROVISIONS. 8.1 NO PARTNERSHIP. Nothing in this Agreement is intended or shall be deemed to constitute a partnership, distributorship, agency employer-employee or joint venture relationship between the Parties. No Party shall incur any debts or make any commitments for the other, except to the extent, if at all, specifically provided herein. 8.2 ASSIGNMENTS. Neither Party shall assign any of its rights or obligations hereunder or this Agreement, except that either Party may do so: (a) as incident to the merger, consolidation, reorganization or acquisition of stock or assets affecting substantially all of the assets or voting control of such Party; (b) to any wholly owned subsidiary if such Party remains liable and responsible for the performance and observance of all of the subsidiary's duties and obligations hereunder; (c) with the prior written consent of the other Party; or (d) as incident to an agreement between Progenics and a major corporate partner. This Agreement shall be binding upon the successors and permitted assigns of the Parties and the name of a Party appearing herein shall be deemed to include the names of such Party's successors and permitted assigns to the extent necessary to carry out the intent of this Agreement. Any assignment not in accordance with this Section 8.2 shall be void. 8.3 FURTHER ACTIONS. Each Party agrees to execute, acknowledge and deliver such further instruments, and to do all such other acts, as may be necessary or appropriate in order to carry out the purposes and intent of this Agreement. 8.4 NO NAME OR TRADEMARK RIGHTS. Except as otherwise provided herein, no right, express or implied, is granted by this Agreement to use in any manner the names "PerImmune, Inc." or "Progenics Pharmaceuticals, Inc." or any contraction thereof or any other trade name or trademark of PerImmune or Progenics in connection with the performance of this Agreement. 8.5 PUBLIC ANNOUNCEMENT. Except as may otherwise be required by applicable law or regulation, neither Party shall make any public announcement concerning this Agreement or the subject matter hereof without the prior written consent of the other Party (not to be unreasonably withheld). 8.6 FORCE MAJEURE. If any default or delay occurs which prevents or materially impairs a Party's performance and is due to a cause beyond the Party's reasonable control, including but not limited to any act of any god or demon, flood, fire, explosion, earthquake, casualty, accident, war, revolution, civil commotion, blockade or embargo, injunction, law, proclamation, order, regulation or governmental demand, the affected Party promptly shall notify the other Party in writing of such cause and shall exercise diligent efforts to resume performance under this Agreement as soon as possible. Neither Party shall be liable to the other Party for any loss or damage due to such cause. Neither Party may terminate this Agreement because of such default or delay. Page 14 8.7 ENTIRE AGREEMENT OF THE PARTIES: AMENDMENTS. This Agreement, including the exhibits attached hereto which are incorporated herein, constitutes and contains the entire understanding and agreement of the Parties and cancels and supersedes any and all prior negotiations, correspondence, understandings and agreements, whether verbal or written, between the Parties respecting the subject matter hereof. No waiver, modification or amendment of any provision of this Agreement shall be valid or effective unless made in writing and signed by a duly authorized officer of each of the Parties. 8.8 SEVERABILITY. In the event that any of the provisions of this Agreement shall for any reason be held by any court or authority of competent jurisdiction to be invalid, illegal or unenforceable, such provision or provisions shall be validly reformed to as nearly as possible approximate the intent of the Parties and, if unreformable, shall be divisible and deleted in such jurisdiction; elsewhere, this Agreement shall not be affected so long as the Parties are still able to realize the principal benefits bargained for in this Agreement. 8.9 CAPTIONS. The captions to this Agreement are for convenience only, and are to be of no force or effect in construing or interpreting any of the provisions of this Agreement. 8.10 APPLICABLE LAW. This Agreement shall be governed by and interpreted in accordance with the laws of Maryland. 8.11 NOTICE. All notices and other communications shall be deemed to have been duly given when delivered in person or by registered or certified mail (postage prepaid, returned receipt requested) to the respective parties as follows: If To Progenics: Paul J. Maddon, M.D., Ph.D. Chairman and CEO - --------------------------- 777 Old Saw Mill River Road - --------------------------- Tarrytown, NY 10591 - ---------------------------- Page 15 If To PerImmune: Michael G. Hanna, Jr. - ------------------------ President & CEO 1330 Piccard Drive - ------------------------ Rockville, MD 20850 - ------------------------ 8.12 SURVIVAL. The representations, warranties, covenants and agreements made herein shall survive any investigation made by a Party and shall be able to be relied fully on by the Parties. IN WITNESS WHEREOF, the parties hereto have caused this Agreement to be signed by their respective corporate officers, duly authorized as of the day and year first above written. PerImmune, Inc., represents and warrants that it has the right and authority to provide to Progenics the material and rights set forth in this agreement pursuant to the transfer of relevant right and authority from Akzo Nobel to PerImmune. PERIMMUNE, INC. PROGENICS PHARMACEUTICALS, INC. By: /s/ Michael G. Hanna, Jr. By: Paul J. Maddon - ---------------------------- ---------------------- Name: Michael G. Hanna, Jr. Name: Paul J. Maddon - --------------------------- ----------------------- Title: President & CEO Title: Chairman and CEO - --------------------------- ----------------------- As set forth in this Exhibit A, the following are the specifications for the Manufacture of KLH, as may from time to time be required by the Food and Drug Administration (the "Specifications"). EXHIBIT A ORGANON TEKNIKA [GRAPHIC] AKZO CERTIFICATE OF ANALYSIS KEYHOLE LIMPET HEMOCYANIN [***] [***] Confidential Treatment Requested -----END PRIVACY-ENHANCED MESSAGE-----