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AMENDED AND RESTATED LICENSE AGREEMENT

License Agreement

AMENDED AND RESTATED LICENSE AGREEMENT | Document Parties: (OSI) Eyetech, Inc | Eyetech Pharmaceuticals, Inc | Pfizer Inc You are currently viewing:
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(OSI) Eyetech, Inc | Eyetech Pharmaceuticals, Inc | Pfizer Inc

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Title: AMENDED AND RESTATED LICENSE AGREEMENT
Governing Law: New York     Date: 5/8/2007
Law Firm: Steven D. Barrett    

AMENDED AND RESTATED LICENSE AGREEMENT, Parties: (osi) eyetech  inc , eyetech pharmaceuticals  inc , pfizer inc
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CONFIDENTIAL MATERIALS OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
ASTERISKS DENOTE OMISSIONS

EXHIBIT 10.3

AMENDED AND RESTATED LICENSE AGREEMENT

          THIS AMENDED AND RESTATED LICENSE AGREEMENT (this “ Agreement ”) dated as of April 20, 2007 (the “ Restatement Date ”) between Pfizer Inc., a corporation organized under the laws of the state of Delaware, with its principal place of business at 235 East 42nd Street, New York, New York 10017 (“ Pfizer ”), and (OSI) Eyetech, Inc. (formerly known as Eyetech Pharmaceuticals, Inc.), a corporation organized under the laws of the state of Delaware, with its principal place of business at 140 E. Hanover Avenue, Cedar Knolls, New Jersey 07927 (“ Eyetech ”).

          WHEREAS, on December 17, 2002, Pfizer and Eyetech entered into a License Agreement (as amended prior to the Restatement Date, the “ Original License Agreement ”), whereby, inter alia , Eyetech granted to Pfizer an exclusive license or sublicense to certain patents and patent applications, know-how, trade secrets and scientific and technical information relating to Macugen® throughout the world, and a Collaboration Agreement (the “ Collaboration Agreement ”), in which Eyetech and Pfizer agreed, inter alia , to co-promote Macugen® in the US Territory (as defined below);

          WHEREAS, the Parties no longer desire to co-promote Macugen® in the US Territory; and

          WHEREAS, Pfizer desires to continue to develop and commercialize the Product (as defined below) in the ROW Territory (as defined below).

          NOW, THEREFORE, the Parties agree to terminate the Collaboration Agreement and amend and restate the Original License Agreement in its entirety as follows:

ARTICLE 1
DEFINITIONS

          1.1 “ AAA ” has the meaning set forth in Section 14.1(a).

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          1.2 “ Affiliate ” means any Person directly or indirectly controlled by, controlling or under common control with, a Party, but only for so long as such control shall continue. For purposes of this definition, “control” (including, with correlative meanings, “controlled by”, “controlling” and “under common control with”) means, with respect to a Person, possession, direct or indirect, of (a) the power to direct or cause direction of the management and policies of such Person (whether through ownership of securities or partnership or other ownership interests, by contract or otherwise), or (b) at least 50% of the voting securities (whether directly or pursuant to any option, warrant or other similar arrangement) or other comparable equity interests. For the avoidance of doubt, neither of the Parties shall be deemed to be an “Affiliate” of the other.

          1.3 “ Bankruptcy Code ” means 11 U.S.C §§ 101-1330, as amended.

          1.4 “ Amended and Restated Distribution Agreement ” means the Amended and Restated Distribution Agreement between Eyetech and Pfizer dated as of the date hereof.

          1.5 “ Amended and Restated Regulatory Services Agreement ” means the Amended and Restated Regulatory Services Agreement between Eyetech and Pfizer dated as of the date hereof.

          1.6 “ Assignment and Assumption Agreement for Manufacturing Agreements ” means the Assignment and Assumption Agreement between Eyetech and Pfizer, dated as of the date hereof, pursuant to which the agreements set forth on Schedule 4.9(b) are assigned from Eyetech to Pfizer.

          1.7 “ Assignment and Assumption Agreement for US Territory Agreements ” means the Assignment and Assumption Agreement among Eyetech, Pfizer and OSI Pharmaceuticals, Inc. (“OSIP”), dated as of the date hereof, pursuant to which the US Territory Agreements are assigned from Pfizer and/or OSIP to Eyetech.

          1.8 “ Bill of Sale ” means the bill of sale in the form attached hereto as Exhibit 1.8 .

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          1.9 “ Bulk Drug Substance Supplier ” means a third-party supplier of bulk drug substance for the Product with which Pfizer has entered into a supply agreement.

          1.10 “ Business Day ” means a day other than a Saturday, Sunday, or bank or other public holiday in New York, New York.

          1.11 “ Collaboration Agreement ” has the meaning set forth in the Recitals to this Agreement.

          1.12 “ Compound ” means the anti-VEGF aptamer that is the active pharmaceutical ingredient in Macugen® as of the Restatement Date, and is more specifically described in Schedule 1.12 .

          1.13 “ Confidential Information ” means all trade secrets or other proprietary information, including without limitation any proprietary data and materials (whether or not patentable or protectable as a trade secret), regarding a Party’s technology, products, business or objectives or regarding the Product, which is disclosed by a Party to the other Party. Notwithstanding the foregoing, there shall be excluded from the foregoing definition of Confidential Information any of the foregoing that:

                    (a) was known by the receiving Party or an Affiliate prior to its date of disclosure to the receiving Party as shown by the receiving Party’s or its Affiliate’s written records; or

                    (b) either before or after the date of the disclosure to the receiving Party is lawfully disclosed to the receiving Party or its Affiliate by third parties not in violation of any obligation to the other Party; or

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                    (c) either before or after the date of the disclosure to the receiving Party becomes published or generally known to the public through no fault or omission on the part of the receiving Party or its Affiliates; or

                    (d) is independently developed by or for the receiving Party or its Affiliate without reference to or reliance upon the Confidential Information as demonstrated by contemporaneous written records of the receiving Party or its Affiliate; or

                    (e) is required to be disclosed by the receiving Party or its Affiliate to comply with applicable Laws, to defend or prosecute litigation or to comply with governmental regulations or the regulations or requirements of any stock exchange, including Nasdaq, provided that the receiving Party provides prior notice of such disclosure to the other Party and takes reasonable and lawful actions to avoid and/or minimize the degree of such disclosure.

          1.14 “ Control ” or “ Controlled ” means, with respect to any intellectual property right, the possession (whether by ownership or license) by a Party (or by any Affiliate of a Party) of the ability to grant to the other Party a license under such right without violating the terms of any agreement with a third party.

          1.15 “ Courts ” has the meaning set forth in Section 15.4.

          1.16 “ Current Inventories ” has the meaning set forth in Section 4.9(c).

          1.17 “ DDMAC ” means the FDA’s Division of Drug Marketing Advertising and Communications, or its equivalent in the ROW Territory.

          1.18 “ Degussa Agreement ” means the Manufacturing and Supply Agreement dated as of November 11, 2003, by and between Degussa Canada Inc. (as successor in interest to Raylo Chemicals Inc.) and Eyetech, assigned to Pfizer pursuant to the Assignment and Assumption Agreement for Manufacturing Agreements.

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          1.19 “ Eyetech Capital Equipment ” has the meaning set forth in Section 4.9(f).

          1.20 “ Eyetech Parties ” has the meaning set forth in Section 11.2.

          1.21 “ Eyetech Patent Rights ” means all Patent Rights Controlled by Eyetech or its Affiliates as of the Restatement Date relating to, or useful in connection with, the manufacture, use or sale of the Compound or the Product in the ROW Territory, including the patents and patent applications set forth on Schedule 1.21 . Any patentable inventions that have been reduced to practice prior to the Restatement Date for which a patent application is not filed until after the Restatement Date shall be included within the definition of Eyetech Patent Rights. **

          1.22 “ Eyetech Technical Information ” means all scientific or technical information and related know-how and trade secrets, Controlled by Eyetech or its Affiliates as of the Restatement Date relating to the Compound or the Product, including but not limited to: (a) medical, clinical, toxicological or other scientific data and (b) processes and analytical methodology useful in the development, testing, analysis, manufacture or packaging of the Compound or the Product.

          1.23 “ Eyetech Third Party Licensors ” shall mean (a) Gilead, Nektar and Isis, and (b) any additional third party licensors that are identified by Eyetech to Pfizer with respect to a New Product in the course of negotiating an agreement pursuant to Section 3.5 concerning such New Product.

          1.24 “ FDA ” means the United States Food and Drug Administration and any successor agency thereto.

          1.25 “ Field ” means the prevention, treatment or control of all ophthalmic diseases or conditions.

 

 

 

 

**

 

This portion has been redacted pursuant to a confidential treatment request.

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          1.26 “ Fill and Finish Services Supplier ” means a third party supplier of fill and finish services necessary to produce the Product in finished (i.e., ready for administration to patients) form for sale in the ROW Territory with which Pfizer has entered into an agreement.

          1.27 “ Gilead License ” means the Licensing Agreement dated as of March 30, 2000, by and among Eyetech, Gilead Sciences, Inc. (“ Gilead ”) and NeXstar Pharmaceuticals, Inc., as amended from time to time.

          1.28 “ Global Congresses ” has the meaning set forth in Section 4.4(g)(ii).

          1.29 “ Governmental Authority ” means any court, agency, department or other instrumentality of any foreign, federal, state, county, city or other political subdivision.

          1.30 “ Isis License ” means the License Agreement dated as of December 31, 2001, by and between Eyetech and Isis Pharmaceuticals, Inc. (“ Isis ”), as amended from time to time.

          1.31 “ Joint Inventions ” shall have the meaning set forth in Section 9.12.

          1.32 “ Joint Patent Rights ” means Patent Rights that claim Joint Inventions.

          1.33 “ Law ” or “ Laws ” means all laws, statutes, rules, codes, regulations, orders, judgments and/or ordinances of any Governmental Authority.

          1.34 “ Losses ” means, subject to Section 10.4, any and all (a) claims, losses, liabilities, damages, fines, royalties, governmental penalties or punitive damages, deficiencies, interest, awards, and judgments, (b) with respect to third parties, settlement amounts and all of the items referred to in clause (a) above which, in accordance with Section 10.4, include third party special, indirect, incidental, consequential damages (including without limitation lost profits) and third party punitive and multiple damages, and (c) in connection with all of the items referred in clauses (a) and (b) above, any and all costs and expenses (including reasonable attorneys’ fees and all other

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expenses reasonably incurred in investigating, preparing or defending any litigation or proceeding, commenced or threatened).

          1.35 “ Nektar License ” means the License, Manufacturing and Supply Agreement dated as of February 5, 2002, by and between Eyetech and Nektar Therapeutics (formerly Shearwater Corporation) (“ Nektar ”), as amended as of January 23, 2006.

          1.36 “ Net Sales ” means the gross amounts billed or invoiced by Pfizer, its Affiliates and sublicensees for the Product in the ROW Territory, less the following deductions:

                    (a) trade, quantity and cash discounts allowed, but expressly excluding discounts or allowances offered as part of a package of products that includes a Product sold by Pfizer, its Affiliates or sublicensees;

                    (b) refunds, chargebacks and any other allowances which effectively reduce the net selling price;

                    (c) actual product returns, credits and allowances allowed to customers, and actual bad debts;

                    (d) rebates actually paid or credited to any governmental agency (or branch thereof) or to any third party payor, administrator or contractee;

                    (e) discounts mandated by, or granted to meet the requirements of, applicable state, provincial or federal law, wholesaler, including required chargebacks and retroactive price reductions;

                    (f) transportation, freight, postage charges and other charges, such as insurance, relating thereto, in each case included as a specific line item on an invoice to such third parties; and

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                    (g) taxes, excises or other governmental charges upon or measured by the production, sale, transportation, delivery or use of goods, in each case included as a specific line item on an invoice to such third parties.

          If any such sales to third parties are made in transactions that are not at arm’s length between the buyer and the seller, then the gross amount to be included in the calculation of Net Sales shall be the amount that would have been invoiced had the transaction been conducted at arm’s length. Such amount that would have been invoiced shall be determined, wherever possible, by reference to the average selling price of the Product in arm’s-length transactions in the relevant country.

          If Pfizer, its Affiliate or sublicensee sells a Product in unfinished form to a third party for resale, then the gross amount to be included in the calculation of Net Sales arising from such sale shall be the amount invoiced by the third party upon resale, in lieu of the amounts invoiced by Pfizer, its Affiliates or sublicensee when selling the Product in unfinished form. Otherwise, where Pfizer, its Affiliate or sublicensee sells a Product in finished form to a third party that does not require a sublicense under the Eyetech Patent Rights for further resale (each such third party hereinafter a “ Distributor ”), the amount to be included in the calculation of Net Sales shall be the price invoiced from Pfizer or its Affiliate or sublicensee to the third party, not the amount invoiced by the third party upon resale.

          If, in addition to or in lieu of a transfer price paid for quantities of Product supplied, any Distributor provides consideration to Pfizer, its Affiliate or sublicensee in connection with any Product or the Distributor’s rights or relationship with Pfizer, its Affiliate or sublicensee in relation thereto, then such consideration shall be included in the calculation of Net Sales in the Pfizer Quarter in which it becomes due to Pfizer or its Affiliate or sublicensee (as applicable).

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Notwithstanding the foregoing, amounts received by Pfizer, or its Affiliates or sublicensees, for the sale of the Product among Pfizer and its Affiliates or sublicensees for resale shall not be included in the computation of Net Sales hereunder.

          Net Sales shall be determined from books and records maintained in accordance with GAAP, consistently applied throughout the organization and across all products of the entity whose sales of Product are giving rise to Net Sales.

          1.37 “ New Product ” means, other than the prescription pharmaceutical product containing the Compound and known as Macugen® as of the Restatement Date and any new doses and dosing regimens thereof approved after the Restatement Date, provided that such new doses or dosing regimens do not alter the Product itself or any ingredient contained in such Product as of the Restatement Date, any product that (a) contains or is based on the Compound, or any metabolites or prodrugs of such aptamer or any hydrates, conjugates, salts, esters, isomers, polymorphs or analogues of any of the foregoing, either alone or in combination with one or more other therapeutically active substances, and (b) is for use in the Field; including for the avoidance of doubt any un-pegylated formulation of the prescription pharmaceutical product containing the Compound and known as Macugen® as of the Restatement Date.

          1.38 “ Ongoing Trials ” has the meaning set forth in Section 4.2.

          1.39 “ Ongoing Trial Data ” means all results and data arising from the Ongoing Trials, including without limitation all raw data and final results.

          1.40 “ Original License Agreement ” shall have the meaning set forth in the Recitals to this Agreement.

          1.41 “ Other Components ” shall have the meaning set forth in Section 4.9(c).

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          1.42 “ Out-of-Pocket Costs ” means costs and expenses paid to third parties (or payable to third parties and accrued in accordance with GAAP), other than Affiliates or employees, by either Party after the Restatement Date.

          1.43 “ Packaging Materials ” has the meaning set forth in Section 9.7.

          1.44 “ Party ” means either Eyetech or Pfizer; “ Parties ” means both Eyetech and Pfizer.

          1.45 “ Patent Rights ” means the rights and interest in and to all issued patents and pending patent applications in any country in the Territory, including all divisionals, continuations, renewals, continuations-in-part, patents of addition, supplementary protection certificates, extensions, registrations or confirmation patents and reissues thereof.

          1.46 “ Person ” means any natural person or any corporation, company, partnership, joint venture, firm or other entity, including without limitation a Party.

          1.47 “ Pfizer Capital Equipment ” has the meaning set forth in Section 4.9(g).

          1.48 “ Pfizer Parties ” has the meaning set forth in Section 11.1.

          1.49 “ Pfizer Patent Rights ” means all Patent Rights Controlled by Pfizer or its Affiliates as of the Restatement Date, relating to, or useful in connection with, the manufacture, use or sale of the Compound or the Product in the US Territory. Any patentable inventions that have been reduced to practice prior to the Restatement Date for which a patent application is not filed until after the Restatement Date shall be included in Pfizer Patent Rights.

          1.50 “ Pfizer Quarter ” means each of the four (4) thirteen (13) week periods, the first commencing on December 1 of any Year.

          1.51 “ Pfizer Technical Information ” means all scientific or technical information and related know-how and trade secrets, Controlled by Pfizer or its Affiliates as of the Restatement Date, including but not limited to: (a) medical, clinical, toxicological or other scientific data and (b)

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processes and analytical methodology useful in the development, testing, analysis, manufacture or packaging of the Compound or the Product.

          1.52 “ Pharmacovigilance Agreement ” has the meaning set forth in Section 4.5.

          1.53 “ Prior Agreements ” means the following agreements entered into between Pfizer and Eyetech: the Collaboration Agreement, the Detailing Services Agreement dated December 17, 2002, and the Mutual Consent Establishing the Technology Subcommittee dated February 4, 2004.

          1.54 “ Product ” means (a) the prescription pharmaceutical product containing the Compound and known as Macugen® as of the Restatement Date, for any use in the Field, and (b) any New Product with respect to which the license granted to Pfizer in Section 3.1 is expanded pursuant to Section 3.5. For the avoidance of doubt, Product shall include new doses and dosing regimens thereof approved after the Restatement Date, provided that such new doses or dosing regimens do not alter the Product itself or any ingredient contained in such Product as of the Restatement Date.

          1.55 “ Product Components ” has the meaning set forth in Section 4.9(a).

          1.56 “ Quarterly Expense Reports ” has the meaning set forth in Section 5.2(a).

          1.57 “ Regulatory Authority ” means any federal, national, multinational, state, provision, or local regulatory agency, department, bureau or other governmental entity with authority over the testing, manufacture, use, storage, import, promotion, marketing and sale of a pharmaceutical product in a country, including the FDA.

          1.58 “ Required Consents ” has the meaning set forth in Section 4.9(b).

          1.59 “ Responsible Party ” has the meaning set forth in Section 4.2.

          1.60 “ Restatement Date ” has the meaning set forth in the opening paragraph of this Agreement.

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          1.61 “ ROW Territory ” means all countries in the world outside the US Territory.

          1.62 “ Technical Information ” means Eyetech Technical Information or Pfizer Technical Information.

          1.63 “ Territory ” means the US Territory and/or the ROW Territory, as the case may be.

          1.64 “ Third Party Claims ” has the meaning set forth in Section 11.1(a)(ii).

          1.65 “ Trademarks ” means (a) the registered and unregistered trademarks and trade names in use as of the Restatement Date related to the Product including those marks reflected on Exhibit 1.65 ; and (b) any aspect of Product packaging in use as of the Restatement Date that constitutes protectable trade dress; but in each case excluding the Eyetech name and logo.

          1.66 “ Transaction Agreements ” mean this Agreement, the Amended and Restated Regulatory Services Agreement, the Amended and Restated Distribution Agreement, the Assignment and Assumption Agreement for Manufacturing Agreements, the Assignment and Assumption Agreement for US Territory Agreements, the Bill of Sale, the Pharmacovigilance Agreement and the Transitional Services Agreement.

          1.67 “ Transitional Services Agreement ” means the transitional services agreement between the Parties entered into on the Restatement Date pursuant to which Eyetech has agreed to provide to Pfizer certain services, including supply, analytical, stability and clinical trial support services, with respect to the Product and Product Components.

          1.68 “ US Territory ” means United States of America, its territories, possessions and Puerto Rico.

          1.69 “ US Territory Agreements ” has the meaning set forth in Section 4.4(e).

          1.70 “ Year ” means a calendar year.

          1.71 Other Definitional Provisions .

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                    (a) The words “hereof”, “herein”, “hereto” and “hereunder” and words of similar import, when used in this Agreement shall refer to this Agreement as a whole and not to any particular provision of this Agreement.

                    (b) The terms defined in the singular shall have a comparable meaning when used in the plural, and vice versa.

                    (c) The term “including” shall mean “including, without limitation”.

ARTICLE 2

AMENDMENT AND RESTATEMENT OF ORIGINAL LICENSE AGREEMENT;
TERMINATION OF PRIOR AGREEMENTS;
OTHER TRANSACTION AGREEMENTS

          2.1 Original License Agreement . This Agreement amends and restates the Original License Agreement in its entirety. Notwithstanding anything to the contrary herein, this Agreement shall not relieve either Party of any obligations the performance of which were owed under the Original License Agreement prior to the Restatement Date.

          2.2 Prior Agreements . Effective as of the Restatement Date, the Prior Agreements, and all rights and obligations of the Parties thereunder, are terminated in their entirety (including, without limitation, provisions under the Prior Agreements that would otherwise survive such termination) by mutual consent of the Parties and shall no longer be in effect, except for the following provisions of the Collaboration Agreement, which shall survive termination of the Collaboration Agreement as set forth below: (a) each Party’s obligations with respect to expenses and Net Sales which have accrued under the Collaboration Agreement prior to the Restatement Date and which shall be reconciled pursuant to Section 5.1 of this Agreement, and (b) the obligations of the Parties with respect to accounts and reports (Article 9 of the Collaboration Agreement), ownership of intellectual property (Article 10 of the Collaboration Agreement), the protection and nondisclosure of Confidential Information (Article 11 of the Collaboration

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Agreement), dispute resolution (Article 15 of the Collaboration Agreement) and indemnification (Sections 12.4, 12.5, 12.6, 12.7, 12.8 and 12.9 of the Collaboration Agreement). For the avoidance of doubt, Section 14.1 of the Collaboration Agreement (Non-Competition) shall terminate and have no further force or effect from and after the termination of the Collaboration Agreement.

          2.3 Other Transaction Agreements . Concurrently with the execution of this Agreement, the Parties are executing the Amended and Restated Distribution Agreement, the Amended and Restated Regulatory Services Agreement, the Assignment and Assumption Agreement for Manufacturing Agreements, the Assignment and Assumption Agreement for US Territory Agreements, the Bill of Sale, and the Transitional Services Agreement. The Pharmacovigilance Agreement shall survive the execution of this Agreement and the termination of the Prior Agreements in accordance with its terms.

ARTICLE 3

LICENSES

          3.1 Eyetech Grants .

               (a) Subject to the terms of this Agreement, Eyetech hereby grants to Pfizer, and Pfizer hereby accepts, (i) an exclusive (even as to Eyetech, subject to a retained right by Eyetech to develop, use, make, have made and import the Product in the ROW Territory solely for the purpose of obtaining regulatory approval(s) for the Product in the US Territory and developing and supplying the Product for sale and importation in the US Territory), royalty-free (except as otherwise set forth in Article 6) license under the Eyetech Patent Rights, Eyetech Technical Information, and Eyetech’s rights under any Joint Patent Rights and Ongoing Trial Data, to develop, use, make, have made, sell, offer for sale, import, and have imported the Product in the ROW Territory, and (ii) a nonexclusive, royalty-free (except as otherwise set forth in Article 6) license under the Eyetech Patent Rights and corresponding US Territory Patent Rights owned or

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Controlled by Eyetech or its Affiliates, Eyetech Technical Information, and Eyetech’s rights under any Joint Patent Rights and Ongoing Trial Data, to develop, use, make, have made and import the Product in the US Territory solely for the purpose of developing and supplying the Product for sale and importation in the ROW Territory.

               (b) The licenses granted in Section 3.1(a) include sublicenses, as applicable. The sublicenses granted by Eyetech to Pfizer in Section 3.1(a) are subject to the following terms of the Gilead License, the Isis License and the Nektar License, respectively:

                    (i) Sections 2.4, 2.5, 3.6, 3.8, 6.3 and 6.7 of the Gilead License;

                    (ii) Sections 4.3 and 4.4 of the Isis License; and

                    (iii) Sections 2.3, 3.2, 3.5, 4.1, 4.9, 8.1, 8.2.3, 9.1 and 9.6 of the Nektar License.

               (c) Any sublicensee obligations required by the Gilead License, the Isis License and the Nektar License to be included in a sublicense thereunder, including without limitation any required provision making the applicable Eyetech Third Party Licensor a third party beneficiary of any sublicense thereunder, shall be deemed to be included in this Agreement.

               (d) The licenses granted by Eyetech in Section 3.1(a) with respect to the following patents: US Patent No. 5,475,096, US Patent No. 5,670,637, and US Patent No. 5,696,249, are subject to 35 USC §§200-212, 37 CFR §401 et seq. and applicable governmental implementing regulations. Any right granted in this Agreement greater than that permitted under 35 USC §§200-212 or 37 CFR §401 et seq. shall be subject to modification as may be required to conform to the provisions of those statutes. All rights reserved to the United States government and others under 35 USC §§200-212 and 37 CFR §401 shall remain and shall in no way be affected by this Agreement.

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          3.2 License Grant to Eyetech . Subject to the terms of this Agreement, Pfizer hereby grants to Eyetech, and Eyetech hereby accepts, (i) an exclusive (even as to Pfizer, subject to a retained right by Pfizer to develop, use, make, have made and import the Product in the US Territory solely for the purpose of obtaining regulatory approval(s) for the Product in the ROW Territory and developing and supplying the Product for sale and importation in the ROW Territory), royalty-free license under the Pfizer Patent Rights, Pfizer Technical Information, and Pfizer’s rights under any Joint Patent Rights and Ongoing Trial Data, to develop, use, make, have made, sell, offer for sale, import, and have imported the Product in the US Territory, and (ii) a nonexclusive, royalty-free license under the Pfizer Patent Rights and corresponding ROW Territory Patent Rights owned or Controlled by Pfizer or its Affiliates, Pfizer Technical Information, and Pfizer’s rights under any Joint Patent Rights and Ongoing Trial Data, to develop, use, make, have made and import the Product in the ROW Territory solely for the purpose of developing and supplying the Product for sale and importation in the US Territory.

          3.3 Sublicensing .

               (a) The licenses granted in Sections 3.1(a) and 3.2 above include the right by either Party to grant sublicenses. Any sublicense granted by a Party must be granted pursuant to a written agreement that subjects the sublicensee to all relevant restrictions, limitations and obligations in this Agreement.

               (b) If a Party grants a sublicense under Section 3.3(a), such Party shall be responsible for failure by its sublicensees to comply with all relevant restrictions, limitations and obligations in this Agreement.

               (c) In the event of a material default by any sublicensee under a sublicense agreement, the sublicensing Party will inform the other Party and take such action, after

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consultation with the other Party, that in the sublicensing Party’s reasonable business judgment is required to address such default.

               (d) Pfizer shall provide Eyetech with a copy of each sublicense agreement, in final executed form, that Pfizer enters into in accordance with this Section 3.3 not later than five (5) days after the execution of such sublicense agreement; provided that Pfizer may redact the financial terms from such copies only if permitted under the applicable requirements of the Gilead License, the Nektar License and the Isis License requiring delivery to Gilead, Nektar or Isis of copies of sublicense agreements.

          3.4 Product Orders or Sales Outside of a Party’s Territory . If Eyetech receives an order for the Product from a third party that is either located in the ROW Territory or that intends to resell the Product into the ROW Territory, Eyetech will not accept such order and shall refer such order to Pfizer. If Pfizer receives an order for the Product from a third party that is either located in the US Territory or that intends to resell the Product into the US Territory, Pfizer will not accept such order and shall refer such order to Eyetech. Each Party agrees that it shall not, and shall cause its Affiliates and licensees or sublicensees not to, (a) solicit active or passive sales of the Product outside of, in the case of Eyetech, the US Territory, and in the case of Pfizer, the ROW Territory, or (b) sell the Product to a third party where the selling Party knows or should reasonably know that such third party intends to resell such Product outside of, in the case of Eyetech, the US Territory, and in the case of Pfizer, the ROW Territory.

          3.5 Right of First Negotiation For New Products . During the period commencing upon the Restatement Date and ending upon the ** anniversary of the Restatement Date (the “ ROFN Period ”), in the event that Eyetech proposes to (a) commence a phase III clinical trial with respect to any New Product that Eyetech intends will serve as a pivotal trial for the purpose of obtaining

 

 

 

 

**

 

This portion has been redacted pursuant to a confidential treatment request.

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regulatory approval(s) for such New Product in the ROW Territory, or (b) grant to any third party any right or license under any Patent Rights Controlled by Eyetech or its Affiliates to offer for sale, sell or have sold any New Product(s) in the ROW Territory, then Eyetech shall provide Pfizer with (x) written notice thereof (“ Notice of Opportunity ”), and (y) any material information regarding the toxicology, safety and efficacy of the New Product(s) identified in the Notice of Opportunity (the ROW Territory commercialization rights with respect to each such identified New Product(s), a “ New Product Opportunity ”), the status of any material discussions with the FDA relating to such New Product, and any relevant patent information, each to the extent that such information is available and permitted to be disclosed by Eyetech as of the date of the Notice of Opportunity. In the case of the foregoing clause (a), Eyetech shall provide Pfizer with the Notice of Opportunity during the time period commencing upon ** and ending with ** . In the case of the foregoing clause (b), Eyetech shall provide Pfizer with the Notice of Opportunity on or about the time at which ** . Pfizer, at its option, will have the right to negotiate with Eyetech for rights to the New Product Opportunity and to expand Pfizer’s license hereunder to include rights to such New Product Opportunity; provided that Pfizer exercises such right by written notice to Eyetech within ** days after receipt of the Notice of Opportunity. In the event that Pfizer does not provide the written notice exercising Pfizer’s right to negotiate as described in the immediately preceding sentence, Eyetech shall have no further obligation to Pfizer, and Pfizer shall have no further rights, with respect to such New Product Opportunity. In the event that Pfizer provides the written notice exercising Pfizer’s right to negotiate as described above, Eyetech shall not commence such phase III clinical trial of the applicable New Product(s) or grant rights to such New Product Opportunity to a third party for a period of up to ** , in order to provide Pfizer with an opportunity to discuss with Eyetech the terms pursuant to which Pfizer would license rights to such New Product

 

 

 

 

**

 

This portion has been redacted pursuant to a confidential treatment request.

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Opportunity. Pfizer’s rights under this Section 3.5 shall apply on a New Product Opportunity-by-New Product Opportunity basis, and Pfizer’s waiver of its rights hereunder with respect to any particular New Product Opportunity shall not constitute a waiver of such rights with respect to any other New Product Opportunity. If the Parties do not reach agreement regarding the terms on which Pfizer would license rights to any New Product Opportunity during any such ** negotiation period, Eyetech shall have no further obligation to Pfizer, and Pfizer shall have no further rights, with respect to such New Product Opportunity; provided that, (A) during the ROFN Period, Eyetech shall not grant any third party a license of any Patent Rights Controlled by Eyetech or its Affiliates for such New Product Opportunity on terms which, ** , and (B) in the case of a New Product Opportunity for which Eyetech provided Pfizer with a Notice of Opportunity pursuant to the foregoing clause (b), if Eyetech has not granted rights to such New Product Opportunity to a third party within ** after the end of such ** negotiation period between Eyetech and Pfizer, the provisions of this Section 3.5 shall once again apply to such New Product Opportunity.

ARTICLE 4

MANUFACTURING, MARKETING, MEDICAL AND REGULATORY MATTERS

          4.1 Meetings and Information Exchange . The Parties recognize that, after the Restatement Date, it is critical to maintain and facilitate ongoing cooperation and information exchange between them concerning the Product. Accordingly, representatives of the Parties shall meet periodically as set forth in this Article 4 in order to exchange, assess and discuss information and strategies related to, inter alia , the: (1) continued clinical development of, and regulatory strategy for, the Product, (2) marketing and promotion for the Product, and (3) manufacture, supply and distribution of the Product. These meetings may be held in person, by videoconference or by

 

 

 

 

**

 

This portion has been redacted pursuant to a confidential treatment request.

19


 

teleconference, as the Parties mutually agree, and all in-person meetings shall be at locations mutually agreed-upon by the Parties.

          4.2 Ongoing Clinical Trials . Schedule 4.2 sets forth a list of the ongoing clinical trials for the Product (the “ Ongoing Trials ”), the identity of the Party responsible for completing the trial and performing remaining activities for each such trial (the “ Responsible Party ”), the allocation between the Parties of the future costs for performing the activities for each such trial, which costs shall be reconciled between the Parties pursuant to Section 5.2 hereof, and the services, if any, to be provided to the Responsible Party by the other Party in connection with each Ongoing Trial. Each Party will cooperate with the other Party, at the other Party’s reasonable request, in order to complete the Ongoing Trials. Except with respect to the CRVO study (study number 1011), for which Eyetech will complete the final clinical study report within one (1) year from completion of such study, the Responsible Party for a particular Ongoing Trial shall have the right to change or terminate such Ongoing Trial as such Party may deem necessary or desirable, provided, that the other Party shall not be liable for any such change or termination and shall be compensated for such Party’s performance of any additional activities or services requested by the Responsible Party in connection with such change or termination. Services to be provided by Eyetech to Pfizer in connection with certain Ongoing Trials will be provided pursuant to the Transitional Services Agreement. Any services to be provided by Pfizer to Eyetech in connection with certain Ongoing Trials will be provided pursuant to the Amended and Restated Regulatory Services Agreement. In addition, ** . In addition, Pfizer shall provide Eyetech access to, and shall reasonably cooperate with Eyetech in compiling, data that may reasonably be deemed necessary by Eyetech to fulfill its post-marketing commitments to the FDA for the Product with respect to ERG and corneal biomicroscopy, and to respond to related queries or requests by the FDA with respect to such post-

 

 

 

 

**

 

This portion has been redacted pursuant to a confidential treatment request.

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marketing commitments to the FDA. Without limiting the Parties’ rights and obligations under the Pharmacovigilance Agreement with respect to the sharing of any clinical data thereunder, with respect to each clinical trial for the Product completed prior to the Restatement Date as well as each Ongoing Trial, Pfizer and Eyetech shall each provide, or cause any third party at which such information is stored to provide, the other Party with all raw data and final results arising from such trials promptly after such data and results become available, but no less frequently than on a quarterly basis for the duration of any Ongoing Trials, provided that , if a Party requests interim disclosure of Ongoing Trial Data in the possession of the other Party, the other Party shall not unreasonably refuse to provide such interim disclosure. Each Party will provide the other with a draft of all public releases of Ongoing Trial Data reasonably in advance of public dissemination of any such release in order to afford the other Party with an opportunity to review and comment upon such draft. The Party identified on Schedule 4.2 as the responsible party for performing activities with respect to an Ongoing Trial may post the final results from such Ongoing Trial on the PhRMA clinical studies database located at www.clinicalstudyresults.org.

          4.3 Future Clinical Trials . Subject to the remainder of this Section 4.3, and in addition to the rights and obligations of the Parties as set forth in Section 4.7(d) below, Pfizer has the right to conduct further clinical studies with respect to the Product in the ROW Territory, and Eyetech has the right to conduct further clinical studies with respect to the Product in the US Territory. At the request of either Party, the Parties shall in good faith meet and discuss jointly conducting additional clinical studies with respect to the Product where preclinical and/or clinical results ** . If the Parties agree to pursue such additional development jointly, the Parties shall agree on both the manner in which the costs for such development will be shared, and each Party’s respective rights to use the data and other information resulting from such development. If the Parties do not agree

 

 

 

 

**

 

This portion has been redacted pursuant to a confidential treatment request.

21


 

to jointly pursue such additional development, either Party shall have the right to pursue such development at its sole expense; provided , however , that ** .

          4.4 Marketing .

               (a) In order to ensure that a consistent message is communicated by the Parties with respect to the Product, representatives of the Parties shall meet at least once each calendar quarter to review and discuss their respective strategies for the advertising and promotion of the Product.

               (b)  **

               (c)  **

               (d)  **

               (e) In connection with the marketing, promotion and medical support of the Product in the US Territory, Pfizer and/or Eyetech (or its Affiliate) have entered into the third party agreements as set forth in Schedule 4.4(e) (the “ US Territory Agreements ”). Subject to the terms and conditions of such agreements and any required third party consents, Pfizer shall assign to Eyetech, and Eyetech will assume, all of Pfizer’s rights and obligations under such US Territory Agreements pursuant to the Assignment and Assumption Agreement for US Territory Agreements. For the avoidance of doubt, if Pfizer is not permitted to assign all of its rights and obligations under a US Territory Agreement to Eyetech, then such US Territory Agreement will be terminated by Pfizer and/or Eyetech (or its Affiliate), as applicable.

               (f) With respect to ** in payments made by Pfizer as of the Restatement on behalf of the Parties to ** to organize two (2) consultant meetings for Product in the US Territory to be held after the Restatement Date and solely under the control of and for the benefit of Eyetech,

 

 

 

 

**

 

This portion has been redacted pursuant to a confidential treatment request.

22


 

Eyetech shall reimburse Pfizer for the Out-of-Pocket Costs thereof. Such costs shall be included in Pfizer’s Quarterly Expense Report.

               (g) In addition, the Parties further agree to:

                    (i) provide each other, for information, with a copy of all new advertising and promotional materials for the Product produced by Eyetech for the US Territory and by Pfizer for all English-speaking countries in the ROW Territory;

                    (ii) discuss, share information concerning, and, to the extent reasonably practicable, coordinate, advisory board meetings, contacts with key opinion leaders, and activities at the ARVO and AAO global congresses and the world ophthalmology conference (WOC) (collectively, “ Global Congresses ”). The Parties will share their planning for all Global Congresses with respect to the Product in advance of the applicable event. In addition, with respect to the two (2) 10x10 Product-specific convention booths in existence as of the Restatement Date, from and after the Restatement Date each Party shall own one (1) such booth as discussed by the Parties prior to the Restatement Date and each Party agrees to execute any assignments and other documents and take any further actions as may be necessary to more fully vest on the other Party such agreed ownership.**

 

**

 

This portion has been redacted pursuant to a confidential treatment request.

23


 

                    (iii) coordinate press releases and other communications on new data or other material information concerning the Product by providing drafts of all such press releases or communications reasonably in advance of public dissemination of any of the foregoing in order to afford the other Party with an opportunity to review and comment upon such draft in advance of dissemination;

                    (iv) exchange, at least once each calendar year, a list of magazines, journals and other publications in which it plans to place advertising for the Product and attempt, to the extent reasonably practicable, to allocate advertising responsibility based on the country in which the applicable magazine, journal or other publication maintains its primary circulation; and

                    (v) cooperate in the development of separate US Territory and ROW Territory Internet websites for the Product. After the Restatement Date, Eyetech shall retain ownership of the websites (including URL) currently located at “www.macugen.com” and “www.macugen.net”, shall continue to operate, maintain and develop the “www.macugen.com” website for Product in the US Territory, and shall be responsible for all costs associated

24


 

therewith. After the Restatement Date, Pfizer shall operate, maintain and develop the website “www.macugen.net” for Product in the ROW Territory, and shall be responsible for all costs associated therewith. Subject to the terms and conditions hereof, Eyetech shall maintain a link on the “www.macugen.com” website to the “www.macugen.net” website, and Pfizer shall maintain a link on the “www.macugen.net” website to the “www.macugen.com” website, such links to be in a form to be mutually agreed by the Parties.

          4.5 Pharmacovigilance and Product Safety Matters . Eyetech and Pfizer shall be responsible for the surveillance, receipt, evaluation, and reporting of adverse drug experiences for the Product in the US Territory and the ROW Territory, respectively, and, with respect to the exchange of adverse event and other safety information relating to the Product, each shall at all times comply with the terms of the Pharmacovigilance Agreement between the Parties dated May 11, 2006 (as it may be amended from time to time, the “ Pharmacovigilance Agreement ”). Pursuant to the Pharmacovigilance Agreement, Pfizer is currently responsible for receipt, processing, evaluation and follow-up of all post-marketing reports for the US Territory. Eyetech has requested that Pfizer, and Pfizer has agreed to, continue to be responsible for receipt, processing, evaluation and follow-up of all post-marketing reports for the US Territory for a period of ** after the Restatement Date. The Pharmacovigilance Agreement will be amended to reflect such transfer of any responsibilities from Pfizer to Eyetech or its successor.

          4.6 Medical Information and Product Complaints . Eyetech shall be responsible for responding to medical, consumer and other inquiries received from the US Territory concerning the Product, including any Product complaints, and, subject to the services to be provided by Pfizer to Eyetech pursuant to the Amended and Restated Regulatory Services Agreement, Pfizer shall direct all such matters to Eyetech’s attention. Pfizer shall be responsible for responding to medical,

 

 

 

 

**

 

This portion has been redacted pursuant to a confidential treatment request.

25


 

consumer and other inquiries received from the ROW Territory concerning the Product, including any Product complaints, and Eyetech shall direct all such matters to Pfizer’s attention. The Parties acknowledge that, as of the Restatement Date, Pfizer is handling certain Product complaints and medical, consumer and other inquiries concerning the Product on behalf of Eyetech for the US Territory. Eyetech shall have the right to request that Pfizer continue to handle these matters for the US Territory pursuant to, and subject to the terms of, the Amended and Restated Regulatory Services Agreement.

          4.7 Regulatory Matters . All regulatory approvals in the ROW Territory relating to the Product shall continue to be the property of Pfizer and held in Pfizer’s or its Affiliate’s name, and all regulatory approvals in the US Territory shall continue to be the property of Eyetech and held in Eyetech’s or its Affiliate’s name. Each Party will cooperate with the other, and provide the other with reasonable assistance, in connection with future filings with Governmental Authorities concerning the Product (including filings related to regulatory approval or safety of, or approval of a new indication for, the Product, but excluding DDMAC filings), in each case at the owning Party’s request and expense, including without limitation by (i) providing reasonable assistance to such owning Party to provide information to, and answer queries posed by, Regulatory Authorities in connection with obtaining or maintaining regulatory approvals for Product, (ii) providing, or causing its third party contractors to provide, the owning Party with non-clinical data concerning the Product including CMC, pharmacology, toxicology, and pharmacodynamics data; and (iii) permitting the applicable Governmental Authorities to inspect manufacturing or testing facilities of the non-owning party as required by such Governmental Authorities. In addition, the Parties agree as follows with respect to future regulatory activities concerning the Product:

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               (a) Each Party will provide the other Party with copies of all material Product-related correspondence that it receives from the FDA or analogous Governmental Authorities or Regulatory Authorities in the European Union, Canada and Japan, except correspondence from DDMAC. In addition to the immediately preceding sentence and to Section 4.1, each Party will provide the other Party with copies, which copies may be in draft form, of (i) the safety sections of material Product-related submissions to the FDA or analogous Governmental Authorities or Regulatory Authorities in the ROW Territory, and (ii) any sections disclosing or concerning any Ongoing Trial Data included in any such submissions, reasonably in advance of submission, and such Party shall, prior to making such submission, reasonably consider the comments, if any, given by the other Party; and

               (b) Any decision to initiate a recall or withdrawal of, or a broad-based non-promotional information update to physicians about (e.g., a “Dear Dr. Letter”), the Product in the US Territory shall be made by Eyetech and any decision to initiate a recall or withdrawal of, or a broad-based non-promotional information update to physicians about, the Product in the ROW Territory shall be made by Pfizer. Before either Party initiates a recal


 
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