EX-10.68 5 a04-3258_1ex10d68.htm EX-10.68

Exhibit 10.68

 

CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

LICENSING AGREEMENT

 

This LICENSING AGREEMENT (“Agreement”), effective as of March 31, 2000 (the “Effective Date”), by and among GILEAD SCIENCES, INC., a Delaware corporation with its principal office located at 333 Lakeside Drive, Foster City, CA 94404 (“Gilead Sciences”), and its wholly-owned subsidiary, NEXSTAR PHARMACEUTICALS, INC., a Delaware corporation (collectively with Gilead Sciences, “Gilead”), and EYETECH PHARMACEUTICALS, INC., a Delaware corporation with its principal offices located at 300 East 42nd Street, Third Floor, New York, New York 10017 (“EyeTech”).  Unless otherwise defined in this Agreement, all capitalized terms shall have the meanings given to them in Section 1.1 of this Agreement.

 

RECITALS

 

1.                                       WHEREAS, Gilead owns certain patents and patent applications and related know-how for NX1838, and has made certain filings for regulatory approvals with respect to NX1838; and

 

2.                                       WHEREAS, Gilead and EyeTech desire to enter into this Agreement and certain other agreements, including an agreement providing for the fill-and-finish manufacture of quantities of Product sufficient for the completion of Phase Ib clinical trials; and

 

3.                                       WHEREAS, subject to the terms and conditions set forth in this Agreement, Gilead wishes to license to EyeTech and EyeTech wishes to license from Gilead all of Gilead’s rights under patents, patent applications and know-how related to NX1838, and have access to all regulatory approvals with respect to NX1838; and

 

4.                                       WHEREAS, subject to the terms and conditions set forth in this Agreement, Gilead also wishes to sell to EyeTech and EyeTech wishes to purchase from Gilead its inventory of NX1838.

 

NOW, THEREFORE, the Parties hereto, intending to be legally bound, hereby agree as follows:

 

SECTION 1
DEFINITIONS

 

1.1                                 Definitions.                                  For purposes of this Agreement, the following terms shall have the meanings set forth below:

 

Affiliate” shall mean any Person that, directly or indirectly, through one or more intermediaries, Owns, is Owned by or is under common Ownership with, a Party, where “Own” or “Ownership” means (a) direct or indirect possession of at least fifty percent (50%) of the outstanding voting securities of a corporation or a comparable ownership in any other type of Person, provided, however, that if the law of the jurisdiction in which such entity operates does not allow fifty percent (50%) or greater ownership by a Party, such ownership interest shall be at

 

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least forty percent (40%) or (b) that a Person or group of Persons otherwise has the unilateral ability to control and direct the management of the entity, whether by contract or otherwise.

 

Business Day” shall mean any day other than a Saturday, Sunday or banking holiday in New York City or San Francisco, California.

 

Calendar Quarter” shall mean a calendar quarter (i.e., period of three (3) consecutive months) ending on March 31, June 30, September 30 or December 31.

 

Calendar Year” shall mean any period of twelve (12) consecutive months ending on December 31.

 

Competitive Product” shall mean a product competitive with a Product.

 

Compulsory License” means a compulsory license under the Licensed Patents obtained by a Third Party through the order, decree, or grant of a governmental authority of competent jurisdiction, authorizing such Third Party to manufacture, use, sell, offer for sale or import a Competitive Product in one or more countries within the Territory.

 

Control”, “Controls”, and “Controlled” shall mean, with respect to a particular item of information or intellectual property right, that the applicable Party owns or has a license to such item or right and has the ability to grant to the other Party access to and a license or sublicense (as applicable) under such item or rights as provided for in this Agreement without violating the terms of any agreement or other arrangement with any Third Party.

 

Damages” shall mean any and all costs, losses, claims, liabilities, fines, penalties, damages and expenses, court costs, and reasonable fees and disbursements of counsel, consultants and expert witnesses incurred by a Party hereto (including any interest payments which may be imposed in connection therewith).

 

Delivery Date” shall mean the date that is ten (10) days after the Effective Date.

 

Effective Date” shall have the meaning given such term in the first sentence of this Agreement.

 

EU” shall mean Austria, Belgium, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, The Netherlands, Portugal, Spain, Sweden and the United Kingdom, and future members of the European Union (or its successor), upon their admission for full membership (with commercial rights and privileges substantially comparable to those of the foregoing countries).

 

EyeTech Rights” shall mean any invention or inventions, patentable or not, know-how, information and/or data relating to the Product, including, without limitation, pre-clinical studies and clinical trial information, manufacturing processes, formulations, modes of delivery and/or data necessary for the manufacture, use or sale of the Product, which are Controlled by EyeTech during the term of this Agreement, and all Patents covering any of the foregoing which are Controlled by EyeTech during the term of this Agreement.

 

CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

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FDA” shall mean the United States Food and Drug Administration, or any successor thereto.

 

Field” shall mean the prevention and treatment of all human and other animal diseases and conditions, and expressly excluding in vivo and in vitro diagnostic applications.

 

First Commercial Sale” shall mean, with respect to any particular country, the first sale of a Product in such country by EyeTech, or any of its Affiliates or sublicensees, after Regulatory Approvals in such country have been granted from the relevant Regulatory Authority in such country for such Product.

 

GAAP” shall mean United States generally accepted accounting principles, consistently applied.

 

Indemnified Party” shall have the meaning given in Section 7.2 hereof.

 

Indemnifying Party” shall have the meaning given in Section 7.2 hereof.

 

Know-How” shall mean all ideas, materials, inventions (whether patentable or not), trade secrets, data, instructions, processes, formulas, expert opinion and information, including, without limitation, the Manufacturing Information and biological, chemical, pharmacological, toxicological, physical and analytical, safety, manufacturing and quality control data and information, in each case within the Field, that, as of the Effective Date are (i) existing, and (ii) Controlled by Gilead as of the Effective Date, in each case which is necessary or useful for the development, manufacture, use, sale or commercialization of the Product in the Field.  Excluded from Know-How are any Patents, the Licensed Patents and the Transferred Assets.

 

License” shall mean the license granted by Gilead to EyeTech pursuant to Section 2.1.

 

Licensed Patents” shall mean any Patents listed in Exhibit D (as updated from time to time pursuant to Section 5.6) which claim the manufacture, use, import, offer for sale or sale of Products in accordance with this Agreement and which now or at any time during the term of this Agreement are Controlled by Gilead or any Affiliate of Gilead.

 

Major Countries” shall mean Canada, France, Germany, Italy, Japan, Spain, United Kingdom and the United States.

 

Manufacturing Information” shall mean copies of all existing information in written and electronic form in Gilead’s possession or control as of the Effective Date, with respect to any Product existing as of the Effective Date, that relates to, in the Field:  (1) processes for the production of NX1838, and intermediates in the preparation of a Product; (2) the in-process analytical controls for production of each of:  (a) NX1838; and (b) a Product; (3) the process, formulation and development reports generated for the preparation of a Product; (4) the analytical methods and validation for the quality control release of each of:  (a) NX1838; and (b) a Product; and (5) the stability protocols, stability indicating methods and stability data for each of:  (a) NX1838; and (b) a Product.

 

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NDA” shall mean a New Drug Application filed with the FDA requesting market approval for a new drug product.

 

Net Sales” shall mean, with respect to the Product, the gross amount billed or invoiced by EyeTech, its Affiliates or sublicensees, to unrelated Third Parties for the Products in finished product form, 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 EyeTech, 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;

 

(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

 

(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.

 

Notwithstanding the foregoing, amounts received by EyeTech, or its Affiliates or sublicensees, for the sale of Products among EyeTech 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.  In the event the Product is sold as part of a combination product, or as part of bundled products or as part of a delivery system, the Net Sales from the combination product, bundled product or delivery system, for the purposes of determining royalty payments, shall be determined by multiplying the Net Sales (as defined without regard to this paragraph) of the combination product by the fraction, A/(A+B) where A is the average sale price of the Product when sold separately in finished form and B is the average sale price of the other product(s) or system sold separately in finished form, or, only if the value of B cannot be determined, where A+B is the average sales price of the product(s) and the delivery system together.  If the value of B can be determined, in no event will the sales price of any combination product, bundled product or delivery system product be less than the sum of A and B.  In the event that such average sale price cannot be determined for both the Product and such other product(s) or system in combination, the following calculation shall be substituted for the calculation recited in (ii) of the preceding sentence: the Net Sales (as defined without regard

 

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to this paragraph) of the combination products shall be multiplied by the fraction C/(C+D) where C is EyeTech’s cost of goods of the Product and D is EyeTech’s cost of goods for the other product(s) or system, determined in accordance with the method of accounting normally employed by EyeTech in computing cost of goods, provided, however, that the minimum value of such fraction as used in the calculation of Net Sales shall be 0.9.

 

NX1838” shall mean Gilead’s proprietary compound known as NX1838, as described in Exhibit A.

 

Party” shall mean either Gilead or EyeTech, and “Parties” shall mean both of Gilead and EyeTech.

 

Patents” shall mean patents and patent applications, both foreign and domestic, including without limitation, all extensions, reissues, renewals, reexaminations, patents of addition, supplementary protection certificates and inventors’ certificates thereof, substitutions, provisionals, divisionals, continuations and continuations-in-part.

 

Person” shall mean a natural person, a corporation, a partnership, a trust, a joint venture, a limited liability company, any governmental authority or any other entity or organization.

 

Pivotal Clinical Trial” shall mean either (a) a trial on sufficient numbers of patients that is designed to establish that a pharmaceutical product is safe and efficacious for its intended use, and to define warnings, precautions and adverse reactions that are associated with the pharmaceutical product in the dosage range to be prescribed, and to support Regulatory Approval of such pharmaceutical product or label expansion of such pharmaceutical product, or (b) a clinical trial that began as a trial on sufficient numbers of patients that is designed to establish the safety and biological activity of a pharmaceutical product for its intended use, and to define warnings, precautions and adverse reactions that are associated with the pharmaceutical product in the dosage range to be prescribed, after such date as the U.S. Food and Drug Administration or its successor (or equivalent regulatory authority) has indicated that the applicable Party may reasonably continue such trials with the intention to establish that a pharmaceutical product is safe and efficacious for its intended use, and to define warnings, precautions and adverse reactions that are associated with the pharmaceutical product in the dosage range to be prescribed, and to support Regulatory Approval of such pharmaceutical product or label expansion of such pharmaceutical product.

 

Product” shall mean any pharmaceutical composition containing NX1838 in any formulation, dosage concentration or volume, together with all label expansions, line extensions and improvements thereon, which may be included in any supplement, modification or addition to the filings for Regulatory Approval of the foregoing compound.

 

Product Data Package” shall include the following information and data related to the Product in the possession or control of Gilead as of the Effective Date:  (a) the Regulatory Documents; (b) pre-clinical and clinical development protocols, data, and reports; (c) manufacturing development technical reports; (d) toxicology reports; and (e) such other information and data specifically identified in Exhibit B attached hereto.

 

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Product Inventory” shall mean the NX1838 and Product inventory, in bulk or finished form, which Gilead Controls as of the Effective Date, as identified in Exhibit C attached hereto.

 

Reasonable Diligence” shall mean commercially reasonable efforts to develop, obtain Regulatory Approval, and/or commercialize, as applicable, a Product in a country in the Territory, consistent with accepted business practices and legal requirements, and comparable to efforts in the pharmaceutical industry applicable to development, obtaining of Regulatory Approval for, or commercialization of human pharmaceutical products at an equivalent stage of development and similar market potential, profit potential and strategic value in view of conditions then prevailing.

 

 “Regulatory Approval” shall mean (a) in the United States, approval by the FDA of an NDA, or equivalent application, for marketing approval and satisfaction of any related applicable FDA registration and notification requirements (if any) and (b) in any country other than the United States, all approvals (including any required marketing, pricing and reimbursement approvals) by the Regulatory Authority in such country of a single application or set of applications comparable to an NDA, enabling legal sale of a product in such country.

 

Regulatory Authority” shall mean the FDA in the United States or the equivalent governmental agency having jurisdiction in any other country in the Territory.

 

Regulatory Documents” shall mean the (a) United States investigational new drug application (the “IND”) #56503 (dated July 12, 1998), and all amendments and annual reports to same;  (b) any pediatric data package or other exclusivity extensions relating to Products; and (c) any other regulatory filings with Regulatory Authorities relating to the Product.

 

Royalty Term” shall mean, with respect to each country in which Product is sold, the period of time equal to the longer of (i) [*] years from the date of First Commercial Sale of the Product in such country, or (ii) the expiration of the last-to-expire Licensed Patent in such country that claims the manufacture, use, and or sale of such Product as such activities are carried out pursuant to this Agreement.

 

Territory” shall mean the world, unless the License terminates with respect to a country pursuant to Section 6.7, in which case the Territory shall exclude any country in which the License has so terminated.

 

Third Party” shall mean a Person other than EyeTech, Gilead or their Affiliates.

 

Transferred Assets” shall mean the Product Inventory and the Product Data Package.

 

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SECTION 2
GRANT OF LICENSES AND TRANSFER AND DELIVERY OF TRANSFERRED
ASSETS AND MANUFACTURING INFORMATION

 

2.1                                 Grant of License. Subject to the terms and conditions of this Agreement, during the term of this Agreement, Gilead hereby grants to EyeTech an exclusive license under the Licensed Patents and Know How to make, have made, use, sell, offer to sell, import and export the Product within the Field throughout the Territory, with a right to sublicense to its Affiliates or (subject to Section 2.4) to any other Person.

 

2.2                                 Transferred Assets.  As of the Effective Date, Gilead hereby assigns, transfers and conveys to EyeTech all of Gilead’s right, title and interest in and to the Transferred Assets (subject to Section 4.5(c)), and EyeTech hereby accepts such assignment, transfer and conveyance.  On or before the Delivery Date, Gilead shall have delivered to EyeTech all of the Transferred Assets and the Manufacturing Information.  EyeTech shall have up to ten (10) days after such delivery to inventory the delivered Transferred Assets and Manufacturing Information and to give notice to Gilead of any Transferred Assets and Manufacturing Information that were not so delivered.  If Gilead receives notice or otherwise learns after the Delivery Date that it has failed to deliver any Transferred Assets or Manufacturing Information to EyeTech, Gilead shall provide to EyeTech any such Transferred Assets or Manufacturing Information no later than five (5) Business Days after receipt of such notice or knowledge (or within such longer time as is mutually agreed by EyeTech and Gilead).  The clinical data portion of the Product Data Package shall be provided to EyeTech in computer-readable format, where available, and otherwise in printed format.  Gilead shall be under no obligation to convert to electronic format any portion of the Product Data Package that currently is available only in printed format.  In the event that EyeTech is unwilling or unable to assume physical possession of the Transferred Assets and Manufacturing Information by the Effective Date, Gilead shall be entitled to charge EyeTech a reasonable fee for storage of the Transferred Assets and Manufacturing Information beyond the Effective Date.  Gilead shall ship the Transferred Assets to EyeTech F.O.B. to EyeTech’s designated facilities.  For a period of 90 days following the receipt by EyeTech of the Transferred Assets and Manufacturing Information, Gilead personnel shall be reasonably available during Gilead’s normal business hours to respond to technical inquiries of EyeTech regarding Products as is reasonably requested by EyeTech.  EyeTech acknowledges that Gilead makes no representations or warranties with respect to the Transferred Assets or Manufacturing Information (other than as expressly set forth in Section 5 below) and that it accepts such Transferred Assets and Manufacturing Information “as is.”

 

2.3                                 Negative Covenant of EyeTech.  EyeTech shall not use or practice Licensed Patents or Know-How outside the Field or outside the Territory or for any other purpose except activities that it conducts in compliance with this Agreement.

 

2.4                                 Sublicenses.  EyeTech shall have the right to sublicense the licenses granted to it by Gilead under this Agreement without the consent of Gilead; provided that (i) prompt notice and a copy of such sublicense shall be given by EyeTech to Gilead pursuant to Section 8.2 of this Agreement; (ii) EyeTech shall remain obligated at all times under this Agreement without regard to whether it has sublicensed its rights or whether EyeTech’s sublicensee has performed; (iii) such sublicense shall name Gilead as a third party beneficiary of such sublicense; and (iv) any such sublicenses granted by EyeTech shall contain provisions providing for its termination or assignment to Gilead, at the option of Gilead, of EyeTech’s interest therein upon termination of this Agreement, and shall further contain provisions which obligate such sublicensee to comply

 

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with such terms, conditions, agreements and obligations that are consistent with the terms, conditions, agreements and obligations to which EyeTech is subject under this Agreement.

 

2.5                                 Gilead Right of First Negotiation. Except as otherwise provided in this Section 2.5, Gilead shall have a right of first negotiation with respect obtaining all rights with respect to any Product which is, or which can reasonably be expected to be, [*] (a “Reversion Product”) as follows:  Eyetech shall notify Gilead in writing if Eyetech intends to seek, negotiate, or solicit offers to license a Third Party to commercialize the Reversion Product for the treatment or prevention [*] (the “Reversion Field”) and a specific territory (the “Reversion Territory”), prior to contacting any such potential Third Party licensees.  Such written notice shall include sufficient detailed technical information concerning the Reversion Product as Gilead may reasonably require to evaluate its interest in such Reversion Product. Within thirty (30) days after receiving Eyetech’s notice as to the Reversion Product, Gilead shall notify Eyetech whether it is interested in negotiating with Eyetech the terms under which Gilead shall obtain a license from Eyetech to research, develop and commercialize Reversion Products as described herein. If Gilead provides such notice, the Parties shall negotiate exclusively and in good faith for a period of up to ninety (90) days after Eyetech receives Gilead’s notice of interest (the “Negotiation Period”) the terms of an agreement pursuant to which Eyetech will grant to Gilead and its Affiliates an exclusive, royalty-bearing, sublicensable license, under all Eyetech Know-How and Eyetech Patents relating to such Reversion Product, to research, develop, make, have made, use, import, offer for sale, sell and otherwise commercialize such Reversion Product within the Reversion Field within the Reversion Territory, and which agreement shall include commercially reasonable provisions for transfer of or access to relevant regulatory filings and technology to Gilead. Neither Gilead nor Eyetech shall have any obligation to actually enter into a license agreement with respect to such Reversion Product. If either Gilead does not respond to Eyetech’s notice of intent to license the Reversion Product within thirty (30) days after Gilead’s receipt thereof, or Gilead and Eyetech fail to agree upon the terms of a license under rights to the Reversion Product during the Negotiation Period, Eyetech shall be free to commercialize such Reversion Product by itself or through its Affiliates or Third Parties without further obligation to Gilead.

 

SECTION 3
PAYMENTS AND DELIVERIES

 

In consideration of the exclusive license granted herein and the transfer of ownership of the Transferred Assets, EyeTech shall pay the following amounts to Gilead:

 

3.1                                 Initial Payments and Deliveries.

 

(a)                                  On or before Tuesday, April 4, 2000, EyeTech shall pay to Gilead the sum of [*] United States Dollars (US$[*]) by Federal Reserve electronic wire transfer in immediately available funds to an account designated by Gilead.  Such amount shall be non-refundable and non-creditable, and shall not be subject to any counterclaim or set-off.

 

(b)                                 On or before the Effective Date, EyeTech and Gilead Sciences shall enter into a Warrant Agreement (the “Warrant Agreement”) mutually satisfactory to both Parties

 

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pursuant to which EyeTech shall issue to Gilead Sciences a warrant to purchase EyeTech Series B Preferred Stock.

 

(c)                                  On or before the Delivery Date, Gilead shall deliver to EyeTech (i) all of the Transferred Assets pursuant to Section 2.2 of this Agreement; (ii) all of the Manufacturing Information pursuant to Section 2.2 of this Agreement; and (iii) a schedule (“Schedule of Transferred Assets and Manufacturing Information”) setting forth each of the Transferred Assets and Manufacturing Information being delivered to EyeTech at such time.

 

(d)                                 Within ten (10) days of delivery of the Transferred Assets and the Manufacturing Information and of the Schedule of Transferred Assets and Manufacturing Information pursuant to Section 3.1(c) above, EyeTech shall inventory the delivered Transferred Assets and Manufacturing Information pursuant to Section 2.2 and shall either (i) deliver to Gilead a receipt acknowledging the receipt of each of the Transferred Assets and the Manufacturing Information set forth on the Schedule of Transferred Assets and Manufacturing Information or (ii) notify Gilead of any Transferred Assets or Manufacturing Information that Gilead did not deliver. If Gilead receives notice or otherwise learns after the Delivery Date that it has failed to deliver any Transferred Assets or Manufacturing Information to EyeTech, Gilead shall provide to EyeTech any such Transferred Assets or Manufacturing Information no later than five (5) Business Days after receipt of such notice or knowledge (or within such longer time as is mutually agreed by EyeTech and Gilead).  Within ten (10) days of Gilead delivering such missing items to EyeTech following notice given by EyeTech pursuant to clause (ii) of this Section 3.1(d), EyeTech shall deliver the receipt described in clause (i) of this Section 3.1(d).

 

3.2                                 Milestone Payments.  Within five (5) Business Days of EyeTech and/or its Affiliates or sublicensees achieving the first occurrence of each of the milestone events listed below with respect to any Product, EyeTech shall notify Gilead of such achievement and the date thereof, and within thirty (30) days of the date of such achievement, pay the one-time non-refundable fees specified below to Gilead by Federal Reserve electronic wire transfer in immediately available funds to an account designated by Gilead; provided, however, that in no event shall the following fees be payable more than once with respect to Products for any particular geographical area or Milestone:

 

Milestone

 

Fee

 

 

 

 

 

First [*] with respect to a Product

 

$

[*]

 

 

 

 

 

First [*] with respect to a Product

 

$

[*]

 

 

 

 

 

First [*] with respect to a Product

 

$

[*]

 

 

 

 

 

First [*] with respect to a Product

 

$

[*]

 

 

 

 

 

First [*] with respect to a Product

 

$

[*]

 

 

 

 

 

First [*] with respect to a Product

 

$

[*]

 

 

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3.3                                 Royalties.

 

(a)                                  Royalty on Products.  EyeTech shall pay Gilead a royalty payment on Net Sales of Products that are made or sold during the Royalty Term and that are sold by EyeTech, its Affiliates or sublicensees (the “Royalty”) according to the following rates, as adjusted in accordance with Sections 3.3(b) below:

 

(i)                                     [*] percent ([*]%) of Net Sales in the United States for the first [*] dollars ($[*]) in Net Sales in the United States in a given Calendar Year;

 

(ii)                                  [*] percent ([*]%) of Net Sales in the United States for the next [*] dollars ($[*]), up to and including, [*] dollars ($[*]) in Net Sales during the same Calendar Year;

 

(iii)                               [*] percent ([*]%) of Net Sales in the United States in excess of [*] dollars ($[*]) during the same Calendar Year; and

 

(iv)                              [*] percent ([*]%) of Net Sales outside the United States in the same Calendar Year.

 

By way of example, if, in the year 2005, EyeTech Net Sales in the United States were equal to [*] dollars ($[*]), and [*] dollars ($[*]) outside the United States, then the Royalty payable to Gilead hereunder would equal [*] dollars ($[*]), calculated in the following manner:

 

Amount of Net Sales

 

Royalty Rate

 

Royalty

 

First $[*] (United States)

 

[*]

%

$

[*]

 

Next $[*] (United States)

 

[*]

%

$

[*]

 

Next $[*] (United States)

 

[*]

%

$

[*]

 

$[*] (outside United States)

 

[*]

%

$

[*]

 

Total Royalty

 

 

 

$

[*]

 

 

 

                By way of further example, if, through the second Calendar Quarter in the year 2005, EyeTech Net Sales in the United States were equal to [*] dollars ($[*]), and [*] dollars ($[*]) outside the United States, then the Royalty payable to Gilead hereunder after such Calendar Quarter would equal [*] dollars ($[*]), calculated in the following manner:

 

 

Amount of Net Sales

 

Royalty Rate

 

Royalty

 

First $[*] (United States)

 

[*]

%

$

[*]

 

Next $[*] (United States)

 

[*]

%

$

[*]

 

$[*] (outside United States)

 

[*]

%

$

[*]

 

Total Royalty

 

 

 

$

[*]

 

 

(b)                                 Offset.  Notwithstanding the forgoing, on a country by country and Product by Product basis, EyeTech may credit against Net Sales [*] percent ([*]%) of any royalties it must pay to any Third Party on any Product:  (1) pursuant to any licenses necessary to practice the License; or (2) resulting from any litigation (including settlement thereof) under

 

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Section 6.16; provided, however, for purposes of this Section 3.3(b) that the applicable royalty rates used for calculation of Royalties payable to Gilead shall not be reduced to less than [*] percent ([*]%) of the royalty rates(s) otherwise applicable pursuant to Section 3.3(a).

 

3.4                                 Payment; Report.  All Royalties payable to Gilead under this Agreement shall be paid in U.S. dollars within sixty (60) days of the end of each Calendar Quarter or as otherwise specifically provided herein by Federal Reserve electronic wire transfer in immediately available funds to an account designated by Gilead.  At the time of payment of Royalties, EyeTech shall send to Gilead a statement with respect to the applicable Calendar Quarter, country by country and Product by Product, for EyeTech, its Affiliates and sublicensees, of the amount of aggregate worldwide gross sales and Net Sales, the amount of gross sales during such Calendar Quarter, an itemized calculation of Net Sales showing deductions provided for in the definition of Net Sales and in Section 3.3(b), and, on a cumulative basis for the current Calendar Year, the amount of Royalties or other payments due on such sales.

 

3.5                                 Exchange Rate; Manner and Place of Payment.

 

(a)                                  All payments due hereunder from time to time shall be paid in U.S. Dollars.  For purposes of computing such payments, the Net Sales of Product in countries other than the United States shall be converted into U.S. Dollars as computed using the average monthly rate of exchange at the time for such currencies as the rate applicable to the transfer of funds arising from payments as published in the Wall Street Journal (New York edition). The currency conversion system used by EyeTech shall be subject to audit by Gilead as described in Section 3.6 and, if not determined to be a system reflecting the fair market value of the currencies in question, shall be modified as necessary to effect currency conversion at fair market value.

 

(b)                                 Notwithstanding the provisions of Section 3.5(a), if by reason of any restrictive exchange laws or regulations, EyeTech shall be unable to convert to U.S. Dollars the amount, determined as above, equivalent to the amount due by EyeTech hereunder, then EyeTech shall so notify Gilead promptly and provide an explanation of the circumstances.  In such event, EyeTech shall make all such payments or the balance thereof due hereunder and which is not paid in foreign currency as provided below, in U.S. Dollars as soon as reasonably possible after and to the extent that such restrictive exchange laws or regulations are lifted so as to permit EyeTech to pay amounts due under this Section 3.5 in U.S. Dollars.  EyeTech shall promptly notify Gilead if such restrictions are so lifted.  At its option Gilead shall meanwhile have the right to request the payment (to it or to its nominee), and, upon request, EyeTech shall pay or cause to be paid amounts due (or such portions thereof as are specified by Gilead) in the currency of any other country designated by Gilead and legally available to EyeTech under the then-existing laws of regulations.  Any payments shall be payable to Gilead by wire transfer at such bank in the United States as Gilead Sciences shall specify from time to time.  Not less than one (1) Business Day prior to such wire transfer, the remitting party shall telefax the receiving party advising it of the amount and of the payment to be made.

 

3.6                                 Audits.  EyeTech and its Affiliates and sublicensees shall keep full and accurate books and records relating to the financial performance of the Product.  During the term of this

 

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Agreement plus four (4) years after termination or expiration of this Agreement, Gilead shall have the right, during regular business hours and upon reasonable advance notice, to have such books and records audited by an independent certified accountant so as to verify the accuracy of the information previously reported to Gilead.  Such information shall be deemed to be Proprietary Information of EyeTech and, as such, subject to confidentiality obligations pursuant to Section 6.3.  The independent certified account shall keep confidential any Proprietary Information obtained during such audit and shall report to Gilead only the amounts of Royalties due and payable.  The cost of such audit shall be borne by Gilead; however, in the event such audit reveals that the Royalties to Gilead constitute an underpayment of five percent (5%) or more from that revealed by the audit to be actually owed, the cost of the audit shall be borne by EyeTech.  EyeTech shall include in all sublicenses granted as permitted under Section 2.4 an audit provision substantially similar to the foregoing requiring the sublicensee to keep full and accurate books and records relating to the Product and granting Gilead the right to audit the accuracy of the information reported by the sublicensee in connection therewith on the same terms as apply to an audit of EyeTech’s records hereunder.  The terms of this Section 3.6 shall survive any termination or expiration or termination of this Agreement for a period of four (4) years.

 

3.7                                 Withholding Taxes.  Any and all taxes levied on account of royalty payments paid or owed from a country in which provision is made in the law or by regulation for withholding will be deducted from royalty payments paid Gilead hereunder.  EyeTech shall cooperate with Gilead to claim exemption from such deductions or withholdings under any double taxation or similar agreement in force from time to time.

 

3.8                                 Sublicensee Obligations.  In the event EyeTech sublicenses its right to sell a Product, such sublicense shall include an obligation for the sublicensee to account for and report its Net Sales of Products and provide that Gilead shall have audit rights therefor pursuant to this Section 3 on the same basis as if such sales were Net Sales of Products by EyeTech, and EyeTech shall pay royalty payments to Gilead as if the Net Sales of the sublicensee were Net Sales of EyeTech.

 

3.9                                 Late Payments.  Any amounts not paid by EyeTech when due under this Agreement shall be subject to interest from and including the date payment is due through and including the date upon which Gilead has collected immediately available funds in an account designated by Gilead at a rate equal to the sum of two percent (2%) plus the prime rate of interest quoted in the Money Rates section of The Wall Street Journal, calculated daily on the basis of a 360-day year, or similar reputable data source.  No special notice by Gilead to EyeTech of such interest due shall be required.

 

3.10                           Compulsory License. If either Party learns that a Third Party has obtained a Compulsory License in any country in the Territory, such Party shall promptly notify the other Party of such occurrence.  If the royalty rate payable by the grantee of the Compulsory License is less than the royalty rates applicable in such country set forth in Section 3.3 of this Agreement, then the applicable royalty rates set forth in Section 3.3 of this Agreement shall be reduced to the lower royalty rates applicable in such country pursuant to such Compulsory License for so long

 

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as sales of a Competitive Product are made by any Third Party pursuant to the Compulsory License.

 

SECTION 4
TERM OF AGREEMENT; TERMINATION

 

4.1                                 Term.  The term of this Agreement shall commence upon the Effective Date and, unless sooner terminated as provided in this Section 4, expire on the expiration of all Royalty Terms for all Products.

 

4.2                                 Licenses upon Expiration.  In the event that the Agreement expires as set forth in Section 4.1 above without early termination, the License shall automatically become, at EyeTech’s election made at least 90 days prior to such expiration, either (i) an exclusive, irrevocable, royalty-bearing license, subject to the surviving provisions of the Agreement, to use and/or sublicense the use of Know How to make, have made, use, import, have imported, offer for sale, sell, and have sold Product(s) in the Field in the Territory as it exists at the time of such expiration, subject to payment by EyeTech to Gilead of a royalty equal to [*] percent ([*]%) of Net Sales of Products made pursuant to the license under this Section 4.2(i) after the expiration of this Agreement, or (ii) a non-exclusive, irrevocable, royalty-free, paid-up license, subject to the surviving provisions of this Agreement, to use and/or sublicense the use of Know How to make, have made, use, import, have imported, offer for sale, sell, and have sold Product(s) in the Field in the Territory as it exists at the time of such expiration.

 

4.3                                 Termination for Breach.  Each Party shall have the right to terminate this Agreement and its obligations hereunder for material breach by the other Party, which breach remains uncured for sixty (60) days after written notice is provided to the breaching Party, or in the case of an obligation to pay royalty payments or other amounts owing under this Agreement, which breach remains uncured for thirty (30) days after written notice to the breaching Party; provided, however, that non-payment of any royalty amounts or other payments owing under this Agreement, for which the non-paying Party reasonably disputes the obligation or amounts not paid, shall not be deemed a breach of an obligation to pay royalty payments or other amounts owing under this Agreement, provided that the non-paying Party has paid all such amounts not in reasonable dispute.