EXHIBIT NO. 10.51
CONFIDENTIAL MATERIALS OMITTED AND FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION. ASTERISKS DENOTE OMISSIONS.
LICENSE AGREEMENT
BY AND BETWEEN
PFIZER INC.
AND
EYETECH PHARMACEUTICALS, INC.
Dated as of December 17, 2002
Table of Contents
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ARTICLE 1 DEFINITIONS...................................................................... 1
ARTICLE 2 LICENSES......................................................................... 14
2.1 Eyetech Grants............................................................................ 14
2.2 License Grant to Eyetech.................................................................. 16
2.3 Sublicensing.............................................................................. 16
ARTICLE 3 BASE PAYMENTS AND PERFORMANCE MILESTONES......................................... 17
3.1 Base Payments............................................................................. 17
3.2 Performance Milestones.................................................................... 18
ARTICLE 4 REVENUE SHARE.................................................................... 21
4.1 Revenue Share............................................................................. 21
4.2 Survival of Licenses After Expiration of Royalty Term and After Expiration of
Co-Promotion Term......................................................................... 23
4.3 Third Party Royalties..................................................................... 23
ARTICLE 5 ACCOUNTING AND PROCEDURES FOR PAYMENTS........................................... 26
5.1 Sales Subject to Royalty Obligations...................................................... 26
5.2 Royalty Payments; Royalty Reports; Pfizer Operating Profit................................ 26
5.3 Currency Exchange; Late Payments.......................................................... 27
5.4 Withholding Taxes......................................................................... 28
5.5 Audits.................................................................................... 28
5.6 Blocked Payments.......................................................................... 29
ARTICLE 6 TECHNICAL AND OTHER INFORMATION.................................................. 29
6.1 Disclosure of Technical Information....................................................... 29
6.2 Confidentiality........................................................................... 30
6.3 Publicity Related to this Agreement....................................................... 30
6.4 Applicability of Obligations to Affiliates, Employees, Directors, Agents,
Independent Contractors and Consultants................................................... 31
ARTICLE 7 PATENTS.......................................................................... 31
7.1 Third Party License Agreements............................................................ 31
7.2 Disclosure of Patent Applications and Proceedings......................................... 32
7.3 Prosecution and Maintenance; Costs........................................................ 33
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Table of Contents
(continued)
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7.4 Third Party Infringement Actions.......................................................... 34
7.5 Patent Term Extensions.................................................................... 36
7.6 US Territory Intellectual Property Infringement Claims.................................... 37
7.7 ROW Territory Intellectual Property Infringement Claims................................... 37
7.8 Ownership and Prosecution of Patent Rights Included in the Collaboration
Intellectual Property..................................................................... 37
ARTICLE 8 REPRESENTATIONS, WARRANTIES AND COVENANTS........................................ 38
8.1 Eyetech Representations and Warranties.................................................... 39
8.2 Pfizer Representations and Warranties..................................................... 44
8.3 Eyetech Covenants......................................................................... 45
8.4 No Consequential or Punitive Damages...................................................... 46
ARTICLE 9 TERM............................................................................. 47
ARTICLE 10 TERMINATION...................................................................... 47
10.1 Termination for Convenience............................................................... 47
10.2 Termination for Breach.................................................................... 48
10.3 Breach of Non-Competition Obligations..................................................... 50
10.4 Effects of Termination.................................................................... 50
10.5 Non-Competition........................................................................... 52
10.6 Acquisitions Involving Competing Products................................................. 54
10.7 Competing Products in the EU.............................................................. 55
ARTICLE 11 DISPUTE RESOLUTION............................................................... 55
11.1 Arbitration............................................................................... 55
11.2 No Limitation............................................................................. 57
ARTICLE 12 MISCELLANEOUS.................................................................... 57
12.1 Force Majeure............................................................................. 57
12.2 Assignment................................................................................ 57
12.3 Governing Law............................................................................. 57
12.4 Jurisdiction.............................................................................. 58
12.5 Notices................................................................................... 58
12.6 Entire Agreements; Amendments............................................................. 59
12.7 Severability.............................................................................. 60
12.8 Waivers................................................................................... 60
12.9 Binding Effect............................................................................ 60
12.10 Further Assurances........................................................................ 60
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(continued)
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12.11 Third Party Beneficiaries................................................................. 61
12.12 Performance by Subsidiaries and Affiliates................................................ 61
12.13 Counterparts.............................................................................. 61
12.14 Headings.................................................................................. 61
12.15 Offset.................................................................................... 62
EXHIBIT 1.8 - COMPOUND
EXHIBIT 1.18 - EYETECH PATENT RIGHTS
EXHIBIT 8.1(f) - CERTAIN INTELLECTUAL PROPERTY MATTERS
EXHIBIT 8.1(i) - FUNDING SOURCES
EXHIBIT 8.1(j) - STUDIES
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LICENSE AGREEMENT
THIS LICENSE AGREEMENT (this "Agreement") dated as of December 17, 2002
(the "Execution Date") between Pfizer Inc., a corporation organized under the
laws of the state of Delaware, 235 East 42nd Street, New York, New York 10017
("Pfizer"), and Eyetech Pharmaceuticals, Inc. ("Eyetech"), a corporation
organized under the laws of the state of Delaware, 500 Seventh Avenue, 18th
Floor, New York, New York 10018.
WHEREAS, Eyetech owns or licenses or may acquire rights under certain
patents and patent applications, licenses to patents and patent applications,
know-how, trade secrets and scientific and technical information relating to the
aptamer known as Macugen;
WHEREAS, the Parties desire to co-promote products containing or based
on the Macugen aptamer in the US Territory (as defined below); and
WHEREAS, Pfizer desires to acquire from Eyetech exclusive rights to
develop and commercialize products containing or based on the Macugen aptamer in
the ROW Territory (as defined below).
NOW, THEREFORE, the Parties agree as follows:
ARTICLE 1
DEFINITIONS
Any capitalized terms used herein that are not expressly defined in
this Agreement shall have the meanings set forth in the Collaboration Agreement.
For purposes of this Agreement, the following definitions shall be applicable:
1.1 "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.
1.2 "AMD Product" means a Product developed for use in the
treatment of age-related macular degeneration.
1.3 "Approval" means receipt from the applicable Regulatory
Authority of approval to market a drug in one or more countries.
1.4 "Bankruptcy Code" means 11 U.S.C Sections 101-1330, as
amended.
1.5 "Cash Flow" means, with respect to any Person (or any
combination of two or more Persons) for any fiscal period, such Person's (or
such combination's) EBITDA for such fiscal period, less any milestone payment
amounts received by such Person (or combination) pursuant to Section 3.1(a) of
this Agreement included in such EBITDA and less any capital expenditures paid by
such Person (or such combination) during such fiscal period.
1.6 "Collaboration Agreement" means the Collaboration Agreement
dated as of the date hereof between the Parties.
1.7 "Collaboration Intellectual Property" means Patent Rights and
Technical Information developed or acquired by either Party, or jointly by the
Parties, or by their respective Affiliates, in the course of the Parties' and
their respective Affiliates' activities pursuant to this Agreement or the
Collaboration Agreement.
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1.8 "Compound" means the anti-VEGF aptamer known as Macugen
(EYE001), as more specifically described in Exhibit 1.8, including without
limitation metabolites or prodrugs thereof, and any hydrates, conjugates, salts,
esters, isomers, polymorphs or analogues of any of the foregoing.
1.9 "Control" or "Controlled" means, with respect to any
intellectual property right, the possession (whether by ownership or license) by
a Party (or by any Subsidiary 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 any third party.
1.10 "Co-Promote" shall have the meaning ascribed to it in the
Collaboration Agreement.
1.11 "DME Product" means a Product developed for use in the
treatment of diabetic macular edema.
1.12 "EBITDA" means, with respect to any Person (or combination of
two or more Persons) for any fiscal period, an amount equal to the sum of (a)
the Net Income of such Person (or such combination) for such fiscal period plus
(b) depreciation, amortization, Interest Expense and taxes deducted in
calculating such Net Income, plus (c) any extraordinary or nonrecurring losses
deducted in calculating such Net Income, minus (d) any extraordinary or
nonrecurring gains included in calculating such Net Income, all as determined in
accordance with GAAP.
1.13 "Effective Date" means the HSR Clearance Date.
1.14 "EMEA" means The European Agency for the Evaluation of
Medicinal Products.
1.15 "Escrow Agent" means the third party financial institution
party to, and serving as escrow agent in accordance with, the Escrow Agreement.
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1.16 "Escrow Agreement" means the escrow agreement entered into by
and among the Parties, and a third party financial institution in accordance
with Section 3.1(c).
1.17 "EU" means the European Union, as it may be expanded from time
to time.
1.18 "Eyetech Patent Rights" means all Patent Rights, now or
hereafter during the Term, Controlled by Eyetech or its Subsidiaries relating
to, or useful in connection with, the manufacture, use or sale of the Compound
or the Products, including, without limitation, the patents and patent
applications set forth on Exhibit 1.18, but excluding patents and patent
applications claiming drug delivery devices, methods or technology licensed by
any third party to Eyetech under any license agreement other than the Gilead
License, the Shearwater License or the Isis License.
1.19 "Eyetech Technical Information" means all scientific or
technical information and related know-how and trade secrets, now or hereafter
during the term of this Agreement, Controlled by Eyetech or its Subsidiaries
relating to the Compound or the Products, 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 Products (excluding drug delivery know-how
and technology licensed by any third party to Eyetech under any license
agreement other than the Gilead License, the Shearwater License or the Isis
License).
1.20 "Field" means the prevention, treatment or control of all
ophthalmic diseases or conditions.
1.21 "Fixed Charge Coverage Ratio" means the ratio of:
(a) the aggregate amount of EBITDA for the twelve (12)
month period ended on the last day of the most recently completed fiscal quarter
referred to in clause (a)(i), (b)(i) or
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(c)(i), as applicable, of the definition of [**] (such four full fiscal quarter
period being referred to herein as the "Prior Quarters") for which financial
statements contained in an SEC Report have been filed with the SEC or, where
Eyetech or any Person acquiring control of or merging with Eyetech in connection
with a Change in Control is not required under applicable law to file SEC
Reports, for which financial statements have been delivered to Pfizer, to
(b) the aggregate amount of Fixed Charges of such Person
for the Prior Quarters.
In addition to and without limitation of the foregoing, for purposes of this
Section 1.21, in the case of a Change in Control of Eyetech, "EBITDA" and "Fixed
Charges" shall be calculated as if such Change in Control occurred during the
most recently completed Prior Quarter after giving effect on a pro forma basis
for the period of such calculation to, without duplication, Interest Expense
with respect to Indebtedness and transaction fees incurred with respect to the
transactions related to such Change in Control of Eyetech and any Person that
acquires control of Eyetech or with whom Eyetech merges in such Change in
Control (and the application of the net proceeds thereof) during the period
commencing on the first day of the Prior Quarters to and including the last day
of the Prior Quarters (the "Reference Period"), all as if such incurrence (and
application) and expense occurred on the first day of the Reference Period.
Furthermore, if interest on any Indebtedness incurred with respect to the
transactions related to such Change in Control may optionally be determined at
an interest rate based upon a factor of a prime, LIBOR, or similar rate, a
eurocurrency interbank offered rate, or other rates, then the interest rate in
effect on the date of such transactions will be deemed to have been the interest
rate in effect on such Indebtedness during the Reference Period.
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1.22 "Fixed Charges" means, with respect to any Person (or any
combination of two or more Persons) for any fiscal period, such Person's (or
such combination's) (a) Interest Expenses and (b) dividends paid by such Person
(or such combination) during such fiscal period, all as determined in accordance
with GAAP.
1.23 "Generic Competition" shall exist during a given calendar
quarter with respect to a Product in any country in the ROW Territory if, during
such calendar quarter, one or more Generic Products shall be commercially
available in such country and shall have, in the aggregate, a [**] percent
([**]%) or more market share of the aggregate of (Products and Generic Products)
(based on data provided by IMS International, or if such data is not available,
such other reliable data source as reasonably determined by Pfizer and agreed by
Eyetech (such agreement not to be unreasonably withheld)) as measured by unit
sales. In the event IMS International data (or such other agreed data source) is
not sufficient to determine the percentage market share for each country in the
EU, the percent market share for the EU countries for which data is not
available will be deemed to be the average percent market share for those EU
countries in which the data is available.
1.24 "Generic Products" mean, with respect to a Product
commercialized by Pfizer in a country, products (other than Products
commercialized by Pfizer pursuant to this Agreement) that (a) contain the same
active chemical entity(ies) as contained in such Product and (b) have the same
therapeutic benefit as such Product.
1.25 "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.
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1.26 "Indebtedness" means (a) indebtedness for borrowed money; (b)
the deferred price of property or services (which shall not include ordinary
course of business payables); (c) obligations evidenced by notes, bonds,
debentures, mortgages or similar instruments; (d) capital or finance lease
obligations or hire purchase arrangements; (e) receivables sold or discounted
(other than on a non-recourse basis); (f) any amount raised under any other
transaction (including any forward sale or purchase agreement) having the
commercial effect of a borrowing; and (g) the amount of any balance sheet
liability in respect of any guarantee or indemnity for any of the items referred
to in paragraphs (a) to (f) above.
1.27 "Interest Expense" means, for any period, without duplication,
the sum of (a) the interest expense of such Person for such period as determined
on a consolidated basis in accordance with GAAP, including, without limitation,
(i) any amortization or accretion of debt discount, (ii) the net cost under any
hedge instrument, (iii) the interest portion of any deferred payment obligation,
and (iv) all accrued interest; (b) the interest component of capitalized lease
obligations determined on a consolidated basis in accordance with GAAP; and (c)
that portion of all operating lease rentals representative of an interest factor
(which shall be deemed to be equal to 1/3 of all operating lease rentals).
1.28 "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.
1.29 "Law" or "Laws" means all laws, statutes, rules, Codes,
regulations, orders, judgments and/or ordinances of any Governmental Authority.
1.30 "Launch" means the initial shipping of a Product as a, or for,
commercial sale to an unaffiliated third party, excluding any shipping for test
marketing, clinical trial purposes or compassionate or similar use.
7
1.31 "[**]:
(a) at any given time, both (i) Eyetech's Quarterly Cash
Flow for each of Eyetech's [**] most recently completed fiscal quarters [**]
and (ii) [**] for the [**] period ended on the last day of the most recently
completed fiscal quarter referred to in clause (i) has been equal to or greater
than [**];or
(b) on the date of [**], both (i) the Quarterly Cash Flow
of the combination of [**] in connection with such [**] for each of such [**]
most recently completed fiscal [**] quarters [**] and (ii) the [**] period
ended on the last day of the most recently completed fiscal quarter referred to
in clause (i) has been equal to or greater than [**]; or
(c) at any given time [**], both (i) the Quarterly Cash Flow
[**] in connection with such [**] as to periods [**] for each of such [**} most
recently completed fiscal quarters [**] and (ii) the [**] as to periods [**]
period ended on the last day of the most recently completed fiscal quarter
referred to in clause (i) has been equal to or greater than [**]; or
(d) [**] pursuant to Section 17.11 of the Collaboration
Agreement.
As used in this Section 1.31 and the other provisions of this Agreement relating
to the defined terms used in this Section 1.31, (x) "fiscal quarters" shall
refer to full calendar quarters or successive periods of 13 weeks, as applicable
and [**] under this Agreement and the Collaboration Agreement [**] immediately
prior to the [**] related to such [**], but otherwise will include only [**] in
connection with or as part of [**].
Notwithstanding anything to the contrary contained herein, if any Quarterly
Cash Flow [**] referenced above is derived from financial statements for any
completed fiscal year ended on or before the last day of the most recently
completed fiscal quarter for which the Quarterly Cash Flow [**] is computed for
the purpose of [**] and either (a) such financial statements for such completed
fiscal year are not accompanied by an audit opinion of a nationally
recognized independent accounting firm or (b) the audit opinion accompanying
such financial statements contains a going concern qualification, then [**]
shall be deemed to exist based upon any such Quarterly Cash Flow [**].
1.32 "Major Country" means France, Germany, Italy, Spain or the
United Kingdom.
1.33 "MEEI/Draper License" means the License Agreement dated as of
April 4, 2002, by and among Eyetech, The Massachusetts Eye and Ear Infirmary
("MEEI") and The Charles Stark Draper Laboratory, Inc. ("Draper"), as amended
from time to time.
1.34 "NDA" means a New Drug Application filed with the FDA with
respect to a Product.
1.35 "Net Income" means, with respect to any Person (or any
combination of two or more Persons) for any fiscal period, the consolidated net
income (or loss) of such Person (or such combination on a pro forma basis), all
as determined in accordance with GAAP.
1.36 "Net Sales" means the gross amounts billed or invoiced by
Pfizer, its Affiliates and sublicensees for Products 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;
8
(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
(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 relevant 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
9
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 Quarter in which it becomes due to Pfizer or its Affiliate or
sublicensee (as applicable). Notwithstanding the foregoing, amounts received by
Pfizer, or its Affiliates or sublicensees, for the sale of Products 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 "Party" means either Eyetech or Pfizer; "Parties" means both
Eyetech and Pfizer.
1.38 "Patent Rights" means the rights and interest in and to all
issued patents and pending patent applications in any country in the Territory,
including, without limitation, all divisionals, continuations, renewals,
continuations-in-part, patents of addition, supplementary protection
certificates, extensions, registrations or confirmation patents and reissues
thereof.
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1.39 "Person" means any natural person or any corporation, company,
partnership, joint venture, firm or other entity, including without limitation a
Party.
1.40 "Pfizer Patent Rights" means all Patent Rights, Controlled by
Pfizer or its Subsidiaries as of the Effective Date or developed or acquired by
Pfizer or its Subsidiaries in the course of the activities contemplated by this
Agreement or the Collaboration Agreement, relating to, or useful in connection
with, the manufacture, use or sale of the Compound or the Products.
1.41 "Pfizer Technical Information" means all scientific or
technical information and related know-how and trade secrets, Controlled by
Pfizer or its Subsidiaries as of the Effective Date or developed or acquired by
Pfizer or its Subsidiaries in the course of the activities contemplated by this
Agreement or the Collaboration Agreement, 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 Products.
1.42 "Product Operating Profit" means Net Sales less the
Product-related costs attributable to the following: cost of goods sold; third
party royalties; advertising and promotion expenses, including but not limited
to Product samples, speaker programs and market research; field force costs,
including but not limited to field aids; continuing medical education programs;
research and development; destroyed returns, destroyed inventory and other
salvage; and other direct expenses relating to the manufacture, promotion and
sale of the Product, including but not limited to direct legal expenses.
1.43 "Products" means any product, which (a) contains or is based
on the Compound, 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 AMD Product, DME Product or
11
other product developed for any new indication in the Field or as a new
un-pegylated formulation of any such AMD Product, DME Product or other product;
and which product either (x) if manufactured, used, sold, offered for sale, or
imported would, in the absence of the licenses granted hereunder, infringe a
Valid Claim, or (y) utilizes Eyetech Technical Information or Collaboration
Intellectual Property in its manufacture, use or development.
1.44 "Quarter" means each of the periods ending on each of the four
(4) thirteen (13) week periods as used by Pfizer as reported in its filings with
the Securities and Exchange Commission, the first commencing on January 1 of any
year. For sake of clarification, outside the United States, Net Sales are
computed on each of four (4) thirteen (13) week periods, the first commencing on
December 1 of any year.
1.45 "Quarterly Cash Flow" means, with respect to any Person (or
any combination of two or more Persons) for any fiscal quarter, such Person's
(or such combination's) Cash Flow for such fiscal quarter.
1.46 "Regulatory Authority" means any Governmental Authority,
including without limitation EMEA or FDA, with responsibility for granting any
licenses or approvals (with the exception of price approvals) necessary for the
marketing and sale of pharmaceutical products in any country.
1.47 "Royalty Term" means, on a country-by-country and
Product-by-Product basis, the period commencing on the Effective Date and ending
on the latest date on which such Product is covered by a Valid Claim, or fifteen
(15) years from the Launch of such Product in such country, whichever is later.
1.48 "ROW Territory" means all countries in the world outside the
US Territory.
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1.49 "SEC Reports" means all annual, quarterly or periodic reports
and registration statements required to be filed with the Securities and
Exchange Commission ("SEC") under applicable law.
1.50 "Shearwater License" means the License, Manufacturing and
Supply Agreement dated as of February 5, 2002, by and between Eyetech and
Shearwater Corporation ("Shearwater"), as amended from time to time.
1.51 "Subsidiary" means, with respect to a Party, a majority or
wholly owned direct or indirect subsidiary of such Party.
1.52 "Technical Information" means Eyetech Technical Information or
Pfizer Technical Information.
1.53 "Term" means the period commencing on the Effective Date and
ending on the expiration of the last-to-expire Royalty Term.
1.54 "Territory" means the US Territory and the ROW Territory.
1.55 "US Territory" means the United States of America, including
its territories, possessions and Puerto Rico.
1.56 "Valid Claim" means any claim from (a) an issued and unexpired
patent included within the Eyetech Patent Rights or the Collaboration
Intellectual Property (other than, in the case of Collaboration Intellectual
Property, claims of Patent Rights that claim inventions solely owned by Pfizer
or solely licensed by Pfizer) that has not been revoked or held unenforceable or
invalid by a decision of a court or other Governmental Authority of competent
jurisdiction, and that has not been disclaimed, denied or admitted to be invalid
or unenforceable through reissue or disclaimer or otherwise; or (b) a patent
application included within the Eyetech Patent Rights or the Collaboration
Intellectual Property (other than, in the case of Collaboration Intellectual
13
Property, claims of Patent Rights that claim inventions solely owned by Pfizer
or solely licensed by Pfizer) that has not been cancelled, withdrawn or
abandoned or been pending for more than [**] years.
1.57 "Year" means a calendar year.
ARTICLE 2
LICENSES
2.1 Eyetech Grants. Subject to the terms of this Agreement,
Eyetech hereby grants to Pfizer, and Pfizer hereby accepts:
(a) an exclusive (even as to Eyetech) license under the
Eyetech Patent Rights and Eyetech Technical Information, and under Eyetech's
rights in Collaboration Intellectual Property, to develop, make, have made, use,
sell, offer for sale, import, and have imported Products in the ROW Territory
and a nonexclusive license under the Eyetech Patent Rights and Eyetech Technical
Information, and under Eyetech's rights in Collaboration Intellectual Property,
to use, make and have made Products in the US Territory solely for export to and
sale in countries in the ROW Territory; and
(b) an exclusive (even as to Eyetech) license under the
Eyetech Patent Rights and Eyetech Technical Information, and under Eyetech's
rights in Collaboration Intellectual Property, to develop, make, have made, use,
sell, offer for sale, import, and have imported Products in the US Territory,
[**] under the Eyetech Patent Rights and Eyetech Technical Information, and
under Eyetech's rights in Collaboration Intellectual Property, to develop, make,
have made, use, sell, offer for sale, import, and have imported Products in the
US Territory [**}; provided that [**], as set forth in this Section 2.1(b) [**]
other than in accordance with the Collaboration Agreement; provided further that
if, [**] set forth in Section 1.31(b)[**] in this Section 2.1(b)[**] at such
time [**] set forth in Section 1.31(d) [**] set forth in Section 1.31(d) [**].
The [**] license set forth in this Section 2.1(b) is subject to all of Pfizer's
obligations under the Collaboration Agreement so long as the Collaboration
Agreement shall remain in effect.
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(c) The licenses granted by Eyetech in Sections 2.1(a)
and 2.1(b) are subject to a retained right of Eyetech to perform Eyetech's
obligations and exercise Eyetech's rights under the Collaboration Agreement and
the Other Product-Related Agreements.
(d) The licenses granted in Sections 2.1(a) and (b)
include sublicenses, as applicable. The sublicenses granted by Eyetech to Pfizer
in Sections 2.1(a) and (b) are subject to the following terms of the Gilead
Agreement, the Isis Agreement and the Shearwater Agreement, respectively:
(i) Sections 2.4, 2.5, 3.6, 3.8, 6.3 and 6.7 of
the Gilead Agreement;
(ii) Sections 4.3 and 4.4 of the Isis Agreement;
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 Shearwater Agreement.
(e) Any sublicensee obligations required by the Gilead
Agreement, the Isis Agreement and the Shearwater Agreement to be included in a
sublicense thereunder, including without limitation any required provision
making the applicable third party licensor a third party beneficiary of any
sublicense thereunder, shall be deemed to be included in this Agreement.
(f) The licenses granted by Eyetech in Sections 2.1(a)
and 2.1(b) with respect to the patents referenced in the third paragraph of
Exhibit 8.1(i) hereof are subject to 35 USC Sections 200-212, 37 CFR Section 401
et seq. and applicable governmental implementing regulations. Any right granted
in this Agreement greater than that permitted under 35 USC Sections 200-212 or
37 CFR Section 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 Sections 200-212 and 37 CFR
Section 401 shall remain and shall in no way be affected by this Agreement.
15
2.2 License Grant to Eyetech. Pfizer hereby grants to Eyetech a
nonexclusive right and license (and sublicense, as applicable) under the Pfizer
Patent Rights and Pfizer Technical Information, and under Pfizer's rights in
Collaboration Intellectual Property, solely to Co-Promote the Products in the US
Territory and to exercise Eyetech's rights and perform Eyetech's obligations
under this Agreement and the Collaboration Agreement.
2.3 Sublicensing.
(a) The license in Section 2.1(a) above includes the
right by Pfizer to grant sublicenses; provided that, Eyetech's prior written
consent, not to be unreasonably withheld or delayed, shall be required for
sublicenses to non-Affiliates under such license. The license in Section 2.1(b)
above does not include any right by Pfizer to grant sublicenses without
Eyetech's prior written consent.
(b) Any sublicense granted by Pfizer must be granted
pursuant to a written agreement that subjects the sublicensee to all relevant
restrictions, limitations and obligations in this Agreement and in the
Collaboration Agreement.
(c) Pfizer shall be responsible for failure by its
sublicensees to comply with, and Pfizer guarantees to Eyetech the compliance by
each of its sublicensees with, all relevant restrictions, limitations and
obligations in this Agreement and in the Collaboration Agreement.
(d) In the event of a material default by any sublicensee
under a sublicense agreement, Pfizer will inform Eyetech and take such action,
after consultation with Eyetech, that in Pfizer's reasonable business judgment
is required to address such default.
(e) Pfizer shall provide Eyetech with a copy of each
sublicense agreement, in final executed form, that Pfizer enters into in
accordance with this Section 2.3 not later than five (5) days after the
execution of such sublicense agreement; provided that Pfizer may redact the
16
financial terms from such copies if permitted under the applicable requirements
of the Gilead License, the Shearwater License and the Isis License requiring
delivery to Gilead, Shearwater or Isis of copies of sublicense agreements.
ARTICLE 3
BASE PAYMENTS AND PERFORMANCE MILESTONES
In consideration of the licenses granted to Pfizer hereunder and the
disclosure to Pfizer of Eyetech Technical Information, and subject to the
provisions of this Agreement, Pfizer shall pay to Eyetech Base Payments and
Performance Milestones as follows:
3.1 Base Payments.
(a) Subject to the terms and conditions of this
Agreement, Pfizer shall pay to Eyetech the following payments (the "Base
Payments"):
- ------------------------------------------------------------------------------
Event Payment
- ------------------------------------------------------------------------------
(i) Signing of this Agreement. $75,000,000
- ------------------------------------------------------------------------------
(ii) Acceptance for filing of [**] Product. $[**]
- ------------------------------------------------------------------------------
(iii) Acceptance for filing of [**] Product. $[**]
- ------------------------------------------------------------------------------
(iv) Approval of [**]. $[**]
- ------------------------------------------------------------------------------
(v) Approval of [**]. $[**]
- ------------------------------------------------------------------------------
(vi) Filing of [**]. $[**]
- ------------------------------------------------------------------------------
(vii) Launch of [**]. $[**]
- ------------------------------------------------------------------------------
(viii) Launch of [**]. $[**]
- ------------------------------------------------------------------------------
(ix) Launch of [**]. $[**]
- ------------------------------------------------------------------------------
(x) Launch of [**]. $[**]
- ------------------------------------------------------------------------------
17
The Parties understand and agree that the payments referenced in this Section
3.1(a) are subject to the terms and conditions set forth in Sections 3.1(b) and
(c).
(b) The signing fee set forth in Section 3.1(a)(i) shall
be made as set forth in Section 3.1(c) below. The payments pursuant to Sections
3.1(a)(ii) through 3.1(a)(v) shall be made within fifteen (15) days after
Pfizer's receipt from Eyetech of copies of the written notifications received by
Eyetech from [**]. The payments pursuant to Sections 3.1(a)(vi) through
3.1(a)(x) shall be made within fifteen (15) days after the date on which the
applicable event has been achieved.
(c) Payment of the $75,000,000 signing fee will be made
by Pfizer no later than five (5) Business Days after the date of execution of
this Agreement to an account of a mutually satisfactory financial institution,
which will serve as Escrow Agent, pending occurrence of the Effective Date. All
amounts held in such account shall be held for the benefit of Eyetech and
Eyetech will receive interest accrued in accordance with the terms of the Escrow
Agreement. Upon the occurrence of the Effective Date, such amounts shall be
released to Eyetech in accordance with the terms of the Escrow Agreement.
3.2 Performance Milestones.
(a) Subject to the terms and conditions of this
Agreement, Pfizer shall pay to Eyetech the following payments (each, a
"Performance Milestone Payment") in respect of each of the following milestone
events (each, a "Performance Milestone"):
- --------------------------------------------------------------------------------------------------------
Milestone Event Payment Amount
- --------------------------------------------------------------------------------------------------------
(i) In the event Net Sales in the [**] equal or exceed $[**] in any Year. $[**]
- --------------------------------------------------------------------------------------------------------
(ii) In the event Net Sales in the [**] equal or exceed $[**] in any Year. $[**]
- --------------------------------------------------------------------------------------------------------
(iii) In the event Net Sales in the [**] equal or exceed $[**] in any Year. $[**]
- --------------------------------------------------------------------------------------------------------
18
- --------------------------------------------------------------------------------------------------------
(iv) In the event Net Sales in the [**] equal or exceed $[**] in any Year. $[**]
- --------------------------------------------------------------------------------------------------------
(v) In the event Net Sales in the [**] equal or exceed $[**] in any Year. $[**]
- --------------------------------------------------------------------------------------------------------
The Parties understand and agree that all of the Performance Milestone Payments
referenced in this Section 3.2(a) are subject to the terms and conditions set
forth in Sections 3.2(b) and (c).
(b) Performance Milestone Payments shall be due and
owing, on or before the date sixty (60) days after the end of the applicable
Year, commencing with the first full Year following (or commencing concurrently
with, if Launch occurs on January 1 of any Year) the first Launch of an AMD
Product in the US Territory and for the subsequent [**] Years immediately
following such first full Year.
(c) Subject to the limitation set forth in Section
3.2(b), each Performance Milestone Payment shall be paid in annual installments
of twenty percent (20%) of the total payment amount over five (5) Years,
commencing with the first Year in which such Performance Milestone is achieved
and continuing for each of the immediately following four (4) Years during which
the Performance Milestone is achieved. It is agreed and understood that no
Performance Milestone Payment (taking all annual installments as a single
Performance Milestone Payment) shall be payable more than once. For the
avoidance of doubt, the following examples are provided to illustrate how
Performance Milestone Payments might be paid:
Example #1
- ------------------------------------------------------------------------------------------------------------
Year 1 Year 2 Year 3 Year 4 Year 5 Year 6
- ------------------------------------------------------------------------------------------------------------
Aggregate Net Sales $[**] $[**] $[**] $[**] $[**] $[**]
Level [**]
- ------------------------------------------------------------------------------------------------------------
19
- ------------------------------------------------------------------------------------------------------------
Performance Milestone $[**] $[**] $[**] $[**] $[**] $[**]
Payment to Eyetech
- ------------------------------------------------------------------------------------------------------------
20
Example #2
- ----------------------------------------------------------------------------------------------
Year 1 Year 2 Year 3 Year 4 Year 5
- ----------------------------------------------------------------------------------------------
Aggregate Net Sales Level [**] >$[**] >$[**] >$[**] >$[**] >$[**]
<$[**] <$[**] <$[**] <$[**]
- ----------------------------------------------------------------------------------------------
>$[**]>$[**] [**] [**] [**] [**] [**]
>$[**]
>$[**]
>$[**]
- ----------------------------------------------------------------------------------------------
Total Performance Milestone $[**] $[**] $[**] $[**] $[**]
Payments to Eyetech
- ----------------------------------------------------------------------------------------------
For avoidance of doubt, the five (5) consecutive Year period during which each
Performance Milestone Payment is payable in increments may be a different five
(5) consecutive Year period for each of the respective Performance Milestone
Payments (e.g., in Example #2 above, the Performance Milestone Payment for
achieving an aggregate annual Net Sales level [**] of $[**] would continue to be
payable in installments in years 6 and 7 if the Performance Milestone were
achieved in such years notwithstanding the fact that the Performance Milestone
Payment for achieving an aggregate annual Net Sales level [**] of $[**] would no
longer be payable after year 5).
ARTICLE 4
REVENUE SHARE
4.1 Revenue Share. In consideration of the licenses granted to
Pfizer hereunder and the disclosure to Pfizer of Eyetech Technical Information,
and subject to the terms and conditions of this Agreement, Pfizer shall share
revenues with Eyetech based on Net Sales by Pfizer, its Affiliates and
sublicensees [**] in accordance with the following:
21
(a) EU. With respect to Net Sales in the EU in each Year,
Pfizer shall pay Eyetech the greater of (i) twenty percent (20%) of Product
Operating Profit and (ii) (x) for aggregate Net Sales of all Products in
such Year below $1 billion, a royalty of fifteen percent (15%) of
such Net Sales, and (y) for aggregate Net Sales of all Products in such Year of
$1 billion or more, a royalty of twenty percent (20%) of such incremental Net
Sales.
(b) Rest of ROW Territory. With respect to Net Sales in
the ROW Territory, excluding the EU, Pfizer shall pay Eyetech a royalty of ten
percent (10%) of aggregate Net Sales of all Products.
(c) Royalty Adjustments for Generic Products. If, during
a given Quarter, there is Generic Competition in a particular country, then, for
each such country in which there is Generic Competition, the royalties set forth
in Section 4.1(a) or 4.1(b) shall be reduced by [**] percent ([**]%).
Notwithstanding anything to the contrary in this Section 4.1(c) or in Section
4.1(d) or 10.7, in no event shall the aggregate reduction in the royalty
payments otherwise payable under Section 4.1(a) or 4.1(b) with respect to any
given Net Sales of Products in a country be reduced by more than an aggregate of
[**] percent ([**]%) as a result of the royalty reduction provisions of this
Section 4.1(c) and Sections 4.1(d) and 10.7.
(d) Revenue Share Term. Royalty payments [**] under this
Section 4.1 shall continue on a Product-by-Product and country-by-country basis
for the applicable Royalty Term; provided that during portions of any Royalty
Term in which no Valid Claim exists with respect to a Product in a country, the
royalty payments otherwise payable under Section 4.1(a) or 4.1(b) shall, subject
to the limitations set forth in Section 4.1(c), be reduced by [**] percent
([**]%).
(e) Certain ROW Sales. Pfizer shall not, for the purpose
of circumventing the higher royalty payable in respect of EU Net Sales, sell
Products to a third party in the ROW
22
Territory outside of the EU in situations in which Pfizer knows that such third
party will resell the Products into the EU.
4.2 Survival of Licenses After Expiration of Royalty Term and
After Expiration of Co-Promotion Term. Upon expiration of each Royalty Term, on
a Product-by-Product and country-by-country basis, the licenses set forth in
Section 2.1(a) and, subject to Pfizer continuing to manufacture the Products in
accordance with the same quality standards observed by Pfizer with respect to
the manufacture of Products during the Royalty Term, the license to Trademarks
in the ROW Territory set forth in Section 10.1(d) of the Collaboration Agreement
shall become fully paid-up and perpetual with respect to such Product in such
country. Upon expiration of the Co-Promotion Term, on a Product-by-Product
basis, the licenses set forth in Sections 2.1(b) shall become fully paid-up,
perpetual non-exclusive licenses with respect to such Product in the US
Territory. For the avoidance of doubt, this Section 4.2 shall not apply with
respect to any license set forth in Section 2.1 that is terminated before the
applicable Royalty Term or Co-Promotion Term expires, as applicable.
4.3 Third Party Royalties. With respect to royalties payable to
third parties payable based on sales of Products:
(a) With respect to such Net Sales in the US Territory,
Eyetech shall pay such royalties and include all such royalty payments in its
Quarterly Expense Reports (as defined in Section 8.6(b) of the Collaboration
Agreement) for the purpose of including such royalty payments in calculations of
the quarterly payments payable pursuant to Section 8.6(d) of the Collaboration
Agreement.
(b) With respect to such sales in the ROW Territory,
Pfizer shall be responsible for [**] percent ([**]%) of such royalties, except
as provided for in subsection (d)
23
below. For the avoidance of doubt, in the event that any withholding or other
taxes are payable by Pfizer on any third party royalty payments due with respect
to sales in the ROW Territory, then Pfizer shall make such tax payments in
addition to making the payments to Eyetech set forth in the immediately
preceding sentence. If any withholding or other taxes are payable by Eyetech on
any third party royalty payments due with respect to sales in the ROW Territory,
and such taxes are not deductible from the royalty payments due to the third
parties, then Pfizer shall pay to Eyetech an additional amount equal to such
taxes. Pfizer shall indemnify Eyetech and its Affiliates and their respective
directors, officers, employees and agents from and against any liability with
respect to withholding or other taxes that are payable by Pfizer or Eyetech on
any third party royalty payments due with respect to sales in the ROW Territory.
The Parties shall establish such procedures as are reasonably necessary to
permit them to reconcile Eyetech's actual payments of such third party royalties
with Pfizer's payments to Eyetech under this Section 4.3(b). Notwithstanding the
foregoing provisions of this Section 4.3(b), Pfizer shall not have any
responsibility for withholding taxes that become payable solely as a result of
an assignment by Eyetech of Eyetech's rights to receive payments from Pfizer to
an Affiliate of Eyetech or other third party.
(c) With respect to Pfizer's responsibility for the
payments of royalties payable by Eyetech to third parties payable based on Net
Sales as set forth in Section 4.3(b), Eyetech shall send Pfizer a quarterly
invoice that shall be based on Pfizer's quarterly report of Net Sales pursuant
to Section 5.2 and shall reflect the amounts due from Pfizer under Section
4.3(b). Pfizer shall, within fifteen (15) days after its receipt of such
invoice, make payment under such invoice by electronic transfer in immediately
available funds to the account
24
designated in writing by Eyetech, which designation shall take place at least
two (2) Business Days before the payment is due.
(d) Pfizer shall be entitled to deduct a portion of third
party royalties payable by Pfizer with respect to sales in the EU from royalties
otherwise payable to Eyetech pursuant to Section 4.1(a) as follows:
(i) With respect to third party royalties
payable pursuant to third party agreements, other than the MEEI/Draper License,
entered into by Eyetech prior to the Execution Date, on sales of Products in the
EU corresponding to increments of aggregate Net Sales of all Products in the EU
of greater than $[**] in any Year, Pfizer may deduct [**]percent ([**]%) of such
incremental third party royalties.
(ii) With respect to third party royalties
payable pursuant to any other third party license agreement, other than the
MEEI/Draper License, on sales of Products in the EU corresponding to increments
of aggregate Net Sales of all Products in the EU of greater than $[**] in any
Year, which agreement is necessary to avoid infringement of third party rights
with respect to Products in the EU, Pfizer may deduct [**] percent ([**]%) of
such incremental third party royalties, up to a maximum aggregate deduction in
any Year of [**] percent ([**]%) of such incremental Net Sales.
(e) Notwithstanding anything to the contrary contained
herein, any and all third party royalties which relate to or otherwise result
from any misrepresentation or breach of Eyetech's representations or warranties
contained in this Agreement or the Collaboration Agreement shall be excluded
from the provisions of this Section 4.3.
(f) Nothing in this Section 4.3 shall be construed to
limit either Party's indemnification obligations pursuant to the Collaboration
Agreement.
25
(g) After the Effective Date, Eyetech shall use
commercially reasonable efforts to negotiate and execute any amendments to the
Gilead License, Shearwater License and Isis License necessary to conform the
definitions of "Net Sales" (or comparable terms thereunder) with the definition
of "Net Sales" hereunder, so as to provide for an equivalent basis for
calculating royalties due under the Gilead License, Shearwater License and Isis
License as is used under this Agreement; provided that Eyetech shall have no
obligation to pay any money to obtain such amendments and Eyetech shall have no
obligation to enter into any amendment that would increase Eyetech's or its
sublicensees' (including Pfizer's) royalty or other obligations under the Gilead
License, Shearwater License or Isis License.
ARTICLE 5
ACCOUNTING AND PROCEDURES FOR PAYMENTS.
Payments hereunder shall be subject to the following provisions:
5.1 Sales Subject to Royalty Obligations. Sales between or among
Pfizer, its Affiliates or sublicensees shall not be subject to royalties under
Section 4.1; royalties shall only be calculated upon sales by Pfizer, its
Affiliates and sublicensees to independent third parties. Pfizer shall be
responsible for payment obligations arising from sales by its Affiliates and
sublicensees.
5.2 Royalty Payments; Royalty Reports; Pfizer Operating Profit.
(a) Pfizer shall provide Eyetech with a report of Net
Sales with respect to each Quarter (based on the quarters specified in the
second sentence of Section 1.44) within forty-five (45) days after the end of
such period, which report shall identify, on a country-by-country basis, the
Product, gross sales, Net Sales, deductions from gross sales taken to calculate
Net Sales, and the royalty amount payable to Eyetech under Section 4.1, as well
as the
26
computation of such royalty amount. Pfizer shall make royalty payments to
Eyetech on Net Sales with respect to each Quarter within sixty (60) days after
the end of each such period. Royalty reports shall be kept confidential by
Eyetech and not disclosed to any other party other than Gilead, Shearwater, Isis
and their respective accountants and Boards of Directors. In addition, Eyetech
shall be entitled to disclose such information as required for the purposes of
preparing and disclosing to third parties Eyetech's financial statements, as
required to comply with applicable Laws or requirements imposed by any stock
exchange or Nasdaq and to third party lenders in connection with Eyetech's
financing activities.
(b) Within ninety (90) days of the end of the final
Quarter of each Year during the Term, Pfizer will provide Eyetech with a report
[**] by which [**] and pay [**] to Eyetech together with such report.
5.3 Currency Exchange; Late Payments. All payments made hereunder
shall be made in U.S. dollars and shall be made by electronic transfer in
immediately available funds to such bank account as Eyetech shall designate in
writing at least five (5) business days before the payment is due. For the
purposes of determining the amount of royalties due for the relevant Quarter,
the amount of Net Sales in any foreign currency shall be computed by (a)
converting such amount for the relevant Quarter into U.S. dollars at the Average
Exchange Rate for the Quarter (the "Average Exchange Rate" means, for each
Quarter for each currency in which Products sales to third parties are
denominated, the average of the prevailing commercial rate of exchange for
purchasing U.S. dollars with such currency on the last business day of each
Pfizer accounting period in the relevant Quarter as published in The Financial
Times), and (b) deducting the amount of any governmental tax, duty, charge or
other fee actually paid by Pfizer or its Affiliates in respect of such
conversion into and remittance of U.S. dollars. All payments
27
under this Agreement shall bear interest from the date due until paid at a rate
equal to the prime rate of Citibank, NA as announced on the date such payment
was due plus three percent (3%), compounded on a calendar quarterly basis. In
addition, Pfizer shall reimburse Eyetech for all reasonable costs and expenses,
including without limitation reasonable attorneys' fees and legal expenses,
incurred in the collection of late payments.
5.4 Withholding Taxes. Except as otherwise provided in Section
4.3(b), any taxes required to be paid or withheld by Pfizer, its Affiliates or
sublicensees for the account of Eyetech on amounts payable under this Agreement
shall be deducted from the amounts payable at the rates specified by applicable
Law. In addition, Pfizer shall provide promptly to Eyetech receipts from the
government or taxing authority-evidencing payment of such taxes.
5.5 Audits. Pfizer shall, and shall cause its Affiliates and
sublicensees to, keep full and accurate books and records setting forth gross
sales, Net Sales, Product Operating Profit for the EU and amounts payable to
Eyetech. Pfizer shall permit Eyetech, at Eyetech's sole expense, by a nationally
recognized independent certified public accountants selected by Eyetech (as to
which Pfizer has no reasonable objection), to examine such books and records
upon at least thirty (30) days' advance written notice during normal business
hours and in a manner that does not materially interfere with Pfizer's business,
but not later than three (3) years following the rendering of any such reports,
accountings and payments. The foregoing right of review may be exercised only
once with respect to each such periodic report and payment. Such accountants may
be required by Pfizer to enter into a reasonably acceptable confidentiality
agreement, and in no event shall such accountants reveal to Eyetech the details
of its review except insofar as is necessary to verify the accuracy of reports
and payments made or due hereunder. The results of any such audit shall be
delivered in writing to each Party. Any underpayment determined by such audit
shall promptly
28
be paid or refunded by Pfizer. If Pfizer has underpaid amounts due under this
Agreement by more than five percent (5%) over any reporting period, Pfizer shall
also reimburse Eyetech for the cost of such audit (with the cost of the audit to
be paid by Eyetech in all other cases), plus interest at the interest rate set
forth in Section 5.3, from the date of any such underpayment. Any dispute
arising out of any such audit and any other dispute arising out of the Parties'
respective payment obligations under this Agreement shall be resolved through
binding arbitration in accordance with Article 11, and either party may submit
such dispute to such binding arbitration.
5.6 Blocked Payments. In the event that, by reason of applicable
Laws or regulations in any country, it becomes impossible or illegal for Pfizer
to transfer, or have transferred on its behalf, royalties or other payments to
Eyetech, such royalties or other payments shall be deposited in local currency
in the relevant country to the credit of Eyetech in a recognized banking
institution designated by Eyetech or, if none is designated by Eyetech within a
period of thirty (30) days, in a recognized banking institution selected by
Pfizer and identified in a notice in writing given to Eyetech.
ARTICLE 6
TECHNICAL AND OTHER INFORMATION
6.1 Disclosure of Technical Information. Promptly upon execution
and delivery of this Agreement, and thereafter periodically during the Term
(periodically shall mean, except as otherwise provided in the Collaboration
Agreement, at least calendar quarterly prior to the first Approval of a Product
in the Territory, and thereafter at least annually), Pfizer and Eyetech shall
each disclose to the other all Eyetech Technical Information and Pfizer
Technical Information not previously disclosed. Each report shall be in the
format and contain the level of detail to be reasonably agreed upon by the
Parties. All Eyetech Technical Information heretofore disclosed
29
by Eyetech to Pfizer shall be deemed to have been disclosed pursuant to this
Agreement and shall be subject to the provisions of this Agreement, including
but not limited to this Article 6.
6.2 Confidentiality. During the Term and for five (5) years after
the expiration or termination of this Agreement, each Party shall maintain
Confidential Information (as defined in Section 11.2 of the Collaboration
Agreement) provided by the other Party in confidence, and shall not disclose,
divulge or otherwise communicate such Confidential Information to others, or use
it for any purpose other than as permitted under this Agreement and the
Collaboration Agreement. The receiving Party shall have the right to disclose
Confidential Information received from the other Party to governmental agencies
to the extent reasonably required or desirable to secure Approval for marketing
of Products (provided that the receiving Party shall use reasonable efforts to
secure confidential treatment thereof), and to preclinical and clinical
investigators where reasonably necessary or desirable for their information to
the extent normal and usual in the custom of the trade and under a
confidentiality agreement with provisions governing confidentiality and non-use
substantially the same as those contained herein.
6.3 Publicity Related to this Agreement. The Parties recognize
that each Party may from time to time desire to issue press releases and make
other public statements or disclosures regarding the subject matter of this
Agreement. In such event, the Party desiring to issue an a press release or make
a public statement or disclosure shall provide the other Party with a copy of
the proposed press release, statement or disclosure for review and approval in
advance, which advance approval shall not be unreasonably withheld, conditioned
or delayed. No other public statement or disclosure concerning the existence or
terms of this Agreement shall be made, either directly or indirectly, by either
Party hereto, without first obtaining the written approval of the other Party.
Once any public statement or disclosure has been approved in accordance with
this
30
Section, then either Party may appropriately communicate information contained
in such permitted statement or disclosure. Notwithstanding the foregoing
provisions of Section 5.2, Section 6.2 or this Section 6.3, a Party may (a)
disclose the existence and terms of the Transaction Agreements (as defined in
the Collaboration Agreement) where required, as reasonably determined by the
disclosing Party, by applicable Law, by applicable stock exchange or Nasdaq
regulation or by order or other ruling of a competent court, (b) disclose the
existence and terms of the Transaction Agreements under obligations of
confidentiality to agents, advisors, contractors, investors and sublicensees,
and to potential agents, advisors, contractors, investors and sublicensees, in
connection with such Party's activities hereunder and in connection with such
Party's financing activities and (c) publicly announce any of the matters set
forth in Exhibit 17.14(c) of the Collaboration Agreement, provided that such
announcements do not entail disclosure of non-public technical or scientific
information (which for clarity, excludes clinical trial results) and the
announcing Party provides the other Party with a copy of the proposed text of
such announcement sufficiently in advance of the scheduled release or
publication thereof to afford such other Party a reasonable opportunity to
review and comment upon the proposed text.
6.4 Applicability of Obligations to Affiliates, Employees,
Directors, Agents, Independent Contractors and Consultants. The confidentiality
obligations of the Parties under this Article 6 shall be applicable to Parties,
as well as their respective Affiliates, employees, directors, agents,
independent contractors and consultants.
ARTICLE 7
PATENTS
7.1 Third Party License Agreements. The Parties acknowledge that
the provisions of this Article 7 are subject in all respects to the provisions
of any license agreements between
31
Eyetech and third party licensors of the Eyetech Patent Rights and the
obligations of Eyetech and the rights of Pfizer under this Article 7 are limited
accordingly. Eyetech and Pfizer shall, within the foregoing constraints,
cooperate in the continued prosecution and maintenance by Eyetech or Gilead of
the Eyetech Patent Rights listed on Exhibit 1.18 and licensed to Eyetech by
Gilead. After the Effective Date, Eyetech shall not, without Pfizer's consent,
enter into any third party license agreement relating to material Patent Rights
that Eyetech proposes to license from a third party and that Eyetech reasonably
foresees would, upon the execution of such third party license agreement,
constitute Eyetech Patent Rights, if Pfizer's obligations, pursuant to
Section(s) 4.3(a) and/or 4.3(b), to share in or pay the royalties payable under
third party license agreements, as applicable, would apply to royalties payable
under such third party license agreement; provided that if Eyetech proposes to
license Patent Rights from a third party that would, upon the execution of such
third party license agreement, constitute Eyetech Patent Rights, and Pfizer
withholds its consent for more than thirty (30) days after Eyetech notifies
Pfizer that Eyetech proposes to license such Patent Rights, then Eyetech may
elect to license such Patent Rights at Eyetech's sole expense, in which case
such Patent Rights shall be excluded from the Eyetech Patent Rights.
7.2 Disclosure of Patent Applications and Proceedings. Eyetech
shall disclose to Pfizer the complete texts of all patent applications within
the Eyetech Patent Rights filed by Eyetech, or by Eyetech's licensors to the
extent Eyetech is permitted to provide such texts to Pfizer under the terms of
Eyetech's agreements with such licensors, as well as information received
concerning the institution or possible institution of any interference,
opposition, re-examination, reissue, revocation or any official proceeding
involving patents and patent applications within the Eyetech Patent Rights
prosecuted and/or maintained by Eyetech, or by
32
Eyetech's licensors to the extent Eyetech receives such information, anywhere in
the Territory. Pfizer shall have the right to review all such pending
applications and other proceedings and make recommendations to Eyetech, and to
Eyetech's licensors if permitted under the terms of Eyetech's agreements with
such licensors, concerning such applications and proceedings and their conduct.
Eyetech agrees, subject to any limitations set forth in Eyetech's agreements
with Eyetech's licensors, to keep Pfizer promptly and fully informed of the
course of such patent prosecution and other proceedings including, without
limitation, by providing Pfizer with copies of all substantive communications
submitted to or received from patent offices throughout the Territory. Pfizer
shall provide such patent consultation at no cost to Eyetech or its licensors,
and shall hold all information disclosed to it under this Section 7.2 as
confidential subject to the provisions of Article 6 of this Agreement.
7.3 Prosecution and Maintenance; Costs. Eyetech shall not abandon
any Eyetech Patent Rights with respect to which Eyetech controls prosecution and
maintenance activities, either directly or through step-in rights granted to
Eyetech in any third party license agreement, without at least 90 days' prior
notice of such abandonment to Pfizer. If Eyetech decides to abandon any such
Eyetech Patent Rights, Pfizer shall have the option to continue the prosecution
and maintenance of such Eyetech Patent Rights in Eyetech's name at Pfizer's
expense, subject to any limitations set forth in Eyetech's agreements with
Eyetech's licensors. If Pfizer desires that Eyetech file any application for a
patent in specific countries, or file any patent applications on improvements
and variations upon inventions disclosed in the Eyetech Patent Rights or
otherwise relating to the Compound or the Products, Pfizer shall advise Eyetech
of such countries or improvements, variations or inventions, as the case may be.
Eyetech shall consider Pfizer's request in good faith and shall not unreasonably
decline to file the requested patent
33
application and, if Eyetech files the patent applications as requested, Pfizer
shall pay all reasonable expenses, including reasonable fees for patent counsel,
for filing and for prosecuting such requested patent applications; provided that
Eyetech may decline to file the requested patent application if Eyetech does not
possess all legal rights necessary to make such filing. Pfizer shall have
reasonable access to all documentation, filings and communications to or from
the respective patent offices and shall be kept advised as to the status of all
pending applications to the extent pertaining to the Compound or any Products
and to the extent Eyetech is able to provide such access, it being understood
that all such documentation, filings and communications shall constitute
Confidential Information of Eyetech. Unless otherwise explicitly set forth above
in this Section 7.3, the Parties shall each be responsible for fifty percent
(50%) of the Parties' patent prosecution and maintenance costs relating to the
Eyetech Patent Rights in the US Territory and Pfizer shall be responsible for
one hundred percent (100%) of the Parties' patent prosecution and maintenance
costs relating to the Eyetech Patent Rights in the ROW Territory. Eyetech shall
include all such US Territory costs in Eyetech's Quarterly Expense Reports
pursuant to Section 8.6(b) of the Collaboration Agreement. Pfizer shall
reimburse Eyetech for Pfizer's share of all such ROW Territory costs within
thirty (30) days after receiving any invoice from Eyetech for such costs.
7.4 Third Party Infringement Actions. If any third party shall in
the reasonable opinion of either Party, within any country in the Territory,
infringe any Eyetech Patent Rights through infringing activities in the Field,
the Party learning of such infringement shall promptly notify the other Party
and provide it with any available evidence of such possible infringement. In the
ROW Territory, as between Pfizer and Eyetech, and subject to any rights retained
by Eyetech's licensors, Pfizer shall have the first right to bring suit and to
take action against such infringer in its own name, or in the name of Eyetech
(or Eyetech's licensor, to the extent Eyetech
34
possesses the rights necessary to enable Pfizer to join such licensor under the
terms of Eyetech's license agreement with such licensor; provided that Eyetech
shall have no liability for any failure of such licensor to appear or cooperate
in such action) where necessary, in which case Pfizer shall control the
prosecution of any such suit or claim, including without limitation the choice
of counsel, and shall have the exclusive right to settle or dispose of any such
suit or claim. In the US Territory, as between Pfizer and Eyetech, and subject
to any rights retained by Eyetech's licensors, Eyetech shall have the first
right to bring suit and to take action against such infringer in its own name,
or in the name of Pfizer where necessary, in which case Eyetech shall control
the prosecution of any such suit or claim, including without limitation the
choice of counsel, and shall have the exclusive right to settle or dispose of
any such suit or claim. Notwithstanding anything to the contrary in this Section
7.4, but subject to any legal obligations of Eyetech to its licensors with
respect to Eyetech Patent Rights, if a Party fails to initiate a suit or take
other appropriate action that it has the initial right to initiate or take
pursuant to this Section 7.4 within ninety (90) days after becoming aware of the
basis for such suit or action, then the other Party may, in its discretion,
provide the Party having the initial right with written notice of such other
Party's intent to initiate a suit or take other appropriate action. If such
other Party provides such notice and the Party having the initial right fails to
initiate a suit or take such other appropriate action within thirty (30) days
after receipt of such notice from the other Party, then the other Party shall
have the right to initiate a suit or take other appropriate action that it
believes is reasonably required to protect the intellectual property rights at
issue. Notwithstanding the foregoing provisions of this Section 7.4, in the case
of an infringement action pursuant to Section 505(b) of the Act, subject to any
legal obligations of Eyetech to its licensors with respect to Eyetech Patent
Rights, if the Party that has the initial right to initiate such action fails to
notify
35
the other Party, at least fifteen (15) days prior to such Party's deadline under
the Act for bringing such action, that such Party will bring such action, then
the other Party may, in its discretion, initiate such action after giving
written notice of such election to the Party with the initial right to initiate
such action. The proceeds of any recovery, court award or settlement of such
action shall, after any required payments to Eyetech's licensors, first be
applied to reimburse the Parties for the costs and expenses of such prosecution
and the balance shall be paid, for amounts relating to the US Territory, [**]
percent ([**]%) to Pfizer and [**] percent ([**]%) to Eyetech, and for amounts
relating to the ROW Territory, [**] percent ([**]%) to Pfizer and [**] percent
([**]%) to Eyetech.
7.5 Patent Term Extensions. The Parties shall cooperate, if
necessary and appropriate, with each other in gaining patent term extension
wherever applicable to Eyetech Patent Rights. The Parties shall, if necessary
and appropriate, use reasonable efforts to agree upon a joint strategy relating
to patent term extensions, but, in the absence of mutual agreement with respect
to any extension issue, a patent shall be extended if either Party elects to
extend such patent. Eyetech shall use commercially reasonable efforts to obtain
from Gilead the right to make determinations with respect to patent term
extensions pursuant to 35 U.S.C. Paragraph 156 ("Hatch-Waxman Extension") for
each Product for which regulatory approval is obtained in the US Territory, it
being agreed that such commercially reasonable efforts shall not require
Eyetech to pay any money to obtain such right. The Parties shall mutually agree
upon the patent for any Hatch-Waxman Extension prior to FDA approval of each
Product. If Eyetech has not obtained the right from Gilead to control
determinations respecting Hatch-Waxman Extensions, Eyetech will advise Gilead
as to the patent selected by the Parties for such extension, and will use
commercially reasonable efforts to have Gilead seek a Hatch-Waxman Extension
for such patent, it being agreed that such commercially reasonable efforts
shall not require Eyetech to pay any money to have Gilead take such action. The
Parties shall each be responsible for fifty percent (50%) of the costs of
seeking and/or obtaining patent term extensions relating to the Eyetech Patent
Rights in the US Territory and Pfizer shall be responsible for one hundred
percent (100%) of the costs of seeking and/or obtaining patent term extensions
relating to the Eyetech Patent Rights in the ROW Territory. Eyetech shall
include all such US Territory costs in Eyetech's Quarterly Expense Reports
pursuant to Section 8.6(b) of the Collaboration Agreement. Pfizer shall
reimburse Eyetech for all such ROW Territory costs incurred by Eyetech within
thirty (30) days after receiving any invoice from Eyetech for such costs.
36
7.6 US Territory Intellectual Property Infringement Claims. Each
Party's indemnification obligations to the other Party with respect to any
actions, claims, demands, suits or other legal proceedings are brought or
threatened to be brought against either Party by a third party for infringement
of such third party's trademarks, know-how, Patent Rights or other intellectual
property rights relating to the Parties' Co-Promotion of Products by virtue of
the Parties' manufacture, use, sale, offer for sale or importation of Products
hereunder or under the Collaboration Agreement in furtherance of such
Co-Promotion of Products are set forth in Section 12.6 of the Collaboration
Agreement.
7.7 ROW Territory Intellectual Property Infringement Claims. Each
Party's indemnification obligations to the other Party with respect to any
actions, claims, demands, suits or other legal proceedings are brought or
threatened to be brought against either Party by a third party for infringement
of such third party's trademarks, know-how, Patent Rights or other intellectual
property rights relating to Pfizer's commercialization of Products in the ROW
Territory by virtue of the Parties' manufacture, use, sale, offer for sale or
importation of Products hereunder or under the Collaboration Agreement in
furtherance of such commercialization of Products in the ROW Territory are set
forth in Section 12.6 of the Collaboration Agreement.
7.8 Ownership and Prosecution of Patent Rights Included in the
Collaboration Intellectual Property. As between Eyetech and Pfizer, (a) Eyetech
shall solely own all inventions included in the Collaboration Intellectual
Property invented solely by Eyetech's employees and agents, (b) Pfizer shall
solely own all inventions included in the Collaboration Intellectual Property
invented solely by Pfizer's employees and agents, and (c) the Parties shall
jointly own all inventions included in the Collaboration Intellectual Property
invented by employees and agents of both Parties. Inventorship shall be
determined in accordance with United States patent
37
law. Each Party shall have the first right to prosecute and maintain Patent
Rights included in the Collaboration Intellectual Property solely owned by such
Party and Eyetech shall have the first right to prosecute and maintain Patent
Rights included in the Collaboration Intellectual Property jointly owned by the
Parties. Neither Party shall abandon any Patent Rights included in the
Collaboration Intellectual Property that such Party has the first right to
prosecute and maintain without at least 90 days' prior notice of such
abandonment to the other Party. If a Party decides to abandon any such Patent
Rights, the other Party shall have the option to continue the prosecution and
maintenance of such Patent Rights in the name(s) of the Party or Parties owning
such Patent Rights and at such other Party's expense. The costs of prosecuting
and maintaining Patent Rights included in the Collaboration Intellectual
Property shall be shared equally by the Parties in the US Territory and borne
entirely by Pfizer in the ROW Territory; provided that either Party may elect
not to pay such costs with respect to any given Patent Rights included in the
Collaboration Intellectual Property being prosecuted and/or maintained by the
other Party incurred from and after such time as such Party notifies the other
Party of such election, and thereafter any licenses granted in this Agreement by
the other Party to the Party making such election shall exclude such Patent
Rights. Such costs of prosecuting and maintaining Patent Rights included in the
Collaboration Intellectual Property in the US Territory shall be included in the
Parties' Quarterly Expense Reports pursuant to Section 8.6(b) of the
Collaboration Agreement. Pfizer shall reimburse Eyetech for all such costs of
prosecuting and maintaining Patent Rights included in the Collaboration
Intellectual Property in the ROW Territory incurred by Eyetech within thirty
(30) days after receiving any invoice from Eyetech for such costs.
38
ARTICLE 8
REPRESENTATIONS, WARRANTIES AND COVENANTS
8.1 Eyetech Representations and Warranties. Eyetech hereby
represents and warrants, as of the date hereof, to Pfizer as follows:
(a) To the best of Eyetech's knowledge, (i) the issued
Eyetech Patent Rights are valid and enforceable patents, (ii) no third party is
infringing any such Eyetech Patent Rights and (iii) except for the third party
intellectual property rights referred to in the letter from Harsha Murthy to
Larry Miller dated December 17, 2002, the manufacture, use, sale, offer for sale
or importation by Pfizer or Eyetech of the Compound described in Exhibit 1.8 or
the Product being used by Eyetech in clinical trials as of the Execution Date
will not infringe any issued patents of third parties and are not covered by
third party patent applications containing claims that would, if issued, be
infringed. Eyetech has furnished to Pfizer all material information in its
possession requested by Pfizer as to the foregoing in the written requests
identified in the letter from Larry Miller to Harsha Murthy dated December 17,
2002. Except with respect to patents and patent applications subject to the Isis
License, Gilead License and Shearwater License listed on Exhibit 1.18, Eyetech
is the legal and beneficial owner of all the Eyetech Patent Rights and all of
the Eyetech Technical Information, and, except as set forth in Exhibit 8.1(i),
no other person, firm, corporation or other entity has any right, interest or
claim in or to, and Eyetech has not entered into any agreement granting any
right, interest or claim in or to, the Eyetech Patent Rights or Eyetech
Technical Information; provided that Eyetech gives no representation or warranty
as to whether any third party has independently developed rights to scientific
or technical information or related know-how or trade secrets. Except with
respect to patents and patent applications licensed to Eyetech under the
MEEI/Draper License, Exhibit 1.18 is a complete and correct list of all patents
and patent applications in the Territory owned by or licensed to Eyetech or any
of its Subsidiaries (and indicating which are owned and which are licensed)
relating to the
39
manufacture, use, sale, offer for sale or importation of the Compound or any
Product. Except with respect to the matters set forth in (x) the letter from
Harsha Murthy to Larry Miller dated December 17, 2002 and (y) Exhibit 8.1(i), to
the best of Eyetech's knowledge, Eyetech or its Subsidiaries own or possess
adequate licenses or other valid rights to use all patents, patent rights and
know-how (collectively, "Intellectual Property") necessary to manufacture the
Compound described in Exhibit 1.8 and the Product being used by Eyetech in
clinical trials as of the Execution Date in the Territory and to distribute, use
and sell such Compound and such Product in the Territory, all free of any lien,
encumbrance, liability or other restriction.
(b) Eyetech has disclosed to Pfizer all material
information known to Eyetech relating to: (i) the drug quality, including
stability, variability, impurities and delivery performance in each case
relating to the Product, and (ii) changes made by Eyetech or its Affiliates
after the initiation of Phase III Clinical Studies for the Products relating to
formulation, packaging and method of manufacture and formulation and to
processing parameters, and (iii) the status of discussions with FDA or any
Governmental Authorities directly relating thereto, and (iv) clinical trial site
and contract research organization compliance with all provisions of the Act
governing clinical investigations, and (v) the safety and efficacy of the
Products.
(c) Eyetech has the corporate power and authority to
execute and deliver this Agreement and the Collaboration Agreement and to
perform its obligations hereunder and thereunder, and the execution, delivery
and performance of this Agreement and the Collaboration Agreement by Eyetech
have been duly and validly authorized and approved by proper corporate action on
the part of Eyetech, and Eyetech has taken all other action required by Law, its
certificate of incorporation or by-laws or any agreement to which it is a party
or by which it or its assets are bound required to authorize such execution,
delivery and (subject to obtaining all
40
necessary governmental approvals with respect to the manufacture, use, sale,
offer for sale or importation of Products and subject to any necessary HSR
Clearance) performance. Assuming due authorization, execution and delivery on
the part of Pfizer, each of this Agreement and the Collaboration Agreement
constitutes a legal, valid and binding obligation of Eyetech, enforceable
against Eyetech in accordance with its respective terms.
(d) The execution and delivery of this Agreement and the
Collaboration Agreement by Eyetech and the performance by Eyetech contemplated
hereunder and thereunder will not violate (subject to obtaining all necessary
governmental approvals with respect to the manufacture, use, sale, offer for
sale or importation of Products and subject to obtaining any necessary HSR
Clearance) any ordinance, Law, decree or government regulation or any order of
any court or other governmental department, authority, agency or instrumentality
therein.
(e) Neither the execution and delivery of this Agreement
or the Collaboration Agreement nor the performance hereof or thereof by Eyetech
requires Eyetech to obtain any permits, authorizations or consents from any
governmental body (subject to obtaining all necessary governmental approvals
with respect to the manufacture, use, sale, offer for sale or importation of
Products and subject to obtaining any necessary HSR Clearance) or from any other
person, firm or corporation, and such execution, delivery and performance will
not result in the breach of or give rise to any termination of any agreement or
contract to which Eyetech may be a party which relates to the Eyetech Patent
Rights, Eyetech Technical Information, the Compound or the Products.
(f) Except for the matters referred to in Exhibit 8.1(f),
there is no action, claim, demand, suit, proceeding, arbitration, grievance,
citation, summons, subpoena, inquiry or investigation of any nature, civil,
criminal, regulatory or otherwise, in law or in equity, pending
41
or, to the best knowledge of Eyetech, threatened against Eyetech or its
Affiliates in connection with the Compound, the Product or any Eyetech Patent
Rights or against or relating to the transactions contemplated by this Agreement
or the Collaboration Agreement. To the best knowledge of Eyetech, except for the
matters referred to in Exhibit 8.1(f), there is no action, claim, demand, suit,
proceeding, arbitration, grievance, citation, summons, subpoena, inquiry or
investigation of any nature, civil, criminal, regulatory or otherwise, in law or
in equity, pending or threatened against, Isis, Gilead, Shearwater or any of
their respective Affiliates in connection with the Compound, the Product or any
Eyetech Patent Rights or against or relating to the transactions contemplated by
this Agreement or the Collaboration Agreement.
(g) The Gilead License as heretofore delivered by Eyetech
to Pfizer represents the complete agreement and understanding between Gilead and
Eyetech relating to the Eyetech Patent Rights and Eyetech Technical Information
which are the subject of the Gilead License. The Isis License as heretofore
delivered by Eyetech to Pfizer represents the complete agreement and
understanding between Isis and Eyetech relating to the Eyetech Patent Rights and
Eyetech Technical Information which are the subject of the Isis License. The
Shearwater License as heretofore delivered by Eyetech to Pfizer represents the
complete agreement and understanding between Shearwater and Eyetech relating to
the Eyetech Patent Rights and Eyetech Technical Information which are the
subject of the Shearwater License. None of the Gilead License, Isis License or
Shearwater License has been modified, supplemented or amended, other than by
amendments thereto provided to Pfizer prior to the Execution Date. Except for
the Gilead License, the Isis License and the Shearwater License, there are no
agreements to which Eyetech or any of its Affiliates is a party pursuant to
which Eyetech or any of its Affiliates has a license, or an option to obtain a
license, or holds an immunity from suit, with respect to patents which (i)
42
are pending, applied for, granted or registered, and (ii) but for Eyetech's
rights under such agreements, could be asserted by third parties to be infringed
by the distribution, use, or sale of the Compound, or the Product being used by
Eyetech in clinical trials as of the Execution Date, in the Territory. Eyetech
has previously delivered to Pfizer all of its agreements with any third parties
regarding supply and manufacture of all goods and services relating to the
Compound and the Product being used by Eyetech in clinical trials as of the
Execution Date (the "Supply Agreements"), none of which have been modified,
supplemented or amended.
(h) Each of the Gilead License, Isis License and
Shearwater License is in full force and effect, all payments to date required to
be made thereunder by Eyetech have been made, and Eyetech is in compliance in
all material respects with its respective obligations thereunder.
(i) Exhibit 8.1(i) sets forth all sources of funding,
grants or loans Eyetech has received and, to Eyetech's knowledge, that Gilead or
NeXstar Pharmaceuticals, Inc. has received, in connection with the discovery,
research and development of the Compound and any Product.
(j) Exhibit 8.1(j) sets forth a list of (i) all
pre-clinical and clinical studies of the Compound, together with the dates and
brief descriptions of such studies, previously or currently undertaken or
sponsored by Eyetech or its Affiliates and by any third-party investigator under
any contract with Eyetech, data and reports relating to which have been
previously provided to Pfizer and (ii) material correspondence and contact
information with the FDA and other Regulatory Authorities regarding the Compound
and the Products, copies of which have been previously provided to Pfizer.
43
(k) No person owns 50% or more of the voting securities
of Eyetech. Eyetech has no subsidiaries other than those whose financial
statements are maintained on a consolidated basis with those of Eyetech.
8.2 Pfizer Representations and Warranties.
Pfizer hereby represents and warrants, as of the date hereof, to
Eyetech as follows:
(a) Pfizer has the corporate power and authority to
execute and deliver this Agreement and the Collaboration Agreement and to
perform its obligations hereunder and thereunder, and the execution, delivery
and performance of this Agreement and the Collaboration Agreement by Pfizer have
been duly and validly authorized and approved by proper corporate action on the
part of Pfizer, and Pfizer has taken all other action required by Law, its
certificate of incorporation or by-laws or any agreement to which it is a party
or by which it or its assets are bound required to authorize such execution,
delivery and (subject to obtaining all necessary governmental approvals with
respect to the manufacture, use, sale, offer for sale or importation of Products
and subject to any necessary HSR Clearance) performance. Assuming due
authorization, execution and delivery on the part of Eyetech, each of this
Agreement and the Collaboration Agreement constitutes a legal, valid and binding
obligation of Pfizer, enforceable against Pfizer in accordance with its
respective terms.
(b) The execution and delivery of this Agreement and the
Collaboration Agreement and the performance by Pfizer contemplated hereunder and
thereunder will not violate (subject to obtaining appropriate governmental
health, pricing and reimbursement approvals) any state, federal or other statute
or regulation or any order of any court or other governmental department,
authority, agency or instrumentality therein.
44
(c) There is no action, claim, demand, suit, proceeding,
arbitration, grievance, citation, summons, subpoena, inquiry or investigation of
any nature, civil, criminal, regulatory or otherwise, in law or in equity,
pending or relating to or, to the knowledge of Pfizer, threatened against Pfizer
in connection with or relating to the transactions contemplated by this
Agreement or the Collaboration Agreement, and assuming the accuracy of the
representations and warranties of Eyetech contained herein, Pfizer is unaware
and has no reason to be aware of any basis for the foregoing.
(d) Neither the execution and delivery of this Agreement
or the Collaboration Agreement nor the performance hereof or thereof by Pfizer
requires Pfizer to obtain any permits, authorizations or consents from any
governmental body (subject to obtaining all necessary governmental approvals
with respect to the manufacture, use, sale, offer for sale or importation of the
Product and subject to obtaining any necessary HSR Clearance) or from any other
person, firm or corporation and such execution, delivery and performance will
not result in the breach of or give rise to any termination of any agreement or
contract to which Pfizer may be a party, except that would not reasonably be
expected to adversely affect the ability of Pfizer to perform its obligations
under this Agreement.
8.3 Eyetech Covenants.
Eyetech covenants and agrees as follows:
(a) As soon as practicable after the date hereof, Eyetech
will provide Pfizer with accurate, complete and final versions of all reports
and studies previously submitted to Pfizer to the extent not previously
provided, together with access to any related data and files, and to principal
investigators and such persons participating in the studies.
45
(b) Subject to Pfizer's and its sublicensees' performance
of their obligations under this Agreement and the Collaboration Agreement
(including such obligations relating to third party royalties), Eyetech shall
use commercially reasonable efforts to maintain the Isis License, Gilead License
and Shearwater License in good standing and not to take any actions (or omit or
fail to take any actions) which would result in a breach of any of such license
agreements. Eyetech agrees that it shall not amend, modify or supplement any of
the Isis License, Gilead License or Shearwater License in any manner that would
adversely affect Pfizer's rights under this Agreement or the Collaboration
Agreement without the consent of Pfizer. In addition, Eyetech shall not sell,
assign, convey, pledge, hypothecate or otherwise transfer any of the Isis
License, Gilead License or Shearwater License or Eyetech's rights or obligations
thereunder, or otherwise make any commitments or offers in a manner that
conflicts with Pfizer's rights hereunder without the consent of Pfizer. Eyetech
shall immediately notify Pfizer upon receipt by Eyetech or its Affiliates of any
notice from Gilead, Isis or Shearwater of such party's intent to terminate
Eyetech's rights, exercise its respective rights or remedies thereunder, or
otherwise take any action that may adversely affect Pfizer's rights under this
Agreement.
8.4 No Consequential or Punitive Damages.
(a) NEITHER PARTY HERETO WILL BE LIABLE FOR INDIRECT,
INCIDENTAL, CONSEQUENTIAL, SPECIAL, EXEMPLARY OR PUNITIVE DAMAGES ARISING FROM
OR RELATING TO ANY BREACH OF THIS AGREEMENT, OR FOR LOST PROFITS ARISING FROM OR
RELATING TO ANY BREACH OF THIS AGREEMENT, REGARDLESS OF ANY NOTICE OF SUCH
DAMAGES. NOTHING IN THIS SECTION 8.4 IS INTENDED TO LIMIT OR RESTRICT THE
INDEMNIFICATION
46
RIGHTS OR OBLIGATIONS OF EITHER PARTY UNDER THIS AGREEMENT WITH RESPECT TO THIRD
PARTY CLAIMS.
(b) Notwithstanding anything to the contrary contained in
this Agreement, in the case of any claim by any party alleging any breach of
this Agreement by the other party, any payment obligation pursuant to Articles 3
and 4 of this Agreement (the "Payment Obligations"), will not be considered as
constituting special, incidental, indirect or consequential damages under this
Agreement (and, accordingly, nothing in Section 8.4(a) shall prevent recovery or
inclusion in the definition of "Losses").
ARTICLE 9
TERM
9.1 This Agreement shall be effective as of the date first set
forth above and shall remain in effect for the Term.
ARTICLE 10
TERMINATION
10.1 Termination for Convenience. This Agreement shall terminate:
(a) upon (i) twelve (12) months prior written notice from Pfizer of termination
of this Agreement, if such notice is given prior to the first Launch of a
Product in the Territory, (ii) nine (9) months prior written notice from Pfizer
of termination of this Agreement, if such notice is given prior to the fifth
anniversary of the first Launch of a Product in the Territory or (iii) six (6)
months prior written notice from Pfizer of termination of this Agreement, if
such notice is given after the fifth anniversary of the first Launch of a
Product in the Territory, in each case which notice Pfizer shall be entitled to
submit in its absolute and sole discretion; and (b) at Eyetech's sole option,
exercisable by giving written notice of termination to Pfizer, following
termination or expiration
47
of the Collaboration Agreement as provided in Sections 13.1, 13.2(b), 13.4,
13.5, 13.6, 13.8 and 17.11 of the Collaboration Agreement.
10.2 Termination for Breach. Eyetech shall have the rights set
forth below in this Section 10.2 by notice to Pfizer, and Pfizer shall have the
rights set forth below in this Section 10.2 by notice to Eyetech.
(a) Upon Eyetech's notice to Pfizer that a Material
Default by Pfizer has occurred, the Parties will meet to discuss in good faith
whether a plan to remedy the Material Default can be mutually agreed. If the
Parties fail to so agree within thirty (30) days after the date of such notice,
Section 10.2(b) below shall apply. Notwithstanding the foregoing provisions of
this Section 10.2(a), in the case of a payment default, the provisions of
Section 10.2(b) below shall apply without any obligation to meet to discuss
remedies pursuant to this Section 10.2(a).
(b) Subject to the terms hereof, upon the occurrence of
any Material Default by Pfizer, Eyetech may, upon ninety (90) days prior written
notice, terminate this Agreement. Eyetech may give the notice specified in this
Section 10.2(b) concurrently with the notice specified in Section 10.2(a) and
shall not give the notice specified in this Section 10.2(b) later than sixty
(60) days after the date of the notice specified in Section 10.2(a).
(c) Upon Pfizer's notice to Eyetech that a Material
Default by Eyetech has occurred, the Parties will meet to discuss in good faith
whether a plan to remedy the Material Default can be mutually agreed. If the
Parties fail to so agree within thirty (30) days after the date of such notice,
Section 10.2(d) below will apply. Notwithstanding the foregoing provisions of
this Section 10.2(c), in the case of a payment default, the provisions of
Section 10.2(d) below shall apply without any obligation to meet to discuss
remedies pursuant to this Section 10.2(c).
48
(d) Subject to the terms hereof, upon the occurrence of
any Material Default by Eyetech, Pfizer may, upon ninety (90) days prior notice,
terminate this Agreement. Pfizer may give the notice specified in this Section
10.2(d) concurrently with the notice specified in Section 10.2(c) and shall not
give the notice specified in this Section 10.2(d) later than sixty (60) days
after the date of the notice specified in Section 10.2(c).
(e) "Material Default" means:
(i) any default by any Party hereto of its
covenants, agreements or other performance obligations under this Agreement or
the Collaboration Agreement other than a payment default (which may include any
one or more defaults of any specific covenant, agreement or other performance
obligations contained herein) that, when aggregated with any other such uncured
defaults by such Party, is (a) material to this Agreement and the Collaboration
Agreement taken as a whole, and (b) shall have continued for thirty (30) days
after written notice thereof was provided to the alleged defaulting Party by the
non-defaulting Party (or, if such default cannot be cured within such thirty
(30) day period, if the alleged defaulting Party does not promptly commence and
diligently continue all reasonable actions to cure such defaults during such
thirty (30) day period or does not cure in full such default within sixty (60)
days after written notice thereof was provided to the alleged defaulting Party);
or
(ii) any default by any Party hereto of its
payment obligations hereunder that shall have continued for fifteen (15) days
after written notice thereof was provided to the alleged defaulting Party by the
non-defaulting Party; provided that, in the event of a good faith payment
dispute, such fifteen (15) day cure period shall be extended through the
fifteenth day following the date on which such dispute is resolved if the
alleged defaulting Party paid all undisputed amounts when due and provided the
non-defaulting Party with a reasonably
49
detailed written explanation of the alleged defaulting Party's basis for
disputing the payment obligation within the fifteen (15) day period following
the written notice of the default by the non-defaulting Party.
10.3 Breach of Non-Competition Obligations. If a Party breaches its
obligations under Section 10.5, the other Party may terminate this Agreement
upon thirty (30) days prior written notice of termination to the breaching
Party; provided that, if the breaching Party permanently ceases the activity or
eliminates the condition, as applicable, giving rise to the breach of its
obligations under Section 10.5 prior to the expiration of such thirty (30) day
notice period, such termination shall not take effect.
10.4 Effects of Termination. In the event that this Agreement is
terminated in accordance with Section 10.1 or 10.2:
(a) the licenses set forth in Sections 2.1 and 2.2 shall
terminate;
(b) Eyetech's right to receive all payments due and owing
under Articles 3 and 4 hereof as of the effective date of such termination shall
survive;
(c) each Party's right to recover against the other Party
for any breaches of any representations, warranties, covenants and agreements of
such other Party under this Agreement as of the effective date of such
termination shall survive;
(d) the provisions of Articles 5 and 11, Section 6.2 and
this Section 10.4 shall survive the expiration or termination of this Agreement
in accordance with their terms;
(e) Pfizer shall promptly and in no event later than
sixty (60) days after termination or expiration (i) transfer to Eyetech
ownership of all governmental or regulatory filings and approvals (including all
INDs and NDAs (and their foreign equivalents)) relating to Products, (ii)
deliver to Eyetech all pre-clinical and clinical data and information in
Pfizer's
50
possession or control relating to the Products, (iii) deliver to Eyetech copies
of all reports, records, regulatory correspondence and other materials in
Pfizer's possession or control relating to the pre-clinical and clinical
development, regulatory approval, manufacture, distribution and sales of
Products, including without limitation all information contained in the
centralized global safety database established and maintained by Pfizer in
accordance with the Regulatory Services Agreement, and (iv) deliver to Eyetech
all data and information relating to process conditions, in-process controls,
analytical methodology and formulation, in each case as developed by Pfizer and
relating to the manufacturing of Products, solely for use in connection with the
Products;
(f) Pfizer shall grant to Eyetech a non-exclusive,
non-royalty-bearing, perpetual right and license under Pfizer's and its
Affiliates' rights in Collaboration Intellectual Property to develop, make, have
made, use, sell, offer for sale, import, and have imported Products in the
Territory;
(g) if Pfizer has taken over responsibility for
contracting with API Bulk Drug Substance Supplier(s) and/or Fill and Finish
Services Supplier(s), or for performing, either directly or through Affiliates,
services that otherwise would be performed by API Bulk Drug Substance
Supplier(s) and/or Fill and Finish Services Supplier(s), Pfizer shall continue
to manufacture or have manufactured (including filling and finishing) Product
being manufactured by Pfizer and/or its Affiliates, on the terms and conditions
in effect immediately prior to termination, for worldwide supply to Eyetech
during the shorter of (i) the twenty-four (24) month period following
termination and (ii) the period following termination and prior to Eyetech's
establishment of its own manufacturing capabilities and/or third party
manufacturing and supply arrangements with respect to the Products; and Pfizer
shall cooperate with Eyetech during such period to assign to Eyetech all third
party manufacturing and supply (including fill
51
and finish services) agreements and transfer to Eyetech all manufacturing
know-how, and to provide Eyetech with such other assistance as may be requested
by Eyetech, reasonably required by Eyetech for the purpose of establishing its
own manufacturing capabilities and/or third party manufacturing and supply
arrangements with respect to the Products;
(h) Pfizer shall permit Eyetech, at Eyetech's option, to
purchase, at Manufacturing Cost, all or any part of Pfizer's worldwide unsold
inventory of raw materials for Products, work-in-progress Products and finished
Products as of the effective date of termination, provided that, Pfizer shall
not be required to sell to Eyetech inventories of raw materials for Products and
work-in-progress Products that Pfizer needs to satisfy its obligations under
Section 10.4(g); and
(i) unless this Agreement expressly provides that
termination shall be the sole and exclusive remedy for a particular breach
hereof, either Party's right to commence an action, suit or other proceeding
claiming breach of this Agreement by the other Party shall survive termination.
Upon any termination of this Agreement, each Party shall promptly
return to the other Party all written Confidential Information, and all copies
thereof, of such other Party.
10.5 Non-Competition. During the Term and Co-Promotion Term (as
defined in the Collaboration Agreement), neither Pfizer nor Eyetech nor any of
their Affiliates shall, directly or indirectly, manufacture commercial
quantities of, or market, sell, detail or promote, any Competing Product in the
Territory (excluding the EU), except for the Products as provided in this
Agreement and in the Collaboration Agreement. If (a) either Party terminates the
Collaboration Agreement pursuant to Section 13.2, 13.4 or 13.5 of the
Collaboration Agreement or (b) Pfizer terminates this Agreement pursuant to
Section 10.1 of this Agreement, then the
52
prohibition set forth in the immediately preceding sentence shall, in the case
of a termination described in clause (a) of this sentence, be extended with
respect to the other Party and its Affiliates through a period immediately
following the effective date of such termination of:
(i) [**], if such termination occurs [**],
(ii) [**], if such termination occurs [**], or
(iii) [**], if such termination occurs [**],
and, in the case of a termination described in clause (b) of this sentence, be
extended with respect to Pfizer and its Affiliates through a period immediately
following the effective date of such termination of:
(i) [**], if such termination occurs [**],
(ii) [**], if such termination occurs [**], or
(iii) [**], if such termination occurs [**].
Notwithstanding the foregoing, Eyetech and its Affiliates, either directly or in
collaboration with third parties, shall be entitled to commercialize products
that contain or are based on the Compound for use outside the Field ("POF"),
provided such products are sold under product trademarks other than the
Trademark(s) and are: (a) in a different dosage strength; (b) in a different
formulation; or (c) with a different delivery system; in each case not intended
or developed for use in the Field. Eyetech and its Affiliates shall not conduct
clinical trials or marketing studies with respect to such POF to support use of
such POF in the Field, and Eyetech and its Affiliates shall require any third
party collaborator to comply with this undertaking with respect to any POF.
Subject to the provisions of Section 10.6, any breach of this Section 10.5 shall
entitle the non-breaching Party to terminate this Agreement pursuant to Section
10.3.
53
10.6 Acquisitions Involving Competing Products. Notwithstanding the
provisions of Section 10.5 above, if during the Term Pfizer or Eyetech or any of
their respective Affiliates acquires or agrees to acquire a Competing Product in
the Territory through acquisition of or merger with a company or entity, or is
acquired or agrees to be acquired by a company or entity that owns a Competing
Product in the Territory, Pfizer or Eyetech, as applicable, shall have thirty
(30) days from the date of public announcement of the acquisition or merger to
notify the other Party as to whether Pfizer or Eyetech or the acquiring company
or entity, as applicable, intends to divest its interest in such Competing
Product. In the event that Pfizer or Eyetech or the acquiring company or entity,
as applicable, elects to divest its interest in such Competing Product, such
Party or the acquiring company or entity shall use reasonable efforts to
identify a third party purchaser to whom such Party or the acquiring company or
entity will divest its interest in such Competing Product and to enter into a
definitive agreement with such third party for such divestiture as soon as
reasonably practicable under the circumstances. If Pfizer or Eyetech or the
acquiring company or entity, as applicable, elects not to divest its interest in
such Competing Product or fails to divest its interest in such Competing Product
within [**] after the closing of the transaction for which Pfizer or Eyetech, as
applicable, has provided the other Party with notice, then the other Party shall
have the option, upon written notice to Pfizer or Eyetech, as applicable, given
no later than ninety (90) days after the earlier of: (i) Pfizer's or Eyetech's
written notice, as applicable, of its election not to divest such Competing
Product; and (ii) the end of such [**] period described above, to terminate this
Agreement pursuant to Section 10.5, treating such election not to divest or
failure to divest such Competing Product as a breach of Section 10.5.
Notwithstanding the provisions of Section 10.5 and this Section 10.6, however,
neither Party shall have the right to terminate this Agreement based on the
other Party's or its
54
Affiliate's or acquiring company's or entity's failure to divest its interest in
a Competing Product that is sold only in the EU.
10.7 Competing Products in the EU. Notwithstanding the provisions
of Sections 10.5 and 10.6 above, (a) if Pfizer or any of its Affiliates,
directly or indirectly, manufactures commercial quantities of, or markets,
sells, details or promotes, any Competing Product in the EU, the licenses
granted by Eyetech to Pfizer in Section 2.1(a) shall at Eyetech's option, which
option shall be exercisable upon notice by Eyetech to Pfizer, convert to
nonexclusive licenses, and (b) if Eyetech or any of its Affiliates, directly or
indirectly, manufactures commercial quantities of, or markets, sells, details or
promotes, any Competing Product in the EU, then with respect to any given Net
Sales of Products in the EU, subject to the limitations set forth in Section
4.1(c), the royalties set forth in Section 4.1(a) or 4.1(b) shall thereafter be
reduced by [**] percent ([**]%).
ARTICLE 11
DISPUTE RESOLUTION
11.1 Arbitration. Any payment dispute or dispute arising out of any
audit conducted pursuant to Section 5.5 shall be resolved through binding
arbitration as follows:
(a) A Party may submit such dispute to arbitration by
notifying the other Party, in writing, of such dispute. Within thirty (30) days
after receipt of such notice, the Parties shall designate in writing a single
arbitrator to resolve the dispute; provided, however, that if the Parties cannot
agree on an arbitrator within such 30-day period, the arbitrator shall be
selected by the New York, New York office of the American Arbitration
Association (the "AAA"). The arbitrator shall be a lawyer knowledgeable and
experienced in the law concerning the subject
55
matter of the dispute, and shall not be an Affiliate, employee, consultant,
officer, director or stockholder of any Party.
(b) Within thirty (30) days after the designation of the
arbitrator, the arbitrator and the Parties shall meet, at which time the Parties
shall be required to set forth in writing all disputed issues and a proposed
ruling on the merits of each such issue.
(c) The arbitrator shall set a date for a hearing, which
shall be no later than thirty (30) days after the submission of written
proposals pursuant to Section 11.1(b), to discuss each of the issues identified
by the Parties. The Parties shall have the right to be represented by counsel.
Except as provided herein, the arbitration shall be governed by the Commercial
Arbitration Rules of the AAA; provided, however, that the Federal Rules of
Evidence shall apply with regard to the admissibility of evidence.
(d) The arbitrator shall use his or her best efforts to
rule on each disputed issue within thirty (30) days after the completion of the
hearings described in Section 11.1(c). The determination of the arbitrator as to
the resolution of any dispute shall be binding and conclusive upon all Parties.
All rulings of the arbitrator shall be in writing and shall be delivered to the
Parties.
(e) The (i) attorneys' fees of the Parties in any
arbitration, (ii) fees of the arbitrator and (iii) costs and expenses of the
arbitration shall be borne by the Parties as determined by the arbitrator.
(f) Any arbitration pursuant to this Section 11.1 shall
be conducted in New York, New York. Any arbitration award may be entered in and
enforced by a court in accordance with Section 12.4.
56
11.2 No Limitation. Nothing in Section 11.1 shall be construed as
limiting in any way the right of a Party to seek a temporary restraining order
or preliminary injunction with respect to any actual or threatened breach of
this Agreement from, or to bring an action in aid of arbitration in, a court in
accordance with Section 12.4. Should any Party seek a temporary restraining
order or preliminary injunction, then for purposes of determining whether to
grant such temporary restraining order or preliminary injunction, the dispute
underlying the request for such temporary restraining order or preliminary
injunction may be heard by a court in accordance with Section 12.4.
ARTICLE 12
MISCELLANEOUS
12.1 Force Majeure. No Party shall be liable for failure of or
delay in performing obligations set forth in this Agreement, and no Party shall
be deemed in breach of its obligations, if such failure or delay is due to
natural disasters or any causes reasonably beyond the control of such Party.
12.2 Assignment. Except as otherwise provided herein, neither this
Agreement nor any of the rights or obligations hereunder may be assigned by
either Party without the prior consent of the other Party, except assignment, in
whole or in part, to an Affiliate of the assigning Party so long as such
Affiliate agrees in writing to be bound by the terms of this Agreement. The
assigning Party shall remain primarily liable hereunder notwithstanding any such
assignment. Any attempted assignment in violation hereof shall be void.
12.3 Governing Law. This Agreement shall be governed by the laws of
the State of New York without regard to its conflict of laws provisions.
57
12.4 Jurisdiction. Except with respect to disputes arising out of
audits conducted pursuant to Section 5.5 or with respect to payment disputes,
which shall be resolved through binding arbitration in accordance with Article
11, each Party (a) irrevocably submits to the exclusive jurisdiction in the
United States District Court for the Southern District of New York and any State
courts sitting in New York, New York (collectively, the "Courts"), for purposes
of any action, suit or other proceeding arising out of this Agreement, and (b)
agrees not to raise any objection at any time to the laying or maintaining of
the venue of any such action, suit or proceeding in any of the Courts,
irrevocably waives any claim that such action, suit or other proceeding has been
brought in an inconvenient forum and further irrevocably waives the right to
object, with respect to such action, suit or other proceeding, that such Court
does not have any jurisdiction over such Party.
12.5 Notices. All notices, instructions and other communications
hereunder or in connection herewith shall be in writing, shall be sent to the
address below and shall be: (a) delivered personally; (b) sent by registered or
certified mail, return receipt requested, postage prepaid; (c) sent via a
reputable nationwide overnight courier service; or (d) sent by facsimile
transmission. Any such notice, instruction or communication shall be deemed to
have been delivered upon receipt if delivered by hand, three (3) Business Days
after it is sent by registered or certified mail, return receipt requested,
postage prepaid, one (1) Business Day after it is sent via a reputable
nationwide overnight courier service, or when transmitted with electronic
confirmation of receipt, if transmitted by facsimile (if such transmission is on
a Business Day; otherwise, on the next Business Day following such
transmission). Notices shall be addressed as follows:
58
If to Pfizer: If to Eyetech:
PFIZER INC. EYETECH PHARMACEUTICALS, INC.
235 East 42nd Street 500 Seventh Avenue, 18th Floor
New York, New York 10017-5755 New York, New York 10018
Fax: 212-808-8652 Fax: 212-997-9251
Attention: President, Pfizer Pharmaceutical Attention: Chief Executive Officer
Group
with a copy to: with a copy to:
PFIZER INC. Hale and Dorr LLP
235 East 42nd Street 60 State Street
New York, New York 10017-5703 Boston, Massachusetts 02109
Attn.: Senior Vice President and General Attn.: David E. Redlick, Esq.
Counsel
Fax: 212-808-8924 Fax: 617-526-5000
Either Party may change its address by giving notice to the other Party in the
manner provided above.
12.6 Entire Agreements; Amendments. This Agreement, together with
the Collaboration Agreement and the other Other Product-Related Agreements, sets
forth the complete understanding of the Parties with respect to the Parties'
joint development and commercialization of Products and supersedes all prior
understandings and writings relating to such subject matter. None of the terms
or this Agreement shall be amended, supplemented or modified except in writing
signed by the Parties hereto. The Parties understand and agree that each of this
Agreement and the Collaboration Agreement are considered to be a single
integrated agreement and contain intellectual property rights and licenses
relating to the Products for which Pfizer has bargained and paid consideration.
If any applicable court of competent jurisdiction determines this Agreement or
the Collaboration Agreement to be executory in nature, such agreements shall
otherwise be deemed to be, for purposes of Section 365 (n) of the Bankruptcy
59
Code, licenses of rights to "intellectual property" as defined under Section 101
of the Bankruptcy Code.
12.7 Severability. If and solely to the extent that any provision
of this Agreement shall be invalid or unenforceable, or shall render this entire
Agreement to be unenforceable or invalid, such offending provision shall be of
no effect and shall not effect the validity of the remainder of this Agreement
or any of its provisions; provided, however, the Parties shall use their
respective reasonable efforts to renegotiate the offending provisions to best
accomplish the original intentions of the Parties.
12.8 Waivers. Any term or condition of this Agreement may be waived
at any time by the Party that is entitled to the benefit thereof, but no such
waiver shall be effective unless set forth in a written instrument duly executed
by or on behalf of the Party or Parties waiving such term or condition. Neither
the waiver by any Party of any term or condition of this Agreement nor the
failure on the part of any Party, on one or more instances, to enforce any of
the provisions of this Agreement or to exercise any right or privilege, shall be
deemed or construed to be a waiver of such term or condition for any similar
instance in the future or of any subsequent breach hereof. All rights, remedies,
undertakings, obligations and agreements contained in this Agreement shall be
cumulative and none of them shall be a limitation of any other remedy, right,
undertaking, obligation or agreement.
12.9 Binding Effect. This Agreement shall be binding upon and inure
to the benefit of the Parties hereto and their respective permitted successors
and assigns.
12.10 Further Assurances. Following the date hereof, Eyetech and
Pfizer shall and, to the extent this Agreement expressly imposes obligations on
its Affiliates, each Party shall cause each of its respective Affiliates to,
from time to time, execute and deliver such additional
60
instruments, documents, conveyances or assurances and take such other actions as
shall be necessary or otherwise reasonably requested by Pfizer or Eyetech, to
confirm and assure the rights and obligations provided for in this Agreement,
and render effective the consummation of the transactions contemplated thereby.
12.11 Third Party Beneficiaries. None of the provisions of this
Agreement shall be for the benefit of or enforceable by any third party
including, without limitation, any creditor of either Party. No third party
shall obtain any right under any provision of this Agreement or shall by reasons
of any such provision make any claim in respect of any debt, liability or
obligation (or otherwise) against either Party hereto.
12.12 Performance by Subsidiaries and Affiliates. To the extent that
this Agreement imposes obligations on Subsidiaries and Affiliates of a Party,
such Party agrees to cause its Subsidiaries and Affiliates to perform such
obligations.
12.13 Counterparts. This Agreement may be executed in any two or more
counterparts, each of which, when executed, shall be deemed to be an original
and all of which together shall constitute one and the same document.
12.14 Headings. Headings in this Agreement are included herein to ease
of reference only and shall have no legal effect. References to Sections and
Exhibits are to Sections and Exhibits of this Agreement unless otherwise
specified.
61
12.15 Offset. All amounts due and payable from Pfizer to Eyetech
pursuant to this Agreement are subject to offset in respect of the amount of any
liabilities of Eyetech paid by Pfizer to Gilead pursuant to Section 3 of the
Stand-By License Agreement between Pfizer and Gilead dated December 13, 2002.
IN WITNESS WHEREOF, the Parties hereto have caused this Agreement to be
executed as of the date first written above by their duly authorized officers.
PFIZER INC. EYETECH PHARMACEUTICALS, INC.
By: /s/ Henry A. McKinnell By: /s/ David R. Guyer
__________________________ __________________________
Name: Henry A. McKinnell Name: David R. Guyer
__________________________ __________________________
Title: Chairman and CEO Title: CEO
__________________________ __________________________
62
EXHIBIT 1.8
COMPOUND
[**]
63
EXHIBIT 1.18
EYETECH PATENT RIGHTS
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EXHIBIT 8.1(f)
CERTAIN INTELLECTUAL PROPERTY MATTERS
[**] which were previously disclosed to Pfizer.
68
EXHIBIT 8.1(i)
FUNDING SOURCES
With respect to Eyetech, other than general corporate funding, Eyetech has not
received any funding, grants or loans in connection with the discovery, research
and development of the Compound or any Product.
To Eyetech's knowledge, with respect to Gilead or NeXstar Pharmaceuticals, other
than general corporate funding received by Gilead or NeXstar Pharmaceuticals,
neither Gilead nor NeXstar Pharmaceuticals has received any funding, grants or
loans in connection with the discovery, research and development of the Compound
or any Product.
To Eyetech's knowledge, the following Patent Rights were supported by grants
[**]. As a result, the Parties are subject to the provisions of Law referenced
in Section 2.1(f) of this Agreement.
69
EXHIBIT 8.1(j)
STUDIES
8.1(j)(i): (A) The following is a list of all pre-clinical and clinical studies
of the Compound, together with the dates and brief descriptions of such studies,
previously or currently undertaken or sponsored by Eyetech or its Affiliates and
by any third-party investigator under any contract with Eyetech, data and
reports relating thereto which have been previously provided to Pfizer.
1. [**]
- Objectives:
- Primary: [**]
- Design:
- [**]
- NO-GO Criteria:
- [**]
- Logistics
- [**]
2. [**]
- Objectives:
- Primary: [**]
- Design:
- [**]
- NO-GO Criteria:
- [**]
- Logistics
- [**]
3. [**]
- Objectives:
- Primary: [**]
- Design:
- [**]
- NO-GO Criteria:
- [**]
- Logistics
- [**]
4. [**]
- Objectives:
- Primary: [**]
- Design:
- [**]
- NO-GO Criteria:
- [**]
- Logistics
- [**]
5. [**]
- Objectives:
- Primary: [**]
- Design:
- [**]
- NO-GO Criteria:
- [**]
- Logistics
- [**]
70
6. [**]
-Objectives:
-Primary: [**]
-Design:
-[**]
-NO-GO Criteria:
-[**]
-Logistics
-[**]
7. [**]
-Objectives:
-Primary: [**]
-Design:
-[**]
-NO-GO Criteria:
-[**]
-Logistics
-[**]
8. [**]
-Objectives
-Primary: [**]
-Design:
-[**]
-NO-GO Criteria:
-[**]
-Logistics
-[**]
8.1(j)(i): (B) In addition, Eyetech plans to undertake the following
clinical studies of the Compound:
1. [**]
-Objectives:
-Primary: [**]
-Design:
-[**]
-NO-GO Criteria:
-[**]
-Logistics
-[**]
2. [**]
-Objectives:
-Primary: [**]
-Design:
-[**]
-NO-GO Criteria:
-[**]
-Logistics
-[**]
3. [**]
-Objectives:
-Primary: [**]
-Design:
-[**]
-NO-GO Criteria:
-[**]
-Logistics
-[**]
71
4. [**]
- Objectives:
- Primary:[**]
- Design:
- [**]
- NO-GO Criteria:
- [**]
- Logistics
- [**]
5. [**]
- Objectives:
- Primary:[**]
- Design:
- [**]
- NO-GO Criteria:
- [**]
- Logistics
- [**]
6. [**]
- Objectives:
- Primary:[**]
- Design:
- [**]
- NO-GO Criteria:
- [**]
- Logistics
- [**]
7. [**]
- Objectives:
- Primary:[**]
- Design:
- [**]
- NO-GO Criteria:
- [**]
- Logistics
- [**]
8. [**]
- Objectives:
- Primary:[**]
- Design:
- [**]
- NO-GO Criteria:
- [**]
- Logistics
- [**]
9. [**]
- Objectives:
- Primary:[**]
- Design:
- [**]
- NO-GO Criteria:
- [**]
- Logistics
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8.1(j)(ii): The following is a list of all material correspondence and contact
information with the FDA and other Regulatory Authorities regarding the Compound
and the Products, copies of which have been previously provided to Pfizer.
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1. EYE001 - [**] - FDA Correspondence (Updated 9/24/02)
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2. [**] Correspondence (Updated 7/26/02)
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3. [**] Correspondence (Updated 6/19/02)
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5. [**] Correspondence (Updated 7/26/02)
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[**]6. [**]Correspondence (Updated 6/19/02)
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7. [**] Correspondence (Updated 8/29/01)
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8. [**] Correspondence (Updated 7/26/02)
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9. [**] Correspondence (Updated 6/19/02)
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10. [**] Correspondence (Updated 6/19/02)
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11. [**] Correspondence (Updated 6/19/02)
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12. [**] Correspondence
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13. [**] Correspondence (Updated 6/19/02)
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15. [**] Correspondence (Updated 7/26/02)
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16. [**] Correspondence
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17. [**] Correspondence (Updated 6/19/02)
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