CONFIDENTIAL MATERIALS OMITTED
AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.
ASTERISKS DENOTE OMISSIONS
AMENDED AND RESTATED LICENSE
AGREEMENT
THIS
AMENDED AND RESTATED LICENSE AGREEMENT (this “
Agreement ”) dated as of April 20, 2007 (the
“ Restatement Date ”) between Pfizer Inc., a
corporation organized under the laws of the state of Delaware, with
its principal place of business at 235 East 42nd Street, New York,
New York 10017 (“ Pfizer ”), and
(OSI) Eyetech, Inc. (formerly known as Eyetech
Pharmaceuticals, Inc.), a corporation organized under the laws of
the state of Delaware, with its principal place of business at 140
E. Hanover Avenue, Cedar Knolls, New Jersey 07927 (“
Eyetech ”).
WHEREAS,
on December 17, 2002, Pfizer and Eyetech entered into a
License Agreement (as amended prior to the Restatement Date, the
“ Original License Agreement ”), whereby,
inter alia , Eyetech granted to Pfizer an exclusive
license or sublicense to certain patents and patent applications,
know-how, trade secrets and scientific and technical information
relating to Macugen® throughout the world, and a Collaboration
Agreement (the “ Collaboration Agreement ”), in
which Eyetech and Pfizer agreed, inter alia , to co-promote
Macugen® in the US Territory (as defined below);
WHEREAS,
the Parties no longer desire to co-promote Macugen® in the US
Territory; and
WHEREAS,
Pfizer desires to continue to develop and commercialize the Product
(as defined below) in the ROW Territory (as defined
below).
NOW,
THEREFORE, the Parties agree to terminate the Collaboration
Agreement and amend and restate the Original License Agreement in
its entirety as follows:
1.1
“ AAA ” has the meaning set forth in
Section 14.1(a).
1
1.2
“ Affiliate ” means any Person directly or
indirectly controlled by, controlling or under common control with,
a Party, but only for so long as such control shall continue. For
purposes of this definition, “control” (including, with
correlative meanings, “controlled by”,
“controlling” and “under common control
with”) means, with respect to a Person, possession, direct or
indirect, of (a) the power to direct or cause direction of the
management and policies of such Person (whether through ownership
of securities or partnership or other ownership interests, by
contract or otherwise), or (b) at least 50% of the voting
securities (whether directly or pursuant to any option, warrant or
other similar arrangement) or other comparable equity interests.
For the avoidance of doubt, neither of the Parties shall be deemed
to be an “Affiliate” of the other.
1.3
“ Bankruptcy Code ” means 11 U.S.C §§
101-1330, as amended.
1.4
“ Amended and Restated Distribution Agreement ”
means the Amended and Restated Distribution Agreement between
Eyetech and Pfizer dated as of the date hereof.
1.5
“ Amended and Restated Regulatory Services Agreement
” means the Amended and Restated Regulatory Services
Agreement between Eyetech and Pfizer dated as of the date
hereof.
1.6
“ Assignment and Assumption Agreement for Manufacturing
Agreements ” means the Assignment and Assumption
Agreement between Eyetech and Pfizer, dated as of the date hereof,
pursuant to which the agreements set forth on
Schedule 4.9(b) are assigned from Eyetech to
Pfizer.
1.7
“ Assignment and Assumption Agreement for US Territory
Agreements ” means the Assignment and Assumption
Agreement among Eyetech, Pfizer and OSI Pharmaceuticals, Inc.
(“OSIP”), dated as of the date hereof, pursuant to
which the US Territory Agreements are assigned from Pfizer and/or
OSIP to Eyetech.
1.8
“ Bill of Sale ” means the bill of sale in the
form attached hereto as Exhibit 1.8 .
2
1.9
“ Bulk Drug Substance Supplier ” means a
third-party supplier of bulk drug substance for the Product with
which Pfizer has entered into a supply agreement.
1.10
“ Business Day ” means a day other than a
Saturday, Sunday, or bank or other public holiday in New York, New
York.
1.11
“ Collaboration Agreement ” has the meaning set
forth in the Recitals to this Agreement.
1.12
“ Compound ” means the anti-VEGF aptamer that is
the active pharmaceutical ingredient in Macugen® as of the
Restatement Date, and is more specifically described in
Schedule 1.12 .
1.13
“ Confidential Information ” means all trade
secrets or other proprietary information, including without
limitation any proprietary data and materials (whether or not
patentable or protectable as a trade secret), regarding a
Party’s technology, products, business or objectives or
regarding the Product, which is disclosed by a Party to the other
Party. Notwithstanding the foregoing, there shall be excluded from
the foregoing definition of Confidential Information any of the
foregoing that:
(a) was
known by the receiving Party or an Affiliate prior to its date of
disclosure to the receiving Party as shown by the receiving
Party’s or its Affiliate’s written records;
or
(b) either
before or after the date of the disclosure to the receiving Party
is lawfully disclosed to the receiving Party or its Affiliate by
third parties not in violation of any obligation to the other
Party; or
3
(c) either
before or after the date of the disclosure to the receiving Party
becomes published or generally known to the public through no fault
or omission on the part of the receiving Party or its Affiliates;
or
(d) is
independently developed by or for the receiving Party or its
Affiliate without reference to or reliance upon the Confidential
Information as demonstrated by contemporaneous written records of
the receiving Party or its Affiliate; or
(e) is
required to be disclosed by the receiving Party or its Affiliate to
comply with applicable Laws, to defend or prosecute litigation or
to comply with governmental regulations or the regulations or
requirements of any stock exchange, including Nasdaq,
provided that the receiving Party provides prior
notice of such disclosure to the other Party and takes reasonable
and lawful actions to avoid and/or minimize the degree of such
disclosure.
1.14
“ Control ” or “ Controlled ”
means, with respect to any intellectual property right, the
possession (whether by ownership or license) by a Party (or by any
Affiliate of a Party) of the ability to grant to the other Party a
license under such right without violating the terms of any
agreement with a third party.
1.15
“ Courts ” has the meaning set forth in
Section 15.4.
1.16
“ Current Inventories ” has the meaning set
forth in Section 4.9(c).
1.17
“ DDMAC ” means the FDA’s Division of Drug
Marketing Advertising and Communications, or its equivalent in the
ROW Territory.
1.18
“ Degussa Agreement ” means the Manufacturing
and Supply Agreement dated as of November 11, 2003, by and
between Degussa Canada Inc. (as successor in interest to Raylo
Chemicals Inc.) and Eyetech, assigned to Pfizer pursuant to the
Assignment and Assumption Agreement for Manufacturing
Agreements.
4
1.19
“ Eyetech Capital Equipment ” has the meaning
set forth in Section 4.9(f).
1.20
“ Eyetech Parties ” has the meaning set forth in
Section 11.2.
1.21
“ Eyetech Patent Rights ” means all Patent
Rights Controlled by Eyetech or its Affiliates as of the
Restatement Date relating to, or useful in connection with, the
manufacture, use or sale of the Compound or the Product in the ROW
Territory, including the patents and patent applications set forth
on Schedule 1.21 . Any patentable inventions that have
been reduced to practice prior to the Restatement Date for which a
patent application is not filed until after the Restatement Date
shall be included within the definition of Eyetech Patent
Rights. **
1.22
“ Eyetech Technical Information ” means all
scientific or technical information and related know-how and trade
secrets, Controlled by Eyetech or its Affiliates as of the
Restatement Date relating to the Compound or the Product, including
but not limited to: (a) medical, clinical, toxicological or
other scientific data and (b) processes and analytical
methodology useful in the development, testing, analysis,
manufacture or packaging of the Compound or the Product.
1.23
“ Eyetech Third Party Licensors ” shall mean
(a) Gilead, Nektar and Isis, and (b) any additional third
party licensors that are identified by Eyetech to Pfizer with
respect to a New Product in the course of negotiating an agreement
pursuant to Section 3.5 concerning such New
Product.
1.24
“ FDA ” means the United States Food and Drug
Administration and any successor agency thereto.
1.25
“ Field ” means the prevention, treatment or
control of all ophthalmic diseases or conditions.
|
|
|
|
|
**
|
|
This portion
has been redacted pursuant to a confidential treatment
request.
|
5
1.26
“ Fill and Finish Services Supplier ” means a
third party supplier of fill and finish services necessary to
produce the Product in finished (i.e., ready for administration to
patients) form for sale in the ROW Territory with which Pfizer has
entered into an agreement.
1.27
“ Gilead License ” means the Licensing Agreement
dated as of March 30, 2000, by and among Eyetech, Gilead
Sciences, Inc. (“ Gilead ”) and NeXstar
Pharmaceuticals, Inc., as amended from time to time.
1.28
“ Global Congresses ” has the meaning set forth
in Section 4.4(g)(ii).
1.29
“ Governmental Authority ” means any court,
agency, department or other instrumentality of any foreign,
federal, state, county, city or other political
subdivision.
1.30
“ Isis License ” means the License Agreement
dated as of December 31, 2001, by and between Eyetech and Isis
Pharmaceuticals, Inc. (“ Isis ”), as amended
from time to time.
1.31
“ Joint Inventions ” shall have the meaning set
forth in Section 9.12.
1.32
“ Joint Patent Rights ” means Patent Rights that
claim Joint Inventions.
1.33
“ Law ” or “ Laws ” means all
laws, statutes, rules, codes, regulations, orders, judgments and/or
ordinances of any Governmental Authority.
1.34
“ Losses ” means, subject to Section 10.4,
any and all (a) claims, losses, liabilities, damages, fines,
royalties, governmental penalties or punitive damages,
deficiencies, interest, awards, and judgments, (b) with
respect to third parties, settlement amounts and all of the items
referred to in clause (a) above which, in accordance with
Section 10.4, include third party special, indirect,
incidental, consequential damages (including without limitation
lost profits) and third party punitive and multiple damages, and
(c) in connection with all of the items referred in clauses
(a) and (b) above, any and all costs and expenses
(including reasonable attorneys’ fees and all
other
6
expenses
reasonably incurred in investigating, preparing or defending any
litigation or proceeding, commenced or threatened).
1.35
“ Nektar License ” means the License,
Manufacturing and Supply Agreement dated as of February 5,
2002, by and between Eyetech and Nektar Therapeutics (formerly
Shearwater Corporation) (“ Nektar ”), as amended
as of January 23, 2006.
1.36
“ Net Sales ” means the gross amounts billed or
invoiced by Pfizer, its Affiliates and sublicensees for the Product
in the ROW Territory, less the following deductions:
(a) trade,
quantity and cash discounts allowed, but expressly excluding
discounts or allowances offered as part of a package of products
that includes a Product sold by Pfizer, its Affiliates or
sublicensees;
(b) refunds,
chargebacks and any other allowances which effectively reduce the
net selling price;
(c) actual
product returns, credits and allowances allowed to customers, and
actual bad debts;
(d) rebates
actually paid or credited to any governmental agency (or branch
thereof) or to any third party payor, administrator or
contractee;
(e) discounts
mandated by, or granted to meet the requirements of, applicable
state, provincial or federal law, wholesaler, including required
chargebacks and retroactive price reductions;
(f) transportation,
freight, postage charges and other charges, such as insurance,
relating thereto, in each case included as a specific line item on
an invoice to such third parties; and
7
(g) taxes,
excises or other governmental charges upon or measured by the
production, sale, transportation, delivery or use of goods, in each
case included as a specific line item on an invoice to such third
parties.
If
any such sales to third parties are made in transactions that are
not at arm’s length between the buyer and the seller, then
the gross amount to be included in the calculation of Net Sales
shall be the amount that would have been invoiced had the
transaction been conducted at arm’s length. Such amount that
would have been invoiced shall be determined, wherever possible, by
reference to the average selling price of the Product in
arm’s-length transactions in the relevant country.
If
Pfizer, its Affiliate or sublicensee sells a Product in unfinished
form to a third party for resale, then the gross amount to be
included in the calculation of Net Sales arising from such sale
shall be the amount invoiced by the third party upon resale, in
lieu of the amounts invoiced by Pfizer, its Affiliates or
sublicensee when selling the Product in unfinished form. Otherwise,
where Pfizer, its Affiliate or sublicensee sells a Product in
finished form to a third party that does not require a sublicense
under the Eyetech Patent Rights for further resale (each such third
party hereinafter a “ Distributor ”), the amount
to be included in the calculation of Net Sales shall be the price
invoiced from Pfizer or its Affiliate or sublicensee to the third
party, not the amount invoiced by the third party upon
resale.
If,
in addition to or in lieu of a transfer price paid for quantities
of Product supplied, any Distributor provides consideration to
Pfizer, its Affiliate or sublicensee in connection with any Product
or the Distributor’s rights or relationship with Pfizer, its
Affiliate or sublicensee in relation thereto, then such
consideration shall be included in the calculation of Net Sales in
the Pfizer Quarter in which it becomes due to Pfizer or its
Affiliate or sublicensee (as applicable).
8
Notwithstanding
the foregoing, amounts received by Pfizer, or its Affiliates or
sublicensees, for the sale of the Product among Pfizer and its
Affiliates or sublicensees for resale shall not be included in the
computation of Net Sales hereunder.
Net
Sales shall be determined from books and records maintained in
accordance with GAAP, consistently applied throughout the
organization and across all products of the entity whose sales of
Product are giving rise to Net Sales.
1.37
“ New Product ” means, other than the
prescription pharmaceutical product containing the Compound and
known as Macugen® as of the Restatement Date and any new doses
and dosing regimens thereof approved after the Restatement Date,
provided that such new doses or dosing regimens do not alter the
Product itself or any ingredient contained in such Product as of
the Restatement Date, any product that (a) contains or is
based on the Compound, or any metabolites or prodrugs of such
aptamer or any hydrates, conjugates, salts, esters, isomers,
polymorphs or analogues of any of the foregoing, either alone or in
combination with one or more other therapeutically active
substances, and (b) is for use in the Field; including for the
avoidance of doubt any un-pegylated formulation of the prescription
pharmaceutical product containing the Compound and known as
Macugen® as of the Restatement Date.
1.38
“ Ongoing Trials ” has the meaning set forth in
Section 4.2.
1.39
“ Ongoing Trial Data ” means all results and
data arising from the Ongoing Trials, including without limitation
all raw data and final results.
1.40
“ Original License Agreement ” shall have the
meaning set forth in the Recitals to this Agreement.
1.41
“ Other Components ” shall have the meaning set
forth in Section 4.9(c).
9
1.42
“ Out-of-Pocket Costs ” means costs and expenses
paid to third parties (or payable to third parties and accrued in
accordance with GAAP), other than Affiliates or employees, by
either Party after the Restatement Date.
1.43
“ Packaging Materials ” has the meaning set
forth in Section 9.7.
1.44
“ Party ” means either Eyetech or Pfizer;
“ Parties ” means both Eyetech and
Pfizer.
1.45
“ Patent Rights ” means the rights and interest
in and to all issued patents and pending patent applications in any
country in the Territory, including all divisionals, continuations,
renewals, continuations-in-part, patents of addition, supplementary
protection certificates, extensions, registrations or confirmation
patents and reissues thereof.
1.46
“ Person ” means any natural person or any
corporation, company, partnership, joint venture, firm or other
entity, including without limitation a Party.
1.47
“ Pfizer Capital Equipment ” has the meaning set
forth in Section 4.9(g).
1.48
“ Pfizer Parties ” has the meaning set forth in
Section 11.1.
1.49
“ Pfizer Patent Rights ” means all Patent Rights
Controlled by Pfizer or its Affiliates as of the Restatement Date,
relating to, or useful in connection with, the manufacture, use or
sale of the Compound or the Product in the US Territory. Any
patentable inventions that have been reduced to practice prior to
the Restatement Date for which a patent application is not filed
until after the Restatement Date shall be included in Pfizer Patent
Rights.
1.50
“ Pfizer Quarter ” means each of the four
(4) thirteen (13) week periods, the first commencing on
December 1 of any Year.
1.51
“ Pfizer Technical Information ” means all
scientific or technical information and related know-how and trade
secrets, Controlled by Pfizer or its Affiliates as of the
Restatement Date, including but not limited to: (a) medical,
clinical, toxicological or other scientific data and (b)
10
processes and
analytical methodology useful in the development, testing,
analysis, manufacture or packaging of the Compound or the
Product.
1.52
“ Pharmacovigilance Agreement ” has the meaning
set forth in Section 4.5.
1.53
“ Prior Agreements ” means the following
agreements entered into between Pfizer and Eyetech: the
Collaboration Agreement, the Detailing Services Agreement dated
December 17, 2002, and the Mutual Consent Establishing the
Technology Subcommittee dated February 4, 2004.
1.54
“ Product ” means (a) the prescription
pharmaceutical product containing the Compound and known as
Macugen® as of the Restatement Date, for any use in the Field,
and (b) any New Product with respect to which the license
granted to Pfizer in Section 3.1 is expanded pursuant to
Section 3.5. For the avoidance of doubt, Product shall include
new doses and dosing regimens thereof approved after the
Restatement Date, provided that such new doses or dosing regimens
do not alter the Product itself or any ingredient contained in such
Product as of the Restatement Date.
1.55
“ Product Components ” has the meaning set forth
in Section 4.9(a).
1.56
“ Quarterly Expense Reports ” has the meaning
set forth in Section 5.2(a).
1.57
“ Regulatory Authority ” means any federal,
national, multinational, state, provision, or local regulatory
agency, department, bureau or other governmental entity with
authority over the testing, manufacture, use, storage, import,
promotion, marketing and sale of a pharmaceutical product in a
country, including the FDA.
1.58
“ Required Consents ” has the meaning set forth
in Section 4.9(b).
1.59
“ Responsible Party ” has the meaning set forth
in Section 4.2.
1.60
“ Restatement Date ” has the meaning set forth
in the opening paragraph of this Agreement.
11
1.61
“ ROW Territory ” means all countries in the
world outside the US Territory.
1.62
“ Technical Information ” means Eyetech
Technical Information or Pfizer Technical Information.
1.63
“ Territory ” means the US Territory and/or the
ROW Territory, as the case may be.
1.64
“ Third Party Claims ” has the meaning set forth
in Section 11.1(a)(ii).
1.65
“ Trademarks ” means (a) the registered and
unregistered trademarks and trade names in use as of the
Restatement Date related to the Product including those marks
reflected on Exhibit 1.65 ; and (b) any aspect of
Product packaging in use as of the Restatement Date that
constitutes protectable trade dress; but in each case excluding the
Eyetech name and logo.
1.66
“ Transaction Agreements ” mean this Agreement,
the Amended and Restated Regulatory Services Agreement, the Amended
and Restated Distribution Agreement, the Assignment and Assumption
Agreement for Manufacturing Agreements, the Assignment and
Assumption Agreement for US Territory Agreements, the Bill of Sale,
the Pharmacovigilance Agreement and the Transitional Services
Agreement.
1.67
“ Transitional Services Agreement ” means the
transitional services agreement between the Parties entered into on
the Restatement Date pursuant to which Eyetech has agreed to
provide to Pfizer certain services, including supply, analytical,
stability and clinical trial support services, with respect to the
Product and Product Components.
1.68
“ US Territory ” means United States of America,
its territories, possessions and Puerto Rico.
1.69
“ US Territory Agreements ” has the meaning set
forth in Section 4.4(e).
1.70
“ Year ” means a calendar year.
1.71
Other Definitional Provisions .
12
(a) The
words “hereof”, “herein”,
“hereto” and “hereunder” and words of
similar import, when used in this Agreement shall refer to this
Agreement as a whole and not to any particular provision of this
Agreement.
(b) The
terms defined in the singular shall have a comparable meaning when
used in the plural, and vice versa.
(c) The
term “including” shall mean “including, without
limitation”.
AMENDMENT AND RESTATEMENT OF
ORIGINAL LICENSE AGREEMENT;
TERMINATION OF PRIOR AGREEMENTS;
OTHER TRANSACTION AGREEMENTS
2.1
Original License Agreement . This Agreement amends and
restates the Original License Agreement in its entirety.
Notwithstanding anything to the contrary herein, this Agreement
shall not relieve either Party of any obligations the performance
of which were owed under the Original License Agreement prior to
the Restatement Date.
2.2
Prior Agreements . Effective as of the Restatement Date, the
Prior Agreements, and all rights and obligations of the Parties
thereunder, are terminated in their entirety (including, without
limitation, provisions under the Prior Agreements that would
otherwise survive such termination) by mutual consent of the
Parties and shall no longer be in effect, except for the following
provisions of the Collaboration Agreement, which shall survive
termination of the Collaboration Agreement as set forth below:
(a) each Party’s obligations with respect to expenses
and Net Sales which have accrued under the Collaboration Agreement
prior to the Restatement Date and which shall be reconciled
pursuant to Section 5.1 of this Agreement, and (b) the
obligations of the Parties with respect to accounts and reports
(Article 9 of the Collaboration Agreement), ownership of
intellectual property (Article 10 of the Collaboration
Agreement), the protection and nondisclosure of Confidential
Information (Article 11 of the Collaboration
13
Agreement),
dispute resolution (Article 15 of the Collaboration Agreement)
and indemnification (Sections 12.4, 12.5, 12.6, 12.7, 12.8 and
12.9 of the Collaboration Agreement). For the avoidance of doubt,
Section 14.1 of the Collaboration Agreement (Non-Competition)
shall terminate and have no further force or effect from and after
the termination of the Collaboration Agreement.
2.3
Other Transaction Agreements . Concurrently with the
execution of this Agreement, the Parties are executing the Amended
and Restated Distribution Agreement, the Amended and Restated
Regulatory Services Agreement, the Assignment and Assumption
Agreement for Manufacturing Agreements, the Assignment and
Assumption Agreement for US Territory Agreements, the Bill of Sale,
and the Transitional Services Agreement. The Pharmacovigilance
Agreement shall survive the execution of this Agreement and the
termination of the Prior Agreements in accordance with its
terms.
(a) Subject
to the terms of this Agreement, Eyetech hereby grants to Pfizer,
and Pfizer hereby accepts, (i) an exclusive (even as to
Eyetech, subject to a retained right by Eyetech to develop, use,
make, have made and import the Product in the ROW Territory solely
for the purpose of obtaining regulatory approval(s) for the Product
in the US Territory and developing and supplying the Product for
sale and importation in the US Territory), royalty-free (except as
otherwise set forth in Article 6) license under the Eyetech
Patent Rights, Eyetech Technical Information, and Eyetech’s
rights under any Joint Patent Rights and Ongoing Trial Data, to
develop, use, make, have made, sell, offer for sale, import, and
have imported the Product in the ROW Territory, and (ii) a
nonexclusive, royalty-free (except as otherwise set forth in
Article 6) license under the Eyetech Patent Rights and
corresponding US Territory Patent Rights owned or
14
Controlled by
Eyetech or its Affiliates, Eyetech Technical Information, and
Eyetech’s rights under any Joint Patent Rights and Ongoing
Trial Data, to develop, use, make, have made and import the Product
in the US Territory solely for the purpose of developing and
supplying the Product for sale and importation in the ROW
Territory.
(b) The
licenses granted in Section 3.1(a) include sublicenses, as
applicable. The sublicenses granted by Eyetech to Pfizer in
Section 3.1(a) are subject to the following terms of the
Gilead License, the Isis License and the Nektar License,
respectively:
(i) Sections 2.4,
2.5, 3.6, 3.8, 6.3 and 6.7 of the Gilead License;
(ii) Sections 4.3
and 4.4 of the Isis License; and
(iii) Sections 2.3,
3.2, 3.5, 4.1, 4.9, 8.1, 8.2.3, 9.1 and 9.6 of the Nektar
License.
(c) Any
sublicensee obligations required by the Gilead License, the Isis
License and the Nektar License to be included in a sublicense
thereunder, including without limitation any required provision
making the applicable Eyetech Third Party Licensor a third party
beneficiary of any sublicense thereunder, shall be deemed to be
included in this Agreement.
(d) The
licenses granted by Eyetech in Section 3.1(a) with respect to
the following patents: US Patent No. 5,475,096, US Patent
No. 5,670,637, and US Patent No. 5,696,249, are subject
to 35 USC §§200-212, 37 CFR §401 et seq. and
applicable governmental implementing regulations. Any right granted
in this Agreement greater than that permitted under 35 USC
§§200-212 or 37 CFR §401 et seq. shall be subject to
modification as may be required to conform to the provisions of
those statutes. All rights reserved to the United States government
and others under 35 USC §§200-212 and 37 CFR §401
shall remain and shall in no way be affected by this
Agreement.
15
3.2
License Grant to Eyetech . Subject to the terms of this
Agreement, Pfizer hereby grants to Eyetech, and Eyetech hereby
accepts, (i) an exclusive (even as to Pfizer, subject to a
retained right by Pfizer to develop, use, make, have made and
import the Product in the US Territory solely for the purpose of
obtaining regulatory approval(s) for the Product in the ROW
Territory and developing and supplying the Product for sale and
importation in the ROW Territory), royalty-free license under the
Pfizer Patent Rights, Pfizer Technical Information, and
Pfizer’s rights under any Joint Patent Rights and Ongoing
Trial Data, to develop, use, make, have made, sell, offer for sale,
import, and have imported the Product in the US Territory, and
(ii) a nonexclusive, royalty-free license under the Pfizer
Patent Rights and corresponding ROW Territory Patent Rights owned
or Controlled by Pfizer or its Affiliates, Pfizer Technical
Information, and Pfizer’s rights under any Joint Patent
Rights and Ongoing Trial Data, to develop, use, make, have made and
import the Product in the ROW Territory solely for the purpose of
developing and supplying the Product for sale and importation in
the US Territory.
(a) The
licenses granted in Sections 3.1(a) and 3.2 above include the
right by either Party to grant sublicenses. Any sublicense granted
by a Party must be granted pursuant to a written agreement that
subjects the sublicensee to all relevant restrictions, limitations
and obligations in this Agreement.
(b) If
a Party grants a sublicense under Section 3.3(a), such Party
shall be responsible for failure by its sublicensees to comply with
all relevant restrictions, limitations and obligations in this
Agreement.
(c) In
the event of a material default by any sublicensee under a
sublicense agreement, the sublicensing Party will inform the other
Party and take such action, after
16
consultation
with the other Party, that in the sublicensing Party’s
reasonable business judgment is required to address such
default.
(d) Pfizer
shall provide Eyetech with a copy of each sublicense agreement, in
final executed form, that Pfizer enters into in accordance with
this Section 3.3 not later than five (5) days after the
execution of such sublicense agreement; provided that
Pfizer may redact the financial terms from such copies only if
permitted under the applicable requirements of the Gilead License,
the Nektar License and the Isis License requiring delivery to
Gilead, Nektar or Isis of copies of sublicense
agreements.
3.4
Product Orders or Sales Outside of a Party’s Territory
. If Eyetech receives an order for the Product from a third party
that is either located in the ROW Territory or that intends to
resell the Product into the ROW Territory, Eyetech will not accept
such order and shall refer such order to Pfizer. If Pfizer receives
an order for the Product from a third party that is either located
in the US Territory or that intends to resell the Product into the
US Territory, Pfizer will not accept such order and shall refer
such order to Eyetech. Each Party agrees that it shall not, and
shall cause its Affiliates and licensees or sublicensees not to,
(a) solicit active or passive sales of the Product outside of,
in the case of Eyetech, the US Territory, and in the case of
Pfizer, the ROW Territory, or (b) sell the Product to a third
party where the selling Party knows or should reasonably know that
such third party intends to resell such Product outside of, in the
case of Eyetech, the US Territory, and in the case of Pfizer, the
ROW Territory.
3.5
Right of First Negotiation For New Products . During the
period commencing upon the Restatement Date and ending upon
the **
anniversary of the Restatement Date
(the “ ROFN Period ”), in the event that Eyetech
proposes to (a) commence a phase III clinical trial with
respect to any New Product that Eyetech intends will serve as a
pivotal trial for the purpose of obtaining
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**
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regulatory
approval(s) for such New Product in the ROW Territory, or
(b) grant to any third party any right or license under any
Patent Rights Controlled by Eyetech or its Affiliates to offer for
sale, sell or have sold any New Product(s) in the ROW Territory,
then Eyetech shall provide Pfizer with (x) written notice
thereof (“ Notice of Opportunity ”), and
(y) any material information regarding the toxicology, safety
and efficacy of the New Product(s) identified in the Notice of
Opportunity (the ROW Territory commercialization rights with
respect to each such identified New Product(s), a “ New
Product Opportunity ”), the status of any material
discussions with the FDA relating to such New Product, and any
relevant patent information, each to the extent that such
information is available and permitted to be disclosed by Eyetech
as of the date of the Notice of Opportunity. In the case of the
foregoing clause (a), Eyetech shall provide Pfizer with the Notice
of Opportunity during the time period commencing upon
** and ending with ** .
In the case of the foregoing clause (b), Eyetech shall provide
Pfizer with the Notice of Opportunity on or about the time at
which **
. Pfizer, at its option, will have
the right to negotiate with Eyetech for rights to the New Product
Opportunity and to expand Pfizer’s license hereunder to
include rights to such New Product Opportunity; provided
that Pfizer exercises such right by written notice to
Eyetech within ** days after receipt of the Notice of Opportunity.
In the event that Pfizer does not provide the written notice
exercising Pfizer’s right to negotiate as described in the
immediately preceding sentence, Eyetech shall have no further
obligation to Pfizer, and Pfizer shall have no further rights, with
respect to such New Product Opportunity. In the event that Pfizer
provides the written notice exercising Pfizer’s right to
negotiate as described above, Eyetech shall not commence such phase
III clinical trial of the applicable New Product(s) or grant rights
to such New Product Opportunity to a third party for a period of up
to **
, in order to provide Pfizer with an
opportunity to discuss with Eyetech the terms pursuant to which
Pfizer would license rights to such New Product
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Opportunity.
Pfizer’s rights under this Section 3.5 shall apply on a
New Product Opportunity-by-New Product Opportunity basis, and
Pfizer’s waiver of its rights hereunder with respect to any
particular New Product Opportunity shall not constitute a waiver of
such rights with respect to any other New Product Opportunity. If
the Parties do not reach agreement regarding the terms on which
Pfizer would license rights to any New Product Opportunity during
any such **
negotiation period, Eyetech shall
have no further obligation to Pfizer, and Pfizer shall have no
further rights, with respect to such New Product Opportunity;
provided that, (A) during the ROFN Period,
Eyetech shall not grant any third party a license of any Patent
Rights Controlled by Eyetech or its Affiliates for such New Product
Opportunity on terms which, ** ,
and (B) in the case of a New Product Opportunity for which
Eyetech provided Pfizer with a Notice of Opportunity pursuant to
the foregoing clause (b), if Eyetech has not granted rights to such
New Product Opportunity to a third party within
** after the end of such ** negotiation period between Eyetech and Pfizer,
the provisions of this Section 3.5 shall once again apply to such
New Product Opportunity.
MANUFACTURING, MARKETING,
MEDICAL AND REGULATORY MATTERS
4.1
Meetings and Information Exchange . The Parties recognize
that, after the Restatement Date, it is critical to maintain and
facilitate ongoing cooperation and information exchange between
them concerning the Product. Accordingly, representatives of the
Parties shall meet periodically as set forth in this Article 4
in order to exchange, assess and discuss information and strategies
related to, inter alia , the: (1) continued clinical
development of, and regulatory strategy for, the Product,
(2) marketing and promotion for the Product, and (3)
manufacture, supply and distribution of the Product. These meetings
may be held in person, by videoconference or by
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teleconference,
as the Parties mutually agree, and all in-person meetings shall be
at locations mutually agreed-upon by the Parties.
4.2
Ongoing Clinical Trials . Schedule 4.2 sets
forth a list of the ongoing clinical trials for the Product (the
“ Ongoing Trials ”), the identity of the Party
responsible for completing the trial and performing remaining
activities for each such trial (the “ Responsible
Party ”), the allocation between the Parties of the
future costs for performing the activities for each such trial,
which costs shall be reconciled between the Parties pursuant to
Section 5.2 hereof, and the services, if any, to be provided
to the Responsible Party by the other Party in connection with each
Ongoing Trial. Each Party will cooperate with the other Party, at
the other Party’s reasonable request, in order to complete
the Ongoing Trials. Except with respect to the CRVO study (study
number 1011), for which Eyetech will complete the final clinical
study report within one (1) year from completion of such
study, the Responsible Party for a particular Ongoing Trial shall
have the right to change or terminate such Ongoing Trial as such
Party may deem necessary or desirable, provided, that the other
Party shall not be liable for any such change or termination and
shall be compensated for such Party’s performance of any
additional activities or services requested by the Responsible
Party in connection with such change or termination. Services to be
provided by Eyetech to Pfizer in connection with certain Ongoing
Trials will be provided pursuant to the Transitional Services
Agreement. Any services to be provided by Pfizer to Eyetech in
connection with certain Ongoing Trials will be provided pursuant to
the Amended and Restated Regulatory Services Agreement. In
addition, **
. In addition, Pfizer shall provide
Eyetech access to, and shall reasonably cooperate with Eyetech in
compiling, data that may reasonably be deemed necessary by Eyetech
to fulfill its post-marketing commitments to the FDA for the
Product with respect to ERG and corneal biomicroscopy, and to
respond to related queries or requests by the FDA with respect to
such post-
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**
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marketing
commitments to the FDA. Without limiting the Parties’ rights
and obligations under the Pharmacovigilance Agreement with respect
to the sharing of any clinical data thereunder, with respect to
each clinical trial for the Product completed prior to the
Restatement Date as well as each Ongoing Trial, Pfizer and Eyetech
shall each provide, or cause any third party at which such
information is stored to provide, the other Party with all raw data
and final results arising from such trials promptly after such data
and results become available, but no less frequently than on a
quarterly basis for the duration of any Ongoing Trials,
provided that , if a Party requests interim
disclosure of Ongoing Trial Data in the possession of the other
Party, the other Party shall not unreasonably refuse to provide
such interim disclosure. Each Party will provide the other with a
draft of all public releases of Ongoing Trial Data reasonably in
advance of public dissemination of any such release in order to
afford the other Party with an opportunity to review and comment
upon such draft. The Party identified on Schedule 4.2
as the responsible party for performing activities with respect to
an Ongoing Trial may post the final results from such Ongoing Trial
on the PhRMA clinical studies database located at
www.clinicalstudyresults.org.
4.3
Future Clinical Trials . Subject to the remainder of this
Section 4.3, and in addition to the rights and obligations of
the Parties as set forth in Section 4.7(d) below, Pfizer has
the right to conduct further clinical studies with respect to the
Product in the ROW Territory, and Eyetech has the right to conduct
further clinical studies with respect to the Product in the US
Territory. At the request of either Party, the Parties shall in
good faith meet and discuss jointly conducting additional clinical
studies with respect to the Product where preclinical and/or
clinical results ** .
If the Parties agree to pursue such additional development jointly,
the Parties shall agree on both the manner in which the costs for
such development will be shared, and each Party’s respective
rights to use the data and other information resulting from such
development. If the Parties do not agree
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**
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to jointly
pursue such additional development, either Party shall have the
right to pursue such development at its sole expense;
provided , however , that ** .
(a) In
order to ensure that a consistent message is communicated by the
Parties with respect to the Product, representatives of the Parties
shall meet at least once each calendar quarter to review and
discuss their respective strategies for the advertising and
promotion of the Product.
(e) In
connection with the marketing, promotion and medical support of the
Product in the US Territory, Pfizer and/or Eyetech (or its
Affiliate) have entered into the third party agreements as set
forth in Schedule 4.4(e) (the “ US Territory
Agreements ”). Subject to the terms and conditions of
such agreements and any required third party consents, Pfizer shall
assign to Eyetech, and Eyetech will assume, all of Pfizer’s
rights and obligations under such US Territory Agreements pursuant
to the Assignment and Assumption Agreement for US Territory
Agreements. For the avoidance of doubt, if Pfizer is not permitted
to assign all of its rights and obligations under a US Territory
Agreement to Eyetech, then such US Territory Agreement will be
terminated by Pfizer and/or Eyetech (or its Affiliate), as
applicable.
(f) With
respect to ** in
payments made by Pfizer as of the Restatement on behalf of the
Parties to ** to
organize two (2) consultant meetings for Product in the US
Territory to be held after the Restatement Date and solely under
the control of and for the benefit of Eyetech,
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**
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Eyetech shall
reimburse Pfizer for the Out-of-Pocket Costs thereof. Such costs
shall be included in Pfizer’s Quarterly Expense
Report.
(g) In
addition, the Parties further agree to:
(i) provide
each other, for information, with a copy of all new advertising and
promotional materials for the Product produced by Eyetech for the
US Territory and by Pfizer for all English-speaking countries in
the ROW Territory;
(ii) discuss,
share information concerning, and, to the extent reasonably
practicable, coordinate, advisory board meetings, contacts with key
opinion leaders, and activities at the ARVO and AAO global
congresses and the world ophthalmology conference (WOC)
(collectively, “ Global Congresses ”). The
Parties will share their planning for all Global Congresses with
respect to the Product in advance of the applicable event. In
addition, with respect to the two (2) 10x10 Product-specific
convention booths in existence as of the Restatement Date, from and
after the Restatement Date each Party shall own one (1) such
booth as discussed by the Parties prior to the Restatement Date and
each Party agrees to execute any assignments and other documents
and take any further actions as may be necessary to more fully vest
on the other Party such agreed ownership.**
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(iii) coordinate
press releases and other communications on new data or other
material information concerning the Product by providing drafts of
all such press releases or communications reasonably in advance of
public dissemination of any of the foregoing in order to afford the
other Party with an opportunity to review and comment upon such
draft in advance of dissemination;
(iv) exchange,
at least once each calendar year, a list of magazines, journals and
other publications in which it plans to place advertising for the
Product and attempt, to the extent reasonably practicable, to
allocate advertising responsibility based on the country in which
the applicable magazine, journal or other publication maintains its
primary circulation; and
(v) cooperate
in the development of separate US Territory and ROW Territory
Internet websites for the Product. After the Restatement Date,
Eyetech shall retain ownership of the websites (including URL)
currently located at “www.macugen.com” and
“www.macugen.net”, shall continue to operate, maintain
and develop the “www.macugen.com” website for Product
in the US Territory, and shall be responsible for all costs
associated
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therewith.
After the Restatement Date, Pfizer shall operate, maintain and
develop the website “www.macugen.net” for Product in
the ROW Territory, and shall be responsible for all costs
associated therewith. Subject to the terms and conditions hereof,
Eyetech shall maintain a link on the “www.macugen.com”
website to the “www.macugen.net” website, and Pfizer
shall maintain a link on the “www.macugen.net” website
to the “www.macugen.com” website, such links to be in a
form to be mutually agreed by the Parties.
4.5
Pharmacovigilance and Product Safety Matters . Eyetech and
Pfizer shall be responsible for the surveillance, receipt,
evaluation, and reporting of adverse drug experiences for the
Product in the US Territory and the ROW Territory, respectively,
and, with respect to the exchange of adverse event and other safety
information relating to the Product, each shall at all times comply
with the terms of the Pharmacovigilance Agreement between the
Parties dated May 11, 2006 (as it may be amended from time to
time, the “ Pharmacovigilance Agreement ”).
Pursuant to the Pharmacovigilance Agreement, Pfizer is currently
responsible for receipt, processing, evaluation and follow-up of
all post-marketing reports for the US Territory. Eyetech has
requested that Pfizer, and Pfizer has agreed to, continue to be
responsible for receipt, processing, evaluation and follow-up of
all post-marketing reports for the US Territory for a period
of **
after the Restatement Date. The
Pharmacovigilance Agreement will be amended to reflect such
transfer of any responsibilities from Pfizer to Eyetech or its
successor.
4.6
Medical Information and Product Complaints . Eyetech shall
be responsible for responding to medical, consumer and other
inquiries received from the US Territory concerning the Product,
including any Product complaints, and, subject to the services to
be provided by Pfizer to Eyetech pursuant to the Amended and
Restated Regulatory Services Agreement, Pfizer shall direct all
such matters to Eyetech’s attention. Pfizer shall be
responsible for responding to medical,
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**
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consumer and
other inquiries received from the ROW Territory concerning the
Product, including any Product complaints, and Eyetech shall direct
all such matters to Pfizer’s attention. The Parties
acknowledge that, as of the Restatement Date, Pfizer is handling
certain Product complaints and medical, consumer and other
inquiries concerning the Product on behalf of Eyetech for the US
Territory. Eyetech shall have the right to request that Pfizer
continue to handle these matters for the US Territory pursuant to,
and subject to the terms of, the Amended and Restated Regulatory
Services Agreement.
4.7
Regulatory Matters . All regulatory approvals in the ROW
Territory relating to the Product shall continue to be the property
of Pfizer and held in Pfizer’s or its Affiliate’s name,
and all regulatory approvals in the US Territory shall continue to
be the property of Eyetech and held in Eyetech’s or its
Affiliate’s name. Each Party will cooperate with the other,
and provide the other with reasonable assistance, in connection
with future filings with Governmental Authorities concerning the
Product (including filings related to regulatory approval or safety
of, or approval of a new indication for, the Product, but excluding
DDMAC filings), in each case at the owning Party’s request
and expense, including without limitation by (i) providing
reasonable assistance to such owning Party to provide information
to, and answer queries posed by, Regulatory Authorities in
connection with obtaining or maintaining regulatory approvals for
Product, (ii) providing, or causing its third party contractors to
provide, the owning Party with non-clinical data concerning the
Product including CMC, pharmacology, toxicology, and
pharmacodynamics data; and (iii) permitting the applicable
Governmental Authorities to inspect manufacturing or testing
facilities of the non-owning party as required by such Governmental
Authorities. In addition, the Parties agree as follows with respect
to future regulatory activities concerning the Product:
26
(a) Each
Party will provide the other Party with copies of all material
Product-related correspondence that it receives from the FDA or
analogous Governmental Authorities or Regulatory Authorities in the
European Union, Canada and Japan, except correspondence from DDMAC.
In addition to the immediately preceding sentence and to
Section 4.1, each Party will provide the other Party with
copies, which copies may be in draft form, of (i) the safety
sections of material Product-related submissions to the FDA or
analogous Governmental Authorities or Regulatory Authorities in the
ROW Territory, and (ii) any sections disclosing or concerning
any Ongoing Trial Data included in any such submissions, reasonably
in advance of submission, and such Party shall, prior to making
such submission, reasonably consider the comments, if any, given by
the other Party; and
(b) Any
decision to initiate a recall or withdrawal of, or a broad-based
non-promotional information update to physicians about (e.g., a
“Dear Dr. Letter”), the Product in the US
Territory shall be made by Eyetech and any decision to initiate a
recall or withdrawal of, or a broad-based non-promotional
information update to physicians about, the Product in the ROW
Territory shall be made by Pfizer. Before either Party initiates a
recal
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