EXHIBIT 10.31
EXECUTION COPY
CERTAIN MATERIAL (INDICATED BY AN ASTERISK) HAS BEEN OMITTED FROM THIS DOCUMENT
PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT. THE OMITTED MATERIAL HAS BEEN
FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
DEVELOPMENT AND SUBLICENSING AGREEMENT
This DEVELOPMENT AND SUBLICENSING AGREEMENT ("Agreement"), effective as
of March 5, 2001 by and among CELL-MATRIX, INC., a Nevada corporation, with its
administrative offices located at Four Xxxx Xxxx, Xxxxxx Xxxx, Xxxxxxxxxxxx
00000 ("CMI") and EYETECH PHARMACEUTICALS, INC., a Delaware corporation with its
principal offices located at 000 Xxxxx Xxxxxx, 00xx Xxxxx, Xxx Xxxx, Xxx Xxxx
00000 ("EyeTech") (each of CMI and EyeTech is hereinafter referred to as a
"Party" and collectively as, the "Parties."). Unless otherwise defined in this
Agreement, all capitalized terms shall have the meanings given to them in
Section 1.1 of this Agreement.
RECITALS
1. WHEREAS, CMI is the licensee of certain antibodies that are
believed to inhibit angiogenesis in the eye;
2. WHEREAS, EyeTech believes that the Antibodies may result in
products that are complementary to EyeTech's product and business line that
focus on the treatment of diseases in the back of the eye;
3. WHEREAS, CMI and EyeTech entered into a binding letter of
intent dated as of November 30, 2000 (the "LOI") in which they agreed to enter
into definitive documentation in the form of this Development and Sublicensing
Agreement which would set forth in detail the terms and conditions under which
EyeTech would sublicense the Antibodies from CMI and then develop the Products
with the purpose of commercially developing ophthalmic therapeutic products and
diagnostic products that are based on biological pathways that antagonize
cryptic epitopes in denatured collagens to prevent, inhibit, treat or detect
angiogenesis in the eye (the "Objective"); and
NOW, THEREFORE, the Parties hereto, intending to be legally bound,
hereby agree as follows:
SECTION 1
DEFINITIONS
1.1 Definitions. For purposes of this Agreement, the following
terms shall have the meanings set forth below:
"Affiliate" shall mean any Person that, directly or indirectly, through
one or more intermediaries, Owns, is Owned by or is under common Ownership with,
a Party, where "Own" or "Ownership" means (a) direct or indirect possession of
at least fifty percent (50%) of the outstanding voting securities of a
corporation or a comparable ownership in any other type of Person, provided,
however, that if the law of the jurisdiction in which such entity operates does
not allow fifty percent (50%) or greater ownership by a Party, such ownership
interest shall be at least equal to the highest level of ownership allowed as
provided under the laws of such
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jurisdiction or (b) that a Person or group of Persons otherwise has the
unilateral ability to control and direct the management of the entity, whether
by contract or otherwise.
"AME" shall mean Applied Molecular Evolution, Inc.
"AME Agreement" shall mean that certain Collaboration Agreement dated
as of November 29, 1999, as amended effective July 3, 2000, between CMI and AME.
"Antibodies" shall mean HUIV26 in Murine and Humanized forms, HU177 in
Murine and Humanized Forms, XL313 in Murine Form and peptide RGDKGE within the
Field of Use that CMI has licensed from USC pursuant to that certain license
agreement effective as of September 14, 1999.
"Biological Pathway" shall mean any physical or chemical means
involving the deployment of Products that antagonize cryptic epitopes in
denatured collagens (including, without limitation, Collagen Types I, II, III,
IV and V) to prevent, inhibit, treat or detect angiogenesis in the eye.
"Business Day" shall mean any day other than a Saturday, Sunday or
banking holiday in New York City or Xxxxxx Hill, Pennsylvania.
"Calendar Quarter" shall mean a calendar quarter (i.e., period of three
(3) consecutive months) ending on March 31, June 30, September 30 or December
31.
"Calendar Year" shall mean any period of twelve (12) consecutive months
ending on December 31.
"Competitive Product" shall mean a product competitive with a Product.
"Compulsory Sublicense" means a compulsory Sublicense under the
Sublicensed Patents obtained by a Third Party through the order, decree, or
grant of a governmental authority of competent jurisdiction, authorizing such
Third Party to manufacture, use, sell, offer for sale or import a Competitive
Product in one or more countries within the Territory.
"Control", "Controls", and "Controlled" shall mean, with respect to a
particular item of information or intellectual property right, that the
applicable Party owns or has a Sublicense to such item or right and has the
ability to grant to the other Party access to and a Sublicense or sublicense (as
applicable) under such item or rights as provided for in this Agreement without
violating the terms of any agreement or other arrangement with any Third Party.
"Damages" shall mean any and all costs, losses, claims, liabilities,
fines, penalties, damages and expenses, court costs, and reasonable fees and
disbursements of counsel, consultants and expert witnesses incurred by a Party
hereto (including any interest payments which may be imposed in connection
therewith).
"Delivery Date" shall mean the date that is ten (10) days after the
Effective Date.
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"Diagnostic Product" shall mean any Product used in the detection or
assessment of disease within the Field of Use that falls within the Sublicense
granted hereunder.
"Effective Date" shall mean the date set forth in the introductory
paragraph of this Agreement, which shall be no earlier than the date that the
Parties have agreed all conditions, representations and warranties contained
herein are satisfied or waived.
"EU" shall mean Austria, Belgium, Denmark, Finland, France, Germany,
Greece, Ireland, Italy, Luxembourg, The Netherlands, Portugal, Spain, Sweden,
Switzerland and the United Kingdom, and future members of the European Union (or
its successor), upon their admission for full membership (with commercial rights
and privileges substantially comparable to those of the foregoing countries)
"EyeTech Rights" shall mean any invention or inventions, patentable or
not, know-how, information and/or data relating to the Product, including,
without limitation, pre-clinical studies and clinical trial information,
manufacturing processes, formulations, modes of delivery and/or data necessary
for the manufacture, use or sale of the Antibodies that are Controlled by
EyeTech during the term of this Agreement, and all Patents covering any of the
foregoing that are Controlled by EyeTech during the term of this Agreement.
"FDA" shall mean the United States Food and Drug Administration, or any
successor thereto.
"Field of Use" shall mean all ophthalmologic indications for any
Product.
"First Commercial Sale" shall mean, with respect to any particular
country, the first sale of a Product in such country by EyeTech, or any of its
Affiliates or sublicensees, after Regulatory Approvals in such country have been
granted from the relevant Regulatory Authority in such country for such Product.
"GAAP" shall mean United States generally accepted accounting
principles, consistently applied.
"Indemnified Party" shall have the meaning given in Section 7.2 hereof.
"Indemnifying Party" shall have the meaning given in Section 7.2
hereof.
"Know-How" shall mean the skill or ingenuity based upon the body of
knowledge which comprises all of the methods, processes, designs, formulas,
expert opinion and all other information and data relating to the Transferred IP
or any part thereof (whether patentable or not), in each case within the Field
of Use, that, as of the Effective Date or subsequent to the Effective Date are
(i) existing, and (ii) Controlled by CMI as of the Effective Date, in each case
which is necessary or useful for the development, manufacture, use, sale or
commercialization of the Products. Excluded from Know-How are any Patents, the
Sublicensed Patents and the Transferred Assets.
"LOI" shall have the meaning set forth in the Recitals to this
Agreement.
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"Major Countries" shall mean Canada, France, Germany, Italy, Japan,
Spain, United Kingdom and the United States.
"Manufacturing Information" shall mean copies of all existing
information in written and electronic form in CMI's possession or control as of
the Effective Date, with respect to any Product existing as of the Effective
Date, that relates to, in the Field of Use: (1) processes for the production of
the Antibodies, and intermediates in the preparation of a Product; (2) the
in-process analytical controls for production of each Antibody and Product; (3)
the process, formulation and development reports generated for the preparation
of each Antibody and Product; (4) the analytical methods and validation for the
quality control release of each Antibody and Product; and (5) the stability
protocols, stability indicating methods and stability data for each Antibody.
"NDA" shall mean a New Drug Application filed with the FDA requesting
market approval for a new drug product.
"Net Sales" shall mean, with respect to Product, the gross amount
billed or invoiced by EyeTech, its Affiliates or sublicensees, to unrelated
Third Parties for the Products in finished product form, less the following
deductions, in each case as actually paid or incurred by Eyetech, its Affiliates
or sublicensees:
(a) trade, quantity and cash discounts allowed, but
expressly excluding discounts or allowances offered as part of a package of
products that includes a Product sold by EyeTech, its Affiliates or
sublicensees;
(b) refunds and chargebacks actually provided which
effectively reduce the net selling price;
(c) actual product returns, credits and allowances;
(d) rebates actually paid or credited to any governmental
agency (or branch thereof) or to any Third Party payor, administrator or
contractee;
(e) discounts mandated by, or granted to meet the
requirements of, applicable state, provincial or federal law, wholesaler,
including required chargebacks and retroactive price reductions;
(f) transportation, freight, postage charges and other
charges such as insurance, relating thereto, in each case included as a specific
line item on an invoice to such Third Parties; and
(g) taxes, excises or other governmental charges upon or
measured by the production, sale, transportation, delivery or use of goods, but
excluding income taxes, in each case included as a specific line item on an
invoice to such Third Parties.
Notwithstanding the foregoing, amounts received by EyeTech, or its Affiliates or
sublicensees, for the sale of Products among EyeTech and its Affiliates or
sublicensees (as opposed to from Third Parties) for resale shall not be included
in the computation of Net Sales hereunder. Net
5
Sales shall be determined from books and records maintained in accordance with
GAAP. In the event the Product is sold as part of a combination product, or as
part of bundled products or as part of a delivery system, the Net Sales from the
combination product, bundled product or delivery system, for the purposes of
determining royalty payments, shall be determined by multiplying the Net Sales
(as defined without regard to this paragraph) of the combination product by the
fraction, A/(A+B) where A is the average sale price of the Product when sold
separately in finished form and B is the average sale price of the other
product(s) or system sold separately in finished form, or, only if the value of
B cannot be determined, where A+B is the average sales price of the product(s)
and the delivery system together. If the value of B can be determined, in no
event will the sales price of any combination product, bundled product or
delivery system product be less than the sum of A and B. In the event that such
average sale price cannot be determined for both the Product and such other
product(s) or system in combination, the following calculation shall be
substituted for the calculation recited in (ii) of the preceding sentence: the
Net Sales (as defined without regard to this paragraph) of the combination
products shall be multiplied by the fraction C/(C+D) where C is EyeTech's cost
of goods of the Product and D is EyeTech's cost of goods for the other
product(s) or system, determined in accordance with the method of accounting
normally employed by EyeTech in computing cost of goods.
"Objective" shall have the meaning given in the recitals to this
Agreement.
"Other Product" shall mean any Product that is not an Antibody.
"Party" shall mean either CMI or EyeTech, and "Parties" shall mean both
of CMI and EyeTech.
"Patents" shall mean patents and patent applications as of the
Effective Date or subsequent to the Effective Date relating to any Product, both
foreign and domestic, including without limitation, all extensions, reissues,
renewals, reexaminations, patents of addition, supplementary protection
certificates and inventors' certificates thereof, substitutions, provisionals,
divisionals, continuations and continuations-in-part.
"Person" shall mean a natural person, a corporation, a partnership, a
trust, a joint venture, a limited liability company, any governmental authority
or any other entity or organization.
"Pivotal Trial" shall mean either (a) a trial on sufficient numbers of
patients that is designed to establish that a Product is safe and efficacious
for its intended use, and to define warnings, precautions and adverse reactions
that are associated with the pharmaceutical product in the dosage range to be
prescribed, and to support Regulatory Approval of such Product or label
expansion of such Product, or (b) a clinical trial that began as a trial on
sufficient numbers of patients that is designed to establish the safety and
biological activity of a Product for its intended use, and to define warnings,
precautions and adverse reactions that are associated with the Product in the
dosage range to be prescribed, after such date as the U.S. Food and Drug
Administration or its successor (or equivalent regulatory authority) has
indicated that the applicable Party may reasonably continue such trials with the
intention to establish that a Product is safe and efficacious for its intended
use, and to define warnings, precautions and adverse reactions that are
associated with the pharmaceutical product in the dosage range to be
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prescribed, and to support Regulatory Approval of such Product or label
expansion of such Product.
"Product" shall mean any Antibody (including, without limitation, any
antibody fragments or small or large molecules related thereto) that is covered
in whole or in part by one or more pending or unexpired Patents that: (i)
employs the Biological Pathway and (ii) is used within the Field of Use, in any
formulation, dosage concentration or volume, together with all label expansions,
line extensions and improvements thereon, which may be included in any
supplement, modification or addition to the filings for Regulatory Approval for
such Antibody.
"Product Data Package" shall include (to the extent such items exist)
the following information and data related to a Product in the possession or
control of CMI as of the Effective Date: (a) pre-clinical and clinical
development protocols, data, and reports; (b) manufacturing development
technical reports; (c) toxicology reports; and (d) such other information and
data specifically identified in Exhibit A attached hereto.
"Product Inventory" shall mean any amounts of Antibodies owned by CMI
that are delivered to EyeTech pursuant to this Agreement.
"Reasonable Diligence" shall mean those efforts which a reasonably
prudent person knowledgeable in such matters as are relevant here would consider
commercially reasonable to further the efforts to develop, obtain Regulatory
Approval, and/or commercialize, as applicable, a Product in a country in the
Territory, consistent with accepted business practices and legal requirements,
and comparable to efforts in the pharmaceutical industry applicable to
development, obtaining of Regulatory Approval for, or commercialization of human
pharmaceutical products at an equivalent stage of development and similar market
potential, profit potential and strategic value in view of conditions then
prevailing.
"Regulatory Approval" shall mean (a) in the United States, approval by
the FDA of an NDA, or equivalent application, for marketing approval and
satisfaction of any related applicable FDA registration and notification
requirements (if any) and (b) in any country other than the United States, all
approvals (including any required marketing, pricing and reimbursement
approvals) by the Regulatory Authority in such country of a single application
or set of applications comparable to an NDA, enabling legal sale of a product in
such country.
"Regulatory Authority" shall mean the FDA in the United States or the
equivalent governmental agency having jurisdiction in any other country in the
Territory.
"Regulatory Documents" shall mean the any other regulatory filings with
Regulatory Authorities relating to a Product.
"Royalty Term" shall mean, with respect to each country in which a
Product is sold, the period of time equal to the longest of (i) ten (10) years
from the date of First Commercial Sale of such Product in such country, (ii) the
expiration of the last-to-expire Sublicensed Patent in such country that claims
the manufacture, use, and or sale of such Product as such activities are carried
out pursuant to this Agreement, (iii) the term set forth in the AME Agreement
with respect to all royalty payment obligations contained therein but only to
the extent such Product is subject to or covered by such AME Agreement, or (iv)
the term set forth in the USC License
7
with respect to all royalty payment obligations contained therein but only to
the extent such Product is subject to or covered by such USC License, in each
case as determined on a Product-by-Product basis.
"Sublicense" shall mean the Sublicense granted by CMI to EyeTech
pursuant to Section 2.1.
"Sublicensed Patents" shall mean any Patents listed in Exhibit C (as
updated from time to time pursuant to Section 5.6) which claim the manufacture,
use, import, offer for sale or sale of Product in accordance with this Agreement
and which now or at any time during the term of this Agreement are Controlled by
CMI or any Affiliate of CMI.
"Territory" shall mean the world, unless the Sublicense terminates with
respect to a country pursuant to Section 6.7, in which case the Territory shall
exclude any country in which the Sublicense has so terminated.
"Therapeutic Product" shall mean any Product used in the treatment,
prevention, or cure of disease within the Field of Use that falls within the
Sublicense granted hereunder.
"Third Party" shall mean a Person other than EyeTech, CMI or their
Affiliates.
"Transferred Assets" shall mean the Product Inventory, cell lines used
to produce the Antibodies, DNA encoding of the Antibodies and the Product Data
Package, in each case if any.
"Transferred IP" shall have the meaning set forth in Section 2.1.
"USC" shall mean the University of Southern California.
"USC License" shall mean that certain License Agreement effective as of
September 14, 1999 between CMI and USC.
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SECTION 2
GRANT OF SUBLICENSES AND TRANSFER AND DELIVERY OF TRANSFERRED
ASSETS AND MANUFACTURING INFORMATION
2.1 Grant of Sublicense. Subject to the terms and conditions of
this Agreement, during the term of this Agreement, CMI hereby grants to EyeTech
an exclusive sublicense of all CMI's rights in the USC License and the AME
Agreement, including, without limitation, its rights in the Antibodies and
Products, the sublicensed Patents and Know-How, to make, have made, use, sell,
offer to sell, import and export the Products or otherwise necessary to practice
this sublicense within the Field of Use throughout the Territory (the
"Transferred IP"), with a right to sublicense to its Affiliates or (subject to
Section 2.4) to any other Person; provided, however, EyeTech's sublicense
hereunder shall be subject to all terms and conditions of the USC License and
the AME Agreement to the extent such provisions are applicable to the
Transferred IP. CMI shall be responsible, at its own cost and expense, for
obtaining any sublicenses, consents or approvals from Third Parties necessary
for CMI to grant to EyeTech the sublicense within the Field of Use contemplated
hereunder.
2.2 Transferred Assets. As of the Effective Date, CMI hereby
assigns, transfers and conveys to EyeTech all of CMI's right, title and interest
in and to the Transferred Assets (subject to Section 4.4(c)), and EyeTech hereby
accepts such assignment, transfer and conveyance. On or before the Delivery
Date, CMI shall have delivered to EyeTech all of the Transferred Assets and the
Manufacturing Information, which are more specifically set forth on Exhibit B
attached hereto. EyeTech shall have up to ten (10) days after such delivery to
inventory the delivered Transferred Assets and Manufacturing Information and to
give notice to CMI of any Transferred Assets and Manufacturing Information that
were not so delivered. If CMI receives notice or otherwise learns after the
Delivery Date that it has failed to deliver any Transferred Assets or
Manufacturing Information to EyeTech, CMI shall provide to EyeTech any such
Transferred Assets or Manufacturing Information no later than five (5) Business
Days after receipt of such notice or knowledge (or within such longer time as is
mutually agreed by EyeTech and CMI). CMI shall ship the Transferred Assets to
EyeTech F.O.B. to EyeTech's designated facilities. For a period of 90 days
following the receipt by EyeTech of the Transferred Assets and Manufacturing
Information, CMI personnel shall be reasonably available during CMI's normal
business hours to respond to technical inquiries of EyeTech regarding Products
as is reasonably requested by EyeTech. EyeTech acknowledges that CMI makes no
representations or warranties with respect to the Transferred Assets or
Manufacturing Information (other than as expressly set forth in Section 5 below)
and that it accepts such Transferred Assets and Manufacturing Information "as
is."
2.3 Negative Covenant of EyeTech. EyeTech shall not use or
practice Sublicensed Patents or Know-How or sell any Product for indications
outside the Field of Use or outside the Territory or for any other purpose
except activities that it conducts in compliance with this Agreement.
2.4 Sublicenses. EyeTech shall have the right to sublicense
Antibodies or Products granted to it by CMI under this Agreement without the
consent of CMI so long as (i) any sublicensee of EyeTech agrees to be bound by
all the obligations and conditions imposed upon
9
CMI by the USC License and AME Agreement; (ii) EyeTech gives prompt notice and a
copy of such sublicense to CMI pursuant to Section 8.2 of this Agreement; (iii)
EyeTech remains obligated at all times under this Agreement without regard to
whether it has sublicensed its rights or whether EyeTech's Sublicensee has
performed; (iv)) such sublicense shall name CMI as a third party beneficiary of
such sublicense; and (v) any such sublicenses granted by EyeTech shall contain
provisions providing for its termination or assignment to CMI, at the option of
CMI, of EyeTech's interest therein upon termination of this Agreement, and shall
further contain provisions which obligate such sublicensee to comply with such
terms, conditions, agreements and obligations that are consistent with the
terms, conditions, agreements and obligations to which EyeTech is subject under
this Agreement.
SECTION 3
PAYMENTS AND DELIVERIES
In consideration of the exclusive Sublicense granted herein and the
transfer of ownership of the Transferred Assets, EyeTech shall pay the following
amounts to CMI:
3.1 Initial Payments and Deliveries.
(a) On the date of execution of this Agreement, EyeTech
shall pay to CMI the sum of [***] by Federal Reserve electronic wire transfer in
immediately available funds to an account designated by CMI. Such amount shall
be non-refundable and non-creditable, and shall not be subject to any
counterclaim or set-off.
(b) On or before the Delivery Date, CMI shall deliver to
EyeTech (i) all of the Transferred Assets pursuant to Section 2.2 of this
Agreement; (ii) all of the Manufacturing Information pursuant to Section 2.2 of
this Agreement; and (iii) a schedule ("Schedule of Transferred Assets and
Manufacturing Information") setting forth each of the Transferred Assets and
Manufacturing Information being delivered to EyeTech at such time.
(c) Within ten (10) days of delivery of the Transferred
Assets and the Manufacturing Information and of the Schedule of Transferred
Assets and Manufacturing Information pursuant to Section 3.1(b) above, EyeTech
shall inventory the delivered Transferred Assets and Manufacturing Information
pursuant to Section 2.2 and shall either (i) deliver to CMI a receipt
acknowledging the receipt of each of the Transferred Assets and the
Manufacturing Information set forth on the Schedule of Transferred Assets and
Manufacturing Information or (ii) notify CMI of any Transferred Assets or
Manufacturing Information that CMI did not deliver. If CMI receives notice or
otherwise learns after the Delivery Date that it has failed to deliver any
Transferred Assets or Manufacturing Information to EyeTech, CMI shall provide to
EyeTech any such Transferred Assets or Manufacturing Information no later than
five (5) Business Days after receipt of such notice or knowledge (or within such
longer time as is mutually agreed by EyeTech and CMI). Within ten (10) days of
CMI delivering such missing items to EyeTech following notice given by EyeTech
pursuant to clause (ii) of this Section 3.1(c), EyeTech shall deliver the
receipt described in clause (i) of this Section 3.1(c).
*** Certain information on this page has been omitted and filed separately with
the Commission. Confidential treatment has been requested with respect to the
omitted portions.
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3.2 Milestone Payments. Within five (5) Business Days of EyeTech
and/or its Affiliates or sublicensees achieving the first occurrence of each of
the milestone events listed below with respect to any Therapeutic Product,
Diagnostic Product or Other Product, EyeTech shall notify CMI of such
achievement and the date thereof, and within thirty (30) days of the date of
such achievement, pay the one-time non-refundable fees specified below to CMI by
Federal Reserve electronic wire transfer in immediately available funds to an
account designated by CMI; provided, however, that in no event shall the
following fees be payable more than once with respect to any given Product for
any particular geographical area or Milestone:
THERAPEUTIC PRODUCTS:
MURINE FORMS:
Milestone Fee
--------- ---
Initiation of Phase I Clinical Trials [***]
Initiation of Phase II Clinical Trials [***]
Initiation of Phase III Clinical Trials [***]
First Filing of NDA in the United States [***]
Regulatory Approval in the United States [***]
First Regulatory Approval in the EU [***]
Regulatory Approval In Japan [***]
Annual U.S. Sales Exceed $300 Million [***]
HUMANIZED FORMS:
Milestone Fee
--------- ---
First IND Submission [***]
Initiation of Phase I Clinical Trials [***]
Initiation of Phase II Clinical Trials [***]
Initiation of Phase III Clinical Trials [***]
First Filing of NDA in the United States [***]
Regulatory Approval in the United States [***]
First Regulatory Approval in the EU [***]
Regulatory Approval In Japan [***]
Annual U.S. Sales Exceed $300 Million [***]
DIAGNOSTIC PRODUCTS:
MURINE FORMS:
Milestone Fee
--------- ---
Initiation of Clinical Trials [***]
Initial of Pivotal Trials [***]
First Regulatory Approval in the U.S. [***]
*** Certain information on this page has been omitted and filed separately with
the Commission. Confidential treatment has been requested with respect to the
omitted portions.
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HUMANIZED FORMS:
Milestone Fee
--------- ---
Initiation of Clinical Trials [***]
Initiation of Pivotal Trials [***]
Submission of Marketing Approval Application [***]
First Regulatory Approval in the U.S. [***]
OTHER PRODUCTS (Same Schedule as in "Murine Forms" Set Forth Above):
THERAPEUTIC PRODUCT:
Milestone Fee
--------- ---
Initiation of Phase I Clinical Trials [***]
Initiation of Phase II Clinical Trials [***]
Initiation of Phase III Clinical Trials [***]
First Filing of NDA in the United States [***]
Regulatory Approval in the United States [***]
First Regulatory Approval in the EU [***]
Regulatory Approval In Japan [***]
Annual U.S. Sales Exceed $300 Million [***]
DIAGNOSTIC PRODUCT:
Milestone Fee
--------- ---
Initiation of Clinical Trials [***]
Initial of Pivotal Trials [***]
First Regulatory Approval in the U.S. [***]
3.3 Royalties.
(a) Royalty on Products. EyeTech shall pay CMI a royalty
payment on Net Sales of Products that are made or sold during the Royalty Term
and that are sold by EyeTech, its Affiliates or sublicensees (the "Royalty")
according to the following rates, as adjusted in accordance with Sections 3.3(b)
below:
THERAPEUTIC PRODUCTS (BOTH MURINE AND HUMANIZED FORMS):
(i) [***] of Net Sales Worldwide for the first
two hundred and fifty million dollars ($250,000,000) of Net Sales Worldwide in a
given Calendar Year;
(ii) [***] of Net Sales Worldwide for the next
two hundred and fifty million dollars ($250,000,000) of Net Sales Worldwide
during the same Calendar Year; and
(iii) [***] for the amount of Net Sales Worldwide
that exceed five hundred million dollars ($500,000,000) during the same Calendar
Year;
*** Certain information on this page has been omitted and filed separately with
the Commission. Confidential treatment has been requested with respect to the
omitted portions.
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By way of example, if, in the year 2005, EyeTech Net
Sales Worldwide were equal to six hundred million dollars ($600,000,000), then
the Royalty payable to CMI hereunder would equal [***] calculated in the
following manner:
AMOUNT OF NET SALES ROYALTY RATE ROYALTY
------------------- ------------ -------
First $250 Million [***] [***]
Next $250 Million [***] [***]
Next $100 Million [***] [***]
Total Royalty [***]
DIAGNOSTIC PRODUCTS (BOTH MURINE AND HUMANIZED FORMS):
(a) [***] of Net Sales Worldwide.
(b) Payments to USC/AME: In addition to the royalty
payments set forth above, EyeTech shall be responsible for paying any royalties
due under the USC License or the AME Agreement that are due USC or AME,
respectively or both; provided, however, EyeTech shall only be responsible for
these payments to the extent CMI would otherwise have to pay these amounts to
USC or AME, as the case may be, with respect to a given Product. All royalty
payments due USC and AME hereunder will be paid to CMI who in turn shall pay USC
and AME, as the case may be, consistent with the USC License and AME Agreement;
provided, further, that once EyeTech has made all such payments due to USC and
AME, EyeTech shall be discharged from any further liability to any Person or
have any further obligations hereunder.
(c) Offset. Notwithstanding the foregoing, if EyeTech is
required to make any payment to a Third Party (1) for any licenses, sublicenses
or other agreements or payments for "unblocking" any threats or actions that are
necessary to practice the Sublicense granted hereunder or (2) resulting from any
litigation (including settlement thereof) under Section 6.16, EyeTech may credit
fifty percent (50%) of any royalties it must pay to any Third Party on any
Product against the royalty payments due CMI above, provided, however, EyeTech
shall provide CMI with evidence reasonably satisfactory to CMI of the amounts of
such Third Party payments and provided, further, for purposes of this Section
3.3(c) the applicable royalty rates used for calculation of Royalties payable to
CMI shall not be reduced to less than fifty percent (50%) of the royalty
rates(s) otherwise applicable pursuant to Section 3.3(a).
3.4 Payment; Report. All Royalties payable to CMI under this
Agreement shall be paid in U.S. dollars within sixty (60) days of the end of
each Calendar Quarter or as otherwise specifically provided herein by Federal
Reserve electronic wire transfer in immediately available funds to an account
designated by CMI. At the time of payment of Royalties, EyeTech shall send to
CMI a statement with respect to the applicable Calendar Quarter, country by
country and Product by Product, for EyeTech, its Affiliates and sublicensees, of
the amount of aggregate worldwide gross sales and Net Sales, the amount of gross
sales during such Calendar Quarter, an itemized calculation of Net Sales showing
deductions provided for in the definition of Net Sales and in Section 3.3(c), an
itemization setting forth the quantities of Products sold and, on a
*** Certain information on this page has been omitted and filed separately with
the Commission. Confidential treatment has been requested with respect to the
omitted portions.
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cumulative basis for the current Calendar Year, the amount of Royalties or other
payments due on such sales.
3.5 Exchange Rate; Manner and Place of Payment.
(a) All payments due hereunder from time to time shall be
paid in U.S. Dollars. For purposes of computing such payments, the Net Sales of
Product in countries other than the United States shall be converted into U.S.
Dollars as computed using the average monthly rate of exchange at the time for
such currencies as the rate applicable to the transfer of funds arising from
payments as published in the Wall Street Journal (New York edition). The
currency conversion system used by EyeTech shall be subject to audit by CMI as
described in Section 3.6 and, if such currency conversion system is not
determined to be a system reflecting the fair market value of the currencies in
question, shall be modified as necessary to effect currency conversion at fair
market value.
(b) Notwithstanding the provisions of Section 3.5(a), if
by reason of any restrictive exchange laws or regulations, EyeTech shall be
unable to convert to U.S. Dollars the amount, determined as above, equivalent to
the amount due by EyeTech hereunder, then EyeTech shall so notify CMI promptly
and provide an explanation of the circumstances. In such event, EyeTech shall
make all such payments or the balance thereof due hereunder and which is not
paid in foreign currency as provided below, in U.S. Dollars as soon as
reasonably possible after and to the extent that such restrictive exchange laws
or regulations are lifted so as to permit EyeTech to pay amounts due under this
Section 3.5 in U.S. Dollars. EyeTech shall promptly notify CMI if such
restrictions are so lifted. At its option CMI shall meanwhile have the right to
request the payment (to it or to its nominee), and, upon request, EyeTech shall
pay or cause to be paid amounts due (or such portions thereof as are specified
by CMI) in the currency of any other country designated by CMI and legally
available to EyeTech under the then-existing laws of regulations. Any payments
shall be payable to CMI by wire transfer at such bank in the United States as
CMI shall specify from time to time. Not less than one (1) Business Day prior to
such wire transfer, the remitting party shall telefax the receiving party
advising it of the amount and of the payment to be made.
3.6 Audits. EyeTech and its Affiliates and sublicensees shall keep
full and accurate books and records relating to the financial performance of the
Product. During the term of this Agreement plus four (4) years after termination
or expiration of this Agreement, CMI shall have the right, during regular
business hours and upon reasonable advance notice, to have such books and
records audited by an independent certified accountant so as to verify the
accuracy of the information previously reported to CMI. Such information shall
be deemed to be Proprietary Information of EyeTech and, as such, subject to
confidentiality obligations pursuant to Section 6.3. The independent certified
accountant shall keep confidential any Proprietary Information obtained during
such audit and shall report to CMI only the amounts of Royalties due and
payable. The cost of such audit shall be borne by CMI; however, in the event
such audit reveals that the Royalties to CMI constitute an underpayment of five
percent (5%) or more from that revealed by the audit to be actually owed, the
cost of the audit shall be borne by EyeTech. EyeTech shall include in all
sublicenses granted as permitted under Section 2.4 an audit provision
substantially similar to the foregoing requiring the sublicensee to keep full
and accurate books and records relating to the Product and granting CMI the
right to audit the
14
accuracy of the information reported by the sublicensee in connection therewith
on the same terms as apply to an audit of EyeTech's records hereunder. The terms
of this Section 3.6 shall survive any termination or expiration or termination
of this Agreement for a period of four (4) years.
3.7 Withholding Taxes. Any and all taxes levied on account of
royalty payments paid or owed from a country in which provision is made in the
law or by regulation for withholding will be deducted from royalty payments paid
CMI hereunder. EyeTech shall provide CMI with such documentation as CMI may
reasonably request to evidence the withholdings and EyeTech shall cooperate with
CMI to claim exemption from such deductions or withholdings under any double
taxation or similar agreement in force from time to time.
3.8 Sublicensee Obligations. In the event EyeTech sublicenses its
right to sell a Product, such sublicense shall include an obligation for the
sublicensee to account for and report its Net Sales of Products, specifically
including an itemization of quantities of Products sold. The sublicense shall
also provide that CMI shall have audit rights therefor pursuant to this Section
3 on the same basis as if such sales were Net Sales of Products by EyeTech, and
EyeTech shall pay royalty payments to CMI as if the Net Sales of the sublicensee
were Net Sales of EyeTech. In addition, all sublicensees shall be subject to all
of the obligations imposed upon CMI and EyeTech by the USC License as described
in Section 2.4 hereof, including, without limitation, the indemnification and
insurance obligations provided therein.
3.9 Late Payments. Any amounts not paid by EyeTech when due under
this Agreement shall be subject to interest from and including the date payment
is due through and including the date upon which CMI has collected immediately
available funds in an account designated by CMI at a rate equal to the sum of
two percent (2%) plus the prime rate of interest quoted in the Money Rates
section of The Wall Street Journal, calculated daily on the basis of a 360-day
year, or similar reputable data source. No special notice by CMI to EyeTech of
such interest due shall be required.
3.10 Compulsory Sublicense. If either Party learns that a Third
Party has obtained a Compulsory Sublicense in any country in the Territory, such
Party shall promptly notify the other Party of such occurrence. If the royalty
rate payable by the grantee of the Compulsory Sublicense is less than the
royalty rates applicable in such country set forth in Section 3.3 of this
Agreement, then the applicable royalty rates set forth in Section 3.3 of this
Agreement shall be reduced pro rata to the lower royalty rates applicable in
such country pursuant to such Compulsory Sublicense for so long as sales of a
Competitive Product are made by any Third Party pursuant to the Compulsory
Sublicense.
SECTION 4
TERM OF AGREEMENT; TERMINATION
4.1 Term. The term of this Agreement shall commence upon the
Effective Date and, unless sooner terminated as provided in this Section 4,
expire on the expiration of all Royalty Terms for all Products.
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4.2 Sublicenses upon Expiration. In the event that the Agreement
expires as set forth in Section 4.1 above without early termination, the
Sublicense granted to EyeTech hereunder shall automatically become an exclusive,
irrevocable, royalty-free, paid-up Sublicense, subject to the surviving
provisions of the Agreement and EyeTech's right to use and/or sublicense the
Products in the Field of Use in the Territory as it exists at the time of such
expiration.
4.3 Termination for Breach. Each Party shall have the right to
terminate this Agreement and its obligations hereunder for material breach by
the other Party, which breach remains uncured for sixty (60) days after written
notice is provided to the breaching Party, or in the case of an obligation to
pay royalty payments or other amounts owing under this Agreement, which breach
remains uncured for thirty (30) days after written notice to the breaching
Party; provided, however, that non-payment of any royalty amounts or other
payments owing under this Agreement, for which the non-paying Party reasonably
disputes the obligation or amounts not paid, shall not be deemed a breach of an
obligation to pay royalty payments or other amounts owing under this Agreement,
provided that the non-paying Party has paid all such amounts not in reasonable
dispute.
4.4 Reversion Rights.
(a) Termination of Agreement. In the event that this
Agreement is terminated pursuant to Sections 4.2 or 4.3 above, other than for
CMI's material breach of this Agreement, the Sublicense shall terminate
immediately upon such termination.
(b) Loss of Sublicense Rights in Country. In the event
that EyeTech, by law, judicial or administrative order or other governmental
action, loses or is suspended from practicing or exercising for an indefinite
period of time the right to use and sell Products in any country other than by
reason of any action or failure to act on the part of CMI or any party acting on
behalf of CMI, the Sublicense shall terminate with respect to such country.
(c) Transfer of Rights. With respect to any and all
countries in which EyeTech's Sublicense rights are terminated pursuant to
Sections 4.4(a), 4.4(b), or 6.7(b): (i) such country(ies) shall automatically be
removed from the Territory; (ii) EyeTech hereby grants to CMI an exclusive,
freely sublicensable Sublicense under the EyeTech Rights, which Sublicense shall
be royalty-free and paid-up, subject to Section 4.4(d), to make, have made, use,
import, offer for sale, sell and otherwise research, develop and commercialize
formulations of the Products in such countries, and CMI covenants not to
practice such Sublicense until the actual termination of EyeTech's Sublicense
rights as to such countries pursuant to Sections 4.4(a) or (b); (iii) EyeTech
shall assign all of its right, title and interest in and to, and shall cooperate
in the transfer of all of, the following related to Antibodies to the extent
that EyeTech Controlled such during the term of this Agreement: (A) INDs and
Regulatory Approvals, (B) all pre-clinical and clinical development protocols,
data, and reports and other information and data (with any clinical data to be
in computer-readable format, where available, and otherwise in printed format,
with no obligation of EyeTech to convert to electronic format any portion of
such clinical data that currently is available only in printed format), (C)
manufacturing development technical reports, (D) toxicology reports, and (E)
such other information and data specifically identified in Exhibit B (the
preceding (A), (B), (C), (D) and (E) constituting the updated Product Data
Package), (iv) EyeTech shall deliver to CMI copies of all information, records
and data that it
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Controls that are reasonably necessary for the research, development and
commercialization of Antibodies, including without limitation all clinical data
relating to Products, forward to CMI samples of all chemical and biological
materials acquired, made, cloned, synthesized, first discovered or collected as
a result of research development or commercialization of Products and reasonable
necessary to continue the research, development and commercialization of
Products, and take such other actions and execute such other instruments,
assignments and documents as may be necessary to effect the transfer of rights
and materials hereunder to CMI; and (v) EyeTech shall provide assistance
reasonably requested by CMI for a period of ninety (90) days following the date
of notice of termination or for such longer period as the Parties may agree as
is necessary to facilitate the exercise of the Sublicense granted to CMI in
Section 4.4(c)(ii).
(d) Royalties. Any Sublicense granted to CMI pursuant to
Section 4.4(c) shall be subject to payment of a royalty to EyeTech on a
country-by-country basis at a rate equal [***] of CMI's net sales of Products in
such country if such Sublicense is granted on or after the first Regulatory
Approval of Product in such country.
4.5 Accrued Rights and Obligations; Survival. Termination or
expiration of this Agreement for any reason shall be without prejudice to any
rights which shall have accrued to the benefit of either Party prior to such
termination or expiration, including damages arising from any breach hereunder.
The following provisions of this Agreement shall survive the expiration or
termination of this Agreement: Sections 2.3, 4.2, 4.5, 5, 6.3, 6.4, 6.5, 6.9,
6.1l(a), 6.12, 6.18, 7, 8. The following provisions of this Agreement shall
survive the expiration of this Agreement to the extent that the Sublicense
granted to EyeTech pursuant to Section 4.2 is in effect: Sections 3.4 through
3.9, 4.3, 4.4, 6.2, 6.7(d), 6.7(f), 6.8, 6.11(b), 6.11(c), 6.11(d), 6.13 and
6.16.
4.6. Termination upon Notice. Either Party may terminate this
Agreement upon 90 days' written notice to the other Party in which case, if
CMI terminates the Agreement, Eyetech will be relieved of all payment
obligations hereunder except for those amounts paid to the date of termination
and if Eyetech terminates this Agreement all rights granted under this
Development and Sublicensing Agreement will revert to CMI.
SECTION 5
REPRESENTATIONS AND WARRANTIES
5.1 Corporate Existence and Power. As of the Effective Date, each
Party represents and warrants to the other that it (a) is a corporation duly
organized, validly existing and in good standing under the laws of the state in
which it is incorporated, and (b) has full corporate power and authority and the
legal right to own and operate its property and assets and to carry on its
business as it is now being conducted and as contemplated in this Agreement,
including, without limitation, the right to grant the Sublicenses granted
hereunder.
5.2 Authority and Binding Agreement. As of the Effective Date,
each Party represents and warrants to the other that it (a) has the corporate
power and authority and the legal right to enter into this Agreement and perform
its obligations hereunder, (b) has taken all necessary corporate action on its
part required to authorize the execution and delivery of the Agreement and the
performance of its obligations hereunder, and (c) the Agreement has been duly
executed
*** Certain information on this page has been omitted and filed separately with
the Commission. Confidential treatment has been requested with respect to the
omitted portions.
17
and delivered on behalf of such Party, and constitutes a legal, valid and
binding obligation of such Party and is enforceable against it in accordance
with its terms.
5.3 Title. As of the Effective Date, each Party represents and
warrants to the other that it has sufficient legal and/or beneficial title under
its intellectual property rights necessary to perform activities contemplated
under this Agreement and to grant the Sublicenses contained in this Agreement
and other ownership rights conveyed pursuant to this Agreement
5.4 No Conflict. Each Party represents and warrants to the other
that it has not entered, and will not enter, into any agreement with any Third
Party which is in conflict with the rights granted to the other Party under this
Agreement, and has not taken and will not take any action that would in any way
prevent it from granting the rights granted to the other Party under this
Agreement, or that would otherwise materially conflict with or adversely affect
the rights granted to the other Party under this Agreement.
5.5 No Approvals or Consents Required. Each Party represents and
warrants to the other that all necessary consents, approvals and authorizations
of all governmental authorities and other persons or entities required to be
obtained by such Party in order to enter into this Agreement have been obtained.
CMI represents and warrants that the consent of AME is not necessary for CMI to
enter into or perform its obligations under this Agreement.
5.6 Patents. CMI represents and warrants to EyeTech that in
Exhibit C, CMI has in good faith supplied a complete list of all the Patents it
has licensed as of the Effective Date, that, but for the grant of the
Sublicense, would be infringed by the development of the Antibodies and the
manufacture, use or sale of Products in the Field of Use. If through Reasonable
Diligence EyeTech determines that any Patent Controlled by CMI or any Affiliate
of CMI as of the Effective Date should be added to Exhibit C because EyeTech's
development, manufacture, use or sale of Products would infringe such Patent,
then there shall be no deemed breach of CMI's representations and warranties in
this Section 5.6 until after the parties negotiate in good faith regarding the
addition of any such Patent to Exhibit C without any additional financial
obligation and are unable to reach agreement on such addition of such Patent.
5.7 No Conflict. Each Party represents and warrants to the other
that the execution and delivery of the Agreement by such Party and the
performance of such Party's obligations hereunder (a) do not conflict with or
violate any requirement of applicable law or regulation or any provision of
articles of incorporation or bylaws of such Party in any material way, and (b)
do not conflict with, violate or breach or constitute a default or require any
consent under, any contractual obligation or court or administrative order by
which such Party is bound.
5.8 Regulatory Action. CMI has received no written notice of any
regulatory action by the relevant Regulatory Authorities which may reasonably be
expected to have a material adverse effect on the ability of a Party to obtain
Regulatory Approval for Products.
5.9 Manufacturing Information. CMI represents and warrants that,
it shall by the Delivery Date deliver to EyeTech all of the Transferred Assets
and the Manufacturing Information.
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5.10 Product Quality. CMI hereby represents and warrants that all
Product Inventory that is provided to EyeTech pursuant to the terms of this
Agreement has been manufactured in compliance with good manufacturing practices.
5.11 Implied Warranties. EXCEPT AS EXPRESSLY PROVIDED IN THIS
SECTION 0, XXX XXXXX XX XXXXXXXXXXXXXX XX XXXXXXXX AS TO THE PATENTS,
SUBLICENSED PATENTS, KNOW-HOW, THE TRANSFERRED ASSETS, PRODUCTS, ITS INVENTORY
OF ANTIBODIES, EXPRESS OR IMPLIED, EITHER IN FACT OR BY OPERATION OF LAW, BY
STATUTE OR OTHERWISE, INCLUDING WITHOUT LIMITATION ANY IMPLIED WARRANTIES OF
MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE OR NON-INFRINGEMENT OF THIRD
PARTY RIGHTS, OR OTHERWISE, AND CMI SPECIFICALLY DISCLAIMS ANY AND ALL IMPLIED
OR STATUTORY WARRANTIES. Without limiting the foregoing, EyeTech acknowledges
that it has not and is not relying upon any implied warranty, including without
limitation implied warranties of merchantability, fitness for a particular
purpose, non-infringement of third party rights, or upon any representation or
warranty whatsoever as to the prospects (financial, regulatory or otherwise), or
the validity or likelihood of success, of any Antibody or Product after the
Effective Date.
5.12 Patents; Prior Art. Except as CMI has otherwise advised
EyeTech in writing, CMI represents and warrants to EyeTech that as of the
Effective Date, to the best of its knowledge, it has sufficient legal and/or
beneficial title and ownership under its intellectual property rights necessary
for it to fulfill its obligations under this Agreement and that it is not aware
of any communication alleging that it has violated or by conducting its business
as contemplated by this Agreement would violate any of the intellectual property
rights of any other person, and that to the best of its knowledge there is no
material unauthorized use, infringement or misappropriation of any of its
intellectual property rights relevant to this Agreement. As used herein,
"intellectual property rights" shall mean all patent rights, copyrights,
trademarks, trade secret rights, chemical and biological material rights and
know-how rights necessary or useful to make, use or sell Product.
5.13 Absence of Litigation. As of the Effective Date, each Party
represents and warrants to the other that it is not aware of any pending or
threatened litigation (and has not received any communication) which alleges
that such Party's activities related to this Agreement have violated, or that by
conducting the activities as contemplated herein such Party would violate, any
of the intellectual property rights of any other person. To the best of each
Party's knowledge, there is no material unauthorized use, infringement or
misappropriation of any of its intellectual property rights licensed hereunder.
SECTION 6
ADDITIONAL COVENANTS AND AGREEMENTS OF THE PARTIES
6.1 Governmental Filings. CMI and EyeTech each agree to prepare
and file whatever filings, requests or applications are required to be filed
with any governmental authority in connection with this Agreement and to
cooperate with one another as reasonably necessary to accomplish the foregoing.
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6.2 Compliance with Law. EyeTech shall comply with all
supranational, national, federal, state, provincial and other local laws and
regulations applicable to EyeTech's manufacture, use, development, marketing and
sale of the Product. Without limiting the generality of the foregoing sentence,
EyeTech shall not promote the Product in any manner in conflict with any
applicable laws or regulations.
6.3 Proprietary Information; Exceptions. Each Party will maintain
all Proprietary Information received by it under this Agreement in trust and
confidence and will not disclose any such Proprietary Information to any Third
Party or use any such Proprietary Information for any purposes other than those
necessary or permitted for performance under this Agreement. In particular,
EyeTech shall not use any Know-How for the manufacture or sale of any product
other than a Product in the Field of Use. Each Party may use such Proprietary
Information only to the extent required to accomplish the purposes of this
Agreement. Proprietary Information shall not be used for any purpose or in any
manner that would constitute a violation of any laws or regulations, including
without limitation the export control laws of the United States. Proprietary
Information shall not be reproduced in any form except as required to accomplish
the intent of this Agreement. No Proprietary Information shall be disclosed to
any employee, agent, consultant, Affiliate, or sublicensee who does not have a
need for such information. To the extent that disclosure is authorized by this
Agreement, the disclosing Party will obtain prior agreement in writing, from its
employees, directors, agents, consultants, Affiliates, sublicensees or clinical
investigators to whom disclosure is permitted to be made, to obligations to hold
in confidence and not make use of such information for any purpose other than
those permitted by this Agreement, that are at least as restrictive as those of
this Section 6.3. Each Party will use at least the same standard of care as it
uses to protect its own Proprietary Information of a similar nature to ensure
that such employees, agents, consultants and clinical investigators do not
disclose or make any unauthorized use of such Proprietary Information, but no
less than reasonable care. Each Party will notify the other within two (2)
Business Days upon discovery of any unauthorized use or disclosure of the
Proprietary Information.
Proprietary Information shall not include any information which, as
shown by competent proof:
(a) is now, or hereafter becomes, through no act or
failure to act on the part of the receiving Party, its employees or contractors
in breach hereof, generally known or available;
(b) is known by the receiving Party at the time of
receiving such information, as evidenced by its contemporaneous written records;
(c) is hereafter furnished to the receiving Party by a
Third Party, as a matter of right and without restriction on disclosure;
(d) is independently developed by the receiving Party
without any breach of this Agreement, as shown by independent, contemporaneous,
written records; or
(e) is the subject of a prior, express, written
permission to disclose provided by the disclosing Party.
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Notwithstanding any other provision of this Section 6.3, (i) the
Parties agree that they shall issue a press release promptly after execution of
this Agreement hereto, but such press release shall specifically exclude any
reference to the royalty rates in Section 3.3 and elsewhere in this Agreement,
and (ii) either Party may disclose such terms to bona fide potential corporate
partners, to the extent required or contemplated by this Agreement, and to
financial underwriters and other Third Parties with a need to know such
information, provided that all such disclosures shall be made only to such Third
Parties under an obligation of confidentiality and appropriately limited use.
The Parties shall have the right to review and comment on each other's public
disclosure (including, without limitation, publications in journals, press
releases subsequent to execution of this Agreement and filings with the U.S.
Securities and Exchange Commission)(collectively, "Disclosures") related to the
Antibodies, the Products and the relationship contemplated this Agreement,
specifically in those instances where one Party's Disclosures make reference to
the other Party's name, the Antibodies, the Products or this Agreement. Each
Party shall consider the other Party's comments on such Disclosures in good
faith and will not unreasonably withhold its acceptance of such Disclosures or
the incorporation of the other Party's comments into any such Disclosure.
6.4 Authorized Disclosure. Notwithstanding any other provision of
this Agreement, each Party may disclose Proprietary Information if such
disclosure:
(a) is in response to a valid order of a court or other
governmental body of the United States or a foreign country, or any political
subdivision thereof; provided, however, that the receiving Party shall first
have given notice to the other Party hereto and shall have made a reasonable
effort to obtain a protective order requiring that the Proprietary Information
so disclosed be used only for the purposes for which the order was issued;
(b) is otherwise required by governmental law, rule or
regulation, including without limitation rules or regulations of the U.S.
Securities and Exchange Commission, or by rules of the National Association of
Securities Dealers; or
(c) is otherwise necessary to file or prosecute patent
applications, prosecute or defend litigation or comply with applicable
governmental regulations or otherwise establish rights or enforce obligations
under this Agreement, but only to the extent that any such disclosure is
necessary. Under no circumstances will EyeTech disclose publicly proprietary
features of CMI manufacturing technology for Antibodies.
6.5 Return of Proprietary Information. In the event that the
Sublicense terminates or expires, EyeTech shall promptly return all Proprietary
Information received by it from CMI.
6.6 Expenses. CMI and EyeTech shall each bear their own direct and
indirect expenses incurred in connection with the negotiation and preparation of
this Agreement and, except as set forth in this Agreement, the performance of
the obligations contemplated hereby.
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6.7 Efforts.
(a) Reasonable Diligence to Develop and Commercialize.
EyeTech shall use Reasonable Diligence to develop, obtain Regulatory Approval
for, and commercialize Product(s) in the Territory and shall be solely
responsible for all related development, regulatory and commercialization
efforts and costs; provided, however, with respect to countries in the Territory
that are not Major Countries (such countries, "Non-Major Countries"), EyeTech
shall have the right to determine, on a country by country basis using its
reasonable discretion not to pursue Regulatory Approval in such Non-Major
Country because commercialization of the Product is not economically feasible
for EyeTech. EyeTech shall provide CMI with written notice of all decisions by
EyeTech to not pursue development, Regulatory Approval or commercialization in a
country in the Territory for a Product in the Field of Use for any reason within
thirty (30) days of such decision.
(b) EyeTech's Responsibilities. EyeTech shall be
responsible, at its sole expense, applying standards of Reasonable Diligence,
for all development of, regulatory activities relating to, the development and
commercialization of Products in the Territory beginning on the Effective Date,
including performing clinical development of Products within the Territory and
making all regulatory filings necessary to obtain Regulatory Approvals of
Products in the Territory. EyeTech shall use Reasonable Diligence to promptly
identify lead candidates for clinical development and once such candidates are
identified to prepare development plans for such Products based on consultation
with CMI.
(c) Termination for Failure to be Reasonably Diligent. In
the event EyeTech or its sublicensees fail to undertake Reasonable Diligence
including, without limitation, obtaining Regulatory Approval of, and/or
commercializing Products in one or more Major Countries in the Territory, such
failure shall (i) automatically cause the Sublicense to terminate with respect
to such Major Country(ies) and have the consequences set forth in Section 4.4(c)
with respect to any such Major Country(ies); and (ii) shall entitle CMI to
terminate this Agreement for material breach under Section 4.3 if there have
been such failures of diligence applying to four (4) or more Major Countries,
with the consequences set forth in Section 4.4(c); provided in each case that
EyeTech (or its sublicensee) does not cure such failure within ninety (90) days
of written notice from CMI specifying its belief that such failure has occurred
and the reasons therefor. CMI shall not be entitled to exercise the foregoing
termination rights if EyeTech reasonably disputes CMI's contention that EyeTech
has failed in such Reasonable Diligence until after the Parties have first
completed dispute resolution procedures pursuant to Section 8.9; and provided,
further, if CMI terminates this Agreement because of EyeTech's failure to
undertake Reasonable Diligence with respect to a Therapeutic Product, then this
Agreement shall only be terminated with respect to Therapeutic Products and not
Diagnostic Products or Other Products, or if CMI terminates this Agreement
because of EyeTech's failure to undertake Reasonable Diligence with respect to
Diagnostic Products, then this Agreement shall only be terminated with respect
to Diagnostic Products and not with respect to Therapeutic Products and Other
Products.
(d) Regulatory Filings and Matters. EyeTech will file
such regulatory filings as may be necessary to obtain Regulatory Approvals of
Products within the Territory. EyeTech will be responsible for all
communications with all supranational, regional, federal, state,
22
provincial or other local regulatory agencies, department, bureaus and other
governmental authorities with jurisdiction over Regulatory Approvals in
connection with such filings. EyeTech will keep CMI informed of the status of
such filings in each country, and will provide CMI with at least sixty (60) days
advance notice of the final submission of an application for Regulatory Approval
in any country of the Territory. EyeTech will promptly advise CMI each time that
it obtains Regulatory Approval of Products in a country of the Territory.
EyeTech shall be responsible for the reporting of adverse events related to the
use of Products marketed by EyeTech, its Affiliates or sublicensees in the
Territory.
(e) Annual Reporting: Meetings. During the Term of this
Agreement, on the anniversary date of this Agreement beginning in the year
following the year in which this Agreement is signed, EyeTech will submit to
CMI, an annual written report summarizing the status and progress of the
clinical development, marketing and commercialization efforts for each Product
in sufficient detail so as to allow CMI to monitor EyeTech's compliance with
Section 6.7. At least once per calendar Year on dates mutually agreed by the
Parties, senior executive and scientific personnel of EyeTech will meet with CMI
representatives to report on the status of development and commercialization of
Products and to consult as to modifications in the development plan referenced
in Section 6.7(b).
6.8 Pricing. EyeTech shall determine, in its sole discretion, the
pricing, discounting policy and other commercial terms relating solely to
Products. EyeTech agrees that EyeTech, its Affiliates and its sublicensees shall
not subject the selling price of Products to abnormal discounts taken against
Products in order to achieve sales of other products.
6.9 Export Control. This Agreement is made subject to any
restrictions concerning the export of products or technical information from the
United States of America or other countries that may be imposed upon or related
to CMI or EyeTech from time to time. Each Party agrees that it will not export,
directly or indirectly, any technical information acquired from the other Party
under this Agreement or any products using such technical information to a
location or in a manner that at the time of export requires an export Sublicense
or other governmental approval, without first obtaining the written consent to
do so from the appropriate agency or other governmental entity.
6.10 Inability to Develop or Commercialize. EyeTech represents that
it has, and covenants that it will maintain adequate resources and expertise to
fulfill its obligations under this Agreement.
6.11 Compliance with Laws; Cooperation: Maintenance of Original
Documents.
(a) Each Party shall carry out its activities pursuant to
this Agreement in compliance with all applicable supranational, national, state,
provincial and local laws, rules, regulations and guidances.
(b) CMI and EyeTech each agree to use all commercially
reasonable efforts to take, or cause to be taken, all actions and to do, or
cause to be done, all things necessary or proper to make effective the
transactions contemplated by this Agreement, including such actions as may be
reasonably necessary to obtain approvals and consents of governmental
23
Persons and other Persons (including, without limitation, all applicable drug
listing and notifications to the relevant Regulatory Authority identifying
EyeTech as the Sublicensee of the Product), in each case as reasonably necessary
to allow EyeTech to develop, obtain Regulatory Approvals for, and commercialize
Products as provided in this Agreement; provided that no Party shall be required
in connection with such activities to (1) make any payment (other than as
expressly required pursuant to this Agreement), or (2) assume any other material
obligation not otherwise required to be assumed by this Agreement.
(c) For so long as EyeTech, its Affiliates or
sublicensees is making, using or selling Antibodies or Products, CMI shall store
and maintain all original Manufacturing Information in a secure location in
accordance with practices customary for CMI and the pharmaceutical industry for
regulatory documents and in compliance with applicable laws and regulations,
and, upon proper notice from a Regulatory Authority of competent jurisdiction
over Products, shall make such Manufacturing Information reasonably available to
such Regulatory Authority.
(d) EyeTech shall store and maintain the Product Data
Package as updated in a secure location in accordance with practices customary
for EyeTech and the pharmaceutical industry for regulatory documents and in
compliance with applicable laws and regulations.
6.12 Cooperation. If either Party shall become engaged in or
participate in any investigation, claim, litigation or other proceeding with any
Third Party, including any proceeding before a Regulatory Authority, relating in
any way to the Product or any of the Sublicensed Patents the other Party shall
cooperate in all reasonable respects with such Party in connection therewith,
including, without limitation, using its reasonable efforts to make available to
the other Party such Party's employees who may be helpful with respect to such
investigation, claim, litigation or other proceeding, provided that, for
purposes of this provision, reasonable efforts to make available any employee
shall be deemed to mean providing a Party with reasonable access to any such
employee at no cost for a period of time not to exceed 24 hours (e.g., three
8-hour Business Days). Thereafter, any such employee shall be made available for
such time and upon such terms and conditions (including, but not limited to,
compensation) as the Parties may mutually agree.
6.13 Exclusive Rights. The Sublicenses granted under this Agreement
to EyeTech are exclusive, and no Person, including without limitation CMI, shall
have any right with respect to such Sublicenses during the term of this
Agreement, except as otherwise permitted under this Agreement. Except as
otherwise permitted by this Agreement, CMI shall refrain from granting any right
to any Third Party relating to the Antibodies, Products, the Sublicensed Patents
or the Transferred Assets that would, in any manner, violate the terms of or
conflict with the rights granted to EyeTech pursuant to this Agreement.
6.14 Patent Prosecution and Maintenance.
(a) Prosecution of Patents. Sublicensed Patents shall be
prosecuted and maintained in the Territory by CMI, consistent with the
provisions of the USC License using diligent efforts, at CMI's expense, except
as otherwise provided in this Section 6.14(a). If USC so consents, upon the
request of CMI or EyeTech, then EyeTech shall have the right to have
24
CMI prosecute and maintain Sublicensed Patents or file for such patent term
extension therefore at EyeTech's sole expense, provided however that CMI must
agree to first consult with and keep USC informed as to the preparation, filing,
prosecution, and maintenance of such patent applications and patents, and CMI
shall furnish to USC (i) copies of documents relevant to any such preparation,
filing, prosecution or maintenance, (ii) all original issued patent documents,
certificates or the equivalents thereof and (iii) at least once each year, no
later than January 1, a summary of the status of each Sublicensed Patent. With
respect to the foregoing inter parties proceeding, EyeTech shall bear all
reasonable costs of any patent proceeding, including without limitation
oppositions, interferences or contested re-examinations, which proceeding shall
be conducted under the control of CMI and USC.
(b) EyeTech shall assist in obtaining patent extensions
and supplementary protection certificates and provide such other assistance as
reasonably requested in connection with the prosecution and maintenance of the
Sublicensed Patents in any part of the Territory at EyeTech's sole expense.
6.15 Infringement of Sublicensed Patents.
(a) Notice. Each Party shall promptly notify the other in
writing of any alleged infringement by Third Parties of any Sublicensed Patent
within the Territory and provide any information available to that Party
relating to such alleged infringement or misappropriation. EyeTech shall have no
rights or responsibilities or liabilities with respect to any infringement of
Sublicensed Patents that occurs outside of the Field of Use and/or outside the
Territory except the right to receive notice pursuant to this Section 6.15(a).
The Parties acknowledge USC's right, as provided under the terms of the USC
License, to participate in any action initiated pursuant to Section 6.15
(b) Enforcement of Sublicensed Patents against
Competitive Products. If any Sublicensed Patent is infringed by a Third Party in
connection with the manufacture, use, sale, offer for sale or import of a
Competitive Product within the Field of Use and within the Territory
("Competitive Product Infringement"), EyeTech shall have the primary right, but
not the obligation, to initiate, prosecute and control any action with respect
to such infringement in the Territory, by counsel of its own choice, to secure
the cessation of the infringement or to enter suit against the infringer. CMI
shall have the right to participate in any such action with respect to the
Sublicensed Patents and to be represented by counsel of its own choice. If
EyeTech fails to bring an action or proceeding to enforce a Sublicensed Patent
within a period of one hundred twenty (120) days after having knowledge of
infringement of such Sublicensed Patent, then CMI shall have the right to bring
and control any such action by counsel of its own choice, and EyeTech shall have
the right to participate in such action and be represented by counsel of its own
choice. If a Party brings any such action or proceeding under this Section
6.15(b), the other Party agrees to be joined as a party plaintiff and to give
the first Party reasonable assistance and authority to control, file and
prosecute the suit as necessary. The costs and expenses of the Party bringing
suit under this Section 6.15(b) (including the internal costs and expenses
specifically attributable to such suit) shall be reimbursed first out of any
damages or other monetary awards recovered in favor of the Parties, and any
remaining damages shall be treated as Net Sales of EyeTech in its Territory if
EyeTech controlled the action or allocated between the parties in accordance
with their economic interest in the profitability of Products if CMI controlled
the
25
action. No settlement or consent judgment or other voluntary final disposition
of a suit under this Section 6.15(b) relating to a Sublicensed Patent may be
entered into without the consent of CMI, not to be unreasonably withheld.
(c) Enforcement of Sublicensed Patents against
Non-Competitive Products. With respect to any infringement of Sublicensed
Patents within the Field of Use and within the Territory that is not a
Competitive Product Infringement, CMI or USC (in the event that CMI elects not
to take any action pursuant to this Section 6.15(c)) shall have the primary
right, but not the obligation, to initiate, prosecute and control any action
with respect to such infringement, by counsel of its own choice, to secure the
cessation of the infringement or to enter suit against the infringer and shall
be the "Lead Party" and EyeTech shall be the "Secondary Party". The Secondary
Party shall have the right to participate in any such action with respect to its
Patents and to be represented by counsel of its own choice. If the Lead Party
fails to bring an action or proceeding to enforce a Sublicensed Patent within a
period of one hundred twenty (120) days after having knowledge of infringement
of such Sublicensed Patent, then the Secondary Party shall have the right to
bring and control any such action by counsel of its own choice, and the Lead
Party shall have the right to participate in such action and be represented by
counsel of its own choice. If a Party brings any such action or proceeding
hereunder, the other Party agrees to be joined as a party plaintiff and to give
the first Party reasonable assistance and authority to control, file and
prosecute the suit as necessary. The costs and expenses of the Party bringing
suit under this Section 6.15(c) (including the internal costs and expenses
specifically attributable to such suit) shall be reimbursed first out of any
damages or other monetary awards recovered in favor of the Parties, and any
remaining damages shall be paid to CMI if CMI controlled the action, or paid to
each Party in proportion to their expenditures in such action, if EyeTech
controlled the action. No settlement or consent judgment or other voluntary
final disposition of a suit under this Section 6.15(c) relating to a Sublicensed
Patent may be entered into without the consent of CMI, not to be unreasonably
withheld.
6.16 Infringement of Third Party's Rights.
(a) If the practice of the Sublicensed Patents through
the manufacture, use or sale of Products by EyeTech, its Affiliates or
sublicensees results in a claim for patent infringement against EyeTech, its
Affiliates or sublicensees, the Party to this Agreement first having notice of
that claim shall promptly notify the other Party in writing. The notice shall
set forth the facts of the claim in reasonable detail. The Parties acknowledge
USC's right (as provided under the terms of the USC License) to participate in
any action initiated pursuant to Section 6.16.
(b) If a Third Party asserts that a patent or other right
owned by or sublicensed to it is infringed by the practice of the Sublicensed
Patents through the manufacture, use or sale of Products by EyeTech, its
Affiliates or sublicensees pursuant to the Sublicense, EyeTech may attempt to
resolve the problem raised by the asserted infringement. The matter shall be
deemed resolved if EyeTech obtains: (a) a Sublicense permitting EyeTech to
manufacture, use and sell Products in that country on a royalty-free or
royalty-bearing basis; (b) a statement or representation from the Third Party
that: (1) no action will be taken against EyeTech, CMI, USC or AME or their
respective Affiliates or sublicensees, or (2) that the patent or other right is
not infringed by the manufacture, use or sale of Products by EyeTech, its
Affiliates or its
26
sublicensees; or (c) a final judgment by a court of competent jurisdiction from
which no appeal has or can be taken that the Third Party's patent(s) alleged to
be infringed is invalid, or the Third Party's patent(s) or other right(s) are
unenforceable or not infringed by the manufacture, use or sale of Products by
EyeTech, its Affiliates or sublicensees. EyeTech shall have the primary right to
defend any such claim. CMI shall have the right, but not the obligation, to
participate in any such suit at its sole option and at its own expense. Each
Party shall reasonably cooperate with the Party conducting the defense of the
claim. Neither Party shall enter into any settlement that affects the other
Party's rights or interests without such other Party's prior written consent,
not to be unreasonably withheld. If EyeTech makes a payment to any Third Party
in the course of defending or settling any claim brought by a Third Party
pursuant to this Section 6.16, EyeTech shall be entitled to offset a percentage
of all such amounts against royalties due to CMI hereunder as provided in
Section 3.3(c).
6.17 Development and Manufacturing.
EyeTech shall be the sole arbiter of decisions regarding manufacturing
and development of the Antibodies and Products contemplated hereunder except
that Eyetech shall act with Reasonable Diligence in making such decisions.
Eyetech shall be solely responsible for the costs associated with the
development, manufacture of and supply of any and all Products following the
Effective Date, including without limitation for clinical trials and
commercialization.
6.18 Use of Names, Logos or Symbols. No Party hereto shall use the
name, trademarks, logos, physical likeness, employee names or owner symbol of
the other Party hereto for any purpose, including, without limitation, in
connection with any private or public securities placements, without the prior
written consent of the affected Party, such consent not to be unreasonably
withheld or delayed so long as such use of name is limited to objective
statements of fact, rather than for endorsement purposes. Nothing contained
herein shall be construed as granting either Party any rights or Sublicense to
use any of the other Party's trademarks or trade names without separate, express
written permission of the owner of such trademark or trade name.
SECTION 7
INDEMNIFICATION
7.1 Indemnification.
(a) CMI shall indemnify, defend and hold EyeTech (and its
directors, officers, employees, consultants, Affiliates and sublicensees) (each,
an "EyeTech Indemnitee") harmless from and against any and all Damages incurred
or suffered by an EyeTech Indemnitee as a result of Third Party claims, actions
or proceedings (collectively, "EyeTech Claims") to the extent such EyeTech
Claims are a consequence of:
(1) the breach or alleged breach of any
representation or warranty by CMI hereunder, or
(2) the negligence or misconduct of CMI in
connection with its activities under this Agreement;
27
except to the extent such EyeTech Claims are a consequence any of the items in
Sections 7.1(b)(1), (2) or (3).
(b) EyeTech shall indemnify, defend and hold CMI, USC and
AME (and their respective directors, officers, employees, consultants and
Affiliates) (each, a "CMI Indemnitee") harmless from and against any and all
Damages incurred or suffered by a CMI Indemnitee as a result of Third Party
claims, actions or proceedings (collectively, "CMI Claims") to the extent such
CMI Claims are a consequence of:
(1) the breach or alleged breach of any
representation or warranty by EyeTech hereunder;
(2) the negligence or willful misconduct of
EyeTech in connection with its activities under this Agreement;
(3) the possession, research, development,
manufacture, use, offer for sale, sale, administration, storage or transport of
Antibodies or Products by EyeTech or its Affiliates or sublicensees;
except to the extent such CMI Claims are a consequence any of the items in
Sections 7.1(a)(l) or (2); provided, however, EyeTech shall have no liability or
obligation under this Section for any CMI Claims that are a consequence of (x)
the breach or alleged breach of any representation or warranty in this
Agreement, the USC License or the AME Agreement by any CMI Indemnitee or (y) the
negligence or willful misconduct of any CMI Indemnitee.
7.2 Mechanics. If a Party or its Affiliate has a right to be
indemnified under this Section 7 (the "Indemnified Party"), such Party or
Affiliate (i) shall give prompt notice of such EyeTech Claim or CMI Claim, as
the case may be (as applicable, a "Claim"), to the other Party (the
"Indemnifying Party") and (ii) subject to Sections 6.15 and 6.16 of this
Agreement, will have the first right to defend any Claims for which it is
entitled to indemnification from the other Party under Section 7.1, with the
cooperation and at the expense of such other Party, provided that it will not
settle any such Claim without the prior written consent of the Indemnifying
Party, which consent shall not be unreasonably withheld. If the Indemnified
Party is defending a Claim, the Indemnifying Party shall have the right to be
present in person or through counsel at substantive legal proceedings. In the
event that the Parties cannot agree as to the application of Section 7.1 to any
Damages or Claim, the Parties may conduct separate defenses of such claim. Each
Party further reserves the right to claim indemnity from the other in accordance
with Section 7.1 upon resolution of the underlying claim.
7.3 Insurance Coverage. Each Party represents and warrants that it
is covered and will continue to be covered by a comprehensive general liability
insurance program that covers all of each Party's activities and obligations
hereunder in accordance with reasonable pharmaceutical industry standards, and
in the case of EyeTech, in an amount no less than the coverage levels specified
in the USC License. In addition, EyeTech shall use reasonable commercial efforts
to cause USC and AME to be added as named insureds to the insurance policies
that EyeTech maintains pursuant to this Section 7.3. Each Party will provide the
other Party with written notice at least fifteen (15) days prior to any
cancellation or material change in
28
such insurance program. Each Party will maintain such insurance program, or
other program with comparable coverage, beyond the expiration or termination of
this Agreement during the period in which any Product is being commercially
distributed or sold, and for a commercially reasonable period thereafter.
7.4 Indemnification Payment Adjustments. If any Indemnified Party
shall have received any payment pursuant to this Section 7 with respect to any
Damages and shall subsequently have received insurance proceeds with respect to
such Damages, then such Indemnified Party shall pay to the Indemnifying Party an
amount equal to the difference (if any) between (1) the sum of the amount of
those insurance proceeds received and the amount of the payment by such
Indemnifying Party pursuant to this Section 7 with respect to such Damages and
(2) the amount necessary to fully and completely indemnify and hold harmless
such Indemnified Party from and against such Damages; provided, however, in no
event will such Indemnified Party have any obligation pursuant to this sentence
to pay to such Indemnifying Party an amount greater than the amount of the
payment by such Indemnifying Party pursuant to this Section 7 with respect to
such Damages.
7.5 Indemnification Payment. Upon the final determination of
liability and the amount of the indemnification payment under this Section 7,
the appropriate Party shall pay to the other in immediately available funds,
within thirty (30) Business Days after such determination, the amount of any
claim for indemnification made hereunder.
7.6 Survival. The provisions of this Section 7 shall survive any
termination of this Agreement with respect to actions of the Parties during the
term of the Agreement or the term of any Sublicense to EyeTech, whichever occurs
later. Each Indemnified Party's rights under this Section 7 shall not be deemed
to have been waived or otherwise affected by such Indemnified Party's waiver of
the breach of any representation, warranty, agreement or covenant contained in
or made pursuant to this Agreement, unless such waiver expressly and in writing
also waives any or all of the Indemnified Party's right under Section 7.
SECTION 8
MISCELLANEOUS
8.1 Successors and Assigns. This Agreement shall be binding upon
and shall inure to the benefit of the Parties hereto and their respective
successors and assigns; provided, however, that neither CMI nor EyeTech may
assign any of its rights, duties or obligations hereunder with the prior written
consent of the other, which consent may not be unreasonably withheld, except
that no prior written consent shall be required in the event that a Third Party
acquires substantially all of the assets or outstanding shares of, or merges
with, EyeTech or CMI, as the case may be. No assignment of this Agreement or of
any rights hereunder shall relieve the assigning Party of any of its obligations
or liability hereunder. Any attempted assignment not in compliance with this
Section 8.1 shall be of no force or effect.
8.2 Notices. All notices or other communications required or
permitted to be given hereunder shall be in writing and shall be deemed to have
been duly given if delivered by hand, prepaid telex, cable, telegram or
facsimile and confirmed in writing, or mailed first class, postage
29
prepaid, by registered or certified mail, return receipt requested (mailed
notices and notices sent by telex, cable or telegram shall be deemed to have
been given on the date received) as follows:
If to CMI, as follows:
Cell-Matrix, Inc.
Administrative Offices
0 Xxxx Xxxx
Xxxxxx Xxxx, Xxxxxxxxxxxx 00000
Attn: Xxxxxxx X. Xxxxx, Xx. - Chief Executive Officer
With a copy to:
Cell-Matrix, Inc.
Administrative Offices
0 Xxxx Xxxx
Xxxxxx Xxxx, Xxxxxxxxxxxx 00000
Attn: Xxxxxx Xxxxxx, Xx. - General Counsel
If to EyeTech, as follows:
EyeTech Pharmaceuticals, Inc.
000 Xxxxx Xxxxxx, 00xx Xxxxx
Xxx Xxxx, X.X. 00000
Facsimile: (000) 000-0000
Attn: Xxxxx X. Xxxxx-Chief Executive Officer
or in any case to such other address or addresses as hereafter shall be
furnished as provided in this Section 8.2 by any Party hereto to the other
Party.
8.3 Waiver; Remedies. Any term or provision of this Agreement may
be waived at any time by the Party entitled to the benefit thereof by a written
instrument executed by such Party. No delay on the part of CMI or EyeTech in
exercising any right, power or privilege hereunder shall operate as a waiver
thereof, nor shall any waiver on the part of either CMI or EyeTech of any right,
power or privilege hereunder operate as a waiver of any other right, power or
privilege hereunder nor shall any single or partial exercise of any right, power
or privilege hereunder preclude any other or further exercise thereof or the
exercise of any other right, power or privilege hereunder.
8.4 Survival of Representations. Each of the representations and
warranties made in this Agreement shall survive the expiration or termination of
this Agreement only with respect to activities conducted or events occurring
prior to the expiration or termination of the Agreement.
8.5 Entire Agreement. This Agreement constitutes the entire
agreement between the Parties with respect to the subject matter hereof and
supersedes all prior agreements or understandings of the Parties relating
thereto.
30
8.6 Amendment. This Agreement may be modified or amended only by
written agreement of the Parties hereto.
8.7 Counterparts. This Agreement may be executed in any number of
counterparts, each of which shall be deemed an original but all of which
together shall constitute a single instrument.
8.8 Governing Law. This Agreement shall be governed and construed
in accordance with the laws of the State of Delaware, excluding its choice of
law rules, except for the application of the Federal Arbitration Act pursuant to
Section 8.9(c)(ii).
8.9 Dispute Resolution.
(a) The Parties recognize that disputes as to certain
matters may from time to time arise during the term of this Agreement that
relate to either party's rights and/or obligations hereunder or thereunder. It
is the objective of the Parties to establish procedures to facilitate the
resolution of disputes arising under this Agreement in an expedient manner by
mutual cooperation and without resort to litigation; provided, however, no
matter with respect to the development or commercialization of the Antibodies or
Products for which EyeTech has full plenary power hereof shall be subject to the
dispute resolution or arbitration procedures set forth herein without EyeTech's
express written consent. To accomplish this objective, the Parties agree to
follow the procedures set forth in this Section 8.9 if and when a dispute arises
under this Agreement. In the event of disputes between the Parties, a Party
seeking to resolve such dispute will, by written notice to the other Party, have
such dispute referred to their respective executive officers designated below or
their successors, for attempted resolution by good faith negotiations within
fourteen (14) days after such notice is received. Said designated officers are
as follows:
For EyeTech: Chief Executive Officer
For CMI: Chief Executive Officer
In the event the designated executive officers are not able to resolve
such dispute, either party may at any time after the 14 day period invoke the
provisions of Section 8.9(b) hereinafter.
(b) Following settlement efforts pursuant to Section
8.9(a), any dispute, controversy or claim arising out of or relating to the
validity, construction, enforceability or performance of this Agreement,
including disputes relating to alleged breach or to termination of this
Agreement under Section 4, other than disputes which are expressly prohibited
herein from being resolved by this mechanism, shall be settled by binding
Alternative Dispute Resolution ("ADR") in the manner described below:
(i) If a party intends to begin an ADR to
resolve a dispute, such party shall provide written notice (the "ADR Request")
to counsel for the other party informing such other party of such intention and
the issues to be resolved. From the date of the ADR Request and until such time
as any matter has been finally settled by ADR, the running of the time periods
contained in Section 4.3 as to which party must cure a breach of this Agreement
shall be suspended as to the subject matter of the dispute.
31
(ii) Within ten (10) business days after the
receipt of the ADR Request, the other party may, by written notice to the
counsel for the party initiating ADR, add additional issues to be resolved.
(iii) Disputes regarding the scope, validity and
enforceability of Patents shall not be subject to this Section 8.9 and such
Patent disputes shall be submitted to a court of competent jurisdiction.
(c) The ADR shall be conducted pursuant to the Federal
Rules of Evidence and Civil Procedure then in effect (or such other rules as the
Parties may mutually agree), except that notwithstanding those rules, the
following provisions shall apply to the ADR hereunder:
(i) The arbitration shall be conducted by a
panel of three arbitrators (the "Panel"). The Panel shall be selected from a
pool of retired independent federal judges to be presented to the Parties by
JAMS.
(ii) The time periods set forth in the JAMS rules
shall be followed, unless a party can demonstrate to the Panel that the
complexity of the issues or other reasons warrant the extension of one or more
of the time tables. In such case, the Panel may extend such time tables, but in
no event shall the time tables being extended so that the ADR proceeding extends
more than 18 months from its beginning to the Award. In regard to such time
tables, the Parties (i) acknowledge that the issues that may arise in any
dispute involving this Agreement may involve a number of complex matters and
(ii) confirm their intention that each party will have the opportunity to
conduct complete discovery with respect to all material issues involved in a
dispute within the framework provided above. Within such time frames, each party
shall have the right to conduct discovery in accordance with the Federal Rules
of Civil Procedure. The Panel shall not award punitive damages to either party
and the Parties shall be deemed to have waived any right to such damages. The
Panel shall, in rendering its decision, apply the substantive law of the State
of Delaware, without regard to its conflict of laws provisions, except that the
interpretation of and enforcement of this Section 8.9(c)(ii) shall be governed
by the Federal Arbitration Act. The Panel shall apply the Federal Rules of
Evidence to the hearing. The proceeding shall take place in Wilmington,
Delaware; New York, New York; or Philadelphia, Pennsylvania. The fees of the
Panels and JAMS shall be paid by the losing Party that shall be designated by
the Panel. If the Panel is unable to designate a losing party, it shall so state
and the fees shall be split equally between the Parties.
(iii) The Panel is empowered to award any remedy
allowed by law, including money damages, multiple damages, prejudgment interest
and attorneys' fee, and to grant final, complete, interim, or interlocutory
relief, including injunctive relief but excluding punitive damages.
(iv) Except as set forth in Section 8.9(c)(ii),
above, each party shall bear its own legal fees. The Panel shall assess its
costs, fees and expenses against the party losing the ADR unless it believes
that neither party is the clear loser, in which case the Panel shall divide such
fees, costs and expenses according to the Panel's sole discretion.
32
(v) The ADR proceeding shall be confidential and
the Panel shall issue appropriate protective orders to safeguard each party's
Proprietary Information. Except as required by law, no party shall make (or
instruct the Panel to make) any public announcement with respect to the
proceedings or decision of the Panel without prior written consent of each other
party. The existence of any dispute submitted to ADR, and the award, shall be
kept in confidence by the Parties and the Panel, except as required in
connection with the enforcement of such award or as otherwise required by
applicable law.
(d) The Parties agree that judgment on any arbitral award
issued pursuant to this Section 8.9 shall be entered in the United States
District Court for the District of Delaware or, in the event such court does not
have subject matter jurisdiction over the dispute in question, such judgment
shall be entered in the trial courts of the State of Delaware, and each Party
agrees to the co-exclusive personal jurisdiction of such courts for the purpose
of entry of such a judgment.
8.10 Captions. All section titles or captions contained in this
Agreement, in any Exhibit referred to herein and the table of contents, if any,
to this Agreement are for convenience only, shall not be deemed a part of this
Agreement and shall not affect the meaning or interpretation of this Agreement.
8.11 No Third Party Rights or Obligations. Except as otherwise
expressly provided in this Agreement, no provision of this Agreement shall be
deemed or construed in any way to result in the creation of any rights or
obligation in any Person not a Party to this Agreement.
8.12 Severability. If any provision of this Agreement is found or
declared to be invalid or unenforceable by any court or other competent
authority having jurisdiction, such finding or declaration shall not invalidate
any other provision hereof, and this Agreement shall thereafter continue in full
force and effect. In the event any such provision is so declared invalid or
unenforceable, the Parties shall negotiate an alternative provision that closely
approximates the Parties' intent, to the extent allowable under law.
8.13 Attachments. All Exhibits and other attachments to this
Agreement are by this reference incorporated herein and made a part of this
Agreement.
8.14 Disclaimer of Agency. This Agreement shall not constitute any
Party the legal representative or agent of another, nor shall any Party have the
right or authority to assume, create, or incur any Third Party liability or
obligation of any kind, express or implied, against or in the name of or on
behalf of another except as expressly set forth in this Agreement.
8.15 Interpretation. This Agreement has been jointly prepared by
the Parties and their respective legal counsel and shall not be strictly
construed against either Party.
8.16 Force Majeure. Each of the Parties hereto shall be excused
from the performance of its obligations hereunder (except the payment of money)
in the event such performance is prevented by force majeure, provided that the
non-performing Party promptly provides notice of the prevention to the other
Party. Such excuse shall be continued so long as the condition constituting
force majeure continues and the non-performing Party makes and continues to make
reasonable efforts to remove or overcome the condition. For the purposes of this
Agreement,
33
force majeure shall mean any act of God, fire, casualty, flood, war, earthquake,
strike, failure of public utilities, any act, exercise, assertion or requirement
of governmental authority, accident, epidemic, destruction of facilities, or
such other similar occurrences beyond the control of the Party whose performance
is affected.
8.17 Limitation of Liability. IN NO EVENT SHALL EITHER PARTY OR ITS
RESPECTIVE AFFILIATES AND PERMITTED SUBLICENSEES BE LIABLE FOR SPECIAL,
EXEMPLARY, CONSEQUENTIAL OR PUNITIVE DAMAGES, WHETHER IN CONTRACT, WARRANTY,
TORT, STRICT LIABILITY OR OTHERWISE, EXCEPT TO THE EXTENT SUCH PARTY MAY BE
REQUIRED TO INDEMNIFY THE OTHER PARTY FROM SUCH DAMAGES CLAIMED BY THIRD PARTIES
UNDER SECTION 7.
8.18 No Assumption of Obligations. Except as expressly provided in
this Agreement: (i) neither Party is assuming any of the other Party's
responsibilities, duties (including, without limitation, compliance with all
applicable laws and regulations), obligations (including payment obligations),
claims, Damages, liabilities, burdens and problems of any nature whatsoever
(collectively, "Obligations"), whether by operation of law or otherwise, and
(ii) without limiting the foregoing, EyeTech is not assuming any of CMI's
Obligations with respect to Transferred Assets.
[SIGNATURES ON FOLLOWING PAGE]
34
IN WITNESS WHEREOF, the Parties have caused this Agreement to be duly
executed and delivered as of the day and year first above written.
CELL-MATRIX, INC. EYETECH PHARMACEUTICALS, INC.
By: /s/ Xxxxxxx X. Xxxxx, Xx. By: /s/ Xxxxx X. Xxxxx
----------------------------------- ----------------------------------
Name: Xxxxxxx X. Xxxxx, Xx. Name: Xxxxx X. Xxxxx
Chairman of the Board and CEO Title: Chief Executive Officer
WE HEREBY CONSENT TO AND APPROVE OF THE SUBLICENSE GRANTED HEREIN:
THE UNIVERSITY OF SOUTHERN CALIFORNIA
By: /s/ Xxxxxx X. Xxxxxxxxx
----------------------------
Name: Xxxxxx X. Xxxxxxxxx
Title: Senior Vice President
Administration
35
LIST OF EXHIBITS
Exhibit A: Product Data Package (see definition of "Product Data Package")
Exhibit B: Transferred Assets and Manufacturing Information (see Section 2.2)
Exhibit C: Sublicensed Patents (see definition and Section 5.6)
EXHIBIT A
(i) Pre-clinical and Clinical Development Protocols, Data, and Reports:
a. Confidential Description of Anti-angiogenis and Anti-Tumor Activity
of Monoclonal Antibody HUIV26 (attached).
b. Confidential Description of Inhibition of Retinal Angiogenesis by
MonoClonal Antibody HUIV26 (attached).
c. Anti-angiogenic and Anti-tumor data for Monoclonal Antibody HUI77
(attached).
d. Anti-angiogenic and Anti-tumor data for Monoclonal Antibody XL313
(attached).
(ii) Manufacturing Development Technical Reports.
[***]
(iii) Toxicology Reports: None
(iv) Other : None
*** Certain information on this page has been omitted and filed separately with
the Commission. Confidential treatment has been requested with respect to the
omitted portions.
[98 Pages of Proprietary Information Deleted Pursuant to Confidential Treatment
Request]
Exhibit B Transferred Assets
[2 Pages of Proprietary Information Deleted Pursuant to Confidential Treatment
Request]
EXHIBIT C
Sublicensed Patents
U.S. Patent Application-Serial No.: [***]
PCT International Application-Serial No.: [***]
*** Certain information on this page has been omitted and filed separately with
the Commission. Confidential treatment has been requested with respect to the
omitted portions.
