Exhibit 10.5
EXECUTION COPY
LICENSE AGREEMENT
BETWEEN
AMGEN INC.
AND
PREDIX PHARMACEUTICALS HOLDINGS, INC.
PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE COMMISSION PURSUANT TO THE COMPANY'S APPLICATION REQUESTING
CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE EXCHANGE ACT; [*] DENOTES
OMISSIONS.
LICENSE AGREEMENT
THIS LICENSE AGREEMENT (this "Agreement") is made and entered into as of
July 31, 2006, by and between Predix Pharmaceuticals Holdings, Inc., a Delaware
corporation headquartered at 0 Xxxxxxx Xxxx, Xxxxxxxxx, XX 00000 ("Predix"), and
Amgen Inc., a Delaware corporation having its principal place of business at Xxx
Xxxxx Xxxxxx Xxxxx, Xxxxxxxx Xxxx, XX 00000-0000 ("Amgen"). Predix and Amgen are
sometimes referred to herein individually as a "Party" and collectively as the
"Parties."
RECITALS
WHEREAS, Predix Controls (as defined below) certain Patent Rights (as
defined below) and know-how rights with respect to the Licensed Compounds (as
defined below); and
WHEREAS, Amgen desires to obtain from Predix the licenses set forth
herein, and Predix desires to grant such licenses to Amgen, all on the terms and
conditions set forth in this Agreement;
NOW, THEREFORE in consideration of the foregoing and the mutual agreements
set forth below, the Parties agree as follows:
ARTICLE 1
DEFINITIONS
The terms in this Agreement with initial letters capitalized, whether used
in the singular or the plural, shall have the meaning set forth below or, if not
listed below, the meaning designated in places throughout this Agreement.
1.1 "Acquired Compounds" means Other Compounds that are designated as
Acquired Compounds pursuant to [********]. "Acquired Compounds" that fall within
the definition of Licensed Compounds shall be deemed Licensed Compounds solely
for purposes of [********].
1.2 "Acquired Products" means any pharmaceutical product containing an
Acquired Compound, in all forms, presentations, formulations and dosage forms.
"Acquired Products" that fall within the definition of Licensed Products shall
be deemed Licensed Products solely for purposes of Article 7.
1.3 "Act" means the United States Food, Drug and Cosmetic Act, as amended.
1.4 "Additional Predix Research" has the meaning set forth in Section
2.6.1.
1.5 "Affiliate" of a Person means any other Person which (directly or
indirectly) is controlled by, controls or is under common control with such
Person. For the purposes of this definition, the term "control" (including, with
correlative meanings, the terms "controlled by" and "under common control with")
as used with respect to a Person means (i) in the case of a
-2-
PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE COMMISSION PURSUANT TO THE COMPANY'S APPLICATION REQUESTING
CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE EXCHANGE ACT; [*] DENOTES
OMISSIONS.
corporate entity, direct or indirect ownership of voting securities entitled to
cast at least fifty percent (50%) of the votes in the election of directors or
(ii) in the case of a non-corporate entity, direct or indirect ownership of at
least fifty percent (50%) of the equity interests with the power to direct the
management and policies of such entity, provided that if local Law restricts
foreign ownership, control shall be established by direct or indirect ownership
of the maximum ownership percentage that may, under such local Law, be owned by
foreign interests. A Person will be an Affiliate for purposes of this Agreement
only so long as such Person satisfies the definition set forth herein.
1.6 "Agreement" means this Agreement, together with all attachments
hereto, as the same may be amended or supplemented from time to time.
1.7 "Amgen Compounds" means all compounds that Modulate the S1P1 receptor
and (a) the composition of matter of which are claimed by the Amgen Patents
and/or (b) are [********] a compound described in the foregoing clause (a). For
avoidance of doubt, any metabolic precursors or prodrugs, isomers, metabolites,
hydrates, anhydrides, solvates, salt forms, free acids or bases, esters, amides,
ethers, complexes, conjugates or polymorphs of any compounds covered by the
foregoing clauses (a) or (b) are also "Amgen Compounds." "Amgen Compounds" that
fall within the definition of [********] shall be deemed to be [********] for
all purposes hereunder; provided that, the Parties agree that any compounds that
are Controlled by Amgen as of the Effective Date (other than by virtue of the
licenses granted hereunder) that would fall within the definition of [********]
solely because they are claimed by a Valid Claim within the [********] that
claims an invention that was conceived and reduced to practice by [********]
after the Effective Date and arises out of the performance of the [********]
(and that is not claimed by the [********] as of the Effective Date) will be
[********] for all purposes hereunder except for purposes of [********], and
such compounds shall be deemed [********] for purposes of [********]. "Amgen
Compounds" that fall within the definition of [********] shall be deemed to be
[********] for all purposes hereunder, except to the extent set forth in
[********].
1.8 "Amgen Patents" means all Patent Rights Controlled (other than those
Patent Rights which are licensed to Amgen hereunder) by Amgen as of the
Effective Date or during the term of this Agreement that claim the composition
of matter of a modulator of the S1P1 receptor, or a method of manufacture, use
or formulation thereof. Amgen Patents shall include Amgen's interest in any
Joint Patents.
1.9 "Amgen Product" means any pharmaceutical product containing an Amgen
Compound, in all forms, presentations, formulations and dosage forms. Amgen
Products that fall within the definition of [********] shall be [********] for
all purposes hereunder; except that a pharmaceutical product that is a
[********] because it contains an Amgen Compound that is deemed a [********] for
all purposes hereunder other than for purposes of [********] (as set forth in
Section 1.7 above) shall be deemed an [********] for purposes of [********].
"Amgen Products" that fall within the definition of [********] shall be deemed
to be [********] for all purposes hereunder.
-3-
PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE COMMISSION PURSUANT TO THE COMPANY'S APPLICATION REQUESTING
CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE EXCHANGE ACT; [*] DENOTES
OMISSIONS.
1.10 "Approval" means, with respect to any product in any regulatory
jurisdiction, approval from the applicable Regulatory Authority sufficient for
the manufacture, distribution, use and sale of the product in such jurisdiction
in accordance with applicable Laws.
1.11 "Business Day" or "business day" means a day other than Saturday,
Sunday or any day on which commercial banks located in New York, New York are
authorized or obligated by applicable Law to close.
1.12 "Calendar Quarter" means the respective periods of three consecutive
calendar months ending on March 31, June 30, September 30 and December 31.
1.13 "Calendar Year" means each successive period of 12 months commencing
on January 1 and ending on December 31.
1.14 "Change of Control" means the occurrence of any of the following
events:
(a) Any person (as such term is defined under Section 13(d)(3) of
the Securities Exchange Act of 1934, as amended (the "Exchange Act")),
corporation or other entity is or becomes the beneficial owner (as such term is
defined in Rule 13d-3 under the Exchange Act) of securities of Predix
representing fifty percent (50%) or more of the combined voting power of the
outstanding securities or ownership interests of Predix which ordinarily (and
apart from rights accruing under special circumstances) have the right to vote
in the election of directors (calculated as provided in paragraph (d) of such
Rule 13d-3 in the case of rights to acquire the Predix securities);
(b) As a result of a tender offer, merger, sale of assets or other
major transaction, the persons who are directors of Predix immediately prior to
such transaction cease to constitute a majority of the Board of Directors of
Predix (or any successor corporations) immediately after such transaction;
(c) Predix is merged or consolidated with any other person, firm,
corporation or other entity and, as a result, the shareholders of Predix, as
determined immediately before such transaction, own less than fifty-one percent
(51%) of the outstanding securities or ownership interests of the surviving or
resulting entity immediately after such transaction; or
(d) Predix transfers all or substantially all of its assets to
another person, firm, corporation or other entity.
The merger of Predix into EPIX Delaware, Inc. ("EPIX"), a subsidiary of
EPIX Pharmaceuticals, Inc., contemplated in the Agreement and Plan of Merger
dated as of April 3, 2006 among Predix, EPIX and EPIX Pharmaceuticals, Inc.
shall not be deemed a Change of Control for purposes of this Agreement; provided
however, that the definition of Change of Control hereunder shall thereafter
apply to the successor entity of Predix's merger into EPIX, as if such entity
was referenced herein instead of Predix.
-4-
PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE COMMISSION PURSUANT TO THE COMPANY'S APPLICATION REQUESTING
CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE EXCHANGE ACT; [*] DENOTES
OMISSIONS.
1.15 "Collaboration" means the activities performed under this Agreement
for the Development and Commercialization of Program Products.
1.16 "Combination Product" means a Program Product that includes at least
one additional therapeutically active ingredient that is not a Program Compound
or Program Product. Drug delivery vehicles, adjuvants, and excipients shall not
be deemed to be "therapeutically active ingredients", except in the case where
such delivery vehicle, adjuvant, or excipient is recognized by the FDA as a
therapeutically active ingredient in accordance with 21 C.F.R. 210.3(b)(7).
1.17 "Commercial Documents" means all agreements and documents to the
extent directly related to a [********] or [********] and useful in the
continued Development and Commercialization of such [********] or [********]
(including documents and agreements relating to the sourcing, manufacture,
testing, clinical development, promotion, distribution, sale or use of
[********]) throughout the Territory that are [********] to [********], are not
[********] to [********] from another source, and that can be produced by
[********] without [********] in light of the importance of the specific
agreements and documents to Predix. Commercial Documents excludes Regulatory
Filings.
1.18 "Commercialization" or "Commercialize" means activities directed to
commercially manufacturing, obtaining pricing and reimbursement approvals,
carrying out Phase 4 Trials for, marketing, promoting, distributing, importing,
exporting, offering for sale or selling a drug product.
1.19 "Commercially Reasonable Efforts" means, with respect to drug
compounds and drug products, the carrying out of Development and
Commercialization activities, and the preparation, filing, prosecution
(including any interferences, reissue proceedings and reexaminations) and
maintenance of Patent Rights claiming such drug compounds and drug products, in
a sustained manner using good faith commercially reasonable and diligent efforts
that a company within the pharmaceutical industry and similarly situated to
Amgen would reasonably devote to a product of similar market potential or profit
potential resulting from its own research efforts and on which it would not owe
royalties to Predix, based on conditions then prevailing and taking into
account, without limitation, issues of safety and efficacy, product profile, the
proprietary position, the then current competitive environment for such product
or compound and the likely timing of the product's entry into the market, the
regulatory environment and status of the product, and other relevant scientific,
technical and commercial factors as they exist at the time throughout the
Territory.
1.20 "Composition License" means a [********] license to be granted by
Amgen to Predix, under certain circumstances, which shall be [********] license
of all of Amgen's rights under [********] that [********] of [********] and
[********] arising out of the performance of the Collaboration, to make, use
(including in activities directed at the research and Development of compounds
and products), have made, sell, offer to sell, export, import and otherwise
exploit or Commercialize such [********] and [********]. Such license shall be
fully-sublicensable. If such [********] or [********] is Developed or
Commercialized as a [********] (which shall include for the purposes of this
definition only a product that contains a [********] and another active
ingredient, which may or may not be a [********] (other than a [********]) or a
[********] (other than a [********])) then, at Predix's request, the Parties
shall
-5-
PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE COMMISSION PURSUANT TO THE COMPANY'S APPLICATION REQUESTING
CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE EXCHANGE ACT; [*] DENOTES
OMISSIONS.
negotiate in good faith for a reasonable period of time towards a license
or similar grant of rights to Predix, on terms to be agreed upon by the Parties,
to enable Predix to continue such Development and Commercialization of such
[********] as part of the relevant Composition License.
1.21 "Confidential Information" means all trade secrets, processes,
formulas, data, know-how, improvements, inventions, chemical or biological
materials, techniques, marketing plans, strategies, customer lists, or other
information that has been created, discovered, or developed by a Party, or has
otherwise become known to a Party, or to which rights have been assigned to a
Party, as well as any other information and materials that are deemed
confidential or proprietary to or by a Party (including all information and
materials of a Party's customers and any other Third Party), in each case that
are disclosed by such Party to the other Party in connection with the Agreement
or the performance of the Parties hereunder, regardless of whether any of the
foregoing are marked "confidential" or "proprietary" or communicated to the
other by the disclosing Party in oral, written, graphic, or electronic form. For
purposes of this Agreement, any know-how that is subject to a license granted
hereunder shall be treated as being Confidential Information of both the
licensor and the licensee.
1.22 "Controlled" or "Controls", when used in reference to intellectual
property or intellectual property rights, means the legal authority or right of
a Party hereto (or any of its Affiliates) to grant a license or sublicense of
intellectual property rights to another Party, or to otherwise disclose
proprietary or trade secret information to such other Party, in each case as
provided herein without breaching the terms of any agreement with a Third Party,
or misappropriating the proprietary or trade secret information of a Third
Party.
1.23 "Co-Promotion Indication" has the meaning set forth in Section 5.1.
1.24 "Designated Country" means any country in which all field sales and
marketing activities can be conducted by [********] or fewer field sales
representatives in a manner that meets Commercially Reasonable Efforts. For
avoidance of doubt, "Designated Countries" will not include any of the following
countries: the [********].
1.25 "Development" means research and drug development activities, both
non-clinical and clinical, that are reasonably related to the development and
submission to a Regulatory Authority of information, including toxicology,
pharmacology and other discovery and pre-clinical efforts (including any
Additional Predix Research), test method development and stability testing,
manufacturing process development, formulation development, delivery system
development, quality assurance and quality control development, statistical
analysis, clinical studies (specifically excluding regulatory activities
directed to obtaining pricing and reimbursement approvals). When used as a verb,
"Develop" means to engage in Development.
1.26 "Development Plan" means a high-level plan specifying clinical
development and, as applicable, Commercialization activities for Program
Products (including a description of the anticipated timing to start, perform
and complete such activities, annual projected development budgets developed
with respect to Program Compounds that have reached the stage in which GLP
Toxicology Studies are performed (or are more advanced), and anticipated phases
and milestones
-6-
PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE COMMISSION PURSUANT TO THE COMPANY'S APPLICATION REQUESTING
CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE EXCHANGE ACT; [*] DENOTES
OMISSIONS.
associated with such activities) to be undertaken with respect to Development
and Commercialization of Program Products in the Territory.
1.27 "Dollar" or "$" means the lawful currency of the United States.
1.28 "Effective Date" means the date specified in the initial paragraph of
this Agreement.
1.29 "EMEA" means the European Agency for the Evaluation of Medicinal
Products, or any successor agency thereto.
1.30 "Europe" means the countries comprising the European Union as it may
be constituted from time to time, together with those additional countries
included in the European Economic Area as it may be constituted from time to
time, and any successors to, or new countries created from, any of the
foregoing.
1.31 "Existing Licenses" has the meaning set forth in Section 8.2.
1.32 "FDA" means the U.S. Food and Drug Administration, or any successor
agency thereto.
1.33 "Federal Court" has the meaning set forth in Section 14.8.
1.34 "Field" means all uses, including the diagnosis, prevention,
treatment or control of any human or animal disease, disorder or condition.
1.35 "First Commercial Sale" means, with respect to any product, the first
sale for use or consumption by the general public of such product in any country
in the Territory after Approval of such product has been granted, or such
marketing and sale is otherwise permitted, by the Regulatory Authority of such
country.
1.36 "GAAP" means generally accepted accounting principles in the United
States.
1.37 "Generic Product" means any pharmaceutical product containing as a
[********] a [********] (or any salt, solvate, crystalline or noncrystalline
form of such [********]) that is also contained in a [********], and which
pharmaceutical product is sold in the same country as such [********] by any
Third Party that is not a Sublicensee, one of Amgen's Affiliates or otherwise
acting on Amgen's behalf in conducting such sales.
1.38 "IND" means an Investigational New Drug Application, as defined in
the Act, filed with the FDA or its foreign counterparts.
1.39 "Indemnification Claim" has the meaning set forth in Section 11.3.
1.40 "Indemnitee" has the meaning set forth in Section 11.3.
1.41 "Indemnitor" has the meaning set forth in Section 11.3.
1.42 "IP Transition Date" has the meaning set forth in Section 9.2.2.
-7-
PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE COMMISSION PURSUANT TO THE COMPANY'S APPLICATION REQUESTING
CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE EXCHANGE ACT; [*] DENOTES
OMISSIONS.
1.43 "Joint Invention" has the meaning set forth in Section 9.1.
1.44 "Joint Patents" has the meaning set forth in Section 9.1.
1.45 "Laws" means all laws, statutes, rules, regulations and ordinances
having the effect of law of any federal, national, multinational, state,
provincial, county, city or other political subdivision, domestic or foreign.
1.46 "Licensed Compound", except as otherwise specifically provided in
[********], means all compounds that Modulate the S1P1 receptor and (a) the
composition of matter of which are claimed by the [********] in the form
attached hereto (regardless of whether such claims are [********] through
prosecution of the [********] to [********] such compounds), or (b) the
composition of matter of which are claimed by a Valid Claim within the Licensed
Patents filed following the Effective Date and that arise out of the performance
of the [********], and/or (c) are [********] a compound described in the
foregoing "(a)" or "(b)". For avoidance of doubt any metabolic precursors or
prodrugs, isomers, metabolites, hydrates, anhydrides, solvates, salt forms, free
acids or bases, esters, amides, ethers, complexes, conjugates or polymorphs of
any compounds covered by the foregoing clauses (a), (b) or (c) are also
"Licensed Compounds."
1.47 "Licensed Know-How" means all technical information and know-how
Controlled by Predix or its Affiliates during the term of this Agreement
(including all biological, chemical, pharmacological, toxicological, clinical,
assay and related know-how and trade secrets, and all manufacturing data, the
specifications of ingredients, the manufacturing processes, specifications,
sourcing information, assays, quality control and testing procedures, and
related know-how and trade secrets) that is necessary or useful for the
manufacture, Development and/or Commercialization of Program Compounds or
Program Products. For avoidance of doubt, "Licensed Know-How" does not include
any know-how, or any intellectual property related thereto, that constitutes or
is related to in-silico drug design, discovery or development technology,
including the in silico receptor modeling and drug design technology licensed by
Predix from RAMOT (Tel Aviv University).
1.48 "Licensed Patents" means all Patent Rights Controlled by Predix or
its Affiliates as of the Effective Date or during the term of this Agreement
that claim the composition of matter of a modulator of the S1P1 receptor, or a
method of manufacture, use or formulation thereof. Licensed Patents include
Predix's interest in Joint Patents. For avoidance of doubt, the Licensed Patents
shall include the Scaffold Patent Applications
1.49 "Licensed Product" means any pharmaceutical product containing a
Licensed Compound, in all forms, presentations, formulations and dosage forms.
1.50 "Losses and Claims" has the meaning set forth in Section 11.1.
1.51 "MAA Approval" means approval by the EMEA of a marketing
authorization application ("MAA") filed with the EMEA for a Program Product
under the centralized European procedure. If the centralized EMEA filing
procedure is not used, MAA Approval shall be achieved upon the first Approval
for the applicable Program Product in [********].
1.52 "Major Market" means the [********].
-8-
PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE COMMISSION PURSUANT TO THE COMPANY'S APPLICATION REQUESTING
CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE EXCHANGE ACT; [*] DENOTES
OMISSIONS.
1.53 "Modulate" means, with reference to a compound, that it: (i) has any
activity with an [****] or [****] for the S1P1 receptor that equals or is less
than [****] and (ii) is or was developed at least in part because of its
modulatory effect on the S1P1 receptor, giving consideration to the overall
intent as evidenced, for example, by patent applications, scientific
publications or Regulatory Filings of the developing Party related to such
compound. For purposes of this definition, [****] means the[****] of a compound,
which produces [****] of the maximum possible response in a biological assay and
[****] means the [****] of a compound, which produces [****] of the maximum
possible inhibitory response in a biological assay.
1.54 "Modulator" means a compound that Modulates the S1P1 receptor.
1.55 "NDA" means a New Drug Application filed with the FDA required for
marketing approval for the applicable Program Product in the U.S.
1.56 "NDA Approval" means the approval of an NDA by the FDA for the
applicable Program Product in the U.S.
1.57 "NDA Filing" means the acceptance by the FDA of the filing of an NDA
for the applicable Program Product.
1.58 "Net Sales" means, with respect to any Program Product, the amount
invoiced by a Party, an Affiliate of such Party, or any permitted Sublicensee of
such Party for sales of such Program Product to a Third Party less:
(a) discounts (including cash discounts, prompt payment discounts,
quantity discounts and patient discount program discounts), retroactive
price reductions, charge-back payments and rebates granted to managed
health care organizations or to federal, state and local governments,
their agencies, and purchasers and reimbursers or to trade customers (a
"Discount"); provided however, that where any such Discount is based on
sales of a bundled set of products in which such Program Product is
included, the Discount shall be allocated to such Program Product on a pro
rata basis based on the sales value (i.e., the unit average selling price
multiplied by the unit volume) of the Program Product relative to the
sales value contributed by the other constituent products in the bundled
set, with respect to such sale;
(b) credits or allowances upon claims, damaged goods, rejections or
returns of such Program Product, including such Program Product returned
in connection with recalls or withdrawals;
(c) freight out, postage, shipping and insurance charges for delivery of
such Program Product; and
(d) taxes or duties levied on, absorbed or otherwise imposed on the sale
of such Program Product, including value-added taxes, or other
governmental charges otherwise imposed upon the invoiced amount, as
adjusted for rebates and refunds, to the extent not paid by the Third
Party.
-9-
PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE COMMISSION PURSUANT TO THE COMPANY'S APPLICATION REQUESTING
CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE EXCHANGE ACT; [*] DENOTES
OMISSIONS.
Any disposal of Program Products for, or use of Program Products in,
clinical or pre-clinical trials (including Phase 4 Trials), given as free
samples, or distributed at no charge to patients unable to purchase Program
Products shall not be included in Net Sales.
Upon any sale or other disposal of any Program Product, that should be
included in Net Sales, for any consideration other than exclusively monetary
consideration on arm's length terms, then for purposes of calculating the Net
Sales under this Agreement, such Program Product shall be deemed to be sold
exclusively for money at the average sales price during the applicable reporting
period generally achieved for such Program Product in such country in which such
sale or other disposal occurred when such Program Product is sold alone and not
with other products.
Net Sales shall be determined in accordance with GAAP.
In the case of any Combination Product sold in the Territory, Net Sales
for such Combination Product shall be calculated by multiplying actual Net Sales
of such Combination Product by the fraction A/(A+B) where A is the invoice price
of the Program Product if sold separately, and B is the total invoice price of
the other active ingredient or ingredients in the Combination Product, if sold
separately. If, on a country-by-country basis, the Program Product is sold
separately in said country but the other active ingredient(s) in the Combination
Product are not sold separately in said country, Net Sales for the purpose of
determining royalties of the Combination Product shall be calculated by
multiplying actual Net Sales of such Combination Product by the fraction A/D,
where A is the invoice price of the Program Product sold separately in said
country, and D is the invoice price of the Combination Product in said country.
If, on a country-by-country basis, the Program Product is not sold separately in
said country but the other active ingredient(s) in the Combination Product are
sold separately in said country, Net Sales for the purpose of determining
royalties of the Combination Product shall be calculated by multiplying actual
Net Sales of such Combination Product by the result of the equation 1-(X/Y),
where X is the total invoice price of the other active ingredient(s) sold
separately in said country, and Y is the invoice price of the Combination
Product in said country. If neither the Program Product nor the other active
ingredient(s) are sold separately in a given country, the Parties shall
determine Net Sales for such Combination Product by mutual agreement based on
the relative contribution of the Program Compound and each other active
ingredient to the Combination Product, and shall take into account in good faith
any applicable allocations and calculations that may have been made for the same
period in other countries (giving more weight to allocations made for Major
Market Countries than for other countries).
For purposes of the preceding paragraph, the invoice price of a Program
Product (which is not a Combination Product) sold separately for an indication
designated as an "Orphan Product" under the U.S. Orphan Drug Act, as amended,
shall not be used to calculate Net Sales for any Combination Product, except
when such Combination Product is approved for an indication designated as an
"Orphan Product" under the U.S. Orphan Drug Act, as amended.
Net Sales shall not include any payments among Amgen, its Affiliates and
Sublicensees.
1.59 "Other Compound" means a compound which Amgen has acquired or desires
to acquire, or for which Amgen has acquired or desires to acquire a license
under a Patent Right
-10-
PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE COMMISSION PURSUANT TO THE COMPANY'S APPLICATION REQUESTING
CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE EXCHANGE ACT; [*] DENOTES
OMISSIONS.
claiming the composition of matter of such compound, on or after the Effective
Date which is or becomes a Modulator.
1.60 "Other Product" means a pharmaceutical product that is comprised of
or incorporates an Other Compound, in all forms, presentations, formulations and
dosage forms.
1.61 "Patent Rights" means specified patents and patent applications
(including provisional applications and claims therein) and (a) any foreign
counterparts thereof, (b) all divisionals, continuations, continuations-in-part
thereof or any other patent application claiming priority to (i) any such
specified patents or patent applications or (ii) any patent or patent
application from which such specified patents or patent applications claim
priority, and (c) all patents issuing on any of the foregoing, and any foreign
counterparts thereof, together with all registrations, reissues,
re-examinations, renewals, supplemental protection certificates, or extensions
of any of the foregoing, and any foreign counterparts thereof.
1.62 "Person" means any individual, firm, corporation, partnership,
limited liability company, trust, business trust, joint venture, governmental
authority, association or other entity.
1.63 "Phase 1 Trial" means a human clinical trial of a Program Product,
the principal purpose of which is a preliminary determination of safety in
healthy individuals or patients, as described in 21 C.F.R. 312.21(a), or a
similar clinical study prescribed by the Regulatory Authorities in a foreign
country. For purposes of this Agreement, "start of a Phase 1 Trial" for a
Program Product means the first dosing of such Program Product in a human in a
Phase 1 Trial.
1.64 "Phase 2 Trial" means a human clinical trial of a Program Product,
the principal purpose of which is a determination of safety and preliminary
efficacy in the target patient population, as described in 21 C.F.R. 312.21(b),
or a similar clinical study prescribed by the Regulatory Authorities in a
foreign country. For purposes of this Agreement, "start of a Phase 2 Trial" for
a Program Product means the first dosing of such Program Product in a human
patient in a Phase 2 Trial.
1.65 "Phase 2b Trial" means a Phase 2 Trial of a Program Product, the
principal purpose of which is a determination of safety and sufficient potential
efficacy to progress such Program Product to a Phase 3 Trial. For purposes of
this Agreement, "start of a Xxxxx 0x Xxxxx" for a Program Product means the
first dosing of such Program Product in a human patient in a Phase 2b Trial.
1.66 "Phase 3 Trial" means a human clinical trial of a Program Product on
a sufficient number of subjects that is designed to establish that a
pharmaceutical product is safe and efficacious for its intended use, and to
determine warnings, precautions, and adverse reactions that are associated with
such pharmaceutical product in the dosage range to be prescribed, which trial is
intended to support Approval of a Program Product, as described in 21 C.F.R.
312.21(c), or a similar clinical study prescribed by the Regulatory Authorities
in a foreign country. For purposes of this Agreement, "start of a Phase 3 Trial"
for a Program Product means the first dosing of such Program Product in a human
patient in a Phase 3 Trial.
1.67 "Phase 4 Trial" means a human clinical trial for a Program Product
commenced after receipt of Approval in the country for which such trial is being
conducted and that is
-11-
PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE COMMISSION PURSUANT TO THE COMPANY'S APPLICATION REQUESTING
CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE EXCHANGE ACT; [*] DENOTES
OMISSIONS.
conducted within the parameters of the Approval for the Program Product. Phase 4
Trials may include epidemiological studies, modeling and pharmacoeconomic
studies, investigator sponsored clinical trials of Program Product and
post-marketing surveillance studies.
1.68 "Program Compounds" means all Licensed Compounds, Amgen Compounds and
Acquired Compounds. Program Compounds shall also include any other [********]
(other than Licensed Compounds, Amgen Compounds and Acquired Compounds)
[********] or their Affiliates, the manufacture, use or sale of which would
[********] a [********].
1.69 "Program Patents" means all Licensed Patents and Amgen Patents, and
all Joint Patents claiming S1P1 receptor modulators or a method of manufacture,
use or formulation thereof.
1.70 "Program Product" means any pharmaceutical product containing a
Program Compound, in all forms, presentations, formulations and dosage forms.
1.71 "Regulatory Authority" means any national or supranational
governmental authority, including the FDA, EMEA or Koseisho (i.e., the Japanese
Ministry of Health and Welfare, or any successor agency thereto), that has
responsibility in countries in the Territory over the Development and/or
Commercialization of the Program Compounds and Program Products.
1.72 "Regulatory Filings" means all regulatory applications, filings,
Approvals and associated correspondence required in connection with the
manufacture, Development, Commercialization, marketing, sale and importation of
Program Products in, or into, each country or jurisdiction in the Territory.
1.73 "Royalty Term" means, on a country-by-country and product-by-product
basis, the period commencing on the First Commercial Sale of a particular
Program Product in a country and lasting until the later of (i) ten (10) years
after the First Commercial Sale of such Program Product in such country or (ii)
the expiration of the last to expire Program Patent in such country (including
any extensions of such patents under applicable Laws, including patent term
extensions, pediatric exclusivity extensions or supplemental protection
certificates or their equivalents in any country) with a Valid Claim claiming
the Program Product or its use for which Approval has been obtained in such
country.
1.74 "Scaffold Patent Applications" means the patent applications attached
hereto as Appendix A.
1.75 "State Court" has the meaning set forth in Section 14.8.
1.76 "Sublicense" means the written agreement pursuant to which a Third
Party becomes a Sublicensee.
1.77 "Sublicensee" means any Third Party granted a sublicense by Amgen of
any of the rights licensed to Amgen by Predix under Section 2.1. For avoidance
of doubt: (i) a "Sublicensee" shall include a Third Party to whom Amgen has
granted the right, under the rights licensed to Amgen under Section 2.1, to
promote or distribute a Program Product if such Third Party is primarily
responsible for marketing and promotion of such Program Product within a
-12-
PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE COMMISSION PURSUANT TO THE COMPANY'S APPLICATION REQUESTING
CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE EXCHANGE ACT; [*] DENOTES
OMISSIONS.
particular country, (ii) a "Sublicensee" shall also include the party to a
further sublicense as set forth in Section 2.2(b)(v), (iii) a "Sublicensee"
shall not include service providers hired on a fee-for-service basis by Amgen,
an Affiliate or Sublicensee to assist in or perform Development, manufacture or
Commercialization activities, for example, contract research organizations,
contract manufacturing organizations and contract sales organizations, provided
that Amgen, an Affiliate or Sublicensee remain primarily responsible for the
overall Development, manufacture or Commercialization of the relevant Program
Product, and as such, amgen shall have the right to enter into such arrangements
without Predix's consent and without otherwise being subject to the provisions
herein relating to the grant or continued effectiveness of Sublicenses, and (iv)
a "Sublicensee" shall not include parties with non-exclusive rights to
participate in customary drug product supply and distribution chains such as
drug distributors and wholesalers, and as such, amgen shall have the right to
enter into such arrangements without Predix's consent and without otherwise
being subject to the provisions herein relating to the grant or continued
effectiveness of Sublicenses.
1.78 "Surviving Sublicensee" has the meaning set forth in Section 2.2(b).
1.79 "Territory" means worldwide.
1.80 "Third Party" means any Person other than Amgen, Predix and their
respective Affiliates.
1.81 "Title 11" has the meaning set forth in Section 12.6.
1.82 "Transfer License" means a [********] license granted by Amgen to
Predix, under certain circumstances, to all intellectual property rights
(including patent applications, patents, trade secrets, and copyrights) (a)
arising out of the performance of the Collaboration (other than patent rights
claiming compositions of matter of compounds which are not [********]), which
license is to make, use (including in activities directed at the research and
Development of compounds and products), have made, sell, offer to sell, export,
import and otherwise exploit or Commercialize [********] and [********], or (b)
[********] by [********] as of the termination date of this Agreement that are
necessary for or used, as of the termination date, in (that is, intellectual
property that has become [********] the manufacture, development or
commercialization of the applicable [********] within the Collaboration and
without which [********] is available without causing [********] or requiring
[********]) the research, development and commercialization of [********] or
[********], which license would be to make, use (including in activities
directed at the research and Development of compounds and products), have made,
sell, offer to sell, export, import and otherwise exploit or Commercialize the
specific [********] or [********] for which the intellectual property [********]
or in which the intellectual property has [********] as of the [********] of
this Agreement. When entering into any [********] or [********] with [********]
with respect to [********] described in the foregoing clause "(b)", [********]
shall use [********] to acquire the rights to provide a [********] or [********]
to [********] to such [********] (and [********] or [********] thereby) as part
of a [********] as provided herein. Such licenses shall be [********] with
respect to Amgen's rights in all technology that is commercially useful solely
in connection with one or more specific [********] or [********]. Such licenses
shall be [********] otherwise. Such license shall be [********].
-13-
PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE COMMISSION PURSUANT TO THE COMPANY'S APPLICATION REQUESTING
CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE EXCHANGE ACT; [*] DENOTES
OMISSIONS.
1.83 "United States" or "U.S." means the United States of America.
1.84 "Valid Claim" means a claim of (i) an issued and unexpired patent or
a supplementary protection certificate, which claim has not been revoked or held
invalid or unenforceable by a court or other government agency of competent
jurisdiction from which no appeal can be or has been taken and has not been held
or admitted to be invalid or unenforceable through re-examination or disclaimer,
reissue, opposition procedure, nullity suit or otherwise, or (ii) solely for
purposes of determining the Royalty Term for Program Patents, a [********] that
has not been [********], which claim in the case of clause (i) or (ii) covers a
Program Product, its manufacture or use provided, however, that if a claim of a
[********] shall not have [********] within [****] (or in Japan, [****]) after
the earliest filing date from which such claim takes priority, such claim shall
not constitute a Valid Claim for the purposes of this Agreement unless and until
a [********] within the Program Patents [********] with such claim.
ARTICLE 2
LICENSE GRANT
2.1 License for Program Compounds and Program Products. Subject to all the
terms and conditions set forth in this Agreement (including the reservation of
rights in Section 2.5), Predix hereby grants to Amgen a non-transferable (except
as provided in Section 14.4), exclusive (even as to Predix and its Affiliates)
license, with the right to sublicense in accordance with Section 2.2, under the
Licensed Patents and Licensed Know-How, to make, use (including in activities
directed at the research and Development of Program Compounds and Program
Products), have made, sell, offer to sell, export, import and otherwise exploit
or Commercialize Program Compounds and Program Products in the Field in the
Territory.
2.2 Sublicenses. Amgen shall have the right to grant sublicenses of same
or lesser scope with respect to the rights licensed to Amgen under Section 2.1
solely in accordance with this Section 2.2.
(a) Amgen shall have the right to grant Sublicenses in a country or
on a regional basis under Licensed Patents and Licensed Know-How; provided,
however, that Amgen shall not, without the prior approval of Predix (such
approval not to be unreasonably withheld), grant any such Sublicenses that
include the right of the Sublicensee to: (i) perform research or development of
a Program Compound or Program Product prior to the receipt of Approval of the
first Program Product in a Major Market, or (ii) market or sell a Licensed
Product in a Major Market (excluding arrangements with distributors or
wholesalers customary in the industry).
(b) Subject to Section 2.2(a), Amgen shall have the right to enter
into a Sublicense with a Third Party, provided that:
(i) such Sublicense shall be subordinate to the terms and
conditions of this Agreement, and shall not limit the ability of Amgen
(individually or through the activities of its Sublicensee) to fully perform all
of its obligations under this Agreement or limit Predix's rights under this
Agreement;
-14-
PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE COMMISSION PURSUANT TO THE COMPANY'S APPLICATION REQUESTING
CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE EXCHANGE ACT; [*] DENOTES
OMISSIONS.
(ii) promptly after execution of the Sublicense agreement,
Amgen shall provide a copy of such Sublicense agreement to Predix, which copy
may be redacted to exclude financial terms and confidential scientific
information, provided that all other relevant terms and information shall be
retained and such copy shall be treated as Amgen Confidential Information
hereunder;
(iii) Amgen shall remain responsible for the performance of
this Agreement and the performance of its Sublicensees hereunder, the payment of
all payments due, and making reports and keeping books and records, and shall
cause such Sublicensee to enable Amgen to comply with the terms and conditions
of this Agreement;
(iv) each Sublicense granted by Amgen to any right licensed to
it hereunder shall terminate immediately upon the termination of the license
from Predix to Amgen with respect to such right hereunder, provided that such
Sublicense shall not terminate if, as of the effective date of such termination
by Predix under Section 12.2, the Sublicensee is not in material breach of its
obligations to Amgen under its Sublicense agreement, and within thirty (30) days
of such termination the Sublicensee agrees in writing to be bound directly to
Predix under a license agreement substantially similar to this Agreement with
respect to the rights sublicensed hereunder, substituting such Sublicensee (a
"Surviving Sublicensee") for Amgen, and provided further that (A) such license
agreement shall not prejudice any remedy Predix may have against Amgen for the
circumstances which were the basis for such termination by Predix; (B) the scope
of the rights granted to the Surviving Sublicensee under such license agreement
(with respect to licensed activities, Licensed Compounds, Licensed Products and
territory) shall be equal to the scope of the rights that had been sublicensed
by Amgen to the Surviving Sublicensee pursuant to the Sublicense agreement; and
(C) such license agreement shall obligate the Surviving Sublicensee to pay
directly to Predix amounts corresponding to those set forth in Sections 7.2, 7.3
and 7.4 hereof which are payable based on the activities of such Surviving
Sublicensee, its Affiliates and its Sublicensees; and
(v) Amgen shall have the right to grant to Sublicensees the
right to grant further sublicenses of same or lesser scope as its sublicense
from Amgen under the grants contained in Section 2.1, provided that such further
sublicenses shall be in accordance with and subject to all of the terms and
conditions of this Section 2.2 (i.e., a sublicensee shall be subject to this
Section 2.2 in the same manner and to the same extent as Amgen) and each such
further sublicensee shall be a "Sublicensee" for all purposes hereunder (subject
to the exclusions to such definition provided in Section 1.77).
For the avoidance of doubt, Amgen shall have the right to grant
sublicenses without Predix's consent and without otherwise being subject to the
provisions herein relating to the grant or continued effectiveness of
Sublicenses, as and to the extent provided in clauses (iii) and (iv) of the
definition of the term "Sublicensee".
Notwithstanding the foregoing, Amgen shall have the right to grant
Sublicenses of the rights granted to Amgen under Section 2.1 hereof to Third
Parties without the consent of Predix for any countries which qualify as
Designated Countries at the time of the grant of such Sublicense.
-15-
PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE COMMISSION PURSUANT TO THE COMPANY'S APPLICATION REQUESTING
CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE EXCHANGE ACT; [*] DENOTES
OMISSIONS.
2.3 No Trademark License. Except as provided in this Section 2.3, no right
or license, express or implied, is granted to Amgen to use any trademark, trade
name, trade dress or service xxxx owned or Controlled by Predix or any of its
Affiliates. Amgen, at its sole cost and expense, shall be responsible for the
selection, registration and maintenance of all trademarks which it employs in
connection with its activities conducted pursuant to this Agreement.
2.4 No Implied Licenses. No license or other right is or shall be created
or granted hereunder by implication, estoppel or otherwise. All such licenses
and rights are or shall be granted only as expressly provided in this Agreement.
2.5 Retained Rights. Predix retains the rights to practice the Licensed
Patents and use the Licensed Know-How, in each case solely to perform research
and development as provided in Section 2.6.1 and to exercise its rights under
Article 5 if applicable. All rights not expressly granted hereunder are reserved
by Predix and may be used by Predix for any purpose.
2.6 Research; Samples.
2.6.1 Predix Research. During the first fifteen (15) months
following the Effective Date, Predix will use commercially reasonable efforts,
at Predix's cost, to design, discover and develop additional Modulators based on
the scaffolds identified in the Scaffold Patent Applications and/or alternative
scaffolds to be identified and agreed upon by the Parties and such other
research activities as may be permitted by the JSC in writing either during or
after such fifteen (15) month period (the "Additional Predix Research"). The
goal of the Additional Predix Research will be the identification of compounds
selective for S1P1 receptor (specific criteria to be established by the JSC).
The JSC will direct the research to be performed by Predix but Predix will
control the execution of the Additional Predix Research. Predix's performance of
the Additional Predix Research shall not limit in any way Amgen's right to
conduct Development of Program Products, including screening compounds
identified within the Scaffold Patent Applications or performing activities or
working on compounds that Predix is also performing or working on in the
Additional Predix Research. Predix will provide to the JSC or Amgen, as the case
may be, updates on the progress and results of the Additional Predix Research
during the first fifteen (15) months of the term of this Agreement.
2.6.2 Provision of Existing Samples of Licensed Compounds and
Licensed Know-How. Within twenty (20) days after the Effective Date, Predix
shall transfer to Amgen at least one (1) gram of PRX-13038 and available
additional quantities of PRX-13038 and any and all other Licensed Compounds in
Predix's possession as of the Effective Date. Promptly after the Effective Date,
Predix will provide to Amgen the Licensed Know-How in sufficient form and detail
to permit Amgen to use and/or practice the Licensed Know-How. Predix and Amgen
will cooperate in advance of and during such transfer of Licensed Know-How to
minimize, to the extent reasonably possible, the burden on each of the Parties
relating thereto and Predix will make persons who are knowledgeable about such
Licensed Know-How reasonably available to Amgen during the first three (3)
months after the first JSC meeting to provide to Amgen context or other useful
information relating to the Licensed Know-How as reasonably requested by Amgen.
-16-
PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE COMMISSION PURSUANT TO THE COMPANY'S APPLICATION REQUESTING
CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE EXCHANGE ACT; [*] DENOTES
OMISSIONS.
ARTICLE 3
DEVELOPMENT
3.1 Joint Steering Committee. The Parties shall form a Joint Steering
Committee (the "JSC") to oversee the collaborative product discovery efforts.
The JSC will meet once per Calendar Quarter to share information and discuss
progress and may meet more often as mutually agreed to enable the Parties to
collaborate and leverage the expertise of both Parties. Amgen will have final
decision-making authority on all research matters. Both Parties would provide
quarterly updates to the JSC of their respective efforts and results in the
discovery and Development of Program Compounds and Program Products. During
clinical development of Program Compounds, the JSC will meet quarterly as a
vehicle to update Predix on the progress of Program Products, protocols, timing
of initiation and results of clinical trials, results of toxicology studies and
changes to the Development Plan for Program Products. Notwithstanding the
foregoing, Predix can elect at any time after the first fifteen (15) months of
the term of the Agreement, on ten (10) days prior notice to Amgen, to withdraw
from participation in the JSC and the JSC shall be disbanded upon such
withdrawal. Thereafter, all information that Amgen was required to report to the
JSC shall be delivered by Amgen directly to Predix.
3.2 Development Plan. A summary of the initial Development Plan for the
Program Products will be provided by Amgen to Predix no later than sixty (60)
days after the Effective Date. During the term of the Agreement, Amgen will
provide Predix with any significant updates and revisions to the Development
Plan at or in conjunction with JSC meetings, to the extent Amgen has the right
to do so under an agreement with a Sublicensee where applicable. Amgen will give
good faith consideration to the recommendations of Predix with respect to
suggested amendments to the Development Plan, including the selection of first
indication to be pursued for the first Program Compound.
3.3 Records. Amgen shall maintain, and shall use reasonable efforts to
require its contractors and Sublicensees to maintain, complete and accurate
records of all work conducted in furtherance of the Development and
Commercialization of Program Compounds and Program Products and all results,
data and developments made in conducting such activities. Amgen's records shall
be complete and accurate and shall fully and properly reflect all such work done
and results achieved by Amgen consistent with good scientific practices within
the biopharmaceutical industry and as appropriate for patent and regulatory
purposes.
3.4 Subcontracting. Subject to and without limiting Section 2.2, Amgen may
perform any activities in support of its Development and/or Commercialization of
Licensed Compounds and Licensed Products through its Affiliates or through
subcontracting to a Third Party contractor or contract service organization,
provided that: (a) none of the rights of Predix hereunder are materially
adversely affected as a result of such subcontracting; (b) any such Third Party
subcontractor to whom Amgen discloses Confidential Information of Predix shall
enter into an appropriate written agreement obligating such Third Party to be
bound by obligations of confidentiality and restrictions on use of such Predix
Confidential Information that are no less restrictive than the obligations in
this Agreement; (c) Amgen will use [********] to gain the written agreement of
such Third Party to assign or license (with the right to grant sublicenses) to
Amgen any inventions (and Patent Rights claiming such inventions) made by such
Third Party in
-17-
PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE COMMISSION PURSUANT TO THE COMPANY'S APPLICATION REQUESTING
CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE EXCHANGE ACT; [*] DENOTES
OMISSIONS.
performing such services for Amgen, that are necessary to the Development or
Commercialization of Program Compounds or Program Products; and (d) Amgen shall
at all times be responsible for the performance of such subcontractor. Amgen
shall have no limitations or restrictions under this Section 3.4 with respect to
Amgen Compounds, Amgen Products, Acquired Compounds or Acquired Products.
3.5 Reporting and Access Limits. All information received or obtained by
Predix under Article 2 or this Article 3 shall be treated as Amgen Confidential
Information hereunder.
ARTICLE 4
RESPONSIBILITIES AND DILIGENCE
4.1 Responsibilities and Costs. Amgen shall have sole responsibility and
final decision-making authority for, and shall bear the cost of conducting, all
Development, manufacturing, regulatory activities and Commercialization with
respect to the Program Compounds and Program Products, except for the Additional
Predix Research which will be governed by Section 2.6.1 and co-promotion
activities of Predix contemplated under Section 5.1 and as set forth in any
co-promotion agreement contemplated therein.
4.2 Regulatory Responsibilities and Costs. Amgen shall have sole
responsibility and final decision-making authority for, and shall bear the cost
of conducting, the preparation, filing, maintenance and ownership (subject to
assignment to Predix of certain Regulatory Filings under certain circumstances)
of all Regulatory Filings relating to the Program Compounds and Program
Products. Upon Predix's request, Amgen would provide Predix copies of Regulatory
Filings with respect to Program Compounds and Program Products (other than
Acquired Compounds and Acquired Products), excluding CMC section(s). Amgen shall
be responsible for meeting the requirements of all pre-approval inspections
required by any Regulatory Authorities. Except as expressly provided in this
Agreement, as between the Parties, Amgen or its Affiliate or Sublicensee shall
own all INDs, Approvals and submissions in connection with Program Compounds and
Program Products and all Approvals shall be obtained by and in the name of Amgen
or its Affiliate or Sublicensee.
4.3 Commercially Reasonable Efforts. Amgen (or its Affiliates or
Sublicensees, as applicable) shall use Commercially Reasonable Efforts to
Develop, obtain Approvals for and Commercialize at least one Program Product
(other than an Acquired Product). Amgen will promptly notify Predix (directly or
through the JSC) if Amgen concludes that the continued Development of any
Program Compound that has been tested in a human, or the continued
Commercialization of any Program Product, should or will be suspended or
terminated. Such notice shall include the reason(s) for such conclusion and, if
Predix so requests, the JSC shall promptly convene to discuss the decision and
other possible alternatives.
4.4 Marking. Each Program Product Commercialized by Amgen under this
Agreement shall be marked (to the extent required by applicable Law): (i) with a
notice that such Program Product is sold under a license from Predix (as
applicable) and (ii) with applicable patent and other intellectual property
notices relating to the Licensed Patents in such a manner as
-18-
PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE COMMISSION PURSUANT TO THE COMPANY'S APPLICATION REQUESTING
CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE EXCHANGE ACT; [*] DENOTES
OMISSIONS.
may be required in order to have and preserve access to the full rights and
remedies provided for patent owners under applicable Law.
ARTICLE 5
PREDIX OPTION TO CO-PROMOTE IN THE U.S.
5.1 Predix Option to Co-Promote. Predix shall have the option to
co-promote one Program Product (other than an Acquired Product) in the U.S. for
one indication to be jointly selected by Predix and Amgen upon exercise of the
option by Predix (the "Co-Promotion Indication"). Such option shall be
exercisable at any time commencing on the Effective Date of the Agreement and
for a period of [****] thereafter. If Predix does not exercise the co-promotion
option within such [****] period, such option shall terminate at the end of such
[****] period. Such option shall be exercisable by Predix providing written
notice to Amgen of its desire to exercise the option. The notice of exercise
from Predix shall specify the percentage of such sales force that Predix desires
to provide, subject to the following limits. Predix shall provide no more than
[****] of the sales force who will promote the relevant Program Product to
specialty physicians in the United States, provided that, in no event will the
number of sales representatives provided by Predix exceed [****]. Predix shall
not be permitted to transfer, assign or sublicense its co-promotion rights
hereunder except as provided in Section 14.4.1, and Predix shall not be
permitted to use any persons other than employees of Predix to perform its
obligations under this Article 5 at anytime following [****] after commencement
by Predix of the detailing activity as part of the co-promotion services for the
Program Product for the Co-Promotion Indication in the United States; and Predix
shall not be permitted to contract with employees of other companies engaged in
the research or development of drug products (other than contract sales
organizations) for the performance of its co-promotion activities. Once the
option is exercised, the co-promotion shall continue [****], if earlier, until
terminated by Predix; provided however, that if the relevant Program Product
does not receive all required Approvals for the Co-Promotion Indication to
permit promotion and sale of the product for such indication throughout the
United States, then the option provided in this Section 5.1 shall [********],
subject to the other terms set forth in this Section 5.1, for [********]
(subject to [********] until the applicable [********]); provided that, Predix
and Amgen shall cooperate in good faith with each other to ensure that the
exercise and performance of the co-promotion rights as described herein can be
exercised by Predix with the minimum reasonable amount of disruption or adverse
impact to Amgen's Commercialization plan for the relevant Program Product in the
United States. Upon exercise of the option, the Parties shall enter into a
written co-promotion agreement, within ninety (90) days thereafter, specifying
the terms of the co-promotion arrangement, which shall be consistent with terms
customary [****] and incorporate the terms and conditions set forth in this
Section 5.1 and in Appendix B hereto. Execution of such agreement shall not be a
pre-condition to Predix's right to exercise the option and to co-promote the
indicated Program Product in the U.S. in the Co-Promotion Indication. Predix's
sales representatives will promote the Program Product in the Co-Promotion
Indication to specialty physicians in the U.S. in accordance with the Amgen
Commercialization plan. Amgen, at its sole expense (not including travel-related
expenses (e.g., transportation, hotel, meals) to attend the training), will
provide product-specific training for the Predix sales representatives and will
supply all promotional and marketing materials used by Amgen to promote the
relevant Program Product in the U.S. for the Co-Promotion Indication. Amgen will
[****] all marketing,
-19-
PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE COMMISSION PURSUANT TO THE COMPANY'S APPLICATION REQUESTING
CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE EXCHANGE ACT; [*] DENOTES
OMISSIONS.
advertising, detailing and operational aspects of promotion activities. Amgen
will compensate Predix for such co-promotion activities on terms consistent with
[****] agreements [****]. Amgen will not participate in start-up costs to build
Predix's sales force.
ARTICLE 6
EXCLUSIVITY; ACQUIRED COMPOUNDS; ACQUIRED PRODUCTS
6.1 Exclusivity. During the term of the Agreement, the Parties and their
respective Affiliates shall not (other than in connection with the activities
conducted pursuant to this Agreement), either on their own, or with or for the
benefit of any Third Party, research, develop, make, have made, use, offer for
sale, sell, have sold, import or otherwise exploit a product that Modulates the
S1P1 receptor.
6.2 Acquisition of Acquired Compounds and Acquired Products; Amgen Option
to Terminate. Notwithstanding the restriction set forth in Section 6.1, Amgen
shall have the right, during the term of the Agreement, to seek to acquire
rights to Other Compounds and Other Products. If Amgen acquires rights, through
licensing, assignment or otherwise, to Develop and/or Commercialize one or more
Other Compounds or Other Products, Amgen will notify Predix thereof and Amgen
will have a period of [****] if the Other Compound or Other Product is
[********], or [****] if the Other Compound or Other Product is acquired in
connection with a [********], to elect either: (i) to terminate the Agreement,
or (ii) to have such Other Compound or Other Product be treated for all purposes
under the Agreement as an [********] or [********]. If Amgen decides to
terminate the Agreement, such Other Compound or Other Product would not be
treated as an [********] or [********] and the termination would be treated as a
termination under [********] for purposes of determining the Parties' rights in
connection with and following the termination. If Amgen does not so terminate
the Agreement, then any such Other Compound will be an [********] and any such
Other Product will be an [********].
6.3 Predix Limited Option [********]. If at anytime during the term of the
Agreement, Amgen starts a [********] (or starts a [********]) with an Acquired
Product, or acquires an Acquired Product that is already in a [********] (or
that is more advanced), and no [********] is then further advanced in
development than the [********], then Predix shall be permitted to [********].
In such event, Amgen shall notify Predix of the start of the [********] or
decision to make such [********], and Predix shall have a period of: (i)
[********] following the later of (A) presentation to the JSC of the [********]
from a [********] for such [********] or (B) the start of a [********] for such
[********], and (ii) [********] from the JSC review of the [********] for an
[********] that is acquired when it is already in a [********] (or that is more
advanced); within which to decide whether to [********] the [********], which
[********] in either case shall be effected, if at all, by written notice to
Amgen within the applicable period. If Predix elects to [********] the
[********] under those circumstances, it shall notify Amgen of such election and
Amgen will have the right to either: (a) prevent such [********] by making an
election, within [********] of receiving Predix's notice, [****] thereafter with
such [********] as if it were a [****] and to pay the [****] thereafter on such
[********] as if it were a [****] (subject to all other applicable [****] set
forth herein); or (b) to allow such [********] of the [********], in which case
such [********]
-20-
PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE COMMISSION PURSUANT TO THE COMPANY'S APPLICATION REQUESTING
CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE EXCHANGE ACT; [*] DENOTES
OMISSIONS.
shall be treated as a [********] under [****] for purposes of determining the
Parties' rights in connection with and following the [********], except that
Predix shall, under such circumstances, have [****]. If Predix does not elect to
[********] the [********] within the applicable period, Predix's right to
[********] the [********] under this Section 6.3 shall [********].
6.4 Continuing Diligence Obligations. Notwithstanding the designation of
any Other Compound or Other Product as an Acquired Compound or Acquired Product,
Amgen shall thereafter continue to have the obligations to Develop and
Commercialize Program Compounds and Program Products that are not Acquired
Compounds or Acquired Products as set forth in Section 4.3, and efforts used
with respect to an Acquired Compound or Acquired Product will not be considered
in any determination as to whether Amgen has satisfied such obligations with
respect to such Program Compounds or Program Products. Amgen shall not have any
diligence obligations with respect to Acquired Compounds or Acquired Products.
In the event Amgen fails to meet its diligence obligations with respect to
Program Compounds and Program Products, and [********] is at a later stage of
development than all other Program Products, Amgen shall have the right to cure
such failure by making an election, within [********] of receiving Predix's
notice of breach with respect to such diligence obligations, to [********] the
[********] thereafter with such [********] as if it were a [********] and to
[********] the [********] thereafter on such [********] as if it were a
[********] (subject to all other applicable [********] set forth herein). If
Amgen elects to [********] on an [********] to prevent a [********] as described
in Section 6.3, or to cure a failure of diligence as described in this Section
6.4, then such [********] shall thereafter: [****].
ARTICLE 7
FINANCIAL TERMS
7.1 Initial Payment. Within ten (10) days after the Effective Date, Amgen
shall pay to Predix a nonrefundable, noncreditable payment of twenty million
Dollars ($20,000,000) in accordance with wire transfer instructions attached
hereto as Appendix C.
7.2 Pre-Commercial Milestone Payments. Amgen shall make milestone payments
to Predix upon achievement of each of the milestone events and in the amounts as
set forth below. A milestone payment set forth below will be payable by Amgen to
Predix within thirty (30) days of the achievement of the corresponding milestone
event. Such milestone payment shall not be refundable or returnable in any
event, nor shall it be creditable against royalties or other payments.
Development Milestones
Event Dollars
----- -------
Start of a [****] with a Program Product [****]
Start of a [****] with a Program Product [****]
Start of a [****] with a Program Product [****]
Start of a [****] with a Program Product [********] [****]
-21-
PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE COMMISSION PURSUANT TO THE COMPANY'S APPLICATION REQUESTING
CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE EXCHANGE ACT; [*] DENOTES
OMISSIONS.
If a milestone event is achieved that triggers a development milestone payment
as set forth above, and the preceding milestone events have not occurred such
that the previous development milestone payments have not been previously paid,
then all such previous development milestone payments shall become due and
payable upon achievement of such milestone event. For example, if a [****] is
started and triggers a development milestone payment as set forth above without
a [****] being previously started (and consequently the applicable start of a
[****] milestone payment has not been previously paid to Predix), in addition to
the milestone payment for the start of a [****], Amgen would also pay to Predix
the applicable milestone payment for the start of a [****].
Regulatory Approval Milestones
Event Dollars
----- -------
[****] for a Program Product [****]
[****] for a Program Product [****] [****]
[****] of a Program Product [****] [****]
[****] a Program Product [****] or by [****] [****]
[****] of a Program Product [****] by [****] [****]
[****] a Program Product in [****] [****]
For both development milestones and regulatory approval milestones, each
milestone payment shall be triggered and payable only one-time, by the first
Program Product to achieve the milestone event. Subject to Section 6.3 and 6.4,
milestone payments for Acquired Products shall [****]; provided that, the
[****]. For example, if a [****] milestone payment were first triggered with an
[****], then [****] would be payable, and if the same milestone were [****] than
an [****], then the [****] would be payable. If a milestone payment is made with
respect to [****], no further milestone payment shall be payable if the
corresponding milestone event is subsequently achieved [****]. In no event shall
Amgen owe any milestone payments in excess of the milestone payment amounts
listed in the tables above for achievement of the corresponding milestone
events, regardless of how many times such corresponding milestone events are
achieved by one or more products.
7.3 Commercialization Milestone Payments. The following milestone payments
will be payable by Amgen to Predix within thirty (30) days of the end of the
Calendar Year in which Amgen (and its Affiliates and Sublicensees, as
applicable) first achieves the following annual Net Sales of all Program
Products in all countries in the Territory (including all indications and
formulations for such Program Products):
Upon annual Net Sales in excess of [****] [****]
Upon annual Net Sales in excess of [****] [****]
Upon annual Net Sales in excess of [****] [****]
The total amount that may become payable by Amgen to Predix under this Section
7.3 shall be [****]. For clarification, by way of example, if the total annual
Net Sales of Program Products for the first Calendar Year in which the First
Commercial Sale of the Program Product occurs is
-22-
PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE COMMISSION PURSUANT TO THE COMPANY'S APPLICATION REQUESTING
CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE EXCHANGE ACT; [*] DENOTES
OMISSIONS.
[****], then [****] would be payable by Amgen to Predix under this Section 7.3.
Subject to Section 6.3 and 6.4, if Predix decides to include Net Sales of an
Acquired Product in the annual Net Sales of Program Products to satisfy the
requirements for meeting any of the above milestones, then a reduced milestone
payment shall become due and payable as determined in accordance with the
following formula:
[****]
[****]
[****]
[****]
[****]
Notwithstanding the foregoing, if a [****] is paid hereunder, and if annual Net
Sales for any one or more subsequent Calendar Years would, under the formula
above, trigger the payment of a [********] of such milestone payment, then, an
amount equal to such [********] will become due and payable as one or more
[********]. Such [********] shall be due and payable, if at all, within thirty
(30) days following the Calendar Year in respect of which they are earned. In no
event shall the achievement of any milestone event require payment(s) in the
aggregate in excess of the full amount of the corresponding milestone payment
(regardless of how many times such milestone event is achieved).
7.4 Royalty Payments.
7.4.1 Subject to the other provisions of this Section 7.4, Amgen
shall pay to Predix the following royalty payments on the total aggregate annual
Net Sales in the Territory of all Program Products (including all indications
and formulations for such Program Products) in a particular Calendar Year by
Amgen, its Affiliates, and Sublicensees in the Territory.
Annual Net Sales Royalties
---------------- ---------
For that portion of annual Net Sales of [****] [****]
For that portion of annual Net Sales of [****] [****]
For that portion of annual Net Sales of [****] and above [****]
By way of example, in a given Calendar Year, if the aggregate annual worldwide
Net Sales for all Program Products is [****], the following royalty payment
would be payable under this Section 7.4.1 (subject to the reductions set forth
below): [****].
Only one royalty shall be due with respect to the same unit of Program
Product.
7.4.2 Certain Reductions.
(a) Subject to Section 6.3 and 6.4, the royalty rate
applicable to Net Sales of Acquired Products shall be equal to [****] of the
rates set forth above in Section 7.4.1 (subject to any other applicable
reductions provided for herein).
-23-
PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE COMMISSION PURSUANT TO THE COMPANY'S APPLICATION REQUESTING
CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE EXCHANGE ACT; [*] DENOTES
OMISSIONS.
(b) If PRX-13038 (or any hydrates, anhydrates, solvates, salt
forms, free acids, complexes, conjugates, polymorphs, in all forms,
presentations and formulations thereof) has not been entered by Amgen, or an
Affiliate or Sublicensee, into GLP Toxicology Studies, then the applicable
royalty rates for all Program Products shall be [****] (so that the range of
[****] payable hereunder would be [****] for all [****] and [****] percent for
all Acquired Products, subject to any applicable [****] herein), unless and
until PRX-13038 (or any hydrates, anhydrates, solvates, salt forms, free acids,
complexes, conjugates, polymorphs, in all forms, presentations and formulations
thereof) is entered by Amgen, or an Affiliate or Sublicensee, into GLP
Toxicology Studies. For purposes of this Section 7.4.2(b), the term "GLP
Toxicology Studies" shall mean a toxicology study conducted under Good
Laboratory Practice regulations, and [****]. Notwithstanding the foregoing, if
Amgen initiates a Phase 1 Trial with a Program Product comprised of or including
PRX-13038 (or any hydrates, anhydrates, solvates, salt forms, free acids,
complexes, conjugates, polymorphs, in all forms, presentations and formulations
thereof) then there will be [****] under this Section 7.4.2(b) thereafter.
(c) The reductions set forth in this Section 7.4.2, if
applicable, shall be applied prior to any other applicable reductions to the
royalties set forth in this Agreement.
7.4.3 Royalty Term. The applicability of royalties under this
Section 7.4 shall be determined on a product-by-product and country-by-country
basis, based on the Royalty Term applicable to the specific Program Product. Net
Sales to which royalties are applicable shall then be aggregated in the
Territory for all Program Products to determine the appropriate royalty rate(s)
under Section 7.4.1 (subject to any applicable reductions thereto provided for
herein).
7.4.4 Royalty Reduction for Generic Competition. The royalty amounts
otherwise payable under Section 7.4.1 (after application of Section 7.4.2) with
respect to a Program Product shall be reduced on a country-by-country basis upon
(a) the expiration or termination of the last Valid Claim within the Program
Patents claiming the manufacture, use, sale or importation of such Program
Product in such country (regardless of any continuing Program Patents claiming
the manufacture, use, sale or importation of such Program Product in any other
country), in which case the royalty rate for Net Sales in such country shall be
reduced to [****] of the royalty rate otherwise applicable, and/or (b) the
Approval of a Generic Product in such country, in which case the royalty rate
for Net Sales in such country shall be reduced to [****] of the royalty rate
otherwise applicable. Notwithstanding the foregoing, in no event will the
reduction to the royalties described in this Section 7.4.4, when combined with
any reduction under Section 7.4.5, reduce the royalties payable under Section
7.4.1 (after application of Section 7.4.2) by more than [****].
7.4.5 Third Party Royalty Payments. If [****] determines that [****]
in a particular country to obtain a license or similar rights under patent
rights controlled by a Third Party in order to [****], then Amgen shall be
entitled to offset up to [****] of the reasonable amounts paid from time-to-time
to such Third Party to permit the [****] in such country against royalties that
would otherwise have been payable hereunder (after any reduction under Section
7.4.2) to Predix upon sales of the applicable Program Product in such country.
Amgen (or its Affiliate or Sublicensee) shall use its commercially reasonable
efforts to minimize the amount of any of the foregoing payments owed to Third
Parties. Notwithstanding the foregoing, in no event will the reduction to the
royalties described in this Section 7.4.5, when combined with any
-24-
PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE COMMISSION PURSUANT TO THE COMPANY'S APPLICATION REQUESTING
CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE EXCHANGE ACT; [*] DENOTES
OMISSIONS.
reduction under Section 7.4.4, reduce the royalties payable under Section 7.4.1
(after application of Section 7.4.2) by more than [****]. Predix shall be
responsible for all payments due to Third Parties under licenses and/or other
agreements between Predix and such Third Parties with respect to Program
Products.
7.5 Manner of Payment. All payments to be made by Amgen hereunder, with
the exception of the initial payment as provided in Section 7.1, shall be made
in Dollars by check, wire transfer or electronic funds transfer, at Amgen's
option, as follows:
(a) If by wire transfer, to such United States bank account as shall
be designated by Predix.
(b) If by check, to the address of Predix set forth in Section 14.2
hereof.
(c) If by electronic funds transfer, Predix shall provide Amgen with
a completed electronic funds transfer form (to be provided by Amgen) within ten
(10) days after receipt thereof from Amgen and payment shall be made to the
designated account.
Upon request, Predix will promptly provide to Amgen a completed Form W-9
and such other requested documentation required to facilitate payment hereunder.
Late payments shall bear interest at the rate provided in Section 7.10.
Additionally, Predix agrees to submit invoices to Amgen (on a timely basis) for
all payments due under the Agreement, except royalties. Any invoice submitted to
Amgen shall be addressed to:
Amgen
Accounts Payable
XX Xxx 000
Xxxxxxx Xxxx, XX 00000-0000
Attention: Partnership Accounting
Invoices not submitted to this address may be subject to delay or return.
In addition, each invoice should reference an applicable purchase order number
that will be communicated by Amgen within ten (10) Business Days after the Form
W-9 is received.
7.6 Sales Reports and Royalty Payments. After the First Commercial Sale of
a Program Product and during the term of this Agreement, Amgen shall furnish to
Predix a written report, within sixty (60) days after the end of each Calendar
Quarter (or portion thereof, if this Agreement terminates during a Calendar
Quarter), showing the amount of royalty due for such Calendar Quarter (or
portion thereof). Royalty payments for each Calendar Quarter shall be due at the
same time as such written report for the Calendar Quarter (i.e., within sixty
(60) days following the end of the Calendar Quarter). With each quarterly
payment, Amgen shall deliver to Predix a full and accurate accounting of the
royalties due for such period, to include at least the following information:
(a) the total gross sales and total Net Sales for each Program
Product (broken down by Europe, North America, Japan, and rest of world) by
Amgen, its Affiliates, and Sublicensees in Dollars;
-25-
PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE COMMISSION PURSUANT TO THE COMPANY'S APPLICATION REQUESTING
CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE EXCHANGE ACT; [*] DENOTES
OMISSIONS.
(b) the royalties payable in Dollars which shall have accrued
hereunder in respect of such Net Sales;
(c) withholding taxes, if any, required by applicable Law to be
deducted in respect of such royalties; and
(d) the dates of the First Commercial Sales of Program Products in
any country during the reporting period.
All sales reports provided hereunder to Predix shall be deemed Amgen
Confidential Information.
7.7 Sales Record Audit. Amgen shall keep, and shall cause each of its
Affiliates, and Sublicensees, if any, to keep, complete and accurate books of
accounting in accordance with GAAP containing all particulars that may be
necessary for the purpose of calculating all royalties payable to Predix. Such
books of accounting (including those of Amgen's Affiliates, and Sublicensees, if
any) shall be kept during the [****] following the end of the Calendar Year to
which each shall pertain, be open for inspection at reasonable times during
normal business hours, upon reasonable advance written notice (but no less than
ten (10) Business Days), by an independent certified accountant selected by
Predix, and as to which Amgen has no reasonable objection, at Predix's expense,
for the sole purpose of verifying royalty statements for compliance with this
Agreement. In no event shall such audits be conducted hereunder more frequently
[****], and books and records for any particular year shall only be subject to
one audit. Such accountant must have agreed in writing with Amgen to maintain
all information learned in confidence, except as necessary to disclose to Predix
such compliance or noncompliance by Amgen, and not to use such information for
any purpose other than the purpose of the audit under this Section 7.7. The
independent accountant or Predix shall provide to Amgen a copy of the
independent accountant's report promptly after it is first provided to Predix.
The report and communication of such accountant to Predix with respect to such
inspection shall be limited to a certificate stating whether any report made or
payment submitted by Amgen during such period is accurate or inaccurate and the
amount of any payment discrepancy, regardless if the discrepancy is favorable or
unfavorable to Predix. Predix shall pay for such inspections, except that in the
event there is any upward adjustment in aggregate royalties payable for any year
shown by such inspection of more than [****] of the amount paid, Amgen shall pay
for such inspection. Any underpayments shall be paid by Amgen within [********]
of notification of the results of such inspection. Any [****] shall be [****]
payable in subsequent payment periods; provided that, if [****] are payable from
[****] prior to termination or expiration of the Agreement, then [****] shall
promptly thereafter pay to [****] the [****] of [****]. All information
disclosed to Predix or its independent accountant in connection with any audit
under this Section 7.7 shall be deemed Amgen Confidential Information.
7.8 Currency Exchange. With respect to Net Sales invoiced in Dollars, the
Net Sales and the amounts due to Predix hereunder shall be expressed in Dollars.
With respect to Net Sales invoiced in a currency other than Dollars, the Net
Sales invoiced shall be converted into the Dollar equivalent using a rate of
exchange which corresponds to the rate used by Amgen,
-26-
PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE COMMISSION PURSUANT TO THE COMPANY'S APPLICATION REQUESTING
CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE EXCHANGE ACT; [*] DENOTES
OMISSIONS.
for the respective reporting period, related to recording such Net Sales in its
books and records that are maintained in accordance with GAAP. All payments
shall be made in Dollars.
7.9 Tax Withholding. The withholding tax, duties, and other levies (if
any) applied by a government of any country of the Territory on payments made by
Amgen to Predix hereunder shall be borne by Predix. Amgen, its Affiliates and
Sublicensees shall cooperate with Predix to enable Predix to claim exemption
therefrom under any double taxation or similar agreement in force and shall
provide to Predix proper evidence of payments of withholding tax and reasonably
assist Predix by obtaining or providing in as far as possible the required
documentation for the purpose of Predix's tax returns.
7.10 Interest Due. Without limiting any other rights or remedies available
to Predix, Amgen shall pay Predix interest on any payments that are not paid on
or before the date such payments are due under this Agreement at [****], or the
maximum rate permitted by law, if less.
7.11 Change of Reporting Periods. In the event that Amgen elects in the
future to change its accounting and public financial reporting practices from
Calendar Quarters and Calendar Years to fiscal quarters and years or vice versa,
Amgen will provide written notice of such election to Predix and thereafter the
payment, reporting and other obligations related to Calendar Quarters and
Calendar Years under Article 7 of this Agreement shall be deemed satisfied by
compliance therewith in accordance with the new reporting periods (fiscal
reporting periods or calendar reporting periods, as the case may be) instead of
the previously utilized reporting periods.
ARTICLE 8
REPRESENTATIONS AND WARRANTIES; DISCLAIMER;
LIMITATION OF LIABILITY
8.1 Mutual Representations and Warranties. Each Party represents and
warrants to the other Party as of the Effective Date that (i) it is duly
organized and validly existing under the laws of its jurisdiction of
incorporation and has full corporate power and authority to own and operate its
property and assets and to carry on its business as it is now being conducted,
(ii) it has all requisite corporate power and authority to enter into this
Agreement and to perform its obligations under this Agreement, (iii) execution
of this Agreement and the performance by such Party of its obligations hereunder
have been duly authorized by all requisite corporate action, (iv) this Agreement
is legally binding and enforceable on each Party in accordance with its terms,
except as enforceability may be limited by bankruptcy, fraudulent conveyance,
insolvency, reorganization, moratorium and other Laws relating to or affecting
creditors' rights generally and by general equitable principles and public
policy constraints, and (v) none of the execution and delivery of this
Agreement, the consummation of the transactions provided for herein or
contemplated hereby, or the fulfillment by it of the terms hereof or thereof,
will (with or without notice or passage of time or both) (1) conflict with or
result in a breach of any provision of the certificate or articles of
incorporation or formation, by-laws, statutes, operating agreement or other
governing documents of it, (2) result in a default, constitute a default under,
give rise to any right of termination, cancellation or acceleration, or require
any consent or approval (other than approvals that have heretofore been
obtained) of any governmental authority or under any of the
-27-
PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE COMMISSION PURSUANT TO THE COMPANY'S APPLICATION REQUESTING
CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE EXCHANGE ACT; [*] DENOTES
OMISSIONS.
terms, conditions or provisions of any material note, bond, mortgage, indenture,
loan, arrangement, license, agreement, lease or other instrument or obligation
to which it is a party or by which its assets may be bound, or (3) violate any
Law or regulation of any stock exchange on which such Party's securities are
listed applicable to it or any of its assets.
8.2 Representations and Warranties of Predix. Predix represents and
warrants to Amgen that as of the Effective Date (i) there is no pending
litigation which alleges, or any written communication received by Predix or its
Affiliates alleging, that Predix's activities with respect to the Licensed
Patents, Licensed Know-How or the Licensed Compounds have infringed or
misappropriated any of the intellectual property rights of any Third Party, (ii)
all fees required to be paid by Predix in order to maintain the Licensed Patents
have been paid to date, and none of the Licensed Patents have been abandoned or
cancelled for failure to prosecute or maintain them, (iii) Predix has not nor
has any of its Affiliates previously assigned, transferred, licensed, conveyed
or otherwise encumbered any of its, or its Affiliates', right, title and
interest in the patent rights set forth on Appendix A hereto or the know-how
used in Predix's S1P1 program, (iv) Predix Controls the Licensed Patents as and
to the extent required to grant the rights and licenses herein to Amgen (and
subject to the rights and licenses granted herein to Amgen), including all
patent rights set forth on Appendix A hereto, (v) a true and complete list of
all Licensed Patents as of the Effective Date is set forth on Appendix A hereto,
and (vi) Appendix D sets forth a true and complete list of the Third Party
licenses under which Predix is granting a sublicense to Amgen hereunder as of
the Effective Date ("Existing Licenses").
8.3 Amgen Covenants. Without limiting any other obligation hereunder,
Amgen covenants that it will use Commercially Reasonable Efforts to perform all
of its obligations hereunder, including the conduct of the Development and
Commercialization of the Program Compounds and Program Products, in accordance
with this Agreement and in material compliance with all applicable material
legal requirements, and that it will take reasonable measures to cure any
material noncompliance as soon as reasonably practicable after becoming aware of
same. Amgen further covenants that it shall not during the term of the Agreement
grant any right, license, consent or privilege to any Third Party or undertake
any action which would materially conflict with the rights granted to Predix
(including rights granted to Predix on terminations of this Agreement) or
materially interfere with any obligations of Amgen under this Agreement.
8.4 DISCLAIMER. EXCEPT AS EXPRESSLY SET FORTH IN THIS AGREEMENT, PREDIX
MAKES NO REPRESENTATIONS OR WARRANTIES OF ANY KIND, EITHER EXPRESS OR IMPLIED,
INCLUDING ANY EXPRESS OR IMPLIED WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A
PARTICULAR PURPOSE WITH RESPECT TO THE LICENSED PATENTS OR LICENSED KNOW-HOW OR
ANY LICENSE GRANTED BY PREDIX HEREUNDER, OR WITH RESPECT TO ANY COMPOUNDS OR
PRODUCTS. FURTHERMORE, NOTHING IN THIS AGREEMENT SHALL BE CONSTRUED AS A
REPRESENTATION OR WARRANTY THAT ANY PATENT OR OTHER PROPRIETARY RIGHTS INCLUDED
IN THE LICENSED PATENTS ARE VALID OR ENFORCEABLE OR THAT USE OF THE LICENSED
PATENTS AND LICENSED KNOW-HOW CONTEMPLATED HEREUNDER DOES NOT INFRINGE ANY
PATENT RIGHTS OR OTHER INTELLECTUAL PROPERTY RIGHTS OF ANY THIRD
-28-
PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE COMMISSION PURSUANT TO THE COMPANY'S APPLICATION REQUESTING
CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE EXCHANGE ACT; [*] DENOTES
OMISSIONS.
PARTY. EXCEPT AS EXPRESSLY SET FORTH IN THIS AGREEMENT, AMGEN MAKES NO
REPRESENTATIONS OR WARRANTIES OF ANY KIND, EITHER EXPRESS OR IMPLIED, INCLUDING
ANY EXPRESS OR IMPLIED WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR
PURPOSE WITH RESPECT TO ANY AMGEN CONFIDENTIAL INFORMATION OR ANY COMPOUNDS,
PRODUCTS, PATENT RIGHTS OR OTHER ASSETS PROVIDED TO PREDIX UPON TERMINATION OF
THIS AGREEMENT UNDER CERTAIN CIRCUMSTANCES.
8.5 Limitation of Liability. NOTWITHSTANDING ANYTHING IN THIS AGREEMENT OR
OTHERWISE, NEITHER PARTY SHALL BE LIABLE TO THE OTHER WITH RESPECT TO ANY
SUBJECT MATTER OF THIS AGREEMENT, WHETHER UNDER ANY CONTRACT, NEGLIGENCE, STRICT
LIABILITY OR OTHER LEGAL OR EQUITABLE THEORY, FOR ANY INCIDENTAL, INDIRECT,
SPECIAL, EXEMPLARY, PUNITIVE, OR CONSEQUENTIAL DAMAGES (INCLUDING LOST PROFITS,
LOSS OF USE, DAMAGE TO GOODWILL, OR LOSS OF BUSINESS); PROVIDED, HOWEVER, THAT
THIS SECTION 8.5 SHALL NOT APPLY TO ANY BREACH BY EITHER PARTY OF ARTICLE 10
HEREOF NOR TO ANY INDEMNIFICATION OBLIGATIONS OF THE PARTIES UNDER SECTIONS 11.1
AND 11.2.
8.6 Covenants of Predix. Predix hereby covenants to Amgen that (i) it
shall maintain and keep in full force and effect all agreements (including all
Existing Licenses and subsequent licenses under which Amgen receives a
sublicense hereunder) and filings (including patent filings) necessary to
perform its obligations hereunder, (ii) it shall not during the term of the
Agreement grant any right, license, consent or privilege to any Third Party or
undertake any action, either directly or indirectly, which would conflict with
the rights granted to Amgen or interfere with any obligations of Predix under
this Agreement. Predix will promptly notify Amgen of any notice of breach or
termination received or delivered by it or its Affiliates under an Existing
License or subsequent license under which Amgen receives a sublicense
hereunder).
ARTICLE 9
PATENT MAINTENANCE; INFRINGEMENT; EXTENSIONS
9.1 Ownership of Inventions. Inventorship of inventions conceived or
reduced to practice in the course of activities performed under or contemplated
by this Agreement shall be determined by application of United States patent
Laws pertaining to inventorship. If such inventions are jointly invented by one
or more employees, consultants or contractors of each Party, such inventions
shall be jointly owned ("Joint Invention"), and if one or more claims included
in an issued patent or pending patent application arising out of the
Collaboration claim such Joint Invention and, under U.S. patent law, would
require the naming of at least one co-inventor who is an employee, consultant or
contractor of Amgen and/or its Affiliates, and at least one co-inventor who is
an employee, consultant or contractor of Predix and/or its Affiliates, such
claims shall be jointly owned ("Joint Patents"). If such an invention is solely
invented by an employee, consultant or contractor of a Party, such invention
shall be solely owned by such Party, and any patent application filed claiming
such solely owned invention shall also be solely owned by such Party. This
Agreement shall be understood to be a joint research agreement in accordance
with 35 U.S.C. Section 103(c)(3) to develop the Program Compounds (other than
Acquired Compounds) and Program Products (other than Acquired
-29-
PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE COMMISSION PURSUANT TO THE COMPANY'S APPLICATION REQUESTING
CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE EXCHANGE ACT; [*] DENOTES
OMISSIONS.
Products). Each Party shall enter into binding agreements, or have entered into
binding agreements that are still effective, obligating its employees performing
activities under or contemplated by this Agreement, including activities related
to the Program Compounds or Program Products, to assign his/her interest in any
invention conceived or reduced to practice in the course of such activities to
such Party.
9.2 Filing, Prosecution and Maintenance.
9.2.1 Mutual Obligations. The Parties shall perform their respective
obligations with respect to the preparation, filing, prosecution (including any
interferences, reissue proceedings and reexaminations), maintenance and defense
of the Patent Rights hereunder in accordance with practices customary in the
pharmaceutical industry, using Commercially Reasonable Efforts, in a manner
reasonably intended to result in obtaining and maintaining a patent estate
conforming to such customary practices in the pharmaceutical industry.
9.2.2 Prior to IP Transition Date. Predix shall have responsibility
and control, using outside patent counsel mutually agreeable to the Parties, for
the preparation, filing, prosecution (including any interferences, reissue
proceedings and reexaminations) and maintenance of the Licensed Patents using
efforts and care consistent with the standard set forth in Section 9.2.1 from
the Effective Date until the earlier of (i) twenty four (24) months after the
Effective Date or (ii) the start of a Phase 1 Trial for the first Program
Product (the earlier of such dates, the "IP Transition Date"). Except as set
forth in this Section 9.2.2 and in Section 9.3.1, Predix shall be responsible
for all costs and expenses related to such preparation, filing, prosecution and
maintenance of Licensed Patents during such period. Amgen shall have the right
to review and comment on such preparation, filing, prosecution and maintenance
of the Licensed Patents and Predix will consult with and reasonably consider in
good faith Amgen's comments thereon. To that end, Predix shall instruct such
outside counsel to furnish Amgen with a reasonably complete draft of each
submission to a patent authority regarding Licensed Patents no later than twenty
(20) days prior to the date such submission is proposed to be made, or if given
less than twenty (20) days to respond by the applicable patent authority or Law
as soon as practicable. Additionally, Predix shall instruct such outside counsel
to provide Amgen with a copy of each submission made to and document received
from a patent authority regarding any Licensed Patents reasonably promptly after
making such filing or receiving such document. Predix shall not knowingly take
any action during filing, prosecution or maintenance of the Licensed Patents
that would materially adversely affect them (including in claim scope), without
prior notice to Amgen. Amgen may file a notice with governmental patent offices
of the exclusive license to the Licensed Patents granted to Amgen hereunder and,
if requested by Amgen, Predix agrees to sign such notices. From time to time,
Amgen may request in writing that Predix file a Licensed Patent in a particular
country and within thirty (30) days thereafter, Predix will notify Amgen in
writing of whether or not Predix elects to do so; provided that [********] shall
[********] by the standard set forth in [********]. If Predix notifies Amgen
that Predix has determined not to file such Licensed Patent in such country,
then Amgen shall have the right, but not the obligation, to assume
responsibility and control (using outside patent counsel mutually acceptable to
the Parties), at Amgen's cost, to prepare, file, prosecute and maintain such
Licensed Patent in such country using efforts and care consistent with the
standard set forth in Section 9.2. In such event, the rights and obligations of
the Parties under Section
-30-
PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE COMMISSION PURSUANT TO THE COMPANY'S APPLICATION REQUESTING
CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE EXCHANGE ACT; [*] DENOTES
OMISSIONS.
9.2.3 shall thereafter apply to such Licensed Patent in such country (regardless
of the fact that the IP Transition Date has not yet then occurred).
9.2.3 After IP Transition Date. From and after the IP Transition
Date until the termination of this Agreement, Amgen shall have responsibility
and control, using outside patent counsel mutually agreeable to the Parties, for
the preparation, filing, prosecution (including any interferences, reissue
proceedings and reexaminations) and maintenance of Licensed Patents in the
Territory using efforts and care consistent with the standard set forth in
Section 9.2.1. Except as set forth in this Section 9.2.3 and in Section 9.3.2,
Amgen shall be responsible for all costs and expenses related to such
preparation, filing, prosecution and maintenance of Licensed Patents during such
period. Upon the occurrence of the IP Transition Date, Predix and Amgen shall
cooperate in the prompt transition of responsibility and control over the
Licensed Patents from Predix to Amgen, including the transfer of such documents
and files and the execution of such documents as are reasonably necessary or
appropriate to facilitate Amgen's responsibility and control over the Licensed
Patents thereafter. Predix shall have the right to review and comment on such
preparation, filing, prosecution and maintenance of the Licensed Patents and
Amgen will consult with and reasonably consider in good xxxxx Xxxxxx'x comments
thereon. To that end, Amgen shall instruct such outside counsel to furnish
Predix with a reasonably complete draft of each submission to a patent authority
regarding the Licensed Patents no later than twenty (20) days prior to the date
such submission is proposed to be made, or if given less than twenty (20) days
to respond by the applicable patent authority or Law as soon as practicable.
Additionally, Amgen shall instruct such outside counsel to provide Predix with a
copy of each submission made to and document received from a patent authority
regarding any Licensed Patents reasonably promptly after making such filing or
receiving such document. Amgen shall not knowingly take any action during
filing, prosecution or maintenance of the Licensed Patents that would materially
adversely affect them (including in claim scope), without prior notice to
Predix. From time to time, Predix may request in writing that Amgen file a
Licensed Patent in a particular country and within thirty (30) days thereafter,
Amgen will notify Predix in writing of whether or not Amgen elects to do so;
provided that [********] shall [********] by the standard set forth in
[********]. If Amgen notifies Predix that Amgen has determined not to file such
Licensed Patent in such country, then Predix shall have the right, but not the
obligation, to assume responsibility and control (using outside patent counsel
mutually acceptable to the Parties), at Predix's cost, to prepare, file,
prosecute and maintain such Licensed Patent in such country. In such event, the
rights and obligations of the Parties under Section 9.2.2 shall thereafter apply
to such Licensed Patent in such country. Notwithstanding the foregoing, in the
event that Amgen reasonably determines that the filing and/or prosecution of any
such patent application would be contrary to the standard set forth in Section
9.2.1, for example because it may trigger a dispute that would put a Licensed
Patent at risk under unfavorable circumstances, then Predix shall cease to file
or prosecute any such patent application.
9.2.4 Joint Patents. Amgen shall have responsibility and control,
using outside patent counsel mutually agreeable to the Parties, for the
preparation, filing, prosecution (including any interferences, reissue
proceedings and reexaminations) and maintenance of Joint Patents using efforts
and care consistent with the standard set forth in Section 9.2.1. Predix shall
have the right to review and comment on such preparation, filing, prosecution
and maintenance of the Joint Patents and Amgen will consult with and reasonably
consider in good xxxxx Xxxxxx'x comments thereon. To that end, Amgen shall
instruct such outside counsel to furnish Predix
-31-
PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE COMMISSION PURSUANT TO THE COMPANY'S APPLICATION REQUESTING
CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE EXCHANGE ACT; [*] DENOTES
OMISSIONS.
with a reasonably complete draft of each submission to a patent authority
regarding the Joint Patents no later than twenty (20) days prior to the date
such submission is proposed to be made, or if given less than twenty (20) days
to respond by the applicable patent authority or Law as soon as practicable.
Additionally, Amgen shall instruct such outside counsel to provide Predix with a
copy of each submission made to and document received from a patent authority
regarding any Joint Patents reasonably promptly after making such filing or
receiving such document. Amgen shall not knowingly take any action during
filing, prosecution or maintenance of the Joint Patents that would materially
adversely affect them (including in claim scope), without prior notice to
Predix. From time to time, Predix may request in writing that Amgen file a Joint
Patents in a particular country and within thirty (30) days thereafter, Amgen
will notify Predix in writing of whether or not Amgen elects to do so; provided
that [********] shall [********] by the standard set forth in [********]. If
Amgen notifies Predix that Amgen has determined not to file such Joint Patent in
such country, then Predix shall have the right, but not the obligation, to
assume responsibility and control (using outside patent counsel mutually
acceptable to the Parties), at Predix's cost, to prepare, file, prosecute and
maintain such Joint Patent in such country. In such event, the rights and
obligations of the Parties under Section 9.2.2 shall thereafter apply to such
Joint Patent in such country.
9.2.5 Not Affecting Licenses. The allocation of responsibility and
control of Licensed Patents and Joint Patents in this Section 9.2 shall not
alter or change the licenses or rights of the Parties in such patent rights
hereunder.
9.3 Patent Abandonment.
9.3.1 Predix Controlled Patent Rights. For any Licensed Patents and
Joint Patents that Predix has responsibility and control for filing, prosecution
or maintenance, Predix will not knowingly permit any of such patent rights to be
abandoned in any country in the Territory if such abandonment would be
[********] to the standard set forth in [********]. Accordingly, Predix shall
provide Amgen with notice of the allowance and expected issuance date of any
patent within such patent rights, or any of the aforementioned filing deadlines,
and Amgen shall provide Predix with notice within thirty (30) days thereafter as
to whether Amgen desires Predix to file such new patent application. In the
event that Predix decides not to continue the prosecution or maintenance of a
patent application or patent within such patent rights in any country, Predix
shall provide Amgen with notice of this decision at least thirty (30) days prior
to any pending lapse or abandonment thereof. In such event, Predix shall provide
Amgen with an opportunity to assume responsibility for all subsequent external
costs reasonably associated with the filing and/or further prosecution and
maintenance of such patent application and any patent issuing thereon (such
filing to occur prior to the issuance of the patent to which the application
claims priority or expiration of the applicable filing deadline, as set forth
above). Amgen shall notify Predix of any election to assume such responsibility
within thirty (30) days after receipt of Predix's notice. In the event that
Amgen elects to assume such responsibility (through outside patent counsel
mutually acceptable to the Parties) for such filing, prosecution and/or
maintenance costs, Predix and Amgen shall cooperate in the prompt transition of
responsibility and control over such patent right from Predix to Amgen,
including the transfer of such documents and files and the execution of such
documents as are reasonably necessary or appropriate to facilitate Amgen's
responsibility and control over such patent right thereafter.
-32-
PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE COMMISSION PURSUANT TO THE COMPANY'S APPLICATION REQUESTING
CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE EXCHANGE ACT; [*] DENOTES
OMISSIONS.
The rights and obligations of the Parties under Section 9.2.3 shall thereafter
apply to such patent right in such country.
9.3.2 Amgen Controlled Patent Rights. For any Licensed Patents and
Joint Patents that Amgen has responsibility and control for filing, prosecution
or maintenance, Amgen will not knowingly permit any of such patent rights to be
abandoned in any country in the Territory if such abandonment would be
[********] to the standard set forth in [********]. Accordingly, Amgen shall
provide Predix with notice of the allowance and expected issuance date of any
patent within such patent rights, or any of the aforementioned filing deadlines,
and Predix shall provide Amgen with notice within thirty (30) days thereafter as
to whether Predix desires Amgen to file such new patent application. In the
event that Amgen decides not to continue the prosecution or maintenance of a
patent application or patent within such patent rights in any country, Amgen
shall provide Predix with notice of this decision at least thirty (30) days
prior to any pending lapse or abandonment thereof. In such event, Amgen shall
provide Predix with an opportunity to assume responsibility for all subsequent
external costs reasonably associated with the filing and/or further prosecution
and maintenance of such patent application and any patent issuing thereon (such
filing to occur prior to the issuance of the patent to which the application
claims priority or expiration of the applicable filing deadline, as set forth
above). Predix shall notify Amgen of any election to assume such responsibility
within thirty (30) days after receipt of Amgen's notice. In the event that
Predix elects to assume such responsibility (through outside patent counsel
mutually acceptable to the Parties) for such filing, prosecution and/or
maintenance costs, Predix and Amgen shall cooperate in the prompt transition of
responsibility and control over such patent right from Amgen to Predix,
including the transfer of such documents and files and the execution of such
documents as are reasonably necessary or appropriate to facilitate Predix's
responsibility and control over such patent right thereafter. The rights and
obligations of the Parties under Section 9.2.2 shall thereafter apply to such
patent right in such country.
9.4 Enforcement Against Infringers.
9.4.1 Enforcement by Amgen. Predix grants to Amgen the right to
enforce the Licensed Patents and Joint Patents. In the event that Predix or
Amgen becomes aware of a suspected infringement of any Licensed Patent or Joint
Patent, or any such Licensed Patent or Joint Patent is challenged in any action
or proceeding (other than any interferences, reissue proceedings or
reexaminations, which are addressed above), such Party shall notify the other
Party promptly, and following such notification, the Parties shall confer.
Subject to Section 9.4.2, Amgen shall have the sole right, but, except as and to
the extent [********] with the standard set forth in [********] above, shall not
be obligated, to (i) defend any such action or proceeding or bring an
infringement action with respect to such infringement at its own expense, in its
own name and entirely under its own direction and control, subject to the
following, or (ii) settle any such action, proceeding or dispute by license.
Predix shall reasonably assist Amgen (at Amgen's expense) in any action or
proceeding being defended or prosecuted if so requested, and shall lend its name
to such actions or proceedings if reasonably requested by Amgen or required by
applicable Law. Predix shall have the right to participate and be represented in
any such suit by its own counsel at its own expense. No settlement of any such
action or proceeding which restricts the scope, or adversely affects the
enforceability, of a Licensed Patent or Joint Patent may be entered into by
Amgen without the prior written consent of Predix, which consent
-33-
PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE COMMISSION PURSUANT TO THE COMPANY'S APPLICATION REQUESTING
CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE EXCHANGE ACT; [*] DENOTES
OMISSIONS.
shall not be unreasonably withheld, delayed or conditioned. For clarification,
Predix shall not be required to take any action pursuant to this Section 9.4
that would violate any court or government order or decree to which Predix is
then subject, provided in such event, Predix shall timely grant to Amgen such
rights as may be necessary for Amgen to exercise its rights under this Section
9.4 (including defending or enforcing any Licensed Patents and Joint Patents)
without Predix's involvement.
9.4.2 Enforcement by Predix. If Amgen elects not to, or fails within
a reasonable amount of time after receipt of notice of infringement, to take any
action to prevent, terminate or limit any infringement described in Section
9.4.1, then Predix may notify Amgen that Predix desires to defend or bring such
action at its own expense, in its own name and entirely under its own direction
and control, and it shall be free to do so unless within a period of [********]
after receipt by Amgen of such notice, Amgen notifies Predix of Amgen's decision
to take action under this Section 9.4.2 and Amgen [********] within a reasonable
period of time but no later than the time specified by Amgen in such notice, if
any, subject to the following. Notwithstanding the foregoing, in the event that
Amgen reasonably determines that such action would be [********] to the standard
set forth in [********], for example because it may [********] that would put a
[********] under [********] circumstances, Amgen may notify Predix thereof. In
such event Predix will not have the right to take such action. If Amgen notifies
Predix that Predix may proceed with such action, Amgen shall reasonably assist
Predix (at Predix's expense) in any such action or proceeding being defended or
prosecuted if so requested, and shall lend its name to such actions or
proceedings if requested by Predix or required by applicable Law. Amgen shall
have the right to participate and be represented in any such suit by its own
counsel at its own expense. No settlement of any such action or proceeding which
restricts the scope, or adversely affects the enforceability, of a Licensed
Patent or Joint Patent may be entered into by Predix without the prior written
consent of Amgen, which consent shall not be unreasonably withheld, delayed or
conditioned.
9.4.3 Withdrawal. If either Party brings an action or proceeding
under this Section 9.4 and subsequently ceases to pursue or withdraws from such
action or proceeding, it shall promptly notify the other Party.
9.4.4 Damages. In the event that either Party exercises the rights
conferred in this Section 9.4 and recovers any damages or other sums in such
action, suit or proceeding or in settlement thereof, such damages or other sums
recovered shall first be applied to all out-of-pocket costs and expenses
incurred by the Parties in connection therewith, including attorneys fees. If
such recovery is insufficient to cover all such costs and expenses of both
Parties, it shall first be allocated to the costs and expenses incurred by the
Party that controlled such enforcement or defense and then to the costs and
expenses of the other Party. If after such reimbursement any funds shall remain
from such damages or other sums recovered, such funds shall be retained by the
Party that controlled such enforcement or defense under this Section 9.4;
provided, however, that if [********] is the Party that controlled such action
or proceeding, [********] shall receive out of any such remaining recovery
received by [********] the following amounts: (i) for amounts awarded to
[********] for [****], an amount equivalent to [****] that [****] under this
Agreement [****] if the [****] that were the basis [****] were actually [****]
made [****] hereunder, and (ii) [****] of the remaining recovered amounts.
-34-
PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE COMMISSION PURSUANT TO THE COMPANY'S APPLICATION REQUESTING
CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE EXCHANGE ACT; [*] DENOTES
OMISSIONS.
9.5 Patent Term Extension. Predix and Amgen shall each cooperate with one
another in obtaining patent term extension (including any pediatric exclusivity
extensions as may be available) or supplemental protection certificates or their
equivalents in any country with respect to patent rights claiming the Program
Products. If elections with respect to obtaining such patent term extensions are
to be made, Amgen shall have the right to make the election to seek patent term
extension or supplemental protection, provided that, such election will be made
so as to maximize the period of marketing exclusivity for the Program Product.
9.6 Notification of Patent Certification. Each Party shall promptly give
notice to the other Party of any notice it receives of certification filed under
the Xxxxx-Xxxxxx Act (or a foreign equivalent thereof) in respect of any Program
Product and claiming that any of the Licensed Patents and/or Joint Patents is
invalid, unenforceable or that any infringement will not arise from the
manufacture, use or sale of the product by a Third Party. Amgen shall have the
sole and exclusive right to bring infringement proceedings in its reasonable
judgment against the entity making such a certification with respect to any such
Licensed Patents and/or Joint Patents. Any suit may be in the name of either or
both Parties, as may be required by Law. For this purpose, Predix shall execute
such legal papers necessary for the prosecution of such suit as may be
reasonably requested by Amgen.
ARTICLE 10
NONDISCLOSURE OF CONFIDENTIAL INFORMATION
10.1 Nondisclosure.
10.1.1 Nondisclosure. Each Party agrees that, for so long as this
Agreement is in effect and for a period of [****] thereafter, a Party (the
"Receiving Party") receiving Confidential Information of the other Party (the
"Disclosing Party") shall (i) maintain in confidence such Confidential
Information using not less than the efforts such Receiving Party uses to
maintain in confidence its own proprietary information of similar kind and
value, (ii) not disclose such Confidential Information to any Third Party
without the prior written consent of the Disclosing Party, except for
disclosures expressly permitted in Sections 10.2 and 10.5 below, and (iii) not
use such Confidential Information for any purpose except those permitted by this
Agreement (it being understood that this clause (iii) shall not create or imply
any rights or licenses not expressly granted under Article 2 hereof).
10.1.2 Exceptions. The obligations in Section 10.1.1 shall not apply
with respect to any portion of the Confidential Information that the Receiving
Party can show by competent proof:
(a) is publicly disclosed by the Disclosing Party, either
before or after it is disclosed to the Receiving Party hereunder; or
(b) was known to the Receiving Party or any of its Affiliates,
without any obligation to keep it confidential or any restriction on its use,
prior to disclosure by the Disclosing Party; or
-35-
PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE COMMISSION PURSUANT TO THE COMPANY'S APPLICATION REQUESTING
CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE EXCHANGE ACT; [*] DENOTES
OMISSIONS.
(c) is subsequently disclosed to the Receiving Party or any of
its Affiliates by a Third Party lawfully in possession thereof and without any
obligation to keep it confidential or any restriction on its use; or
(d) is published by a Third Party or otherwise becomes
publicly available or enters the public domain, either before or after it is
disclosed to the Receiving Party; or
(e) is independently discovered or developed by the Receiving
Party without reference to or the use of Confidential Information of the
Disclosing Party, as evidenced by the Receiving Party's written records.
10.2 Authorized Disclosure. The Receiving Party may disclose Confidential
Information received from the Disclosing Party to the extent (and only to the
extent) such disclosure is reasonably necessary in the following instances:
(a) filing or prosecuting (including defending before patent
agencies) patents as contemplated under this Agreement;
(b) disclosure to regulatory authorities in connection with
regulatory filings contemplated under this Agreement;
(c) prosecuting or defending litigation as contemplated under this
Agreement;
(d) subject to Section 10.4, complying with applicable governmental
Laws (including the rules and regulations of the Securities and Exchange
Commission or any national securities exchange) and with judicial process, if in
the reasonable opinion of the Receiving Party's counsel, such disclosure is
necessary for such compliance; and
(e) disclosure, solely on a "need to know basis", to Affiliates,
potential and future collaborators (including sublicensees), permitted acquirers
or assignees under Section 14.4, research collaborators, subcontractors, each of
whom prior to disclosure must be bound by written obligations of confidentiality
and non-use no less restrictive than the obligations set forth in this Article
10; provided, however, that the Receiving Party shall remain responsible for any
failure by any Person who receives Confidential Information pursuant to this
Section 10.2(e) to treat such Confidential Information as required under this
Article 10. Notwithstanding anything herein to the contrary, Predix shall not
disclose to potential or future collaborators, potential permitted acquirers or
potential assignees any Licensed Know-How or Confidential Information related to
the Program Compounds, Program Products or the activities conducted pursuant
hereto (including Amgen Confidential Information), other than financial
information; provided however, that in the event of a reversion to Predix of
rights to Licensed Compounds and Licensed Products under Article 12, Predix will
be permitted to disclose Confidential Information relating to Licensed Compounds
and Licensed Products in the exercise of such rights.
If and whenever any Confidential Information is disclosed in accordance
with this Section 10.2, such disclosure shall not cause any such information to
cease to be Confidential Information except to the extent that such disclosure
results in a public disclosure of such
-36-
PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE COMMISSION PURSUANT TO THE COMPANY'S APPLICATION REQUESTING
CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE EXCHANGE ACT; [*] DENOTES
OMISSIONS.
information (otherwise than by breach of this Agreement). Where reasonably
possible and subject to Section 10.4 and other than pursuant to Section 10.2(e),
the Receiving Party shall notify the Disclosing Party of the Receiving Party's
intent to make such disclosure pursuant to this Section 10.2 sufficiently prior
to making such disclosure so as to allow the Disclosing Party adequate time to
take whatever action it may deem appropriate to protect the confidentiality of
the information.
10.3 Terms of this Agreement. Neither Party (nor their Affiliates) shall
disclose the terms of this Agreement to any Third Party without the consent of
the other Party. Notwithstanding the foregoing, either Party may disclose the
terms of this Agreement without such consent (i) to its legal and accounting
representatives, (ii) to government agencies with authority over such Party that
request to review this Agreement in connection with a review, audit or
investigation of the operations of such Party by such agency (and provided that
review of the terms of this Agreement are reasonably pertinent to such review,
audit or investigation), (iii) if required by applicable Law or an order of a
court or governmental agency of competent jurisdiction, or (iv) to Third Parties
in connection with a bona fide proposed acquisition of, or merger with, such
Party; provided that, in each of the foregoing cases, the receiving party is
subject to confidentiality obligations no less restrictive than those set forth
in this Article 10. If a Party reasonably and in good faith believes that a
public announcement or other public disclosure of the execution of this
Agreement or the terms of this Agreement is required by applicable Law or an
order of a court or governmental agency of competent jurisdiction, then, to the
extent permissible by law, such Party will provide the other Party with notice
of the intended disclosure at least [********] days in advance of such
disclosure (or, if the Party is required to make such disclosure in less than
such period, as soon as practicable) and will make itself available to consult
with the other Party with respect to the nature and scope of such intended
disclosure. In addition to the foregoing, In the event either Party proposes to
file with the Securities and Exchange Commission or the securities regulators of
any state or other jurisdiction a registration statement or any other disclosure
document which discloses, describes or refers to the terms and conditions of
this Agreement under the Securities Act of 1933, as amended, the Securities
Exchange Act of 1934, as amended, or any other applicable securities Law, the
Party shall notify the other Party of such intention and shall provide such
other Party with a copy of relevant portions of the proposed filing not less
than [********] prior to such filing (and any revisions to such portions of the
proposed filing a reasonable time prior to the filing thereof), including any
exhibits thereto relating to the terms and conditions of this Agreement, and
shall use reasonable efforts to obtain confidential treatment of the terms and
conditions of this Agreement that such other Party requests be kept
confidential, and shall only disclose Confidential Information which it is
advised by counsel is legally required to be disclosed or required to be
disclosed. No such notice shall be required under this Section 10.3 if the
substance of the disclosure or description of or reference to this Agreement
contained in the proposed filing has been included in any previous filing made
by either Party hereunder or otherwise approved by the other Party.
10.4 Relationship to Confidentiality Agreement. This Agreement supersedes
the Confidential Disclosure Agreement between the Parties executed February 15,
2006, provided that all "Confidential Information" disclosed or received by the
Parties thereunder shall be deemed "Confidential Information" hereunder and
shall be subject to the terms and conditions of this Agreement.
-37-
PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE COMMISSION PURSUANT TO THE COMPANY'S APPLICATION REQUESTING
CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE EXCHANGE ACT; [*] DENOTES
OMISSIONS.
10.5 Publication. Amgen may publish or present data and/or results
relating to a Licensed Compound or Licensed Product in scientific journals
and/or at scientific conferences. Amgen shall provide Predix with the
opportunity to review any proposed abstract, manuscript or presentation which
discloses confidential information relating to a Licensed Compound or Licensed
Product by delivering a copy thereof to Predix no less than [****] before its
intended submission for publication or presentation. Predix shall have [****]
from its receipt of any such abstract, manuscript or presentation in which to
notify Amgen in writing of its comments. Amgen will consider in good faith any
comments provided by Predix, but Amgen will have final decision-making authority
with respect to the content of publications and presentations. Amgen will comply
with any Predix request to delete references to Predix's Confidential
Information in any such publication or presentation (except for information
relating to Licensed Compounds or Licensed Products, which Amgen shall have the
right to publish or present). Amgen will identify Predix's role in the discovery
of compounds or technology described in any such publication, as appropriate in
light of customary scientific practices, and will otherwise include appropriate
attribution of credit to Predix and its employees for any contribution made to
the results included in any such publication. Predix will not publish scientific
results or other information of work conducted with respect to the
Collaboration, Program Compounds or Program Products, without the prior written
consent of Amgen, such consent not to be unreasonably withheld or delayed
(consistent with the standards that Amgen uses for its own publications);
provided that Predix shall first provide Amgen with an opportunity to review and
comment (in the same manner and to the same extent as is described above for
Predix to review and comment on Amgen's publications) on any such proposed
publication and further provided that Predix shall not publish any Confidential
Information of Amgen nor any other information to the extent it would undermine
the commercial potential of any Program Compound or Program Product.
ARTICLE 11
INDEMNITY
11.1 Amgen Indemnity. Amgen shall indemnify, defend and hold harmless
Predix and its Affiliates, and their respective officers, directors, employees
and agents, and their respective successors, heirs and assigns (the "Predix
Indemnitees"), from and against any and all claims, threatened claims, damages,
losses, suits, proceedings, liabilities, costs (including reasonable legal
expenses, costs of litigation and reasonable attorneys fees) or judgments,
whether for money or equitable relief, of any kind ("Losses and Claims"), but
only to the extent arising out of a claim or demand made by a Third Party,
arising out of or relating to (i) the Development or Commercialization of
Program Compounds or Program Products by or on behalf of Amgen, its Affiliates
or Sublicensees other than the Predix Indemnitees (including claims based on
product liability, infringement or misappropriation of Third Party intellectual
property, or its co-promotion activities), (ii) breach of this Agreement,
including the representations and warranties of Amgen hereunder, by Amgen, or
(iii) any failure of Amgen, its Affiliates or Sublicensees to comply with
applicable Laws with respect to their performance hereunder; except in any such
case for Losses and Claims to the extent arising out of or relating to any
breach of this Agreement by Predix or the negligence, recklessness or willful
misconduct of any Predix Indemnitee.
-38-
PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE COMMISSION PURSUANT TO THE COMPANY'S APPLICATION REQUESTING
CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE EXCHANGE ACT; [*] DENOTES
OMISSIONS.
11.2 Predix Indemnity. Predix shall indemnify, defend and hold harmless
Amgen and its Affiliates and Sublicensees, and their respective officers,
directors, employees and agents, and their respective successors, heirs and
assigns (the "Amgen Indemnitees"), from and against any and all Losses and
Claims, but only to the extent arising out of a claim or demand made by a Third
Party arising out of or relating to (i) the Development or Commercialization of
Program Compounds or Program Products by or on behalf of Predix, its Affiliates
or sublicensees other than the Amgen Indemnitees (including claims based on
product liability, infringement or misappropriation of Third Party intellectual
property, or its co-promotion activities), (ii) breach of this Agreement,
including the representations and warranties of Predix hereunder, by Predix, or
(iii) any failure of Predix, its Affiliates or sublicensees to comply with
applicable Laws with respect to their performance hereunder; except in any such
case for Losses and Claims to the extent arising out of or relating to any
breach of this Agreement by Amgen or the negligence, recklessness or willful
misconduct of any Amgen Indemnitee.
11.3 Indemnification Procedure. A claim to which indemnification applies
under Section 11.1 or Section 11.2 shall be referred to herein as an
"Indemnification Claim". If any Person or Persons (collectively, the
"Indemnitee") intends to claim indemnification under this Article 11, the
Indemnitee shall notify the other Party (the "Indemnitor") in writing promptly
upon becoming aware of any claim that may be an Indemnification Claim (it being
understood and agreed, however, that the failure by an Indemnitee to give such
notice shall not relieve the Indemnitor of its indemnification obligation under
this Agreement except and only to the extent that the Indemnitor is actually
prejudiced as a result of such failure to give notice). The Indemnitor shall
have the right to assume and control the defense of the Indemnification Claim at
its own expense with counsel selected by the Indemnitor; provided that, the
Indemnitee shall have the right to have counsel selected by it participate, at
the Indemnitee's expense, in any action for which the Indemnitee seeks to be
indemnified by the Indemnitor. If the Indemnitor does not assume the defense of
the Indemnification Claim as aforesaid, the Indemnitee may defend the
Indemnification Claim but shall have no obligation to do so. The Indemnitee
shall not settle or compromise the Indemnification Claim without the prior
written consent of the Indemnitor, and the Indemnitor shall not settle or
compromise the Indemnification Claim in any manner which would have an adverse
effect on the Indemnitee's interests (including any rights under this Agreement
or the scope or enforceability of the Indemnitee's Patents Rights or
Confidential Information), without the prior written consent of the Indemnitee,
which consent, in each case, shall not be unreasonably withheld, delayed or
conditioned. The Indemnitee shall reasonably cooperate with the Indemnitor at
the Indemnitor's expense and shall make available to the Indemnitor all
reasonably requested information under the control of the Indemnitee, which
information shall be subject to Article 10.
11.4 Insurance. Each Party shall at its own expense procure and maintain
during the term of the Agreement and for five (5) years thereafter insurance
policy/policies, including product liability insurance, adequate to cover its
obligations hereunder and which are consistent with normal business practices of
prudent companies similarly situated. Each Party may self-insure all or part of
its obligations hereunder consistent with pharmaceutical industry practices. Any
insurance shall not be construed to create a limit of the insuring Party's
liability with respect to its indemnification obligations under this Article 11.
Each Party's insurance hereunder shall be primary with respect to the
obligations for which such Party is liable hereunder and non-
-39-
PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE COMMISSION PURSUANT TO THE COMPANY'S APPLICATION REQUESTING
CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE EXCHANGE ACT; [*] DENOTES
OMISSIONS.
contributing with respect to the obligations for which such Party is to be
indemnified by the other Party.
ARTICLE 12
TERM AND TERMINATION
12.1 Term. This Agreement shall commence as of the Effective Date and,
unless earlier terminated in accordance with the terms hereof or by mutual
written consent, shall continue on a Program Product-by-Program Product and
country-by-country basis until the end of the Royalty Term with respect to such
Program Product in such country or, if no Program Products are being
commercialized in a country upon expiration of the last to expire Program Patent
in such country, upon expiration of the last to expire Program Patent in such
country, at which time it shall terminate. Upon the end of the Royalty Term for
each country and each Program Product, the license grants contained in Section
2.1 shall become perpetual, irrevocable and fully paid up with respect to such
Program Product in such country if Amgen is not then in breach of the license.
If Amgen is then in breach, such conversion shall be delayed until the breach is
cured or the Agreement is terminated.
12.2 Termination By Predix. Predix shall have the right to terminate this
Agreement, at Predix's sole discretion, as follows.
12.2.1 Insolvency. Predix may terminate this Agreement in the event
any of the following occurs with respect to Amgen: (i) Amgen becomes bankrupt or
insolvent, or files a petition in bankruptcy or makes a general assignment for
the benefit of creditors or otherwise acknowledges in writing insolvency, or is
adjudged bankrupt, and Amgen (A) fails to assume this Agreement in any such
bankruptcy proceeding within thirty (30) days after filing or (B) assumes and
assigns this Agreement to a Third Party; (ii) Amgen goes into or is placed in a
process of complete liquidation; (iii) a trustee or receiver is appointed for
any substantial portion of Amgen's business and such trustee or receiver is not
discharged within sixty (60) days after appointment; (iv) any case or proceeding
shall have been commenced or other action taken against Amgen in bankruptcy or
seeking liquidation, reorganization, dissolution, a winding-up arrangement,
composition or readjustment of its debts or any other relief under any
applicable bankruptcy, insolvency, reorganization or similar Law now or
hereafter in effect and is not dismissed or converted into a voluntary
proceeding governed by clause (i) above within sixty (60) days after filing; or
(v) there shall have been issued a warrant of attachment, execution, distraint
or similar process against any substantial part of the property of Amgen and
such event shall have continued for a period of sixty (60) days and none of the
following has occurred: (A) it is dismissed, (B) it is bonded in a manner
reasonably satisfactory to Predix, or (C) it is discharged.
12.2.2 Breach. Subject to Section 12.2.3 below, Predix shall have
the right to terminate this Agreement, at Predix's sole discretion, upon
delivery of written notice to Amgen in the event of any material breach by Amgen
of any terms and conditions of this Agreement (including a material breach of
any representation or warranty by Amgen hereunder), provided that, such breach
has not been cured within [********] after written notice thereof is given by
Predix to Amgen specifying the nature of the alleged breach, provided, however,
that to the
-40-
PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE COMMISSION PURSUANT TO THE COMPANY'S APPLICATION REQUESTING
CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE EXCHANGE ACT; [*] DENOTES
OMISSIONS.
extent such material breach involves the failure to make a payment when due,
such breach must be cured within [********] after written notice thereof is
given by Predix to Amgen.
12.2.3 Disputed Breach. If Amgen disputes in good faith the
existence or materiality of a breach specified in a notice provided by Predix
pursuant to Section 12.2.2, and Amgen provides notice to Predix of such dispute
within the applicable thirty (30) day or ninety (90) day period, Predix shall
not have the right to terminate this Agreement under Section 12.2.2 unless and
until it has [********] in a [********] or other [********] mutually agreed upon
by the Parties that this Agreement was [********] and Amgen fails to cure such
breach within [********] following such [********] (except to the extent such
breach involves the failure to make a payment when due, which breach must be
cured within [********] following such [********]). It is understood and
acknowledged that during the pendency of such a dispute, all of the terms and
conditions of this Agreement shall remain in effect and the Parties shall
continue to perform all of their respective obligations hereunder. The Parties
further agree that any disputed payments under the Agreement may, in lieu of
[********] to the [********] hereunder, be [********] pending resolution of the
dispute and, [********], such [********] shall be promptly dispersed [********]
consistent with such resolution.
12.3 Termination by Amgen.
12.3.1 Convenience. Amgen may terminate this Agreement for
convenience for any reason, at Amgen's discretion, on a country-by-country and
product-by-product basis, effective upon [********] prior written notice if
exercised prior to [********] of the relevant product in the relevant country
and [********] prior written notice [********]; provided, however, that no such
termination right may be exercised as to a Major Market unless all countries in
the Territory are so terminated.
12.3.2 Breach. Subject to Section 12.3.3 below, Amgen shall have the
right to terminate this Agreement (or effect the other remedy available under
Section 12.4.2(b)), at Amgen's sole discretion, upon delivery of written notice
to Predix in the event of any material breach by Predix of any terms and
conditions of this Agreement (including a material breach of any representation
or warranty by Predix hereunder), provided that, such breach has not been cured
within [********] after written notice thereof is given by Amgen to Predix
specifying the nature of the alleged breach, provided, however, that to the
extent such material breach involves the failure to make a payment when due,
such breach must be cured within [********] after written notice thereof is
given by Amgen to Predix.
12.3.3 Disputed Breach. If Predix disputes in good faith the
existence or materiality of a breach specified in a notice provided by Amgen to
Predix pursuant to Section 12.3.2, and Predix provides notice to Amgen of such
dispute within such thirty (30) day or ninety (90) day period, Amgen shall not
have the right to terminate this Agreement under Section 12.3.2 unless and until
it has [********] in a [********] or other [********] mutually agreed upon by
the Parties that this Agreement was [********] and Predix fails to cure such
breach within [********] following such [********] (except to the extent such
breach involves the failure to make a payment when due, which breach must be
cured within [********] following such [********]). It is understood and
acknowledged that during the pendency of such a dispute, all of the terms and
conditions of this Agreement shall remain in effect and the Parties shall
-41-
PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE COMMISSION PURSUANT TO THE COMPANY'S APPLICATION REQUESTING
CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE EXCHANGE ACT; [*] DENOTES
OMISSIONS.
continue to perform all of their respective obligations hereunder. The Parties
further agree that any disputed payments under the Agreement may, in lieu of
[********] to the [********] hereunder, be [********] pending resolution of the
dispute and, [********], such [********] shall be promptly dispersed [********]
consistent with such resolution.
12.4 Effect of Termination. The rights to terminate this Agreement under
this Article 12, the other remedies set forth herein, and all of the following
effects of termination are in addition to the other rights and remedies that may
be available to the Parties at law or in equity.
12.4.1. Termination by Predix for Breach by Amgen. Upon termination
of this Agreement under Section 12.2:
(a) All licenses granted under Section 2.1 shall terminate and
all rights of Amgen under the Licensed Patents and Licensed Know-How shall
revert to Predix, and
(b) (i) Amgen shall assign and transfer to Predix the
Regulatory Filings (to the extent Amgen has the right to assign them), or, in
the event that Amgen or another holder of such Regulatory Filings requires the
continued benefit of such filings in connection with other products or
activities, then Amgen shall not be required to assign or transfer such
Regulatory Filings to Predix if Amgen can provide Predix with the full benefit
of such Regulatory Filings and any related Approvals of Licensed Compounds and
Licensed Products through a right of reference or similar mechanism, and (to the
extent contractually and legally permissible, and with an appropriate novation)
the Commercial Documents, in each case pertaining to each Licensed Compound and
Licensed Product that is a Licensed Compound and Licensed Product for purposes
of Article 12 as of the effective date of such termination, xxxxx Xxxxxx the
Composition License and Transfer License, and Predix would have no continuing
obligations to Amgen under this Agreement with respect to any Licensed Compounds
and Licensed Products (except as provided in Section 12.5), and (ii) Amgen would
retain rights to commercialize the Amgen Compounds, Amgen Products, Acquired
Compounds and Acquired Products, provided that, with respect to all Amgen
Compounds and Amgen Products identified as of the effective date of termination,
and Acquired Compounds and Acquired Products as to which Amgen has acquired
rights as of the effective date of termination, (A) if such termination occurs
within [****] following the Effective Date, then Amgen's payment obligations
with respect to such Amgen Compounds, Amgen Products, Acquired Compounds and
Acquired Products shall [****], or (B) if such termination occurs following
[****] but prior to the start of a [****] for the [********] Program Product,
then Amgen's payment obligations hereunder with respect to such Amgen Compounds,
Amgen Products, Acquired Compounds and Acquired Products shall continue for the
balance of what would have been the applicable [********] but for such
termination, [****].
Notwithstanding the foregoing, no such [********] of Amgen's payment
obligations with respect to such Amgen Compounds, Amgen Products, Acquired
Compounds and Acquired Products shall apply if any such termination occurs after
the start of a [********] for the [********] Program Product, and in such event
Amgen's payment obligations with respect to such Amgen Compounds, Amgen
Products, Acquired Compounds and Acquired Products would [********] for the
balance of what would have been the [********] but for such termination.
-42-
PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE COMMISSION PURSUANT TO THE COMPANY'S APPLICATION REQUESTING
CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE EXCHANGE ACT; [*] DENOTES
OMISSIONS.
(c) All amounts due or payable to Predix that were accrued, or
that arise out of acts or events occurring, prior to the effective date of
termination under this Section 12.4.1 shall remain due and payable; but (except
as otherwise expressly provided herein) no additional amounts shall be payable
based on events occurring after the effective date of termination.
(d) Should Amgen have any inventory of the Licensed Compound
suitable for use in clinical trials, Amgen shall, upon request by Predix,
negotiate in good faith to sell such inventory to Predix (which sale would
include an appropriate indemnity from Predix for any liability resulting from
use of such inventory).
(e) If any Licensed Product is being commercialized as of the
date of termination, Amgen (and its Affiliates and Sublicensees) shall have
[****] thereafter in which to dispose of any inventory of Licensed Product
(subject to the payment to Predix of any royalties due hereunder thereon),
provided however, that (i) such right shall terminate, on a country-by-country
basis, at such time that Predix or a sublicensee of Predix begins to
commercially sell such Licensed Product in the applicable country and (ii) such
Licensed Product shall not be sold at a discount to a purchaser that is greater
than the average discount provided to such purchaser for the Licensed Product in
the applicable country during the twelve (12) month period preceding such
termination and, in addition, Amgen shall use reasonable efforts to avoid sales
that would result in the applicable wholesaler inventory levels for such
Licensed Product exceeding the average levels for the twelve (12) month period
preceding such termination.
(f) In the case where Amgen has [********] from a [********]
patent rights and such [********] patent rights are [********] to Predix (by
means of the [********]) pursuant to this Section 12.4 and used by Predix with
respect to a Licensed Compound or Licensed Product, Predix shall reimburse Amgen
for any payments that Amgen pays to such [********] that results from Predix's
use of such [********] patent rights.
(g) Upon request of Predix, Amgen shall assign (or, if
applicable, cause its Affiliate to assign) to Predix all of Amgen's (or such
Affiliate's) right, title and interest in and to any registered trademark,
trademark application or internet domain name that is specific to a Licensed
Product that is then being commercialized and which has been used in connection
with such commercialization (subject to a written indemnity from Predix to Amgen
with respect to any and all liabilities related thereto arising after such
assignment) (it being understood that the foregoing assignment shall not include
any trademarks that contain the name "Amgen" or the name of any Affiliate of
Amgen).
12.4.2. Termination by Amgen for Breach by Predix. Upon occurrence
of an uncured material breach pursuant to which Amgen could terminate this
Agreement under Section 12.3.2, Amgen shall have the right to either:
(a) terminate the Agreement, in which event
(i) Amgen shall assign and transfer to Predix the
Regulatory Filings (to the extent Amgen has the right to assign them), or, in
the event that Amgen or another
-43-
PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE COMMISSION PURSUANT TO THE COMPANY'S APPLICATION REQUESTING
CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE EXCHANGE ACT; [*] DENOTES
OMISSIONS.
holder of such Regulatory Filings requires the continued benefit of such filings
in connection with other products or activities, then Amgen shall not be
required to assign or transfer such Regulatory Filings to Predix if Amgen can
provide Predix with the full benefit of such Regulatory Filings and any related
Approvals of Licensed Compounds and Licensed Products through a right of
reference or similar mechanism, and (to the extent contractually and legally
permissible, and with an appropriate novation) the Commercial Documents, in each
case pertaining to Licensed Product(s) then being marketed and sold in the
Territory, but solely to the extent necessary to continue Commercializing
Licensed Product(s) then being marketed and sold in the Territory,
(ii) all licenses granted under Section 2.1 shall
terminate and all rights of Amgen under the Licensed Patents and Licensed
Know-How shall revert to Predix,
(iii) Predix would have no continuing obligations to
Amgen with respect to Licensed Compounds and Licensed Products, and Amgen would
have no continuing obligations to Predix under this Agreement with respect to
Amgen Compounds, Amgen Products, Acquired Compounds or Acquired Products
(except, in each case, as provided in Section 12.5), and,
(iv) if Predix so requests, Amgen and Predix will
negotiate in good faith towards the grant by Amgen to Predix of those portions
of the Composition License and Transfer License necessary to allow Predix to
advance Development and Commercialization of compounds claimed within the
Scaffold Patent Applications as such Scaffold Patent Applications exist as of
the effective date of termination, on terms to be agreed to by the Parties,
including reasonable royalties to be paid to Amgen [****] to method of
manufacturing or formulation patents, while for patents claiming composition of
matter or method of use, there would be no [********] on the royalty), such
royalties to be determined considering the significance of the technology and
stage of development of the compound for which it would be used, or
(b) not terminate the Agreement, retain rights to Licensed
Compounds and Licensed Products and Amgen's payment obligations with respect to
Program Compounds and Program Products shall be [****].
12.4.3 Termination for Convenience by Amgen. If Amgen terminates the
Agreement for convenience under Section 12.3.1 or the Agreement is terminated
according to [********], then:
(a) (i) Amgen shall assign and transfer to Predix the
Regulatory Filings of Licensed Compounds and Licensed Products (to the extent
Amgen has the right to assign them), or, in the event that Amgen or another
holder of such Regulatory Filings requires the continued benefit of such filings
in connection with other products or activities, then Amgen shall not be
required to assign or transfer such Regulatory Filings to Predix if Amgen can
provide Predix with the full benefit of such Regulatory Filings and any related
Approvals of Licensed Compounds and Licensed Products through a right of
reference or similar mechanism, and (to the extent contractually and legally
permissible, and with an appropriate novation) the Commercial Documents, in each
case pertaining to each Licensed Compound and Licensed
-44-
PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE COMMISSION PURSUANT TO THE COMPANY'S APPLICATION REQUESTING
CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE EXCHANGE ACT; [*] DENOTES
OMISSIONS.
Product that is a Licensed Compound and Licensed Product for purposes of Article
12 as of the effective date of such termination,
(ii) Amgen shall xxxxx Xxxxxx the Composition License
and the Transfer License, and
(iii) Predix would have no continuing obligations to
Amgen under this Agreement with respect to Licensed Compounds and Licensed
Products (except as provided in Section 12.5), and
(iv) All licenses granted under Section 2.1 shall
terminate and all rights granted to Amgen under the Licensed Patents and
Licensed Know-How shall revert to Predix, and
(b) Amgen would retain rights to commercialize the Amgen
Compounds, Amgen Products, Acquired Compounds and Acquired Products, provided
that, with respect to all Amgen Compounds and Amgen Products identified as of
the effective date of termination, and Acquired Compounds and Acquired Products
as to which Amgen has acquired rights as of the effective date of termination,
(i) if such termination occurs [****] following the [****], then Amgen's payment
obligations with respect to such Amgen Compounds, Amgen Products, Acquired
Compounds and Acquired Products shall [********], or (ii) if such termination
occurs [****] after the [****], but prior to the [****] of a [****] for the
[********], then Amgen's payment obligations with respect to such Amgen
Compounds, Amgen Products, Acquired Compounds and Acquired Products shall
[********] for the balance of what would have been the [********] but for such
termination, [****] obligation shall be [****].
Notwithstanding the foregoing, no such [********] of Amgen's payment obligations
with respect to such Amgen Compounds, Amgen Products, Acquired Compounds and
Acquired Products shall apply if any [****] occurs after the start of a [****]
for the [****], and in such event Amgen's payment obligations with respect to
such Amgen Compounds, Amgen Products, Acquired Compounds and Acquired Products
shall [********] for the balance of what would have been the [********] but for
such [********].
If the Agreement is terminated under Section 12.3.1 solely with respect to
particular product(s) and/or country(ies), then the provisions of this Section
12.4.3 shall apply solely with respect to such product(s) and/or country(ies).
12.5 Survival. Except as set forth in Section 12.8, only the following
provisions shall survive termination or expiration of this Agreement: Articles 1
(as applicable), 10, 11 and 13 and Sections 2.2(b)(iv), 7.7, 7.10, 8.4, 8.5,
9.1, 9.2.4, 9.3, 9.4 (9.2.4, 9.3 and 9.4 are with respect to Joint Patents
only), 12.1, 12.4, 12.5, 12.7, 14.2, 14.4, 14.5, 14.7, 14.8, 14.15 and 14.16.
Termination or expiration of this Agreement shall not relieve the Parties of any
liability or obligation which accrued hereunder prior to the effective date of
such termination or expiration nor preclude either Party from pursuing all
rights and remedies it may have hereunder or at law or in equity with respect to
any breach of this Agreement nor prejudice either Party's right to
-45-
PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE COMMISSION PURSUANT TO THE COMPANY'S APPLICATION REQUESTING
CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE EXCHANGE ACT; [*] DENOTES
OMISSIONS.
obtain performance of any obligation. All other rights, licenses and obligations
shall terminate upon termination or expiration of this Agreement.
12.6 Bankruptcy. The Parties agree that in the event a Party becomes a
debtor under Title 11 of the U.S. Code ("Title 11"), this Agreement shall be
deemed to be, for purposes of Section 365(n) of Title 11, a license to rights to
"intellectual property" as defined therein. Each Party as a licensee hereunder
shall have the rights and elections as specified in Title 11. Any agreements
supplemental hereto shall be deemed to be "agreements supplementary to" this
Agreement for purposes of Section 365(n) of Title 11. The Parties agree that, in
the event of the commencement of a bankruptcy proceeding by or against either
Party under Title 11, the Party hereto that is not a party to such proceeding
shall be entitled to a complete duplicate of (or complete access to, as
appropriate) any such intellectual property and all embodiments of such
intellectual property, and same, if not already in its possession, shall be
promptly delivered to them (i) upon any such commencement of a bankruptcy
proceeding upon its written request therefor, unless the Party subject to such
proceeding elects to continue to perform all of its obligations under this
Agreement, or (ii) if not delivered under (i) above, following the rejection of
this Agreement by or on behalf of the Party subject to such proceeding upon
written request therefor by the non-subject Party.
12.7 Sublicenses. Notwithstanding the foregoing, any licenses granted from
Amgen to Predix under Section 12.4 shall not include any sublicense of Third
Party intellectual property unless and until Predix shall agree in writing to
comply (directly to the licensor as if Predix was the licensee) with all terms,
conditions and obligations of the license which grants such rights to Amgen and
to indemnify Amgen for any breach thereof by Predix.
12.8 Change of Control.
12.8.1 Upon or before filing any public filing or issuing any press
release disclosing or announcing the pending occurrence of a Change of Control
of Predix, or upon an actual Change of Control of Predix, Predix shall notify
Amgen thereof, specifying the name(s) of the acquiring Third Party(ies), if
known. If the identity of the acquiring Third Party(ies) is not known, Predix
will promptly notify Amgen upon learning the identity of such party(ies). Upon
receipt of such notice, Amgen shall have the right to effect any or all of the
following upon written notice to Predix if the Change of Control is consummated
and results in Predix becoming controlled by an entity that is other than a
financial investor (for example, a venture capital firm, hedge fund, investment
bank or similar entity) which, with its Affiliates, has no operations in the
bio-pharmaceutical industry: (i) to cause Predix to terminate performance of the
Additional Predix Research and to promptly provide to Amgen all results, data
and materials arising from the Additional Predix Research, (ii) to terminate the
JSC, which would then no longer meet, and any rights of Predix related thereto,
(iii) to terminate the co-promotion option of Predix under Article 5 (or any
actual co-promotion if the option has then already been exercised), and (iv) to
terminate any obligations of Amgen to assign or transfer Commercial Documents to
Predix upon termination of this Agreement other than Commercial Documents that
are necessary for the continued development and commercialization of Licensed
Products.
12.8.2 In connection with any Change of Control that would result in
Predix becoming controlled by an entity that is other than a financial investor
(for example, a venture
-46-
PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE COMMISSION PURSUANT TO THE COMPANY'S APPLICATION REQUESTING
CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE EXCHANGE ACT; [*] DENOTES
OMISSIONS.
capital firm, hedge fund, investment bank or similar entity) which, with its
Affiliates, has no operations in the bio-pharmaceutical industry, Predix agrees
that:
(a) Predix will keep confidential, and not provide such
acquiring party access to, any information relating to this Agreement, Program
Products or the activities conducted pursuant hereto (including Amgen
Confidential Information) that have not already been made public, other than the
respective financial obligations of the Parties hereunder (it is the intent of
the Parties that, for the purpose of protecting the interests of Amgen, its
Affiliates and Sublicensees under the Collaboration, a complete firewall be
established between Predix and its Affiliates, on the one hand, and the
acquiring Third Party, its Affiliates and other Third Parties, on the other
hand, with respect to such information),
(b) within thirty (30) days after the consummation of the
Change of Control, Predix or its successor-in-interest shall notify Amgen as to
whether it chooses: (i) to continue with the Agreement and to remain subject to
the terms and conditions herein, including Section 6.1, or (ii) to terminate the
Agreement in which case it is the intent of the Parties that Amgen shall
continue to receive the benefits of this Agreement, except for the exclusivity
obligations of Predix under Section 6.1, with no further participation by Predix
and Predix's rights under the Agreement shall be limited to solely a passive
financial interest and such rights (as set forth below) necessarily attendant to
that passive financial interest; consistent with this intent, (A) Amgen shall
retain all of its rights under the Agreement (including the licenses granted to
Amgen under Section 2.1), which shall survive such termination and Amgen's
Sublicenses shall remain in effect (without application of Section 2.2(b)(iv)),
(B) all obligations of Amgen, its Affiliates and Sublicensees under the
Agreement shall terminate (including any obligation to obtain approval to grant
sublicenses hereunder), except solely Amgen's obligations under the following
provisions, which shall survive such termination, Article 11 and Sections 7.5,
7.6, 7.7, 7.8, 7.9, 7.10, 7.11 (for Sections 7.5, 7.6, 7.7, 7.8, 7.9, 7.10 and
7.11, solely as they relate to payments due prior to the termination and
[********] under clause (B)(1) or (B)(2) below), 8.4, 8.5, 10.1, 10.2, 10.3,
10.4, 14.2, 14.5, 14.7, 14.8, and 14.15, and except that Amgen's payment
obligations hereunder that (1) relate to Program Products that are in [****] as
of the termination date shall [********] as provided herein, (2) relate to
Program Compounds or Program Products that have started [****] but have not yet
started [****] as of the termination date shall [********] as provided herein
but be [****], and (3) accrued prior to the termination shall survive, and there
shall be no other remaining [********] (including [********] for any Program
Products that have not started [****] as of the termination date), (C) all of
Predix's obligations under the Agreement shall survive other than its
obligations under Section 2.6 and 6.1, (D) all of Predix's rights under the
Agreement shall terminate, except solely its rights under the following
provisions, which shall survive such termination, Article 11 and Sections 7.5,
7.6, 7.7, 7.8, 7.9, 7.10, 7.11 (for Sections 7.5, 7.6, 7.7, 7.8, 7.9, 7.10 and
7.11, solely as they relate to payments due prior to the termination and amounts
payable under clause (B)(1) or (B)(2) above), 8.4, 8.5, 14.2, 14.5, 14.7, 14.8,
and 14.15, and its rights to receive [********] from Amgen [********] above, and
(E) if the IP Transition Date has not occurred as of the termination date, it
shall be deemed to have occurred as of the termination date and Amgen will
continue to control the preparation, filing, prosecution and maintenance of
Licensed Patents. Without limiting the foregoing, any other rights, obligations
or provisions herein necessary to effectuate the intent described in clause
(b)(ii) of this Section 12.8.2 shall also apply. In the event of a termination
under clause (b)(ii) of this
-47-
PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE COMMISSION PURSUANT TO THE COMPANY'S APPLICATION REQUESTING
CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE EXCHANGE ACT; [*] DENOTES
OMISSIONS.
Section 12.8.2, upon request of Amgen, Predix (or its successor-in-interest)
will enter into a new license agreement with Amgen consistent with the surviving
terms hereof to evidence the continuing rights and obligations of the Parties.
If Predix or its successor-in-interest does not notify Amgen of its choice under
clause (b) of this Section 12.8.2 within thirty (30) days after the consummation
of the Change of Control, then Predix (or its successor-in-interest) shall be
deemed to have chosen to continue with the Agreement and to remain subject to
the terms and conditions herein, including Section 6.1.
ARTICLE 13
DISPUTE RESOLUTION
13.1 Resolution by Senior Executives. In the event of any dispute between
the Parties in connection with this Agreement, the construction hereof, or the
rights, duties or liabilities of either Party hereunder, the Parties shall first
attempt in good faith to resolve such dispute by negotiation and consultation
between themselves. In the event that such dispute is not resolved on an
informal basis within ten (10) Business Days, either Party may, by written
notice to the other Party, refer the dispute to a Vice President of Amgen and a
Vice President of Predix for attempted resolution by good faith negotiation
within thirty (30) days after such notice is received.
13.2 Immediate Remedy. Notwithstanding anything in this Article 13, each
Party shall have the right to seek injunctive or other equitable relief from a
court of competent jurisdiction pursuant to Section 14.8 that may be necessary
to avoid irreparable harm, maintain the status quo or preserve the subject
matter of a dispute.
ARTICLE 14
MISCELLANEOUS
14.1 Severability. If any one or more of the provisions of this Agreement
is held to be invalid or unenforceable, the provision shall be considered
severed from this Agreement and shall not serve to invalidate any remaining
provisions hereof. The Parties shall make a good faith effort to replace any
invalid or unenforceable provision with a valid and enforceable one such that
the objectives contemplated by the Parties when entering this Agreement may be
realized.
14.2 Notices. Any notice required or permitted to be given by this
Agreement shall be in writing and shall be delivered by hand or overnight
courier with tracking capabilities or mailed postage prepaid by first class,
registered or certified mail addressed as set forth below unless changed by
notice so given:
If to Amgen:
Amgen Inc.
Xxx Xxxxx Xxxxxx Xxxxx
Xxxxxxxx Xxxx, XX 00000-0000
Attention: Corporate Secretary
Telephone: (000) 000-0000
-48-
PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE COMMISSION PURSUANT TO THE COMPANY'S APPLICATION REQUESTING
CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE EXCHANGE ACT; [*] DENOTES
OMISSIONS.
Facsimile: (000) 000-0000
With a copy to:
Amgen Inc.
Xxx Xxxxx Xxxxxx Xxxxx
Xxxxxxxx Xxxx, XX 00000-0000
Attention: Vice President, Licensing
Telephone: (000) 000-0000
Facsimile: (000) 000-0000
If to Predix:
Predix Pharmaceuticals Holdings, Inc.
0 Xxxxxxx Xxxx
Xxxxxxxxx, XX
Attention: Chief Business Officer
Telephone: (000) 000-0000
Facsimile: (000) 000-0000
With a copy to:
Xxxxxxx Procter LLP
Exchange Place
Boston, Massachusetts 02109
Attention: Xxxxxxxxxxx Xxxx, Esq.
Telephone: 000-000-0000
Facsimile: 000-000-0000
Any such notice shall be deemed given on the date received. A Party may
add, delete, or change the person or address to whom notices should be sent at
any time upon written notice delivered to the other Party in accordance with
this Section 14.2.
14.3 Force Majeure. Neither Party shall be liable for delay or failure in
the performance of any of its obligations hereunder if such delay or failure is
due to causes beyond its reasonable control, including acts of God, fires,
earthquakes, strikes and labor disputes, acts of war, terrorism, civil unrest or
intervention of any governmental authority ("Force Majeure"); provided, however,
that the affected Party promptly notifies the other Party and further provided
that the affected Party shall use its commercially reasonable efforts to avoid
or remove such causes of non-performance and to mitigate the effect of such
occurrence, and shall continue performance with the utmost dispatch whenever
such causes are removed.
14.4 Assignment.
14.4.1 Subject to Section 12.8, Predix may not assign or transfer
this Agreement or any rights or obligations hereunder without the prior written
consent of Amgen, except that Predix may make such an assignment without Amgen's
consent to Affiliates or to an entity that acquires all or substantially all of
the business of Predix and its Affiliates, whether in a merger, consolidation,
reorganization, acquisition, sale or otherwise; provided, however, that such
assignee shall provide to Amgen a signed, written expression of its agreement to
be bound
-49-
PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE COMMISSION PURSUANT TO THE COMPANY'S APPLICATION REQUESTING
CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE EXCHANGE ACT; [*] DENOTES
OMISSIONS.
by the terms of this Agreement, in form reasonably acceptable to Amgen, and
where this Agreement is assigned or transferred to an Affiliate, Predix remains
responsible for the performance of this Agreement. To the extent any rights
and/or obligations of Predix are held by an Affiliate of Predix then any
business transaction, change in control of a majority of the voting power or
other event that, in each case, causes such Affiliate to cease to be an
Affiliate of the Predix, shall be deemed an assignment of the rights and/or
obligations held by such former Affiliate and require prior written consent of
Amgen. The Parties also acknowledge that Predix has entered into an Agreement
and Plan of Merger dated as of April 3, 2006 with EPIX and that the consummation
of a merger between Predix and EPIX shall not require further consent from Amgen
under this Agreement.
14.4.2 Amgen may not assign or transfer this Agreement or any rights
or obligations hereunder without the prior written consent of Predix, except
that Amgen may make such an assignment without Predix's consent to Affiliates or
to an entity that acquires all or substantially all of the business of Amgen and
its Affiliates, whether in a merger, consolidation, reorganization, acquisition,
sale or otherwise; provided, however, that (i) Amgen's rights and obligations
under this Agreement [********] and [********] from all or substantially all of
its other [********], including those [********] that are subject to this
Agreement, (ii) such assignment includes all [********] and all rights and
obligations under this Agreement, (iii) such successor in interest or Affiliate
shall have agreed as of such assignment or transfer to be bound by the terms of
this Agreement in a writing provided to Predix, in form reasonably acceptable to
Predix, and (iv) where this Agreement is assigned or transferred to an
Affiliate, Amgen remains responsible for the performance of this Agreement.
14.4.3 Subject to the foregoing, this Agreement shall inure to the
benefit of and be binding on the Parties' successors and assigns, including that
this Agreement shall inure to the benefit of and be binding on the successor
entity in Predix's merger with EPIX as if such successor entity was referenced
herein instead of Predix. Any assignment or transfer in violation of the
foregoing shall be null and void and wholly invalid, the assignee or transferee
in any such assignment or transfer shall acquire no rights whatsoever, and the
non-assigning non-transferring Party shall not be required to recognize such
assignment or transfer.
14.5 Further Assurances. Each Party agrees to do and perform all such
further acts and things and shall execute and deliver such other agreements,
certificates, instruments and documents necessary or that the other Party may
deem advisable in order to carry out the intent and accomplish the purposes of
this Agreement and to evidence, perfect or otherwise confirm its rights
hereunder.
14.6 Waivers and Modifications. The failure of any Party to insist on the
performance of any obligation hereunder shall not be deemed to be a waiver of
such obligation. Waiver of any breach of any provision hereof shall not be
deemed to be a waiver of any other breach of such provision or any other
provision on such occasion or any succeeding occasion. No waiver, modification,
release or amendment of any obligation under or provision of this Agreement
shall be valid or effective unless in writing and signed by all Parties hereto.
-50-
PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE COMMISSION PURSUANT TO THE COMPANY'S APPLICATION REQUESTING
CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE EXCHANGE ACT; [*] DENOTES
OMISSIONS.
14.7 Choice of Law. This Agreement shall be governed by, and enforced and
construed in accordance with, the laws of the State of
Delaware without regard
to its conflicts of law provisions.
14.8 Jurisdiction. Unless the Parties otherwise agree in writing, each
Party hereby irrevocably submits to the exclusive jurisdiction of the courts of
the State of
Delaware ("State Court") and the courts of the United States of
America located in the State of
Delaware ("Federal Court"), for the purposes of
any suit, action or other proceeding arising out of this Agreement or out of any
transaction contemplated hereby. Each Party agrees that service of any process,
summons, notice or document by personal delivery, by registered mail, or by a
recognized international express delivery service to such Party's respective
address set forth above (as such address may be changed by notice delivered
pursuant to Section 14.2) shall be effective service of process for any action,
suit or proceeding in the applicable Federal Court or State Court with respect
to any matters to which it has submitted to jurisdiction in this Section. Each
Party irrevocably and unconditionally waives any objection to the laying of
venue of any action, suit or proceeding arising out of this Agreement or the
transactions contemplated hereby in the applicable Federal Court or State Court,
and hereby and thereby further irrevocably and unconditionally waives and agrees
not to plead or claim in any such court that any such action, suit or proceeding
brought in any such court has been brought in an inconvenient forum.
14.9 Publicity. Upon execution of this Agreement, the Parties shall issue
a press release announcing the existence of this Agreement in the form attached
hereto as Appendix E. Each Party agrees not to issue any other press release or
other public statement disclosing other information relating to this Agreement
or the transactions contemplated hereby without the prior written consent of the
other Party, other than with respect to the terms and conditions of this
Agreement in accordance with Section 10.3, provided, however, that any
disclosure which is required by applicable Law (including the Securities Act of
1933, as amended, and the Securities Exchange Act of 1934, as amended), or the
rules of a securities exchange or the Securities and Exchange Commission or the
securities regulators of any state or other jurisdiction, as reasonably advised
by the disclosing Party's counsel, may be made subject to the following. The
Parties will use appropriate diligent efforts to minimize such disclosure and
obtain confidential treatment for any such information which is disclosed to a
governmental agency. Each Party agrees to provide to the other Party a copy of
any public announcement regarding this Agreement or the subject matter thereof
as soon as reasonably practicable under the circumstances prior to its scheduled
release. Except under extraordinary circumstances, each Party shall provide the
other with an advance copy of any such announcement at least ten (10) business
days prior to its scheduled release. Each Party shall have the right to
expeditiously review and recommend changes to any such announcement and, except
as otherwise required by applicable Law or such rules or regulators, the Party
whose announcement has been reviewed shall remove any Confidential Information
of the reviewing Party that the reviewing Party reasonably requests. The
contents of any announcement or similar publicity which has been reviewed and
approved by the reviewing Party can be re-released by either Party without a
requirement for re-approval. Notwithstanding the foregoing, Amgen shall be
permitted to issue press releases related to the Development and
Commercialization of Program Products, subject to providing Predix with an
advance copy for review and comment.
-51-
PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE COMMISSION PURSUANT TO THE COMPANY'S APPLICATION REQUESTING
CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE EXCHANGE ACT; [*] DENOTES
OMISSIONS.
14.10 Relationship of the Parties. Each Party is an independent contractor
under this Agreement. Nothing contained herein is intended or is to be construed
so as to constitute Predix and Amgen as partners, agents or joint venturers.
Neither Party shall have any express or implied right or authority to assume or
create any obligations on behalf of or in the name of the other Party or to bind
the other Party to any contract, agreement or undertaking with any Third Party.
There are no express or implied third party beneficiaries hereunder.
14.11 Headings. Headings and captions are for convenience only and are not
be used in the interpretation of this Agreement.
14.12 Entire Agreement. This Agreement and the attached Appendices
constitutes the entire agreement between the Parties as to the subject matter of
this Agreement, and supersedes and merges all prior negotiations,
representations, agreements and understandings regarding the same.
14.13 Counterparts. This Agreement may be executed in counter-parts with
the same effect as if both Parties had signed the same document. All such
counterparts shall be deemed an original, shall be construed together and shall
constitute one and the same instrument.
14.14 Exports. Each Party agrees not to export or re-export, directly or
indirectly, any information, technical data, the direct product of such data,
samples or equipment received or generated under this Agreement in violation of
any applicable export control Laws.
14.15 Interpretation.
14.15.1 Each of the Parties acknowledges and agrees that this
Agreement has been diligently reviewed by and negotiated by and between them,
that in such negotiations each of them has been represented by competent counsel
and that the final agreement contained herein, including the language whereby it
has been expressed, represents the joint efforts of the Parties hereto and their
counsel. Accordingly, in interpreting this Agreement or any provision hereof, no
presumption shall apply against any Party hereto as being responsible for the
wording or drafting of this Agreement or any such provision, and ambiguities, if
any, in this Agreement shall not be construed against any Party, irrespective of
which Party may be deemed to have authored the ambiguous provision.
14.15.2 The definitions of the terms herein shall apply equally to
the singular and plural forms of the terms defined. Whenever the context may
require, any pronoun shall include the corresponding masculine, feminine and
neuter forms. The words "include", "includes" and "including" shall be deemed to
be followed by the phrase "without limitation". The word "will" shall be
construed to have the same meaning and effect as the word "shall".
-52-
PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE COMMISSION PURSUANT TO THE COMPANY'S APPLICATION REQUESTING
CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE EXCHANGE ACT; [*] DENOTES
OMISSIONS.
14.15.3 Unless the context requires otherwise, (a) any definition of
or reference to any agreement, instrument or other document herein shall be
construed as referring to such agreement, instrument or other document as from
time to time amended, supplemented or otherwise modified (subject to any
restrictions on such amendments, supplements or modifications set forth herein
or therein), (b) any reference to any Laws herein shall be construed as
referring to such Laws as from time to time enacted, repealed or amended, (c)
any reference herein to any Person shall be construed to include the Person's
successors and assigns, (d) the words "herein", "hereof" and "hereunder", and
words of similar import, shall be construed to refer to this Agreement in its
entirety and not to any particular provision hereof, and (e) all references
herein to Articles, Sections or Appendices, unless otherwise specifically
provided, shall be construed to refer to Articles, Sections and Appendices of
this Agreement.
14.16. Performance by Affiliates. Each of Amgen and Predix
acknowledge that obligations under this Agreement may be performed by Affiliates
of Amgen and Predix, respectively, and that, notwithstanding Section 2.2,
licenses granted hereunder to a Party shall include an extension of such rights
to such Party's Affiliates for the performance of such Party's obligations
hereunder, without being subject to the provisions herein related to the grant
or continued effectiveness of Sublicenses but otherwise subject to all of the
obligations and limitations applicable to Predix or Amgen, as relevant. Each of
Amgen and Predix, respectively, shall be responsible for any performance of such
Party's obligations under this Agreement by its Affiliates.
* * *
[signature page follows]
-53-
PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE COMMISSION PURSUANT TO THE COMPANY'S APPLICATION REQUESTING
CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE EXCHANGE ACT; [*] DENOTES
OMISSIONS.
IN WITNESS WHEREOF, the Parties have caused this Agreement to be executed
by their respective duly authorized officers.
AMGEN INC.
By:
------------------------------------
(Signature)
Name:
------------------------------------
Title:
------------------------------------
PREDIX PHARMACEUTICALS HOLDINGS, INC.
By:
------------------------------------
(Signature)
Name:
------------------------------------
Title:
------------------------------------
-54-
PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE COMMISSION PURSUANT TO THE COMPANY'S APPLICATION REQUESTING
CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE EXCHANGE ACT; [*] DENOTES
OMISSIONS.
APPENDIX A
LICENSED PATENTS AND SCAFFOLD PATENT APPLICATIONS
1. THE SCAFFOLD PATENT APPLICATIONS ARE ATTACHED HERETO AND HEREBY MADE A PART
OF THIS APPENDIX A.
COUNTRY TITLE INVENTORS APPLICATION FILING DATE
US [*************************************] [*******] [*******] [*******]
US [*************************************] [*******] [*******] [*******]
US [*************************************] [*******] [*******] [*******]
US [*************************************] [*******] -- [*******]
PCT [*************************************] [*******] -- [*******]
US [*************************************] [*******] [*******] [*******]
2. FOLLOWING IS A COMPLETE LIST OF LICENSED PATENTS AS OF THE EFFECTIVE DATE.
COUNTRY TITLE INVENTORS APPLICATION FILING DATE
US [*************************************] [*******] [*******] [*******]
US [*************************************] [*******] [*******] [*******]
US [*************************************] [*******] [*******] [*******]
US [*************************************] [*******] -- [*******]
PCT [*************************************] [*******] -- [*******]
US [*************************************] [*******] [*******] [*******]
-55-
PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE COMMISSION PURSUANT TO THE COMPANY'S APPLICATION REQUESTING
CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE EXCHANGE ACT; [*] DENOTES
OMISSIONS.
APPENDIX B
CO-PROMOTION TERMS AND CONDITIONS
If Predix exercises its co-promotion pursuant to Section 5.1, the following
terms and conditions shall apply and relate to the co-promotion of the
applicable Program Product to specialty physicians in the U.S. in the
Co-Promotion Indication.
--------------------------------------------------------------------------------
PRODUCT SALES Amgen shall [*******] of the Program Product,
including in the Co-Promotion Indication, and
shall be responsible for receiving and filling
orders, controlling invoicing, collection of
payments, returns, charge-backs and rebates on
sales of the Program Product, and shall have
sole control over pricing strategies and
distribution of the Program Product.
--------------------------------------------------------------------------------
DESIGNATED CONTACTS Each Party shall designate an employee of such
Party to serve as the primary contact for the
Parties with respect to the co-promotion of the
applicable Program Product in the Co-Promotion
Indication to specialty physicians in the U.S.
(each such designee, a "Designated Contact").
Either party may change its Designated Contact
upon written notice thereof to the other
Party. If a Party's Designated Contact is
unable to attend a meeting of the Designated
Contacts, such Party may designate an alternate
representative (who is also an employee) to
attend in his/her place. The Predix Designated
Contact shall be responsible for overseeing and
coordinating the Predix sales representatives.
--------------------------------------------------------------------------------
ESTABLISHMENT OF Prior to launch of the Program Product in the
COMMERCIALIZATION PLAN Co-Promotion Indication in the U.S. and on an
annual basis thereafter, Amgen shall develop a
Commercialization plan which shall include an
annual plan and budget for the promotion and
marketing of the Program Product in the
Co-Promotion Indication to specialty physicians in
the U.S. (which may be part of a larger
Commercialization plan related to the Program
Product). The Commercialization plan shall contain
the number of details to be carried out during the
year with respect to specialty physicians in the
U.S. for the Co-Promotion Indication, and each
Party's allocation of such details. Amgen will
have final decision making authority on all
Commercialization matters.
--------------------------------------------------------------------------------
-56-
PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE COMMISSION PURSUANT TO THE COMPANY'S APPLICATION REQUESTING
CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE EXCHANGE ACT; [*] DENOTES
OMISSIONS.
--------------------------------------------------------------------------------
USE AND DISTRIBUTION OF Amgen shall have responsibility to prepare and
PROMOTIONAL MATERIALS produce all promotional materials for the
Program Product in the Co-Promotion Indication,
and shall provide such materials to Predix in
accordance with the Commercialization plan. Each
party's sales force shall use, and if applicable,
distribute promotional materials to healthcare
professionals to whom it details the Program
Product. Promotional materials shall not be used
unless approved by Amgen.
To the extent permitted under applicable Law,
Amgen shall include on Co-Promotion Indication
materials in the U.S. that are intended for use in
the same setting as the co-promoted product (such
as detail aids) and will make reasonable efforts
to include on other Co-Promotion Indication
promotional materials (such as exhibit booths and
conference presentations) in the U.S. relating to
such product (but not including labeling or
packaging) both Amgen and Predix (or its
successor) [********], in which event such
[********] would be [********] with substantially
equivalent [********] on [********].
-------------------------------------------------------------------------------
SAMPLES The Parties shall use and distribute samples in
accordance with the Commercialization plan and all
applicable laws.
-------------------------------------------------------------------------------
SALES FORCE TRAINING Amgen shall develop and provide training
programs and materials for the Program Product
in the Co-Promotion Indication to ensure a
consistent, focused promotional strategy.
Amgen shall treat the Predix and Amgen sales
representatives as a combined sales force and
shall provide the Predix representatives with
the same support and assistance it provides its
own representatives.
-------------------------------------------------------------------------------
TERMINATION Predix may terminate its co-promotion of the
applicable Program Product in the Co-Promotion
Indication upon not less than one hundred
eighty (180) days prior written notice to
Amgen. Amgen and Predix shall reasonably
cooperate to transition to Amgen Predix's
co-promotion activities with respect to the
applicable Program Product so as to minimize
disruption to sales activity and Predix shall
withdraw its sales representatives from such
co-promotion activities in a professional
manner. For the avoidance of doubt, Predix
shall not be entitled to reactivate its
co-promotion right once it terminates such
co-promotion activities.
-------------------------------------------------------------------------------
-57-
PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE COMMISSION PURSUANT TO THE COMPANY'S APPLICATION REQUESTING
CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE EXCHANGE ACT; [*] DENOTES
OMISSIONS.
-------------------------------------------------------------------------------
COMPLIANCE AND PERFORMANCE Each Party shall be responsible for its own
compliance with all applicable Laws and
regulatory authority policies and guidelines
relating to the co-promotion of the applicable
Program Product in the Co-Promotion
Indication. Predix shall be solely responsible
for ensuring that its sales representatives
promote the applicable Program Product in a
manner consistent with the Commercialization
plan. The co-promotion agreement shall contain
provisions for resolution and correction of
unethical or illegal behavior on the part of
Predix sales representatives. Predix sales
representatives shall be held to the same
standards of performance as the Amgen sales
representatives, and shall meet certain minimum
qualifications. The co-promotion agreement
shall also include an audit provision for
purposes of measuring Predix sales force
effectiveness and performance.
-------------------------------------------------------------------------------
REGULATORY Amgen shall be solely responsible for
communicating with the applicable regulatory
authorities, including any adverse event
reporting, recall notifications and safety
updates. Predix shall reasonably cooperate
with Amgen regarding co-promotion activities so
that Amgen can meet its regulatory obligations.
-------------------------------------------------------------------------------
INDEMNIFICATION Amgen and Predix shall indemnify each other as
provided in the Agreement and Predix shall obtain
and/or maintain insurance for its co-promotion
activities.
-------------------------------------------------------------------------------
-58-
PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE COMMISSION PURSUANT TO THE COMPANY'S APPLICATION REQUESTING
CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE EXCHANGE ACT; [*] DENOTES
OMISSIONS.
APPENDIX C
WIRE TRANSFER INSTRUCTIONS FOR INITIAL PAYMENT
[*******]
-59-
PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE COMMISSION PURSUANT TO THE COMPANY'S APPLICATION REQUESTING
CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE EXCHANGE ACT; [*] DENOTES
OMISSIONS.
APPENDIX D
EXISTING LICENSES
None.
-60-
PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE COMMISSION PURSUANT TO THE COMPANY'S APPLICATION REQUESTING
CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE EXCHANGE ACT; [*] DENOTES
OMISSIONS.
APPENDIX E
FOR IMMEDIATE RELEASE
CONTACTS:
Xxxxxx X. Xxxxxxxx, Pure Communications
(000) 000-0000
Xxxxxx Xxxxx, Pure Communications
(000) 000-0000
PREDIX PHARMACEUTICALS ANNOUNCES COLLABORATION FOR DEVELOPMENT OF S1P1
MODULATORS FOR THE TREATMENT OF AUTOIMMUNE DISEASES
Total Payments to Predix Could Exceed $300 Million; Predix Has Option to
Co-promote In a Selected Indication
LEXINGTON, Mass., July 31, 2006 -- Predix Pharmaceuticals, which recently
announced a definitive agreement to merge with EPIX Pharmaceuticals (NASDAQ:
EPIX), announced today that it has entered into an exclusive collaboration and
licensing agreement with Amgen for the development of novel, orally available
S1P1 modulators for the treatment of multiple autoimmune diseases.
Under the terms of the agreement, Predix and Amgen will collaborate on the
development of existing Predix preclinical compounds and new S1P1 modulators.
Amgen will be responsible for clinical development and commercialization of the
product candidate(s). Predix will receive an upfront payment of $20 million.
Additionally, if certain clinical, regulatory and sales milestones are achieved,
Predix can earn up to an additional $287.5 million in milestone payments. Under
the agreement, Predix will have the opportunity to receive potential
double-digit royalties on future sales of products resulting from this
collaboration and will have the option to promote a product resulting from this
collaboration to specialty physicians in the U.S. for a selected indication.
"Amgen is recognized as an industry leader in the research, development and
commercialization of therapies for autoimmune and inflammatory diseases," stated
Chen Xxxxx, chief business officer of Predix. "We are very pleased to enter into
this collaboration and look forward to working with Amgen. This collaboration
provides Predix with the option to transform into a fully integrated
pharmaceutical company by exercising our co-promote option with Amgen. This deal
comes as we are in the process of finalizing our merger with EPIX and will
further enable the combined company to pursue this research program along with
our other development programs."
Xxxxxx Xxxxxxx, Ph.D., vice president of preclinical development at Predix
added, "The goal of this collaboration is to leverage both Amgen's and Predix's
expertise in autoimmune research. We believe that combining Predix's S1P1
program with Amgen's assets and capabilities will lead to new therapies that
will more effectively treat a variety of autoimmune disorders."
-61-
PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE COMMISSION PURSUANT TO THE COMPANY'S APPLICATION REQUESTING
CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE EXCHANGE ACT; [*] DENOTES
OMISSIONS.
ABOUT S1P1 MODULATORS
Predix's preclinical-stage S1P1 agonists are potent and selective for S1P1 over
other S1P receptors and many other GPCRs, potentially providing an improved side
effect profile in the clinic compared to currently available immunosuppressive
drugs. S1P1 is one of at least five different GPCRs that are activated by the
phospholipid Sphingosine-1-phosphate (S1P). These GPCRs play a role in multiple
biological processes, including immune system activation and cardiovascular
function. Compounds which activate the S1P1 receptor, called S1P1 agonists, have
been shown to induce peripheral lymphopenia, which is a reduction in circulating
lymphocytes in the blood. Instead of inactivating lymphocytes and hampering the
immune response entirely like conventional immunosuppressive drugs, S1P1
agonists appear to work by temporarily maintaining lymphocytes in the lymphatic
system (e.g., lymph nodes). This mechanism of action has been suggested to be
beneficial in a variety of autoimmune disorders, such as multiple sclerosis,
rheumatoid arthritis, inflammatory bowel disease and rejection of transplanted
organs.
ABOUT AUTOIMMUNE DISEASES
Autoimmune diseases afflict millions of Americans. There are many different
autoimmune diseases. Some examples are multiple sclerosis, type 1 diabetes, and
rheumatoid arthritis. Autoimmune diseases can each affect the body in different
ways. For instance, the autoimmune reaction is directed against the brain in
multiple sclerosis and the intestines or gastrointestinal tract in Crohn's
disease. In other diseases, such as lupus, affected tissues and organs may vary
among individuals with the same disease.
ABOUT PREDIX PHARMACEUTICALS HOLDINGS, INC.
Predix, based in Lexington, MA, is a pharmaceutical company focused on the
discovery and development of novel, highly selective, small-molecule drugs that
target G-Protein Coupled Receptors (GPCRs) and ion channels. Using its
proprietary drug discovery technology and approach, Predix has advanced four
internally-discovered drug candidates into clinical trials and has five
additional programs in preclinical development and discovery. Predix is expected
to complete the first of at least two pivotal Phase III clinical trials for
generalized anxiety disorder for its lead drug candidate, PRX-00023, in the
second half of 2006. In addition to PRX-00023, Predix has three other
clinical-stage drug candidates: PRX-03140 for the treatment of Alzheimer's
disease, which is expected to enter Phase IIa later this year; PRX-08066 for the
treatment of pulmonary hypertension (PH) and PH associated with chronic
obstructive pulmonary disease, which recently entered a Phase II trial; and,
PRX-07034, which recently entered a Phase I trial and is expected to be
developed for the treatment of obesity and also cognitive impairment associated
with Alzheimer's disease or schizophrenia. Additional information about Predix
can be found on the company's website at xxx.xxxxxxxxxxx.xxx.
ADDITIONAL INFORMATION ABOUT THE MERGER AND WHERE TO FIND IT EPIX has filed a
registration statement on Form S-4 with the Securities and Exchange Commission
containing a joint proxy statement/prospectus in connection with the proposed
merger with Predix Pharmaceuticals. Investors and security holders are advised
to read the joint proxy statement/prospectus (including any amendments or
supplements thereto) regarding the proposed merger, because it contains
important information about EPIX, Predix and the
-62-
PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE COMMISSION PURSUANT TO THE COMPANY'S APPLICATION REQUESTING
CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE EXCHANGE ACT; [*] DENOTES
OMISSIONS.
proposed transaction and other related matters. The joint proxy
statement/prospectus has been mailed to stockholders of EPIX and Predix seeking
their approval of the proposed transaction. Investors and security holders may
obtain a free copy of the joint proxy statement/prospectus and any amendments or
supplements thereto (when they are available) and other documents filed by EPIX
at the Securities and Exchange Commission's web site at xxx.xxx.xxx. The joint
proxy statement/prospectus and such other documents may also be obtained for
free by directing such request to
EPIX Pharmaceuticals, Inc., 000 Xxxxx Xxxxxx,
Xxxxxxxxx, Xxxxxxxxxxxxx, Attn: Investor Relations, tel: (000) 000-0000; e-mail:
xxxxxxxx@xxxxxxxxxx.xxx or Predix Pharmaceuticals Holdings, Inc., 0 Xxxxxxx
Xxxx, Xxxxxxxxx, Xxxxxxxxxxxxx 00000, Attn: Investor Relations, tel: (781)
000-0000; e-mail: xxxxxxxxx@xxxxxxxxxxx.xxx.
EPIX and Predix and their respective directors, executive officers and other
members of management and employees may be deemed to be participants in the
solicitation of proxies with respect to the adoption of the merger agreement and
the transactions associated with the merger. A description of any interests that
EPIX and Predix directors and executive officers have in the merger is included
in the registration statement containing the joint proxy statement/prospectus
filed with the Securities and Exchange Commission and available free of charge
as indicated above. Information regarding EPIX's executive officers and
directors is also available in EPIX's Form 10-K, as amended, for the year ended
December 31, 2005, which was filed with the Securities and Exchange Commission
on March 1, 2006 and amended on April 28, 2006. You can obtain free copies of
these documents using the contact information above.
SAFE HARBOR STATEMENT
Certain statements in this news release concerning Predix's business are
considered "forward-looking statements" within the meaning of the Private
Securities Litigation Reform Act of 1995. These statements include, but are not
limited to, those relating to the expected future development of Predix's
preclinical compounds for its S1P1 program, the ability of Predix to realize
certain benefits under its strategic agreement with Amgen, as well as the timing
and results of future clinical development of Predix's drug candidates and their
potential efficacy, safety and tolerability. Any or all of the forward-looking
statements in this press release can be affected by inaccurate assumptions
Predix might make or by known or unknown risks and uncertainties, including, but
not limited to: the early stage of product development; uncertainties as to the
future success of ongoing and planned clinical trials; and the unproven safety
and efficacy of products under development. Consequently, no forward-looking
statement can be guaranteed, and actual results may vary materially. Predix
undertakes no obligation to publicly update forward-looking statements, whether
because of new information, future events or otherwise, except as required by
applicable law.
###
-63-
PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE COMMISSION PURSUANT TO THE COMPANY'S APPLICATION REQUESTING
CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE EXCHANGE ACT; [*] DENOTES
OMISSIONS.
