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<PAGE>
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.
<PAGE>
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 4 Maguire Road, Lexington, MA 02421
("Predix"), and
Amgen Inc., a Delaware corporation having its principal place of
business at One
Amgen Center Drive, Thousand Oaks, CA 91320-1799 ("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
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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.
<PAGE>
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.
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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.
<PAGE>
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.
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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.
<PAGE>
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
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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.
<PAGE>
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
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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.
<PAGE>
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.
<PAGE>
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 [********].
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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.
<PAGE>
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.
<PAGE>
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.
<PAGE>
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 Phase 2b Trial" 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.
<PAGE>
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.
<PAGE>
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.
<PAGE>
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.
<PAGE>
(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.
<PAGE>
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 mark 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.
<PAGE>
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.
<PAGE>
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.
<PAGE>
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.
<PAGE>
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.
<PAGE>
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
<Table>
<Caption>
Event Dollars
----- -------
<S> <C>
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 [********] [****]
</Table>
-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.
<PAGE>
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
<Table>
<Caption>
Event Dollars
----- -------
<S> <C>
[****] 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 [****] [****]
</Table>
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):
<Table>
<S> <C>
Upon annual Net Sales in excess of [****] [****]
Upon annual Net Sales in excess of [****] [****]
Upon annual Net Sales in excess of [****] [****]
</Table>
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.
<PAGE>
[****], 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.
<Table>
<Caption>
Annual Net Sales Royalties
---------------- ---------
<S> <C>
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
[****]
</Table>
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.
<PAGE>
(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.
<PAGE>
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
PO Box 667
Newbury Park, CA 91319-0667
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 Quarte
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