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Exhibit
10.38
EXCLUSIVE LICENSE
AGREEMENT
This License Agreement
(“ Agreement ”) is entered into as of this 19
day of December, 2006 (“ Effective Date ”), by
and between:
on the one hand,
Pfizer Inc, a corporation
organized and existing under the laws of the State of Delaware,
with its principal place of business at 234 East 42
nd Street, New York, New York 10017 (including its
Affiliates (as defined herein, “ Licensee
”),
and on the other
hand,
Kosan Biosciences Incorporated, a
corporation organized and existing under the laws of the State of
Delaware, with its principal place of business at 3832 Bay Center
Place, Hayward, California 94545 (“ Kosan ”).
Licensee and Kosan each may be referred to herein as a
“Party,” and collectively as
“Parties.”
WHEREAS, Kosan owns or
possesses certain patent rights and know-how with respect to
motilin agonist compounds, including KOS-2187;
WHEREAS, Kosan desires to
license its technology and rights to Licensee for the continued
development and commercialization of Kosan’s motilin agonist
compounds, including but not limited to KOS-2187;
WHEREAS, Licensee desires to
continue the development and commercialization of KOS-2187 and such
other Kosan compounds as Licensee may determine could be beneficial
in the treatment of GI disorders;
WHEREAS, Licensee desires to
obtain an exclusive license under Kosan’s patent rights and
know-how with respect to such compounds, including KOS-2187;
and
WHEREAS, Kosan is willing to
grant an exclusive license to Licensee under such patent rights and
know-how all as more particularly described in, and subject to the
terms and conditions of, this Agreement.
NOW THEREFORE, in
consideration of the foregoing and of the mutual covenants
hereinafter set forth and other good and valuable consideration,
the receipt and sufficiency of which is hereby acknowledged, the
Parties mutually agree as follows:
CERTAIN
CONFIDENTIAL INFORMATION
CONTAINED IN THIS
DOCUMENT , MARKED BY
BRACKETS , HAS BEEN
OMITTED AND FILED
SEPARATELY WITH THE
SECURITIES AND
EXCHANGE COMMISSION
PURSUANT TO RULE 24b-2
OF THE SECURITIES
EXCHANGE ACT OF 1934,
AS AMENDED .
ARTICLE 1
DEFINITIONS
As used in this Agreement,
the following terms shall have the following meanings, and singular
forms, plural forms and derivative forms (i.e. other parts of
speech), shall be interpreted accordingly:
1.1 “ Affiliate
” means any corporation or non-corporate business entity
which controls, is controlled by, or is under common control with a
Party to this Agreement. A corporation or non-corporate business
entity shall be regarded as in control of another corporation if it
owns or directly or indirectly controls greater than fifty percent
(>50%) of the voting stock of the other corporation or such
lesser maximum percentage permitted in those jurisdictions where
majority ownership by foreign entities is prohibited, or
(a) in the absence of the ownership of greater than fifty
percent (>50%) of the voting stock of a corporation, or
(b) in the case of a non-corporate business entity, if it
possesses, directly or indirectly, the power to direct or cause the
direction of the management and policies of the corporation or
non-corporate business entity, as applicable, whether through the
ownership or control of voting securities, by contract or
otherwise.
1.2 “
Approval” or “Approved ” means any and all
approvals, including supplements and amendments, licenses,
registration or authorizations of any agency, department or bureau
or government authority that are necessary for the manufacture,
distribution, use marketing or sale of a pharmaceutical product in
a regulatory jurisdiction.
1.3 “ Bulk
KOS-2187 ” means Kosan’s inventory of the active
pharmaceutical ingredient for KOS-2187.
1.4 “ Business
Day ” or business day means a day other than Saturday,
Sunday or any other day on which commercial banks located in New
York, New York are obligated by applicable laws to
close.
1.5 “ CTA
” means a Clinical Trial Authorization filed with the EMEA
with respect to the EU or with the Regulatory Agency of a country
within the EU for a compound to be developed for use within the
Field.
1.6 “ Combination
Product ” means a product that contains a Licensed
Product in any dosage strength or formulation and one
(1) additional active ingredient.
1.7 “
Commencement ” means, with respect to a clinical
trial, the date upon which the first patient receives the first
dose of an item that is the subject of such clinical
trial.
CERTAIN
CONFIDENTIAL INFORMATION
CONTAINED IN THIS
DOCUMENT , MARKED BY
BRACKETS , HAS BEEN
OMITTED AND FILED
SEPARATELY WITH THE
SECURITIES AND
EXCHANGE COMMISSION
PURSUANT TO RULE 24b-2
OF THE SECURITIES
EXCHANGE ACT OF 1934,
AS AMENDED .
2
1.8 “
Commercialize ” or “ Commercialization
” means all activities relating to the commercialization of a
Licensed Product including, without limitation, promotion,
marketing, sales and distribution.
1.9 “ Commercially
Reasonable Efforts ” means those efforts and resources
that Licensee would use were it developing or commercializing its
own pharmaceutical products that are of similar market potential as
the Licensed Product, taking into account product labeling or
anticipated labeling, present and future market potential, past
performance, financial return, medical and clinical considerations,
present and future regulatory environment and competitive market
conditions in the Field, all as measured by the facts and
circumstances at the time such efforts are due.
1.10 “ Control
” means the possession of the ability to grant a license or
sublicense as provided for herein without violating the terms of
any agreement or other arrangement with any Third Party.
1.11 “ Dollars
” or “ $ ” means US dollars.
1.12 “ EU
” means the European Union.
1.13 “ FDA
” means the US Food and Drug Administration and any successor
entity thereto.
1.14 “ Field
” [*].
1.15 “ First
Commercial Sale ” means the first sale of a Licensed
Product to a Third Party.
1.16 [*]
1.17 [*]
1.18 “ GI
Indication ” [*]
1.19 “ GI
Product ” [*]
1.20 “ IND
” means an Investigational New Drug Application filed with
FDA for a Licensed Product to be developed for use in the Field or
foreign equivalent.
1.21 “ Joint
Research and Development Plan ” shall have the meaning
given in Section 6.4.
1.22 “ Know-How
” means all non-patented data, information, methods,
procedures, processes and other know-how related to the use,
manufacture or sale of Kosan Compound Library. Know-How includes
but is not limited to: biological, chemical, biochemical,
toxicological, pharmacological, metabolic, formulation, clinical,
analytical and stability information, standard operating procedures
and protocols relating
CERTAIN
CONFIDENTIAL INFORMATION
CONTAINED IN THIS
DOCUMENT , MARKED BY
BRACKETS , HAS BEEN
OMITTED AND FILED
SEPARATELY WITH THE
SECURITIES AND
EXCHANGE COMMISSION
PURSUANT TO RULE 24b-2
OF THE SECURITIES
EXCHANGE ACT OF 1934,
AS AMENDED .
3
to the research scale, pilot scale and
commercial scale synthesis of the Kosan Compound Library (other
than such information and data which is or becomes the subject of a
patent or patent application).
1.23 “ KOS-2187
” means the compound known as [*].
1.24 “ Kosan
Compound Library ” means the compounds generically or
specifically described in the Kosan Patent Rights.
1.25 “ Kosan [*]
Patent Rights ” means the patent applications listed on
Exhibit A as Kosan Patent Family [*], including any patents issuing
therefrom, as well as all continuations, continuations-in-part,
divisions, patents of addition, reissues, renewals, extensions,
substitutions, and supplementary protection certificates thereof,
and the foreign patents and foreign patent applications
corresponding to any of the foregoing.
1.26 “ Kosan
Know-How ” means all Know-How that is Controlled by Kosan
as of the Effective Date.
1.27 “ Kosan Patent
Rights ” means all patents and patent applications that
are Controlled by Kosan as of the Effective Date, including all
continuations, continuations-in-part, divisions, patents of
addition, reissues, renewals, extensions, substitutions, and
supplementary protection certificates thereof, and the foreign
patents and foreign patent applications corresponding to any of the
foregoing. The Kosan Patent Rights existing as of the Effective
Date are set forth in Exhibit A.
1.28 “ Kosan
Technology ” means collectively Kosan Know-How and Kosan
Patent Rights.
1.29 “ Licensed
Product ” means (a) any product the manufacture, use
or sale of which is covered by a Valid Claim or (b) any
product covered by Section 4.1(c) with respect to countries
where the manufacture, use or sale of the product is not covered by
a Valid Claim.
1.30 “ Licensee
” means Licensee and its Affiliates.
1.31 “ Licensee
Quarter ” means (i) in the US, each of the four
(4) thirteen (13)-week periods used by Licensee in its audited
financial reports, the first such period commencing on
January 1 of any year and (ii) in any country in the
Territory other than the US, each of the four (4) thirteen
(13)-week periods used by Licensee in its audited financial
reports, the first such period commencing on December 1 of any
year. Provisions in this Agreement requiring a calculation of sales
in the Territory in the first Licensee Quarter or in [*]
consecutive Licensee Quarters shall be calculated by adding the
sales in the first Licensee Quarter in the US pursuant to clause
(i) above and the sales in the first Licensee Quarter outside
of the US pursuant to clause (ii) above and likewise for each
of the [*] Licensee Quarters in a particular year.
CERTAIN
CONFIDENTIAL INFORMATION
CONTAINED IN THIS
DOCUMENT , MARKED BY
BRACKETS , HAS BEEN
OMITTED AND FILED
SEPARATELY WITH THE
SECURITIES AND
EXCHANGE COMMISSION
PURSUANT TO RULE 24b-2
OF THE SECURITIES
EXCHANGE ACT OF 1934,
AS AMENDED .
4
1.32 [*]
1.33 “ NDA
” means a New Drug Application filed with the FDA (or foreign
equivalent thereof) for approval to market and sell a
drug.
1.34 “ Net Sales
” means:
(a) with respect to a
Licensed Product (subject to subsection (b) below), the amount
invoiced by Licensee or a sublicensee for sales of such Licensed
Product, to Third Parties, less, without duplication, (i) [*],
(ii) [*]; and
(b) in the case of a
Combination Product,
(i) if Licensee or any
sublicensee separately sells in such country during such year when
it sells such Combination Product both (1) one or more
Licensed Products as a single chemical entity and (2) other
products containing active pharmaceutical ingredient(s) as a single
chemical entity, both of which are also contained in such
Combination Product, then the Net Sales attributable to such
Combination Product during such year shall be calculated by
multiplying actual Net Sales of such Combination Product by the
fraction A/(A+B) where: A is the sum of Licensee’s (or its
sublicensees’) average Net Sales prices per daily dose during
such year for each Licensed Product in such Combination Product as
a single chemical entity in such country and B is the sum of the
average of Licensee’s (or its sublicensees’) Net Sales
prices per daily dose during such year in such country, for each
product(s) containing the active pharmaceutical ingredient(s) in
such Combination Product (other than the Licensed Product) as a
single chemical entity;
(ii) if Licensee or any
sublicensee separately sells, in such country during such year when
it sells such Combination Product, one or more Licensed Products as
a single chemical entity but does not separately sell, in such
country, other products containing the active pharmaceutical
ingredient(s) that are also contained in such Combination Product,
then the Net Sales attributable to such Combination Product during
such year shall be calculated by multiplying the Net Sales of such
Combination Product by the fraction A/C where: A is the sum of
Licensee’s (or its sublicensees’) average Net Sales
prices per daily dose during such year for each Licensed Product in
such Combination Product as a single chemical entity in such
country, and C is Licensee’s (or its sublicensees’)
average Net Sales price per daily dose during such year for the
Combination Product in such country; and
(iii) if Licensee or its
sublicensee does not separately sell, in such country during such
year when it sells such Combination Products, each Licensed Product
contained in the Combination Product, then the Net Sales
attributable to such Combination Product during such year shall be
calculated by multiplying the Net Sales of such Combination Product
by the fraction D/D+E where D is the fair market value of the
portion of the Combination Product that contains the Licensed
Product and E is the fair market value of the portion of the
Combination Product containing the other active ingredient in the
Combination Product, as the fair market values are determined by
mutual agreement of the Parties.
CERTAIN
CONFIDENTIAL INFORMATION
CONTAINED IN THIS
DOCUMENT , MARKED BY
BRACKETS , HAS BEEN
OMITTED AND FILED
SEPARATELY WITH THE
SECURITIES AND
EXCHANGE COMMISSION
PURSUANT TO RULE 24b-2
OF THE SECURITIES
EXCHANGE ACT OF 1934,
AS AMENDED .
5
In all cases, Net Sales shall be
determined from books and records maintained in accordance with
[*]
1.35 “ Non-GI
Product ” means a Licensed Product that has been Approved
for an indication [*].
1.36 “ Phase I
” means, with respect to the US, the first phase of human
clinical trials using a limited number of human subjects to gain
evidence of the safety and tolerability of a Licensed Product and
information regarding pharmacokinetics and potentially
pharmacological activity for such Licensed Product, which human
clinical trials are completed prior to the initiation of Phase II,
as described in 21 C.F.R. § 312.21(a), as may be amended, or,
with respect to any other country or jurisdiction, the equivalent
of such a clinical trial in such other country or
jurisdiction.
1.37 “ Phase II
” means, with respect to the US, the second phase of human
clinical trials of a Licensed Product to gain evidence of the
efficacy in one or more indications and expanded evidence of the
safety of such Licensed Product, as well as an indication of the
dosage regimen required, as described in 21 C.F.R.§ 312.21(b),
as may be amended, or, with respect to any other country or
jurisdiction, the equivalent of such a clinical trial in such other
country or jurisdiction.
1.38 [*]
1.39 [*]
1.40 [*]
1.41 “
Registration ” in relation to any Licensed Product
means such approvals by government authorities in a country or
community or association of countries included in the Territory
(including, where applicable, price approvals) that are required to
be obtained prior to marketing or selling such Licensed Product for
use in the Field.
1.42 “ Regulatory
Agency ” means, with respect to any particular country,
the governmental authority, body, commission, agency or other
instrumentality of such country (or the EMEA with respect to the
EU), with the primary responsibility for the evaluation or approval
of pharmaceutical products before a Licensed Product can be tested,
marketed, promoted, distributed or sold in such country, including
such governmental bodies that have jurisdiction over the pricing of
such pharmaceutical product. The term “Regulatory
Agency” includes the FDA.
1.43 “ Regulatory
Filing ” means any filing with a Regulatory Agency
relating to or to permit or request, as applicable, the clinical
evaluation or Registration of a pharmaceutical product. Regulatory
Filings include without limitation INDs, CTAs and NDAs.
CERTAIN
CONFIDENTIAL INFORMATION
CONTAINED IN THIS
DOCUMENT , MARKED BY
BRACKETS , HAS BEEN
OMITTED AND FILED
SEPARATELY WITH THE
SECURITIES AND
EXCHANGE COMMISSION
PURSUANT TO RULE 24b-2
OF THE SECURITIES
EXCHANGE ACT OF 1934,
AS AMENDED .
6
1.44 “ Reverted
Product ” means a Licensed Product (a) [*] and
(b) that is required to be reverted to Kosan in accordance
with Section 12.8.
1.45 “ Royalty
Term ” shall be as defined in
Section 4.1.
1.46 “ Second GI
Product ” [*].
1.47 “ Second Non-GI
Product ” [*]
1.48 “ Territory
” means the entire world.
1.49 “ Third
Party ” means any party other than Kosan, Kosan’s
Affiliates or Licensee.
1.50 “ US
” means the United States of America, its territories and
possessions.
1.51 “ Valid
Claim ” means any claim from (a) an issued and
unexpired patent included within the Kosan Patent Rights that has
not been revoked or held unenforceable or invalid by a final
decision of a court or other governmental authority of competent
jurisdiction, unappealable or unappealed within the time allowed
for appeal or that has not been disclaimed, denied or admitted to
be invalid or unenforceable through reissue or disclaimer or
otherwise; or (b) a patent application included within the
Kosan Patent Rights; provided however, that such a claim from a
patent application has not been canceled, withdrawn, or abandoned
or been pending for more than [*] from the date of its first
priority filing anywhere in the world. If a claim of a patent
application that ceased to be a Valid Claim under item
(b) because of the passage of time that later issues as part
of a patent within item (a), then it shall again be considered to
be a Valid Claim effective as of the earlier of the grant,
allowance or issuance of such patent.
ARTICLE 2
GRANT OF
LICENSE/ASSIGNMENT OF PATENTS
2.1 Grant . Subject to
the terms and conditions of this Agreement, Kosan hereby grants to
Licensee, and Licensee hereby accepts on its and their behalf, an
exclusive license, with a right to sublicense as provided in
Section 2.2, under the Kosan Technology to (a) develop,
use, sell, offer for sale, import and/or export Licensed Products
in the Territory and in the Field, and (b) make and have made
Licensed Products in the Territory for such development, use, sale,
offering for sale, importation and/or exportation. [*]
CERTAIN
CONFIDENTIAL INFORMATION
CONTAINED IN THIS
DOCUMENT , MARKED BY
BRACKETS , HAS BEEN
OMITTED AND FILED
SEPARATELY WITH THE
SECURITIES AND
EXCHANGE COMMISSION
PURSUANT TO RULE 24b-2
OF THE SECURITIES
EXCHANGE ACT OF 1934,
AS AMENDED .
7
2.2 Right to
Sublicense . Licensee shall have the right to sublicense the
rights granted under Section 2.1 to Third Parties in the Field
or the Territory. Licensee assumes full responsibility for the
performance of such sublicense, and compliance with the terms of
this Agreement by such sublicensee, and will itself pay and account
to Kosan for all royalties or other payments due under this
Agreement by reason of the operations of any such sublicensee. Any
agreement governing the terms of a sublicense by Licensee or any of
its sublicensees of any of the rights granted under
Section 2.1 must be consistent with the terms and conditions
of this Agreement.
ARTICLE 3
MILESTONE
PAYMENTS
3.1 Upfront Payment .
Upon the Effective Date hereof, Licensee shall pay Kosan a
non-refundable upfront license fee in the amount of Twelve Million
Five Hundred Thousand Dollars ($12,500,000).
3.2 Milestone Payments
.
(a) Development .
Licensee shall pay to Kosan non-refundable milestone payments
specified below with respect to development by Licensee and its
sublicensees of Licensed Product as a human therapeutic no later
than thirty (30) days after the following events have
occurred.
Licensee will only pay the development
milestones listed below once for each Licensed Product.
Licensee will pay development milestones
for a Second GI Product only if [*]. Development milestone payments
will then be paid [*] for the Second GI Product.
Licensee will pay development milestones
for a Second Non-GI Product only if [*]. Milestone payments will
then be paid [*] for the Second Non-GI Product.
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Milestone
Event
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Milestone Payment |
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[*]
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[ |
*] |
It is the parties’ intent that
each of the foregoing [*]. However, the parties recognize that it
is possible that during the development of a Licensed Product, one
or more of the above milestone events may be skipped. Therefore, if
a particular milestone event occurs on a given date and, as of such
date, any of the prior milestone events have not occurred, Licensee
shall be required to make the prior milestone payment(s) as if such
milestone event(s) had occurred as of the date the subsequent
milestone event occurred.
CERTAIN
CONFIDENTIAL INFORMATION
CONTAINED IN THIS
DOCUMENT , MARKED BY
BRACKETS , HAS BEEN
OMITTED AND FILED
SEPARATELY WITH THE
SECURITIES AND
EXCHANGE COMMISSION
PURSUANT TO RULE 24b-2
OF THE SECURITIES
EXCHANGE ACT OF 1934,
AS AMENDED .
8
(b) Examples
.
(i) KOS-2187 enters into [*]
but is discontinued in favor of another Licensed Product
(“KOS-X”), which proceeds to [*]. In this situation,
Licensee would be required to pay Kosan [*] within 30 days after
[*] with KOS-2187, would not be required to pay Kosan a milestone
payment for [*] with KOS-X and would be required to pay Kosan [*]
within 30 days after [*] with KOS-X.
(ii) KOS-2187 proceeds
through clinical development and is first Approved (in the US) on
[*]. On [*], KOS-X is in [*] and [*] of KOS-X is initiated on [*].
In this situation, (A) with respect to KOS-2187, Licensee
would be required to pay Kosan each of the first [*] milestone
payments listed in the table above within 30 days of the occurrence
of the applicable milestone event and (B) with respect to
KOS-X, Licensee would be required to pay Kosan the [*] milestone
payments listed in the table above within 30 days after
[*].
(c) Commercialization
. Licensee shall pay to Kosan non-refundable milestone payments
specified below with respect to Commercialization by Licensee and
its sublicensees of each Licensed Product as a human therapeutic no
later than sixty (60) days after the end of the applicable
Licensee Quarter. Licensee will pay each Commercialization
milestone only once for each Licensed Product:
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Milestone
Event
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Milestone Payment |
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Upon aggregate Net Sales in the
Territory reaching $[*] in any [*] consecutive Licensee
Quarters
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$ |
[ |
*] |
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Upon aggregate Net Sales in the
Territory reaching $[*] in any [*] consecutive Licensee
Quarters
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$ |
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*] |
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Upon aggregate Net Sales in the
Territory reaching $[*] in any [*] consecutive Licensee
Quarters
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$ |
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*] |
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Upon aggregate Net Sales in the
Territory reaching $[*] in any [*] consecutive Licensee
Quarters
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$ |
[ |
*] |
(d) [ * ]
CERTAIN
CONFIDENTIAL INFORMATION
CONTAINED IN THIS
DOCUMENT , MARKED BY
BRACKETS , HAS BEEN
OMITTED AND FILED
SEPARATELY WITH THE
SECURITIES AND
EXCHANGE COMMISSION
PURSUANT TO RULE 24b-2
OF THE SECURITIES
EXCHANGE ACT OF 1934,
AS AMENDED .
9
ARTICLE 4
ROYALTIES
4.1 Royalties in
General . For each Licensed Product, the obligation of Licensee
to pay Kosan royalties in a given country shall commence on the
date of the First Commercial Sale of such Licensed Product by the
Licensee in such country and shall continue until the later of
(i) the date upon which no Valid Claim would cover the
manufacture, use or sale of such Licensed Product in the country of
manufacture, use or sale, or (ii) the date which is [*] after
the date of such First Commercial Sale in such country (the “
Royalty Term ”).
(a) Licensee shall pay or
cause to be paid to Kosan a royalty based on Net Sales of Licensed
Products made by Licensee and its sublicensees [*] as provided for
in the table below in this Section 4.1(a).
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Total Annual Net Sales
of Licensed
Products [*]
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Royalty Rate |
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[*]
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*] |
(b) [*].
(c) [*]
(d) Examples
(1) [*]
4.2 Accrual of
Royalties . No royalty shall be due or owing from the use or
distribution of Licensed Product in transactions where no
consideration is received by the Licensee, such as when Licensed
Product is made or used for tests or development purposes or is
distributed as samples. Royalties shall accrue based on the fair
market value of any non-monetary consideration received. No
royalties shall be payable on sales between Licensee, its
Affiliates and sublicensees, but royalties shall be payable on
subsequent sales by any such entities. No multiple royalties shall
be payable under this Agreement because Commercialized Licensed
Product is covered by more than one Valid Claim.
4.3 Compulsory
Licenses . If Licensee is required to grant a compulsory
license to a Third Party as required by the applicable laws of any
country in the Territory under the Kosan Patent Rights, and the
royalty rate payable to Licensee for sales of Licensed Product by
such Third Party is lower than the royalty rate payable by Licensee
to Kosan for such sales, then the royalty rate payable hereunder by
Licensee for sales
CERTAIN
CONFIDENTIAL INFORMATION
CONTAINED IN THIS
DOCUMENT , MARKED BY
BRACKETS , HAS BEEN
OMITTED AND FILED
SEPARATELY WITH THE
SECURITIES AND
EXCHANGE COMMISSION
PURSUANT TO RULE 24b-2
OF THE SECURITIES
EXCHANGE ACT OF 1934,
AS AMENDED .
10
of Licensed Products by such Third Party
in such country shall be [*] payable by such Third Party to
Licensee for such country. If Licensee is required to grant a
license under this Section 4.3, the compulsory licensee shall
not be considered a licensee under Section 4.4.
4.4 [*]
4.5 Third Party Royalty
Obligations . If (a) in order to avoid infringement of any
patent not licensed hereunder, it is reasonably necessary for
Licensee to obtain a license from a Third Party in order to make,
use, sell, offer for sale, supply, cause to be supplied, or import
a Licensed Product in a country in the Territory and to pay a
royalty or other consideration under such license (including in
connection with the settlement of a patent infringement claim), in
which case, Licensee shall discuss the matter with Kosan prior to
obtaining such a license, or (b) shall be subject to a final
court or other similar binding order or ruling requiring any
payments, including the payment of a royalty to a Third Party
patent holder in respect of sales of any Licensed Product in a
country in the Territory, then the amount of Licensee’s
royalty payments with respect to Net Sales for such Licensed
Product in such country shall be reduced by [*] of (i) the
royalties on sales of such Licensed Product payable by Licensee to
such Third Party or (ii) other amount payable by Licensee
specifically as a total buyout of all of the Third Party’s
expected royalties on sales of such Licensed Product, provided,
however, that in no event will a deduction, or deductions, under
this Section 4.5, in the aggregate, reduce any royalty payment
made by Licensee in respect of Net Sales of such Licensed Product
by more than [*]. If, but for the proviso in the preceding
sentence, the deduction under Section 4.5(ii) would have
reduced a royalty payment made by Licensee by more than [*], then
the amount of such deduction that exceeds [*] will be carried over
to the subsequent royalty payment until the full amount the
Licensee would have been entitled to deduct (absent the above
limitation) is deducted.
ARTICLE 5
ROYALTY REPORTS AND
ACCOUNTING
5.1 Royalty Payments;
Royalty Reports . After the First Commercial Sale and for the
remaining term of this Agreement, Licensee shall submit with each
payment of royalties to Kosan a written royalty report (“
Royalty Report ”) covering sales of Licensed Product
for each Licensee Quarter with the following information provided
on a country-by-country basis:
(a) [*] for each Licensed
Product (by country) in local currency and in Dollars;
(b) the royalties, payable in
Dollars, which shall have accrued hereunder in respect to such Net
Sales;
(c) withholding taxes, if
any, required by law to be deducted in respect of such
sales;
CERTAIN
CONFIDENTIAL INFORMATION
CONTAINED IN THIS
DOCUMENT , MARKED BY
BRACKETS , HAS BEEN
OMITTED AND FILED
SEPARATELY WITH THE
SECURITIES AND
EXCHANGE COMMISSION
PURSUANT TO RULE 24b-2
OF THE SECURITIES
EXCHANGE ACT OF 1934,
AS AMENDED .
11
(d) the exchange rates used
in determining the amount of Dollars; and
(e) the names and addresses
of all sublicensees.
Royalty Reports shall be due
for the entire Territory no later than sixty (60) days after
the end of the Licensee Quarter to which they pertain. Royalty
payments for each Licensee Quarter with respect to Net Sales
covered by a Royalty Report shall be due at the same time as such
written report for the Licensee Quarter.
5.2 Manner of Payment
. All payments due under this Agreement shall be made in Dollars
via wire transfer of immediately available funds.
5.3 Sales Record Audit
. Licensee shall keep, and shall cause each of its Affiliates, and
sublicensees, if any, to keep, full 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 Kosan. Such books of accounting (including, without
limitation, those of the Licensee’s Affiliates, and
sublicensees, if any) shall be kept at their principal place of
business and, with all necessary supporting data, shall during all
reasonable times for the [*] next following the end of the calendar
year to which each shall pertain, be open for inspection at
reasonable times by an independent certified accountant selected by
Kosan, and reasonably acceptable to Licensee, at Kosan’s
expense, for the purpose of verifying royalty statements for
compliance with this Agreement. Such accountant must have agreed in
writing to maintain all information learned in confidence, except
as necessary to disclose to Kosan such compliance or noncompliance
by the Licensee. The results of each inspection, if any, shall be
binding on both Parties other than in the case of manifest error.
Kosan shall pay for such inspections, except that in the event
there is any upward adjustment in aggregate royalties payable for
the Licensee Quarter period of such inspection of more than [*] of
the amount paid, Licensee shall pay for the reasonable
out-of-pocket costs of such inspection. Any underpayments shall be
paid by Licensee within ten (10) Business Days of notification
of the results of such inspection. Any overpayments shall be
promptly paid by Kosan.
5.4 Currency Exchange
. Conversion of sales recorded in local currencies to Dollars for
the purpose of calculating the sales milestone payments under
Section 3.2(b) or royalty payments will be performed
[*].
5.5 Taxes . It is
understood and agreed between the Parties that any payments made
under Sections 3.1, 3.2 or 4.1 of this Agreement are inclusive of
any value added or similar tax imposed upon such payments. In
addition, in the event any such payments made by Licensee become
subject to withholding taxes under the laws of any jurisdiction,
Licensee shall deduct and withhold the amount of such taxes for the
account of Kosan to the extent required by applicable laws or
regulations, such amounts payable to Kosan shall be reduced by the
amount of taxes deducted and withheld, and Licensee shall pay the
amounts of such taxes to the proper governmental authority in a
timely manner and promptly transmit to Kosan an official tax
certificate or other
CERTAIN
CONFIDENTIAL INFORMATION
CONTAINED IN THIS
DOCUMENT , MARKED BY
BRACKETS , HAS BEEN
OMITTED AND FILED
SEPARATELY WITH THE
SECURITIES AND
EXCHANGE COMMISSION
PURSUANT TO RULE 24b-2
OF THE SECURITIES
EXCHANGE ACT OF 1934,
AS AMENDED .
12
evidence of such tax obligations
together with proof of payment from the relevant governmental
authority of all amounts deducted and withheld sufficient to enable
Kosan to claim such payment of taxes. Any such withholding taxes
required under applicable laws or regulations to be paid or
withheld shall be an expense of, and borne solely by, Kosan.
Licensee will provide Kosan with reasonable assistance to enable
Kosan to recover such taxes as permitted by applicable laws or
regulations.
5.6 Interest Due .
Without limiting any other rights or remedies available to Kosan
, Licensee shall pay Kosan interest on any payments that are
not paid on or before the date such payments are due under this
Agreement at an annual rate equal to the [*] rate effective for the
date the payment was due, as reported by the Wall Street Journal.
If the payment is still not received [*] after its due date, the
interest rate will increase to [*].
ARTICLE 6
DEVELOPMENT AND
MARKETING
6.1 Development and
Commercialization . Licensee will use Commercially Reasonable
Efforts to develop, seek Approval for and Commercialize [*],
including KOS-2187, and in the event that [*], develop, seek
Approval for and Commercialize [*], the manufacture, use or sale of
which is covered by a Valid Claim. Licensee’s initial
development plan for KOS-2187 is attached as Exhibit B. Licensee
will have the sole authority and discretion to modify the
development plan and to make all decisions relating to Licensed
Product development and Commercialization, including
termination.
6.2 Development
Information Exchange . It is the parties’ intent that
there will be open communications between the Parties to discuss
the development of Licensed Products. [*] the Parties shall meet to
review and discuss (a) past, current and anticipated
development and regulatory activities with respect to Licensed
Products, including without limitation the then current development
plans and projected timing for the milestone events listed in
Section 3.2, and (b) the status of prosecution and
maintenance of Kosan Patent Rights. Development information
exchange meetings shall be held at mutually agreeable times and at
least [*] per calendar year shall be in person at a location to be
designated by each Party in turn in Sandwich, UK, Nagoya, Japan,
California, US or another location agreed by the Parties. Licensee
and Kosan shall each bear all expenses of their respective
representatives at development information exchange meetings.
Licensee’s development lead for the Licensed Product will
actively participate in each development information exchange
meeting. [*], shall also be available at reasonable times to answer
questions Kosan may have between development information exchange
meetings.
6.3 Supply of Compound by
Kosan . If requested by Licensee, Kosan shall deliver to
Licensee or designee [*] within thirty (30) days after such
request. If
CERTAIN
CONFIDENTIAL INFORMATION
CONTAINED IN THIS
DOCUMENT , MARKED BY
BRACKETS , HAS BEEN
OMITTED AND FILED
SEPARATELY WITH THE
SECURITIES AND
EXCHANGE COMMISSION
PURSUANT TO RULE 24b-2
OF THE SECURITIES
EXCHANGE ACT OF 1934,
AS AMENDED .
13
requested by Licensee in writing within
sixty (60) days after the Effective Date, Kosan [*] within
thirty (30) days after the request by Licensee. Title and risk
of loss of Bulk KOS-2187 and compounds within the Kosan Compound
Library shall [*]. If requested by Licensee, Kosan will use
reasonable efforts to obtain the consent of its Third Party
manufacturer for KOS-2187 in order for Kosan to assign its rights
under the manufacturing agreement with that manufacturer dated [*]
with respect to manufacture of KOS-2187.
6.4 Research and
Development Collaboration . In order to transition the
continued research, Kosan Know-How, and initiate Phase I
development of KOS-2187, the Parties will agree [*] to the Joint
Research and Development Plan, as may be amended or supplemented
from time to time by the Parties (the “Joint Research and
Development Plan. The agreed elements of the Joint Research and
Development Plan are attached as Exhibit C. If the Parties are
unable to agree on the Joint Research and Development Plan,
Licensee shall have the right to make any final decisions relating
to development activities. Kosan shall use commercially reasonable
efforts to conduct, on behalf of Licensee, the research and
development activities set forth in the Joint Research and
Development Plan. In conducting the Joint Research and Development
Plan, Kosan shall comply with all applicable laws, regulations and
generally accepted principles of good clinical practice. Licensee
will pay Kosan its reasonable costs, as agreed in advance by the
Parties, for its work under the Joint Research and Development
Plan. Such payments shall be made on a quarterly basis within sixty
(60) days after receipt of Kosan’s invoice therefor. Any
taxes or withholding on the payments to be made by Licensee under
this Section 6.4 (other than taxes on Kosan’s income)
shall be borne by Licensee. Any invention covering the manufacture,
use or sale of a compound within the Kosan Compound Library
conceived or reduced to practice by employees or agents of Kosan or
Licensee in performance of the Joint Research and Development Plan
shall be [*] owned by [*], such inventions shall [*] and [*]. All
data and information generated in the performance of the Joint
Research and Development Plan shall be owned by [*] and shall be
considered [*] Confidential Information, subject to the exceptions
set forth in Section 10.3. Except for accrued obligations, and
unless otherwise agreed by the Parties, the Parties’
obligations under the Joint Research and Development Plan shall
terminate upon Commencement of the first Phase II trial for
Licensed Product. In the event Licensee decides to initiate
development activities with respect to a compound within the Kosan
Compound Library other than KOS-2187 during the term of this
Agreement, Licensee shall notify Kosan, and the Parties shall
discuss whether Licensee is interested in having Kosan assist in
any such activities under an amended Joint Research and Development
Plan. In the event Kosan undergoes a Change of Control, Licensee
shall have the right to terminate the Joint Research and
Development Plan upon thirty days notice. Change of Control means
that any of the following has occurred (i) a pharmaceutical
company with sales of greater than $1 billion per year
(“Large Pharmaceutical Company”) becomes the beneficial
owner, directly or indirectly, of fifty percent or more of the
voting stock of Kosan; (ii) Kosan enters into agreement with a
Large Pharmaceutical Company providing for the sale of
substantially all of Kosan’s assets; or (iii) Kosan
enters into a merger, reorganization or consolidation agreement or
other similar transaction with a Large Pharmaceutical
Company.
CERTAIN
CONFIDENTIAL INFORMATION
CONTAINED IN THIS
DOCUMENT , MARKED BY
BRACKETS , HAS BEEN
OMITTED AND FILED
SEPARATELY WITH THE
SECURITIES AND
EXCHANGE COMMISSION
PURSUANT TO RULE 24b-2
OF THE SECURITIES
EXCHANGE ACT OF 1934,
AS AMENDED .
14
ARTICLE 7
PATENT
RIGHTS
7.1 Ownership, Prosecution
and Maintenance of Kosan Patent Rights in the Territory, Except in
the US . Within thirty (30) days of the Effective Date,
Kosan shall execute an assignment transferring all of Kosan’s
right, title and interest in and to the Kosan Patent Rights to
Licensee in every country in the Territory except the US (“
Ex-US Kosan Patent Rights ”). Licensee shall have the
right, but not the obligation, to prosecute any and all patent
applications within the Ex-US Kosan Patent Rights, including but
not limited to, the right to conduct interferences, oppositions,
reissue proceedings and reexaminations, to obtain patents thereon,
and to maintain all patents included therein. The prosecution and
maintenance of the Ex-US Kosan Patent Rights may be performed by
outside counsel of Licensee’s choosing. Kosan’s
comments regarding the choice of such outside counsel shall be
considered, but Licensee’s decision in this regard shall be
final. Kosan will not file any additional patents claiming the
manufacture, use or sale of any compound within the Kosan Compound
Library, unless requested by Licensee. Licensee shall be
responsible for one hundred percent (100%) of expenses
incurred in preparing, filing, prosecuting and maintaining the
Ex-US Kosan Patent Rights. Licensee shall keep Kosan fully informed
in a timely manner, and, as is reasonably practicable, of the
progress regarding the prosecution of each patent application
included within the Ex-US Kosan Patent Rights. Kosan shall have the
right to review all pending patent applications and other
proceedings, and to make recommendations to Licensee regarding the
prosecution of such patent applications; provided that all final
decisions regarding the prosecution and maintenance of such Ex-US
Kosan Patent Rights shall be made by Licensee.
7.2
Discontinuance/Abandonment . Notwithstanding
Section 7.1, Licensee shall have the right to discontinue the
prosecution of any patent application, or to abandon any patent, on
a country-by-country basis, encompassed within the Ex-US Kosan
Patent Rights. The cancellation or amendment of a claim or claims
during the prosecution of a patent application in a country within
the Ex-US Kosan Patent Rights shall not constitute a discontinuance
or abandonment under this section, provided that such cancellation
or abandonment does not prejudice the ability to obtain granted
claims to the cancelled subject matter in a related continuation,
divisional, or other application in such country. If Licensee
decides to discontinue the prosecution of any patent application or
to abandon any patent within the Ex-US Kosan Patent Rights in any
country, Licensee shall inform Kosan at least sixty (60) days
prior to such discontinuance and Kosan shall be given the
opportunity to prosecute such patent application and/or maintain
such patent at its expense prior to the date that such
discontinuance would otherwise take effect. Kosan shall advise
Licensee in writing of its decision regarding the opportunity to
prosecute and/or maintain such application or
CERTAIN
CONFIDENTIAL INFORMATION
CONTAINED IN THIS
DOCUMENT , MARKED BY
BRACKETS , HAS BEEN
OMITTED AND FILED
SEPARATELY WITH THE
SECURITIES AND
EXCHANGE COMMISSION
PURSUANT TO RULE 24b-2
OF THE SECURITIES
EXCHANGE ACT OF 1934,
AS AMENDED .
15
patent within thirty (30) days of
the date of discontinuance and in the absence of a written decision
from Kosan, Licensee shall have the right to discontinue or abandon
such application or patent. In the event Kosan timely elects to
prosecute and maintain such patent or patent application, Licensee
shall execute an assignment transferring ownership of the patent or
patent application to Kosan in each such country. Effective upon
Kosan’s election to prosecute and maintain any patent or
patent application in a particular country, Kosan may, in its sole
discretion, elect, by written notice to Licensee, to exclude such
patent or patent application from the Kosan Patent Rights under
this Agreement.
7.3 Status of Ex-US Kosan
Patent Rights .
(a) Initial . As of
the Effective Date, Kosan shall advise Licensee as to the current
status of any patent applications and patents included within the
Ex-US Kosan Patent Rights, and, to the extent it has not previously
done so, promptly make available to Licensee all documentation
relating to such patent applications and patents, including, but
not limited to, copies of all patent applications, relevant prior
art, search reports, official actions and examination reports, and
all correspondence to and from local agents or attorneys
responsible for local prosecution of such applications.
(b) Annual . Within
thirty (30) days after the end of each calendar year, Licensee
shall: (i) advise Kosan as to the then-current status of any
patent applications or patents within the Ex-US Kosan Patent Rights
specifically relevant to any Licensed Product; and (ii) to the
extent Kosan requests, make available to Kosan materially relevant
documentation relating to such patent applications and patents,
including, but not limited to, copies thereof.
(c) Notices . Kosan
will execute and file at Licensee’s expense those notices and
other filings as Licensee shall reasonably request be made, from
time to time with any patent office or patent agency in the Ex-US
Territory, and in all other respects shall reasonably cooperate
with Licensee, to affect an orderly transfer of ownership and
affect the further prosecution and maintenance of the Ex-US Kosan
Patent Rights granted to Licensee under this Agreement.
7.4 Ownership, Prosecution
and Maintenance of Kosan Patent Rights in the US
Prior to the assignment under
Section 7.7, Kosan shall have the right to prosecute any and
all patent applications within Kosan Patent Rights within the US
(“ US Kosan Patent Rights ”) including but not
limited to, the right to conduct interferences, oppositions,
reissue proceedings and reexaminations, to obtain patents thereon,
and to maintain all patents included therein. The prosecution and
maintenance of US Kosan Patent Rights may be performed by outside
counsel of Kosan’s choosing and approved by Licensee, which
approval shall not be unreasonably withheld or delayed. Licensee
hereby approves [*] as outside counsel. Licensee shall be
responsible for one hundred percent (100%) of expenses
incurred by Kosan in preparing, filing, prosecuting and maintaining
the US Kosan Patent Rights. Kosan shall keep Licensee fully
informed in a
CERTAIN
CONFIDENTIAL INFORMATION
CONTAINED IN THIS
DOCUMENT , MARKED BY
BRACKETS , HAS BEEN
OMITTED AND FILED
SEPARATELY WITH THE
SECURITIES AND
EXCHANGE COMMISSION
PURSUANT TO RULE 24b-2
OF THE SECURITIES
EXCHANGE ACT OF 1934,
AS AMENDED .
16
timely manner, and as is reasonably
practicable, of the progress regarding the prosecution of each
patent application included within the US Kosan Patent Rights.
Licensee shall have the right to review all pending patent
applications and other proceedings, and to make recommendations to
Kosan regarding the prosecution of such patent applications;
provided that all final decisions regarding the prosecution and
maintenance of such US Kosan Patent Rights shall be made by
Kosan.
7.5
Discontinuance/Abandonment . Notwithstanding
Section 7.4, Kosan shal
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