Exhibit 10.5
WHENEVER CONFIDENTIAL INFORMATION IS OMITTED
HEREIN (SUCH OMISSIONS ARE DENOTED BY AN ASTERISK *) SUCH
CONFIDENTIAL INFORMATION HAS BEEN SUBMITTED SEPARATELY TO THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO A REQUEST FOR
CONFIDENTIAL TREATMENT.
LICENSE AGREEMENT
This agreement (the
“Agreement”), dated the
[ ] th day of
[October] , 2008 (the “Effective Date”),
is by and between [PURCHASER], a Delaware corporation
(“Purchaser”), and [THE COMPANY], a Delaware
corporation (the “Company”).
INTRODUCTION
1.
The Company owns the Product
Intellectual Property (as such term is defined herein).
2.
The Purchaser is in the business of
developing and marketing pharmaceutical products.
3.
The Company and the Purchaser are
interested in establishing a licensing relationship pursuant to
which the Company shall grant the Purchaser certain rights and
licenses under the Product Intellectual Property.
NOW, THEREFORE, the Purchaser and
the Company agree as follows:
Article I
Definitions
When used in this Agreement, each of
the following terms shall have the meanings set forth in this
Article I:
Section 1.1
“ Affiliate ”
means, with respect to a Party, any Person that controls, is
controlled by, or is under common control with such Party. For
purposes of this Section 1.1, “control” shall
refer to (a) in the case of a Person that is a corporate
entity, direct or indirect ownership of fifty percent (50%) or more
of the stock or shares having the right to vote for the election of
directors of such Person and (b) in the case of a Person that
is not a corporate entity, the possession, directly or indirectly,
of the power to direct, or cause the direction of, the management
or policies of such Person, whether through the ownership of voting
securities, by contract or otherwise.
Section 1.2
“ Bankruptcy Code
” means 11 U.S.C §§ 101-1330, as
amended.
Section 1.3
“ Confidential
Information ” means non-public information disclosed by
the Company to the Purchaser relating to the Products, Licensed
Patent Rights or Licensed Know-How, but specifically excluding
Product Clinical Data disclosed in connection with the clinical
development of, or regulatory approval for, a Product.
*CONFIDENTIAL TREATMENT REQUESTED
1
Section 1.4
“ Control ” and
cognates thereof means, with respect to any Licensed Know-How,
Patent Rights or Confidential Information, the possession by a
Party, whether directly or through Affiliates of such Party, of the
ability to grant the right to access or use, or to grant a license
or the right to disclose or transfer such Licensed Know-How, Patent
Rights or Confidential Information, without violating the terms of
any agreement or other written arrangement with, or the rights of
any Third Party.
Section 1.5
“ Cover ” and
cognates thereof means, with respect to a product, that, but for a
license granted to a Party under a Valid Claim, the Development or
Commercialization of such product would infringe such Valid
Claim.
Section 1.6
“ FDA ” means
the U.S. Food and Drug Administration.
Section 1.7
“ Governmental
Authority ” means any court, tribunal, arbitrator,
arbitrational panel or authority, agency, commission, official or
other instrumentality of the United States or any other country, or
any supra-national organization, state, county, city or other
political subdivision or any self-regulatory
organization.
Section 1.8
“ Improvements
” means any improvements, modifications, developments or
inventions which a Party may make to the Product Intellectual
Property after the Effective Date.
Section 1.9
“ Licensed Know-How
” means all inventions, methods, processes, techniques,
improvements, designs, formulae, specifications, and technical,
scientific and business information (including, without limitation,
all biological, chemical, pharmacological, toxicological, clinical
and assay information, data and analyses), whether or not
patentable, which are Controlled by the Company and which relate to
the Licensed Patent Rights or the Product in any way, in any field
or for any purpose and in whatever form existing (including,
without limitation, paper, notebooks, books, files, ledgers,
records, tapes, discs, diskettes, CD-Rom and any other media on
which the foregoing can be stored).
Section 1.10
“ Licensed Patent
Rights ” means (a) the Patent Rights set forth on
Exhibit A hereto, (b) counterparts of the Patent
Rights set forth on Exhibit A in any country of the
world and (c) all other patent rights owned or licensed by the
Company and related in any way to the Product.
Section 1.11
“ Net Sales ”
means the aggregate amount invoiced on account of sales of a
Product by the Purchaser or any of its Affiliates or sublicensees
to a third party in the Territory (but not including sales between
the Purchaser and its Affiliates where the Product is intended for
resale) less the following reductions relating to such
sales:
(i) trade, quantity and cash
discounts or rebates, which are not already reflected in the amount
invoiced;
(ii) any adjustments or
allowances on account of price adjustments, billing errors,
rejected goods, damaged goods, returns and withdrawal, recall or
relabeling of Product;
*CONFIDENTIAL TREATMENT
REQUESTED
2
(iii) credits, volume
rebates, charge-back and prime vendor rebates, reimbursements or
similar payments granted or given to, or related administrative,
processing or other fees charged to, wholesalers and other
distributors, buying groups, health care insurance carriers,
pharmacy benefit management companies, health maintenance
organizations or other institutions or health care organizations,
which are not already reflected in the amount invoiced;
(iv) any tax, tariff,
customs duty, excise or other duty or other governmental charge
including, without limitation, value added taxes(other than a tax
on income) levied on the manufacture, sale, transportation or
delivery of the Product and remitted to the applicable taxing
authority;
(v) payments or rebates paid
in connection with sales of the Product to any governmental or
regulatory authority in respect of any state or federal Medicare,
Medicaid or similar programs, or other managed care programs, which
are not already reflected in the amount invoiced;
(vi) freight, postage,
handling, shipping, insurance or other transportation costs charged
to the customer whether invoiced separately or included within the
selling price; and
(vii) amounts allocated for
bad debt determined by generally accepted accounting principles
consistently applied.
For purposes of this definition,
the Product shall be considered “sold” and
“reductions” allowed when so recorded in the Purchaser
or its Affiliates or sublicensees (as the case may be) consolidated
and consolidating financial statements prepared in accordance with
generally accepted accounting principles. The first sale to a third
party in an arms-length transaction shall be regarded as the first
sale for the purpose of calculating Net Sales.
Section 1.12
“ NDA ” means a
New Drug Application and amendments thereto filed pursuant to the
requirements of the FDA, as defined in 21 C.F.R. § 314 et
seq., for FDA approval of a new drug product.
Section 1.13
“ Order ” means
any writ, judgment, decree, injunction, award or similar order of
any Governmental Authority, including any award in an arbitration
proceeding (in each case, whether preliminary or
final).
Section 1.14
“ Parties ”
means the Purchaser and the Company.
Section 1.15
“ Party ” means
the Purchaser or the Company, as the context may
require.
Section 1.16
“ Patent Rights
” means United States and foreign patents and patent
applications and all substitutions, divisions, continuations,
continuations-in-part, requests for continued examinations,
reissues, reexaminations and extensions thereof.
Section 1.17
“ Person ”
means any natural person or any corporation, company, partnership,
joint venture, firm or other entity, including without limitation a
Party.
Section 1.18
“ Product ” and
cognates thereof mean celecoxib in all delivery methods,
formulations and dosages.
*CONFIDENTIAL TREATMENT
REQUESTED
3
Section 1.19
“ Product Clinical
Data ” means all pre-clinical and clinical data,
databases and intellectual property relating to the Product and the
Licensed Patent Rights, including without limitation, raw case
report files, final study reports, toxicology reports, regulatory
information including all investigational new drug applications and
such other information and data as may have been generated during
or in connection with any pre-clinical and phase I clinical studies
or other studies conducted on the Product or with respect to any
Licensed Patent Rights.
Section 1.20
“ Product Intellectual
Property ” means all Product Clinical Data, Licensed
Patent Rights and Licensed Know-How, and any Improvements to any
such Product Intellectual Property to the extent performed by the
Company or by a third party at the Company’s direction in
accordance with the terms of this Agreement.
Section 1.21
“ Product Payments
” means the Upfront License Payment and the Regulatory
Milestone Payment.
Section 1.22
“ Regulatory Milestone
Payment ” has the meaning ascribed to such term in
Section 2.11.
Section 1.23
“ Requirements of Law
” means any law, statute, code, treaty, Order, ordinance,
rule, regulation or other requirement promulgated or enacted by any
Governmental Authority.
Section 1.24
“ Royalty ” has
the meaning ascribed to such term in Section 2.11.
Section 1.25
“ Tax ” and
cognates thereof mean all of the following: (i) any sales, use
ad valorem, transfer, franchise, license, excise, stamp,
production, withholding, value added, environmental, or other tax,
custom or duty or governmental fee or other like assessment or
charge to the extent directly related to the sale of Products
(thereby explicitly excluding any income, employment or profits tax
or any sort) that may be imposed by any Governmental Authority for
such sale of Products and (ii) any liability for the payment
of amounts described in (i) above as a result of being a
member of an affiliated, consolidated, combined or unitary group
for any taxable period.
Section 1.26
“ Territory ”
means all locations and jurisdictions worldwide.
Section 1.27
“ Third Party
” means any person or entity other than a Party or any
of its Affiliates.
Section 1.28
“ Upfront License
Payment ” has the meaning ascribed to such term in
Section 2.9.
Section 1.29
“ Valid Claim ”
means a claim of any issued, unexpired United States or foreign
patent, which shall not have been donated to the public,
disclaimed, nor held invalid or unenforceable by a court of
competent jurisdiction in an unappealed or unappealable
decision.
*CONFIDENTIAL TREATMENT
REQUESTED
4
Article II
Grant of License; Disclosure of Know-How; Clinical
Data
Section 2.1
License
Grant . Subject to the terms and
conditions of this Agreement, the Company hereby grants to the
Purchaser the exclusive, worldwide, irrevocable right and license
under the Licensed Patent Rights and the Licensed Know-How for any
and all applications, uses and purposes and in any field with
respect to the Product, including without limitation, to develop,
make, have made, use, offer for sale, sell and import
pharmaceutical formulations and products. The term of such license
shall be determined on a country-by-country basis, with such
license to continue with respect to a specific country until the
expiration in such country of any Patent Rights owned by Company
providing market exclusivity to the Purchaser under the Product in
the applicable country, including any Licensed Patent
Rights.
Section 2.2
Commercialization
. The Purchaser
agrees to use commercially reasonable efforts to develop and
commercialize the Product in the United States on a timely basis
and thereafter to sell the Product in the United
States.
Section 2.3
Disclosure of
Licensed Know-How . During the term of this
Agreement, the Purchaser shall have access, as reasonably requested
by the Purchaser, to personnel of the Company and its Affiliates at
reasonable times during normal business hours and upon prior notice
for discussions relating to regulatory, scientific, medical and
other technology contained in or relating to the Licensed Know-How.
In addition, to the extent required by the Purchaser, the Purchaser
shall have access to all documents of the Company and its
Affiliates related in any way to any such discussions.
Section 2.4
Transfer of
Pre-Clinical and Clinical Data . During the term of this
Agreement, the Purchaser shall have access, as reasonably requested
by the Purchaser, to personnel of the Company and its Affiliates at
reasonable times during normal business hours and upon prior notice
for discussions relating to regulatory, scientific, medical and
other matters relating to preclinical and clinical data related in
any way to the Product or the Product Intellectual Property. In
addition, to the extent required by the Purchaser, the Company
shall provide access to its, and its Affiliates, facilities,
personnel and records in connection with any regulatory filings or
submissions that the Purchaser may make with respect to the
Product. After the transfer of such preclinical and clinical data
related in any way to the Product Intellectual Property, the
Company shall have no right, title or interest in such
data.
Section 2.5
Sublicensees
. The Purchaser
shall be entitled to grant one or more sublicenses under the
licenses granted pursuant to this Agreement, provided, however,
that the Purchaser shall not be permitted to sublicense rights
broader than those granted hereunder. Notwithstanding the
foregoing, no such sublicense by Purchaser shall alter
Purchaser’s obligation to pay the Royalty to the Company in
accordance with Section 2.11.
Section 2.6
Section 365(n) of
the Bankruptcy Code . All rights and licenses
granted under or pursuant to this Agreement are, and shall
otherwise be, deemed to be, for purposes of
Section 365(n) of the Bankruptcy Code, licenses of rights
to “intellectual property” as defined under
Section 101(35A) of the Bankruptcy Code. The Parties shall
retain and may fully exercise all of their respective rights and
elections under the Bankruptcy Code.
*CONFIDENTIAL TREATMENT
REQUESTED
5
Section 2.7
Improvements
. Each Party
shall own all right, title and interest in and to any Improvements
it creates or develops. To the extent that the Company creates or
develops Improvements, such Improvements shall become part of the
Product Intellectual Property and shall be licensed to the
Purchaser pursuant hereto, and the Company shall notify the
Purchaser of such Improvements and deliver such Improvements and
all records, data, information and know-how related thereto to the
Purchaser, in each such case promptly after the creation or
development of such Improvements and no later than thirty (30) days
after the creation or development of such Improvements.
Section 2.8
Additional
Assignments . On the Effective Date, the
Parties shall execute the Assignment Agreement attached hereto as
Exhibit D .
Section 2.9
Upfront
License Payment . Upon the Effective Date,
the Purchaser shall pay to the Company a one-time upfront license
payment of Five Million U.S. Dollars ($5,000,000) (the
“Upfront License Payment”).
Section 2.10
Regulatory
Milestone License Payment . In addition to the Upfront
License Payment, upon the Purchaser’s receipt from the FDA of
final approval of the first NDA prepared by the Purchaser with
respect to the Product for any indication, the Purchaser shall pay
within thirty (30) days of such final approval to the Company an
additional one-time payment of Fifteen Million U.S. Dollars
($15,000,000) (the “Regulatory Milestone
Payment”).
Section 2.11
Royalties
. In addition to
the Product Payments, the Purchaser shall pay to the Company a
royalty of * percent (*%) of Net Sales of the Products in the
Territory (the “Royalty”). The Purchaser shall pay such
royalty on a country-by-country basis for the Net Sales of the
Products in the applicable country during each calendar quarter,
within forty-five (45) days after the end of the applicable
calendar quarter. The Purchaser shall pay the Royalty applicable to
each country in US dollars. At the time of such payment, the
Purchaser shall also provide to the Company a written statement of
Net Sales showing in reasonably specific detail, on a
country-by-country basis, (a) the calculation of Net Sales;
(b) royalties payable in US dollars, which shall have accrued
hereunder based upon Net Sales; (c) withholding taxes, if any,
required by law to be deducted with respect to such sales;
(d) the dates of the first commercial sales of the Product in
any jurisdiction during the reporting period; and (e) the
exchange rates used to determine the amount of US dollars
(collectively, the “Royalty Statement”). If any
currency conversion shall be required in connection with the
calculation of payments hereunder, such conversion shall be made
using the average exchange rates published by OANDA.com or a
comparable service for the applicable period in which Purchaser
records the sale giving rise to the payment obligation set forth
herein. Purchaser shall be entitled to deduct Purchaser’s
actual currency conversion costs from the Royalties payable
hereunder.
Section 2.12
Consideration
. The Product
Payments, the Royalty payments and the mutual promises provided
herein shall constitute consideration for the licenses and other
rights granted hereunder.
Section 2.13
Records and
Audit . During the term of this
Agreement, for a period of three (3) years after the
conclusion of the applicable calendar year, the Purchaser shall
keep complete and accurate records of Net Sales in sufficient
detail to permit the Company to confirm
*CONFIDENTIAL TREATMENT REQUESTED
6
the completeness and accuracy of: (i) the
information presented in each Royalty Statement and (ii) the
calculation of Net Sales. The Purchaser shall permit a recognized
independent auditing firm reasonably acceptable to the Purchaser to
audit and/or inspect records of the Purchaser solely to the extent
required to verify: (A) the completeness and accuracy of the
Royalty Statements; (B) the calculation of Net Sales and
(C) the amount of Royalty payments for the Product for the
previous year. Such inspection shall be conducted during the
Purchaser’s normal business hours, no more than once in any
twelve (12) month period and upon at least thirty (30) days prior
written notice by the Company to the Purchaser. If such firm
establishes that such payments were underpaid for the preceding
year, the Purchaser shall have the right to engage a recognized
independent auditing firm to verify the findings of the audit. If
the firm engaged by Purchaser verifies the findings of the firm
engaged by the Company, the Purchaser shall pay the Company the
amount of any such underpayments for the preceding year, plus
interest at a rate equal to the Prime Rate of interest as reported
in the Wall Street Journal on the date payment is due, within
thirty (30) days after the date the Purchaser delivers to the
Company the report of the firm engaged by the Purchaser, which
report so establishes that such payments were underpaid for the
preceding year. Notwithstanding the foregoing, the firm engaged by
the Purchaser shall deliver its findings in a prompt manner after
being engaged by the Purchaser. If the firm engaged by the Company
establishes that such payments were overpaid for the preceding
year, the Company shall pay the Purchaser the amount of any such
overpayment for the preceding year, within thirty (30) days after
the date the Company delivers to the Purchaser such firm’s
report so establishing that such payments were overpaid for the
preceding year. The Company shall bear the full cost of the firm it
engages unless such audit discloses an underpayment by more than
five percent (5%) of the amount due for the preceding year and such
underpayment of more than five percent (5%) is verified by the firm
engaged by the Purchaser if it chooses to engage a firm for audit
verification purposes. The Purchaser shall bear the full cost of
the firm it engages to verify the audit findings.
Section 2.14
Payments
. The Product
Payments and the Royalty payments shall be made electronically in
US Dollars and to such place and account as may be designated from
time to time for that purpose by the Company to Purchaser in
writing.
Section 2.15
Withholding
Taxes . All sums payable by either
Party under this Agreement (including without limitation the
Product Payments and the Royalty payments) shall be paid in full
and without any set-off, counterclaim, taxes, duties, levies, fees,
charges, deduction or withholding on any ground whatsoever, except
as may be required by law. The Parties shall consider together to
what extent, if at all, it may lawfully be possible to mitigate the
amount of such deduction or withholding or of the amount required
to be paid as aforesaid, including the use of best efforts to make
timely and procedurally correct application for relief from
withholding tax in respect of any such payment. For any taxes,
duties, levies, fees, charges, deduction or withholding on any
ground whatsoever withheld or to be withheld, each Party agrees to
timely deliver all certificates and forms as may be necessary and
appropriate to establish an exemption from Tax or file Tax returns
as would be necessary with respect to such Taxes.
*CONFIDENTIAL TREATMENT
REQUESTED
7
|