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LICENSE AND SUPPLY AGREEMENT
THIS AGREEMENT is made on September 27, 2007,
between
Columbia
Laboratories, Inc. (“Columbia”), a company
incorporated under the laws of the state of Delaware, with
offices at 354 Eisenhower Parkway, Livingston,
New Jersey 07039;
and
Ascend
Therapeutics, Inc.(“Ascend”),
a company incorporated under
the laws of the state of Virginia, with offices at 607 Herndon
Parkway, Suite 210, Herndon, Virginia 20170.
RECITALS :
Whereas,
Columbia possesses certain proprietary bioadhesive drug
delivery technology as well as proprietary know-how and
confidential information used or useful in the
manufacture
and use of bioadhesive drug products and is the owner or has
licensed or has control of and is beneficially entitled to a
number of patents that have been granted
or
are pending in relation to the development and production of
such products; and
Whereas,
Columbia possesses, or controls and directs, the requisite
expertise, personnel and facilities for the formulation,
development and supply of Product (as defined
below)
utilizing the Columbia Technology (as defined below);
and
Whereas,
Ascend wishes to have Columbia supply Product to Ascend for
commercial sale, and for clinical studies required to obtain
regulatory approvals necessary for
Indications
(as defined below); and
Whereas,
Columbia and Ascend both desire to enter into an agreement to
give effect to the arrangements described herein,
Now
Therefore, in consideration of the premises, which are
incorporated herein by reference, and other good and valuable
consideration, the receipt and adequacy of which
is
hereby
acknowledged, the Parties hereto agree as
follows:
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1.1
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In
this Agreement, unless the context otherwise requires:
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“Affiliate”
means any corporation or entity controlling, controlled by, or
under common control with Columbia or Ascend, as the case may
be. For the purposes of this Agreement,
“control” (including "controlling", "controlled
by" and "under common control with") of any Party, corporation
or other business entity shall mean the direct or indirect
beneficial ownership of more than fifty percent (50%) of the
voting stock of, or more than a fifty percent (50%) interest
in the income of, such corporation or other business entity,
or such other direct or indirect interest or relationship as
in fact constitutes actual control.
[***]
A CONFIDENTIAL PORTION OF THE MATERIAL HAS BEEN OMITTED AND
FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.
“Adverse
Drug Experience” means any “adverse drug
experience” as defined or contemplated by 21 C.F.R.
314.80 or 312.32, associated with the Product.
“Adverse
Drug Experience Report” means any oral, written or
electronic report of any Adverse Drug Experience transmitted
to any Party.
“Ascend”
means Ascend Therapeutics, Inc., and any of its
Affiliates.
“Columbia”
means Columbia Laboratories, Inc., and any of its
Affiliates.
“Columbia
Know-How” means all knowledge, information, trade
secrets, data (including all clinical data) and expertise
associated with Columbia's bioadhesive drug delivery
technology that is not generally known to the public, owned or
licensed by Columbia or to be developed or licensed
by Columbia before or during the Term,
whether or not covered by any patent, copyright, design,
trademark or other industrial or intellectual property
rights.
“Columbia
Patents” means any and all patents and patent
applications as set forth in Exhibit A, and all rights
therein, and including all extensions, continuations,
continuations-in-part, divisionals, patents-of-additions,
re-examinations, re-issues, supplementary protection
certificates and foreign counterparts thereto owned by
Columbia, or licensed to Columbia and associated with
Columbia's bioadhesive drug delivery technology.
“Columbia
Technology” means the Columbia Know-How and Columbia
Patents.
"Commercially
Reasonable" means with respect to a Party, and with respect to
a Product, efforts and resources that are comparable to those
generally used by a company in the pharmaceutical industry in
the exercise of its reasonable business judgment relating to
other prescription pharmaceutical products owned or licensed
by it or to which it has exclusive rights, which have market
potential and are at a stage of development or product life
similar to the Product, taking into account measures of
relative safety and efficacy, Product profile, the
competitiveness of the marketplace, the proprietary position
of the Product, the regulatory structure involved, the
relative profitability of the Product, and other relevant
factors, including without limitation comparative technical,
legal, scientific, and/or medical factors.
“Contract
Year” means a period beginning on the Effective Date and
each anniversary of the Effective Date and continuing up to
the subsequent anniversary of the Effective Date.
“Current
Good Manufacturing Practice” or “cGMP” means
manufacture in accordance with 21 CFR Parts 210 and 211; as
they may be amended from time to time.
“DDMAC”
means the FDA’s Division of Drug Marketing, Advertising
and Communications.
[***]
A CONFIDENTIAL PORTION OF THE MATERIAL HAS BEEN OMITTED AND
FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.
“Effective
Date” means January 1, 2008.
“FDA”
means the United States Food and Drug
Administration.
"Finished
Package Form" means six (6) Product applicators individually
wrapped in foil with required leaflet printed in one color and
inserted into an appropriate box with customary trade dress
printed in up to four colors. The boxes will be
placed into appropriate outer cartons (of twelve (12) boxes)
which will be printed in one color with required labeling and
UPC codes.
“Indication”
means any gynecological indication that the Product now has or
may have in the future, including without limitation
amenorrhea and endometrial protection, provided, however, that
Indication shall not include uses relating to fertility,
pregnancy, or preterm birth.
“Joint
Steering Committee” has the meaning set forth in Section
4.
“Minimum
Purchase Obligations” means Ascend’s obligations
to purchase Product set forth on Exhibit B hereto for
each period specified therein.
“NDA”
means a New Drug Application as such term is defined in 21 CFR
Part 314.
“Net
Selling Price” means, in the case of Product sold by
Ascend or a sub-licensee, that sum determined by deducting
from the aggregate gross sales proceeds billed for Product by
Ascend or a sub-licensee, as the case may be, all as
determined in accordance with generally accepted accounting
principles on a basis consistent with Ascend’s audited
financial statements, a maximum aggregate deduction of [***]
to cover the following:
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(a)
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customs
duties, sales or use taxes, or other taxes (excluding income or
corporation tax), directly related to the sale of Product which are
paid by Ascend or its sub-licensees, as the case may
be;
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(b)
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a
discount from the gross sales proceeds to cover such normal costs
as are incurred by Ascend or its sub-licensees, as the
case may be, in respect of transport, shipping, and insurance, to
the extent specifically referenced in the invoice and included in
the invoice price;
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(c)
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customary
trade, quantity and cash discounts, chargebacks, deductions, and
rebates directly related to the sale of Product and actually
allowed and taken;
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(d)
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amounts
repaid or credited by reasons of rejections or return of goods, or
because of retroactive price reductions specifically identifiable
to the Product; and
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[***]
A CONFIDENTIAL PORTION OF THE MATERIAL HAS BEEN OMITTED AND
FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.
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(e)
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amounts
payable resulting from governmental (or agency thereof) mandated
rebate programs and other third-party rebates to the extent
actually allowed.
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Provided,
however, that in the event Ascend shall sell Product together
with other products of Ascend to third parties (by the method
commonly known in the pharmaceutical industry as "bundling")
and the price attributable to Product is less than the average
price of "arms length" sales to similar customers for the
reporting period in which sales occur (such bundled sales to
be excluded from the calculation of the average price of "arms
length" sales), gross sales proceeds for any such sales shall
be the average price of "arms length" sales by Ascend or a
sublicensee to similar customers during the reporting period
in which such sales occur.
"Party"
or “Parties” means Ascend or Columbia, or both, as
the case may be.
“PDMA”
means the Prescription Drug Marketing Act, as amended, and the
rules and regulations promulgated thereunder.
“Phase
IV Clinical Study” means any post-marketing human
clinical trial to confirm with statistical significance the
safety and efficacy of the Product, whether initiated by a
Party or at the request of the FDA, to delineate additional
information about a drug’s risks, benefits, and optimal
use, including, without limitation, safety surveillance
studies, pharmacoeconomic studies, pharmacoepidemiology
studies, studies relating to different dosing or schedules of
administration, studies of the use of the drug in other
patient populations or other stages of a disease or condition
or for indications including (but not limited to) for the
treatment of hyperplasia or hormone replacement therapy, or
studies of the use of the drug over a longer period of
time.
“Phase
IV Clinical Study Costs” shall mean all direct and
indirect expenses and other costs incurred by or on behalf of
a Party in connection with a Phase IV Clinical Study,
including, without limitation, the costs of clinical studies,
the preparation, collation and/or validation of data from such
clinical studies and the preparation of medical writing and
publishing. Without limitation of the foregoing,
Phase IV Clinical Study Costs shall
include: (a) all reasonable out-of-pocket
costs incurred by a Party or its Affiliates, including
payments made to Third Parties, with respect to any of the
foregoing; (b) the direct and indirect costs of
scientific, medical or technical personnel (including
personnel expense, reasonable travel expenses and
infrastructure costs but not including the costs of
managerial, financial or legal personnel) engaged in such
efforts; (c) the costs of clinical supply and related
disposal; (d) the costs of preparing and submitting
applications for FDA approvals; and (e) the acquisition
costs of the Product.
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“Product”
means the 4% w/w progesterone gel (45 mg) in single use, one piece,
disposable vaginal applicators containing 1.45 g of gel and
delivering 1.125 g of gel, utilizing the Columbia Technology, and
approved by the FDA under NDA 20-701.
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[***]
A CONFIDENTIAL PORTION OF THE MATERIAL HAS BEEN OMITTED AND
FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.
“Product
Complaint” means any report concerning the quality,
purity, quantity, weight, pharmacologic activity, labeling or
appearance of the Product.
“Serious
Adverse Drug Experience” means any Adverse Drug
Experience that is fatal or life-threatening, requires
hospitalization or prolongation of existing hospitalization,
results in persistent or significant disability or incapacity,
is a congenital anomaly/birth defect, or is of comparable
medical significance or any other event which would constitute
a “serious” Adverse Drug Experience pursuant to
the terms of 21 C.F.R. 314.80 or 312.32.
“Serious
Adverse Drug Experience Report” means any Adverse Drug
Experience Report that involves a Serious Adverse Drug
Experience.
“Trademark”
means Prochieve® 4% and any other mark selected by the
Parties for use with the Product.
“Territory”
means the United States, its territories and
possessions.
SECTION 2 – LICENSE
2.1
License
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2.1.1 |
Columbia
hereby grants to Ascend an exclusive license (even as to Columbia)
in the Territory under the Columbia Technology to the extent it
relates exclusively to the Product, and not to any other product or
active component, to import, market, promote, use, distribute,
offer to sell, and sell the Product in the Territory, but for the
avoidance of doubt no rights are granted hereunder for Ascend to
manufacture the Product.
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2.1.2 |
Columbia
hereby grants to Ascend a non-exclusive license under Columbia
Technology that is not associated exclusively with the Product but
that, in the absence of the license provided in this
Section 2.1.2, would necessarily be infringed by Ascend's
practice of the license granted in Section 2.1.1. This
non-exclusive license shall apply only to the extent necessary for
Ascend to exercise its rights and discharge its obligations under
this Agreement with respect to the Product.
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2.1.3 |
Ascend
shall have the right to grant sublicenses under the rights and
licenses granted to it in this Article 2, provided that, any
such sublicense shall be approved by Columbia, said approval not
being unreasonably withheld, conditioned or delayed, and shall
obligate the sublicensee to comply with all relevant terms of this
Agreement and Ascend remains liable to Columbia for all material
acts and omissions of any such sublicensee.
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2.1.4 |
Except
as specifically set forth in this Agreement, neither Party shall
acquire any license or other intellectual property interest, by
implication or otherwise, in any
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[***]
A CONFIDENTIAL PORTION OF THE MATERIAL HAS BEEN OMITTED AND
FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.
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information
disclosed to it under this Agreement or under any patents or patent
applications owned or controlled by the other Party or its
Affiliates.
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2.2
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Except
as otherwise expressly provided herein, nothing in this Agreement
shall, during or after the Term hereof, grant Ascend any of
Columbia’s rights in or related to the Product, including,
but not limited to, Columbia’s rights in or to trademarks,
copyrights, the Product’s NDA, Drug Master Files, patent or
other intellectual property rights, preclinical or clinical data,
manufacturing rights relating to the Product, or any supply of the
Product or the active ingredient thereof. For the
avoidance of doubt, no rights are granted to Ascend hereunder with
respect to the Product or the manufacture, use, promotion,
marketing or sale thereof outside the Territory.
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SECTION 3 - INTELLECTUAL PROPERTY
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3.1
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Ownership of Intellectual Property
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3.1.1 |
Columbia
shall remain the sole owner of all Columbia
Technology.
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3.1.2 |
Columbia
shall be entitled to use the Columbia Technology in connection with
Columbia’s commercial arrangements otherwise than in relation
to the Product in the Territory, and in connection with the Product
following termination of this Agreement.
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3.2
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Each
Party shall promptly notify the other if it becomes aware of any
claim or threatened or likely claim that the Product or the
development, manufacture, importation, marketing, use or sale
thereof infringes a patent or other intellectual property right of
any third party. In the event of such an infringement
claim or potential claim, the Parties shall discuss in good faith
the actions, if any, to be taken; provided that in no event shall
either Party be obligated to continue manufacture, importing,
marketing, sale and distribution of the Product if it reasonably
believes that such action would constitute infringement of a third
party's intellectual property rights.
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3.3.1
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Ascend
and Columbia shall promptly inform the other in writing of any
alleged infringement of which it shall become aware by a third
party of any patents within the Columbia Technology and Ascend
shall provide Columbia with any available evidence of
infringement.
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3.3.2
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Columbia,
at its option, shall be entitled to institute or have instituted
any administrative, judicial or other proceeding ("Enforcement
Proceedings") to prevent or stop any infringement or unauthorized
use of the Columbia Technology at its own expense and for its own
benefit. Ascend agrees to provide all reasonable co-operation and
assistance to Columbia in relation to any such Enforcement
Proceedings and agrees to be named as a party in any
Enforcement
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[***]
A CONFIDENTIAL PORTION OF THE MATERIAL HAS BEEN OMITTED AND
FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.
Proceedings,
as necessary, that may be instituted
hereunder. Columbia shall reimburse Ascend its
reasonable costs and expense for such
cooperation.
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3.3.3
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In
the event that Columbia does not institute or have instituted
Enforcement Proceedings relating to Columbia Patents, then Ascend
may enforce such rights at its own expense. Columbia
shall cooperate with Ascend and provide all reasonable assistance
in relation to any such Enforcement Proceedings
and agrees to be named as a party in any
Enforcement Proceedings, as necessary, instituted by Ascend
hereunder. Ascend shall seek written approval
from Columbia, which may not be unreasonably withheld or delayed,
prior to taking action and shall keep Columbia informed of the
action and may not enter into any settlement agreement without
Columbia’s consent, which may not be unreasonably withheld or
delayed. Any reasonable fees and costs borne by Columbia
shall be reimbursed by Ascend. In the event that Ascend
decides to enforce the Columbia Patents in accordance with this
paragraph, any recovery remaining after the deduction of reasonable
expenses (including attorneys' fees and expenses) incurred in
relation to such Enforcement Proceedings shall
be shared equally between the
Parties.
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3.4.1
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In
the event that a claim or proceeding is threatened or brought
against a Party by a third party alleging that the manufacture,
sale, use or offer for sale of Product infringes the patent or
other intellectual property rights of that or any other third party
in the Territory (“IP Claim”), that Party shall
promptly advise the other Party of such IP Claim and the Parties
shall meet to discuss the manner in which such IP Claim should be
defended.
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3.4.2
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Neither
Party shall acknowledge to the third party or to any other person
the validity of any IP Claim of such a third party, and shall not
compromise or settle any IP Claim relating thereto without the
prior written consent of the other Party, such consent not to be
unreasonably withheld or delayed. Ascend shall be
responsible for the conduct of the proceedings in defending any IP
Claim, with counsel acceptable to Columbia. Ascend shall
keep Columbia advised of all material developments in said
proceedings.
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3.4.3
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Ascend
shall indemnify Columbia and its Affiliates against any and all
actions, losses, claims, demands, damages, costs and liabilities
(including reasonable attorneys’ fees) due to any IP Claim,
except to the extent that (i) use of the Columbia Technology as
contemplated by this Agreement necessarily infringes third party
patent rights or (ii) the Product necessarily infringes third party
intellectual property rights by reason of the Columbia
Technology.
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3.4.4
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In
accordance with their obligations pursuant to this Agreement, the
Parties shall take such action as is reasonable, such as to cease
selling the Product, or to re-engineer or modify the Product so as
to avoid infringing the patent rights of a
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[***]
A CONFIDENTIAL PORTION OF THE MATERIAL HAS BEEN OMITTED AND
FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.
third
party, or entering into a license agreement with such third
party after due consideration of each of the Party’s
interests in the matter.
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3.4.5
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Neither
Party shall have any liability to the other Party whatsoever or
howsoever arising for any losses incurred as a result of Ascend
having to cease selling the Product as a result of an IP
Claim, except that if such an IP
Claim arises due to (i) use of the Columbia Technology as
contemplated by this Agreement necessarily infringes third party
patent rights or (ii) the Product necessarily infringes third party
intellectual property rights by reason of the Columbia Technology,
Columbia shall repay to Ascend the purchase price of any Product
purchased and in Ascend’s then current inventory that can no
longer be sold, including reasonable, documented, direct,
out-of-pocket costs incurred for transportation and/or destruction
of said Product. Columbia shall have no liability to Ascend for any
enhanced or punitive damages awarded as a result of any willful
patent infringement, unless such damages are the direct result of
Columbia’s breach of this Agreement.
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3.5.1
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Should
the Parties agree to use a trademark other than Prochieve® 4%
for the Product, Columbia shall register the trademark in its name
with respect to the Product.
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3.5.2
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Columbia
hereby grants to Ascend a non-assignable, non-sublicensable,
non-exclusive, royalty-free right and license to use the Trademark
in the Territory solely in connection with Ascend’s promotion
of the Product in accordance with this Agreement. Such license
shall expire immediately upon the expiration or termination of this
Agreement. Ascend recognizes Columbia’s title to the
Trademark, and shall not at any time, during or after the Term, do
or knowingly suffer to be done any act or thing which will in any
way impair the rights of Columbia in or to the
Trademark. Ascend acknowledges and agrees that it shall
not acquire and shall not claim any title to the Trademark adverse
to Columbia by virtue of the rights granted under this Agreement or
through Ascend’s use of the Trademark, it being the intention
of the parties that all goodwill and improved reputation generated
by Ascend and use of the Trademark shall inure to the benefit of
Columbia.
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[***]
A CONFIDENTIAL PORTION OF THE MATERIAL HAS BEEN OMITTED AND
FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.
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SECTION 4 - JOINT STEERING COMMITTEE
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4.1
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The
Parties recognize that cooperation will be required from each Party
to successfully commercialize the Product, and for this purpose,
the Parties will establish a Joint Steering Committee.
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4.2
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The
Joint Steering Committee shall consist of a chief representative
from each Party together with such additional personnel,
consultants or sub-contractors, from each Party who are
appropriately skilled and knowledgeable in relation to the Product.
A Party may change any of its representatives at any time if a new
person (with appropriate expertise to replace the outgoing member)
is appointed by giving written notice to the other
Party. The total number of members may be changed by
unanimous vote of the Joint Steering Committee from time to time as
appropriate; provided, that the Joint Steering Committee shall in
all cases be comprised of an equal number of members from each of
Columbia and Ascend. One representative from Ascend
shall serve as Chairman of the Joint Steering
Committee. The members appointed to the Joint Steering
Committee by each Party shall be vested with appropriate
decision-making authority and power by such Party.
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4.3
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Unless
otherwise agreed by the Parties, the Joint Steering Committee shall
meet at least once each calendar quarter. The first
meeting of the Joint Steering Committee shall be held in December
2007. The Joint Steering Committee may meet in person or
by means of such telephone, video or other communication facilities
as permit all members of the Joint Steering Committee to
communicate with each other simultaneously and instantaneously,
provided, however, that the Joint Steering Committee shall meet at
least once per year in person and such meetings shall be held at
the offices of Columbia, or as otherwise agreed by the
Parties. Meetings shall be co-chaired by the chief
representatives of the Parties. Subject to
Section 4.4, decisions shall be made unanimously, each Party
having one (1) vote regardless of the number of representatives
present or voting; provided, that no such vote shall be valid
unless each party is represented by at least one member either by
written proxy or actual presence at the meeting at which the vote
is taken. At and between meetings of the Joint Steering Committee,
each Party shall keep the other fully and regularly informed as to
its progress with its respective obligations.
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4.4
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In
the event of a dispute within the Joint Steering Committee that
cannot be resolved by consensus, such dispute shall be referred to
the Presidents of Ascend and Columbia who shall discuss the matter
and attempt to reach an amicable solution. The
provisions of this Section 4.4 shall be without prejudice to the
Parties’ other rights and remedies.
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4.5
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The
Joint Steering Committee shall not have the authority to amend,
modify or waive any of the terms or conditions of this
Agreement.
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4.6
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The
responsibilities of the Joint Steering Committee shall be exercised
consistent with this Agreement and shall include, but shall not be
limited to:
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4.6.1
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reviewing
and approving the marketing plan prior to the beginning of
each
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[***]
A CONFIDENTIAL PORTION OF THE MATERIAL HAS BEEN OMITTED AND
FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.
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calendar
year, including matters relating to managed markets, distribution
and trade pipeline;
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4.6.2
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monitoring
and reviewing compliance with the marketing plan and, in connection
therewith, reviewing and approving any material change
thereto;
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4.6.3
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reviewing,
coordinating and directing all development activities for the
Product, including matters concerning Product labeling and Phase IV
Clinical Study;
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4.6.4
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reviewing
and approving protocols to be used in any Phase IV Clinical Study
with respect to the Product;
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4.6.5
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reviewing
and discussing manufacturing and regulatory status updates provided
by Columbia to the Joint Steering Committee;
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4.6.6
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reviewing
pricing for the Product, including the timing of any pricing
changes; provided that any price increase is subject to Columbia
approval in its sole discretion and in no event shall the wholesale
acquisition cost for the Product be less than $38.89 per Finished
Dosage Form without the prior written consent of Columbia in its
sole discretion; and
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4.6.7
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such
other functions as may be mutually agreed upon by the parties from
time to time.
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4.7
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For
the avoidance of doubt, any decisions of the Joint Steering
Committee with respect to matters that require FDA approval or
otherwise relate to regulatory compliance of the Product shall
require Columbia’s prior written consent.
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4.8
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The
Joint Steering Committee shall have responsibility for and shall
make all decisions with respect to any recall, market withdrawal or
any other corrective action related to the Product. In
the interest of clarity, the power of the Joint Steering Committee
with respect to the foregoing is limited to (i) the ability to
sanction, but not to mandate a recall by Ascend, and (ii) vetoing a
suggestion by either Party. At Ascend’s request
and expense, Columbia shall provide assistance to Ascend in
conducting such recall, market withdrawal or other corrective
action. Columbia shall be under no liability whatsoever to
compensate Ascend or make any other payment to Ascend for any
decision to recall, initiate a market withdrawal or take any other
corrective action with respect to the Product, except in the case
of a recall or market withdrawal caused solely by the negligence or
willful malfeasance of Columbia, its Affiliates or subcontractors,
or by the breach by Columbia of its representations and warranties
in this Agreement, in which case Columbia shall replace Product
returned and reimburse Ascend for
its reasonable, documented, direct, out-of-pocket costs in
connection with such recall, market withdrawal or other corrective
action provided that Ascend shall not be in material breach of its
obligations hereunder and Columbia’s
liability to reimburse Ascend hereunder shall not exceed
[***].
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SECTION 5 - ASCEND OBLIGATIONS
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5.1
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Ascend
shall, at its sole expense, warehouse and distribute the Product,
and may at its sole discretion negotiate and enter into accounts
with managed market entities and institutional customers (e.g.,
pharmacy benefit managers, health plans, long term care pharmacy
providers, employers, the United States Government and state and
local governments, including Medicare), and otherwise ensure that
the Product is freely
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[***]
A CONFIDENTIAL PORTION OF THE MATERIAL HAS BEEN OMITTED AND
FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.
distributed
in all trade channels and not subject to unusual restraints or
conditions to access as compared to
similar products.
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5.2
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Ascend
shall be responsible for:
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5.2.1
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all
direct and indirect costs incurred by Ascend for its sales force in
connection with marketing and selling the Product including
(without limitation) sales representative training, sample
accountability, sales force automation and sales operations
support;
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5.2.2
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having
a marketing presence in at least two national-level meetings per
year; and
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5.2.3
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exploring
the possibility of re-branding the Product for gynecological
indications and exploring regulatory options for expanding
gynecological indications for the Product.
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5.3
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Ascend
shall, at its sole expense, use Commercially Reasonable efforts to
promote the Product and endeavor to persuade health care
professionals to prescribe, and patients to use, the
Product. All statements, core selling messages and
materials to be utilized by Ascend to promote the Product shall be
subject to the prior approval of Columbia in accordance with
Section 5.8 below. Ascend will cause its sales
force and Ascend employees and agents acting on Ascend’s
behalf to comply with this Agreement and all applicable legal
requirements in connection with the promotion of the Product,
including, without limitation, the FDA’s regulations and
guidelines concerning the advertising of prescription drug
products, DDMAC’s promotional guidelines, the American
Medical Association’s Guidelines on Gifts to Physicians, the
Pharmaceutical Research and Manufacturers of America Guidelines for
Marketing Practices, the Prescription Drug Marketing Act of 1987,
as amended, and the rules and regulations promulgated thereunder,
and the Accreditation Council for Continuing Medical Education
Standards for Commercial Support of Continuing Medical Education,
which may be applicable to the activities (including, without
limitation, the warehousing, handling and distribution of Samples)
to be performed by Ascend hereunder. It is understood,
and Ascend agrees, that it will be accountable for the acts or
omissions of the sales force and its employees and agents to the
extent such acts or omissions fail to comply with Ascend’s
obligations under this Agreement.
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5.4
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Ascend
will not make any false or misleading representations to health
care professionals, customers or others regarding Columbia or the
Product and will not make any representations, warranties or
guarantees with respect to the specifications, features or
capabilities of the Product that are not consistent with the
applicable current FDA approved labeling, package insert or other
documentation accompanying or describing the Product, including
Columbia’s limited warranty and
disclaimers. Ascend shall not make any negative
statements about any other Columbia products in an effort to
promote the Product.
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5.5
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To
the extent requested by Ascend, Columbia shall deliver to Ascend
all training materials for the Product in its possession on the
date hereof less a reasonable amount
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[***]
A CONFIDENTIAL PORTION OF THE MATERIAL HAS BEEN OMITTED AND
FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.
thereof
for archival purposes. Ascend shall, at its own
expense, develop training materials for its sales
representatives in other media or forms provided that such
materials shall be subject to Columbia’s review as
promotional materials as provided in
Section 5.8. Ascend shall, at its own expense,
train its sales representatives using such training materials,
the other promotional materials and such programs as Ascend
shall deem appropriate that are in compliance with
Ascend’s obligations hereunder and all other legal
requirements. Such programs shall include training
with respect to reporting Adverse Drug Experiences and Product
Complaints. None of Ascend, the sales force and Ascend’s
employees and agents shall offer, pay, solicit or receive any
remuneration to or from healthcare professionals in order to
induce referrals of or purchase of the Product. The
sales force shall have no direct contact with, nor shall the
sales force be involved with the delivery of Product to
patients, other than delivery of Samples directly to
healthcare professionals authorized to prescribe the
Product. The sales force shall be trained in
connection with compliance with Sec. 1128B(b) of the
Social Security Act and the AMA Guidelines on Gifts to
Physicians from Industry prior to engaging in promotion of the
Product.
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5.6
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Columbia
will have no obligation to train Ascend’s sales
force. Ascend may request Columbia’s assistance in
the initial training and additional training on new developments in
connection with the Product. Any such request shall be
made with reasonable notice to Columbia and shall be at
Ascend’s expense for Columbia’s out-of-pocket
costs.
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5.7
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Ascend
shall at its sole expense, create, develop, produce or otherwise
obtain, and utilize promotional, marketing, educational and
training materials that are necessary to support fully the
promotional effort for the Product. Such promotional
materials may include, by way of example, detailing aids; leave
behind items; journal advertising; educational programs; formulary
binders; appropriate reprints and reprint carriers; product
monographs; patient support kits; materials to support the handling
of physician requests; convention exhibit materials; direct mail;
market research survey and analysis; training materials; and
scripts for telemarketing and teleconferences.
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5.8
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Prior
to the use thereof, Ascend shall provide to Columbia for review
prototypes of all promotional materials created by
Ascend. Columbia shall notify Ascend of any objections
it has to such prototype and the basis therefor within thirty (30)
days following its receipt thereof. Ascend shall modify
such promotional materials to the extent necessary to resolve any
objections made by Columbia to such promotional materials on the
grounds that such promotional materials are inconsistent with any
legal requirements or this Agreement and shall in good faith
consider and address any of Columbia’s other
objections. If such promotional materials are approved
by Columbia in accordance with this Section 5.8, Ascend shall
provide Columbia with the requisite number of copies of the final
form thereof in a timely manner so as to allow Columbia to satisfy
its obligation to file such materials with DDMAC.
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[***]
A CONFIDENTIAL PORTION OF THE MATERIAL HAS BEEN OMITTED AND
FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.
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5.9
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To
the extent requested by Ascend, Columbia shall deliver to Ascend
all promotional materials created by Columbia in its inventory on
the date hereof less a reasonable amount thereof for archival
purposes. Columbia shall have no obligation to create
additional copies of any existing promotional materials or to
otherwise incur any expense in connection with providing such
existing promotional materials to Ascend. Ascend agrees
to reimburse Columbia for any direct costs incurred by Columbia in
connection with fulfilling any request made by Ascend under this
Section 5.9. Any existing promotional materials
supplied to Ascend under this Section 5.9 shall be delivered
to a single location specified by Ascend in writing prior to such
delivery. Columbia hereby grants to Ascend the
non-exclusive right, during the Term, to use any existing
promotional materials supplied to Ascend pursuant to this
Section 5.9 in the performance of its obligations under this
Agreement.
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5.10
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On
or prior to (a) December 1, 2007, and (b) October 1 of the
preceding calendar year with respect to each calendar year during
the Term, Ascend shall develop a marketing plan for the calendar
year (as applicable), and submit the marketing plan to the Joint
Steering Committee for review and approval. The
marketing plan shall set forth the manner in which the Product is
to be promoted during the period to which the marketing plan
relates.
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5.11
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The
Parties acknowledge that each may receive requests for medical
information concerning the Product from health care professionals
and consumers regarding the Product. Until the date six
(6) months after the date hereof or such earlier date as Ascend may
specify to Columbia in writing, the Parties shall coordinate all
professional services activities through Columbia, who shall be the
responsible party for responding to all such requests until such
time. Commencing on the date six (6) months after the
date hereof or such earlier date as Ascend may specify to Columbia
in writing, Ascend shall be responsible for promptly responding to
such requests, which response shall be in compliance with all
applicable legal requirements. Each Party shall promptly
provide the other Party with (i) copies of all written
materials and (ii) written s
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