EXHIBIT 10.2
***TEXT OMITTED AND FILED SEPARATELY
CONFIDENTIAL TREATMENT REQUESTED
UNDER 17 C.F.R. SECTIONS 200.80(b)(4),
200.83 AND 240.24b-2
U.S. CO-PROMOTION AGREEMENT
BY AND BETWEEN
AMYLIN PHARMACEUTICALS, INC.
AND
XXX XXXXX AND COMPANY
EFFECTIVE AS OF
SEPTEMBER 19, 2002
U.S. CO-PROMOTION AGREEMENT
This U.S. Co-Promotion Agreement (the "Agreement") is made effective as of the
19th day of September, 2002 (the "Effective Date") by and between Amylin
Pharmaceuticals, Inc. ("Amylin"), a Delaware corporation having its principal
place of business at 0000 Xxxxx Xxxxxx Xxxxx, Xxxxx 000, Xxx Xxxxx, Xxxxxxxxxx,
00000,
and
Xxx Xxxxx and Company, an Indiana corporation having its principal place of
business at Lilly Xxxxxxxxx Xxxxxx, Xxxxxxxxxxxx, Xxxxxxx, 00000 ("Lilly").
RECITALS
1. Amylin is developing Product for the prevention and treatment of
diabetes and obesity and potentially other indications. Pursuant to the terms of
a Collaboration Agreement of even date herewith, Lilly and Amylin have agreed to
cooperate in the development and marketing of Product.
2. In furtherance of the goals of the Collaboration Agreement, the
parties desire to enter into this agreement for the Co-Promotion of Product in
the United States.
NOW THEREFORE, in consideration of the foregoing premises and the mutual
covenants contained in this Agreement, the Parties agree as follows:
ARTICLE I
DEFINITIONS
As used herein, the following terms shall have the meanings indicated:
"ADDITIONAL INDICATION" shall have the meaning provided in the Collaboration
Agreement.
"ADVERSE EVENT" OR "ADVERSE EXPERIENCE" shall have the meaning provided in the
Collaboration Agreement.
"ADVERSE EVENT REPORT" shall have the meaning provided in the Collaboration
Agreement.
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"AFFILIATE" shall have the meaning provided in the Collaboration Agreement.
"AMYLIN DETAIL PERCENTAGE" shall mean the percentage of total Product Details to
be delivered by Amylin in the Co-Promotion Territory, as determined from time to
time by the JCC.
"AMYLIN XXXX" shall have the meaning set forth in the Collaboration Agreement.
"AMYLIN SALES FORCE" has the meaning set forth in Section 2.2.
"ALTERNATE DELIVERY" shall have the meaning provided in the Collaboration
Agreement.
"APPLICABLE LAWS" shall have the meaning provided in the Collaboration
Agreement.
"COLLABORATION AGREEMENT" means the Collaboration Agreement between the Parties
of even date herewith, as the same may be amended from time to time by the
Parties.
"COMMERCIALIZATION PLAN" shall have the meaning provided in the Collaboration
Agreement.
"COMMERCIALLY REASONABLE EFFORTS" shall have the meaning provided in the
Collaboration Agreement.
"CO-PROMOTE" OR "CO-PROMOTION" means an arrangement between Amylin and Lilly in
which unless otherwise agreed by the Parties: (i) Amylin is the registration
holder for the Product; (ii) Amylin makes all decisions regarding pricing of the
Product (iii) Amylin Manufactures or has Manufactured for it all Product sold
(iv) Amylin makes and records all sales of Product; (v) Amylin distributes all
Product by utilizing the agreed upon channels of distribution (vi) a single
trademark is used in connection with the Product; (vii) both Parties promote and
market the Product; and (viii) both names or logos of the Parties appear on the
Product (to the extent permitted by Applicable Law).
"CO-PROMOTION TERRITORY" means the fifty (50) states of the United States of
America, the District of Columbia and any territory, possession, or protectorate
of the United States of America.
"CSO" means a contract sales organization in the business of providing sales
Details for pharmaceutical products.
"DETAILS" means a Primary Detail and/or a Secondary Detail.
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"EFFECTIVE DATE" means the date this Agreement was entered into as stated in the
first paragraph of this Agreement.
"FDA" shall have the meaning provided in the Collaboration Agreement.
"FIRST PRIORITY PRODUCT" means a pharmaceutical product for which a sales
representative is expected to present the uses and benefits as the first product
discussed in each of his or her face-to-face meetings with health care
professionals during which he or she presents the uses and benefits of
pharmaceutical products.
"GOVERNMENTAL AUTHORITY" shall have the meaning provided in the Collaboration
Agreement.
"INDICATION" shall have the meaning provided in the Collaboration Agreement.
"JOINT COMMERCIALIZATION COMMITTEE" OR "JCC" shall have the meaning provided in
the Collaboration Agreement.
"LILLY DETAIL PERCENTAGE" shall mean the percentage of total Product Details to
be delivered by Lilly in the Co-Promotion Territory, as determined from time to
time by the JCC.
"LILLY GOOD PROMOTIONAL PRACTICE GUIDELINES" means the proprietary guidelines
adopted from time to time by Lilly, based on its understanding of Applicable
Laws, regarding the promotion of a pharmaceutical products in the Co-Promotion
Territory.
"XXXXX XXXX" shall have the meaning set forth in the Collaboration Agreement.
"MANUFACTURE" OR "MANUFACTURING" OR "MANUFACTURED" shall have the meaning
provided in the Collaboration Agreement.
"MARKETING APPROVAL" shall have the meaning provided in the Collaboration
Agreement, but for purposes of this Agreement shall relate only to the
Co-Promotion Territory.
"NDA" shall have the meaning provided in the Collaboration Agreement.
"PARTY OR PARTIES" shall have the meaning provided in the Collaboration
Agreement.
"PRIMARY DETAILS" means promotion of Product to medical professionals by a sales
representative with the product presentation occurring as the First Priority
Product or Second Priority Product.
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"PRODUCT" shall have the meaning provided in the Collaboration Agreement.
"PRODUCT COMPLAINT" shall have the meaning provided in the Collaboration
Agreement.
"PRODUCT LAUNCH" shall have the meaning provided in the Collaboration Agreement.
"PROMOTION RELATED ACTIVITIES" means lunches, snacks, dinners, entertainment, or
medically related gifts for health care professionals with prescribing authority
used to promote Product to such persons. For purposes of this Agreement,
Promotion Related Activities expressly excludes conference or convention
participation, continuing medical education programs, grants, paid speaker
programs, symposiums and entertainment.
"PROMOTIONAL MATERIALS" shall have the meaning provided in the Collaboration
Agreement.
"PROMOTIONAL PLAN" shall mean an annual strategic plan for the Co-Promotion of
the Product by Amylin and Lilly in the Co-Promotion Territory developed by the
JCC as part of the Commercialization Plan.
"REGULATORY MATERIALS" shall have the meaning provided in the Collaboration
Agreement.
"RELATED AGREEMENTS" shall have the meaning provided in the Collaboration
Agreement.
"SAMPLES" mean quantities of Product given to authorized medical professionals
for no or minimal consideration as part of the marketing, advertising and
promotion of the Product.
"SECOND PRIORITY PRODUCT" means the second priority pharmaceutical product for
which a sales representative is expected to present the uses and benefits after
presenting the First Priority Product in his or her face-to-face meetings with
health care professionals during which he or she presents the uses and benefits
of pharmaceutical products.
"SECONDARY DETAILS" means promotion of Product to medical professionals by a
sales representative that is not a Primary Detail.
"STEERING COMMITTEE" or "JSC" shall have the meaning set forth in the
Collaboration Agreement.
"TARGETED PHYSICIANS" means those categories of health care professionals with
prescribing authority selected from time to time by the JCC as professionals
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to which Primary Details are to be delivered by Amylin and/or Lilly sales
representatives.
"THIRD PERSON" shall have the meaning provided in the Collaboration Agreement.
"TRAINING MATERIALS" means the items the JCC develops after the Effective Date
to train persons to promote Product in the Co-Promotion Territory.
ARTICLE II
CO-PROMOTION AND SALES FORCES
2.1 PRODUCT PROMOTION.
Upon the terms and conditions set forth in this Agreement, Amylin hereby grants
Lilly during the term of this Agreement the co-exclusive right with Amylin to
promote and detail Product in the Co-Promotion Territory in accordance with the
terms of this Agreement. The principal objective of the Parties hereunder is to
maximize the commercialization of the Product in the Co-Promotion Territory.
Following receipt of Marketing Approval in the Co-Promotion Territory, the
Parties shall each use their Commercially Reasonable Efforts to promote Product
in the Co-Promotion Territory and to fulfill their obligations under this
Agreement. The Parties shall deploy each of their respective sales forces in an
effort to promote the Product in the Co-Promotion Territory in accordance with
the Commercialization Plan in effect from time to time, the directions of the
JCC, and the terms of this Agreement. Prior to Product Launch, and thereafter or
an annual basis, the JCC shall agree upon (i) the number of Details needed for
the following year, (ii) the number of Details that must be made as First
Priority Product, Second Priority Product or as a Secondary Detail, (iii) the
Amylin Detail Percentage and the Lilly Detail Percentage, and (iv) the size of
each party's Sales Force and Detail Position necessary to permit each party to
fulfill its obligations under this Agreement. Notwithstanding the foregoing,
unless the Parties agree otherwise, each Party will [...***...] to the promotion
of the product.
2.2 AMYLIN SALES FORCE.
Amylin will establish a sales force of sales representatives responsible for
Co-Promoting Product in the Co-Promotion Territory with Lilly (the "Amylin Sales
Force") under this Agreement.
(a) Qualifications for Members of the Amylin Sales Force. Amylin will be
solely responsible for recruiting, hiring and maintaining the Amylin Sales Force
*CONFIDENTIAL TREATMENT REQUESTED
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in accordance with its standard procedures and the guidelines, if any, developed
by the JCC.
(b) Number of Sales Representatives. Amylin will be responsible for
providing the Amylin Detail Percentage of the Details determined by the JCC to
be needed to promote Product in the Co-Promotion Territory, and Amylin's Sales
Force will detail Product in the Co-Promotion Territory to Targeted Physicians
in accordance with the Promotion Plan and the strategies established by the JCC.
(c) Training. The JCC shall establish procedures for sales training and
for preparation of Training Materials related to Product. Amylin will be
responsible for general sales training of its sales representatives and will
implement Product related sales training in accordance with the procedures
established by the JCC.
(d) CSOs. Amylin may not employ a CSO to fulfill any of its product
detail obligations in the Co-Promotion Territory without the prior consent of
Lilly, not to be unreasonably withheld. In any event, Amylin may only use a CSO
to fulfill some of its Product detail obligations in the Co-Promotion Territory
if such CSO is reputable and Amylin can demonstrate to Lilly that such CSO has
been integrated into Amylin's sales force and business practices in the
Co-Promotion Territory.
2.3 LILLY SALES FORCE.
Lilly will establish or designate a sales force of sales representatives,
responsible for Co-Promoting Product in the Co-Promotion Territory with Amylin
(the "Lilly Sales Force") under this Agreement.
(a) Qualifications for Members of the Lilly Sales Force. Lilly will be
solely responsible for recruiting hiring and/or maintaining the Lilly Sales
Force in accordance with its standard procedures and the guidelines, if any,
developed by the JCC.
(b) Number of Sales Representatives. Lilly will be responsible for
providing the Lilly Detail Percentage of the Details determined by the JCC to be
needed to promote Product in the Co-Promotion Territory, and Lilly's Sales Force
will detail Product in the Co-Promotion Territory to Targeted Physicians in
accordance with the Promotion Plan and the strategies established by the JCC.
(c) Training. The JCC shall establish procedures for sales training and
for preparation of Training Materials related to Product. Lilly will be
responsible for general sales training of its sales representatives and will
implement Product related sales training in accordance with the procedures
established by the JCC.
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(d) CSOs. Lilly may not employ a CSO to fulfill any of its Product
detail obligations in the Co-Promotion Territory without the consent of Amylin,
not to be unreasonably with held. In any event Lilly may only use a CSO to
fulfill Product detail obligations in the Co-Promotion Territory if such CSO is
reputable and Lilly can demonstrate to Amylin that such CSO has been integrated
into Lilly's sales force and business practice in the Co-Promotion Territory.
2.4 ALIGNMENT OF AMYLIN'S SALES TERRITORIES AND SALES DISTRICTS.
(a) Sales Territories. The sales territories, sales districts, and sales
regions for the Amylin Sales Force shall to the extent practicable be
geographically aligned with Lilly's sales territories, sales districts and sales
regions for Product in the Co-Promotion Territory at Product Launch. If Lilly
changes its territories, sales districts or sales regions after Launch, Amylin
shall in good faith consider the advantages of alignment with Lilly's Sales
Force, but shall not be obligated to make any change. Amylin's Sales Force shall
include representatives for each state, territory, possession and protectorate
within the Co-Promotion Territory.
(b) Compensation. Each Party will use its Commercially Reasonable
Efforts to ensure that variable pay components of its compensation structure,
including but not limited to incentives, for its sales force with responsibility
for promoting Product are consistent with the detail position the Parties' have
agreed upon for Product with such sales force. To facilitate the determination
of the incentives, the JCC will work with the Parties to coordinate annual sales
plans.
2.5. TRACKING OF DETAILS. [...***...] The JCC shall establish reasonable
procedures for monitoring of sales force activities to ensure that each Party is
complying with its obligations under this Agreement, and each Party agrees to
make available to the other such information as may reasonably be required in
order for the other Party to monitor compliance with this Agreement. As provided
in Section 2.1, the JCC shall annually agree upon the size of the Amylin and
Lilly sales forces and Detail position necessary to permit Amylin to fulfill its
obligation to provide the Amylin Detail Percentage and Lilly its obligation to
provide the Lilly Detail Percentage.
2.6 RESPONSIBILITY FOR THE SALES FORCE. In implementing the obligations
contained in this Agreement, each Party shall have sole discretion as to the
manner (which shall not be inconsistent with the Commercialization Plan, and
provided that neither Party will utilize any Promotional Materials not approved
by
*CONFIDENTIAL TREATMENT REQUESTED
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the JCC) in which it promotes and Details (including any expenditure of funds in
connection therewith) the Product in the Co-Promotion Territory.
Neither party shall distribute or have distributed any information that bears
the name or logo of the other Party without the prior approval of the other
through the Steering Committee or the JCC, which approval shall not be
unreasonably withheld.
Each Party shall have sole authority and responsibility for recruiting, hiring,
training, managing, compensating, subject to Section 2.4(b) (including paying
for all benefits, wages, special incentives, workers' compensation, and
employment taxes), disciplining, firing, and otherwise controlling the persons
comprising its sales force and for paying for any and all costs associated with
its sales force's efforts under the Agreement. Each Party will provide the
day-to-day management of its sales force, including, without limitation,
furnishing administrative support, financial resources, equipment, and supplies,
monitoring detail reporting and Sample accounting; and assuring the Sales
Force's understanding and compliance with this Agreement and Applicable Laws.
ARTICLE III
COMMERCIALIZATION RESPONSIBILITIES
3.1 COMMERCIALIZATION EFFORTS
(a) Commercialization Plan
The JCC will develop a promotional detailing plan ("Promotional Plan") as part
of the Commercialization Plan. The Commercialization Plan (including the
Promotional Plan) will include, but not be limited to the following activities
and state the responsibilities of each Party with respect to the activity, and
the sharing of costs for each activity:
(i) Promotion Related Activities;
(ii) Medical plans (Phase 3 clinical trials and investigator
initiated studies);
(iii) Publications;
(iv) Journal and magazine advertisements; advertising
regulatory fees, media production;
(v) Health economics studies and activities;
(vi) Patient marketing activities (direct to consumer
advertising, patient education, direct patient
marketing, direct mail, web site development and
maintenance);
(vii) Market research;
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(viii) Product Launch meetings, training materials and
Promotional Materials;
(ix) Public relations and community relations related to
Product consultantships;
(x) Business to business programs such as setting up
programs with pharmacy benefit managers, wholesalers and
chain drug stores and other activities in managed care;
(xi) "Peer to Peer" activities such as continuing medical
education, speaker training, consultants, advisory
boards; and
(xii) Symposia, conferences, trade shows and conventions,
convention donations, convention exhibits, grants,
educational materials, compassionate use product,
indigent programs
(b) Sales Force Activities. The Promotional Plan will set forth is
reasonable detail all material matters related to sales force activities. Each
Party will utilize its Commercially Reasonable Efforts consistent with its
customary business practices and Applicable Laws to deploy its sales force to
promote and detail the Product in the Co-Promotion Territory in accordance with
the Promotional Plan.
(c) Managed Payors. The JCC will determine the authority of each Party,
if any, to detail or otherwise promote Product to any physicians or to any
contracting agents, medical directors, formulary decision makers, benefit
managers, or administrators (even if such persons are health care professionals
legally authorized to prescribe Product) of a managed care organization (e.g.,
health maintenance organization, prescription benefits manager, insurance
company, or similar entity), government-funded insurance or medical program, or
employer. Amylin shall be solely responsible for the pricing of Product and any
discounts, rebates or other deviations from the established price. All Product
promotion and contracting activities with managed care entities will be
conducted by the Party or Parties designated by the JCC.
(d) Promotion Related Activities. As part of the efforts under this
Agreement, each Party, in accordance with the Commercialization Plan, may have
its Sales Force conduct Promotion Related Activities with the health care
professionals to whom it is required to detail Product, but only to the extent
such Promotion Related Activities are conducted in accordance with the Lilly
Good Promotional Practice Guidelines or the Amylin equivalent and the American
Medical Association's and PhRMA's related guidelines. Except pursuant to
procedures approved by the JCC, neither Party has authority independent of the
other Party, (i) to conduct any form of direct-to-consumer promotion related to
Product, (ii) to schedule or manage conference involvement pertaining to
Product, (iii) to establish or manage advisory boards and opinion leaders for
Product, (iv) to conduct or sponsor continuing medical education programs, paid
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speaker programs, or symposia related to Product, (v) provide grants; or (vi)
take any other action that the JCC determines will require its direction. All of
such matters will be conducted as provided by the Commercialization Plan.
(e) Compliance. Each Party agrees that all activities under this
Agreement by it or on its behalf, including, but not limited to, training,
detailing, Promotional Activities, record-keeping, collection of consumer data
(if any), and sampling, will be done in compliance with the FDA-approved package
insert and labeling of Product, the applicable Promotional Materials, the Lilly
Good Promotional Practice Guidelines or the Amylin equivalent and all Applicable
Laws. Amylin has been provided a copy of the United States Federal Trade
Commission's Decision and Order for In the Matter of Xxx Xxxxx and Company
(Docket No. C-4047) issued May 8, 2002, and relating to the protection of
patient identifiable information and agrees to cooperate with Lilly with respect
to such Decision and Order provided that Lilly shall have ultimate
responsibility for compliance.
(f) Sales Force Issues. Should either Party identify a sales
representative or member of sales force management in the other Party's Sales
Force that the Party believes is damaging relationships with health care
professionals or damaging the Product brand, such Party shall promptly notify
the other Party in writing of such belief and the basis therefore. Following
such notification, the Parties shall meet to discuss such belief and basis. The
Party, in response to the other Party's concerns about such individual, shall
take such action as it deems reasonable in the situation.
3.2 DISTRIBUTION OF SAMPLES OF PRODUCT.
(a) Rights. As part of the efforts under this Agreement, each Party's
Sales Force will distribute Samples of Product to the health care professionals
to whom it Details Product. The JCC will develop appropriate procedures for
delivery of Samples and Sample accountability. Amylin will supply, and Lilly
will obtain, all such Samples from Amylin. The quantity and type of Product
Samples to be distributed by the Parties' Sales Forces will be part of the
Commercialization Plan. Each Party shall use Samples strictly in accordance with
the then current Commercial Plan and shall distribute Samples in full compliance
with all Applicable Laws.
(b) Sample Forecasts, Purchase Orders, and Delivery. The JCC will
establish a procedure for forecasting Sample needs, ordering, and delivery of
Samples.
(c) Allocations. In the event in any month there is shortage of Samples,
unless otherwise agreed by the Parties, available samples will be allocated in
accordance with each Party's share of the detailing responsibility.
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(d) Lilly's Responsibilities for Samples. Lilly shall be solely
responsible for the transport, storage, handling, and distribution (both to the
Lilly Sales Force and to the health care professionals) of the Product Samples
it obtains under this Section. Lilly will transport, store, handle, and
distribute all Samples in compliance with all Applicable Laws and with the
procedures established by the JCC.
(e) Amylin's Responsibilities for Samples. Amylin shall be solely
responsible for the transport, storage, handling, and distribution (both to the
Amylin Sales Force and to the health care professionals) of the Product Samples
it distributes. Amylin will transport, store, handle, and distribute all Samples
in compliance with all Applicable Laws and with the procedures established by
the JCC.
3.3 USE AND DISTRIBUTION OF PROMOTIONAL MATERIALS.
(a) Promotional Materials. All Promotional Materials will be developed,
produced and provided to and utilized by the Parties in accordance with the
directions of the JCC. Promotional Materials will be reviewed and approved
before use by a Medical/Regulatory/Legal Team created by the JCC.
(b) Lilly's Use and Distribution of Promotional Material. As part of its
efforts under this Agreement, the Lilly Sales Force will use and, as applicable,
distribute Promotional Materials to the health care professionals to whom it
Details Product in accordance with the Commercialization Plan. The Promotional
Materials will be used by Lilly only for purposes of this Agreement. Lilly will
obtain all Promotional Materials from the Party responsible for obtaining
Promotional Materials pursuant to the Commercialization Plan in the quantity and
of the type required by the Commercialization Plan. Lilly agrees that it will
not create any Promotional Materials except as authorized by the JCC. Lilly also
agrees that it will not copy or alter in any manner (including rearranging,
underlining, highlighting, recording notes, etc.) the Promotional Materials nor
will it allow its Sales Force to use any such unauthorized, copied, or altered
Promotional Materials.
(c) Amylin Use and Distribution of Promotional Materials. As part of its
efforts under this Agreement, the Amylin Sales Force will use and, as
applicable, distribute Promotional Materials to the health care professionals to
whom it Details Product in accordance with the Commercialization Plan. The
Promotional Materials will be used by Amylin only for purposes of this
Agreement. Amylin will obtain all Promotional Materials from the Party
responsible for obtaining Promotional Materials pursuant to the
Commercialization Plan in the quantity and of the type required by the
Commercialization Plan Amylin agrees that it will not create any Promotional
Materials except as authorized by the JCC. Amylin also agrees that it will not
copy or alter in any manner (including rearranging, underlining, highlighting,
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recording notes, etc.) the Promotional Materials nor will it allow its Sales
Force to use any such unauthorized, copied, or altered Promotional Materials.
(d) Order and Delivery Procedures. The JCC will establish a procedure
for forecasting Promotional Material needs, ordering, and delivery of
Promotional Materials.
(e) Allocation. If the Party responsible for supplying Promotional
Materials does not have a sufficient supply in inventory to satisfy requests for
any Promotional Materials, unless otherwise agreed by the Parties, the available
supply will be allocated in accordance with each Party's share of the detailing
responsibility.
3.4 DISCONTINUATION OF MATERIALS AND SAMPLES.
If the Party responsible for Training Material, Promotional Material or Samples
informs the JCC in writing that a Training Material, Promotional Material, or
Sample may no longer be used or distributed, each Party agrees that it will not
allow its Sales Force to use or distribute such Training Material, Promotional
Material, or Sample after the no-use date identified by the responsible Party in
its notice.
3.5 DISCRETION REGARDING STRATEGY FOR SALES FORCE.
(a) Lilly Responsibilities. Lilly will employ the strategies developed
by the JCC and set forth in the Promotional Plan regarding Product sampling,
Promotional Materials, and Promotion Related Activities for the Lilly Sales
Force, but Lilly agrees that all activities under this Agreement by it or on its
behalf, including, but not limited to, training, detailing, Promotion Related
Activities, record-keeping, and sampling, will be done in compliance with the
FDA-approved package insert and labeling of Product, all Applicable Laws, the
Lilly Good Promotional Practice Guidelines and applicable PhRMA marketing
practices guidelines.
Lilly covenants that it will not promote Product for any use not approved by the
FDA. Lilly also covenants that it will not knowingly make any false or
misleading representation to any health care professional or others regarding
Product and that it will not make, except as contained in the Promotional
Materials and the product's package insert and labeling, any representation,
warranty, or guarantee with respect to the specifications, features, or
capabilities of Product.
(b) Amylin Responsibilities. Amylin will employ the strategies developed
by the JCC and set forth in the Promotional Plan regarding Product sampling,
Promotional Materials, and Promotion Related Activities for the Amylin Sales
Force, but Amylin agrees that all activities under this Agreement by it or on
its behalf, including, but not limited to, training, detailing, Promotion
Related
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Activities, record-keeping, and sampling, will be done in compliance with the
FDA-approved package insert and labeling of Product, all Applicable Laws, the
Lilly Good Promotional Practice Guidelines or Amylin equivalent, and applicable
PhRMA marketing practices guidelines.
Amylin covenants that it will not promote Product for any use not approved by
the FDA. Amylin also covenants that it will not knowingly make any false or
misleading representation to any health care professional or others regarding
Product and that it will not make, except as contained in the Promotional
Materials and the product's package insert and labeling, any representation,
warranty, or guarantee with respect to the specifications, features, or
capabilities of Product.
3.6 SALES FORCE MEETINGS.
The JCC will work together to coordinate the timing of sales force meetings and
to determine whether and when sales force meetings regarding Product should be
jointly or separately held by the Parties.
3.7 PROMOTION OF OTHER PRODUCTS.
While this Agreement is in effect, each Party has the right to have its Product
sales force detail other products in any detail positions not reserved by the
Parties for Product.
3.8 INFORMATION TECHNOLOGY FRAMEWORK.
To ensure efficient, timely and accurate communication of data and information
between the Parties regarding activities under the Agreement, each Party, at its
cost and on a time frame to be agreed upon by the Parties, will have in place
and maintain an appropriate information technology infrastructure that includes
a sales force automation tool, knowledge management tool, secure connectivity
for sharing Sample and call activity, call notes, voice mail and e-mail and the
use of which, as contemplated by the Parties under this Agreement, will not
infringe or violate a Third Person's intellectual property or privacy rights.
The Parties agree to work in good faith to create and implement processes and
technological mechanisms to prevent the disclosure between the Amylin Sales
Force and Lilly's sales forces of call notes and similar information, regarding
Amylin or Lilly promoted products other than the Product.
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3.9 INSURANCE COVERAGE.
Each Party will maintain, at its own expense, insurance coverage on its
activities under this Agreement. Such insurance will be maintained with a
reputable insurance carrier(s), and will include, without limitation, errors and
omissions insurance and comprehensive general liability insurance for claims for
damages arising from bodily injury (including death) and property damages
arising out of acts or omissions of the Party under this Agreement. Such
insurance will also be written on a per occurrence basis, except that the
Party's comprehensive general liability and directors and officers liability
insurance may be on a claims-made basis. In addition, such insurance will
provide that the insurer will notify each Party at least thirty (30) days in
advance of any cancellation or modification of such insurance coverage.
Maintenance of such insurance coverage will not relieve either Party of any
responsibility under this Agreement for damage in excess of insurance limits or
otherwise. Upon a Party's written request, the other Party will promptly provide
it with a certificate from the insurer(s) evidencing such insurance coverage.
Each Party will also maintain, at its expense, workers' compensation and
employer's insurance for its Sales Force.
3.10 TRADEMARKS AND LOGOS.
Trademarks and logos used in connection with Product shall be governed by the
terms of the Collaboration Agreement.
3.11 MARKET INFORMATION.
Each Party will provide the other with all information that the disclosing party
deems significant and relevant to the detailing and promotion of the Product
within a reasonable time after such information becomes known to the party,
provided such information is not received under a secrecy obligation.
3.12 USE OF AFFILIATES.
A Party may sublicense or subcontract its rights or obligations under this
Agreement only with the approval of the Parties, not to be unreasonably
withheld, except that a Party may sublicense or subcontract to the extent
permitted under Section 9.2 of the Collaboration Agreement and may subcontract
its obligations under this Agreement to an Affiliate (but only for so long as
such person or entity remains an Affiliate). However, the Party is solely
responsible for the performance of its obligations under the Agreement whether
performed by itself or by others, including an Affiliate, and even if a Party
uses an Affiliate to assist it in performing any of its obligations under the
Agreement, the other Party will continue to look exclusively to that Party for
performance of such obligation.
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ARTICLE IV
PRODUCT SALES
Amylin will make and record all sales of Product in the Co-Promotion Territory.
Amylin will manufacture, or have manufactured, Product and supply it to the
market in the Co-Promotion Territory. Amylin will maintain all responsibility
for returns, charge-backs, and rebates on such sales, and solely control
distribution (except sampling by the Lilly Sales Force) and pricing of Product
in the Co-Promotion Territory. Amylin, through its wholesalers and distribution
system, shall have in the Co-Promotion Territory the sole right to (1) receive,
accept and fill orders for Product, (2) distribute the Product to customers, (3)
control invoicing, order processing and collection of accounts receivable for
Product sales, and (4) record Product sales in its books of account. Amylin
shall determine, and the Commercial Plan shall include, commercial terms and
conditions with respect to the sale and distribution of Product, including
matters such as the price at which the Product shall be sold and whether any
discounts, rebates or other deductions should be made, paid or allowed. Amylin
shall arrange and be solely responsible for shipment, distribution and delivery
of the Product.
(a) Misdirected Orders. If, for any reason, Lilly receives orders for
Product, Lilly shall forward such orders to Amylin (or if directed by Amylin to
Amylin's wholesalers) as soon as practicable.
(b) Product Returns. If any quantities of the Product are returned to
Xxxxx, Xxxxx shall immediately notify Amylin and ship them to the facility
designated by Amylin. Lilly, at its option, may advise the customer who made the
return that the Product should have been returned to Amylin, but shall take no
other actions with respect to the return without Amylin's consent. All returns
of Samples used by the Lilly Sales Force shall first be returned to Lilly and
Lilly shall then ship returned Samples to Amylin.
ARTICLE V
GOVERNANCE OF THE RELATIONSHIP
Governance of the activities contemplated by this Agreement shall be effected
through the Steering Committee and Joint Commercialization Committee established
pursuant to and in accordance with the terms of the Collaboration Agreement.
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ARTICLE VI
OTHER INDICATIONS AND PRODUCTS
6.1 CO-PROMOTION FOR OTHER INDICATIONS.
If the Parties develop Compound for any Additional Indication as provided in the
Collaboration Agreement, the Parties' rights to, and responsibilities for, the
commercialization of such Additional Indication will be consistent with their
respective rights to, and responsibilities for promoting Product as set forth in
this Agreement. The JCC will establish the detail level, detail position,
promotion message, promotion materials and additional promotional matters for
each Additional Indication consistent with the terms of this Agreement.
6.2 ALTERNATE DELIVERY.
If the Parties develop Alternate Delivery for Product as provided in the
Collaboration Agreement, the Parties' rights to, and responsibilities for, the
commercialization of such Alternate Delivery Product will be consistent with the
respective rights to and responsibilities for promoting Product as set forth in
this Agreement. The JCC will establish the detail level, detail position,
promotion message, promotion materials and additional promotional matters for
each Alternate Delivery Product consistent with the terms of this Agreement.
ARTICLE VII
FINANCIAL PROVISIONS
All matters related to the Parties' compensation for their respective services
hereunder and right to reimbursement for expenses and other financial matters
shall be as set forth in the Collaboration Agreement.
ARTICLE VIII
REGULATORY MATTERS
8.1 REGULATORY COMPLIANCE.
The rights and obligations of the Parties with respect to regulatory matters
shall be as set forth in the Collaboration Agreement.
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8.2 PRODUCT COMPLAINTS.
The JCC will establish appropriate procedures for handling and reporting of
product complaints.
8.3 MEDICAL INQUIRIES.
The JCC will establish appropriate procedures for dealing with medical
inquiries.
8.4 PRODUCT RECALL OR REMOVAL FROM THE MARKET IN THE CO-PROMOTION TERRITORY.
In the event that a governmental entity issues a request, directive, or order,
or the Parties determine in accordance with the Collaboration Agreement to
recall or remove from the market some or all of the Product distributed in the
Co-Promotion Territory, Lilly will cooperate with Amylin in conducting such
recall or market removal (and any subsequent investigation by Amylin into the
cause of the recall or market removal) to the extent such recall or market
removal involves Product Samples distributed by Lilly. Lilly will maintain, and
make available to Amylin, accountability and traceability records on all Product
Samples it purchases from Amylin so as to permit, if necessary, a recall, market
removal, or field correction of such Samples.
ARTICLE IX
CONFIDENTIALITY
9.1 OBLIGATIONS. Each Party agrees to hold in confidence the other Party's
Confidential Information in accordance with the terms of the Collaboration
Agreement.
9.2 DISCLOSURE OF THE TERMS OF THE AGREEMENT. Neither Party shall disclose the
terms of this Agreement or use the names of the other Party except to the extent
permitted under the terms of the Collaboration Agreement.
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ARTICLE X
REPRESENTATIONS, WARRANTIES, AND DISCLAIMERS
10.1 NO DEBARMENT UNDER THE GENERIC DRUG ENFORCEMENT ACT OF 1992.
Each Party represents and warrants to the other Party that it is not debarred
under the Generic Drug Enforcement Act of 1992 (the "GDE Act") and is in
compliance with the provisions of the GDE Act. Each Party also covenants that,
while this Agreement is in effect, it will comply with the GDE Act, will not
become debarred under the GDE Act, and will not use in connection with this
Agreement the services of any person or entity debarred under the GDE Act.
Finally, upon request by the other Party, a Party will certify its compliance
with the GDE Act and this Section in writing to such other Party. If, at any
time, a Party breaches a covenant under this Section, the breaching Party will
immediately notify the other Party of such fact.
10.2 PRODUCT SAMPLES.
At the time Amylin delivers Product Samples to Lilly's carrier as described in
Section 3.2, Amylin represents and warrants to Lilly that such Samples:
(i) comply in all material respects with the specifications in the
NDA for Product,
(ii) comply in all material respects with the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. Section 301 et seq.) and regulations
issued hereunder, both as amended from time to time ("FDCA"),
(iii) are not products that have been adulterated or misbranded within
the meaning set forth in FDCA and any state or local law or
regulation substantially similar to FDCA,
(iv) are products that may be introduced into interstate commerce,
and
(v) have been manufactured, packaged, stored, and shipped in
conformity with all applicable current good manufacturing
practices.
10.3 TRAINING MATERIALS AND PROMOTIONAL MATERIALS.
No employee or representative of a Party shall have any authority to bind or
obligate the other Party to this Agreement for any sum or in any manner
whatsoever, or to create or impose any contractual or other liability on the
other Party without the other Party's authorized written approval. For all
purposes, and notwithstanding any other provisions of this Agreement to the
contrary, the legal
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relationship under this Agreement of the Parties shall be that of independent
contractors. Each Party shall be responsible for ensuring that its Promotional
Activities under this Agreement are in full compliance with all Applicable Laws,
including without limitation applicable FDA regulations, and are consistent with
the Marketing Approval and package insert.
10.4 DISCLAIMER OF IMPLIED WARRANTIES.
EXCEPT AS EXPRESSLY PROVIDED IN THIS AGREEMENT, NEITHER PARTY MAKES ANY OTHER
REPRESENTATION OR WARRANTY, EXPRESS OR IMPLIED, EITHER IN FACT OR BY OPERATION
OF LAW, STATUTE, OR OTHERWISE, AND EACH PARTY SPECIFICALLY DISCLAIMS ANY AND ALL
IMPLIED OR STATUTORY WARRANTIES INCLUDING WARRANTIES OF MERCHANTABILITY, OF
FITNESS FOR A PARTICULAR PURPOSE, AND OF NON-INFRINGEMENT.
10.5 LIMITATION OF LIABILITY.
NEITHER PARTY WILL BE LIABLE TO THE OTHER PARTY FOR INDIRECT, INCIDENTAL,
CONSEQUENTIAL, OR SPECIAL DAMAGES INCLUDING, BUT NOT LIMITED TO, LOST PROFITS
ARISING FROM OR RELATING TO ANY BREACH OF THIS AGREEMENT, REGARDLESS OF ANY
NOTICE OF THE POSSIBILITY OF SUCH DAMAGES. HOWEVER, NOTHING IN THIS SECTION IS
INTENDED TO LIMIT OR RESTRICT THE INDEMNIFICATION RIGHTS OR OBLIGATIONS OF ANY
PARTY.
ARTICLE XI
TERM AND TERMINATION
11.1 TERM.
Unless extended by the Parties or terminated earlier, this Agreement will be in
effect from the Effective Date until termination or expiration of the
Collaboration Agreement, at which time this Agreement shall be deemed
terminated.
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ARTICLE XII
GENERAL PROVISIONS
12.1 LEGAL COMPLIANCE.
Each Party will comply with all Applicable Laws in the performance of its
obligations or the exercise of its rights hereunder.
12.2 ASSIGNMENT.
This Agreement may be assigned only as provided in the Collaboration Agreement.
12.3 INDEPENDENT CONTRACTORS.
It is understood and agreed that the Parties are independent contractors and are
engaged in the operation of their own respective businesses, and neither Party
is to be considered the agent of the other Party for any purpose whatsoever.
Neither Party will have any authority to enter into any contracts or assume any
obligations for the other Party nor make any warranties or representations on
behalf of that other Party.
12.4 GOVERNING LAW. This Agreement and all amendments, modifications,
alterations, or supplements hereto, and the rights of the Parties hereunder,
will be construed under and governed by the laws of the state of New York
exclusive of its conflicts of laws principles.
12.5 ENTIRE AGREEMENT. This Agreement, including any exhibits or attachments
attached hereto and the Related Agreements constitutes the entire agreement
between Amylin and Lilly with respect to the subject matter hereof, and all
previous or other negotiations, representations and understandings with respect
to the subject matter hereof between Amylin and Lilly are superseded as of the
Effective Date. This Agreement has been prepared jointly and will not be
strictly construed against either Party.
12.6 SEVERABILITY. If a provision of this Agreement (or portion thereof) is held
to be illegal, invalid, or unenforceable by a court of competent jurisdiction,
the remaining provisions (and portions thereof) of the Agreement shall remain in
full force and effect. In addition, to the extent feasible and legally
permissible, the court of competent jurisdiction will replace the illegal,
invalid, or unenforceable provision of this Agreement with a valid provision
that eliminates such violation while conforming as closely as possible to the
original terms of this Agreement.
If a provision of this Agreement (or portion thereof) that is essential to the
commercial purpose of this Agreement is held to be illegal, invalid, or
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unenforceable by a court of competent jurisdiction and such court cannot replace
(either because such replacement is not feasible or not legally permissible)
such provision with a valid provision that eliminates such violation while
conforming as closely as possible to the original terms of this Agreement, the
remaining provisions (and portions thereof) of the Agreement remain in full
force and effect, but either Party may terminate the Agreement upon written
notice to the other.
12.8 COUNTERPARTS. This Agreement may be executed in one or more counterparts,
each of which will be deemed an original, but all of which together will
constitute one and the same instrument.
12.9 NOTICES. All notices, statements, and reports required to be given under
this Agreement shall be given in the manner specified in the Collaboration
Agreement.
12.10 WAIVER. The failure of either Party to enforce any provision of this
Agreement at any time will not be construed as a present or future waiver of
such provision or any other provision of this Agreement.
12.11 MODIFICATIONS. No amendment, waiver or modification of this Agreement will
be valid or binding on either Party unless made in writing and signed by duly
authorized representatives of both Parties.
12.12 HEADINGS. All headings and captions used in this Agreement are for
convenience only, and are not intended to have any substantive effect.
12.13 NO OTHER LICENSES OR RIGHTS. Except as specifically provided for in this
Agreement, neither Party grants, expressed or implied, any license or rights to
the other Party.
12.14 FURTHER ACTIONS. Each Party agrees to execute, acknowledge, and deliver
such further instruments, and to do all other acts, as may be reasonably
necessary or appropriate within the contemplation of this Agreement to carry out
the purposes and intent of this Agreement.
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IN WITNESS WHEREOF, each Party has executed this Agreement by its respective,
duly authorized officer as of the day and year herein written.
AMYLIN PHARMACEUTICALS, INC. XXX XXXXX AND COMPANY
By: /s/ XXXXXX X. XXXX, XX. By: /s/ AUGUST X. XXXXXXXX
------------------------------ -------------------------------------
Name: Xxxxxx X. Xxxx, Xx. Name: August X. Xxxxxxxx
---------------------------- -----------------------------------
Title: Chairman and Chief Title: Executive Vice President
Executive Officer Science/Technology
[Signature Page -- Co-Promotion Agreement]
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