Exhibit 10.3
***Text Omitted and Filed Separately
Confidential Treatment Requested
Under 17 C.F.R. Section 200.80(b)(4)
And 240.24b-2
Addendum to September 19,
2002
U.S. Co-Promotion
Agreement
by and between
Amylin
Pharmaceuticals, Inc.
and
Eli Lilly and
Company
Addendum Effective as
of
May 8th, 2008
ADDENDUM TO U.S. CO-PROMOTION
AGREEMENT
This Addendum to the U.S. Co-Promotion Agreement
(the “Addendum”) is made effective as of the 8
th day of May, 2008 (the “Effective Date”)
by and between Amylin Pharmaceuticals, Inc.
(“Amylin”), a Delaware corporation having its principal
place of business at 9360 Towne Center Drive, San Diego,
California, 92121.
and
Eli Lilly and Company, an Indiana corporation
having its principal place of business at Lilly Corporate Center,
Indianapolis, Indiana, 46285 (“Lilly”).
RECITALS:
Whereas, Amylin and Lilly are
parties to a Collaboration Agreement dated September 19, 2002
(the “Collaboration Agreement”), regarding the
development and commercialization of Product, and U.S. Co-Promotion
Agreement (“Co-Promotion Agreement”) dated
September 19, 2002, regarding the promotion of
Product;
Whereas, Lilly desires to engage,
PharmaBio Development, Inc d/b/a NovaQuest, having its principal
place of business at 4709 Creekstone Dr., Durham NC 37703
(hereinafter “NovaQuest”) to provide contract sales
services for the Product.
Whereas, the Parties are entering
into this Addendum to set forth the terms and conditions of
Lilly’s engagement of NovaQuest to promote Product pursuant
to the terms and conditions of the Co-Promotion
Agreement.
NOW THEREFORE,
in consideration of the foregoing
premises and the mutual covenants contained in this Addendum, the
Parties agree as follows:
Amylin and Lilly wish to append
certain additional rights and obligations for each Party in
addition to the Party’s respective rights and obligations
under the Co-Promotion Agreement. To the extent not otherwise
modified in this Addendum, the rights and obligations of each Party
under the Co-Promotion Agreement shall continue in full force and
effect.
2
ARTICLE I
DEFINITIONS
As used herein, the following terms shall have
the meanings indicated and any capitalized terms used herein and
not defined herein shall have the meanings provided in the
Co-Promotion Agreement:
“Co-Promotion Start Date”
shall mean the date on which the
NovaQuest’s Sales Force has received training on the Product
in accordance with this Addendum and begins making NovaQuest
Details, which shall be not later than July 1,
2008.
“NovaQuest Detail”
means a face to face presentation by
a representative of the NovaQuest sales force to a healthcare
professional in a setting appropriate for a meaningful medical
dialogue during which presentation such representative makes a
Secondary Detail relating to Product. A delivery of Samples
does not constitute a NovaQuest Detail.
“Sample”
shall mean quantities of Product or
vouchers allowing patients to acquire Product at no charge given to
authorized medical professionals for no or minimal consideration as
part of the marketing, advertising and promotion of the
Product.
“Third Priority
Product” means the third priority pharmaceutical product
for which a sales representative is expected to present the uses
and benefits after presenting the First Priority Product and Second
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.
“ U.S. Ops” shall mean the
committee established by Amylin and Lilly as the successor, in
part, of the responsibilities and obligations of the
JCC.
ARTICLE II
USE OF NOVAQUEST BY
LILLY
2.1
Product Promotion by
NovaQuest.
Pursuant to Section 2.3(d) of the
Co-Promotion Agreement, Amylin hereby consents to Lilly’s
engagement of NovaQuest as a CSO to help fulfill Product detail
obligations in the Co-Promotion Territory; provided, however that
Lilly shall remain liable and responsible for the performance and
observance of all its duties and obligations under the Co-Promotion
Agreement and the obligations of NovaQuest pursuant to this
Addendum.
3
2.2
Compliance with Law by
NovaQuest.
Lilly represents and warrants that NovaQuest
will have prior to the Effective Date agreed that they shall comply
with all applicable laws, rules and regulations including, but
not limited to the Federal Equal Employment Opportunity Act, Title
VII of the Civil Rights Act of 1964, the Age Discrimination in
Employment Act, the Americans with Disabilities Act, the Fair Labor
Standards Act, the Immigration Reform and Control Act of 1986, the
Food, Drug and Cosmetic Act, Section 1128B(b) of the
Social Security Act (42 U.S.C.§ 1320(a)-7(b(b), the
Prescription Drug Marketing Act . NovaQuest prior to the Effective
Date will agree to and shall comply with all applicable data
protection laws and regulations, including without limitation, the
Health Insurance Portability and Accountability Act (HIPAA) Privacy
Regulations. Further, Lilly represents and warrants that NovaQuest
prior to the Effective Date will have certified to Lilly that it
has not and will not use in any capacity (either directly or
through subcontractors) the services of any person debarred under
the Generic Drug Enforcement Act of 1992 (GDEA) (specifically,
under 21 USC 335a) in connection with services provided on behalf
of Lilly during the term of this Addendum.
2.3
Compliance with Agreements and
Policies by NovaQuest.
Lilly shall ensure that NovaQuest, in carrying
out its responsibilities and activities under this Addendum on
behalf of Lilly, complies with the terms and conditions of the
Co-Promotion Agreement and Collaboration Agreement as applicable
and any applicable company policies outlined by the Parties.
NovaQuest’s breach of imposed duties and obligations shall be
deemed to be Lilly’s breach of the Co-Promotion Agreement
and/or Collaboration Agreement as applicable for purposes of this
Addendum.
2.4
NovaQuest Sales
Force.
NovaQuest currently has a sales force of sales
representatives, district managers and regional sales directors
dedicated to promoting products on behalf of Lilly.
(“NovaQuest Sales Force”). Under this Addendum,
the Parties agree that Lilly will engage NovaQuest to help fulfill
Product detail obligations pursuant to the Co-Promotion Agreement
and Collaboration Agreement
(a)
Lilly shall cause the NovaQuest
Sales Force to Detail Product in the Co-Promotion Territory to
Targeted Physicians in accordance with the Promotion Plan and the
strategies established by US Ops. Lilly will be
responsible for general sales training and Product related sales
training of the NovaQuest Sales Force in accordance with the
procedures established by US Ops. Lilly shall cause NovaQuest
not to hold their own sales force meetings regarding
Product.
4
(b)
Lilly will use its Commercially
Reasonable Efforts to ensure that variable pay components of
NovaQuest’s compensation structure, including but not limited
to incentives, for the NovaQuest Sales Force is consistent with the
NovaQuest Detail position the Parties have agreed upon for Product
with such sales force. The NovaQuest Detail position of
Products addressed herein and incentive weighting agreed upon by
the Parties as of the Effective Date is specified in
Exhibit A attached hereto and incorporated by
reference
(c)
Lilly shall cause NovaQuest to
conduct all of its activities under this Addendum, including, but
not limited to, training, NovaQuest Detail, Promotional Activities,
record-keeping, collection of consumer data (if any), and sampling
(if any), 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.
(d)
Size of the NovaQuest Sales
Force . Lilly
shall use its Commercially Reasonable Efforts to have in place as
of the Co-Promotion Start Date not less than [***] ([***])
full-time, trained and placed sales representatives in the
NovaQuest Sales Force for purposes of detailing Product. Upon
the Parties’ execution of this Agreement, Lilly shall notify
Amylin in writing of the exact size of the NovaQuest Sales Force
that it intends to field. Lilly shall use its Commercially
Reasonable Efforts to maintain the NovaQuest Sales Force at such
size during the term of this Addendum.
2.5
Information Lilly and/or
NovaQuest Will Provide to Amylin.
Lilly will cause NovaQuest to maintain, in
accordance with applicable laws, records regarding the NovaQuest
Sales Force Activities under this Addendum and will provide Amylin,
following the Co-Promotion Start Date, with the following written
reports and such other information as Amylin may from time to time
reasonably request:
|
(i)
|
|
Within [***] ([***]) days after the end of each
[***]:
|
|
|
|
·
|
[***];
|
|
|
|
·
|
[***];
|
|
|
|
·
|
[***]; and
|
|
|
|
·
|
[***].
|
|
|
|
|
|
|
(ii)
|
|
Within [***] ([***]) days after the end of each
Calendar [***]:
|
|
|
|
·
|
[***]; and
|
|
|
|
·
|
[***].
|
* Confidential treatment
request(ed)
5
Lilly will cause NovaQuest to keep records in
sufficient detail to enable the accuracy of the information
provided under (i) through (ii) of this Section to
be verified. NovaQuest will keep such records for at least
one (1) year after the expiration or termination of this
Addendum, unless a longer retention period for a particular record
is specified in this Addendum or by Applicable Laws.
Lilly shall from time to time provide such
information as Amylin may reasonably request in order for Amylin to
track NovaQuest’s activities under this Addendum and
facilitate promotion of Product to Targeted Physcians by NovaQuest
during the Term and by Amylin following the Term; provided,
however, that following the Term, Amylin shall reimburse any Third
Person out-of-pocket costs reasonably incurred by Lilly in
providing such information. This may include assistance from
Lilly in creating and updating prescriber profiles and otherwise
transitioning promotional responsibility from Lilly to Amylin after
the Term.
ARTICLE III
3.1
Distribution of
Samples.
(a)
Rights . It is contemplated that in support
of NovaQuests’ Detailing of the Product hereunder, an
appropriate level of Samples will be supplied to NovaQuest.
US Ops will determine the appropriate level and develop appropriate
procedures for delivery of Samples and Sample accountability for
the NovaQuest Sales Force. Amylin will supply, and Lilly will
obtain, all such Samples from Amylin. Lilly shall cause
NovaQuest to use Samples strictly in accordance with the then
current Commercial Plan and Lilly shall cause NovaQuest to
distribute Samples in full compliance with all Applicable
Laws.
(b)
Lilly’s Responsibilities
for Samples. Lilly
shall be solely responsible for the transport, storage, handling,
and distribution of Samples (if any) NovaQuest obtains under
this Addendum. Lilly will cause NovaQuest to transport,
store, handle, and distribute all Samples in compliance with all
Applicable Laws and with the procedures established by US
Ops.
3.2
NovaQuest’s Use and
Distribution of Promotional Materials.
As part of its efforts under this
Addendum, Lilly will cause the NovaQuest Sales Force to use and, as
applicable, distribute Promotional Materials to health care
professionals to whom it details Product in accordance with the
Commercialization Plan. The Promotional Materials will be
used by NovaQuest only for purposes addressed herein. Lilly
will not permit NovaQuest to create any Promotional
Materials. Lilly will not permit NovaQuest to copy or alter
in any manner (including rearranging, underlining, highlighting,
recording notes, etc.) the Promotional