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Exhibit 10.1
U.S. CO-PROMOTION AGREEMENT
BY AND BETWEEN
ZYMOGENETICS, INC.
AND
BAYER HEALTHCARE LLC
EFFECTIVE AS OF JUNE 18, 2007
"[ * ]" = omitted,
confidential material, which material has been separately filed
with
the Securities and Exchange Commission pursuant
to a request for confidential treatment.
U.S. CO-PROMOTION
AGREEMENT
THIS U.S. CO-PROMOTION AGREEMENT is made as of the 18
th day of June,
2007 (the " Effective Date ") by and between
ZymoGenetics, Inc., a corporation organized and existing under the
laws of Washington State, U.S.A. (" ZGEN "), and
Bayer HealthCare LLC, a limited liability company organized and
existing under the laws of Delaware (" Bayer "). ZGEN
and Bayer are sometimes referred to herein individually as a "
Party " and collectively as the "
Parties ."
RECITALS
A. ZGEN is developing certain products containing Recombinant
Thrombin (as defined in the LCA) for use in hemostasis.
B. Concurrent with the execution of this Agreement, ZGEN and
Bayer’s Affiliate, Bayer Schering Pharma A.G., are entering
into a License and Collaboration Agreement of even date herewith
(the " LCA "), pursuant to which ZGEN and Bayer
Schering Pharma A.G. have agreed to collaborate in the global
development of certain Licensed Products (as defined in the LCA)
and Bayer Schering Pharma A.G. has agreed to develop and
Commercialize certain Licensed Products outside of the United
States.
C. In furtherance of the goal of maximizing Commercialization
(defined below), the Parties desire to enter into this Agreement
for the time-limited co-promotion of Initial Licensed Products
(defined below) in the United States.
AGREEMENT
NOW, THEREFORE, the Parties, intending to be legally bound,
agree as follows:
ARTICLE 1
Definitions
Where words and phrases are used herein in the singular, such
usage is intended to include the plural forms where appropriate to
the context, and vice versa. The words " including, "
" includes " and " such as " are used
in a non-limiting sense and have the same meaning as "
including without limitation " and " including,
but not limited to. " References to Articles, Sections,
Subsections and paragraphs are to the same with all their subparts
as they appear in this Agreement. " Herein " means
anywhere in this Agreement. " Hereunder " and
"hereto" mean under or pursuant to any provision of this Agreement.
The Article and Section headings contained herein are for
reference only and shall not be considered a part of this
Agreement, nor shall they in any way affect the interpretation
hereof. All references to time are to the time in Seattle,
Washington, U.S.A. As used herein, the following terms shall have
the meanings indicated and any capitalized terms used, but not
otherwise defined, in this Agreement shall have the meanings
defined in the LCA:
1.1 " Active Period " means the period of
time commencing on the Launch Date and ending on (i) the last
day of the calendar quarter that contains the third
(3rd) anniversary of the Launch Date or (ii) if extended
pursuant to Section 3.2.3 , the last day of the
calendar quarter that contains the
[ * ]
anniversary of the Launch Date or (iii) if terminated early
pursuant to Section 3.2.4 , the last day of the
calendar quarter that contains the
[ * ]
anniversary of the Launch Date.
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1.2 " Adverse Event " means
any event defined as an adverse experience pursuant to 21 CFR
600.80(a), as the same may be amended from time to time.
1.3 " Affiliate " means, with respect to a
Party, an individual, a partnership, a joint venture, a
corporation, or any other entity or any combination of the
aforementioned entities that, directly or indirectly, through one
or more intermediaries, controls, is controlled by or is under
common control with such Party. For purposes of this definition,
"control" will mean the possession, direct or indirect, of the
power to cause the direction of the management and policies of a
Party, whether through ownership of more than fifty percent
(50%) of the voting securities of such Party, by contract or
otherwise.
1.4 " Alliance Manager " means a single
contact person within a Party’s organization who shall be
designated by such Party to act as liaison and serve as the
principal point of communication with the other Party with respect
to the Parties’ activities under this Agreement.
1.5 " Annual Revenue Threshold " is defined
in Section 3.2.1 .
1.6 " Applicable Laws " means all laws,
rules, regulations, guidance and guidelines that are applicable to
the marketing, sale and promotion of pharmaceutical products for
human use in the Co-Promotion Territory and that materially affect
a Party’s performance under this Agreement, including the
United States Federal Food, Drug, and Cosmetic Act, the Public
Health Service Act, the Prescription Drug Marketing Act, Federal
Health Care Program Anti-Kickback Law (42 U.S.C. ss.1320a-7b), the
Health Insurance Portability and Accountability Act of 1996, and
all rules and regulations promulgated thereunder, the Office of
Inspector General (" OIG ") Compliance Guidance
Program, the Code on Interactions with Healthcare Professionals
promulgated by the Pharmaceutical Research and Manufacturers of
America (PhRMA) and the American Medical Association Guidelines on
Gifts to Physicians, as any of the foregoing may be amended.
1.7 " Bayer Indemnitees " is defined in
Section 8.1.1 .
1.8 " Bayer MSLs " is defined in
Section 2.7.6 .
1.9 " Bayer Sales Force " is defined in
Section 2.7.5 .
1.10 " Bulk Drug Substance " has the
meaning defined in the LCA.
1.11 " Commercialization " or "
Commercialize " means all activities relating to the
promotion, marketing, advertisement, sale, reimbursement and
distribution of Initial Licensed Product in the Co-Promotion
Territory, and other pre-launch and post-launch marketing and sale
activities for Initial Licensed Product in the Co-Promotion
Territory. When used as a verb, " Commercialize "
means to engage in Commercialization.
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1.12 " Commercially Reasonable
Efforts " means the level of efforts and resources required to
Commercialize an Initial Licensed Product in the Co-Promotion
Territory in a sustained manner consistent with the efforts a
similarly situated biopharmaceutical company (in the case of ZGEN)
or pharmaceutical company (in the case of Bayer) would reasonably
devote to a product of similar market potential at a similar stage
in its product life, profit potential or strategic value resulting
from its own research efforts, based on conditions then
prevailing.
1.13 " Confidential Information " means all
tangible and intangible techniques, technology, practices, trade
secrets, inventions (whether patentable or not), methods,
knowledge, know-how, conclusions, skill, experience, test data and
results (including pharmacological, toxicological and clinical test
data and results), analytical and quality control data, results or
descriptions, software and algorithms received by either Party or
its Affiliates from the other Party or its Affiliates pursuant to
(1) this Agreement, (2) the Confidentiality Agreement,
dated as of January 24, 2006, by and between ZGEN and Bayer
Pharmaceuticals Corporation (as amended by Amendment No. 1 to
Confidentiality Agreement, dated January 5, 2007), or
(3) Confidential Disclosure Agreement, dated April 19,
2006, by and between Bayer and ZGEN, other than that portion of
such information that:
(a) is publicly disclosed by the disclosing Party, either before
or after it becomes known to the receiving Party;
(b) was known to the receiving Party, without obligation to keep
it confidential, prior to when it was received from the disclosing
Party;
(c) is subsequently disclosed to the receiving Party by a Third
Party lawfully in possession thereof without obligation to keep it
confidential;
(d) has been publicly disclosed other than by the disclosing
Party and without breach of an obligation of confidentiality with
respect thereto; or
(e) has been independently developed by the receiving Party
without the aid, application or use of Confidential Information, as
demonstrated by competent written proof.
1.14 " Content Compliance Contact " a
member of a Party’s Review Board designated by that Party to
coordinate the review of Promotional Materials and Medical
Education Materials when required by this Agreement.
1.15 " Control " has the meaning defined in the
LCA.
1.16 " Coordination Committee " is defined
in Section 2.3.1 .
1.17 " Co-Promotion Plan " means a
strategic plan for the promotion and Detailing of the Initial
Licensed Products by ZGEN and Bayer in the Co-Promotion Territory
during the Active Period, including the methodology for deployment
of Sales Representatives, call patterns and mechanisms for
coordination among field representatives for each Party, as
developed by the CPT in accordance with
Section 2.4.3 and approved by the Coordination
Committee in accordance with Section 2.3.4 .
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1.18 " Co-Promotion
Territory " means the United States.
1.19 " Courts " is defined in
Section 10.5 .
1.20 " CPT " is defined in
Section 2.4.1 .
1.21 " CSO " means a contract sales
organization in the business of providing sales details for
pharmaceutical products.
1.22 " Detail " or "
Detailing " means a face-to-face meeting (including a
live video presentation but not including Promotion Related
Activities) in the Co-Promotion Territory between a Party’s
Sales Representative and (a) a medical professional with
prescribing authority or other individuals or entities that have a
significant impact/influence on prescribing decisions or
(b) such other groups as may be mutually agreed by the
Parties, during which the Sales Representative provides an oral
presentation of an Initial Licensed Product’s attributes in a
fair and balanced manner consistent with the requirements of this
Agreement and Applicable Law and in a manner that is customary in
the industry for the purpose of promoting a prescription
pharmaceutical product. When used as a verb, "Detail" shall mean to
engage in the activities set forth in this paragraph.
1.23 " Dispute " is defined in
Section 2.3.5 .
1.24 " Effective Date " means the date this
Agreement was entered into and is defined in the introduction to
this Agreement.
1.25 " Expert " means a mutually
acceptable, disinterested, conflict-of-interest-free individual
with such scientific, technical, regulatory and commercial
experience as is necessary to resolve a Dispute. The Expert shall
not be or have been during the preceding five (5) years an
Affiliate, employee, consultant, officer or director of either
Party or any of its respective Affiliates.
1.26 " FDA " means the United States Food
and Drug Administration, or any successor agency thereto.
1.27 " Force Majeure " means any occurrence
beyond the reasonable control of a Party that prevents or
substantially interferes with the performance by such Party of any
of its obligations hereunder, if such occurs by reason of any act
of God, flood, fire, explosion, earthquake, breakdown of plant,
shortage of critical equipment, loss or unavailability of
manufacturing facilities or material, strike, lockout, labor
dispute, casualty or accident, or war, revolution, civil commotion,
terrorism and acts of public enemies, blockage or embargo, or any
injunction, law, order, proclamation, regulation, ordinance, demand
or requirement of any government or of any subdivision, authority
or representative of any such government, inability to procure or
use materials, labor, equipment, transportation or energy
sufficient to meet manufacturing needs without allocation, or any
other cause whatsoever, whether similar or dissimilar to those
above enumerated, beyond the reasonable control of such Party, if
and only if the Party affected will have used reasonable efforts to
avoid such occurrence and to remedy it promptly if it will have
occurred.
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1.28 " Individual Annual Revenue
Threshold " is defined in Section 3.2.2
.
1.29 " Initial Licensed Products " means
the Presentations (as defined in the LCA) listed as
paragraphs 1 through 3 on Exhibit
A attached hereto and incorporated herein.
1.30 " Knowledge " means (a) the
[ * ] of any
individual within a group consisting of
[ * ] (the "
ZGEN Management ") and (b) the
[ * ] the ZGEN
Management
[ * ] have
based on the
[ * ] of any
ZGEN employee of
[ * ] ;
provided that in no event shall ZGEN be required to
[ * ] . In
addition, the determination of the knowledge ZGEN Management
[ * ] and the
information that is
[ * ] shall
take into consideration that
[ * ] .
1.31 " Launch Date " means the date of
[ * ] in the
[ * ] of the
[ * ] Initial
Licensed Product
[ * ] Third
Party after obtaining the required Regulatory Approval from the FDA
[ * ] Initial
Licensed Product in the
[ * ] . For
purposes of the foregoing,
[ * ] .
1.32 " LCA " means the License and
Collaboration Agreement between ZGEN and Bayer Schering Pharma A.G.
of even date herewith, as the same may be amended from time to time
in accordance with its terms.
1.33 " Losses " means liabilities, costs,
fees, expenses and/or losses, including reasonable legal costs and
expenses and attorneys’ fees for outside counsel.
1.34 " Medical Education Materials " means,
with respect to an Initial Licensed Product, (a) all written,
printed, graphic, electronic, audio or video matter intended for
(i) use in responding to unsolicited questions from health
care professionals relating to the Initial Licensed Products and/or
Recombinant Thrombin or (ii) proactive use with physician
thought leaders, and (b) scientific publications and materials
produced for independent education programs by Third Party
education providers.
1.35 " Medical Education Activities " means
business meals with, or medically related items for, physician
thought leaders. For purposes of this Agreement, Medical Education
Activities expressly includes conference or convention
participation, continuing medical education programs, paid speaker
programs and symposia.
1.36 " Medical Education Plan " means a
strategic plan for scientific interchange with physician thought
leaders relating to the Initial Licensed Products by ZGEN and Bayer
in the Co-Promotion Territory during the Active Period, as
developed by the MET in accordance with
Section 2.5.3 and approved by the Coordination
Committee in accordance with Section 2.3.4 .
1.37 " MET " is defined in
Section 2.5.1 .
1.38 " MSL " means an individual who is
regularly employed by the applicable Party on a full-time basis,
whose skills, training and experience are consistent with industry
standards applicable to scientific interchange (as opposed to
product promotion) with physician thought
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leaders, including meeting minimum professional
standards of a four-year college degree (B.A., B.S. or equivalent),
and who shall have (a) satisfactorily completed the
product–specific training developed by ZGEN and the ethics
and compliance training required by the Party by whom he or she is
employed and (b) become adequately equipped and knowledgeable
with respect to the Initial Licensed Products, including the
Product Labels and the use of the Medical Education Materials in
accordance with this Agreement and the Medical Education Plan.
Titles of such personnel may be Medical Science Liaisons,
Scientific Affairs Liaisons or Medical Liaisons.
1.39 " Net Sales " means the gross amount
invoiced with respect to the sale or other disposition of Initial
Licensed Products in the Co-Promotion Territory by ZGEN or its
Affiliates or sublicensees to a non-sublicensee Third Party after
deducting returns and allowances (actually paid or allowed)
including prompt payment and any other discounts (including
deductions commonly referred to as "fee for service"), price
reductions, including government reimbursement programs in the
Co-Promotion Territory such as Medicare and Medicaid and similar
types of rebates, chargebacks from wholesalers of Initial Licensed
Product (whether in cash or trade), and rebates, when included in
gross sales, but not including taxes when assessed on income
derived from such sales and bad debts. Amounts received by ZGEN or
its Affiliates for the sale in the Co-Promotion Territory of
Initial Licensed Product between ZGEN and its Affiliates for resale
or for transfer in the Co-Promotion Territory of Initial Licensed
Product to a sublicensee for resale will not be included in the
computation of Net Sales hereunder. Any Initial Licensed Product
sold or otherwise transferred in the Co-Promotion Territory in
other than an arm’s-length transaction or for other property
(e.g., barter) shall be deemed invoiced at its fair market price in
the Co-Promotion Territory.
1.40 " Party " is defined in the
introduction to this Agreement.
1.41 " Product Labels " means all
FDA-approved labels and other written, printed or graphic matter
upon any container, wrapper or any package insert or outsert
utilized with or for an Initial Licensed Product in the
Co-Promotion Territory.
1.42 " Product Trademark " means any
Trademarks that are (a) Controlled by ZGEN or Bayer and
(b) actually applied to or used, or intended to be used, with
any Initial Licensed Product or any Promotional Materials or
Medical Education Materials in the Co-Promotion Territory.
1.43 " Promotional Materials " means, with
respect to an Initial Licensed Product, all written, printed,
graphic, electronic, audio or video matter, including journal
advertisements and sales visual aids, direct mail,
direct-to-consumer advertising, Internet postings, broadcast
advertisements, sales reminder aids (e.g., scratch pads, pens and
other such items) and other Detail aids, intended for use or used
by a Party in connection with any promotion of such Initial
Licensed Product, except for: (a) the FDA-approved full
prescribing information for such Initial Licensed Product,
including any required patient information; (b) Product
Labels; and (c) Medical Education Materials.
1.44 " Promotion Related Activities " means
business meals (including promotional speaker programs) with, or
medically related items for, health care professionals with
prescribing authority or other individuals or entities that have a
significant impact/influence on prescribing
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decisions used to promote Initial Licensed
Products to such persons. For purposes of this Agreement, Promotion
Related Activities expressly excludes conference or convention
participation (other than promotional exhibit booths), independent
medical education programs and grants.
1.45 " Recall " means an event, incident or
circumstance that may result in the need for a "recall" or "market
withdrawal" (as those terms are defined in United States
regulations in 21 C.F.R. 7.3) or field alert (including biological
product deviation reports) or field correction of an Initial
Licensed Product or any lot thereof.
1.46 " Regulatory Approval " means any
approvals (including supplements, amendments, pre- and
post-approvals, reimbursement approvals and price approvals),
licenses, registrations or authorizations of any national, state or
local regulatory agency, department, bureau, commission, council or
other governmental entity, including the FDA, necessary for the
marketing and sale of Initial Licensed Product in the Co-Promotion
Territory. Regulatory Approval does not include any site license
for a Party’s manufacturing facility.
1.47 " Review Board " means the
multi-disciplinary committee within a Party: (a) tasked with
reviewing Promotional Materials for compliance with Applicable
Laws, known at Bayer as the "LMR" and at ZGEN as the "Promotional
Review Board" or (b) tasked with reviewing Medical Education
Materials for compliance with Applicable Laws, as applicable.
1.48 " Safety Issues " is defined in
Section 3.1.4(c) .
1.49 " Sales Bonuses " means collectively
the First Sales Bonus and the Second Sales Bonus as described in
Section 4.3 .
1.50 " Sales Force " means, as applicable,
the ZGEN Sales Force or the Bayer Sales Force and " Sale
Forces " means both the ZGEN Sales Force and the Bayer
Sales Force.
1.51 " Sales Representative " means an individual
who is regularly employed by the applicable Party on a full-time
basis, whose skills, training and experience are consistent with
industry standards applicable to the promotion, marketing and sale
of a prescription pharmaceutical product, including meeting minimum
professional standards of a four-year college degree (B.A., B.S. or
equivalent), and who shall have (a) satisfactorily completed
the product–specific training developed by ZGEN and the
ethics and compliance training required by the Party by whom he or
she is employed and (b) become adequately equipped and
knowledgeable with respect to the Initial Licensed Products,
including the Product Labels and the use of the Promotional
Materials in accordance with this Agreement and the Co-Promotion
Plan.
1.52 " Samples " means units of Initial
Licensed Product distributed or provided at no cost to health care
professionals in response to their request for "evaluation and
trial use" in treating patients in the Co-Promotion Territory as
part of the marketing, advertising and promotion of the Initial
Licensed Product.
1.53 " Sunset Period " is defined in
Section 4.2.2 .
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1.54 " Target Audience "
means targets identified by the Coordination Committee as being
suitable targets for the promotion and Detail of Initial Licensed
Products in the Co-Promotion Territory, which targets may include
health care professionals with actual prescribing authority as well
as other individuals or entities that have a significant
impact/influence on prescribing decisions.
1.55 " Term " is defined in
Section 9.1 .
1.55 " Third Party " means any individual
or entity other than ZGEN or Bayer or an Affiliate of either of
them.
1.56 " Trademark " means any and all
service marks, logos or trademarks and trademark applications
(whether or not registered) together with all good will associated
therewith, and any renewals, extensions or modifications thereto
either filed or used.
1.57 " United States " means the United
States of America, together with its territories and
possessions.
1.58 " ZGEN Enabling Technology " has the
meaning defined in the LCA.
1.59 " ZGEN Indemnitees " is defined in
Section 8.2.1 .
1.60 " ZGEN MSLs " is defined in
Section 2.7.4 .
1.61 " ZGEN Sales Force " is defined in
Section 2.7.3 .
ARTICLE 2
Co-Promotion Rights and Obligations
2.1 Co-Promotion Right
Subject to the terms and conditions of this Agreement:
(a) ZGEN hereby grants Bayer during the Active Period the
co-exclusive right with ZGEN to promote and Detail the Initial
Licensed Products in the Co-Promotion Territory.
(b) ZGEN grants Bayer a fully paid license during the Active
Period under ZGEN’s entire right, title and interest in and
to the Product Trademarks Controlled by ZGEN, to use and display
such Product Trademarks solely in connection with the marketing and
promotion of the Initial Licensed Products in the Co-Promotion
Territory as contemplated in this Agreement. In order to maintain
the value of ZGEN’s Product Trademarks, corporate name and
logo, Bayer will maintain quality standards comparable to those it
maintains for its own product-related Trademarks, corporate name or
logo, which, in any event, shall not be less than reasonable, and
Bayer will use ZGEN’s Product Trademarks consistent with
Product Trademark usage guidelines developed by ZGEN.
(c) Bayer grants ZGEN a fully paid license during the Active
Period under Bayer’s entire right, title and interest in and
to the Product Trademarks Controlled by Bayer to
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use and display such Product Trademarks solely in
connection with the marketing and promotion of the Initial Licensed
Products in the Co-Promotion Territory as contemplated in this
Agreement. In order to maintain the value of Bayer’s Product
Trademarks, corporate name and logo, ZGEN will maintain quality
standards comparable to those it maintains for its own
product-related Trademarks, corporate name or logo, which, in any
event, shall not be less than reasonable, and ZGEN will use
Bayer’s Product Trademarks consistent with Product Trademark
usage guidelines developed by Bayer.
2.2 Responsibilities Reserved to ZGEN
(a) ZGEN shall have sole responsibility for:
(i) strategic decisions relating to marketing, advertising and
medical education programs in support of the Initial Licensed
Products in the Co-Promotion Territory;
(iii) pricing of the Initial Licensed Products in the
Co-Promotion Territory, including any discounts, rebates or other
deviations from the established pricing;
(iv) distribution and delivery of the Initial Licensed Products
to customers in the Co-Promotion Territory;
(v) regulatory matters relating to the Initial Licensed Products
in the Co-Promotion Territory; and
(vi) scientific publication strategies.
The Parties agree that ZGEN may make decisions regarding the
foregoing matters within its sole responsibility in its absolute
discretion.
(b) In addition, ZGEN shall have sole responsibility for the
matters listed in this Section 2.2(b) ; provided
that, ZGEN’s decisions relating to materials, activities,
campaigns and programs to be used or participated in by
Bayer’s Sales Force or Bayer’s MSLs shall be subject to
review by Bayer’s Review Board in accordance with
Section 2.6 . The matters include:
(i) all marketing, advertising and medical education programs in
support of the Initial Licensed Products in the Co-Promotion
Territory, including the content of Promotional Materials and
Medical Education Materials;
(ii) public relation activities and campaigns;
(iii) supplementary non-personal promotional programs (such as
compliance, telemarketing and Internet activities);
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(iv) professional/medical education programs
(including seminars, symposia, participation at professional and
medical conferences, and conventions, physician advocacy programs
and event marketing programs);
(v) ensuring that all materials, campaigns and programs comply
with Applicable Laws; and
(vi) product-related training.
(c) Any responsibilities delegated to the Coordination Committee
pursuant to Section 2.3.4 shall be subject to
the decision-making mechanism described in
Section 2.3.5 .
(d) Bayer shall have no authority independent of ZGEN to:
(i) conduct any form of direct-to-consumer promotion related to
Initial Licensed Products in the Co-Promotion Territory;
(ii) schedule or manage conference involvement pertaining to
Initial Licensed Products in the Co-Promotion Territory;
(iii) establish or manage advisory boards and opinion leaders
for Initial Licensed Products in the Co-Promotion Territory;
(iv) conduct or sponsor continuing medical education programs,
paid speaker programs, or symposia related to Initial Licensed
Products in the Co-Promotion Territory; or
(v) provide grants with respect to Initial Licensed Products in
the Co-Promotion Territory.
2.3 Coordination Committee
2.3.1 Formation of Coordination Committee . Within ten
(10) days following the Effective Date, the Parties will
establish a committee (the " Coordination Committee
") to coordinate the co-promotion and medical education activities
to be undertaken by the Parties in the Co-Promotion Territory
during the Active Period. The Coordination Committee may form such
subcommittees as it, from time to time, deems appropriate,
including the CPT and MET. The Coordination Committee and its
subcommittees shall be disbanded upon expiration or earlier
termination of the Active Period. The Coordination Committee will
be comprised of at least three (3) members representing each
Party, one of whom shall be such Party’s Alliance Manager,
and all of whom shall have appropriate expertise and seniority to
enable them to make decisions on behalf of the Parties with respect
to the issues falling within the jurisdiction of the Coordination
Committee. Either Party, in its sole discretion, may substitute
members of the Coordination Committee from time to time upon
written notice to the other Party; provided, however that, without
limiting the generality of the foregoing, a key objective with
respect to membership in the Coordination Committee shall be
preserving balance and continuity.
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2.3.2 Coordination Committee Meetings .
The Coordination Committee will establish its own procedural rules
for its operation, consistent with the terms of this
Section 2.3.2 . Regular meetings of the
Coordination Committee will be held either by phone,
videoconference or in person at least once per calendar quarter,
unless the Coordination Committee chooses to reduce the frequency
of such meetings. Unless otherwise agreed by the members of the
Coordination Committee, the location of Coordination Committee
meetings will alternate between ZGEN’s offices in Seattle,
Washington and, until December 31, 2007, Bayer’s offices
in West Haven, Connecticut and, on and after January 1, 2008,
Bayer’s offices in Wayne, New Jersey. The Coordination
Committee shall be chaired at each meeting by a representative of
ZGEN. The chairperson of the Coordination Committee will be
responsible for calling regular meetings of the Coordination
Committee and for leading the meetings. ZGEN’s Alliance
Manager will serve as secretary of that meeting. Promptly following
each meeting, the secretary of the meeting will prepare and
distribute to all members of the Coordination Committee the written
minutes of the meeting. The minutes will provide a reasonably
detailed description of the meeting discussions and a list of any
actions, decisions or determinations approved by the Coordination
Committee. The minutes of each Coordination Committee meeting will
be approved or disapproved by each Party (on behalf of such
Party’s Coordination Committee members) promptly following
receipt, and revised as necessary, for approval at the next
meeting. Final minutes of each meeting will be distributed to the
members of the Coordination Committee by the chairperson prior to
commencement of the next meeting. Each Party shall bear its own
costs associated with its participation on the Coordination
Committee, including all travel and living expenses.
2.3.3 Attendance at Meetings . If a Party’s
representative is unable to attend a meeting, that Party may
designate an alternate representative with decision-making
authority for that Party to attend the meeting. Any decision made
by that attendee will be considered to be a decision made by the
absent representative. In addition, each Party may, at its
discretion (and with the consent of the other Party), invite
additional employees, consultants or scientific advisors to attend
any Coordination Committee meeting, provided that any individual so
invited will not have any voting power at such Coordination
Committee meeting and is subject to obligations of confidentiality
comparable to Article 6 . A quorum for each
Coordination Committee meeting will consist of at least two
(2) members from each Party.
2.3.4 Responsibilities of Coordination Committee . The
Coordination Committee shall have responsibility for coordinating
the promotional and medical educational activities of the Parties
under this Agreement in the Co-Promotion Territory during the
Active Period, including:
(a) discussing strategies (i) for marketing the Initial
Licensed Products in the Co-Promotion Territory, including
allocation of the Parties’ responsibility for such marketing
activities; (ii) relating to Detailing activity, including the
Target Audience for such Details; and (iii) for scientific
interchange with physician thought leaders relating to the Initial
Licensed Products in the Co-Promotion Territory;
(b) approving (i) the Co-Promotion Plan and Medical
Education Plan; (ii) the proposed Individual Annual Revenue
Threshold for each Party; and (iii) adjustments under
Sections 2.7.3 and 2.7.5 ; and
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(c) such other matters as the Parties may
delegate.
2.3.5 Coordination Committee Decision-Making . The
Coordination Committee shall operate by consensus. The
representatives from each Party on the Coordination Committee shall
have collectively one (1) vote on behalf of that Party.
(a) If the Coordination Committee cannot reach consensus on any
matter within the area of responsibility of the Coordination
Committee as described in Section 2.3.4(b) or
(c) (a " Dispute "), the Dispute
shall be referred for resolution to the Chief Executive Officer of
ZGEN and the Head of the responsible Business Unit within the
Pharmaceutical Division of Bayer in accordance with
Section 10.2 . Until a Dispute is resolved in
accordance with Section 10.2 , the Parties shall
refrain from taking action on the matter; provided, however, that
if the matter in Dispute pertains to any activity that is required
by Applicable Law, the affected Party shall be entitled to conduct
such activity as so required.
(b) Any Dispute that cannot be resolved in accordance with
Section 10.2 shall be resolved by an Expert in
accordance with Section 10.3 .
2.4 Co-Promotion Team; Co-Promotion Plan
2.4.1 Formation of CPT . Within ten (10) days
following the Effective Date, the Parties will establish a
co-promotion team (the " CPT "), as the standing
sub-committee of the Coordination Committee for co-promotion
activities. Each Party may appoint as many members to the CPT it
feels is necessary or useful to perform the functions of the CPT.
Either Party, in its sole discretion, may substitute members of the
CPT from time to time upon written notice to the other Party. The
CPT will establish its own rules for operation, including rules
relating to procedure and attendance, consistent with those of the
Coordination Committee.
2.4.2 Responsibilities of CPT . The CPT shall have
responsibility for the day-to-day coordination of the co-promotion
activities of the Parties under this Agreement in the Co-Promotion
Territory during the Active Period, including:
(a) discussing strategies for marketing the Initial Licensed
Products in the Co-Promotion Territory;
(b) developing the Co-Promotion Plan and potential amendments
thereto, and submitting them to the Coordination Committee for
approval;
(c) reviewing progress against the current Co-Promotion
Plan;
(d) establishing individual and area performance measures for
the activities of the respective Sales Forces; and
(e) discussing Samples practices, if any.
2.4.3 Co-Promotion Plan . As provided in, and without
limiting the generality of, Section 2.4.2 , the
CPT shall develop the Co-Promotion Plan. The CPT shall develop the
initial Co-Promotion Plan prior to the Launch Date and amend and
update the Co-Promotion
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Plan annually during the Active Period, or more
frequently as determined by the Coordination Committee. The
Co-Promotion Plan for the year scheduled to be the final year of
the Active Period shall be submitted to the Coordination Committee
ninety (90) days in advance of the start of such year and
shall specifically address transitioning all promotional activities
to ZGEN, including phasing out the use of Bayer’s Product
Trademarks, in an orderly and efficient manner. The CPT may address
and include any of the activities or responsibilities set forth in
Section 2.4.2 in the Co-Promotion Plan and, to
the extent included therein, the Co-Promotion Plan will state the
responsibilities of each Party with respect to the same. Neither
Party shall make any material change in any Co-Promotion Plan
without the prior approval of the CPT.
2.4.4 CPT Decision-Making . The representatives from each
Party on the CPT shall have collectively one (1) vote on
behalf of that Party. Members of the CPT shall endeavor to reach
decisions via consensus; provided that if they are unable to do so
a member from either Party may refer the matter to the Coordination
Committee for resolution.
2.5 Medical Education Team; Medical Education Plan
2.5.1 Formation of MET . Within ten (10) days
following the Effective Date, the Parties will establish a medical
education team (the " MET "), as the standing
sub-committee of the Coordination Committee for medical education
activities. Each Party may appoint as many members to the MET it
feels is necessary or useful to perform the functions of the MET.
Either Party, in its sole discretion, may substitute members of the
MET from time to time upon written notice to the other Party. The
MET will establish its own rules for operation, including rules
relating to procedure and attendance, consistent with those of the
Coordination Committee.
2.5.2 Responsibilities of MET . The MET shall have
responsibility for the day-to-day coordination of the medical
education activities of the Parties under this Agreement in the
Co-Promotion Territory during the Active Period, including:
(a) discussing strategies for scientific interchange with
physician thought leaders relating to the Initial Licensed Products
in the Co-Promotion Territory;
(b) developing the Medical Education Plan and potential
amendments thereto, and submitting them to the Coordination
Committee for approval;
(c) reviewing progress against the current Medical Education
Plan; and
(d) establishing individual and area performance measures for
MSL activities.
2.5.3 Medical Education Plan . As provided in, and
without limiting the generality of,
Section 2.5.2 , the MET shall develop the
Medical Education Plan. The MET shall develop the initial Medical
Education Plan prior to the Launch Date and amend and update the
Medical Education Plan annually during the Active Period, or more
frequently as determined by the Coordination Committee. The Medical
Education Plan for the year scheduled to be the final year of the
Active Period shall be submitted to the Coordination Committee
ninety (90) days in advance of the start of such year and
shall specifically address transitioning all medical education
activities to ZGEN, including phasing out the use of Bayer’s
Product Trademarks, in an orderly and efficient manner. The MET may
address and include any of the activities or responsibilities
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set forth in Section 2.5.2 in
the Medical Education Plan and, to the extent included therein, the
Medical Education Plan will state the responsibilities of each
Party with respect to the same. Neither Party shall make any
material change in any Medical Education Plan without the prior
approval of the MET.
2.5.4 MET Decision-Making . The representatives from each
Party on the MET shall have collectively one (1) vote on
behalf of that Party. Members of the MET shall endeavor to reach
decisions via consensus; provided that if they are unable to do so
a member from either Party may refer the matter to the Coordination
Committee for resolution.
2.6 Review Board
2.6.1 Review . Any materials (including program manuals)
subject to the review by Bayer’s Review Board pursuant to
Section 2.2(b) shall be submitted to
Bayer’s Review Board in proof form at least
[ * ] days
prior to intended use. Bayer’s Review Board will review the
materials submitted and give its comments to ZGEN no later than
[ * ] days
after receipt. The Parties’ Content Compliance Contacts may
agree to alternative time periods, taking into consideration the
nature and use of the materials to be reviewed. ZGEN agrees to take
into consideration any comments received during the foregoing time
period. If ZGEN disagrees with any comments received by Bayer,
Section 2.7.2(d) may apply (i.e., Bayer’s
Sales Force and Bayer’s MSLs will have no obligation to use
the relevant materials or participate in the relevant
programs).
2.6.2 Content Compliance Contacts . The Parties’
Content Compliance Contacts may from time to time exchange or
discuss their respective internal guidelines and such other matters
as may facilitate the review of materials by Bayer’s Review
Board.
2.7 Co-Promotion Efforts and Medical Education
Efforts
2.7.1 Efforts . The principal objective of the Parties
under this Agreement is to maximize the Commercialization of the
Initial Licensed Products in the Co-Promotion Territory. Following
receipt of all Regulatory Approvals in the Co-Promotion Territory
with respect to each Initial Licensed Product, the Parties shall
use Commercially Reasonable Efforts to (a) promote such
Initial Licensed Product in the Co-Promotion Territory,
(b) engage in scientific interchange with physician thought
leaders relating to Initial Licensed Product in the Co-Promotion
Territory and (c) to otherwise fulfill their obligations under
this Agreement.
2.7.2 Compliance and Training .
(a) Each Party agrees that all activities under this Agreement
by it or on its behalf, including training, Detailing, Promotion
Related Activities, Medical Education Activities, record-keeping,
reporting, collection of consumer data (if any), sales activities
under Section 3.1.1 and provision of Samples,
will be conducted in compliance with the Product Labels, Regulatory
Approvals, Promotional Materials or Medical Education Materials (as
applicable), a Party’s promotional practice or medical
education guidelines, if any, and all Applicable Laws, including
applicable PhRMA marketing practices guidelines.
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(b) At all times during the Active Period after
the Launch Date, each Party shall maintain a corporate compliance
program consistent with 2003 Health and Human Services (HHS) Office
of Inspector General (OIG) Compliance Program Guidance for
Pharmaceutical Manufacturers, to the extent applicable to the
activities of such Party hereunder. Without prejudice to the
generality of the foregoing, each Party’s corporate
compliance program shall include written policies requiring
adherence to the 2002 PhRMA Code on Interactions with Healthcare
Professionals, and training for field representatives on such
policy.
(c) The Sales Forces and MSLs of each Party shall participate in
a product-related training to be developed by ZGEN, subject to
Section 2.2(b) and
Section 2.6 . In addition, each Party will
maintain a broad training program, including training on proper
promotion and marketing techniques, ethics, and compliance with
Applicable Laws in a manner consistent with all applicable
pharmaceutical industry standards. Within a reasonable time period
after the Effective Date, the Parties shall meet and confer to
review and discuss each Party’s ethics and compliance
training program.
(d) No Party shall be required to undertake any obligation, or
incur any cost or reimbursement obligation, in connection with any
activity under this Agreement that such Party believes, in good
faith, (i) may violate any Applicable Law or any Corporate
Integrity Agreement entered into by such Party with OIG, or
(ii) does not meet its internal pharmaceutical promotional
guidelines. The Parties will exchange their internal pharmaceutical
promotional guidelines, if any, within thirty (30) days after
the Effective Date and thereafter within thirty (30) days
after such pharmaceutical promotional guidelines are approved or
modified.
2.7.3 ZGEN Sales Force . ZGEN will establish a sales
force of Sales Representatives responsible for promoting and
Detailing Initial Licensed Products in the Co-Promotion Territory
in accordance with this Agreement (the " ZGEN Sales
Force "). The ZGEN Sales Force shall consist of
[ * ] Sales
Representatives employed by ZGEN, with final allocation of effort
being at least sufficient to cover the market potential for the
Initial Licensed Product allocated to the ZGEN Sales Force. Market
potential shall be allocated to ZGEN based on a percentage obtained
by dividing ZGEN’s Individual Annual Revenue Threshold (as
determined in accordance with Section 3.2.2 ) by
the Annual Revenue Threshold. Following the Launch Date, ZGEN
will, subject to review and adjustment, if any, under this
Section 2.7.3 , devote
[ * ] percent
( [ * ] %) of
the aggregate effort of ZGEN’s Sales Force to fulfill the
foregoing obligation. On a regular basis, ZGEN will perform a
review and determine whether the effort put forth by ZGEN’s
Sales Force is sufficient to cover the market potential for the
Initial Licensed Product allocated to the ZGEN Sales Force, based
on then current business and market conditions, and will determine
what adjustments, if any, are required to meet the foregoing
obligation. ZGEN will report any adjustments that ZGEN proposes to
make, together with a justification for such adjustments, to the
Coordination Committee. If the Coordination Committee does not
agree that such adjustments are appropriate, then such matter shall
be considered a Dispute and shall be resolved as set forth in
Section 2.3.5 .
2.7.4 ZGEN MSLs . ZGEN has a group of
[ * ] MSLs,
subject to normal operating fluctuations in staffing due to
vacancies or otherwise, who will be responsible for scientific
interchange (as opposed to product promotion) with physician
thought leaders relating to the Initial Licensed Products in the
Co-Promotion Territory in accordance with this Agreement (the "
ZGEN MSLs ").
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2.7.5 Bayer Sales Force . Bayer will
establish or designate a sales force of Sales Representatives
responsible for promoting and Detailing Initial Licensed Products
in the Co-Promotion Territory in accordance with this Agreement
(the " Bayer Sales Force "). The Bayer Sales Force
shall consist of all the sales representatives in Bayer’s
Hospital/Surgical sales force group (as of the Effective Date,
[ * ] ), with
final allocation of effort being at least sufficient to cover the
market potential for the Initial Licensed Product allocated to the
Bayer Sales Force. Market potential shall be allocated to Bayer
based on a percentage obtained by dividing Bayer’s Individual
Annual Revenue Threshold (as determined in accordance with
Section 3.2.2 ) by the Annual Revenue
Threshold. Following the Launch Date, Bayer will, subject to
review and adjustment, if any, under this
Section 2.7.5 , devote
[ * ] percent
( [ * ] %) of
the aggregate effort of Bayer’s Sales Force to fulfill the
foregoing obligation. On a regular basis, Bayer will perform a
review and determine whether the effort put forth by Bayer’s
Sales Force is sufficient to cover the market potential for the
Initial Licensed Product allocated to the Bayer Sales Force, based
on then current business and market conditions, and will determine
what adjustments, if any, are required to meet the foregoing
obligation. Bayer will report any adjustments that Bayer proposes
to make, together with a justification for such adjustments, to the
Coordination Committee. If the Coordination Committee does not
agree that such adjustments are appropriate, then such matter shall
be considered a Dispute and shall be resolved as set forth in
Section 2.3.5 .
2.7.6 Bayer MSLs . Bayer has a group of MSLs who will be
responsible for scientific interchange (as opposed to product
promotion) with physician thought leaders relating to the Initial
Licensed Products in the Co-Promotion Territory in accordance with
this Agreement (the " Bayer MSLs "). As of the
Effective Date, Bayer has a group of
[ * ] MSLs who
will support the Initial Licensed Products, among other
products.
2.7.7 CSOs . Bayer may not employ a CSO to fulfill any of
its Detail or other obligations under this Agreement in the
Co-Promotion Territory without the prior written consent of ZGEN.
ZGEN may employ a CSO to fulfill any of its Detail or other
obligations under this Agreement in the Co-Promotion Territory. In
any event, each Party may only use a CSO to fulfill some of its
Detail or other obligations under this Agreement in the
Co-Promotion Territory if such CSO is reputable and experienced. If
a Party engages a CSO, such Party will require the CSO to comply in
all material respects with the obligations of such Party as
contained herein and such Party will remain responsible for the
full and complete performance of all of its obligations and duties
under this Agreement, whether the obligations and duties are
performed by such Party or by its CSO.
2.7.8 Responsibility for Sales Forces and MSLs . In
implementing its obligations under this Agreement and subject to
compliance with the other provisions of this Agreement (including
Section 2.7.2 ), each Party shall have sole
discretion as to the manner (which shall not be inconsistent with
the Co-Promotion Plan, Medical Education Plan or directions of the
Coordination Committee) in which it promotes and Details, or
engages in scientific interchange relating to, the Initial Licensed
Products in the Co-Promotion Territory. Each Party shall have sole
authority and responsibility for recruiting, hiring, training
(provided that all Bayer’s Sales Representatives shall
participate in the product-related training developed
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by ZGEN, subject to
Section 2.2(b) and
Section 2.6 ), managing, compensating
(including, subject to Section 2.7.9 , designing
and paying for all benefits, wages and incentives programs and
paying for all workers’ compensation and employment taxes),
disciplining and firing (notwithstanding
Section 2.7.12 ) and otherwise controlling the
persons comprising its Sales Force and MSLs in accordance with such
Party’s standard procedures. Subject to the terms and
conditions of this Agreement, each Party will provide the
day-to-day management of its Sales Force and MSLs, including
furnishing administrative support, transport, lodging, establishing
monitoring and recordkeeping practices, and assuring its Sales
Force and MSLs understand and comply with this Agreement and
Applicable Laws.
2.7.9 Sales Force Incentives . The aggregate incentive
compensation for the Bayer Sales Force shall be structured to
provide that the Initial Licensed Product’s weighting shall
be at least
[ * ] percent
( [ * ] %) of
the aggregate target incentive compensation available during each
calendar year during the Active Period assuming all incentive goals
are fully accomplished. The aggregate incentive compensation for
the ZGEN Sales Force shall be structured to provide that the
Initial Licensed Product’s weighting shall be at least
[ * ] percent
( [ * ] %) of
the aggregate target incentive compensation available during each
calendar year during the Active Period assuming all incentive goals
are fully accomplished. Each Party shall provide the other Party
with a written report on its incentive compensation program in June
and December of each year of the Active Period, and such reports
shall be discussed by the Coordination Committee at the meeting
immediately following distribution of the report.
2.7.10
[ * ]
Products . During the Active Period, Bayer’s Sales
Force shall not promote, market or sell any
[ * ] product
in the Co-Promotion Territory without the consent of ZGEN, such
consent not to be unreasonably withheld. For the avoidance of
doubt, Trasylol is not a
[ * ] product
for purposes of this provision.
2.7.11 Coordinating, Monitoring Sales Force Activities and
MSL Activities .
(a) The CPT or MEC, as the case may be, shall establish
reasonable procedures for monitoring Sales Force activities and MSL
activities to ensure that each Party is complying
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