|
Exhibit
10.1
U.S. C O -P
ROMOTION A GREEMENT
BY
AND BETWEEN
Z YMO G
ENETICS , I NC .
AND
B AYER H
EALTH C ARE LLC
E FFECTIVE
AS OF J UNE 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. C O -P
ROMOTION A GREEMENT
T HIS U.S. C
O -P ROMOTION A
GREEMENT 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
.”
R
ECITALS
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.
A
GREEMENT
NOW, THEREFORE, the Parties,
intending to be legally bound, agree as follows:
A RTICLE
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.
|
|
|
|
|
| [ * ]
Confidential Treatment Requested |
|
|
Page 2 |
|
|
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.
|
|
|
|
|
| [ * ]
Confidential Treatment Requested |
|
|
Page 3 |
|
|
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 .
|
|
|
|
|
| [ * ]
Confidential Treatment Requested |
|
|
Page 4 |
|
|
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.
|
|
|
|
|
| [ * ]
Confidential Treatment Requested |
|
|
Page 5 |
|
|
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
|
|
|
|
|
| [ * ]
Confidential Treatment Requested |
|
|
Page 6 |
|
|
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
|
|
|
|
|
| [ * ]
Confidential Treatment Requested |
|
|
Page 7 |
|
|
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 .
|
|
|
|
|
| [ * ]
Confidential Treatment Requested |
|
|
Page 8 |
|
|
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 .
A RTICLE
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
|
|
|
|
|
| [ * ]
Confidential Treatment Requested |
|
|
Page 9 |
|
|
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);
|
|
|
|
|
| [ * ]
Confidential Treatment Requested |
|
|
Page 10 |
|
|
(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.
|
|
|
|
|
| [ * ]
Confidential Treatment Requested |
|
|
Page 11 |
|
|
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
|
|
|
|
|
| [ * ]
Confidential Treatment Requested |
|
|
Page 12 |
|
|
(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
|
|
|
|
|
| [ * ]
Confidential Treatment Requested |
|
|
Page 13 |
|
|
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
|
|
|
|
|
| [ * ]
Confidential Treatment Requested |
|
|
Page 14 |
|
|
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.
|
|
|
|
|
| [ * ]
Confidential Treatment Requested |
|
|
Page 15 |
|
|
(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 ”).
|
|
|
|
|
| [ * ]
Confidential Treatment Requested |
|
|
Page 16 |
|
|
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
|
|
|
|
|
| [ * ]
Confidential Treatment Requested |
|
|
Page 17 |
|
|
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 pro
|