Exhibit 10.53
CO-PROMOTION AGREEMENT
BY AND BETWEEN
SMITHKLINE XXXXXXX CORPORATION D/B/A GLAXOSMITHKLINE
AND
ALLERGAN, INC.
AND
ALLERGAN SALES LLC
SEPTEMBER 30, 2005
CO-PROMOTION AGREEMENT
This Co-Promotion Agreement (the "Co-Promotion Agreement" or this
"Agreement"), dated September 30, 2005 (the "Effective Date"), is made by and
between SmithKline Xxxxxxx Corporation d/b/a GlaxoSmithKline, a corporation
organized and existing under the laws of the Commonwealth of Pennsylvania and
having a place of business at Xxx Xxxxxxxx Xxxxx, Xxxxxxxxxxxx, XX 00000
("GSK"), Allergan, Inc., a corporation organized and existing under the laws of
the State of Delaware and having a principal place of business at 0000 Xxxxxx
Xxxxx, Xxxxxx, Xx 00000-0000 ("Allergan, Inc.") and Allergan Sales LLC, a
limited liability company organized and existing under the laws of the state of
Delaware and having a principal place of business at 0000 Xxxxxx Xxxxx, Xxxxxx,
Xx 00000-0000 ("Allergan LLC"), ("Allergan LLC" and, together with Allergan,
Inc., "Allergan").
RECITALS
WHEREAS, GSK owns or controls all rights to the Product (as defined below)
in the Territory (as defined below);
WHEREAS, GSK and Allergan each have an internal sales and marketing
organization to promote certain products to physicians and other health care
professionals; and
WHEREAS, GSK desires to engage Allergan to co-promote and detail the
Product to selected physicians and other health care professionals within the
Territory upon the terms and conditions contained herein.
NOW, THEREFORE, in consideration of the mutual covenants contained herein
and other good and valuable consideration, the receipt and sufficiency of which
is hereby acknowledged, the Parties hereto agree as follows:
ARTICLE 1
DEFINITIONS
As used in this Agreement, the following capitalized terms have the
following meanings:
1.1 "ADDITIONAL NEURO PRODUCT" means the Imitrex(R) (sumatriptan succinate)
STATdose System(R), which has been approved by the FDA for the treatment of
migraine and cluster headaches, and which is sold by GSK or its Affiliates in
the Territory, or such other branded, non-generic prescription pharmaceutical
products as determined by GSK in its sole discretion which are sold by GSK or
its Affiliates under the Imitrex(R) trademark in the Territory.
*** Certain confidential information contained in this document, marked with 3
asterisks, has been omitted and filed separately with the Securities and
Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act
of 1934, as amended.
1
1.2 "ADDITIONAL NEURO PRODUCT BASELINE" means the ***, which is calculated
using the methodology set forth in EXHIBIT A of this Agreement ***.
1.3 "ADDITIONAL NEURO PRODUCT FAILURE" will have the meaning set forth in
SECTION 7.1.3(B) (ADDITIONAL NEURO PRODUCT FAILURE).
1.4 "ADDITIONAL NEURO PRODUCT NET SALES" means Net Sales of Additional
Neuro Product achieved from prescriptions from the Neurologist Segment and those
primary care physicians who comprise the Additional Neuro Product Target
Audience and calculated using the Allocation Factors listed in EXHIBIT A to this
Agreement.
1.5 "ADDITIONAL NEURO PRODUCT TARGET AUDIENCE" means as to the Additional
Neuro Product (i) certain of those physicians in the Neurologist Segment and
(ii) primary care physicians, both of whom meet the profile of target physicians
established by the JCC and set forth in the Marketing Plan, which Target
Audience may be modified *** by the JCC. As of sixty (60) days after the
Effective Date, the Parties will agree on fewer than *** primary care physicians
to comprise the Target Audience, in addition to certain of those physicians in
the Neurologist Segment.
1.6 "AFFILIATE" of a Person means any individual, sole proprietorship,
firm, partnership, corporation, trust, joint venture or other entity, whether de
jure or de facto, which, directly or indirectly, controls, is controlled by or
is under common control with such Person. As used in this definition, "control"
means the possession, directly or indirectly, of the power to direct or cause
the direction of the policies and management of a person or entity, whether by
the ownership of stock, by contract or otherwise.
1.7 "AGREEMENT" will have the meaning set forth in the Preamble.
1.8 "ALLERGAN" will have the meaning set forth in the Preamble.
1.9 "ALLERGAN MINIMUM DETAILS COMMITMENT" has the meaning set forth in
SECTION 3.2.5(A) (ALLERGAN PRODUCT MINIMUM DETAIL COMMITMENTS).
1.10 "ALLERGAN PSR" means a member of Allergan's sales force.
1.11 "ALLIANCE MANAGER" as to either of GSK or Allergan, as the case may
be, means a full time employee of either GSK or Allergan, as the case may be,
having primary oversight responsibility for the implementation of that Party's
obligations under this Agreement.
1.12 "ANTI-KICKBACK STATUTE" means the Medicare and Medicaid Anti-Kickback
Statute set forth at 42 U.S.C. Section 1320a-7b(b).
1.13 "APPLICABLE COMMERCIAL PRACTICES POLICIES" means the portions as
identified by GSK of the Commercial Practices Policies of GSK applicable to the
marketing, sale, promotion and detailing of pharmaceutical products, as amended
or supplemented from time to time, a copy
*** Certain confidential information contained in this document, marked with 3
asterisks, has been omitted and filed separately with the Securities and
Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act
of 1934, as amended.
2
of which will be delivered to Allergan by GSK prior to or simultaneously with
the execution of this Agreement.
1.14 "APPLICABLE LAW" means all applicable provisions of any and all
federal, national, state, provincial, and local statutes, laws, rules,
regulations, administrative codes, ordinances, decrees, orders, decisions,
injunctions, awards, judgments, permits and licenses of or from any governmental
authorities relating to or governing the use or regulation of the subject item
or action, including, without limitation, the Anti-Kickback Statute, the FD&C
Act, and HIPAA.
1.15 "CALENDAR QUARTER" means each of the three (3) month periods ending
March 31, June 30, September 30 and December 31; provided, however, that the
first Calendar Quarter of the Term will extend from the Effective Date to the
end of the first complete Calendar Quarter thereafter.
1.16 "COMMERCIALLY REASONABLE EFFORTS" means efforts and resources normally
used by a Party in the Territory relating to a prescription pharmaceutical
product owned by it or to which it has rights, which is of similar market
potential and at a similar stage in its development or product life, taking into
account issues of safety and efficacy, product profile, the competitiveness of
the marketplace, the proprietary position of the compound or product, the
regulatory structure involved, the profitability of the applicable products and
other relevant factors including, without limitation, technical, legal,
scientific and/or medical factors.
1.17 "COMMITMENT YEAR" means, for the first Commitment Year, the period
beginning on the Effective Date and ending on December 31, 2006, and for each
Commitment Year thereafter, each successive period beginning on January 1 and
ending twelve (12) consecutive calendar months later on December 31; provided,
however, that the last Commitment Year may be for a term of less than twelve
(12) months until the end of the Commitment Term.
1.18 "COMMITMENT TERM" will have the meaning set forth in SECTION 3.2.5(C)
(COMMITMENT TERM).
1.19 "CONFIDENTIAL INFORMATION" will have the meaning set forth in SECTION
9.2 ("CONFIDENTIAL INFORMATION").
1.20 "CO-PROMOTION AGREEMENT" will have the meaning set forth in the
Preamble.
1.21 "CO-PROMOTION COMMENCEMENT DATE" means the date on which Allergan
commences the Promotion and Detailing of Product in the Territory in accordance
with the Marketing Plan and the terms and conditions of this Agreement, which
Co-Promotion Commencement Date will not be more than *** after the Effective
Date.
1.22 "DETAIL" means a face-to-face meeting, in an individual or group
practice setting, between one (1) or more physicians in the Primary Product
Target Audience or Additional Neuro Product Target Audience, as the case may be,
and one GSK PSR or Allergan PSR, as the case
*** Certain confidential information contained in this document, marked with 3
asterisks, has been omitted and filed separately with the Securities and
Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act
of 1934, as amended.
3
may be, during which a complete Product presentation is communicated (a)
describing in a fair and balanced manner, the FDA-approved indicated uses, and
other relevant characteristics, of the Product, and (b) using the Product
Promotional Materials in an effort to increase the prescribing preferences of
the Product for its FDA-approved indicated uses. When used as a verb, "Detail"
means to engage in a Detail.
1.23 "DIRECT DETAILING EXPENSES" means the following costs and expenses
associated with a Party's PSRs, District Managers and Sales Management Team: all
costs and expenses of salary, benefits and employment taxes (including but not
limited to base salary and incentive compensation); all costs and expenses of
recruiting and hiring; all costs and expenses of automobiles, equipment and
supplies; and all travel costs and expenses. Direct Detailing Expenses do not
include the costs and expenses associated with marketing, Promotion, sales and
Product Promotional Materials, and Samples.
1.24 "DISTRICT MANAGER" means a full time employee of either GSK or
Allergan, as the case may be, who is responsible for supervising the respective
Party's PSRs.
1.25 "EFFECTIVE DATE" will have the meaning set forth in the Preamble.
1.26 "FDA" means the United States Food and Drug Administration and any
successor agency thereto.
1.27 "FD&C ACT" means the Food, Drug, and Cosmetic Act as amended, and the
regulations promulgated thereunder from time to time.
1.28 "GSK" will have the meaning set forth in the Preamble.
1.29 "HIPAA" means the Healthcare Insurance Portability & Accountability
Act of 1996 as amended, and the regulations promulgated thereunder from time to
time.
1.30 "JCC" has the meaning set forth in SECTION 2.1 (JOINT
COMMERCIALIZATION COMMITTEE).
1.31 "GSK PROMOTIONAL REVIEW COMMITTEE" has the meaning set forth in
SECTION 3.3.1 (PRODUCT PROMOTIONAL MATERIALS).
1.32 "GSK PSR" means a member of GSK's sales force.
1.33 "MARKET" means, when used as a verb, to market, sell, distribute,
Promote or advertise a product.
1.34 "MARKETING PLAN(S)" means one (1) or more plans detailing the
activities to be performed by each Party in the Territory during the Commitment
Term, as more fully detailed in ARTICLE 2 (GOVERNANCE AND MARKETING PLAN) of
this Agreement.
*** Certain confidential information contained in this document, marked with 3
asterisks, has been omitted and filed separately with the Securities and
Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act
of 1934, as amended.
4
1.35 "NET SALES" means, with respect to a given period of time, gross sales
of Primary Product and/or Additional Neuro Product by GSK, its Affiliates, and
sublicensees in the Territory in such period, as the case may be, less the
following deductions from such gross amounts which are actually incurred,
allowed, paid, accrued or specifically allocated:
(A) credits or allowances actually granted for damaged Product,
returns or rejections of Product, price adjustments and billing errors;
(B) governmental and other rebates (or equivalents thereof) granted to
managed health care organizations, health management organizations, pharmacy
benefit managers (or equivalents thereof), federal, state/provincial, local and
other governments, their agencies and purchasers and reimbursers or to trade
customers;
(C) normal and customary trade, cash and quantity discounts,
allowances and credits actually allowed or paid;
(D) commissions allowed or paid to Third Party distributors, brokers
or agents other than sales personnel, sales representatives and sales agents
employed by GSK;
(E) transportation costs, including insurance, for outbound freight
related to delivery of the Product to the extent included in the gross amount
invoiced;
(F) sales taxes, value added taxes (VAT), and other taxes directly
linked to the sales of Product to the extent included in the gross amount
invoiced;
(G) the actual amount of any write offs for bad debt directly relating
to sales of Product in such period; and
(H) any other items actually deducted from gross sales amounts as
reported by GSK in its financial statements in accordance with the International
Financial Reporting Standards ("IFRS"), applied on a consistent basis.
Sales between or among GSK and its Affiliates or sublicensees will be excluded
from the computation of Net Sales, but the subsequent final sales to Third
Parties by such Affiliates or sublicensees will be included in the computation
of Net Sales.
GSK shall apply the Allocation Factors listed in EXHIBIT A to this Agreement to
arrive at Net Sales to the Neurologist Segment and to identified Primary Care
Physicians.
1.36 "NEUROLOGIST SEGMENT" means physicians who are neurologists or have
specialty training in neurology in the Territory.
1.37 "PARTY" means either of GSK or Allergan and "Parties" means both of
them.
1.38 "PDMA" means the Prescription Drug Marketing Act of 1987 as amended,
and the regulations promulgated thereunder from time to time.
*** Certain confidential information contained in this document, marked with 3
asterisks, has been omitted and filed separately with the Securities and
Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act
of 1934, as amended.
5
1.39 "PRIMARY PRODUCT PERFORMANCE PAYMENT" has the meaning set forth in
SECTION 7.1.1(B) (PRIMARY PRODUCT PERFORMANCE PAYMENT).
1.40 "PERSON" means an individual, a corporation, a partnership, an
association, a trust or other entity or organization, including a government or
political subdivision or an agency or instrumentality thereof.
1.41 "PERSONNEL" has the meaning set forth in SECTION 3.2.12(A) (STATUS OF
ALLERGAN AND ITS PERSONNEL).
1.42 "PHRMA CODE" means the PhRMA Code on Interactions with Health Care
Professionals, as amended from time to time.
1.43 "PRIMARY DETAIL" means a Detail in which the Product information that
is communicated by a GSK PSR or Allergan PSR, as the case may be, to a
physician(s) in the Primary Product Target Audience or Additional Neuro Product
Target Audience, as the case may be, is the first product information
communicated by such GSK PSR or Allergan PSR.
1.44 "PRIMARY PRODUCT" means Amerge(R) or any prescription branded
non-generic prescription pharmaceutical product containing naratriptan
hydrochloride as the sole therapeutically active ingredient, in any dosage form
for human prescription use and for all indications, which is sold by GSK or its
Affiliates in the Territory.
1.45 "PRIMARY PRODUCT BASELINE" means the ***, which is calculated using
the methodology set forth in EXHIBIT A of this Agreement ***.
1.46 "PRIMARY PRODUCT FAILURE" will have the meaning set forth in SECTION
7.1.3(A)(I).
1.47 "PRIMARY PRODUCT NET SALES" means Net Sales of Primary Product
achieved from prescriptions from the Neurologist Segment and those primary care
physicians who comprise the Primary Product Target Audience and calculated using
the Allocation Factors listed in EXHIBIT A to this Agreement.
1.48 "PRIMARY PRODUCT TARGET AUDIENCE" means as to the Primary Product (i)
certain of those physicians in the Neurologist Segment and (ii) primary care
physicians, both of whom meet the profile of target physicians established by
the JCC and set forth in the Marketing Plan, which Primary Product Target
Audience may be modified *** by the JCC. As of sixty (60) days after the
Effective Date, the Parties will agree on fewer than *** primary care physicians
to comprise the Primary Product Target Audience, in addition to certain of those
physicians in the Neurologist Segment.
1.49 "PRODUCT" when used alone means either or both the Primary Product and
the Additional Neuro Product.
*** Certain confidential information contained in this document, marked with 3
asterisks, has been omitted and filed separately with the Securities and
Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act
of 1934, as amended.
6
1.50 "PRODUCT PROMOTIONAL GUIDELINES" has the meaning set forth in SECTION
2.5.2 (PLAN CONTENTS AS TO THE PRIMARY PRODUCT).
1.51 "PRODUCT PROMOTIONAL MATERIALS" has the meaning set forth in SECTION
3.3.1 (PRODUCT PROMOTIONAL MATERIALS).
1.52 "PROMOTION" means those activities, including, without limitation,
detailing and distributing samples of a product, normally undertaken by a
pharmaceutical company's sales force to implement marketing plans and strategies
aimed at encouraging the purchase and appropriate use of a particular
prescription pharmaceutical product. When used as a verb, "Promote" means to
engage in such activities.
1.53 "PROMOTIONAL EXPENSES" means all costs and expenses of Allergan
allocated to the Primary Product, less all of Allergan Direct Detailing
Expenses.
1.54 "PSR" means Professional Sales Representative, either a Allergan PSR
or a GSK PSR, and "PSRs" means both Allergan PSRs and GSK PSRs.
1.55 "RESIDUAL TERM" has the meaning set forth in SECTION 12.1.3 (RESIDUAL
TERM).
1.56 "RESIDUAL TERM ROYALTY" has the meaning set forth in SECTION 7.1.2
(RESIDUAL TERM PAYMENTS).
1.57 "SALES CALL" means an interaction between a PSR and a physician or
other health care provider in which the Product is the subject of a Detail.
1.58 "SALES CALL PLAN" means a plan established from time to time by the
JCC and set forth in the Marketing Plan that sets forth, at a minimum, the
profile of Primary Product Target Audience and Additional Neuro Product Target
Audience, and the Detailing reach (i.e., number of physicians) and frequency
(i.e., number of Details per physician and the relevant timing of such Details)
objectives for the PSRs in a manner that reflects the promotional effort for the
Primary Product or Additional Neuro Product, as the case may be, as outlined in
the Marketing Plan and this Agreement. The Sales Call Plan may be modified from
time to time by the JCC.
1.59 "SALES MANAGEMENT TEAM" means one (1) or more regional directors or
Vice Presidents of GSK or Allergan, as the case may be, each of whom will be (a)
full time employees of GSK or Allergan, as the case may be, and (b) primarily
responsible for supervising a group of the District Managers within a geographic
region of the Territory.
1.60 "SALES TERRITORY" means one of the geographic regions within the
Territory, as established from time to time by the JCC and set forth in the
Marketing Plan, in which one or more PSRs will be assigned by GSK and/or
Allergan, as the case may be, to Promote the Primary Product. The Sales
Territories may be modified from time to time by the JCC.
1.61 "SAMPLES" means individual physician sample units of the Product, the
amounts of which are for the Primary Product and Additional Neuro Product.
*** Certain confidential information contained in this document, marked with 3
asterisks, has been omitted and filed separately with the Securities and
Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act
of 1934, as amended.
7
1.62 "SAMPLE RECEIPT FORMS" means those multi-part paper or electronic
forms used for the purpose of recording Detail and Sample request and receipt
activity performed by PSRs during Sales Calls. These forms are also used as
Sample receipts on which to obtain a physician's signature in acknowledgment of
the physician's receipt of a Sample. The Sample Receipt Forms will be in a form
agreed to by the JCC.
1.63 "SECONDARY DETAIL" means a Detail in which Product information is
communicated by a GSK PSR or Allergan PSR, as the case may be, to a physician(s)
in the Primary Product Target Audience or the Additional Neuro Product Target
Audience, as the case may be, and is the second product information communicated
by such GSK PSR or Allergan PSR.
1.64 "TECHNICAL AGREEMENT" has the meaning set forth in SECTION 5.4
(GENERAL; ADVERSE DRUG EXPERIENCES AND PRODUCT COMPLAINTS; PRODUCT AUDITS).
1.65 "TERM" has the meaning set forth in SECTION 12.1 (TERM).
1.66 "TERRITORY" means the fifty (50) states of the United States of
America and the District of Columbia.
1.67 "THIRD PARTY" means any Person other than a Party or any Party's
respective Affiliates.
1.68 "TRADEMARK" has the meaning set forth in SECTION 3.4.2 (TRADEMARKS).
1.69 "TRAINING PROGRAM" has the meaning set forth in SECTION 3.3.3(A)
(SALES TRAINING).
1.70 "WORKING GROUP" has the meaning set forth in SECTION 2.2 (WORKING
GROUPS).
ARTICLE 2
GOVERNANCE AND MARKETING PLANS
2.1 JOINT COMMERCIALIZATION COMMITTEE (JCC).
2.1.1 STRUCTURE. The Parties will establish a Joint Commercialization
Committee (the "JCC") during the Commitment Term, which will be comprised of at
least three (3) members from each Party, each with appropriate decision-making
authority. In addition, the JCC may from time to time include additional
non-voting, ad-hoc representatives from either Party on specific issues as the
need arises. The chairperson of the JCC will be one of the members of the JCC
and chairmanship of the JCC will rotate every six (6) months between a GSK JCC
member and an Allergan JCC member, commencing with a GSK JCC member. The
chairperson of the JCC will distribute a draft agenda prior to, and meeting
minutes reasonably promptly following, each meeting of the JCC. The JCC will
meet periodically as agreed by the Parties, but in no event less than once
during each Calendar Quarter during the Commitment
*** Certain confidential information contained in this document, marked with 3
asterisks, has been omitted and filed separately with the Securities and
Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act
of 1934, as amended.
8
Term, in person not more than twice per year (with locations to alternate
between the Parties), or by video teleconference or teleconference as mutually
agreed, to discuss matters within its purview. Each Party will bear all expenses
it incurs in regard to participating in any JCC meetings, including all travel
and living expenses as provided in SECTION 6.2.2 (ALLERGAN DETAIL RELATED COSTS
AND EXPENSES) and SECTION 6.3.2 (GSK DETAIL RELATED COSTS AND EXPENSES). At
least one (1) representative from each Party must be present at any meeting of
the JCC to represent a quorum for voting purposes. The members of the JCC will
seek to make all determinations to be made by them unanimously following full
discussion thereof (with each Party having one (1) vote). If the JCC is unable
to reach a unanimous decision on any matter for which it has responsibility as
set forth in this Agreement within ten (10) days after such matter is first
presented to the JCC, then GSK will make the final decision on any such matters
or disputes relating to the content of the Marketing Plans, Product strategy,
marketing, distribution and trade channels for Product, and all other Promotion
and marketing related topics relating to Product, which decision of GSK will be
binding upon both Parties; provided, however, that Allergan will have final say
on any disputes relating to Allergan PSRs Promotion strategy, deployment,
incentive compensation, tactics, or other Promotion execution or sales execution
related topics that are specifically related to Allergan's PSRs, provided that
Allergan will use good faith efforts to resolve any such disputes in a manner
consistent with the Marketing Plan and Applicable Law.
2.1.2 DUTIES. The JCC will have the overall responsibility to manage
and coordinate all Promotion activities relating to the Product in the Territory
during the Commitment Term, to approve the Marketing Plans submitted by the
Parties for each Commitment Year as provided in SECTION 2.5 (MARKETING PLAN)
below, and to settle any disputes between the Parties relating to the
preparation of any such Marketing Plans prior to their submission to the JCC for
review and approval. In addition, the JCC will coordinate the activities of the
Parties to implement and execute each such Marketing Plan, which activities will
include, without limitation with respect to the Primary Product, developing
advertising, marketing and promotional strategies for the Primary Product in the
Territory, developing and establishing all Product Promotional Guidelines, Sales
Call Plans, Sales Territories and Target Physician lists. The JCC will also be
responsible for overseeing all Working Groups (if any) of the JCC. For the
avoidance of doubt, unless provided otherwise by this Agreement, the JCC has no
authority to (i) modify any material term or condition of this Agreement or (ii)
create or provide for any financial obligation of either Party.
2.2 WORKING GROUPS. From time to time during the Commitment Term, the JCC
may establish and delegate duties to other committees, sub-committees, or
directed teams (each, a "WORKING GROUP") on an "as needed" basis to oversee
particular projects or activities. Each such Working Group will be constituted
and will operate as the JCC determines; provided that each Working Group will
have equal representation from each Party except as otherwise mutually agreed by
the Parties. Working Groups may be established on an ad hoc basis as the JCC
will determine. Each Working Group and its activities will be subject to the
oversight, review and approval of, and will report to the JCC. In no event will
the authority of the Working Group exceed that specified for the JCC under this
ARTICLE 2 (GOVERNANCE AND MARKETING PLANS).
*** Certain confidential information contained in this document, marked with 3
asterisks, has been omitted and filed separately with the Securities and
Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act
of 1934, as amended.
9
2.3 MANAGED CARE. Subject to SECTION 3.2.6 (MANAGED CARE AND
REIMBURSEMENT), the Parties agree, that periodically with respect to managed
care formularies for the Primary Product, they will discuss in good faith
potential establishment and active initiation of a managed care penetration
strategy for the Primary Product.
2.4 ALLIANCE MANAGERS. Each Party will appoint and notify the other Party
of its respective Alliance Manager, including any changes in such designation
from time to time during the Commitment Term. Further, the Parties acknowledge
and agree that each Party may designate their respective Alliance Manager to be
a member of the JCC.
2.5 MARKETING PLAN.
2.5.1 MARKETING PLAN. The principal mechanism by which the Parties
will coordinate their respective Promotion activities for Product under this
Agreement will be through the Marketing Plans, each (with the exception of the
initial Marketing Plan as described below) to be prepared jointly by GSK and
Allergan, and each (including the initial Marketing Plan as described below) to
be reviewed and approved by the JCC and periodically updated as set forth
herein. No later than thirty (30) days after the Effective Date, GSK will submit
the initial Marketing Plan, which was prepared by GSK prior to the Effective
Date, to the JCC for review and approval. The initial Marketing Plan will cover
the first (1st) Commitment Year. GSK and Allergan will be jointly responsible
for preparing drafts of all Marketing Plans subsequent to the initial Marketing
Plan, which will be presented to the JCC for review and approval on an annual
basis, and each such Marketing Plan will cover a full Commitment Year,
commencing with the second Commitment Year which will commence January 2007.
Each draft annual Marketing Plan will be ready for presentation to the JCC not
later than sixty (60) days prior to the end of each Commitment Year, and will be
approved by the JCC not later than the end of each Commitment Year. If the
Parties can not agree on the content of any such Marketing Plan, then such
matter will be resolved by the JCC as provided in SECTION 2.1.1 (STRUCTURE)
prior to the commencement of the relevant Commitment Year.
2.5.2 PLAN CONTENTS AS TO THE PRIMARY PRODUCT. Each Marketing Plan
will, at a minimum, include: a review of the triptan marketplace in the
Territory and more specific detail of the long acting triptans and the
positioning of the Primary Product in the Territory against Third Party long
acting triptan competition, provided, however, that GSK will not be obligated to
provide to Allergan, or include in the Marketing Plan, any strategic information
on GSK neurological products other than the Products; Marketing and Promotion
objectives/strategies for the Primary Product in the Territory for the relevant
Commitment Year; clinical and publication support plans and plans (if any) for
Phase IIIb/IV studies and investigator-sponsored studies; delineation of Sales
Force efforts for the Primary Product in the Territory for the relevant
Commitment Year, including a profile of the Primary Product Target Audience, a
Sales Call Plan, and a Samples plan; general delineation of Sales Territories;
budgets for Marketing and Promotion of the Primary Product in the Territory for
the relevant Commitment Year; a non-binding multi-Commitment Year projection of
plans and budgets for the Marketing and Promotion of, and forecasts for, the
Primary Product in the Territory; desired call frequency and reach; revenue and
expense forecasts for the Primary Product in the Territory for the relevant
*** Certain confidential information contained in this document, marked with 3
asterisks, has been omitted and filed separately with the Securities and
Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act
of 1934, as amended.
10
Commitment Year; and the overall level of anticipated resource commitments on
the part of each Party under this Agreement relating to the Primary Product in
the Territory for the relevant Commitment Year. The Marketing Plan will also
contain promotional guidelines for the Primary Product (the "PRODUCT PROMOTIONAL
GUIDELINES"), which will be updated from time to time as necessary or desirable
by the JCC as provided in SECTION 3.2.1 (MARKETING AND PROMOTION PLANNING,
STRATEGY AND CONTENT). Such Marketing Plan will be in a form generally
consistent with the outline attached hereto as EXHIBIT B.
2.5.3 MARKETING PLAN CONTENTS AS TO ADDITIONAL NEURO PRODUCT. Each
Marketing Plan will also include such contents, as determined by the Parties and
agreed to by the JCC, which pertain to the Detailing and Promotion of the
Additional Neuro Product by the Parties in the Territory, which contents will
include a review of the triptan marketplace in neurology for both short-acting
and long-acting triptans, a Sales Call Plan, a budget for the Detailing and
Promotion of the Additional Neuro Product, sampling requirements promotional
guidelines for the Additional Neuro Product, the allocation of Details between
Primary Details and Secondary Details for the Additional Neuro Product, and the
Additional Neuro Product Target Audience. Allergan will have no marketing and
Promotion spend commitments for the Additional Neuro Product. The Marketing Plan
will also include an explanation of GSK's co-positioning of the Products
relative to GSK PSR detailing efforts within the triptan marketplace.
2.5.4 MARKETING AND PROMOTION COSTS. GSK and Allergan will be
responsible for Marketing and Promotion costs and expenses incurred in
accordance with the Primary Product Marketing Plan in accordance with SECTION
6.1 (JOINT MARKETING AND PROMOTION COSTS AND EXPENSES), which costs will be part
of the budget in the Marketing Plan and approved by the JCC as provided in
SECTION 2.1.1 (STRUCTURE).
ARTICLE 3
PROMOTIONAL MATERIAL DELIVERABLES AND OBLIGATIONS
3.1 PRIMARY PRODUCT CO-EXCLUSIVE CO-PROMOTION ARRANGEMENT; ADDITIONAL NEURO
PRODUCT NON-EXCLUSIVE CO-PROMOTION ARRANGEMENT; RESTRICTIVE COVENANT.
(A) GSK hereby engages Allergan, on a co-exclusive basis (with GSK),
and Allergan agrees, to Promote and Detail the Primary Product to the Primary
Product Target Audience in the Territory, commencing on the Co-Promotion
Commencement Date continuing thereafter during the Commitment Term, in
accordance with the Marketing Plan as directed by the JCC and the terms and
conditions of this Agreement. Notwithstanding the previous sentence, (i) GSK may
enter into co-promotion arrangements with respect to the Primary Product at any
time during the Term with (a) its Affiliates; provided that it will notify
Allergan in writing of any such Affiliate arrangement, and (b) Third Parties
with respect to physicians other than those included in the Primary Product
Target Audience; and (ii) GSK will at all times during the Term have a right to
Market, Detail and Promote the Product (a) outside of the Primary Product Target
Audience wherever and to whomever it chooses or (b) within the Primary Product
Target Audience as determined in writing by the JCC. For purposes of
clarification, any such
*** Certain confidential information contained in this document, marked with 3
asterisks, has been omitted and filed separately with the Securities and
Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act
of 1934, as amended.
11
promotional efforts by GSK will not affect or alter GSK's Fixed Payment, Primary
Product Performance Payment or Additional Neuro Product Performance Payment
obligations under SECTION 7.1.1 (COMMITMENT TERM PAYMENTS).
(B) GSK hereby engages Allergan, on a non-exclusive basis, and
Allergan agrees, to Promote and Detail the Additional Neuro Product to the
Additional Neuro Product Target Audience in the Territory, commencing on the
Co-Promotion Commencement Date and continuing thereafter during the Commitment
Term, in accordance with the Marketing Plan as directed by the JCC and the terms
and conditions of this Agreement. For clarity, the Parties acknowledge and agree
that, (i) GSK may enter into co-promotion arrangements with respect to the
Additional Neuro Product with (a) its Affiliates, and (b) Third Parties; and
(ii) GSK will at all times during the Term have a right to promote the
Additional Neuro Product wherever and to whomever it chooses.
(C) Allergan will have no right to sublicense any of its rights under
this Agreement, including, without limitation, its rights under SECTIONS 3.1(A)
and (B) above, to any Affiliate or Third Party without the prior written consent
of GSK. Notwithstanding anything in this Agreement to the contrary, either Party
may contract or agree with one or more of its Affiliates to have such Affiliate
perform any of such Party's obligations herein. In no event, will such use of an
Affiliate be deemed to relieve a Party of its liabilities or obligations to the
other Party under this Agreement. Each Party expressly acknowledges and agrees
that it will remain fully and unconditionally obligated and responsible for the
full and complete performance of all of its obligations under the terms and
conditions of this Agreement whether or not such performance is carried out by
such Party or any of its Affiliates.
(D) During the Term, Allergan will not, and will cause its Affiliates
not to, directly or indirectly detail, promote, market and/or sell any
prescription pharmaceutical product in the Territory in which at least one
active component of such product may be included in the Triptan class of drugs
(selective 5-HT1 (serotonin) receptor agonists) (a "Competing Product"), or
acquire directly or indirectly any rights or interest in or to a Competing
Product which is being detailed, promoted, marketed and/or sold in the
Territory.
3.2 CO-PROMOTION OBLIGATIONS
3.2.1 MARKETING AND PROMOTION PLANNING, STRATEGY AND CONTENT. During
the Commitment Term, the JCC will have exclusive responsibility with respect to
Promotion planning and strategy applicable to the Parties for the Product in the
Territory during the Commitment Term and the content of Product Promotional
Guidelines. The JCC will have final authority for the Product's Promotion
strategies and plans as to the Parties, identification of Primary Product Target
Audience and the Additional Neuro Product Target Audience, Sales Call Plans, and
the strategies and plans with respect to the Product Promotional Materials;
provided, however, that prior to first use, the form and content of any and all
Product Promotional Materials will be subject to the approval of GSK as provided
in SECTION 3.3.1 (PRODUCT PROMOTIONAL MATERIALS) below.
*** Certain confidential information contained in this document, marked with 3
asterisks, has been omitted and filed separately with the Securities and
Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act
of 1934, as amended.
12
3.2.2 CO-PROMOTION. As of the Effective Date and thereafter during the
Commitment Term, Allergan will, at its sole expense and pursuant to SECTION
6.2.1 (ALLERGAN CO-PROMOTION COSTS AND EXPENSES) use Commercially Reasonable
Efforts to Promote the Product in the Territory in accordance with Promotion
strategies determined by the JCC under SECTION 3.2.1 (MARKETING AND PROMOTION
PLANNING; STRATEGY AND CONTENT) and set forth in the then-current JCC-approved
Marketing Plan, and the terms and conditions of this Agreement. During the
Commitment Term, neither Party will engage in any activities with respect to the
Product in the Territory that are outside of or inconsistent with the
then-current JCC-approved Marketing Plan for the Product, except with prior
express written approval of the JCC.
3.2.3 PROFESSIONAL SALES REPRESENTATIVES (PSRS).
(A) GENERALLY. In connection therewith, as of the Effective Date
and thereafter during the Commitment Term, Allergan will maintain, in the
Territory, a well-trained sales force consisting of full-time PSRs to Promote
and Detail the Products using Product Promotional Materials generated and
approved as provided in SECTION 3.3.1 (PRODUCT PROMOTIONAL MATERIALS) below
prior to first use. Allergan will supervise its PSRs, District Managers and
Sales Management Team and be responsible for its remuneration, incentives and,
subject to SECTION 3.2.4 (SALES MANAGEMENT) below, and general sales training.
The Allergan PSRs, District Managers and Sales Management Team will remain
exclusively under the authority of Allergan.
(B) MINIMUM PSR'S. Allergan will Promote and Detail the Product
in the Territory during the Commitment Term with such minimum number Allergan
PSRs actively Promoting and Detailing, or in a position to Promote and Detail,
Product as provided herein: (i) at least *** PSRs as of, and for *** after, the
Co-Promotion Commencement Date, and (ii) at least *** PSRs at all times during
the Commitment Term after *** the Co-Promotion Commencement Date.
3.2.4 SALES MANAGEMENT. Each Party will be responsible for supervising
its PSRs. In connection therewith, as of the Effective Date and thereafter
during the Commitment Term, Allergan will provide a sufficient number of full
time employees to serve as District Managers. Allergan may, but will not be
obligated to, designate one (1) or more full time employees to serve as regional
directors having the responsibility for supervising a group of Allergan's
District Managers in a particular geographic region of the Territory. Allergan
will provide GSK with contact information for Allergan's District Managers and
regional directors (if any) and will update that information periodically or as
requested by GSK from time to time during the Commitment Term. For the avoidance
of doubt, each Party's regional directors and District Managers may communicate
directly with their counterparts of the other Party to support each Party's
obligations under this Agreement.
3.2.5 DETAILS. After the Effective Date and thereafter during the
Commitment Term (defined below), Allergan will Detail and Promote the Product in
the Territory in accordance with the applicable JCC-approved Marketing Plan
under SECTION 2.5.1 (MARKETING PLAN) and JCC-approved strategies and tactics
under SECTION 3.2.1 (MARKETING AND PROMOTION
*** Certain confidential information contained in this document, marked with 3
asterisks, has been omitted and filed separately with the Securities and
Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act
of 1934, as amended.
13
PLANNING; STRATEGY AND CONTENT), including by satisfying the specific
commitments set forth in this SECTION 3.2.5.
(A) ALLERGAN PRODUCT MINIMUM DETAIL COMMITMENTS. After the
Co-Promotion Commencement Date and thereafter during the Commitment Term,
Allergan, at its own expense pursuant to SECTION 6.2.2(A) (ALLERGAN DETAIL
RELATED COSTS AND EXPENSES), will be required to deliver the Details indicated
in the table below to this Agreement for the Product per Commitment Year to the
Primary Product Target Audience and the Additional Neuro Product Target
Audience, which Detail amounts will be prorated for any partial calendar year
comprising a Commitment Year ("ALLERGAN MINIMUM DETAILS COMMITMENT"). The
Allergan Minimum Details Commitment for the Primary Product will be comprised of
*** Primary Details in *** the Commitment Term and *** Primary Details in ***
the Commitment Term, with all remaining Details being at least Secondary
Details. Subject to the immediately preceding sentence, the JCC will determine
in good-faith the Primary/Secondary Detail Commitment split for the Primary
Product for Allergan for *** of the Commitment Term.
ADDITIONAL
TOTAL MINIMUM # OF PRIMARY NEURO
COMMITMENT YEAR DETAILS PRODUCT PRODUCT
--------------- ------------------ ------- ----------
*** *** *** ***
The Parties may, not later than ninety (90) days prior to the commencement of
any Commitment Year, agree in writing to change the distribution of Allergan
Minimum Details Commitment amounts between the Primary Product and Additional
Neuro Product from that as set forth in the table above. In the event that the
Parties cannot agree as to any such change in the distribution of Allergan
Minimum Details Commitment amounts between the Primary Product and Additional
Neuro Product for a Commitment Year within such ninety (90) day period, the
Allergan Minimum Details Commitment amounts set forth in the table above for the
Primary Product and Additional Neuro Product will remain in place during such
Commitment Year.
(B) SALES DEPLOYMENT COSTS. Each Party will be responsible for
its own costs and expenses for sales deployment and internal distribution of
Product Promotional Materials pursuant to and as further set forth in SECTION
6.2.2(B) (ALLERGAN DETAIL RELATED COSTS AND EXPENSES as to Allergan and SECTION
6.3.2(A) (GSK DETAIL RELATED COSTS AND EXPENSES) as to GSK.
(C) COMMITMENT TERM. The Allergan Minimum Details Commitment will
commence as of the Co-Promotion Commencement Date and will terminate
automatically on the fifth (5th) year anniversary of the Co-Promotion
Commencement Date (the "COMMITMENT TERM"). The Commitment Term may be extended
under SECTION 12.1.2 (EXTENSION OF COMMITMENT TERM) in twelve (12) month
increments by the mutual written agreement of the Parties, on prior written
request to the JCC by either Allergan or GSK, provided, however, that Allergan
will have first met the Allergan Minimum Details Commitment
*** Certain confidential information contained in this document, marked with 3
asterisks, has been omitted and filed separately with the Securities and
Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act
of 1934, as amended.
14
in each year of the Commitment Term as set forth in SECTION 3.2.5(A) (ALLERGAN
PRODUCT MINIMUM DETAIL COMMITMENTS) above before the JCC can consider any such
request.
(D) NO AGENCY. In no event will any PSR or any member of the
Sales Management Team for one Party at any time identify, either expressly or
through implication, themselves as a an employee or agent of the other Party.
3.2.6 MANAGED CARE AND REIMBURSEMENT. During the Term, the managed
care strategy for Product in the Territory including, without limitation,
contracting with, and pricing for, managed care customers, will be defined and
approved exclusively by GSK. All costs and expenses arising from managed care,
Medicare/Medicaid execution, personnel, and other related costs associated with
Product in the Territory will be the sole responsibility and obligation of GSK
as set forth in SECTION 6.3.4(B) (OTHER GSK COSTS AND EXPENSES).
3.2.7 DATA COLLECTION AND REPORTING SYSTEMS. As soon as practicable,
but in any event prior to the Co-Promotion Commencement Date, Allergan, at no
expense to GSK, will establish and, during the Term and the three (3)-year
period following the expiration or earlier termination of this Agreement,
maintain true and accurate data collection and reporting systems for both
Details performed and Samples distributed by Allergan's PSRs, District Managers
or any member of Allergan's Sales Management Team during the Commitment Term.
3.2.8 SALES FORCE INCENTIVE PLAN. As soon as practicable, but in any
event prior to the Co-Promotion Commencement Date, Allergan will establish and,
throughout the Commitment Term, maintain, a sales force incentive plan for its
PSRs, District Managers and Sales Management Team responsible for the Promotion
of the Product in the Territory, which in each case will be consistent with the
incentive plan and promotional strategy determined by the JCC and set forth in
the Marketing Plan.
3.2.9 QUARTERLY REPORTS. Starting as of the Co-Promotion Commencement
Date for Allergan, at the end of each Calendar Quarter during the Commitment
Term, Allergan will provide to the JCC a quarterly written report providing
information on the numbers of Details and Samples distributed by its PSRs,
District Managers and Sales Management Team. Starting as of the Co-Promotion
Commencement Date for GSK, at the end of each Calendar Quarter during the Term,
GSK will provide to the JCC information on Net Sales as provided in SECTION
7.2.1 (PAYMENT OF COMPENSATION PAYMENTS), as well as updates on managed care
contracting with respect to the Primary Product, GSK advertising, overall brand
strategy and tactics in the Territory relating to the Primary Product that is
directly relevant to the Primary Product Target Audience, and Primary Product
improvements and enhancements, if any. Promptly after the Effective Date, the
Parties will agree on mutually acceptable quarterly written report/statement
formats; provided that each Party may reasonably request in writing report
modifications and/or additional Product-related information from time to time to
satisfy accounting, regulatory or legal requirements, including, but not limited
to, the Xxxxxxxx-Xxxxx Act of 2002, as amended and all United States Securities
an Exchange Commission (SEC) rules and regulations relating thereto. Each Party
will provide their respective quarterly
*** Certain confidential information contained in this document, marked with 3
asterisks, has been omitted and filed separately with the Securities and
Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act
of 1934, as amended.
15
reports/statements as referenced above within sixty (60) days after the end of
such applicable Calendar Quarter.
3.2.10 EMPLOYMENT QUALIFICATIONS. At all times during the Commitment
Term, *** of all Allergan PSRs will have prior experience and training in
pharmaceutical or other medical product sales and *** of Allergan's District
Managers will have sales management experience in the pharmaceutical industry.
Each member of Allergan's Sales Management Team will have sales management
experience in the pharmaceutical industry. Each Allergan PSR, District Manager
and Sales Management Team member will possess a Bachelor of Science or Bachelor
of Arts degree from an accredited four (4) year college or university, will be
professional in manner and appearance, and will be recruited and hired in
accordance with all applicable Federal and state laws. At the time each Allergan
PSR is hired, and at all times subsequent thereto, each such Allergan PSR will
have any and all licenses, permits, and insurance or other coverage as may be
required to enable the Allergan PSR to Promote and Detail the Product as
contemplated under this Agreement. Allergan will hire only competent PSRs,
District Managers and Sales Management Team members. Before hiring any
individual in connection with this Agreement, Allergan will ensure that such
individuals have (i) at least two satisfactory references, provided such
individuals have given written Allergan permission to obtain such references,
(ii) passed a criminal background check conducted by Allergan, (iii) not been
debarred, nor be currently under investigation by the FDA for debarment action
or pursuant to the Generic Drug Enforcement Act, (iv) passed a drug screening
test administered by Allergan, and (v) successfully passed a driving record
screening conducted by Allergan. In addition, before hiring any individuals in
connection with this Agreement that have former experience as a GSK (or any of
its predecessor companies such as SmithKline Xxxxxxx or Glaxo Wellcome Inc.)
employee or contractor, Allergan will notify GSK of such individuals so that GSK
may confirm employment history.
3.2.11 INELIGIBLE PERSONS. During the Commitment Term, Allergan will
use Commercially Reasonable Efforts to not hire or employ an Ineligible Person
as either an employee or contractor to Allergan to Promote Product as
contemplated under this Agreement. For the purposes of this SECTION 3.2.11
(INELIGIBLE PERSONS), the term "INELIGIBLE PERSON" means a Person who is
currently excluded, debarred, suspended or otherwise ineligible to participate
in the Federal health care programs or in Federal procurement or nonprocurement
programs, or has been convicted of a criminal offense that falls within the
ambit of 42 U.S.C. 1320a-7(a), but has not yet been excluded, debarred,
suspended or otherwise declared ineligible. To prevent the hiring or engaging of
Ineligible Persons, Allergan will screen all prospective employees and
contractors prior to engaging their services by (i) requiring such persons to
disclose to Allergan whether there are Ineligible Persons; and (ii)
appropriately querying the General Administrative Services Administration's List
of Parties Excluded from Federal Programs (currently available through the
Internet at xxxx://xxx.xxx.xxx) (these lists of excluded persons hereinafter
referred to as the "Exclusion Lists"), and will review its list of employees and
contractors against the Exclusion Lists prior to January 1st of each Commitment
Year. Prior to the execution of this Agreement, and by January 1st of each
Commitment Year, Allergan will provide GSK with a written certification that
Allergan has performed its obligations relating to Ineligible Persons under this
SECTION 3.2.11 (INELIGIBLE PERSONS) in a format acceptable to GSK. In addition,
*** Certain confidential information contained in this document, marked with 3
asterisks, has been omitted and filed separately with the Securities and
Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act
of 1934, as amended.
16
Allergan represents and warrants to GSK that Allergan has policies and
procedures in effect that require, and that it will otherwise require, all
employees and contractors to immediately disclose to Allergan any debarment,
exclusion, suspension or other event that may make such employee or contractor
an Ineligible Person. Upon learning or acquiring knowledge of any facts and
circumstances which may lead to an employee or contractor of Allergan providing
services under this Agreement becoming an Ineligible Person, Allergan will
immediately disclose such facts to GSK. If Allergan has actual notice that one
of its employees or contractors providing services under this Agreement has
become or is likely to become an Ineligible Person, Allergan will remove such
Person from any responsibility associated with this Agreement and the Product
Promoted hereunder. If Allergan has actual notice that one of its employees or
contractors is charged with a criminal offense related to any Federal health
care program, or is proposed for exclusion, Allergan will take all appropriate
action to ensure that the responsibilities of such Person has not and will not
in the future adversely affect this Agreement and the Product Promoted
hereunder. Allergan will promptly provide to GSK all data requested by GSK for
purposes of complying with disclosure, reporting or compliance obligations under
Federal and state laws relating to reporting obligations for Ineligible Persons.
3.2.12 STATUS OF ALLERGAN AND ITS PERSONNEL.
(A) GSK is engaging Allergan hereunder, and Allergan will perform
its obligations hereunder, strictly as an "independent contractor." PSRs, Sales
Management Team and any other employee or agent that is involved in performing
Allergan's obligations under this Agreement (collectively, "PERSONNEL") will not
be, and will not be considered or deemed to be, employees of GSK for any
purpose. GSK will not have any responsibility for the hiring, termination,
compensation, benefits or other conditions of employment or engagement of the
Personnel of Allergan.
(B) Personnel of Allergan are not eligible to participate in any
benefits programs offered by GSK to its employees, or in any pension plans,
profit sharing plans, insurance plans or any other employee benefits plans
offered from time to time by GSK to its employees. Allergan acknowledges and
agrees that GSK does not, and will not, maintain or procure any workers'
compensation or unemployment compensation insurance for or on behalf of
Allergan's Personnel. Allergan acknowledges and agrees that it will be solely
responsible for paying all salaries, wages, benefits and other compensation
which its Personnel may be entitled to receive in connection with the
performance of the services hereunder and that Allergan will be liable for all
taxes, excises, assessments and other charges levied by any governmental agency
on, or because of, the services to be provided by Allergan under the terms of
this Agreement.
3.2.13 COMPLIANCE WITH LAWS AND REGULATIONS. In connection with the
Promotion and Detailing of the Product in the Territory and all other activities
under this Agreement, each Party will comply and will cause each of its
respective Personnel, including, without limitation, each PSR, to comply with
all applicable Federal and state laws and regulations in the Territory,
including but not limited to all Federal and State Medicare and Medicaid
anti-kickback statutes and regulations, PDMA and regulations thereunder, FD&C
Act and regulations thereunder, and HIPAA and regulations thereunder.
*** Certain confidential information contained in this document, marked with 3
asterisks, has been omitted and filed separately with the Securities and
Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act
of 1934, as amended.
17
3.3 RESPONSIBILITIES OF THE PARTIES.
3.3.1 PRODUCT PROMOTIONAL MATERIALS. All advertising, promotional,
educational and communication materials used by either Party in the Marketing
and/or Promotion of the Product in the Territory pursuant to this Agreement, in
any format, including, without limitation, audio, visual, digital or computer
formats (collectively, the "PRODUCT PROMOTIONAL MATERIALS"), will be generated
by or on behalf of the JCC and subject to the review and approval by an internal
working committee at GSK responsible for reviewing and approving such Product
Promotional Materials (the "GSK PROMOTIONAL REVIEW COMMITTEE") prior to being
used by Allergan in the Territory. The JCC will submit any proposed Product
Promotional Materials to the GSK Promotional Review Committee at least thirty
(30) days prior to the next meeting of the GSK Promotional Review Committee for
review and approval, which submitted materials will be reviewed at such next GSK
Promotion Review Committee meeting. Notwithstanding the foregoing, the Parties
will immediately cease using any previously approved Product Promotional
Materials in connection with the Promotion of Product in the Territory upon the
request of GSK, which request may be made at any time during the Commitment Term
but must be reasonably explained to the JCC.
GSK, at its sole expense pursuant to SECTION 6.3.2(B) (GSK DETAIL
RELATED COSTS AND EXPENSES), will be responsible for the production of all
Product Promotional Materials for the Product. All Product Promotional Materials
will comply with the Product Promotional Guidelines set forth in the
then-current Marketing Plan, and neither Allergan nor GSK will distribute or
permit any use of any materials within the above definition of Product
Promotional Materials that are not approved by the JCC and GSK Promotional
Review Committee as provided herein. Each Party will be responsible, at its own
expense, for distributing Product Promotional Materials to their respective
PSRs, District Managers and Sales Management Team, and for ensuring use only of
Product Promotional Materials approved as provided hereunder. Product
Promotional Materials will be used only for the purposes of this Agreement and
all unused quantities of such Product Promotional Materials or any Product
Promotional Materials which can no longer be used in the Promotion of Product
per the request of GSK as provided above, will in each case be properly returned
to GSK or destroyed by Allergan, as determined by GSK in its sole discretion,
upon expiration or earlier termination of this Agreement.
3.3.2 CME AND GRANTS. GSK will have sole responsibility, in its sole
discretion, for conducting or arranging for the conducting of any continuing
medical education (CME) and/or grant programs relating in any way to Product
during the Term. GSK will advise Allergan through the JCC of any CME and/or
grant programs relating to Product during the Commitment Term. Notwithstanding
the foregoing, GSK will in no way have any obligation to conduct or arrange for
the conducting of any CME and/or grant programs relating in any way to Product
during the Term. For the avoidance of doubt, Allergan will not conduct or
arrange for the conducting of any CME and/or grant programs relating in any way
to Product during the Term.
3.3.3 SALES TRAINING.
*** Certain confidential information contained in this document, marked with 3
asterisks, has been omitted and filed separately with the Securities and
Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act
of 1934, as amended.
18
(A) GSK will be responsible for planning and conducting all
training for the Allergan PSRs, District Managers and Allergan's Sales
Management Team relating to the Product and the Promotion thereof approved by
the JCC (the "TRAINING PROGRAM"). Such Training Program will be comparable to
and no more burdensome to Allergan PSRs than training that GSK provides to its
own PSRs. As soon as practicable, but in any event prior to the Co-Promotion
Commencement Date one hundred twenty (120) days of the Effective Date, Allergan
will organize and conduct the first Training Program (referred to herein as the
"initial Training Program") at a time, date and location mutually agreed to by
the Parties, using GSK trainers to educate the Allergan PSRs, District Managers
and Allergan's Sales Management Team on the Product and the Promotion thereof,
the Applicable Commercial Practices Policies and such other sales training as
GSK or Allergan reasonably deems necessary and appropriate. GSK will provide the
training materials and will provide Allergan with an up-to-date programmed
learning system for the Product to be sent to each of Allergan's PSRs, District
Managers and Sales Management Team members for the "Homestudy Program" prior to
the commencement of the Training Program. Upon completion of the Training
Program, Allergan PSR, District Manager and Sales Management Team member will,
at GSK's sole discretion, be required to sign a certificate(s) acknowledging
their participation in the Training Program, and certifying and acknowledging
their understanding of the foregoing policies and statutes and the specified
acts prohibited thereunder.
(B) Allergan will cause all of the Allergan PSRs, District
Managers and each member of Allergan's Sales Management Team to attend and
successfully complete a GSK Training Program prior to Promoting the Product as
contemplated in this Agreement, and to successfully complete GSK's programmed
learning system for the Product prior to the commencement of the Training
Program. After the initial Training Program, GSK will periodically conduct
additional Training Programs for newly hired Allergan PSRs, Allergan District
Managers and Allergan Sales Management Team members during the Commitment Term.
GSK will be responsible for all costs and expenses associated with the Training
Program pursuant to and as further set forth in SECTION 6.3.2(D) (GSK DETAIL
RELATED COSTS AND EXPENSES), and Allergan will be responsible for all costs and
expenses associated with the training activities pursuant to and as further set
forth in SECTION 6.2.2(D) (ALLERGAN DETAIL RELATED COSTS AND EXPENSES).
(C) In order for any Allergan's PSRs, District Managers or Sales
Management Team members to Promote the Product in the Territory as contemplated
herein, such PSRs, District Managers and Sales Management Team members must
demonstrate thorough knowledge of the Product and the laws, rules, guidelines
and policies applicable to the Promotion of the Product by passing GSK's product
certifications. Such product certifications will be administered to each PSR,
District Manager and Sales Management Team member during the Training Program
and the scores of such certifications will be verified to the satisfaction of
GSK. GSK reserves, and will at all times have, the right to review any and all
product certifications taken by Allergan's PSRs, District Managers and Sales
Management Team members. Any Allergan PSR, District Manager or Sales Management
Team member failing to pass GSK's Homestudy Program product certifications with
at least an eighty percent (80%) score (or the same standards as GSK's internal
requirements for newly hired XXX XXXx, Xxxxxxxx
*** Certain confidential information contained in this document, marked with 3
asterisks, has been omitted and filed separately with the Securities and
Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act
of 1934, as amended.
19
Managers and Sales Management Team members) on each such certification may be
removed from Detailing the Product by Allergan.
3.3.4 PROMOTIONAL CLAIMS. Allergan and GSK each agree to limit the
claims of efficacy and safety for the Product made by the Parties' respective
PSRs and Sales Management Teams to those that are consistent with FDA-approved
labeling for the Product in the Territory. Neither Party will add, delete or
modify claims of efficacy or safety in its Promotion of the Product nor make any
changes in Product Promotional Materials approved by the GSK Promotional Review
Committee pursuant to SECTION 3.3.1 (PRODUCT PROMOTIONAL MATERIALS) above. Each
Party's Detailing and Promotion of the Product will be in strict adherence to
all regulatory, professional and legal requirements including, without
limitation, FDA regulations and guidelines concerning the advertising of
prescription drug products, the American Medical Association's Guidelines on
Gifts to Physicians, the PhRMA Code, the Anti-Kickback Statute, the Applicable
Commercial Practices Policies and the Product Promotion Guidelines in the
then-current JCC-approved Marketing Plan for the Product, and any approved
updates thereto.
3.3.5 COMMUNICATIONS WITH SALES REPRESENTATIVES. Each Party will have
full responsibility for the dissemination of information regarding the Product
to its Sales Management Team, District Managers and PSRs based on the Training
Program, Product Promotional Guidelines and the Product Promotional Materials
approved by GSK pursuant to SECTION 3.3.1 (PRODUCT PROMOTIONAL MATERIALS) above.
All written communications from Allergan to Allergan's Sales Management Team and
the Allergan PSRs concerning the Promotion of the Product to Primary Product
Target Audience and the Additional Neuro Product Target Audience, other than
communications described in the next sentence, will be subject to prior written
approval by the JCC or the GSK Promotional Review Committee, as the case may be.
Prior approval will not be required for communications that do not contain any
drug information other than Product name, and other routine business reports
that do not contain any substantive drug information about the Product.
3.3.6 PRICING. GSK will have exclusive responsibility and authority
with respect to the pricing of the Product. If GSK desires to modify pricing for
the Primary Product, GSK will inform Allergan prior to implementation and
discuss any implications of such modification to this Agreement.
3.3.7 MANUFACTURING; DISTRIBUTION; AND SALE OF PRODUCT. GSK will be
solely responsible for all activities relating to manufacture, supply and
distribution of the Product (including Samples) in the Territory, including,
without limitation, order processing, inventory warehousing, delivery to
customers, invoicing and collection of receivables. Costs and expenses for the
foregoing activities will be borne exclusively by GSK pursuant to SECTION
6.3.3(B) (GSK MANUFACTURING, DISTRIBUTION, SALE AND SAMPLE COSTS AND EXPENSES).
GSK will have the sole right and responsibility to arrange for all distribution
of the Product in the Territory, and to effect and account for all sales and to
establish and modify the terms and conditions with respect to the sale of the
Product, including any terms and conditions relating to or affecting the price
at which the Product will be sold, any discount attributable to payments on
receivables, distribution of the Product, credit to be granted or refused and
the like. GSK will process, administer and pay
*** Certain confidential information contained in this document, marked with 3
asterisks, has been omitted and filed separately with the Securities and
Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act
of 1934, as amended.
20
pursuant to SECTION 6.3.3(B) (GSK MANUFACTURING, DISTRIBUTION, SALE AND SAMPLE
COSTS AND EXPENSES) any and all rebates, chargebacks and discounts.
During the Term, GSK will use its Commercially Reasonable Efforts
to manufacture, supply and distribute sufficient Product (including Samples with
adequate shelf life as specified in SECTION 4.1 (PROVISION OF SAMPLES)) to
satisfy the Allergan Minimum Detail Commitments and support the then-current
JCC-approved Marketing Plan and JCC-approved strategies under SECTION 3.2.1
(MARKETING AND PROMOTION PLANNING; STRATEGY AND CONTENT) above. GSK agrees to
discuss with Allergan through the JCC any reasonable concerns of Allergan
relating to manufacture, supply or distribution capacity and/or quality of
Product in the Territory as provided under this Agreement.
3.3.8 PROCESS CHANGES BY GSK. GSK will provide written notice to
Allergan of any material changes contemplated or proposed by GSK to any material
manufacturing processes that will impact the safety, strength, purity,
integrity, or quality (SSPIQ) of the Product.
3.3.9 ON-GOING DEVELOPMENT AND LINE EXTENSIONS. GSK will use its
Commercially Reasonable Efforts to continue existing (as of the Effective Date)
and planned pre-clinical and clinical development and line extensions of the
Primary Product, including, integrating and applying GSK's RT technology, which
may enhance the dispersion and dissolution of the Primary Product even in the
presence of gastric stasis. Any and all costs and expenses associated with such
activities will be the sole and exclusive responsibility of GSK pursuant to
SECTION 6.3.4(D) (OTHER GSK COSTS AND EXPENSES). GSK will keep Allergan
reasonably informed of such efforts and will communicate such efforts to
Allergan regularly.
3.4 OWNERSHIP OF PRODUCT.
3.4.1 OWNERSHIP OF PRODUCT. GSK retains, and will during the Term
retain, all proprietary and property interests in and to the Product until the
point of sale. GSK's National Drug Code (NDC) number will at all times remain on
the Product. Allergan will not have nor represent that it has any control over,
or proprietary or property interests in, the Product. Nothing contained in this
Agreement will be deemed to grant to Allergan or its Affiliates any license,
right, title or interest in or to any patent, trademark, copyright, trade secret
or other similar property of GSK, including without limitation, any Product
Promotional Materials and training materials used in the Training Program.
3.4.2 TRADEMARKS. The Product will be Promoted by Allergan in
accordance with the terms and conditions of this Agreement under the trademark
"AMERGE(R)" or "IMITREX(R)", as the case may be, (the "TRADEMARK"). Allergan
will use Trademark, other trademarks, trade names, and copyrighted materials of
GSK only as authorized by GSK and will take all reasonable precautions to ensure
the protection of GSK's rights in such materials. It is understood by Allergan
that GSK is not by this Agreement granting any right or license to Allergan or
to any other Person to use any trademarks, trade names, designs, logos, slogans,
taglines, or trade dress of GSK or its Affiliates or to utilize any information,
know-how, data or
*** Certain confidential information contained in this document, marked with 3
asterisks, has been omitted and filed separately with the Securities and
Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act
of 1934, as amended.
21
patent rights GSK or its Affiliates may have or may secure in the future
regarding the manufacture, use, and sale of the Product or any components
thereof except such limited licenses to use the Trademark, subject to any other
applicable provisions of this Agreement, as are necessary to fulfill the
obligations of Allergan hereunder with respect to Detailing and Promoting the
Product in the Territory pursuant to the terms and conditions contained in this
Agreement. Notwithstanding the foregoing, Allergan will not at any time use the
Trademark, other trademarks, trade names and copyrights of GSK in a manner
inconsistent with their established policy for use of such intellectual property
unless otherwise authored by GSK. All use of the Trademark by Allergan at all
times inures to the benefit of GSK, as licensee of the Trademark, and Glaxo
Group Limited, GSK's Affiliate and owner of the Trademark. GSK consents to the
use of Allergan's logo on all Product Promotional Materials ,but not on Product
packaging. GSK's logo will be used on all Product Promotional Materials and all
Product packaging.
3.5 PATENTS. This Agreement does not grant to Allergan any license, right,
title or interest in or to any patent applications or patents of GSK, except to
the extent necessary to allow Allergan to Promote the Product in accordance with
the terms and conditions of this Agreement.
3.6 NO DISTRIBUTION BY ALLERGAN. The Parties recognize that Allergan may
from time to time receive orders for the Product directly from Third Parties. In
such event, Allergan will promptly advise the customer that Allergan is not
authorized to accept orders for the Product and it will use its Commercially
Reasonable Efforts to provide the customer with adequate information to complete
the customer's order directly with GSK.
ARTICLE 4
SAMPLES
4.1 PROVISION OF SAMPLES. GSK will use Commercially Reasonable Efforts to
provide Samples to Allergan in such quantities and pursuant to such timings as
set forth in the then current Marketing Plan, which quantities and timings will
be determined by the JCC and will be provided at GSK's cost and expense, for use
by Allergan in Promoting the Product to Primary Product Target Audience and the
Additional Neuro Product Target Audience in accordance with the Marketing Plan
as directed by the JCC and the terms and conditions of this Agreement.
Notwithstanding the foregoing, during each Commitment Year, GSK will provide
Allergan with such quantity of Samples of Primary Product that is equal to ***.
The JCC may, at any time during the Term, agree to increase the number of sample
packs of Primary Product provided to Allergan for each Detail comprising the
Allergan Minimum Detail Commitment amount for such Commitment Year.
Allergan will cause, and will maintain written procedures to ensure that all of
its PSR's, District Managers and Sales Management Team members comply with all
Applicable Laws relating to the distribution of, and accountability for,
Samples. All Samples provided by GSK under this Agreement will at the time of
delivery by GSK to Allergan hereunder, have *** of remaining shelf life based on
Product labeling and the relevant date of manufacture.
*** Certain confidential information contained in this document, marked with 3
asterisks, has been omitted and filed separately with the Securities and
Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act
of 1934, as amended.
22
4.2 SHIPPING OF SAMPLES. GSK will deliver Samples to Allergan FCA shipping
point (Incoterms 2000) at a single location designated by Allergan, which
location will be designated by Allergan on a quarterly basis, for distribution
by Allergan to a Third Party or the Allergan PSRs and Allergan's District
Managers. The storage by Allergan, the Allergan PSRs and Allergan's District
Managers of such Samples will be at Allergan's expense and Allergan will be
responsible for storing such Samples or causing such Samples to be stored under
label conditions and with adequate security to maintain the integrity and
usability of such Samples. All Samples that are in the possession of Allergan,
the Allergan PSRs or Allergan's District Managers and that are undistributed by
their expiration date will be returned by Allergan, at its expense, to GSK's
preferred destruction vendor, and destruction of such outdated Samples will be
at Allergan's expense; provided, however, that if GSK delivers Samples that do
not meet the shelf life requirements under SECTION 4.1 (PROVISION OF SAMPLES),
all return and destruction will be at GSK's expense.
4.3 COMPLIANCE WITH PDMA.
4.3.1 Allergan will be an "Authorized Distributor of Record" for the
Product for purposes of the requirements of the PDMA and will comply with the
PDMA, FDA regulations and applicable State law requirements regarding the
Marketing, sale and distribution of the Product, including, without limitation,
applicable wholesale drug distribution licensing guidelines and requirements.
GSK will have the right to audit the records and inspect the facilities of any
warehouse or distribution agent identified by Allergan under SECTION 4.2
(SHIPPING OF SAMPLES) for the storage and distribution of Samples, on advance
written notice to Allergan and during regular business hours. Upon request by
GSK, Allergan will provide GSK with copies of such agent's State registration
certificate as a licensed distribution center and State board of pharmacy
inspection report. Allergan understands that no Samples will be shipped until
such agent is verified by GSK to be in PDMA compliance.
4.3.2 Each Party will take all steps necessary to ensure that each
Party's PSRs, District Managers and Sales Management Team members comply with
the requirements of the PDMA, all regulations promulgated thereunder and each
State's companion PDMA statutes and regulations that relate to the distribution
of Samples of a prescription drug product. This compliance includes, but is not
limited to, obtaining written requests, obtaining the licensed healthcare
professional's signature for all Samples delivered, ensuring validity of the
practitioner's State license, storage of all Samples at label conditions and
sending all documentation to the Party in a timely manner for retention.
4.3.3 Each Party will take all steps necessary to ensure that each
Party's PSR and District Manager, and each member of its Sales Management Team
complies with all applicable Federal and state rules and policies concerning all
aspects of the storage, handling and distribution of Samples. This compliance
includes, but is not limited to, distribution to all PSRs, District Managers and
all members of Sales Management Teams an appropriate "Sample Accountability
System," adherence to the provisions contained therein, and attendance by each
Party's PSRs, District Managers, and Sales Management Team at training classes
on procedures for storage, handling and distribution of Samples.
*** Certain confidential information contained in this document, marked with 3
asterisks, has been omitted and filed separately with the Securities and
Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act
of 1934, as amended.
23
4.3.4 Sample Receipt Forms, final reconciliation reports, signature
audit data and findings, and for-cause investigation reports and associated data
with respect to Samples distributed in the Territory or otherwise for
distribution to customers in the Territory for free, where the purpose of the
free supply is to maximize sales and market share during the Term, will be
generated from compliance reports, accountability cards and the like produced by
Allergan, and will be maintained by Allergan for a period of not less than three
(3) years. All such information of Allergan will be considered GSK property.
Allergan will fully cooperate with GSK in the production and delivery of any
such documentation as may be requested or required by FDA and/or other
governmental agencies. Allergan will compile Sample reports on the Sample
Receipt Forms that are completed and returned by each Allergan PSR, and will
share such reports with GSK. Further, GSK will, at all times, have the right to
inspect and copy such documentation upon reasonable notice to Allergan. In the
event that GSK receives a request for any of such documentation from any Federal
or state authority, Allergan will provide copies to GSK of said requested
documentation within fifteen (15) days of written or verbal notice from GSK. In
the event that Allergan receives a request for any of such documentation from
any Federal or state authority to the extent that it relates to the Product or
this Agreement, Allergan will immediately notify GSK of such request. At GSK's
option, on a case by case basis, GSK may participate in the process to respond
to such authority. Copies of any and all reports, notices and the like with
respect to the Samples which Allergan is required to file by any Federal or
state authority will be submitted to GSK prior to the delivery of said documents
to the relevant authorities. GSK may, at its option, offer comments to such
reports and notice, and Allergan will include such comments in the filings. The
rights and obligations of the Parties under this SECTION 4.3.4 will survive the
expiration or termination of this Agreement.
4.3.5 GSK agrees that Allergan may develop its own, or with a Third
Party, Sample systems, policies, procedures and documentation (including Sample
Receipt Forms), subject to GSK's prior review and approval for use with the
Product.
4.3.6 Allergan will notify GSK promptly upon learning that any Samples
shipped by GSK to Allergan have been lost or have not been received as
scheduled. All reports regarding Sample accountability filed with the FDA will
be prepared and submitted to the FDA by GSK, regardless of whether such theft or
significant loss occurred with respect to GSK's or Allergan's PSRs, District
Managers or Sales Management Teams. For the purposes of filing such reports with
the FDA, Allergan agrees to fully cooperate and provide all relevant information
to GSK so that GSK, in turn, may comply with its reporting requirements to the
FDA.
4.3.7 Allergan will notify GSK promptly upon learning that any of the
subject Samples had not been properly handled or had been handled in a manner
prohibited by law. Allergan will take all steps necessary to aid and support GSK
in a full investigation of any suspected mishandling of Samples.
4.3.8 If Allergan or any of its PSRs fails to comply or causes GSK to
fail to comply with applicable Federal or state legal requirements and as a
direct result a penalty(ies) is assessed against GSK or any of its Affiliates or
employees, then, subject to ARTICLE 11
*** Certain confidential information contained in this document, marked with 3
asterisks, has been omitted and filed separately with the Securities and
Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act
of 1934, as amended.
24
(INDEMNIFICATION AND INSURANCE), Allergan will hold harmless and indemnify GSK,
its Affiliates or its employees from any such civil or criminal penalty or other
damages or losses related thereto, including reasonable attorneys' fees, costs
and expenses as provided in SECTION 11.1 (INDEMNIFICATION BY ALLERGAN).
4.4 ADDITIONAL REQUIREMENTS. Allergan will maintain and provide to GSK,
upon request, an updated written list of full names and addresses of each
Allergan PSR and each member of Allergan's Sales Management Team as well as the
address of each site where Samples are stored. GSK will keep this information
confidential and will use this information solely to satisfy applicable legal or
regulatory requirements under this Agreement and for no other purpose.
4.5 RETURN OF SAMPLES. Within forty-five (45) days following the
termination or expiration of the Commitment Term, Allergan will cause and ensure
that all of its PSRs and District Managers send all Samples back to Allergan or
Allergan's distribution agent. During such time period, GSK will provide Sample
disposition instructions to Allergan. Upon receipt of such instructions,
Allergan will, at its expense, comply with such Sample disposition instructions
within forty-five (45) days. Allergan will prepare and provide a detailed Sample
reconciliation report within sixty (60) days following termination or expiration
of the Commitment Term. GSK must receive and approve the Sample reconciliation
report prior to being obligated to pay, and Allergan being entitled to receive,
any of the Residual Term Royalty.
ARTICLE 5
REGULATORY COMPLIANCE
5.1 MARKETING AUTHORIZATION AND REGULATORY MATTERS. GSK will have the sole
right and responsibility between the Parties to take, and will use Commercially
Reasonable Efforts to maintain the authorization to Market the Product as a
pharmaceutical product in the United States. GSK will own or hold legal
responsibility and maintain the new drug application with respect to the Product
and will retain responsibility for all regulatory filings for the Product as
required under the FD&C Act and Applicable Law.
5.2 RECALLS. GSK will promptly notify Allergan if GSK determines, in its
sole discretion, to authorize a Product recall in the Territory. The Parties
will allocate responsibilities between them for any such recall, such as, for
example, distributing notices of the recall and collecting samples. At GSK's
request and expense, Allergan will reasonably assist GSK in handling any recalls
of the Product. GSK will manage effecting any such recall of Product in the
Territory. Allergan will make available to GSK, upon request and at GSK's
expense, all pertinent records of Allergan that GSK may reasonably request to
assist GSK in effecting any such recall of Product in the Territory.
5.2.1 MANUFACTURING RECALLS. In the event of any manufacturing-related
recall of Product (including Samples, will) hereunder, the provisions of SECTION
7.1.3(A) (PRIMARY PRODUCT FAILURE) and SECTION 7.1.3(B) (ADDITIONAL NEURO
PRODUCT FAILURE) will apply.
*** Certain confidential information contained in this document, marked with 3
asterisks, has been omitted and filed separately with the Securities and
Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act
of 1934, as amended.
25
5.3 RETURNS. Any Product returned to Allergan will be shipped as directed
by GSK to GSK's nearest facility, with any reasonable, documented direct cost to
be paid by GSK.
5.4 GENERAL; ADVERSE DRUG EXPERIENCES AND PRODUCT COMPLAINTS; PRODUCT
AUDITS. GSK will be solely responsible for processing all adverse event reports
and Product complaints as required under Applicable Law. Both Parties will
collaborate in developing procedures for providing GSK information related to
adverse events and Product complaints, with such agreed upon procedures to be
evidenced by a separate agreement attached not later than sixty (60) days after
the Effective Date as an addendum to this Agreement (the "TECHNICAL AGREEMENT")
(attached as EXHIBIT C). The Technical Agreement will also contain procedures
for providing Allergan information related to adverse events and Product
complaints.
5.5 PRODUCT INQUIRIES. If Allergan, or any Allergan PSR, receives any
inquiries about the Product, Allergan's responsibilities will be as follows:
5.5.1 For questions that Allergan PSRs are unable to answer concerning
Product identification, Product availability or general inquiries, Allergan will
contact GSK Customer Service at ***, (or such other Person, at the address and
phone number as GSK may designate from time to time by written notice to
Allergan).
5.5.2 For medical inquiries, including those related to information
outside of labeling or which Allergan PSRs are unable to answer, such medical
inquiries will go to GSK's Medical Information Department.
5.6 COMMUNICATIONS WITH FDA. All communications with the FDA concerning the
Product will be the sole responsibility of GSK and will be initiated solely by
GSK. GSK will keep Allergan informed of any material interactions with FDA with
respect to the Product. Allergan, at its own expense, will provide reasonable
assistance to GSK to the extent deemed necessary by GSK.
5.7 ADDITIONAL RESPONSIBILITIES OF THE PARTIES.
5.7.1 The Parties will keep each other advised of significant market,
economic, regulatory and other developments that may affect the Promotion of the
Product in the Territory by the Parties pursuant to this Agreement.
5.7.2 Each Party will report promptly to the other Party all other
significant information concerning any complaint of any kind regarding the
Product, its labeling, quality or packaging, including, without limitation, any
adverse drug experience not reported under the Technical Agreement.
ARTICLE 6
COSTS AND EXPENSES.
6.1 JOINT MARKETING AND PROMOTION COSTS AND EXPENSES.
*** Certain confidential information contained in this document, marked with 3
asterisks, has been omitted and filed separately with the Securities and
Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act
of 1934, as amended.
26
6.1.1 During each Commitment Year, excluding GSK's cost and expense
obligations in SECTION 6.3. below, Allergan will be responsible for all budgeted
Promotion costs and expenses set forth in the Marketing Plan for such Commitment
Year for the Primary Product only, which expenses are ***, pro rated as
necessary, which costs and expenses will be paid for directly by Allergan.
During each Commitment Year, GSK may be responsible for a share of all budgeted
Promotion costs and expenses set forth in the Marketing Plan for such Commitment
Year for the Primary Product only, which are ***, if any.
6.1.2 During each Commitment Year, GSK will be responsible for
production and provision of all Product Promotional Materials and Sample costs
as set forth below in SECTION 6.3 (GSK COSTS AND EXPENSES) and for all Promotion
and Marketing costs and expenses for the Additional Neuro Product as set forth
in the Marketing Plan for such Commitment Year.
6.2 ALLERGAN COSTS AND EXPENSES. Allergan will be responsible for the
following costs and expenses which are incurred by Allergan in each Commitment
Year:
6.2.1 ALLERGAN CO-PROMOTION COSTS AND EXPENSES. All other costs and
expenses incurred by Allergan in its Promotion of the Product in the Territory
pursuant to SECTION 3.2.2 (CO-PROMOTION) that are not included in Allergan's
obligations pursuant to SECTION 6.1 (JOINT MARKETING AND PROMOTION COSTS AND
EXPENSES).
6.2.2 ALLERGAN DETAIL RELATED COSTS AND EXPENSES.
(A) All costs and expenses associated with the delivery of
Details with respect to the Allergan Minimum Details Commitment pursuant to
SECTION 3.2.6 (DETAILS).
(B) All costs and expenses related to Allergan's own sales
deployment and internal distribution of Product Promotional Materials under this
Agreement, including its Direct Detailing Expenses, but excluding costs for
Samples.
(C) All costs and expenses related to Allergan's distribution of
the Product Promotional Materials to its PSRs and Sales Management Team and
Allergan's efforts to ensure use only of Product Promotional Materials approved
as provided under this Agreement pursuant to SECTION 3.3.1 (PRODUCT PROMOTIONAL
MATERIALS).
(D) All costs and expenses incurred in connection with Allergan's
participation at any JCC meetings as set forth in SECTION 2.1.1 (STRUCTURE).
(E) All costs and expenses incurred in connection with an
Allergan employee's attendance at any Training Program pursuant to SECTION 3.3.3
(SALES TRAINING), including without limitation air and rail travel, hotel
accommodations and meals.
6.2.3 OTHER ALLERGAN COSTS AND EXPENSES.
*** Certain confidential information contained in this document, marked with 3
asterisks, has been omitted and filed separately with the Securities and
Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act
of 1934, as amended.
27
(A) All costs and expenses related to Allergan's obligations to
compile and generate all reports, including, without limitation, under SECTION
3.2.7 (DATA COLLECTION AND REPORTING SYSTEMS) and SECTION 3.2.9 (QUARTERLY
REPORTS).
(B) All payments of net wages, incentive compensation and fringe
benefits, if any, to Allergan's Personnel as well as costs and expenses
associated with liability and Workers' Compensation insurance coverage
applicable to such Personnel.
(C) All costs and expenses of Allergan incurred in complying with
SECTION 3.2.10 (EMPLOYMENT QUALIFICATIONS) and SECTION 3.2.11 (INELIGIBLE
Persons).
(D) All costs and expenses of Allergan as set forth in SECTION
4.2 (SHIPPING OF SAMPLES).
(E) Subject to GSK's obligation to co-fund such costs in SECTION
6.3.2(H) below, all costs and expenses incurred by Allergan in connection with
obtaining national and territory/physician level Primary Product Target
Audience, Additional Neuro Product Target Audience and Neurologist Segment total
and new prescription data, which data is in addition to what is purchased by GSK
in the ordinary course of business prior to the Effective Date.
6.3 GSK COSTS AND EXPENSES. GSK will be responsible for the following costs
and expenses which are incurred by GSK in each Commitment Year:
6.3.1 GSK CO-PROMOTION COSTS AND EXPENSES. All other costs and
expenses incurred by GSK in its Promotion of the Product in the Territory
pursuant to SECTION 3.2.2 (CO-PROMOTION) that are not included in GSK's
obligations pursuant to SECTION 6.1 (JOINT MARKETING AND PROMOTION COSTS AND
EXPENSES).
6.3.2 GSK DETAIL RELATED COSTS AND EXPENSES.
(A) All costs and expenses related to GSK's own sales deployment
and internal distribution of Product Promotional Materials under this Agreement,
including its Direct Detailing Expenses.
(B) All costs and expenses related to GSK's production and
provision of the Product Promotional Materials to either GSK or Allergan PSRs
for the Product as set forth in SECTION 3.3.1 (PRODUCT PROMOTIONAL MATERIALS).
(C) All costs and expenses related to GSK's distribution of the
Product Promotional Materials to its PSRs and Sales Management Team provided
under this Agreement pursuant to SECTION 3.3.1 (PRODUCT PROMOTIONAL MATERIALS).
(D) All costs and expenses incurred in connection with the
training of any GSK employee or agent regarding the Promotion of Product in the
Territory.
*** Certain confidential information contained in this document, marked with 3
asterisks, has been omitted and filed separately with the Securities and
Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act
of 1934, as amended.
28
(E) All costs and expenses related to GSK's conducting of the
Training Program pursuant to SECTION 3.3.3 (SALES TRAINING), including the cost
of producing and distributing training materials to Allergan, and the costs of
its designated training personnel.
(F) All costs and expenses incurred in connection with compiling
and generating all GSK reports required under this Agreement, including, without
limitation, as set forth in SECTION 3.2.9 (QUARTERLY REPORTS).
(G) All costs and expenses incurred in connection with GSK's
participation at any JCC meetings as set forth in SECTION 2.1.1 (STRUCTURE).
(H) All costs and expenses incurred by GSK in connection with
obtaining national and territory/physician level Primary Product Target
Audience, Additional Neuro Product Target Audience and Neurologist Segment total
and new prescription data, and *** costs and expenses incurred by Allergan under
SECTION 6.2.3(E) above directly related to Allergan's acquisition of
territory/physician level Primary Product Target Audience, Additional Neuro
Product Target Audience and Neurologist Segment total and new prescription data,
***.
6.3.3 GSK MANUFACTURING, DISTRIBUTION, SALE AND SAMPLE COSTS AND
EXPENSES.
(A) All costs and expenses related to GSK's distribution and
provision of Samples to Allergan pursuant to ARTICLE 4 (SAMPLES).
(B) All costs and expenses related to GSK's obligations under
SECTION 3.3.7 (MANUFACTURING; DISTRIBUTION; AND SALE OF PRODUCT). Such costs and
expenses include those incurred by the activities relating to manufacture,
supply and distribution of the Product (including Samples, which, manufacturing
and supply costs will be at GSK's expense) in the Territory, including, without
limitation, order processing, inventory warehousing, delivery to customers,
invoicing and collection of receivables. In addition, GSK will pay any and all
rebates, chargebacks and discounts that have been approved by GSK.
6.3.4 OTHER GSK COSTS AND EXPENSES.
(A) All costs and expenses related to GSK's obligations to
compile and generate statements under this Agreement, including, without
limitation under SECTION 7.2.1 (PAYMENT OF COMPENSATION PAYMENTS; STATEMENTS).
(B) All costs and expenses arising from managed care,
Medicare/Medicaid execution, personnel, and other related costs associated with
Product in the Territory as set forth in SECTION 3.2.6 (MANAGED CARE AND
REIMBURSEMENT).
(C) All payments of net wages, incentive compensation and fringe
benefits, if any, to GSK's Personnel as well as costs and expenses associated
with liability and Workers' Compensation insurance coverage applicable to such
Personnel.
*** Certain confidential information contained in this document, marked with 3
asterisks, has been omitted and filed separately with the Securities and
Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act
of 1934, as amended.
29
(D) Any and all costs and expenses associated with the efforts of
GSK to continue existing and planned pre-clinical and clinical development and
line extensions of the Product, pursuant to SECTION 3.3.9 (ON-GOING DEVELOPMENT
AND LINE EXTENSIONS).
(E) All costs and expenses of GSK relating to regulatory
compliance as set forth in ARTICLE 5 (REGULATORY COMPLIANCE).
6.4 ADDITIONAL COSTS AND EXPENSES. In addition to the costs and expenses
set forth in this ARTICLE 6, unless otherwise provided in this Agreement,
Allergan and GSK will be responsible for all other costs and expenses associated
with their respective obligations under this Agreement.
ARTICLE 7
COMPENSATION.
7.1 COMPENSATION ARRANGEMENT.
7.1.1 COMMITMENT TERM PAYMENTS. Subject to the provisions of this
SECTION 7.1, during the Commitment Term, GSK hereby agrees to compensate
Allergan by paying the sum of the Annual Fixed Payment in SECTION 7.1.1(A)
(FIXED PAYMENT) below plus the Primary Product Performance Payment in SECTION
7.1.1(B) (PRIMARY PRODUCT PERFORMANCE PAYMENT) and the Additional Neuro Product
Performance Payment in SECTION 7.1.1(C) (ADDITIONAL NEURO PRODUCT PERFORMANCE
PAYMENT) below, each payable in four (4) Calendar Quarter installments per
Commitment Year as provided in SECTION 7.2 (PAYMENT TERMS).
(A) FIXED PAYMENT. Beginning as of the Co-Promotion Commencement
Date and subject to SECTION 7.2 (PAYMENT TERMS), GSK will pay Allergan on a
Calendar Quarter bases an amount based on a yearly minimum reimbursement payment
for its Promotion of Product as provided in this Agreement equal to *** per
Commitment Year, pro rated as necessary (i.e. ***) per Calendar Quarter, pro
rated as necessary); provided Allergan has met the Allergan Minimum Details
Commitment for Primary Product and Additional Neuro Product for such Commitment
Year as provided in SECTION 3.2.5 (DETAILS).
(B) PRIMARY PRODUCT PERFORMANCE PAYMENT. Subject to SECTION 7.2
(PAYMENT TERMS), GSK will pay to Allergan, on a Calendar Quarter basis, an
amount based on actual Primary Product Net Sales for each Commitment Year, which
are above the Primary Product Baseline for each such Commitment Year (the
"PRIMARY PRODUCT PERFORMANCE PAYMENT") according to the following non-cumulative
schedule, provided that Allergan has satisfied the Allergan Product Minimum
Detail Commitments for the Primary Product for such Commitment Year, as provided
in SECTION 3.2.5 (DETAILS):
PRIMARY PRODUCT NET SALES IN EACH PRIMARY PRODUCT PERFORMANCE PAYMENT*
COMMITMENT YEAR IN EACH COMMITMENT YEAR
--------------------------------- -----------------------------------
*** Certain confidential information contained in this document, marked with 3
asterisks, has been omitted and filed separately with the Securities and
Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act
of 1934, as amended.
30
PRIMARY PRODUCT NET SALES IN EACH PRIMARY PRODUCT PERFORMANCE PAYMENT*
COMMITMENT YEAR IN EACH COMMITMENT YEAR
--------------------------------- ------------------------------------
*** ***
* by way of example only, ***. Such Primary Product Performance Payment is
subject to SECTION 7.2 (PAYMENT TERMS) and would be paid on a Calendar
Quarter basis as provided therein.
(C) ADDITIONAL NEURO PRODUCT PERFORMANCE PAYMENT. Subject to
SECTION 7.2 (PAYMENT TERMS), GSK will pay to Allergan, on a Calendar Quarter
basis, an amount based on actual Additional Neuro Product Net Sales for each
Commitment Year that are above the Additional Neuro Product Baseline for each
such Commitment Year (the "ADDITIONAL NEURO PRODUCT PERFORMANCE PAYMENT")
according to the following non-cumulative schedule, provided that Allergan has
satisfied the Allergan Product Minimum Detail Commitments for the Additional
Neuro Product for such Calendar Quarter, as set forth in the Marketing Plan
based upon the Commitment Year Detail requirements as provided in SECTION 3.2.5
(DETAILS):
ADDITIONAL NEURO PRODUCT NET SALES IN ADDITIONAL NEURO PRODUCT PERFORMANCE
EACH COMMITMENT YEAR PAYMENT IN EACH COMMITMENT YEAR*
------------------------------------- ------------------------------------
*** ***
***
* by way of example only, ***. Such Additional Neuro Product Performance
Payment is subject to SECTION 7.2 (PAYMENT TERMS) and would be paid on a
Calendar Quarter basis as provided therein..
7.1.2 RESIDUAL TERM PAYMENTS. Subject to SECTION 4.5 (RETURN OF
SAMPLES) and SECTION 7.2 (PAYMENT TERMS), Allergan will, in further
consideration for the Promotion and Detailing of Product as provided herein, be
entitled to a payment during the Residual Term after the Commitment Term (the
"RESIDUAL TERM ROYALTY"); provided that Allergan has satisfied the Allergan
Product Minimum Detail Commitments for *** during the Commitment Term for the
Primary Product, as provided in SECTION 3.2.5 (DETAILS). Such Residual Term
Royalty will be based on Net Sales from the Primary Product Target Audience
during the Residual Term, according to the schedule below.
YEAR DURING THE RESIDUAL TERM ROYALTY AS % OF PRIMARY PRODUCT TARGET AUDIENCE NET
SALES IN EXCESS OF THE PRIMARY PRODUCT BASELINE
----------------------------- ---------------------------------------------------
*** ***
*** Certain confidential information contained in this document, marked with 3
asterisks, has been omitted and filed separately with the Securities and
Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act
of 1934, as amended.
31
7.1.3 ADJUSTMENTS FOR FAILURE OF THE PARTIES TO MEET CERTAIN
OBLIGATIONS.
(A) PRIMARY PRODUCT FAILURE.
(i) If (A) GSK is unable to fulfill at least *** of
outstanding purchase orders from Third Parties for Primary Product in the
Territory as provided in SECTION 3.3.7 (MANUFACTURING; DISTRIBUTION; AND SALE OF
PRODUCT) or supply at least *** of the quantities Samples for Primary Product
that Allergan is entitled to receive as set forth in the Marketing Plan, (in
each case other than as a result of an event arising under SECTION 13.9 (FORCE
MAJEURE), any direct or indirect act or omission of Allergan, or any action of
any governmental agency or authority or court injunction), including, but not
limited to, any manufacturing recall, or, if (B) GSK is otherwise prevented or
prohibited from marketing, distributing or selling the Primary Product in the
Territory for any reason (other than as a result of an event arising under
SECTION 13.9 (FORCE MAJEURE), any direct or indirect act or omission of
Allergan, or any action of any governmental agency or authority or court
injunction), including, without limitation, as a result of any action of any
Primary Product safety concerns on the part of GSK (each situation in (A) and
(B) referred to as a "PRIMARY PRODUCT FAILURE"), then as to each Primary Product
Failure set forth in (A) and (B), GSK will have *** from the commencement date
of such Primary Product Failure to cure such Primary Product Failure. If after
such *** period, such Primary Product Failure has not been cured and solely as a
result of such Primary Product Failure (e.g., not because Allergan is in breach
of this Agreement, such as, by way of example only, failing to have the minimum
number of PSRs as provided in SECTION 3.2.3(B) (MINIMUM PSRS)), Allergan does
not meet the Allergan Minimum Detail Commitments for the Commitment Year for the
Primary Product during the period when any such Primary Product Failure
occurred, Allergan will be deemed to have met the Allergan Minimum Detail
Commitments for Primary Product for the purposes of SECTION 7.1.1(A) (FIXED
PAYMENTS) during such period. In addition, GSK will pay Allergan, for each
Calendar Quarter during which such Primary Product Failure exists until another
Neurology product has been selected to replace the Primary Product or the
Details for the Primary Product have been reallocated to Additional Neuro
Product as provided in SECTION 7.1.3(A)(II), the Primary Product Performance
Payment amount owed for the Calendar Quarter immediately preceding the Calendar
Quarter in which the Primary Product Failure occurred, pro-rated as necessary to
apply solely to the period of such Primary Product Failure.
(ii) If a Primary Product Failure exists with respect to
Product as referenced in (A) in SECTION 7.1.3(A)(I) above during each month of a
*** period during the Commitment Term, or if a Primary Product Failure with
respect to Samples as referenced in (A) in SECTION 7.1.3(A)(I) above during each
month of a *** period during the Commitment Term, or if a Primary Product
Failure exists with respect to Product as referenced in (B) in SECTION
7.1.3(A)(I) above during each month of a *** period during the Commitment Term,
then at such time, Allergan may require, through the JCC, that GSK in its sole
discretion either (A) substitute another agreed upon Neurology product to
replace the Primary Product, or (B) reallocate the Allergan Minimum Detail
Requirements for the Primary Product to the Additional Neuro Product for the
remainder of the Commitment Term and create a new performance structure that
*** Certain confidential information contained in this document, marked with 3
asterisks, has been omitted and filed separately with the Securities and
Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act
of 1934, as amended.
32
would enable Allergan to earn at least the same Primary Product Performance
Payment as it received in the immediately preceding Commitment Year with respect
to the Primary Product.
(iii) If there is not at least one valid and enforceable
patent claiming the Primary Product in the Territory, or if there is not
regulatory exclusivity covering (e.g., pediatric exclusivity) the Primary
Product in the Territory, in either case at any time during the Commitment Term,
then at such time, Allergan may require, through the JCC, that GSK in its sole
discretion either (A) substitute another agreed upon Neurology product to
replace the Primary Product, or (B) reallocate the Allergan Minimum Detail
Requirements for the Primary Product to the Additional Neuro Product for the
remainder of the Commitment Term and create a new performance structure that
would enable Allergan to earn at least the same Primary Product Performance
Payment as it received in the immediately preceding Commitment Year with respect
to the Primary Product.
(B) ADDITIONAL NEURO PRODUCT FAILURE. If (A) GSK is unable to
fulfill at least *** of outstanding purchase orders from Third Parties for
Additional Neuro Product in the Territory as provided in SECTION 3.3.7
(MANUFACTURING; DISTRIBUTION; AND SALE OF PRODUCT) or supply at least *** of the
quantities Samples for Additional Neuro Product that Allergan is entitled to
receive as set forth in the Marketing Plan, (in each case other than as a result
of an event arising under SECTION 13.9 (FORCE MAJEURE), any direct or indirect
act or omission of Allergan, or any action of any governmental agency or
authority or court injunction), including, but not limited to, any manufacturing
recall, or, (B) GSK is otherwise prevented or prohibited from marketing,
distributing or selling the Additional Neuro Product in the Territory for any
reason (other than as a result of an event arising under SECTION 13.9 (FORCE
MAJEURE), any direct or indirect act or omission of Allergan, or any action of
any governmental agency or authority or court injunction), including, without
limitation, as a result of any action of any Additional Neuro Product safety
concerns on the part of GSK (each situation in (A) and (B) referred to as a
"ADDITIONAL NEURO PRODUCT FAILURE"), then as to each Additional Neuro Product
Failure set forth in (A) and (B), GSK will have forty-five (45) consecutive days
from the commencement date of such Additional Neuro Product Failure to cure such
Additional Neuro Product Failure. If after such forty-five (45) consecutive day
period, such Additional Neuro Product Failure has not been cured and solely as a
result of such Additional Neuro Product Failure (e.g., not because Allergan is
in breach of this Agreement, such as, by way of example only, failing to have
the minimum number of PSRs as provided in SECTION 3.2.3(B) (MINIMUM PSRS)),
Allergan does not meet the Allergan Minimum Detail Commitments for the
Commitment Year for the Additional Neuro Product during the period when any such
Additional Neuro Product Failure occurred, Allergan will be deemed to have met
the Allergan Minimum Detail Commitments for Additional Neuro Product for the
purposes of SECTION 7.1.1(A) (FIXED PAYMENTS) during such period. Further, GSK
will pay Allergan, for each Calendar Quarter during which such Additional Neuro
Product Failure exists, the Additional Neuro Product Performance Payment amount
owed for the Calendar Quarter immediately preceding the Calendar Quarter in
which the Additional Neuro Product Failure occurred, pro-rated as necessary to
apply solely to the period of such Additional Neuro Product Failure.
*** Certain confidential information contained in this document, marked with 3
asterisks, has been omitted and filed separately with the Securities and
Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act
of 1934, as amended.
33
(C) FAILURE BY ALLERGAN TO MEET MINIMUM COMMITMENTS. If Allergan
does not meet the Allergan Minimum Details Commitment as defined in SECTION
3.2.5 (DETAILS) of this Agreement for any Commitment Year for reasons unrelated
to a Primary Product Failure or an Additional Neuro Product Failure, the
following in this SECTION 7.1.3(C) will apply. For every *** Details below the
Minimum Details Commitment which are not performed by Allergan for a given
Commitment Year, Allergan will pay to GSK, or GSK will be entitled to reduce the
Fixed Payment by, an amount equal to ***, pro rated as necessary.
7.1.4 EFFECT OF TERMINATION ON PAYMENTS.
(A) TERMINATION PRIOR TO END OF COMMITMENT TERM. In the event
that Allergan terminates this Agreement prior to the end of the Commitment Term
for any reason, other than for cause under SECTION 12.2 (TERMINATION OF CAUSE),
effective as of the effective date of such termination, Allergan will not be
entitled to receive further payments under this SECTION 7.1 except for
previously owed or accrued amounts that have not yet been paid to Allergan (if
any).
(B) TERMINATION AFTER COMMITMENT TERM. In the event that this
Agreement has not been terminated pursuant to ARTICLE 12 (TERM AND TERMINATION)
prior to the end of the Commitment Term, Allergan will be compensated according
to the Residual Term Royalty in SECTION 7.1.2 (RESIDUAL TERM ROYALTY) above.
7.2 PAYMENT TERMS.
7.2.1 PAYMENT OF COMPENSATION PAYMENTS. Subject to the other terms of
this Agreement, GSK will make any compensation payments owed to Allergan in
United States Dollars, within sixty (60) days following the end of each Calendar
Quarter during the Commitment Term using the wire transfer provisions of SECTION
7.2.3 (WIRE TRANSFERS). With respect to the first Commitment Year (and for
information purposes for each subsequent Commitment Year), each compensation
payment will be accompanied by a written statement for the Calendar Quarter
covered by such statement, specifying: the Net Sales in the Territory showing
deductions specified in SECTION 1.35 (NET SALES); the applicable compensation
rate under this Agreement, applying the terms of SECTION 7.1 (COMPENSATION
ARRANGEMENT); and the compensation payments payable in United States Dollars.
The Fixed Payment component of such Calendar Quarter payment will be *** and
will be subject to reduction by GSK at the end of each Commitment Year pursuant
to SECTION 7.1.3(C) (FAILURE BY ALLERGAN TO MEET MINIMUM COMMITMENTS).
(A) During each Commitment Year, the portion of the Primary
Product Performance Payment due after each Calendar Quarter will be based on a
comparison of actual Net Sales reported in the above statement, during such
Calendar Quarter to twenty five percent (25%) of the Primary Product Baseline
and applying the difference on an quarterly basis to the schedule in SECTION
7.1.1(B) (PRIMARY PRODUCT PERFORMANCE PAYMENT). At the end of each Commitment
Year the Parties will determine the actual Primary Product Performance Payment
*** Certain confidential information contained in this document, marked with 3
asterisks, has been omitted and filed separately with the Securities and
Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act
of 1934, as amended.
34
due for such Commitment Year based on actual Net Sales for such Commitment Year
and adjust the final Calendar Quarter Payment for such Commitment Year
accordingly.
(B) During each Commitment Year, the portion of the Additional
Neuro Product Performance Payment due after each Calendar Quarter will be based
on a comparison of actual Net Sales reported in the above statement, during such
Calendar Quarter to twenty five percent (25%) of the Additional Neuro Product
Baseline and applying the difference on an quarterly basis to the schedule in
SECTION 7.1.1(C) (ADDITIONAL NEURO PRODUCT PERFORMANCE PAYMENT). At the end of
each Commitment Year the Parties will determine the actual Additional Neuro
Product Performance Payment due for such Commitment Year based on actual Net
Sales for such Commitment Year and adjust the final Calendar Quarter Payment for
such Commitment Year accordingly.
(C) An example of the calculation of the Primary Product
Performance Payments on a Calendar Quarter basis and annual true up described in
SECTION 7.2.1(A) above is provided in EXHIBIT D to this Agreement. The
calculation for the Additional Neuro Product Net Sales on a Calendar Quarter
basis and annual true up as described in Section 7.2.1(a) would be performed in
the same manner as provided in the example in Exhibit D using the Additional
Neruo Product Baseline.
7.2.2 TAXES. GSK may withhold taxes, duties, levels fees or charges if
revenue authorities in such country require the withholding of taxes, duties,
levies, fees or charges on any amounts paid or owed by GSK hereunder. GSK will
deduct any such taxes, duties, levies, fees or charges from such payment and
will pay such taxes, duties, levies, fees or charges to the property taxing
authority on behalf of the payee. GSK agrees to assist and, to the extent
provided by the relevant taxing authority, provide evidence of payment of such
tax promptly to Allergan in claiming exemption from such deductions or
withholdings under any applicable double taxation or similar agreement or
treaty.
7.2.3 WIRE TRANSFERS. All payments hereunder will be made to Allergan
by bank wire transfer in immediately available funds to Allergan in accordance
with the wire instructions set forth below, which may be changed only by written
notice to GSK from the Chief Financial Officer of Allergan under SECTION 13.7
(NOTICES).
***
7.2.4 OVERDUE COMPENSATION PAYMENTS. Subject to the other terms of
this Agreement, compensation payments not paid to Allergan within the time
period set forth in this ARTICLE 7 will bear interest at an annual rate of ***.
*** Certain confidential information contained in this document, marked with 3
asterisks, has been omitted and filed separately with the Securities and
Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act
of 1934, as amended.
35
ARTICLE 8
RECORD KEEPING; REPORTING AND AUDITS
8.1 DETAILS AND SAMPLES. The Parties will keep complete and accurate
records of (i) all Details delivered by the PSRs and the District Managers, and
(ii) with respect to Samples delivered by the PSRs, the quantity and dates of
delivery of such Samples to each physician. Each Party also will keep its copies
of the completed Sample Receipt Forms. In addition, Allergan will keep complete
and accurate records of all of its costs and expenses for Promotion under this
Agreement (except for Direct Detailing Expenses).
8.2 COMPENSATION PAYMENTS. GSK and its Affiliates will keep, for at least
one (1) year from the end of the Commitment Year to which they pertain, complete
and accurate records of sales by GSK and its Affiliates of the Product in the
Territory, in sufficient detail to allow the accuracy of the compensation
payments to be confirmed as set forth in SECTION 8.3 (FINANCIAL AUDIT RIGHTS).
8.3 FINANCIAL AUDIT RIGHTS.
8.3.1 Subject to the other terms of this SECTION 8.3.1, at the request
of either Party upon at least thirty (30) business days' prior written notice
from the requesting Party to the other Party, not more than once in any calendar
year, and at the expense of the requesting Party (except as otherwise provided
herein), the other Party will permit an independent certified public accountant
reasonably selected by the requesting Party and reasonably acceptable to the
other Party to inspect (during regular business hours) the relevant records
required to be maintained by the other Party under this SECTION 8.3.1. At
Allergan's request, the accountant will be entitled to review the then-preceding
three (3) years of GSK's records as provided under SECTION 8.1 (DETAILS AND
SAMPLES) and the then-preceding one (1) year of GSK's records as provided under
SECTION 8.2 (COMPENSATION PAYMENTS) for purposes of (i) verifying Allergan's
compensation payments, including verification of GSK's Net Sales, and GSK's
determination of numbers of Details and Samples provided by GSK and its
Affiliates under SECTION 3.2.5 (DETAILS), or (ii) complying with the
Xxxxxxxx-Xxxxx Act of 2002, as amended, including, but not limited to all United
States Securities an Exchange Commission (SEC) rules and regulations relating
thereto. At GSK's request, the accountant will be entitled to review the
then-preceding three (3) years of Allergan's records as provided under SECTION
8.1 (DETAILS AND SAMPLES) for purposes of verifying Allergan's costs and
expenses for Marketing and Promotion under this Agreement (except for Direct
Detailing Expenses) and determination of numbers of Details and Samples provided
by Allergan under SECTION 3.2.5 (DETAILS). In every case the accountant must
have previously entered into a confidentiality agreement with both Parties
substantially similar to the provisions of ARTICLE 9 (CONFIDENTIALITY) and
limiting the disclosure and use of such information by such accountant to
authorized representatives of the Parties and the purposes germane to this
SECTION 8.3.1. Results of any such review will be made available to both Parties
and will be binding on both Parties.
*** Certain confidential information contained in this document, marked with 3
asterisks, has been omitted and filed separately with the Securities and
Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act
of 1934, as amended.
36
If any review reveals a deficiency in the calculation of compensation
payments resulting from any underpayment by GSK, GSK will, within thirty (30)
days pay Allergan the amount remaining to be paid (plus interest thereon at the
rate provided in SECTION 7.2.4 (OVERDUE COMPENSATION PAYMENTS) above), and if
such underpayment is by *** or more, GSK will also pay all costs and expenses of
the review. If any review reveals an error in the calculation of compensation
payments resulting in an overpayment by GSK, Allergan will, within thirty (30)
days pay to GSK such overpayment. If any review reveals that Allergan has not
met the Allergan Minimum Details Commitment as defined in SECTION 3.2.5
(DETAILS) for any Commitment Year, then SECTION 7.1.3(C) (FAILURE BY ALLERGAN TO
MEET MINIMUM COMMITMENTS) will apply, and if any review reveals that Allergan
has not met its funding for Promotional expenses as set forth in SECTION 6.1
(JOINT MARKETING AND PROMOTION COSTS AND EXPENSES), then Allergan will, within
thirty (30) days pay to GSK the amount remaining to be paid.
8.3.2 Subject to the other terms of this SECTION 8.3.2, at the request
of Allergan upon at least thirty (30) business days' prior written notice to
GSK, not more than once in any calendar year, and at the expense of Allergan
(except as otherwise provided herein), GSK will permit an independent auditor
reasonably selected by Allergan and reasonably acceptable to GSK to inspect
(during regular business hours) the relevant records required to be maintained
by GSK under this SECTION 8.3.2. At Allergan's request, the auditor will be
entitled to review the then-preceding two (2) years of GSK's records regarding
the allocation factors applied to the data obtained as provided in EXHIBIT A to
this Agreement, including all prescription source data for both the Neurologist
Segment and PCP's, *** as to the PCP allocation factor, in all cases for both
Primary Product and Additional Neuro Product for purposes of verifying GSK's Net
Sales during such period. The auditor must have previously entered into a
confidentiality agreement with both Parties substantially similar to the
provisions of ARTICLE 9 (CONFIDENTIALITY) and limiting the disclosure and use of
such information by such auditor to authorized representatives of Allergan and
the purposes germane to this SECTION 8.3.2. Results of any such review will be
made available to both Parties and will be binding on both Parties.
If any review reveals a deficiency in the calculation Net Sales
attributable to the Neurologist Segment and to PCP's as set forth in Exhibit A
to this Agreement, resulting in any underpayment by GSK, GSK will, within thirty
(30) days, pay Allergan the amount remaining to be paid (plus interest thereon
at the rate provided in SECTION 7.2.4 (OVERDUE COMPENSATION PAYMENTS) above),
and if such deficiency in the calculation of Net Sales is *** or more, GSK will
also pay all costs and expenses of the review; provided, however, that if
notwithstanding a deficiency in the calculation of Net Sales that is *** or
more, Allergan is not entitled to receive any additional compensation from GSK
notwithstanding such deficiency (such as, for the purposes of example only, if
Primary Product Net Sales in a Commitment Year, even after such review, are
equal to or less than the Primary Product Baseline and Allergan would still not
be entitled to receive any Primary Product Performance Payment in such
Commitment Year), then GSK will not be obligated to pay any costs and expenses
of the review. If any review reveals an excess in the calculation of Net Sales
resulting in any overpayment by GSK, Allergan will, within thirty (30) days, pay
GSK any excess compensation payments received during such period.
*** Certain confidential information contained in this document, marked with 3
asterisks, has been omitted and filed separately with the Securities and
Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act
of 1934, as amended.
37
8.4 MONTHLY AND QUARTERLY REPORTS. Within fifteen (15) business days after
the end of each month during each Commitment Term, each Party will provide to
the other Party the raw data of Sales Call activity, and within forty (40) days
after the end of each month during the Commitment Term, each Party will provide
the other Party with Sample disbursements for the immediately preceding month,
all as provided in the remainder of this SECTION 8.4. All such monthly reports
will be in the form of a written report, and, at the other Party's option, an
electronic file, each formatted in such manner as may be reasonably requested by
the other Party (taking into account each Party's existing computer systems),
for each Sales Territory and on a cumulative basis for the entire Territory,
setting forth the following information (and such modifications and/or
additional Product-related information as either Party may reasonably request
from time to time, particularly to satisfy accounting, regulatory or legal
requirements):
8.4.1 the number of Primary and Secondary Details delivered by each
PSR during such month and on a cumulative basis for all PSRs and District
Managers for such month;
8.4.2 the number of Primary and Secondary Details delivered by the
PSRs to each physician during such month, sorted by delivery to physicians who
are and who are not included in the Primary Product Target Audience and
Additional Neuro Product Target Audience;
8.4.3 the total number of Samples delivered by each PSR during the
preceding month and on a cumulative basis for all PSRs and District Managers
during the immediately preceding month;
8.4.4 the number of Samples delivered to each physician by the PSRs
and District Managers during the immediately preceding month, which report will
also identify each such physician as either a Target Physician or a non-Target
Physician;
8.4.5 the number of Samples remaining in inventory and in each PSRs
and each District Manager's inventory on the last day of the immediately
preceding month;
8.4.6 the calculated percentage of total Details delivered by the PSRs
during such month which were Details to the Primary Product Target Audience and
the Additional Neuro Product Target Audience;
8.4.7 from GSK only, a calculation of the estimated Net Sales and
estimated portion of the Primary Product Performance Payment and Additional
Neuro Product Performance Payment applicable for such month; and
8.4.8 from GSK only, a statement of inventory returns to GSK from its
distributors for such month.
After the end of each Calendar Quarter during the Commitment
Term, at the same time as the written statement from GSK set forth in SECTION
7.2.1 (PAYMENT OF COMPENSATION PAYMENTS) above, each Party will provide to the
other Party with a written report, and, at the other Party's option, an
electronic file, each formatted in such manner as may
*** Certain confidential information contained in this document, marked with 3
asterisks, has been omitted and filed separately with the Securities and
Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act
of 1934, as amended.
38
be reasonably requested by the other Party (taking into account each Party's
existing computer systems), for each Sales Territory and on a cumulative basis
for the entire Territory, setting forth the same information as the foregoing
SECTIONS 8.4.1 THROUGH 8.4.8 in this case covering the Calendar Quarter;
provided, however, that GSK's written report to Allergan will accompany its
written statement to Allergan under SECTION 7.2.1 (PAYMENT OF COMPENSATION
PAYMENTS; STATEMENTS) above.
8.5 AUDIT OF WAREHOUSE AND DISTRIBUTION FACILITY. Upon request of GSK,
Allergan will permit GSK or its authorized representatives access to audit, on
an annual basis or more frequently as may be required by Applicable Law,
Allergan's or the Third Party's facility where Allergan stores Samples and
Promotional Materials for distribution to its PSRs, District Managers and Sales
Management Team members. GSK will use Commercially Reasonable Efforts not to
jeopardize or interfere with Allergan's ongoing business operations or
jeopardize Allergan trade secrets in conducting any such audit.
ARTICLE 9
CONFIDENTIALITY
9.1 REQUIREMENTS.
9.1.1 Each Party agrees not to use Confidential Information (as
hereinafter defined) furnished by the other Party for any purpose other than for
purposes of performing its obligations under this Agreement. Each Party will
treat Confidential Information furnished by the other Party with the same degree
of care as it treats its own proprietary information and will not disclose the
same, for a period of *** after the expiration or earlier termination of this
Agreement, to any Third Party without the prior written consent of the Party
which furnished such information.
9.1.2 If, to carry out its obligations under this Agreement, a Party
must disclose Confidential Information of the other Party to a Third Party, such
disclosing Party will first require any such Third Party to be bound by the
confidentiality provisions of this Agreement by requiring such Third Party to
enter into an appropriate written confidentiality agreement. This provision will
not be applicable to confidential information disclosed by the Parties pursuant
to SECTION 9.2 (CONFIDENTIAL INFORMATION) below.
9.2 CONFIDENTIAL INFORMATION. "Confidential Information" refers to all
proprietary technical, business and Marketing information of the other Party
(including, without limitation, the Marketing Plans and training materials
provided to Allergan by GSK as part of the Training Program, each of which will
constitute GSK Confidential Information) disclosed by one Party to the other
pursuant to this Agreement. Notwithstanding the foregoing or any other provision
in this Agreement to the contrary, a Party's Confidential Information will not
include:
*** Certain confidential information contained in this document, marked with 3
asterisks, has been omitted and filed separately with the Securities and
Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act
of 1934, as amended.
39
9.2.1 information which at the time of disclosure is in the public
domain or thereafter becomes part of the public domain through no breach of this
Agreement by the receiving Party;
9.2.2 information which the receiving Party can establish by competent
written proof was in its possession at the time of disclosure by the disclosing
Party and was not acquired, directly or indirectly, from the disclosing Party;
9.2.3 information which the receiving Party receives from a Third
Party; provided, however, that such information was not obtained by said Third
Party, directly or indirectly from the disclosing Party; or
9.2.4 information or data which is independently developed by the
receiving Party without the reference to or any other use of the disclosing
Party's Confidential Information.
9.3 GSK DATA PROTECTIONS. Allergan agrees and understands that Confidential
Information of GSK, including but not limited to, data disclosed to Allergan
through the JCC or otherwise and arising under or related to Product, is very
sensitive and GSK would not enter into this Agreement without additional
assurances from Allergan with respect to Allergan's use of such Confidential
Information or possible disclosure of such Confidential Information to GSK's
competitors. Accordingly, Allergan will not use, and will cause its Affiliates
not to use, directly or indirectly, any Confidential Information of GSK in
connection with any neurology product other than as provided under this
Agreement.
9.4 DISCLOSURE REQUIRED BY LAW. Notwithstanding anything else in this
Agreement, the receiving Party will not be prohibited from disclosing
Confidential Information of the disclosing Party to the extent such information
is required to be disclosed to governmental agencies or by legal process or
Applicable Laws, in which case the receiving Party will notify the disclosing
Party in writing of the need for such disclosure and will cooperate with the
disclosing Party to seek confidential treatment of the information.
9.5 REMEDIES. The receiving Party agrees that its obligations hereunder are
necessary and reasonable to protect the disclosing Party's business interests
and that the unauthorized disclosure or use of Confidential Information of a
disclosing Party would cause irreparable harm and significant injury, the degree
of which may be difficult to ascertain. The receiving Party further acknowledges
and agrees that in the event of any actual or threatened breach of this
Agreement, the disclosing Party may have no adequate remedy at law and,
accordingly, that the disclosing Party will have the right to seek an immediate
injunction enjoining any breach or threatened breach of this Agreement, as well
as the right to pursue any and all other rights and remedies available at law or
in equity for such breach or threatened breach.
9.6 RETURN OF CONFIDENTIAL INFORMATION. Upon termination of this Agreement
and upon the request of the disclosing Party, the receiving Party will return
all such Confidential
*** Certain confidential information contained in this document, marked with 3
asterisks, has been omitted and filed separately with the Securities and
Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act
of 1934, as amended.
40
Information and copies thereof in its possession; provided, however, that one
(1) copy of the disclosing Party's Confidential Information may be retained by
the legal department of the receiving Party solely for the purpose of
determining compliance with this ARTICLE 9.
9.7 DISCLOSURE OF AGREEMENT, PUBLICITY AND PUBLICATIONS. Except as
expressly provided otherwise in SECTION 9.1 (REQUIREMENTS) or SECTION 9.3
(DISCLOSURE REQUIRED BY LAW), neither GSK nor Allergan will release to any Third
Party or publish in any way any non-public information with regard to the terms
of this Agreement or concerning their cooperation without the prior written
consent of the other, which consent will not be unreasonably withheld or
delayed. Subject to the foregoing, the Allergan will issue a press release,
public statement or disclosure regarding this Agreement, which press release,
public statement or disclosure will be mutually agreed upon by the Parties.
Nothing in the foregoing, however, will prohibit a Party from making disclosures
to the extent deemed necessary under applicable federal or state securities laws
or any rule or regulation of any nationally recognized securities exchange. In
such event, however, the disclosing Party will use good faith efforts to consult
with the non-disclosing Party prior to such disclosure and will request
confidential treatment to the extent available. Allergan acknowledges and agrees
that GSK will have the right, without obtaining Allergan's prior consent, to
submit manuscripts relating to the Product for scientific publications. A copy
of any scientific abstract or manuscript that is submitted for publication will
be provided by GSK to Allergan within thirty (30) days after such submission.
Allergan further acknowledges and agrees that GSK will have the right, without
obtaining Allergan's prior consent, to publish clinical trial results or
summaries of clinical trial results on GSK's Clinical Trial Registry.
ARTICLE 10
REPRESENTATIONS AND WARRANTIES
10.1 MUTUAL REPRESENTATIONS AND WARRANTIES. As of the Effective Date, each
of GSK and Allergan hereby represents, warrants and covenants to the other Party
hereto that:
10.1.1 it is a corporation or entity duly organized and validly
existing under the laws of the State or other jurisdiction of its incorporation
or formation;
10.1.2 the execution, delivery and performance of this Agreement by
such Party has been duly authorized by all requisite corporate action and does
not require any shareholder action or approval;
10.1.3 it has the power and authority to execute and deliver this
Agreement and to perform its obligations hereunder and this Agreement
constitutes and when executed will constitute, its legal, valid and binding
obligation, enforceable in accordance with its terms, except as may be limited
by bankruptcy and equitable principles limiting specific performance;
10.1.4 the execution, delivery and performance by such Party of this
Agreement and its compliance with the terms and provisions hereof does not and
will not conflict with or result in a breach of any of the terms and provisions
of or constitute a default under (i) a loan
*** Certain confidential information contained in this document, marked with 3
asterisks, has been omitted and filed separately with the Securities and
Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act
of 1934, as amended.
41
agreement, guaranty, financing agreement, agreement affecting a product or other
agreement or instrument binding or affecting it or its property; (ii) the
provisions of its charter or operative documents or bylaws; or (iii) any order,
writ, injunction or decree of any court or governmental authority entered
against it or by which any of its property is bound; and
10.1.5 during the Term, it and its Affiliates will not, Market (in the
case of GSK only) or Promote the Product in violation of Applicable Law and
professional requirements in the Territory, including but not limited to the
Anti-Kickback Statute and any State Medicare and Medicaid anti-kickback statutes
and regulations, the PDMA and regulations thereunder, the FD&C Act and
regulations thereunder, HIPAA, FDA regulations and guidelines concerning the
advertising of prescription drug products, the American Medical Association's
Guidelines on Gifts to Physicians, the PhRMA Code , the Applicable Commercial
Practices Policies, and any approved updates thereto.
10.2 REPRESENTATIONS AND WARRANTIES OF GSK. As of the Effective Date, GSK
hereby represents, warrants and covenants to Allergan that:
10.2.1 it has the legal power to extend the rights granted to Allergan
in this Agreement necessary to enable Allergan to carry out its obligations and
exercise its rights under this Agreement, and has not made and will not make any
commitments to others inconsistent or in derogation of such rights.
10.3 REPRESENTATIONS AND WARRANTIES OF ALLERGAN. As of the Effective Date,
Allergan hereby represents, warrants and covenants to GSK that:
10.3.1 It is not legally prevented from Promoting or Detailing the
Product as contemplated under this Agreement. Allergan represents and warrants
to GSK that Allergan has the requisite Personnel, facilities, equipment,
expertise, experience and skill to perform its obligations hereunder and to
render the services contemplated hereby; and it covenants that it will perform
the services in a professional, timely, competent and efficient manner. Allergan
further covenants that it will abide by all laws, rules and regulations that
apply to the performance of the services to be performed hereunder (including,
without limitation, the Anti-Kickback Statute and the PDMA), and that in
performing the services to be performed hereunder it will not, nor will the
PSRs, District Managers or Sales Management Team members, engage in the
counseling or promotion of a business arrangement or other activity that
violates any State or Federal Law. When on GSK's premises or a GSK customer's
premises, Allergan personnel will comply with all of GSK's or GSK customer's
policies regarding the conduct of visitors.
10.3.2 Neither Allergan, nor any PSR, District Manager or Sales
Management Team member or other employee or agent of Allergan (i) is currently
excluded, debarred, suspended, or otherwise ineligible to participate in the
Federal health care programs or in Federal procurement or non-procurement
programs; (ii) has been convicted of a criminal offense that falls within the
ambit of 42 U.S.C. Section 1320a-7(a) but has not yet been excluded, debarred,
suspended, or otherwise declared ineligible, or (iii) has been debarred, nor is
currently under
*** Certain confidential information contained in this document, marked with 3
asterisks, has been omitted and filed separately with the Securities and
Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act
of 1934, as amended.
42
investigation by the FDA for debarment action or pursuant to the Generic Drug
Enforcement Act.
ARTICLE 11
INDEMNIFICATION AND INSURANCE.
11.1 INDEMNIFICATION BY ALLERGAN. Allergan will indemnify, defend and hold
GSK, and its officers, directors, agents, employees, and Affiliates
(collectively, the "GSK INDEMNITEES"), harmless from any claims, damages, causes
of action, actions, liabilities, losses, costs and expenses, including costs of
investigation and reasonable attorneys' fees incurred hereunder (hereinafter,
collectively, "CLAIMS") of a Third Party arising out of or in connection with
(i) the material breach by Allergan of any of its representations, warranties,
covenants or obligations under this Agreement; (ii) any activities by any
Allergan Indemnitee that violate any Applicable Law or are inconsistent with the
Marketing Plan, the Product Promotional Materials or any guidelines approved by
the JCC; (iii) any Claims brought by or on behalf of any Allergan PSR, Allergan
District Manager or member of Allergan's Sales Management Team in connection
with their employment or the performance of Allergan's obligations under this
Agreement; and (iv) any negligent act or omission of any Allergan Indemnitee in
the performance of any obligation under this Agreement; provided, however, that
in each of (i) through (iv), Allergan will have no liability as set forth in
this SECTION 11.1 to the extent such Claims are the responsibility of GSK under
SECTION 11.2 (INDEMNIFICATION BY GSK).
11.2 INDEMNIFICATION BY GSK. GSK will indemnify, defend and hold Allergan,
and its officers, directors, agents, employees, and Affiliates (collectively,
the "ALLERGAN INDEMNITEES"), harmless from any Claim of a Third Party arising
out of or in connection with (i) the material breach by GSK of any of its
representations, warranties, covenants or obligations under this Agreement; (ii)
any activities by any GSK Indemnitee that violate any Applicable Law or are
inconsistent with the Marketing Plan, the Product Promotional Materials or what
has been approved by the JCC; (iii) any theory of product liability concerning
the development, testing, manufacture, promotion (but only to the extent that
such Claims do not arise out of conduct covered by Allergan's indemnification
obligations set forth in SECTION 11.1 (INDEMNIFICATION BY ALLERGAN)), sale or
use of the Product by GSK, its Affiliates or its sublicensees; (iv) any Claims
brought by or on behalf of any GSK PSR, GSK District Manager or member of GSK's
Sales Management Team in connection with their employment or the performance of
GSK's obligations under this Agreement; (v) any negligent act or omission of any
GSK Indemnitee in the performance of any obligation under this Agreement; (vi)
any activities or omissions of any GSK Indemnitee unrelated to the Promotion of
Product under this Agreement, whether inside or outside the Territory; and (vii)
any Claims that relate to any GSK arrangement under this Agreement with an
Affiliate or a Third Party other than Allergan to co-promote the Product in the
Territory; provided, however, that in each of (i) through (vii), GSK will have
no liability as set forth in this SECTION 11.2 to the extent such Claims are the
responsibility of Allergan under SECTION 11.1 (INDEMNIFICATION BY ALLERGAN).
*** Certain confidential information contained in this document, marked with 3
asterisks, has been omitted and filed separately with the Securities and
Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act
of 1934, as amended.
43
11.3 PROCEDURE. A Party asserting a claim for indemnification under this
ARTICLE 11 will notify the indemnifying Party in writing of any such claims as
follows: (a) within fifteen (15) days after receipt of service of process of the
commencement of suit, or (b) for non-litigated matters, within thirty (30) days
after receipt of notice thereof; provided, however, that failure to give such
notice will not relieve the indemnifying Party of its obligation to provide
indemnification hereunder except, if and to the extent that such failure
materially and adversely affects the ability of the indemnifying Party to defend
the applicable Claim. The indemnifying Party will be entitled to assume sole
control over the defense of any such claim at its own cost and expense;
provided, however, that the indemnitee will have the right to be represented by
its own counsel at its own cost in such matters. Neither the indemnifying Party
nor the indemnified Party will settle or dispose of any such matter in any
manner which would adversely affect the rights or interests of the other Party
without the prior written consent of the other Party, which will not be
unreasonably withheld or delayed. Each Party will reasonably cooperate with the
other Party and its counsel in the course of the defense of any such Claim, such
cooperation to include without limitation using reasonable efforts to provide or
make available documents, information and witnesses.
11.4 LIMITATION OF LIABILITY. With respect to any claim by one Party
against the other arising out of the performance or failure of performance of
the other Party under this Agreement, the Parties expressly agree that the
liability of such Party to the other Party for such breach will be limited under
this Agreement or otherwise at law or equity to direct damages only. IN NO EVENT
WILL A PARTY BE LIABLE TO THE OTHER PARTY FOR ANY INDIRECT, SPECIAL, PUNITIVE,
EXEMPLARY, INCIDENTAL OR CONSEQUENTIAL DAMAGES, INCLUDING WITHOUT LIMITATION,
LOSS OF PROFIT, LOSS OF BUSINESS , LOSS OF SAVING OR OTHER LOSS. The limitations
set forth in this SECTION 11.4 will not apply with respect to the obligations of
either Party to indemnify the other under SECTIONS 11.1 (INDEMNIFICATION BY
ALLERGAN) or 11.2 (INDEMNIFICATION BY GSK) in connection with a Claim of a third
party.
11.5 INSURANCE. Each Party hereby represents that it currently carries, in
full force and effect, commercial general liability insurance against claims
judgments, liabilities and expenses for which it is obligated to indemnify the
other Party under this ARTICLE 11 , in such amounts and with such deductibles as
are customary at the time for companies engaged in a similar business, and will
provide the other Party with written evidence of such insurance upon request as
well as a certificate of such insurance naming such other Party as an additional
insured. The Party carrying such insurance policy will require at least thirty
(30) days' notice to the other Party prior to cancellation or material change in
such policy.
*** Certain confidential information contained in this document, marked with 3
asterisks, has been omitted and filed separately with the Securities and
Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act
of 1934, as amended.
44
ARTICLE 12
TERM AND TERMINATION
12.1 TERM. The term of this Agreement (the "TERM") will commence as of the
Effective Date and will include the Commitment Term and the Residual Term, as
such terms are defined in this Agreement.
12.1.1 COMMITMENT TERM. The Commitment Term, as defined in SECTION
3.2.5 (DETAILS) above, will be effective as of the Effective Date and, if not
terminated earlier pursuant to another provision of this ARTICLE 12, will
continue until the fifth (5th) anniversary of the Co-Promotion Commencement
Date; subject to a possible extension as set forth in SECTION 12.1.2 below.
12.1.2 EXTENSION OF COMMITMENT TERM. Once Allergan will have met its
Minimum Details Commitment in each Commitment Year during the Commitment Term,
the Parties will have the option to extend the Commitment Term by mutual written
agreement as more fully described in SECTION 3.2.5(C) (COMMITMENT TERM). Other
elements of SECTION 12.1.1 (COMMITMENT TERM) above will remain unchanged. The
Party desiring an extension will provide the other Party with written notice of
any proposed extension at least one hundred eighty (180) days before the end of
the Commitment Term in order to enable the Parties to cooperate on such
extension.
12.1.3 RESIDUAL TERM. Upon the expiration of the Commitment Term and
this Agreement, Allergan will be entitled to the Residual Term Royalty described
in SECTION 7.1.2 (RESIDUAL TERM PAYMENTS) during the *** period immediately
following the expiration of the Commitment Term (the "RESIDUAL TERM"). As of
such commencement of the Residual Term, Allergan's obligations under SECTION
3.2.5 (DETAILS) and any other obligation related to Allergan Minimum Detail
Commitments will terminate. All other obligations of the Parties under this
Agreement will continue in full force and effect, including, but not limited to,
GSK's obligation to continue to compensate Allergan according to ARTICLE 7
(COMPENSATION).
12.2 TERMINATION FOR CAUSE.
12.2.1 MATERIAL BREACH. In the event of a material breach or default
of this Agreement by either Party that is not cured within *** after receipt of
notice thereof from the other Party, the non-breaching Party will be entitled to
terminate this Agreement by giving written notice to the other Party, such
termination to take effect immediately. The right to terminate this Agreement
will not be affected in any way by a waiver of, or failure to take action with
respect to, any previous default.
12.2.2 BANKRUPTCY OR INSOLVENCY. Either Party will have the right to
terminate this Agreement effective upon written notice to the other Party in the
event the non-notifying Party becomes insolvent or makes an assignment for the
benefit of creditors, or in the event
*** Certain confidential information contained in this document, marked with 3
asterisks, has been omitted and filed separately with the Securities and
Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act
of 1934, as amended.
45
bankruptcy or insolvency proceedings are instituted against the non-notifying
Party or on the non-notifying Party's behalf.
12.3 TERMINATION WITHOUT CAUSE. Allergan will have the right to terminate
this Agreement without cause upon one hundred eighty (180) days' advance written
notice to GSK.
12.4 MUTUAL TERMINATION. This Agreement may be terminated at any time by
mutual written consent of the Parties.
12.5 EFFECT OF TERMINATION. Upon any termination or expiration of this
Agreement, Allergan will immediately cease any and all Promotion of the Product
and Allergan will promptly destroy, or will cooperate with GSK in the collection
and return to GSK of, all Product Promotional Materials, scientific literature
relating to the Product, Samples, and other sales or sales training materials in
the possession of Allergan, any Allergan PSR, Allergan District Manager and/or
any member of Allergan's Sales Management Team, as promptly as practical after
the date thereof. The foregoing destruction and/or returns will be at GSK's
expense if this Agreement has been terminated by Allergan under SECTION 12.2
(MATERIAL BREACH) and otherwise will be at Allergan's expense. In the event that
Allergan terminates this Agreement prior to the end of the Commitment Term for
any reason, other than for cause under SECTION 12.2 (MATERIAL BREACH), effective
as of the effective date of such termination, Allergan will not be entitled to
receive further payments under SECTION 7.1 (COMPENSATION ARRANGEMENT) except for
previously owed or accrued amounts that have not yet been paid to Allergan (if
any).
12.6 NO WAIVER OF REMEDIES. Termination of this Agreement will not preclude
either Party from (a) claiming any other damages, compensation or relief that it
may be entitled to upon such termination, (b) any right to receive any amounts
accrued under this Agreement prior to the termination date but which are unpaid
or become payable thereafter and (c) any right to obtain performance of any
obligation provided for in this Agreement which will survive termination.
12.7 SURVIVAL OF CERTAIN PROVISIONS. Termination or expiration of this
Agreement for any reason will terminate all outstanding obligations and
liabilities between the Parties arising out of this Agreement, except:
12.7.1 those described in Section 3.4 (Ownership of Product), Section
5.1 (Marketing Authorization and Regulatory Matters), Article 9
(Confidentiality), Article 11 (Indemnification and Insurance), Section 8.1
(Details and Samples), Section 8.2 (Compensation Payments), Section 8.3
(Financial Audit Rights), Section 12.5 (Effect of Termination), Section 12.6 (No
Waiver of Remedies), this Section 12.7 (Survival of Certain Provisions), Section
13.1 (Integration/ Modification), Section 13.3 (Non-Waiver), Section 13.6
(Severability), Section 13.7 (Notices), Section 13.10 (Dispute Resolution),
Section 13.12 (Jurisdiction and Governing Law), Section 13.13 (Interpretation)
and Section 13.16 (Non-Solicitation), all of which will survive termination or
expiration of this Agreement for the time specified in such Articles and
Sections; provided, however, that if no such time period is specified in such
Articles and Sections, they will all survive termination or expiration of this
Agreement indefinitely;
*** Certain confidential information contained in this document, marked with 3
asterisks, has been omitted and filed separately with the Securities and
Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act
of 1934, as amended.
46
12.7.2 Article 1 (Definitions) for the sole purposes of interpreting
the obligations and liabilities between the Parties surviving termination or
expiration of this Agreement;
12.7.3 and, to the extent applicable, and any remedies for the breach
thereof, will survive the expiration or any termination of this Agreement.
ARTICLE 13
MISCELLANEOUS
13.1 INTEGRATION/MODIFICATION. This Agreement by and between the Parties
hereto, is both a final expression of the Parties' agreement and a complete and
exclusive statement with respect to all of its terms. The Exhibits referred to
in this Agreement are incorporated herein and made a part of this Agreement by
this reference. This Agreement supersedes all prior and contemporaneous
agreements and communications, whether oral, written or otherwise, concerning
any and all matters contained herein, provided, however, that the
confidentiality provisions of ARTICLE 9 (CONFIDENTIALITY) are in addition to and
do not supersede the terms and conditions of the Confidential Disclosure
Agreement between the Parties dated September 27, 2004. No rights or licenses
are granted or deemed granted hereunder or in connection herewith, other than
those rights expressly granted in this Agreement. No trade customs, courses of
dealing or courses of performance by the Parties will be relevant to modify,
supplement or explain any term(s) used in this Agreement. This Agreement may
only be modified or supplemented in a writing expressly stated for such purpose
and signed by the Parties to this Agreement.
13.2 RELATIONSHIP BETWEEN THE PARTIES. The Parties have no ownership
interest in the other and their relationship, as established by this Agreement,
is solely that of independent contractors. This Agreement does not create any
partnership, joint venture or similar business relationship between the Parties.
Neither Party is a legal representative of the other Party, and neither Party
can assume or create any obligation, representation, warranty or guarantee,
express or implied, on behalf of the other Party for any purpose whatsoever.
13.3 NON-WAIVER. The failure of a Party to insist upon strict performance
of any provision of this Agreement or to exercise any right arising out of this
Agreement will neither impair that provision or right nor constitute a waiver of
that provision or right, in whole or in part, in that instance or in any other
instance.
13.4 ASSIGNMENT. This Agreement is binding upon and inures to the benefit
of the Parties, and to their permitted successors and assigns. No Party may
assign or delegate any or all of its rights or obligations under this Agreement
to any Person without the prior written consent of the other Party except that
GSK may assign this Agreement to an Affiliate without the prior written consent
of Allergan. Any assignment or delegation, or any other transfer or change of
control by sale, acquisition, merger, or otherwise, or attempt at the same,
(other than to an Affiliate in the case of GSK), made in the absence of such
prior written consent will be void and
*** Certain confidential information contained in this document, marked with 3
asterisks, has been omitted and filed separately with the Securities and
Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act
of 1934, as amended.
47
without effect; provided, however, that in the event of the foregoing, such
written consent will not be unreasonably withheld.
13.5 NO THIRD PARTY BENEFICIARIES. This Agreement is neither expressly nor
impliedly made for the benefit of any Party other than those executing it.
13.6 SEVERABILITY. If, for any reason, any part of this Agreement is
adjudicated invalid, unenforceable or illegal by a court of competent
jurisdiction, such adjudication will not affect or impair, in whole or in part,
the validity, enforceability or legality of any remaining portions of this
Agreement. All remaining portions will remain in full force and effect as if the
original Agreement had been executed without the invalidated, unenforceable or
illegal part.
13.7 NOTICES. Any notice to be given under this Agreement must be in
writing and delivered either in person, by any method of mail (postage prepaid)
requiring return receipt, or by overnight courier or facsimile confirmed
thereafter by any of the foregoing, to the Party to be notified at its
address(es) given below, or at any address such Party has previously designated
by prior written notice to the other. Notice will be deemed sufficiently given
for all purposes upon the earlier of: (a) the date of actual receipt; (b) if
mailed, three (3) days after the date of postmark; or (c) if delivered by
overnight courier, the next business day the overnight courier regularly makes
deliveries.
If to GSK, notices must be addressed to:
SmithKline Xxxxxxx Corporation d/b/a GlaxoSmithKline
0 Xxxx Xxxxx
Xxxxxxxx Xxxxxxxx Xxxx, Xxxxx Xxxxxxxx 00000
Attention: Senior Vice President, US Pharmaceuticals RTP
Facsimile:
With a copy to:
Xxxxx Xxxxx Xxxxxxx Corporation d/b/a GlaxoSmithKline
0000 Xxxxxxxxxxx Xxxxxxxxx
Xxxx xx Xxxxxxx, XX 00000-0000
Attention: Vice President and Associate General Counsel,
R&D Legal Operations, Business Development Transactions Team
Facsimile: 000-000-0000
If to Allergan, notices must be addressed to:
Allergan Sales, LLC.
0000 Xxxxxx Xxxxx
Xxxxxx, Xxxxxxxxxx 00000 X.X.X.
Attention: Vice President, Operations
Telephone: (000) 000-0000
Facsimile: (000) 000-0000
*** Certain confidential information contained in this document, marked with 3
asterisks, has been omitted and filed separately with the Securities and
Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act
of 1934, as amended.
48
with a copy to:
Allergan, Inc.
0000 Xxxxxx Xxxxx
Xxxxxx, Xx 00000 U.S.A.
Attention: General Counsel
Telephone: (000) 000-0000
Facsimile: (000) 000-0000
In case of notices given pursuant to SECTION 11.5 (INSURANCE), with a copy
to:
Allergan, Inc.
0000 Xxxxxx Xxxxx
Xxxxxx, Xx 00000 X.X.X.
Attention: Risk Management Department
Facsimile: (000) 000-0000
13.8 COMPLIANCE WITH LAWS. Each Party will at all times comply with all
applicable Federal and state laws and regulations relating to its activities
under this Agreement.
13.9 FORCE MAJEURE. Each Party will be excused from liability for the
failure or delay in performance of any obligation under this Agreement by reason
of any extraordinary, unexpected and/or unavoidable event, such as acts of God,
fire, flood, explosion, earthquake, or other natural forces, war, civil unrest,
accident, destruction or other casualty, any lack or failure of transportation
facilities, any lack or failure of supply of raw materials, any strike or labor
disturbance, or any other event similar to those enumerated above. Such excuse
from liability will be effective only to the extent and duration of the event(s)
causing the failure or delay in performance and provided that the Party has not
caused such event(s) to occur. Notice of a Party's failure or delay in
performance due to force majeure must be given to the other Party within ***
after its occurrence. All delivery dates under this Agreement that have been
affected by force majeure will be tolled for the duration of such force majeure.
In no event will any Party be required to prevent or settle any labor
disturbance or dispute. Notwithstanding the foregoing, but except as set forth
in SECTION 7.1.3(A) (FAILURE TO SUPPLY PRODUCT OR SAMPLES), should the event(s)
of force majeure suffered by a Party extend beyond a *** period, the other Party
may then terminate this Agreement by written notice to the non-performing Party.
13.10 DISPUTE RESOLUTION. Except with regard to any matters or disputes
between the Parties that are to be resolved by the JCC as set forth in this
Agreement, if a dispute or controversy regarding any other matter under this
Agreement, arises between the Parties which they are unable to resolve (a
"DISPUTE"), each of the Parties will (subject to any applicable cure period as
set forth in this Agreement), be entitled to submit to the other Party written
notice of such Dispute, with such notice setting forth in reasonable detail the
nature of the Dispute (the "DISPUTE NOTICE"). For a period of thirty (30) days
after the date of the receiving Party's receipt of the Dispute Notice, the
Parties will seek to resolve such Dispute by good faith negotiation between the
President U.S. Pharmaceuticals for GSK or his/her designee and the President
U.S.
*** Certain confidential information contained in this document, marked with 3
asterisks, has been omitted and filed separately with the Securities and
Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act
of 1934, as amended.
49
for Allergan or his/her designee. If at the end of such thirty (30) day period
the Dispute remains unresolved, the Parties may seek relief for such Dispute
using any appropriate administrative or judicial mechanism which may be
available, subject to SECTION 13.12 (JURISDICTION AND GOVERNING LAW). The
provisions of this SECTION 13.10 will not restrict in any way the Parties'
rights to seek preliminary injunctive or other equitable relief from any court
having jurisdiction.
13.11 LEGAL FEES. If any Party to this Agreement resorts to any legal
action in connection with this Agreement, the prevailing Party will be entitled
to seek reasonable fees of attorneys and other professionals in addition to all
court costs which that Party may incur as a result.
13.12 JURISDICTION AND GOVERNING LAW. Notwithstanding its place of
execution or performance, this Agreement will be governed by and construed in
accordance with the laws of the State of New York, irrespective of its laws
regarding choice or conflict of laws. The Parties hereby agree that for the
purposes of resolving any Disputes hereunder, in accordance with SECTION 13.10,
that the Parties hereby submit to the exclusive jurisdiction of the courts of
New York.
13.13 INTERPRETATION.
13.13.1 The captions and headings of clauses contained in this
Agreement preceding the text of the articles, sections, subsections and
paragraphs hereof are inserted solely for convenience and ease of reference only
and will not constitute any part of this Agreement, or have any effect on its
interpretation or construction.
13.13.2 All references in this Agreement to the singular will include
the plural where applicable, and all references to gender will include both
genders and the neuter.
13.13.3 Unless otherwise specified, references in this Agreement to
any article will include all sections, subsections, and paragraphs in such
article; references in this Agreement to any section will include all
subsections and paragraphs in such sections; and references in this Agreement to
any subsection will include all paragraphs in such subsection.
13.13.4 All references to days in this Agreement will mean calendar
days, unless otherwise specified.
13.13.5 The word "including" or any variation thereof means "including
without limitation" and the word "including" or any variation thereof will not
be construed to limit any general statement which it follows to the specific or
similar items or matters immediately following it.
13.13.6 Ambiguities and uncertainties in this Agreement, if any, will
not be interpreted against either Party, irrespective of which Party may be
deemed to have caused the ambiguity or uncertainty to exist.
*** Certain confidential information contained in this document, marked with 3
asterisks, has been omitted and filed separately with the Securities and
Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act
of 1934, as amended.
50
13.14 COUNTERPARTS. This Agreement may be executed in one or more
counterparts (which may be delivered via facsimile), each of which will be
deemed an original document, and all of which, together with this writing, will
be deemed one instrument.
13.15 FURTHER ASSURANCES. Each Party to this Agreement will, at its own
expense, furnish, execute, and deliver all documents and take all actions as may
reasonably be required to effect the terms and purposes of this Agreement.
13.16 NON-SOLICITATION. The Parties hereto recognize that each Party has a
substantial interest in preserving and maintaining confidential its Confidential
Information hereunder. Each Party hereto recognizes that certain of the other
Party's employees may have access to such Confidential Information of the other
Party. The Parties hereto therefore agree not to solicit or otherwise induce or
attempt to induce for purposes of employment, any PSRs from the other Party
during the Term of this Agreement and for a period of one (1) year thereafter.
Notwithstanding the foregoing, nothing herein will restrict or preclude either
Party's right to make generalized searches for employees by the issue of
advertising in the media or by engaging search firms to engage in searches that
are not targeted or focused on any PSR of the other Party.
[Signatures on next page]
*** Certain confidential information contained in this document, marked with 3
asterisks, has been omitted and filed separately with the Securities and
Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act
of 1934, as amended.
51
IN WITNESS WHEREOF, the Parties hereto have caused this Co-Promotion
Agreement to be executed by their duly authorized officers as of the day and
year first above written.
SMITHKLINE XXXXXXX CORPORATION ALLERGAN, INC.
D/B/A GLAXOSMITHKLINE
By: /s/ XXXXXX X. XXXXXX By: /s/ XXXXX XXXXX
--------------------------------- ------------------------------------
Name: Xxxxxx X. Xxxxxx Name: Xxxxx Xxxxx
------------------------------- ----------------------------------
Title: Vice President and Secretary Title: Chairman & CEO
------------------------------ ---------------------------------
ALLERGAN SALES LLC
By: /s/ XXXXXXX X. XXXXXXX
------------------------------------
Name: Xxxxxxx X. Xxxxxxx
----------------------------------
Title: Vice President and
Chief Financial Officer
---------------------------------
*** Certain confidential information contained in this document, marked with 3
asterisks, has been omitted and filed separately with the Securities and
Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act
of 1934, as amended.
52
EXHIBIT A
NET SALES CALCULATION ADJUSTMENTS
NEUROLOGIST SEGMENT ALLOCATION FACTOR
The Net Sales for the Primary Product and the Additional Neuro Product in the
Neurologist Segment will be based on ***.
PCP SEGMENT ALLOCATION FACTOR
The Net Sales for the Primary Product and Additional Neuro Product for
identified Primary Care Physicians (PCP's) will be obtained based on ***.
***
*** Certain confidential information contained in this document, marked with 3
asterisks, has been omitted and filed separately with the Securities and
Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act
of 1934, as amended.
53
EXHIBIT B
MARKETING PLAN OUTLINE FOR THE PRIMARY PRODUCT
TO THE PRIMARY PRODUCT TARGET AUDIENCE
1) Executive Summary
2) Market Analysis as to the Primary Product Target Audience
3) Product Profile
- Product Description
- Indications
- Clinical Experience and Program
- Formulation, Packaging and Administration
4) SWOT Analysis
5) One (1) - year Sales Forecasts of Net Sales from the Primary Product Target
Audience
- Units, Dollars, Prescriptions, Market Share from the Primary Product
Target Audience
6) Objectives - In each case as to the Primary Product Target Audience
- Communication
- Sales
- Market Share
- Managed Care/Formulary - Message development only
7) Key Issues
8) Strategies
- Product Positioning
- Audiences - Primary Product Target Audience
- Sales Force
- Managed Care/Formulary - Message development only
9) Tactics - In each case as to the Primary Product Target Audience
- Market Research
- Product Promotional Guidelines
- Personal Selling Materials/Program
*** Certain confidential information contained in this document, marked with 3
asterisks, has been omitted and filed separately with the Securities and
Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act
of 1934, as amended.
54
- Non-Independent Medical Education
- Publication Plan
- Physician Targets
- Sales Training
- Sales Force Incentive Plan
- Territory Sales Force Effort
- Sampling Plans and Forecasts
- Managed Care / Formulary
10) Budget for Following Year
11) Timelines
*** Certain confidential information contained in this document, marked with 3
asterisks, has been omitted and filed separately with the Securities and
Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act
of 1934, as amended.
55
EXHIBIT C
TECHNICAL AGREEMENT
To be provided by GSK within thirty (30) days of the Effective Date
*** Certain confidential information contained in this document, marked with 3
asterisks, has been omitted and filed separately with the Securities and
Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act
of 1934, as amended.
EXHIBIT D
QUARTERLY PERFORMANCE PAYMENT EXAMPLE
***
*** Certain confidential information contained in this document, marked with 3
asterisks, has been omitted and filed separately with the Securities and
Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act
of 1934, as amended.
