EXHIBIT 4.34
COPROMOTION AGREEMENT
THIS AGREEMENT is made, effective as May 1, 2003, by and
between XXXXXXX-XXXXX SQUIBB COMPANY, a Delaware corporation ("BMS"), and XXXXX
(CHEMICALS) LIMITED, a corporation of the Republic of Ireland ("Xxxxx").
Capitalized terms not otherwise defined in the text of this Agreement shall have
the meanings set forth in Article 1 of this Agreement.
W I T N E S S E T H:
WHEREAS, BMS has received FDA clearance to market the Vitamin
D3 analog MC 903/calcipotriene under the trademark "Dovonex(R)"; and
WHEREAS, Xxxxx is engaged in the business of marketing
pharmaceutical products to physicians; and
WHEREAS, BMS wishes to engage Xxxxx to assist in the promotion
of Dovonex(R) to certain physicians, and Xxxxx desires to have the right to
copromote said product to such physicians, upon the terms specified herein.
NOW, THEREFORE, in consideration of the mutual covenants
herein set forth, and intending to be legally bound hereby, the Parties hereto
agree as follows:
ARTICLE 1 - DEFINITIONS.
For purposes of this Agreement, the following terms shall have
the corresponding meanings set forth below:
"Actual Demand-Based Mail Order Net Sales" means, for
an applicable accounting period, the Demand-Based Mail Order Gross Sales for
such accounting period times the Gross to Net Factor for such accounting period.
"Actual Demand-Based Other Net Sales" means, for an
applicable accounting period, the Demand-Based Other Gross Sales for such
accounting period times the Gross to Net Factor for such accounting period.
"Actual Demand-Based Retail Net Sales" means, for an
applicable accounting period, the Demand-Based Retail Gross Sales for such
accounting period times the Gross to Net Factor for such accounting period.
"Actual Demand-Based Retail/MO Net Sales" means, for
an applicable accounting period, the sum of Actual Demand-Based Retail Net Sales
for such accounting period plus the Actual Demand-Based Mail Order Net Sales for
such accounting period.
"Actual Net Sales from All Segments" means the sum of
Actual Demand-Based Retail/MO Net Sales and Actual Demand-Based Other Net Sales.
"Advertising and Promotional Costs" or "A&P Costs"
means those costs that are reasonably incident to the advertising and promotion
of the Product in the Territory, including without limitation, costs incurred:
(i) to develop and distribute reasonable and
customary selling and A&P Materials that have been approved by the JEC
relating to the use of the Product, including without limitation field
literature, Direct to Consumer (DTC) advertising campaigns, and
media/journal advertising; provided, that any costs associated with the
distribution of A&P Materials by a Party to its Sales Force Personnel
shall be at such Party's own expense and shall not be included within
Advertising and Promotion Costs; and
(ii) to develop and implement symposia and
medical educational programs and related materials, as well as Managed
Care Organization (MCO) pull-through and promotional programs, relating
to the Product; and
(iii) to develop and copy training/motivation and
communications materials relating to the Product; and
(iv) to develop, conduct and obtain market
research analyses and materials relating to the Product; and
(v) to develop and coordinate public relations
for the Product, including convention costs and promotional premiums;
and
(vi) to develop, publish, and disseminate
publications relating to the Product; and
(vii) to obtain Product samples and ship the same
to a Party's central distribution facility (it being understood that
any costs associated with the distribution of Product samples by a
Party from its central distribution facility to its own Sales Force
Personnel shall be at such Party's own expense and shall not be
included within Advertising and Promotion Costs); and
(viii) to develop and conduct micro-marketing
programs (which are defined as customary dinner, lunch and other
meeting programs conducted by Sales Force Personnel) implemented by
Sales Force Personnel.
For purposes of subparts (i) - (vi) of this definition, the term "Advertising
and Promotional Costs" means the out-of-pocket costs and expenses paid by BMS,
Xxxxx or their respective Affiliates to a Third Party, as the case may be (and a
reasonable charge for internal copying
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expenses). For purposes of subpart (vii) of this definition, the cost to a Party
of obtaining Product samples shall be the Manufacturing Cost therefor incurred
by BMS or Xxxxx in accordance with Section 3.4, as the case may be, and shall
include any sales/use taxes, if any, associated with the distribution or use of
the samples. For purposes of subpart (viii) of this definition, the term
"Advertising and Promotion Costs" means the out-of-pocket costs of
micro-marketing programs conducted by BMS or Xxxxx. Except as set forth in the
definition of "Manufacturing Cost", for purposes of clarity, the Parties
acknowledge that "Advertising and Promotion Costs" do not include the costs and
overhead associated with Galen's Sales Force Personnel, BMS' Sales Force
Personnel or other employees of BMS and/or Xxxxx responsible for performance of
this Agreement. The term "Advertising and Promotional Costs" or "A&P Costs" as
it relates to Xxxxx shall include any such costs reimbursed to BMS by Xxxxx.
"Affiliate" means, with respect to any Person, any
other Person which is controlled by, controlling or under common control with,
the specified Person, with "control" meaning direct or indirect beneficial
ownership or control of more than fifty percent (50%) of the voting stock of
such corporation or other business entity.
"Agreement" means this agreement, together with all
appendices, exhibits and schedules hereto, and as the same may be amended or
supplemented from time to time hereafter by a written agreement duly executed by
authorized representatives of each Party hereto.
"Agreement Quarter" means each three-month period
commencing on the first day of January, April, July, or October, as the case may
be, during the Copromotion Term; provided, that the first Agreement Quarter
shall commence on the Effective Date and end on June 30, 2003.
"Agreement Year" means each 12-month period
commencing on January 1 and each anniversary thereof during the Copromotion
Term; provided, that the first Agreement Year shall commence on the Effective
Date and end on December 31, 2003.
"AMP", as used in Exhibit 11.1.4, means the Average
Manufacturer's Price per topical gram (as finally calculated by BMS quarterly
for Medicaid processing) for a given presentation of the Product.
"A&P Material" has the meaning set forth in Section
3.2.2 hereof.
"Baseline Agreement Year Prescriptions"," Baseline
Semi-Annual Prescriptions", "Baseline Quarterly Prescriptions", "Baseline Mail
Order Prescriptions", and "Baseline Retail Prescriptions", shall have the
meaning set forth in Exhibit 11.1.5 hereof.
"Baseline Demand-Based Mail Order Gross Sales" for
any accounting period means the Weighted Average Mail Order Selling Price per
mail order prescription for such period times the Baseline Mail Order
Prescriptions for the Product for such period.
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"Baseline Demand-Based Retail/MO Gross Sales" for any
accounting period means the sum of Baseline Demand-Based Retail Gross Sales and
Baseline Demand-Based Mail Order Gross Sales for such period.
"Baseline Demand-Based Retail Gross Sales" for any
accounting period means the Weighted Average Retail Selling Price per retail
prescription for such period times the Baseline Retail Prescriptions for the
Product for such period.
"Baseline Demand-Based Retail/MO Net Sales" means,
for an applicable accounting period, the Baseline Demand-Based Retail/MO Gross
Sales times the Gross to Net Factor for such accounting period.
"BMS Know-How" means all proprietary information that
is now or may hereafter during the term of this Agreement be controlled by BMS
or any of its Affiliates regarding the Compound or the Product.
"Call" means a face-to-face contact (including a live
video presentation or group presentations to Prescribing Professionals), between
a professional sales representative of the applicable Party during which a
Primary Position Detail or Secondary Position Detail is made to a Prescribing
Professional or other healthcare professionals or entities that have a
significant impact/influence on prescribing decisions including, but not limited
to Managed Health Care Organizations, in each case as measured by each Party's
internal recording of such activity; provided that such meeting is consistent
with and in accordance with the procedures customarily employed by such Party's
professional sales representatives responsible for performing such activities
for the majority of its other pharmaceutical products, consistently applied.
With respect to certain group or institutional Product presentations, Exhibit
1.1 sets forth how such presentations will be counted for determination of the
number of Details.
"Call List" means those Prescribing Professionals in
the Territory to whom Xxxxx will be responsible for detailing the Product.
"Competing Product" has the meaning set forth in
Section 2.4 hereof.
"Compound" means the crystalline vitamin D3 analogue
MC 903 that is licensed to BMS under the XXX License Agreement.
"Combination Product" means any Product that contains
the Compound in combination with one or more other pharmaceutically active
ingredients, excluding Dovobet.
"Confidential Information" has the meaning set forth
in Article 15 hereof.
"Controlled by" means, with respect to any product,
information or intellectual property right, that the applicable Party or Person,
in whole or in part, owns or has a
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license to such product, information or intellectual property right and has the
ability to grant access or a license (or a sublicense), as applicable, without
violating the terms of any agreement or other arrangements with any Third Party
existing at the time such Party or Person would be first required to grant such
access, license or sublicense.
"Copromotion Term" has the meaning set forth in
Section 13.1 hereof.
"Demand-Based Government Gross Sales" means the
demand-based gross sales reported by BMS based on internally recorded sales
figures for this segment for the Product for a given accounting period.
"Demand-Based Hospital/MHC Gross Sales" means the
demand-based gross sales reported by IMS Provider Perspective for Hospital and
IMS Provider Perspective for Managed Healthcare to these segments for the
Product for a given accounting period.
"Demand-Based Mail Order Gross Sales" means, for an
applicable accounting period, the total mail order prescriptions for the Product
reported by IMS National Prescription Audit for a given period, multiplied by
the Weighted Average Mail Order Selling Price for such period.
"Demand-Based Nursing Home Gross Sales" means the
demand-based gross sales reported by IMS Provider Perspective for Nursing Homes
to this segment for the Product for a given accounting period.
"Demand-Based Other Gross Sales" means, for an
applicable accounting period, the sum of Puerto Rico Gross Sales, plus
Demand-Based Government Gross Sales, plus Demand-Based Hospital/MHC Gross Sales,
plus Demand-Based Nursing Home Gross Sales.
"Demand-Based Retail Gross Sales" means, for an
applicable accounting period, the total retail prescriptions for the Product
reported by IMS National Prescription Audit for a given period, multiplied by
the Weighted Average Retail Selling Price for such period.
"Diligent Efforts" means the carrying out of
obligations or tasks in a manner consistent with the efforts a Party devotes to
its other products of similar market potential, profit potential or strategic
value resulting from its own internal research efforts, based on conditions then
prevailing.
"Dovobet" means a pharmaceutical preparation
containing both the Compound and the steroid betamethasone dipropionate, in all
dosage forms, formulations, presentations and line extensions.
"Dovobet(R) Product" means any prescription
pharmaceutical product which is a presentation of Dovobet(R).
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"Effective Date" means May 1, 2003.
"Execution Date" means the date this Agreement is
signed by the last party to sign.
"ERISA" means the Employee Retirement Income Security
Act of 1974, as amended.
"FDA" means the U.S. Food and Drug Administration.
"FD&C Act" means the Federal Food, Drug and Cosmetic
Act, as amended, and all applicable regulations thereunder.
"Xxxxx Improvements" means any inventions,
developments, modifications or improvements to the Product or the Compound which
are made by Xxxxx or any of its Affiliates during the term of this Agreement (x)
as a result of research activities conducted by or for it or its Affiliates
relating to the Product or the Compound or (y) through the use of BMS Know-how,
whether patentable or registerable or not, except as any of the foregoing may
relate solely to Dovobet(R) and not any other Product or product.
"Xxxxx Know-How" means all proprietary information
regarding the Compound or the Product that is now or may hereafter during the
Copromotion Term be controlled by Xxxxx or any of its Affiliates, except as any
of the foregoing may relate solely to Dovobet(R) and not any other Product or
product.
"Governmental or Regulatory Authority" means any
court, tribunal, arbitrator, agency, commission, official or other
instrumentality of any federal, state, county, city or other political
subdivision, foreign or domestic.
"Gross to Net Factor", for a given accounting period,
means a fraction (x) the numerator of which is the sum of Demand-Based Retail
Gross Sales, plus Demand-Based Mail Order Gross Sales, plus Demand-Based Other
Gross Sales, less Total Discounts for such accounting period, and (y) the
denominator of which is the sum of Demand-Based Retail Gross Sales, plus
Demand-Based Mail Order Gross Sales, plus Demand-Based Other Gross Sales for
such accounting period.
"Gross Margin Percentage" for a given accounting
period, means a fraction, (A) the numerator of which represents (i) Actual Net
Sales from All Segments during such accounting period, less (ii) the
Manufacturing Cost of the Product represented by such Actual Net Sales from All
Segments for such accounting period, less (iii) the royalties due XXX on such
Actual Net Sales from All Segments during such accounting period, and (B) the
denominator of which represents Actual Net Sales from All Segments during such
accounting period. As of the Effective Date the Gross Margin Percentage equals
seventy percent (70%).
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"IMS" means (x) IMS Health Incorporated and its
successors or (y) such other internationally recognized market research firm
(including, without limitation, NDC Health) to which Xxxxx and BMS may mutually
agree to in writing.
"IND" means an Investigational New Drug Application,
as defined in the FD&C Act and applicable regulations promulgated thereunder as
amended from time to time, filed in the United States.
"Law" means all laws, statutes, rules, regulations,
ordinances and other pronouncements or orders having the effect of law of any
Governmental or Regulatory Authority.
"XXX" means XXX Pharmaceuticals Products, Ltd. A/S
(Lovens Kemiske Fabrik Produktionsaktieselskab), a corporation organized under
the laws of Denmark), and having an address at Xxxxxxxxxxxxxx 00, XX-0000
Xxxxxxxx, Xxxxxxx.
"XXX License Agreement" means the agreement between
X.X. Xxxxxx & Sons, Inc. and XXX for the development and commercialization of
products containing the Compound in the Licensed Territory within the
dermatological field dated September 28, 1989, as heretofore amended by
amendments thereto dated as of July 6, 1992 and April 8, 1993, and as the same
may be amended or supplemented in the future, subject to Section 2.3.3.
"XXX Supply Agreement" means the agreement between
Xxxxxxx-Xxxxx Squibb Company and XXX for the supply of finished and packaged
products containing the Compound in the Licensed Territory for use within the
dermatological field dated April 8, 1993, as amended heretofore, and as the same
may be amended or supplemented in the future, subject to Section 2.3.3.
"XXX Patents" means those pending patent applications
and issued patents owned by XXX having claims covering the Product and are
licensed to BMS under the XXX License Agreement.
"Manufacturing Cost" for Product samples, as well as
for any Product and any comparators (whether active or placebo) supplied for use
in any Phase IV and later clinical trial, means: (i) if and to the extent the
Product or comparator is manufactured, finished or packaged, in whole or in
part, by BMS and/or any of its Affiliates, the direct costs incurred in
manufacturing, finishing, and packaging same, plus BMS' fully-absorbed
allocation of indirect and overhead expenses connected therewith (including
without limitation manufacturing and charges in the nature of depreciation and
amortization of capitalized costs of manufacturing equipment and facilities and
reasonable allocation of idle capacity), as determined in accordance with U.S.
generally accepted accounting principles, consistently applied), (ii) if and to
the extent the Product or comparator is manufactured for BMS or any of its
Affiliates by a Third Party, in whole or in part, the costs (including
applicable royalties) actually charged by the Third Party to BMS or such
Affiliate for same.
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"Minimum Annual PDE and Minimum Semi-Annual PDEs"
shall have the meaning under Section 3.5.1 of this Agreement.
"Minimum Quarterly PDEs" has the meaning set forth in
Section 3.5.1 hereof.
"NDA" means a New Drug Application, as defined in the
United States Federal Food, Drug and Cosmetic Act and applicable regulations
promulgated thereunder as amended from time to time, filed in the United States.
"NDA Approval" means the marketing clearance granted
by the FDA required for the marketing and promotion of the Product in the United
States.
"NDCHealth" means National Data Corporation, a
leading healthcare information services company.
"Net Weighted Average Mail Order Selling Price" per
mail order prescription for a given period means the Weighted Average Mail Order
Selling Price for a given accounting period, times the Gross to Net Factor for
such accounting period.
"Net Weighted Average Retail Selling Price" per
retail prescription for a given period means the Weighted Average Retail Selling
Price for a given accounting period, times the Gross to Net Factor for such
accounting period.
"Party" means Xxxxx or BMS, as the case may be.
"Patents" means all patents and patent applications
in the Territory which are or become Controlled by BMS or any of its Affiliates
which patents generically or specifically claim the composition or use of any
Product in the Territory, including without limitation all continuations,
continuations-in-part, divisions, patents of addition, reissues, renewals,
substitutions, registrations, confirmations or extensions thereof.
"PDMA" means the Prescription Drug Marketing Act of
1987, as amended (as such may be subsequently modified and including any
applicable implementing regulations).
"Performance Compensation" has the meaning set forth
in Article 11 hereof.
"Person" means an individual, corporation,
partnership, limited liability company, trust, business trust, association,
joint stock company, joint venture, pool, syndicate, sole proprietorship,
unincorporated organization, Governmental or Regulatory Authority, or any other
form of legal entity not specifically listed herein.
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"Phase IV Study" means (i) any Phase IV clinical
study (including without limitation opinion leader studies) pertaining to the
Product that are sponsored by BMS or any of its Affiliates in the Territory or
conducted by or through BMS in the Territory, or (ii) any pharmacoeconomic study
relating to the Product that are sponsored by BMS or any of its Affiliates in
the Territory or conducted by or through BMS in the Territory.
"Phase IV Study Costs" means all costs and other
payments for any Phase IV Study that are incurred by a Party or any of its
Affiliates in the Territory, plus the Manufacturing Cost of all Product and any
comparators (including active comparators and placebo) supplied in connection
with such Studies.
"Prescribing Professional" means (x) physicians and
osteopaths and (y) any nurse practitioners, physicians' assistants, and other
healthcare professionals where any of the foregoing in (y) have prescribing
authority under applicable Law.
"Primary Position Detail" means a promotional message
involving a full Product presentation delivered during a Call by a Party's
professional sales representatives in which key Product attributes are verbally
presented in the first position, consistent with the terms of this Agreement,
where such Product is given primary emphasis (i.e., an emphasis that is more
important than the emphasis given to any other product presented), and where no
more than three products are presented during such Call.
"Primary Detail Equivalent" or "PDE" means either one
Primary Position Detail or two Secondary Position Details.
"Product" means (x) all current pharmaceutical
preparations for human use in final topical dosage forms which contain the
Compound as a therapeutically active ingredient that have been approved for use
and sale in the Territory as of the Effective Date by any relevant Governmental
or Regulatory Authority in the Territory, and any line extensions thereof; and
(y) all future pharmaceutical preparations for human use in final dosage forms
which contain the Compound as a therapeutically active ingredient, but excluding
Dovobet(R), that are approved by any Governmental or Regulatory Authority in the
Territory during the Copromotion Term of this Agreement, and that (i) BMS is
able to promote, and has accepted to promote, under the XXX License Agreement
during the Copromotion Term and (ii) Xxxxx has accepted in writing to co-promote
under this Agreement.
"Product Registration" has the meaning set forth in
Section 10.3 hereof.
"Promotion" means those activities normally
undertaken by a professional sales representative of a pharmaceutical company to
implement promotion plans for a particular prescription pharmaceutical product
aimed at encouraging the appropriate use of such product by a health care
professional with actual prescribing authority. When used as a verb, "Promote"
means to engage in such activities.
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"Promotion Plan" means the then current plan for the
Promotion of the Product in the Territory and which is described in more detail
in Section 3.3.
"Puerto Rico Demand Based Gross Sales" means the
amount of factory gross sales of the Product reported by BMS' divisional
Affiliate in Puerto Rico.
"Regulatory Approvals" means the required approval of
the applicable Governmental or Regulatory Authority.
"Sales Force Personnel" means a Party's and/or its
Affiliates' sales force representatives and their managers (whether the same be
employees or, subject to the terms of Section 3.5.2 of this Agreement,
independent contractors of a Party) that are involved in the Promotion of the
Product in the Territory.
"Secondary Position Detail" means a promotional
message involving a Product that is delivered in the second position during a
Call by a Party's professional sales representatives, consistent with the terms
of this Agreement, where such Product is given significant emphasis (i.e., an
emphasis that is at least or more important than the emphasis given to any other
product presented (other than the product that is presented as the Primary
Position Detail)), and where no more than three products are presented during
such Call.
"Semi-Annual Periods" means the half-years comprising
(a) the first and second Agreement Quarter and (b) the third and fourth
Agreement Quarter of each Agreement Year.
"Serious Adverse Event" and "Non-Serious Adverse
Event" have the meanings set forth in Section 9.7 hereof.
"Territory" means the fifty (50) states of the United
States of America and the District of Columbia, and any U.S. possessions and
territories.
"Third Party(ies)" means any Person other than: (1)
Xxxxx and BMS and (2) any Affiliates of Xxxxx and BMS.
"Total Discounts" for an accounting period means the
following costs and expenses reasonably incurred by BMS with respect to the
Product, to the extent not reimbursed by a Third Party:
(i) trade, quantity and cash discounts or rebates
actually and lawfully granted or given and any other
similar adjustments, including, without limitation,
those granted on account of price adjustments,
billing errors, rejected goods, and damaged goods;
(ii) price reductions, credits, rebates, product returns,
charge-backs and prime
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vendor rebates, fees, reimbursements or similar
payments or adjustments actually granted or given to
wholesalers and other distributors, buying groups,
health care insurance carriers, pharmacy benefit
management companies, health maintenance
organizations or other institutions or health care
organizations; and
(iii) price reductions, credits, rebates, product returns,
charge-backs and prime vendor rebates, fees,
reimbursements or similar payments or adjustments
actually granted or given in connection with Product
sales to any Governmental or Regulatory Authority in
respect of any state or federal Medicare, Medicaid or
similar programs.
Notwithstanding the foregoing, in the event that the "Incentive Discounts"
granted in the aggregate for all presentations of Dovonex in the Territory for a
given Agreement Quarter exceed fifteen percent (15%) or more of the
corresponding gross sales (based on list price) of Dovonex in such Agreement
Quarter, then, for purposes of calculating the compensation due Xxxxx under this
Agreement for such Agreement Quarter only, the aggregate amount of Incentive
Discounts that may be taken into account in determining Total Discounts for such
Agreement Quarter shall equal 15% of such gross sales (based on list price), and
the Total Discounts for such Agreement Quarter shall equal such 15% figure plus
such other amounts (e.g., product returns) as may be deducted under (i)-(iii).
For purposes of the preceding sentence, "Incentive Discounts" shall mean all
discounts granted under (i), (ii) and (iii) above and any price reductions below
the Dovonex list price for a given presentation as such list price for such
presentation exists on the Effective Date (or, for any new presentations
hereafter, as it is first priced for commercial sale), but excluding such
discounts, credits, or rebates that relate to matters such as product returns,
rejected or damaged goods, billing errors, and the like (which may still be
taken into account in determining Total Discounts for a given Agreement
Quarter); provided, that where the list price for a given presentation is
reduced by BMS below the list price for such presentation as of the Effective
Date, the 15% threshold shall be determined by reference to such list price as
of the Effective Date and not the then lower current list amount. For sake of
clarity and example, if the price for a given presentation of Dovonex is
$100/gram as of the Effective Date, then BMS is entitled as of the Effective
Date to grant $15 of Incentive Discounts before the excess above that figure
must be taken into account in determining whether BMS has exceeded the 15%
threshold in the aggregate for all presentations. If a year later: (A) the price
of the presentation has dropped to $90, then BMS would be entitled as of the
Effective Date to grant only an additional $5 of Incentive Discounts before the
excess above that figure must be taken into account in determining whether BMS
has exceeded the 15% threshold in the aggregate for all presentations, and (B)
the price of the presentation has increased to $110, then BMS would be entitled
as of the Effective Date to grant $16.50 of Incentive Discounts before the
excess above that figure must be taken into account in determining whether BMS
has exceeded the 15% threshold in the aggregate for all presentations.
An example calculation showing the determination of the maximum Incentive
Discounts is attached as Exhibit 11.1.6 hereto. The usual and customary
discounts and deductions described
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above will be consistent with those used by BMS in determining net sales of its
pharmaceutical products for external reporting purposes.
"Trademark" means the Dovonex(R) trademark and any
other trademark or trade name (whether registered or unregistered) used on or
with the Product or in any A&P Material related to the Product in the Territory
during the Copromotion Term (other than the name and logo of BMS, Xxxxx or any
of their respective Affiliates), subject to the terms of this Agreement.
"Valid Claim" means a composition of matter claim, or
method of use claim (or its equivalent) of an issued and unexpired Patent in the
Territory which is owned or controlled by BMS, which covers the Compound and/or
the Product, and which (i) has not been revoked or held unenforceable or invalid
by a decision of a Governmental or Regulatory Authority of competent
jurisdiction, unappealable or unappealed within the time allowed for appeal; and
(ii) has not been abandoned, disclaimed, or admitted to be invalid or
unenforceable through reissue or disclaimer or otherwise.
"Weighted Average Mail Order Selling Price" per mail
order prescription is calculated in the manner shown on Exhibit 11.1.4.
"Weighted Average Retail Selling Price" per retail
prescription is calculated in the manner shown on Exhibit 11.1.4.
ARTICLE 2 - GRANT OF RIGHTS TO XXXXX; BMS RESERVED RIGHTS; NON-COMPETITION; XXX
LICENSE AGREEMENT; RIGHT TO CROSS-REFERENCE.
Section 2.1 Engagement of Xxxxx to Promote. BMS hereby grants to Xxxxx
the co-exclusive right (exclusive except as to BMS and its Affiliates), to
Promote the Product during the Copromotion Term, within the Territory, upon the
terms and conditions set forth in this Agreement. Galen's co-promotion rights
under this Agreement shall be exclusive as to any other Third Party within the
Territory, and BMS may not, without the prior written consent of Xxxxx (not to
be unreasonably withheld) or except as provided in Section 3.5.2, enter into any
agreement with a Third Party to Promote or market the Product in the Territory,
during the Copromotion Term. Xxxxx shall have the right to enter into any
written agreement with one or more of its Affiliates with respect to any right,
representation, warranty, or obligation of Xxxxx under this Agreement; provided,
that Xxxxx shall remain jointly and severally liable and responsible with such
Affiliate for the performance of any obligations, representations or warranties
delegated, contracted, assigned or otherwise transferred. Xxxxx shall not
Promote or market the Product except in accordance with the rights expressly
granted to it under, and in accordance with the terms of, this Agreement.
Section 2.2 BMS Reserved Rights. BMS reserves all rights not expressly
granted
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under this Agreement. Xxxxx agrees that it will not practice any rights reserved
by BMS that are not expressly granted to Xxxxx under this Agreement.
Section 2.3 Compliance with XXX License Agreement; Amendments.
2.3.1 Compliance with License Agreement. To the extent not
encompassed by the terms of this Agreement, Xxxxx shall abide by all applicable
terms of the XXX License Agreement as are communicated to it by BMS in writing,
and any conflict between this Agreement and the XXX License Agreement shall be
governed by and subject to the terms in the XXX License Agreement.
2.3.2 Maintenance of License Agreement. BMS agrees that, with
respect to any rights or licenses granted to it under the XXX License Agreement,
BMS shall perform and observe in all material respects all of its duties and
obligations under the XXX License Agreement that are required to maintain in
effect such licenses or rights, and shall otherwise use commercially reasonable
efforts to maintain the XXX License Agreement; provided that the foregoing shall
not be construed to require that BMS maintain the XXX License Agreement if (x)
generic competition has entered the Territory for the Product, (y) XXX has
materially breached its obligations under the XXX License Agreement and BMS is
entitled under the terms of the XXX License Agreement to terminate such
agreement, or (z) XXX has materially breached its obligations under the XXX
Supply Agreement and BMS consequently is entitled to terminate the XXX License
Agreement pursuant to Article XIII(C) thereof.
2.3.3 Amendment of License Agreement. BMS agrees not to amend
the XXX License Agreement or the XXX Supply Agreement in a manner that would
materially adversely affect Xxxxx rights and obligations under this Agreement
without Galen's prior written consent (not to be unreasonably withheld).
Section 2.4 Noncompetition.
2.4.1 Subject to Section 2.5.1, during the Copromotion Term
and for six (6) months thereafter, Xxxxx and its Affiliates shall not
market, Promote or sell within the Territory any other drug product
that has received marketing clearance from the FDA for psoriasis
treatment or prevention and which is either (x) a topical vitamin D(3)
or vitamin D(3) analog or (y) a fixed combination of vitamin D(3) or
any vitamin D(3) analog with a corticosteriod (a "Competing Product");
provided, that
2.4.1.1 said six-month post-Copromotion Term
restriction shall be inapplicable if the Copromotion Term
shall have expired under Section 13.1.1, the term of this
Agreement has expired or otherwise been terminated pursuant to
Section 13.2.1, or this Agreement shall have been terminated
pursuant to any of Sections 11.6, 13.2.2, 13.2.3, 13.2.5,
13.3.1, 13.3.7 or 13.5 (where Xxxxx is the terminating Party
due to BMS insolvency);
13
2.4.1.2 this Section 2.4 shall not apply to (i)
Dovobet, or (ii) or to any other product for which prior
written approval has been granted by a Vice-President (or
higher) within BMS; and
2.4.1.3 this Section 2.4 shall not apply in the event
that, and from and after the date that, Xxxxx purchases the
NDA and Trademarks for the Product from BMS.
For sake of clarity and avoidance of doubt, a corticosteroid shall not
be considered a Vitamin D(3) analog for purposes of the determination of whether
a product is a Competing Product. For sake of clarity and avoidance of doubt,
any breach by Xxxxx and/or its Affiliates of the terms of this Section 2.4
shall, in addition to any remedies to which BMS may have hereunder or at law or
in equity, entitle BMS to terminate this Agreement upon thirty (30) days' prior
written notice to Xxxxx, unless Xxxxx, within such 30-day period, ceases the
breaching activity (or causes its Affiliate(s) to cease such breaching activity)
and provides reasonable assurances to BMS that it will not happen again during
the Copromotion Term. In the event that Xxxxx or any of its Affiliates breaches
this provision a second time during the Copromotion Term, BMS shall be entitled
to terminate this Agreement upon thirty (30) days' prior written notice to
Xxxxx, but without any opportunity on the part of Xxxxx to cure such breach and
prevent such termination.
The Parties further agree that the marketing, promotion and/or sale of
a Competing Product in the Territory by Xxxxx and/or its Affiliates in breach of
this Section 2.4 may cause irreparable injury to BMS for which monetary damages
alone may not be an adequate remedy. In the event of such breach, BMS shall be
entitled to seek, upon petition to a court of competent jurisdiction and without
resort to any dispute resolution procedures as may be provided for in this
Agreement, equitable relief to prevent such breach, in addition to any remedies
it may have hereunder or at Law.
2.4.2 Subject to Section 2.5.2, during the Copromotion Term
BMS and its Affiliates shall not market, Promote, or sell within the Territory
any Competing Product.
Section 2.5 Effect of Acquisition of Competing Product.
2.5.1 In the event that during the Copromotion Term:
2.5.1.1 a Person becomes an Affiliate of Xxxxx, or
2.5.1.2 Xxxxx or any of its Affiliates merges or
consolidates with any Third Party,
(each of the foregoing, a "Triggering Event"), and such Person or Third Party
(or any Affiliate of such Person or Third Party) is then marketing a Competing
Product in the Territory, then, within thirty (30) days after the applicable
Triggering Event, Xxxxx shall notify BMS in writing of such
14
circumstances and shall notify BMS in writing (the date that both such notices
are received by BMS is referred to as the "Notice Date") as to whether:
2.5.1.3 the Competing Product will be divested by
Xxxxx (or the applicable Xxxxx Affiliate, or such Third Party or such
Third Party's Affiliate) within the Territory; or
2.5.1.4 Xxxxx elects to terminate this Agreement,
which termination shall be effective on the later of one hundred eighty
(180) days after the Notice Date and December 31, 2005, unless BMS
notifies Xxxxx within ninety (90) days after the Notice Date that the
termination will be effective on an earlier date, provided that such
date is not less than one hundred eighty (180) days after the Notice
Date.
If no such written notice is timely received by BMS, then this Agreement shall
terminate on the later of two hundred forty (240) days after the Triggering
Event and December 31, 2005, unless BMS notifies Xxxxx within one hundred twenty
(120) days after the Triggering Event either that the termination will be
effective on an earlier date, provided that such date is not less than two
hundred forty (240) days after the Triggering Event, or that BMS elects to waive
such termination, in which event, BMS shall not be entitled to terminate this
Agreement thereafter with respect to such Competing Product. If this Agreement
is to be terminated as a result of a Triggering Event, Xxxxx and BMS shall each
continue to perform its duties under this Agreement in accordance with the terms
hereof until the actual termination date, provided, however, that the marketing
of a Competing Product by Xxxxx or such Affiliate or Third Party during the
period extending from the Triggering Event until the actual termination date
shall not be considered a breach by Xxxxx of its obligations under this
Agreement.
If Xxxxx informs BMS that such Competing Product will be divested, then
Xxxxx (or such Third Party or Affiliate) shall use commercially reasonable and
diligent efforts to divest itself of such Competing Product in a manner
consistent with reasonable business judgment and to complete such divestiture of
the Competing Product as promptly as practicable following notification to BMS
of the decision to divest. Xxxxx shall have until the date that is twelve (12)
months after the applicable Triggering Event to complete such divestiture (the
"Grace Period"); provided, that, so long as Xxxxx demonstrates to BMS'
reasonable satisfaction that Xxxxx used commercially reasonable and diligent
efforts to effect such divestiture within such 12-month Grace Period, but was
unable reasonably to effect such divestiture, then such 12-month Grace Period
shall be extended for such additional reasonable period thereafter as is
necessary to enable such Competing Product to be in fact divested. Xxxxx (or
such Third Party or Affiliate) shall keep BMS reasonably informed of its efforts
and progress in effecting such divestiture until it is completed, and shall
provide a written summary of such efforts quarterly during such 12-month Grace
Period, and if applicable, monthly thereafter. Subject to the foregoing, the
marketing of a Competing Product by Xxxxx or such Affiliate or Third Party
during the period extending from notification to BMS of the decision to divest
until the completion of the divestiture shall not be considered a breach by
Xxxxx of its obligations under this Agreement.
15
2.5.2 In the event that during the Copromotion Term:
2.5.2.1 a Person becomes an Affiliate of BMS, or
2.5.2.2 BMS or any of its Affiliates merges or
consolidates with any Third Party,
and such Person or Third Party (or any Affiliate of such Person or Third Party)
is then marketing a Competing Product in the Territory, then BMS (or the
applicable BMS Affiliate, or such Third Party or such Third Party's Affiliate)
may continue to market such Competing Product within the Territory thereafter
without BMS being deemed in violation of Section 2.4.2.
2.5.3 Nothing in this Section 2.5 is intended to affect
Galen's or BMS' obligations, covenants, warranties, representations set forth in
other sections of this Agreement.
ARTICLE 3 - PROMOTION, COMMERCIALIZATION AND DISTRIBUTION OF PRODUCT
Section 3.1 General Diligence Obligation. Subject to the terms and
conditions of this Agreement, Xxxxx will exercise Diligent Efforts to Promote
the Product in the Territory during the Copromotion Term in accordance with the
Promotion Plan, the Product labeling, the guidelines then approved by the Joint
Executive Committee, the terms of this Agreement, and applicable Law. All such
activity shall occur at Galen's sole expense except as may otherwise be
expressly provided by this Agreement.
Section 3.2 Joint Executive Committee.
3.2.1 Joint Executive Committee.
3.2.1.1 Promptly after the Effective Date, the
Parties shall form a Joint Executive Committee ("JEC") comprised of
three (3) individuals, two (2) of which shall be appointed by BMS and
one of which shall be appointed by Xxxxx and all of whom shall be
qualified to appropriately represent such Party. The JEC shall be
chaired by one of the two (2) BMS representatives. Additional employees
of either Party or its Affiliates may attend the JEC meeting as
non-voting members on an ad hoc basis as deemed necessary or
appropriate by such Party; consultants or contractors assisting a Party
may attend only with the prior consent of the other Party's members of
the JEC (such consent not to be unreasonably withheld). The chairperson
of the JEC shall be responsible for preparation and distribution of the
minutes of each JEC meeting. Such minutes shall memorialize decisions
made by the JEC, but shall avoid details relating to discussions and
general matters not involving decisions. Minutes of meetings shall be
disseminated to committee members not later than ten (10) business days
following any meeting of the JEC. All JEC meeting minutes shall,
following review by the Parties and agreement of their contents, be
countersigned on behalf of each Party as evidence of acceptance of the
16
correctness of such minutes.
3.2.1.2 The JEC will be used as the forum for the
Parties to provide input to each other, to
enable the Parties to approve the Promotion
Plan and monitor its progress and to enable
the Parties to monitor each Party's
compliance with its obligations under this
Agreement, excluding those matters that are
specifically reserved exclusively to the
sole discretion of BMS or Xxxxx under this
Agreement. The JEC will focus on the overall
business plan and positioning strategies for
the Product, shall approve the Promotion
Plan and material changes thereto. The JEC
shall meet at least twice each year during
the Copromotion Term (and more frequently if
necessary), to discuss the actual results of
the promotion of the Product in the
Territory by the Parties as compared to the
Promotion Plan, approve the Promotion Plan
for the next succeeding Agreement Year and
to discuss any other matters pertaining to a
Party's performance of its Promotion
obligations under this Agreement; provided,
that it is understood that the first meeting
of the JEC shall be held as soon as
practical after the Execution Date. Meetings
of the JEC shall be held alternately at a
location designated by each Party or as the
members of the JEC may agree. JEC meetings
may not necessarily be face-to-face
meetings, but upon unanimous agreement of
the JEC, can be via other methods of
communication, such as teleconferences
and/or videoconferences. Subject to the
terms and conditions of this Agreement,
decisions of the JEC shall be by majority
vote of a quorum of its members (with each
of the three members having one vote), with
a quorum constituting at least one voting
representative of each Party. The majority
vote provision under the preceding sentence
shall not, however, apply: (A) where this
Agreement specifically requires unanimous
written consent of both Parties for a given
matter to be decided by the JEC, (B) to
matters involving a breach of this
Agreement, and (C) as provided in Section
3.2.4.2 hereof.
3.2.1.3 Each Party shall bear the costs of its
representatives attending and participating
in meetings of the JEC.
3.2.2 Regulatory Approvals. BMS shall have strategic
responsibility and sole authority and responsibility for obtaining and
maintaining all Regulatory Approvals that are related to the Product. and,
except where BMS has delegated this responsibility to Xxxxx in writing, that are
related to the use of promotional and advertising materials or programs ("A&P
Materials") prepared or approved by the JEC. BMS hereby delegates to Xxxxx the
authority and responsibility for obtaining all Regulatory Approvals that are
related to the use of promotional and advertising materials or programs
contained in the approved Promotion Plan. Xxxxx shall
17
provide BMS with a copy of such A&P Materials at least fifteen (15) days prior
to first submission of the A&P Materials to FDA or first printing of same
(whichever is earlier). In the event that BMS has an objection to the content of
any such material or programs, BMS shall notify Xxxxx within such fifteen (15)
day period. If BMS does not object within such fifteen (15) day period, Xxxxx
shall be entitled to use such A&P Materials. Any reasonable changes recommended
by BMS must be incorporated into the A&P Materials. Xxxxx will promptly notify
BMS of any warning/untitled letters received from DDMAC and provide BMS with
copies of all communications with FDA and information on resolution of the
matter.
3.2.3 Formulary Relationships. BMS shall retain sole
responsibility in its sole discretion for all contractual relationships for the
Product with formularies (including managed care and hospital), insurers, and
Governmental or Regulatory Authorities (including without limitation Medicare,
Medicaid, the Veterans Administration, and military entities). Xxxxx will
consult with BMS with respect to strategy for obtaining and maintaining
contractual/formulary relationships for the Product with such entities, and will
consult with and assist BMS in obtaining entry into such entities for the sale
of the Product and subsequent pull-through of the Product.
3.2.4 No Adverse Change to Xxxxx Rights Without Xxxxx Consent.
Notwithstanding any term or condition of this Agreement that may state or imply
to the contrary:
3.2.4.1 Xxxxx shall not be required to follow the
Promotion Plan or any decision or guideline determined or promulgated
by BMS or the JEC where Xxxxx believes in good faith based on opinion
of counsel that doing so would conflict in any material way with its
obligations under applicable Law; and
3.2.4.2 No Promotion Plan, or any decision or
guideline promulgated by BMS or the JEC, may materially adversely
affect any of Galen's obligations, rights or benefits under this
Agreement, or require Xxxxx to spend any funds or reimburse or absorb
any costs that are not expressly provided for under this Agreement,
without Galen's prior written consent.
3.2.5 Cost and Control of Sales Forces. Except as otherwise
specifically provided in this Agreement, each Party shall be solely responsible
for the costs and expenses of establishing and maintaining its Sales Force
Personnel and conducting its other activities under this Agreement, and shall
have sole authority to control and direct the activities of the Sales Force
Personnel used by it to Promote the Product in the Territory in accordance with
its obligations hereunder and the terms of this Agreement.
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Section 3.3 Promotion Plan. Subject to Section 4.1:
3.3.1 Approval by JEC. All advertising, promotion, selling and
other commercialization activities contemplated for the Product for a given
Agreement Year (and each Agreement Quarter in such Agreement Year) shall be set
forth to the extent practical in the Promotion Plan for the Product. The
approved Promotion Plan for the first Agreement Year is attached hereto as
Exhibit 3.3.1. For each subsequent Agreement Year, Xxxxx shall prepare the
Promotion Plan for such Agreement Year and deliver a copy thereof to BMS on or
before August 15 of the preceding Agreement Year. The Promotion Plan for any
Agreement Year, and all material changes or supplements thereto, must be
approved by the JEC before such Plan, change or supplement shall be deemed
effective; provided, that if Xxxxx has delivered the Promotion Plan to BMS on or
before August 15 and the JEC has not approved the Promotion Plan by January 1 of
the Agreement Year covered by the Promotion Plan, and such failure is not due to
the unavailability of Xxxxx representatives, then Xxxxx shall be entitled to
rely on the Promotion Plan submitted in order to perform its promotion
obligations under this Agreement until such time as the JEC approves such
Promotion Plan or a modified Promotion Plan. JEC approval shall not be required
for implementation of the details of advertising, promotion, selling or other
commercialization activities where the activity and the overall budget for such
activity was approved by the JEC as part of the Promotion Plan; provided, that
if the JEC believes any activity was not authorized by the Promotion Plan or
that the implementation of an authorized activity is not appropriate in any way,
the JEC may specify the given activity and implementation details that should be
curtailed or modified.
3.3.2 Content of Promotion Plan. Subject to applicable terms
of this Agreement, the Promotion Plan will focus principally on the Promotion of
the Product by Xxxxx in the Territory, and will include matters such as:
3.3.2.1 the Call plan, including total Calls and the
target prescribers;
3.3.2.2 the breakdown of budgeted A&P Costs into the
following categories: samples, A&P Materials and literature, medical
education, market research, conventions, agency fees, and
micro-marketing programs;
3.3.2.3 Product positioning and overall strategies
and tactics, including promotional claims that may be made about the
Product;
3.3.2.4 the quantity and timing of samples of
Product(s) to be made available to Galen's sales forces for use in the
Territory and the strategy/processes for the provision of same within
the Territory; and
3.3.2.5 the level of marketing and other support for
the Product, if any, to be provided directly by BMS.
19
In the event of any conflict between this Agreement and the terms of any
Promotion Plan, the terms of this Agreement shall control.
Section 3.4 Product Samples. The following terms shall apply to the
manufacture, use and distribution of Product samples in the Territory during the
Copromotion Term:
3.4.1 Quantity. Xxxxx shall determine a reasonable level of
samples to be provided to its Sales Force for use in the Territory. As samples
must be ordered by BMS from XXX, BMS will provide to Xxxxx in writing such
forecasting, advance notice, and ordering requirements as BMS will require to
ensure timely manufacture of the samples by XXX and delivery of such samples to
Xxxxx, which requirements BMS will provide to Xxxxx in writing upon execution of
this Agreement and which may be amended by BMS upon reasonable notice from time
to time. Such requirements may be changed by BMS for future orders upon written
notice to Xxxxx. Xxxxx will order a sufficient number of samples for each
Agreement Year as are reasonably necessary to ensure that it meets its Diligent
Efforts obligations hereunder and that will provide adequate and effective
support for achievement of the Baselines in each Agreement Year. The number of
samples approved as part of the applicable Promotion Plan shall be deemed to be
adequate for purposes of this Section 3.4.1.
3.4.2 Title. Title to the samples shall remain with BMS, and
Xxxxx shall be responsible for such sales/use taxes, if any, associated with the
distribution or use of the samples.
3.4.3 Distribution of Samples to Xxxxx. BMS shall be
responsible for the delivery of Product samples to be provided to Xxxxx under
the Promotion Plan to one central distribution point designated by Xxxxx. The
storage of Product samples at the Xxxxx central distribution point and the
distribution of samples to Xxxxx Sales Force Personnel shall be at Galen's sole
expense.
3.4.4 Sample Cost. Xxxxx shall pay BMS for all Product samples
provided by BMS to Xxxxx at the Manufacturing Cost therefore, plus the cost of
shipping such samples to Galen's central distribution point, payment to be due
and payable within thirty (30) days after the later of (x) receipt by Xxxxx of
an invoice therefor or (y) receipt of the samples.
3.4.5 Compliance with Prescription Drug Marketing Act. Each
party will ensure that its marketing and Promotion of the Product shall comply
with all requirements of applicable Law, including without limitation, the PDMA.
Such compliance shall include, without limitation, maintenance of written
procedures designed to ensure that its Sales Force Personnel marketing the
Product in the Territory comply with the PDMA; provided, that if both Parties so
agree in writing, the Parties will comply with any proposed implementing
regulation (or portion thereof) with respect to any Promotional activity under
this Agreement.
Each Party shall use Diligent Efforts to ensure that its Sales
Force Personnel comply with such written procedures. Each Party shall provide
the other Party with a copy of its procedures for review and comment, it being
understood that the content of a Party's procedures
20
shall be the sole responsibility of such Party. Such procedures shall include a
requirement that each Party shall be responsible for reporting directly to the
FDA any known thefts or significant losses of samples and other reportable
incidents as set forth in the PDMA, as the same is required by then applicable
Law during the Copromotion Term, and each Party shall promptly provide the other
written notice that a report has been made and a complete copy of any such
report. Furthermore, such procedures shall include a requirement that Xxxxx will
notify BMS promptly after Xxxxx learns that any samples shipped by BMS to Xxxxx
have been lost or have not been received as scheduled or damaged in transit,
such that BMS will have a reasonable period of time to enable it to comply with
all applicable legal requirements with respect to such samples. Xxxxx shall
promptly inform BMS of any violations of its written procedures or the PDMA by
its Sales Force Personnel.
BMS shall be entitled, at its expense and upon reasonable (but
not less than ten (10) business days) advance written notice to Xxxxx, to
conduct an inspection and audit of Galen's compliance with this Section 3.4.5 at
any of its or its Affiliates' owned or controlled facilities in the Territory
where Product samples are stored. The purpose of such inspection and audit shall
be solely to ensure compliance by Xxxxx with respect to the applicable
provisions of the PDMA as they apply to Galen's duties and obligations under
this Agreement and at Law, as well as to copy records relating to Product sample
receipt, storage and distribution.
Section 3.5 Sales Force Deployment. The following terms shall apply to
promotion of Product(s) in the Territory by Xxxxx and BMS under this Agreement:
3.5.1 Minimum PDEs.
3.5.1.1 During each Agreement Year, Xxxxx shall
provide at least Sixty-Five Thousand (65,000) internally reported PDEs
within the Territory for the Product to the Prescribing Professionals
indicated on the Call List (the "Minimum Annual PDEs"). Unless
otherwise unanimously agreed upon by all members of the JEC, during
each semi-annual period of each Agreement Year, Xxxxx shall provide at
least Thirty-two Thousand Five Hundred (32,500) internally reported
PDEs within the Territory for the Product to the Prescribing
Professionals indicated on the Call List (the "Minimum Semi-Annual
PDEs"). Unless otherwise unanimously agreed upon by all members of the
JEC, during each Agreement Quarter, Xxxxx shall provide at least
Sixteen Thousand Two Hundred Fifty (16,250) internally reported PDEs
within the Territory for the Product to the Prescribing Professionals
indicated on the Call List (the "Minimum Quarterly PDEs"). Where
applicable, the foregoing figure shall be proportionately adjusted
based on the actual number of days in the applicable period as a result
of early termination of the Copromotion Term, of termination of the
Copromotion Term other than at the end of an Agreement Year,
Semi-Annual Period or Agreement Quarter, and/or for the initial
Agreement Year being shorter than twelve months. At least seventy-five
percent (75%) of Galen's Minimum Quarterly PDE requirements shall be
delivered as Primary Position Details, with the balance delivered as
Second Position Details. BMS shall not be entitled
21
to terminate this Agreement for any Xxxxx failure to miss the minimums
except as set forth in Section 3.5.1.3.
3.5.1.2 It is understood that BMS does not have any
minimum annual PDE obligations and may provide no PDEs in its
discretion without affecting Galen's rights, benefits or obligations
hereunder.
3.5.1.3 BMS may terminate this Agreement as set forth
herein in the event that:
3.5.1.3.1 In any Agreement Year, Xxxxx does
not provide at least ninety percent (90%) of its
Minimum Annual PDEs; or
3.5.1.3.2 In any two consecutive Agreement
Quarters, during the Copromotion Term, Xxxxx does not
provide at least ninety percent (90%) of its Minimum
Quarterly PDEs; or
3.5.1.3.3 If in any Agreement Year, at least
seventy-five percent (75%) of Galen's Minimum Annual
PDE requirements are not delivered as Primary
Position Details, with the balance delivered as
Second Position Details.
For purposes of Sections 3.5.1.3.1 and 3.5.1.3.2 and for purposes of
determining whether Xxxxx has met its obligations under section
3.5.1.1, (x) any PDEs that exceed one hundred ten percent (110%) of the
Minimum Quarterly PDEs required for a given Agreement Quarter shall not
be taken into account, and (y) any Calls made to Prescribing
Professionals who are not part of the Call List shall not be taken into
account.
Any termination by BMS under this Section 3.5.1.3 with respect to a
shortfall in a given Agreement Year or two consecutive Agreement
Quarters must be made by BMS by written notice delivered to Xxxxx
within ninety (90) days after BMS is informed by Xxxxx in writing of
such shortfall or breach. The effective date of any such termination
shall be specified by BMS in its written notice of termination but such
date shall be not later than one hundred eighty (180) days after
delivery of the written notice of termination to Xxxxx, unless
otherwise mutually agreed in writing. Any such termination shall also
be subject to applicable provisions of Article 13. Xxxxx shall continue
to perform in accordance with the terms of this Agreement during the
period between notice of termination and the actual termination date.
3.5.1.4 If, during any Semi-Annual period during any
Agreement Year of the Copromotion Term, Xxxxx delivers less than one
hundred percent (100%) of the total Minimum PDEs required of it for
such Semi-Annual period, the Performance Compensation due to Xxxxx
shall be adjusted as follows: the amount determined under Section
11.1.1 for such Semi-Annual period shall be reduced by the percentage
amount
22
that such actual PDEs are deficient (e.g., if the Performance
Compensation due Xxxxx under Article 11 is Twenty Million U.S. dollars
(U.S. $20,000,000), but only 92% of the Minimum Semi-Annual PDEs were
performed in such Semi-Annual period, the Performance Compensation due
Xxxxx under Article 11 would be reduced by the deficient percentage,
i.e., eight percent (8%), to Eighteen Million Four Hundred Thousand
U.S. dollars (U.S. $18,400,000). This remedy shall be in addition to
any termination of this Agreement that may be exercised by BMS pursuant
to Sections 3.5.1.3, but otherwise this reduction shall be BMS' sole
and exclusive remedy for damages incurred by it by reason of any such
shortfall.
3.5.2 Use of Independent Contractors and Part-Time
Representatives.
3.5.2.1 Xxxxx agrees not to use any independent
contractors to provide any of its Minimum Annual PDEs without the prior
written consent of BMS or approval of the JEC. Xxxxx will discuss its
proposed independent contractor arrangements with the JEC. If the use
of any independent contractors is approved by BMS or the JEC, Xxxxx
shall be jointly and severally liable with its Third Party contractee
for any breach of this Agreement or failure to perform such delegated
duties by such Third Party contractee (as well as for any breach by
such Third Party contractee of its Agreement with Xxxxx, as the case
may be), and hereby unconditionally guarantees the performance by such
Third Party contractee of, and shall cause such Third Party contractee
to comply with the provisions of, this Agreement. All compensation,
reimbursement of costs and other payments to be made for any Third
Party contractee's services is solely a matter between Xxxxx and such
Third Party contractee.
3.5.2.2 For geographical reasons, as approved by the
JEC, Galen's Sales Force(s) detailing the Product may retain part-time
employees. The total number of these part-time individuals will be kept
to a minimum, but in any event shall not exceed ten percent (10%) of
the total number of Sales Force Personnel detailing the Product.
3.5.3 Disclosure of Internally Reported Calls; Auditing.
3.5.3.1 Disclosure of Internally Reported Calls.
Xxxxx shall report to BMS the actual number of Calls reported
internally to Galen's management that are made by it within the
Territory to Prescribing Professionals on its Call List during each
month during the Copromotion Term, as well as the position (Primary or
Secondary) of such Calls. Such internal reporting shall be determined
in accordance with the procedures customarily employed by Xxxxx for the
majority of its other pharmaceutical products, consistently applied.
Xxxxx shall provide an interim report of the actual number of Calls
made (and their position) in a given month to BMS within thirty (30)
days after the end of such month and a final report within sixty (60)
days after the end of the applicable month.
3.5.3.2 Audited Calls. BMS shall be entitled to
obtain at its expense from IMS or other recognized service a report of
the audited Calls provided by Xxxxx under this
23
Agreement. If permitted by such service, BMS shall promptly provide a
copy of such report to Xxxxx. BMS shall use reasonable efforts at its
expense to secure IMS's or such other service's approval to providing
the report to Xxxxx. If the ratio of internally reported Calls to
audited Calls is greater than 2:1 for any particular Agreement Quarter,
then the JEC shall investigate the discrepancy and whether the
internally reported calls are being accurately reported, and each Party
shall cooperate with any such investigation and allow the other Party
to review pertinent records.
3.5.3.3 Auditing of a Party's Internal Call Records.
BMS may demand an audit of Galen's relevant books and records in order
to verify its reports on its internally reported PDEs used in
calculating whether Xxxxx has met its obligations under Section 3.5.1.
in accordance with the provisions of Section 11.5.
Section 3.6 Provisions Applicable to All Xxxxx Sales Force Personnel.
3.6.1 Noncompliance by Representative. In the event that
information comes to BMS' attention which gives BMS a reasonable basis for
believing that any Xxxxx Sales Force Personnel may have (i) violated any
applicable Laws or an applicable Xxxxx policy, or (ii) failed to provide
satisfactory service or comply with this Agreement, BMS shall have the right to
request Xxxxx immediately to address the performance of such individual, in
addition to any other rights or remedies available to BMS under this Agreement,
at law or in equity. Xxxxx shall promptly use commercially reasonable efforts to
evaluate and resolve such issue in accordance with Xxxxx policies or as it may
otherwise deem appropriate. Xxxxx shall keep BMS informed of the progress of,
and information learned during, its evaluation, and shall provide BMS with a
reasonably detailed written report summarizing any steps taken toward resolution
of the matter within thirty (30) days after same.
3.6.2 Equal Opportunity Employer. Unless exempted from such
compliance, Xxxxx will comply with all applicable Laws in the hiring,
employment, and discharge of all Xxxxx Sales Force Personnel. Xxxxx represents
to BMS that Xxxxx is an Equal Opportunity Employer and does not discriminate
against any person because of race, color, creed, age, sex, or national origin.
3.6.3 Compliance with Xxxxx Policies. All Xxxxx Sales Force
Personnel shall execute or shall previously have executed an agreement with
Xxxxx, that includes, among other terms, appropriate language under which the
individual:
3.6.3.1 agrees to perform his or her obligations as
part of the Xxxxx sales force and to use and account for
Product samples as required by Law including without
limitation, the PDMA and any applicable final FDA regulations,
and this Agreement; and
3.6.3.2 agrees to perform his/her duties in
accordance with Xxxxx internal policies, a copy of which is
provided or made available by Xxxxx to all its Sales
24
Force Personnel.
3.6.4 Worker's Compensation Insurance. Xxxxx acknowledges and
agrees that BMS does not and will not maintain or procure any worker's
compensation insurance for or on behalf of Xxxxx or its Sales Force Personnel,
all of which shall be Galen's sole responsibility.
3.6.5 Confidentiality and Inventions Agreement with Xxxxx. All
Xxxxx Sales Force Personnel and any other employee or contractor of Xxxxx or its
Affiliates who comes into contact with any BMS Confidential Information shall
have first executed an appropriate agreement with Xxxxx that includes
appropriate language under which the individual is bound to maintain
confidentiality of any Confidential Information disclosed by BMS on terms
consistent with Galen's obligations hereunder. All Xxxxx Sales Force Personnel
and any other employee of Xxxxx or its Affiliates who comes into contact with
any BMS Confidential Information (including BMS Know-how or XXX Know-how) shall
have first executed an appropriate agreement with Xxxxx under which such
individual is bound to assign to Xxxxx all his/her rights, title and interests
in any inventions made by such individual during the Copromotion Term relating
to any Xxxxx Improvements described in Section 3.11; with respect to independent
contractors coming into contact with such BMS Confidential Information, Xxxxx
shall use commercially reasonable efforts to obtain a corresponding assignment
of rights.
3.6.6 No Participation in BMS Benefit Plans. Xxxxx
acknowledges and agrees that all Xxxxx Sales Force Personnel are not, and are
not intended to be or be treated as, employees of BMS or any of its Affiliates,
and that such individuals are not, and are not intended to be, eligible to
participate in any benefits programs or in any "employee benefit plans", as such
term is defined in section 3(3) of ERISA, that are sponsored by BMS or any of
its Affiliates or that are offered from time to time by BMS or its Affiliates to
their own employees (the "BMS Benefit Plans"). All matters of compensation,
benefits and other terms of employment for any such personnel shall be solely a
matter between Xxxxx and such individual. Xxxxx shall be solely responsible and
liable for the payment of all compensation and benefits under any such employee
benefit plan to its Sales Force Personnel.
BMS shall not be responsible to Xxxxx or to its Sales
Force Personnel used by it to Promote the Product for any compensation, expense
reimbursements or benefits (including, without limitation, vacation and holiday
remuneration, healthcare coverage or insurance, life insurance, pension or
profit-sharing benefits and disability benefits), payroll-related taxes or
withholdings, or any governmental charges or benefits (including without
limitation unemployment and disability insurance contributions or benefits and
workmen' compensation contributions or benefits) that may be imposed upon or be
related to the performance by Xxxxx and its Sales Force Personnel of its
obligations under this Agreement, all of which shall be the sole responsibility
of Xxxxx, even if it is subsequently determined by any court, the IRS or any
other Governmental or Regulatory Authority that such individual may be a common
law employee of BMS or any of its Affiliates.
25
3.6.7 Responsibility for Acts and Omissions of its Personnel.
Xxxxx shall be solely responsible for its acts and omissions and for those acts
or omissions of its Sales Force Personnel while performing any of the services
to be provided by Xxxxx under this Agreement.
3.6.8 Indemnification for Employee Reclassification.
3.6.8.1 Xxxxx will indemnify, defend, and hold
harmless BMS and its Affiliates, and its and their directors, employees
and agents (collectively, the "BMS Indemnitees") from and against any
damages, liability, loss and costs that may be paid or payable by any
such BMS Indemnitee resulting from or in connection with any claim or
other cause of action asserted by any Xxxxx Sales Force Personnel, or
by any Third Party (including without limitation Governmental or
Regulatory Authorities) arising out of the execution and/or performance
of this Agreement that is based on or with respect to:
3.6.8.1.1 costs, damages and losses that BMS
or its Affiliates may incur resulting from any claims for
benefits that any Xxxxx Sales Force Personnel may make under
or with respect to any BMS Benefit Plan; and
3.6.8.1.2 any payment or obligation to make
a payment to any Xxxxx Sales Force Personnel relating in any
way to any compensation, benefits of any type under any
employee benefit plan (as such term is defined in Section 3(3)
of ERISA), and any other bonus, stock option, stock purchase,
incentive, deferred compensation, supplemental retirement,
severance and other similar fringe or employee benefit plans,
programs or arrangements that may be sponsored at any time by
BMS or any of its Affiliates or by Xxxxx or any of its
Affiliates, even if it is subsequently determined by any
court, the IRS or any other Governmental or Regulatory
Authority that any Xxxxx Sales Force Personnel may be a common
law employee of BMS or any of its Affiliates; and
3.6.8.1.3 the payment or withholding of any
contributions, payroll taxes, or any other payroll-related
item by or on behalf of Xxxxx or any of its Sales Force
Personnel with respect to which Xxxxx or any of its Sales
Force Personnel may be responsible hereunder or pursuant to
applicable Law to pay, make, collect, withhold or contribute,
even if it is subsequently determined by any court, the IRS or
by any other Governmental or Regulatory Authority that any
such Sales Force Personnel may be a common law employee of BMS
or any of its Affiliates; and
3.6.8.1.4 failure of Xxxxx to withhold or
pay required taxes or failure to file required forms with
regard to compensation paid to Xxxxx by BMS and compensation
and benefits paid or extended by Xxxxx to its Sales Force
Personnel.
3.6.8.2 Notwithstanding anything to the contrary in
Section 3.6.8.1 above,
26
Xxxxx shall have no liability to any BMS Indemnitee to the extent
attributable to any discriminatory, harassing or retaliatory acts of
BMS or any BMS Indemnitee, or any tortious acts (including without
limitation acts constituting assault, battery or defamation) by BMS or
any BMS Indemnitee, with respect to any Xxxxx Sales Force Personnel.
3.6.8.3 Nothing contained in this Section 3.6.8 is
intended to affect or limit any Performance Compensation payable by BMS
to Xxxxx for the services rendered by Xxxxx pursuant to this Agreement.
3.6.9 Xxxxx Responsibility for Disciplinary Actions of Its
Employees. Xxxxx shall be solely responsible and liable for all probationary and
termination actions taken by it, as well as for the formulation, content, and
for the dissemination (including content) of all employment policies and rules
(including written probationary and termination policies) applicable to its
employees and contractors.
3.6.10 Reassignment. Removal or reassignment of any Xxxxx
Sales Force Personnel, including managers, to other Xxxxx sales forces will be
made in a manner that does not disrupt or jeopardize Galen's ability to meet its
obligations under this Agreement.
Section 3.7 Promotional and Advertising Responsibilities.
3.7.1 Overall Responsibility. Subject to Sections 3.2.2 and
3.3.1, all A&P Materials and literature to be used by Xxxxx in the Territory in
connection with the promotion of the Product shall be subject to review and
approval of same by BMS prior to any use thereof. Xxxxx shall submit samples of
such materials to BMS for its prior review and approval. BMS shall inform Xxxxx
of its approval or rejection of such materials within fifteen (15) business days
of their receipt by BMS. If BMS does not approve or reject the materials within
such fifteen (15) business day period, then approval of such materials shall be
deemed granted by BMS, unless and until BMS subsequently notifies Xxxxx in
writing that the materials may not be used. If BMS or the JEC requests that
Xxxxx modify (or cease using) previously approved materials or literature or
modify (or not use) materials and literature submitted for review, Xxxxx shall
promptly undertake to comply with same. BMS shall provide to Xxxxx the rationale
under which BMS shall request that any materials or literature be modified or
cease being (or not be) used, and whether or not Xxxxx agrees with BMS'
rationale, Xxxxx shall promptly comply with BMS' request and not use any
materials and literature that have not been approved in writing (or been deemed
approved in writing) by BMS or the JEC. Xxxxx shall be solely responsible for
all fees payable to any Governmental or Regulatory Authority in connection with
the review and approval of any such A&P Materials and literature and for all
costs incurred by either Party in connection with the development, preparation,
copying and dissemination of A&P Materials and literature, provided, that Xxxxx
shall only be required to supply or bear the cost of one color reproduction of
any such A&P Materials and literature for BMS' review and that any additional
copies may be black and white photocopies. Notwithstanding the foregoing, in the
event that, subsequent to (i) the deemed approval of A&P Materials or literature
by BMS (or product positioning messages, pursuant to
27
Section 3.7.7), BMS notifies Xxxxx that it may not use such A&P Materials and/or
literature (or product positioning messages) or (ii) the approval of A&P
Materials or literature (or product positioning messages) by BMS, BMS requests
that Xxxxx modify or cease using previously approved A&P Materials or literature
(or product positioning message), BMS shall promptly reimburse Xxxxx for its out
of pocket cost incurred in connection with changing and reproducing such A&P
Materials or literature (or product positioning message) and, with retrieving
such materials from the field; provided, that such reimbursement obligation
shall not apply if BMS' subsequent notification or request is required because
of a change in the package insert or NDA, by a change in applicable Law or a new
Law.
3.7.2 Xxxxx Duties. During the Copromotion Term:
3.7.2.1 Xxxxx agrees to instruct its Sales Force
Personnel to use, and to use Diligent Efforts to monitor its Sales
Force Personnel to ensure that such Sales Force Personnel use, only A&P
Materials, Product samples, and literature approved by Xxxxx and BMS
under this Agreement for the promotion of the Product in the Territory;
and
3.7.2.2 Any A&P Material, literature, and Product
samples approved by BMS or supplied by BMS shall not be misbranded,
changed, altered or adulterated prior to their distribution or use by
Xxxxx or its Sales Force Personnel; and
3.7.2.3 Xxxxx will instruct its Sales Force Personnel
to, and will use Diligent Efforts to monitor its Sales Force Personnel
so that such personnel will:
3.7.2.3.1 limit claims of efficacy and
safety for Product in the Territory to those that are
consistent with the promotional claims permitted by the
Promotion Plan and that are consistent in all material
respects with the FDA-approved prescribing information for the
Product in the Territory and with applicable Law;
3.7.2.3.2 not add, delete or modify claims
of efficacy and safety in the Promotion of the Product under
this Agreement in any respect from those claims of efficacy
and safety that are contained in the Promotion Plan and in any
manner that would be inconsistent in any material respect with
the FDA-approved prescribing information and with applicable
Law;
3.7.2.3.3 not make any changes in A&P
Materials and literature approved by BMS, except in accordance
with Section 3.7.1;
3.7.2.3.4 use A&P Materials, literature, and
samples in the Territory in a manner that is consistent with
the Promotion Plan and only in furtherance of this Agreement;
and
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3.7.2.3.5 Promote the Product under this
Agreement in adherence in all material respects to the
Promotion Plan and to applicable legal requirements, as well
as the American Medical Association Gifts to Physicians From
Industry Guidelines.
3.7.2.4 Xxxxx will be solely responsible and liable for any
failure by its Sales Force Personnel to use only those A&P Materials,
Product samples, and literature approved by Xxxxx and BMS (or deemed
approved by BMS) under this Agreement for the promotion of the Product
in the Territory, for any misbranding, change, or alteration of any A&P
Material or literature by Xxxxx or its Sales Force Personnel that was
not expressly approved in writing by BMS, for any alteration,
misbranding or adulteration of any Product Samples by Xxxxx or its
Sales Force personnel, and for any failure of Xxxxx or any of its Sale
Force Personnel to comply with any of sections 3.7.2.3.1-3.7.2.3.5
hereof.
3.7.3 Minimum Advertising and Promotional Spending.. During
the Copromotion Term, and subject to the terms of this Agreement, Xxxxx agrees
to spend not less than Five Million dollars ($5,000,000) in each Agreement Year
on Advertising and Promotion Costs for the Product in accordance with the
Promotion Plan approved by the JEC; provided, that such $5,000,000 figure shall
be prorated for any Agreement Year that is less 365 days based on the number of
days in the actual Agreement Year divided by 365. If Xxxxx breaches the
preceding sentence, then BMS may terminate this Agreement, unless the failure to
spend was attributable to the JEC's failure to approve such advertising and
promotion programs as would have enabled Xxxxx to spend such $5,000,000 in such
preceding Agreement Year or, unless BMS and Xxxxx shall have reached written
agreement on application of the underspend to a succeeding Year (with BMS being
under no obligation, express or implied, to agree to same).
3.7.4 Reimbursement by Xxxxx of Advertising and Promotion.
Xxxxx will reimburse BMS for any A&P Costs incurred by BMS after the Effective
Date where such Advertising and Promotion Costs incurred by BMS were requested
in writing by Xxxxx or involve A&P Costs incurred by BMS that were approved in
advance by unanimous approval of all members of the JEC; provided, that the
foregoing shall not require JEC approval for individual budget line items or
implementation of the details of an advertising and promotion program as a
condition of reimbursement where the overall budget for such program was
unanimously approved by the JEC. Except for the foregoing, any other A&P Costs
incurred by BMS shall be the responsibility of BMS.
Any reimbursement amount due BMS shall be deducted on a
quarterly basis from the Performance Compensation payments due Xxxxx under
Article 11 and shall be reconciled, or trued up, semi-annually. If there is not
sufficient Performance Compensation due Xxxxx to cover such reimbursement of A&P
Costs to BMS, Xxxxx shall make payment of the deficiency within thirty (30) days
after presentation by BMS of an invoice detailing the charges and deficiency.
BMS will provide a statement to Xxxxx within sixty (60) days after the end of
each Agreement Quarter, identifying in reasonable detail the Advertising and
Promotion Costs incurred by BMS in
29
such Agreement Quarter subject to reimbursement by Xxxxx under this Section
3.7.4. The calculation of such Advertising and Promotion Costs and the
reconciliation thereof shall be subject to audit and inspection in accordance
with Article 11 hereof.
The preceding two paragraphs of this section 3.7.4 shall not
apply to reimbursement of Samples costs, which shall be governed by section
3.4.4.
3.7.5 BMS Commitment. It is understood that BMS has no
obligation, express or implied, to incur any A&P Costs or to engage in any
advertising and promotion activities on its own, except where the advertising
and promotion activities shall have been approved by the JEC.
3.7.6 Compliance by Applicable Law. Each Party will use
commercially reasonable efforts to ensure that promotional and education
materials and literature developed, approved, or used by it or its Affiliates
for the Product in the Territory during the Copromotion Term, and all Product
advertising in the Territory during the Copromotion Term (whether in print,
radio, television, Internet, or otherwise) developed, approved, or used by it or
its Affiliates, comply in all material respects with the FDA-approved labeling
for the Product and with applicable Law. Xxxxx will use Diligent Efforts to
ensure that it develops, implements, and uses promotional and educational
materials and literature and advertising programs that are of a nature,
quantity, and quality sufficient to ensure that the Minimum Baselines are
achieved each Agreement Year.
3.7.7 Approval of Product Positioning Messages. All written,
electronic and visual communications provided by Xxxxx to a majority of its
Sales Force Personnel detailing the Product for use by such personnel regarding
Product strategy, positioning or selling messages shall be subject to prior
review and approval by BMS, or subject to modification or cessation upon request
by BMS, in the same manner as promotional and advertising materials and
literature are handled pursuant to Section 3.7.1.
Section 3.8 Market Research Data. During the term of this Agreement,
each Party shall provide the other with access to all lawfully available primary
and secondary (audited and non-audited) market research data for the Product
reasonably promptly if and after the same are made available to it and so long
as it has the lawful right to provide same to the other Party; provided, that
the recipient Party shall hold such information in confidence until made
publicly available by the providing Party or by the Third Party source providing
same, and shall have executed such confidentiality agreement as may be requested
by such Third Party with respect to such disclosure of such information to it.
Section 3.9 Medical Education Programs. Medical education programs for
the Product in the Territory may be approved by the JEC in the applicable
Promotion Plan or by the JEC on an ad hoc basis. Xxxxx shall not be obligated to
conduct any medical education programs and symposia for the Product except as
set forth in the approved Promotion Plan or as approved by the JEC. All such
Medical Education Programs shall be conducted at Galen's sole expense, and Xxxxx
shall reimburse BMS for any A&P Costs incurred by BMS as part of such medical
30
education programs in accordance with Section 3.7.4.
Section 3.10 Clinical Trials. Except as set forth on Exhibit 3.10:
3.10.1 Control of Clinical Trials. Except as set forth in
Section 3.10.3, BMS shall have sole responsibility for the sponsorship, conduct
and termination of any clinical trials (including all Phase IV Studies) relating
to the Product. It is understood that BMS shall have no obligation, express or
implied, to Xxxxx to incur any Phase I-IV study costs or to sponsor or conduct
any Phase I-IV studies for the Product and that Xxxxx has no obligation, express
or implied, to propose any Phase IV Studies or to reimburse BMS for costs
incurred in connection with sponsoring and conducting any such Phase IV Study
other than those proposed or approved by Xxxxx; provided, however, that:
3.10.1.1 BMS shall, through the JEC, provide Xxxxx
with a reasonable opportunity to design and present for BMS or JEC
approval a program of Phase IV Studies relating to the Product that
will be sponsored by BMS or its Affiliates in the Territory (it being
understood that BMS, as the NDA holder, must remain responsible for
sponsoring and conducting Phase IV Studies, although either BMS or
Xxxxx (as a CRO under contract with BMS) may monitor and supervise the
studies). Xxxxx shall be solely responsible for all fully-burdened
costs incurred by Xxxxx or BMS associated with sponsoring and
conducting such Phase IV Studies proposed by Xxxxx that are approved by
BMS or the JEC, and will reimburse BMS for its fully-burdened costs
incurred in sponsoring and conducting any such Phase IV Study.
3.10.1.2 BMS may also design and present Phase IV
Studies for JEC approval as well. Xxxxx shall have the opportunity to
review and comment on the protocol for any such study. If the Xxxxx
members of the JEC approve the Phase IV Study proposed by BMS, then
Xxxxx shall reimburse BMS for its fully-burdened costs incurred in
sponsoring and conducting any such Phase IV Study; if they do not so
approve, BMS shall be responsible for its own costs incurred in
sponsoring and conducting any such Phase IV Study.
3.10.1.3 Any reimbursement amount due BMS shall be
deducted on a quarterly basis from the Performance Compensation
payments due Xxxxx under Article 11, and shall be reconciled, or trued
up, semi-annually. If there is not sufficient Performance Compensation
due Xxxxx to cover such reimbursement of costs to BMS, Xxxxx shall make
payment of the deficiency within thirty (30) days after presentation by
BMS of an invoice detailing the charges and deficiency. BMS will
provide a statement to Xxxxx within sixty (60) days after the end of
each Agreement Quarter, identifying in reasonable detail the
fully-burdened Phase I-IV Study Costs incurred by BMS in such Agreement
Quarter subject to reimbursement by Xxxxx under this Section 3.10.1.
The calculation of such fully-burdened Phase I-IV Study Costs, and the
reconciliation thereof, shall be subject to audit and inspection in
accordance with Article 11 hereof.
31
3.10.1.4 Nothing in this Agreement shall limit or
restrict BMS' ability to propose, sponsor or conduct any comparator
studies in which the Product is compared to any other product or
combination of products that is being developed or marketed by BMS.
3.10.1.5 As between BMS and Xxxxx, notwithstanding
the foregoing, Xxxxx shall have no obligation or liability to BMS or
any Third Party in connection with any sponsorship, conduct and
termination of any clinical trials (including Phase IV Studies)
relating to the Product, to the extent that (a) such study has
commenced prior to the Effective Date, (b) BMS has executed an
agreement with any Third Party in connection with such study prior to
the Effective Date, or (c) BMS has awarded a grant to any Third Party
in connection with any such study prior to the Effective Date.
3.10.2 Use of Data. During the term of this Agreement, without
the prior written consent of Xxxxx (not to be unreasonably withheld), BMS shall
not use and disclose, and to permit others to use and disclose, for any purpose,
the data resulting from clinical studies relating to the Product conducted or
sponsored by either or both Parties (regardless of whether any of such costs are
reimbursed by Xxxxx, in whole or in part), including, but not limited to, use in
the Product Registrations; provided, that, subject to BMS' obligations under
Article 15 hereof, the foregoing shall not apply to any study conducted after
the Effective Date that is sponsored or conducted by BMS or any of its
Affiliates in which the Product is compared to any other product or combination
of products being developed or marketed by BMS.
3.10.3 No Conduct of Studies of the Product or Combination
Product Without BMS Approval . Except as provided in Section 3.10.1, Xxxxx will
not, and will cause its Affiliates not to, conduct any pre-clinical, clinical,
pharmacogenomic, or Phase IV Studies involving the Product or the Compound or
Combination Product using a Product or the Compound; provided, that the
foregoing shall not apply to any studies involving Dovobet. In the event that
Xxxxx or its Affiliates wish to conduct or sponsor a clinical study comparing
Dovobet to Dovonex, whether singly or in combination with other products, Xxxxx
shall provide BMS with a copy of the protocol and design for any such clinical
study in sufficient time prior to its submission to an IRB for approval so that
BMS shall have a reasonable opportunity to comment on the protocol and design
with respect to the scientific validity (e.g., in terms of safety or bias) and
applicable Law. Xxxxx shall adopt such changes suggested by BMS as Xxxxx may in
good faith believe to be necessary or desirable.
Section 3.11 Improvements and Know-how.
3.11.1 In the event that Xxxxx or any of its Affiliates make
any Xxxxx Improvements during the Copromotion Term, such Xxxxx Improvements
shall be promptly and fully advised to BMS in writing. Subject to Section
13.7.4, Xxxxx hereby grants to BMS a non-exclusive, perpetual, irrevocable,
sublicensable, fully paid-up, right and license under Xxxxx Know-How and Xxxxx
Inventions to use same for any purpose anywhere in the world in connection with
the research, manufacture, use, sale, import, and offer for sale of the
Compound,
32
the Product, and any Combination Product, but no other products. Xxxxx shall
not, and shall cause its Affiliates not to, register or permit to be registered
any industrial or intellectual property right embodying BMS' or LEO's
Improvements in any country without BMS' and LEO's prior written consent,
respectively. All rights, title and interests in any industrial or intellectual
property right applied for or obtained by Xxxxx or its Affiliates in breach of
the preceding sentence shall be assigned gratis to BMS upon its request. From
time to time during the term of this Agreement (but not less frequently than
semi-annually), Xxxxx shall furnish BMS with Xxxxx Know-How that Xxxxx or its
Affiliates acquires or develops.
Section 3.12 Bonus Structure of Xxxxx Sales Force Personnel. Galen's
target bonus incentives program for its Sales Force Personnel for the Product
during each Agreement Year will be based upon market performance similar to
Galen's then current other highest priority product and which is Promoted during
the same Agreement Year by any similar sales force within Xxxxx, but not less
than the following: Each Xxxxx sales representative detailing the Product in any
Agreement Year shall have at least forty percent (40%) of his/her dermatology
incentive compensation based on promotion of the Product, with at least fifty
percent (50%) of such Xxxxx sales representatives having at least forty percent
of his/her entire incentive compensation based on Promotion of the Product. In
the event that BMS is concerned that Galen's target bonus incentives for the
Product do not meet the above guidelines, then the JEC will discuss the issue at
its next meeting in a good faith attempt to help resolve any of the perceived
inequities. If the JEC is unable to resolve any of such perceived inequities,
upon reasonable prior notice to Xxxxx, BMS' independent public accountants shall
have access to the relevant books and records of Xxxxx in order to conduct a
review or audit of Galen's sales force compensation practices to confirm whether
or not Xxxxx is complying with the requirements set forth in this Section 3.12.
Such access shall be made available during normal business hours not more than
once in each Agreement Year. BMS shall provide a copy of its audit report to
Xxxxx. Xxxxx may designate competitively sensitive information which such
auditor may see and review but which it may not disclose to BMS; provided,
however, that such designation shall not encompass or restrict the auditor's
investigation or conclusions. BMS' independent public accountants shall enter
into a confidentiality agreement (in form and substance reasonably acceptable to
Xxxxx) requiring such auditor to keep any information gathered from the
inspection of such records and books confidential. Subject to the foregoing,
Xxxxx shall retain final control over all decisions relating to compensation and
bonus incentives for its Sales Force Personnel. Xxxxx will utilize NDCHealth
data (or other mutually agreed upon service) to determine the actual performance
of its Sales Force Personnel for purposes of establishing compensation and
bonuses.
Section 3.13 Management of Sales Force Personnel. During the
Copromotion Term, Xxxxx shall ensure that the management of its Sales Force
Personnel shall use Diligent Efforts to Promote the Product in accordance with
Galen's obligations hereunder.
Section 3.14 Response by Xxxxx to Competitor. Upon being contacted by
any Third Party regarding an efficacy, safety, intellectual property rights,
supply or competition issue relating to the Product, Xxxxx shall promptly notify
BMS of same. Xxxxx will allow BMS to assume, if elected by BMS, exclusive
control over the timing and content of the response to any
33
such Third Party and Xxxxx will not respond to such Third Party unless it has
first consulted with BMS and, subject to Section 10.1, received BMS' permission
to do so. BMS shall provide Xxxxx with a copy of its response to such Third
Party inquiry where the issue involves a matter that, if adversely determined,
would materially adversely affect Galen's rights or obligations under this
Agreement (in which event BMS shall use reasonable efforts to consult with Xxxxx
in connection therewith prior to the delivery of such response to such Third
Party).
Section 3.15 Non-Solicitation. During the Copromotion Term a Party and
its Affiliates shall not solicit for employment the other Party's or its
Affiliates' sales or marketing personnel who are involved in the performance of
this Agreement. For purposes of the foregoing, "solicit" shall not be deemed to
mean (a) circumstances where a solicited employee initially contacts the other
Party or any of its Affiliates with regard to possible employment, or (b)
general solicitations of employment not specifically targeted at employees of a
Party or any of its Affiliates, including responses to general advertisements.
ARTICLE 4 - PRODUCT PRICING; REVENUE RECOGNITION; MANUFACTURING.
Section 4.1 Product Pricing. BMS shall have the sole right and
responsibility for establishing and modifying the terms and conditions with
respect to the sale of Product in the Territory, including (a) any terms and
conditions relating to or affecting the price at which Product will be sold; (b)
any discount attributable to payments on receivables; (c) distribution of
Product; (d) credit, price adjustments, discounts and allowances to be granted
or refused; and (e) price increases or decreases and the timing thereof. BMS has
sole authority and discretion to implement pricing change. BMS shall notify
Xxxxx in writing of such changes at the same time as BMS notifies its own sales
force representatives.
Section 4.2 Revenue Recognition. BMS will book all sales of the Product
in the Territory. BMS shall be exclusively responsible for accepting and filling
purchase orders, billing, and returns with respect to Product. If Xxxxx receives
an order for Product, it shall promptly transmit such order to BMS for
acceptance or rejection, which acceptance or rejection shall be at BMS' sole
discretion. BMS shall have the sole responsibility, at its sole cost and
expense, for Product shipping, distribution and warehousing in a timely manner,
for the invoicing and billing of purchasers of the Product, for order
confirmation (if any) in accordance with BMS' customary practices, and for the
collection of receivables resulting from sales of the Product.
Section 4.3 Supply of Product.
4.3.1 BMS Responsibility. Pursuant to the XXX License
Agreement and XXX Supply Agreement, XXX is obligated to supply BMS, and BMS is
obligated to purchase, all of BMS' requirements for the Product, in finished and
packaged form, for use in the Territory. Subject to the terms of the XXX License
and Supply Agreements and to Sections 3.4 and 4.3 and to Article 8 of this
Agreement, and except as otherwise expressly provided herein, BMS shall use
commercially reasonable efforts to cause XXX to manufacture, finish, label,
package and supply,
34
at BMS' sole cost and expense, all of BMS's and Galen's (with respect to Product
samples only) requirements for the Product and Product samples in the Territory
during the Copromotion Term. BMS shall be solely responsible at its sole expense
for the distribution of Product in the Territory during the term of the
Agreement to Third Party purchasers (including without limitation distributors
and wholesalers) of the Product. BMS shall have no obligation to manufacture
Product itself.
4.3.2 Product Packaging; Manufacturing Representations and
Warranties. BMS represents and warrants to Xxxxx that, under the XXX Supply
Agreement, XXX is obligated to ensure that all Product manufactured and/or sold
to BMS during the Copromotion Term and all samples of Product manufactured by or
for BMS during the Copromotion Term:
4.3.2.1 shall be manufactured, packaged and labeled,
at the time of delivery to BMS (or to Xxxxx for Product samples), in
compliance in all material respects with current Good Manufacturing
Practices (as may be promulgated by FDA and in effect from time to time
during the Copromotion Term), with the CMC section of the Product's
NDA, and with all applicable Laws; and
4.3.2.2 shall not be adulterated or misbranded in any
material respect at the time of delivery to BMS (or to Xxxxx for
Product samples).
4.3.3 Quality Control. Under the XXX Supply Agreement, XXX
shall conduct quality control testing of Product prior to shipment to BMS in
accordance with the Product's NDA and all applicable Laws and in accordance with
prevailing industry standards and LEO's practices in effect on the Effective
Date, shall exercise not less than a reasonable standard of care in connection
with same, and shall prepare and retain records pertaining to such testing as
required by Law and XXX' standard operating procedures.
4.3.4 Change of Product Specifications and/or Source of
Supply. BMS shall have the right, at their respective sole discretion and
expense, to change the Product specifications from time to time at any time
during the term of this Agreement if required by XXX (where XXX is the
manufacturer) or if it is required to do so by any Governmental or Regulatory
Authority having jurisdiction over the Product or if BMS has undertaken
manufacturing or finishing of the Product. In the event of any such change, BMS
shall be responsible, at its sole cost and expense, for ensuring that any such
change is approved by each such applicable Governmental or Regulatory Authority.
If a change requires prior approval by the FDA, such change shall not be
implemented until such change has been so approved. As between BMS and Xxxxx,
BMS shall determine in its sole discretion, and may from time to time change,
the source of supply of the Product without the consent of Xxxxx; provided that
BMS shall give Xxxxx prior written notice of its intention to do so, and that
BMS shall be responsible for securing all Regulatory Approvals at BMS' expense
that may be required to effect such change; and provided, further that Xxxxx
understands that all Product is currently sourced by BMS directly from XXX and
that any such change would also need to be permitted by or consistent with the
terms of the XXX Supply Agreement and XXX License Agreement.
35
4.3.5 Product Returns. Any Product or Product-related items
returned to Xxxxx shall be shipped by Xxxxx to BMS' facility identified by BMS
as the point for receiving returned goods, with any reasonable or authorized
shipping or other documented direct cost to be paid or reimbursed by BMS to
Xxxxx.
4.3.6 Timely Supply. BMS will use Diligent Efforts during the
Copromotion Term to cause XXX to supply Product to meet Galen's reasonable
projections of the requirements of Third Party purchasers in the Territory and
to supply the quantities of Product samples ordered by Xxxxx to Promote the
Product; provided, that Xxxxx has provided BMS with sufficient advance written
notice of such projections in accordance with this Agreement (so that BMS can
meet its forecasting and order obligations to XXX) and provided that XXX makes
timely delivery of conforming Product ordered to BMS. Xxxxx acknowledges that it
has reviewed Section V (B) of XXX Supply Agreement and understands the ordering
and forecasting requirements imposed on BMS that are contained therein. Provided
that Xxxxx shall have given BMS at least ten (10) days written notice of its
forecasting and order requirements consistent with BMS' obligations under the
XXX Supply Agreement, then, if BMS fails to provide XXX for a given quarter
timely written notice of BMS' orders and forecasts for Product and Product
samples, Xxxxx shall have the right, upon ten (10) business days' prior notice
to BMS, to provide such orders and forecasts to XXX on BMS' behalf that Xxxxx
had provided to BMS; provided, that Xxxxx may not do so if BMS notifies Xxxxx in
writing that doing so could result in BMS holding in excess of three (3) months'
of inventory of Product (including safety stock), based upon BMS' latest
estimates for projected sales. Nothing in this Section 4.3.6 is intended to
alter BMS' obligations and rights under the XXX Supply Agreement.
4.3.7 Excess Product and Inventory. The Parties will use good
faith commercially reasonable efforts to minimize the possibility that BMS will
be carrying inventory over and above the amount of Product that can reasonably
be sold in the ordinary course of business plus a reasonable amount of safety
stock.
36
ARTICLE 5 - TRADEMARKS AND COPYRIGHTS.
Section 5.1 Determination of Trademark. The Dovonex(R) trademark shall
be used on the Product for marketing within the Territory. BMS shall own all
rights, title and interests, and be solely entitled to all goodwill developed,
in and to this trademark and any other Trademark.
Section 5.2 Use of BMS and Xxxxx Names on Labeling and Packaging. The
parties agree that, subject to the requirements of applicable Law and the
approval of FDA, BMS and Xxxxx shall be given equal exposure and prominence on
all Product package inserts, packaging, samples and all A&P Materials used or
distributed in connection with the Product under this Agreement, provided, that
the Xxxxx name and logo will not appear until the first re-printing of each of
the applicable components following the Effective Date. All Product labels, A&P
Materials, and commercial packs shall contain a reference to XXX as the licensor
and bulk manufacturer of the Product. Positioning of the Xxxxx and XXX names and
logos shall be determined by the JEC in a manner consistent with applicable Law.
Regarding the Physicians Desk Reference ("PDR"), under Xxxxx (or its permitted
designee's) listing in the PDR, there will be included the package inserts for
the Product included under BMS's listing in the PDR together with an appropriate
indication that the Product is manufactured by XXX and marketed by BMS and Xxxxx
(or its permitted designee). All costs incurred by either Party with placing the
package insert in the PDR under Galen's name shall be borne solely by Xxxxx.
Section 5.3 Trademark Maintenance. BMS shall maintain a registration
for the Trademarks in the Territory at its expense. The Trademarks shall be
owned solely by BMS. Xxxxx will not contest the ownership of the Trademarks,
their validity, or the validity of any registration therefor during the term of
this Agreement. This Agreement does not and is not intended to create a grant to
Xxxxx of any property right or interest in any Trademark. All labeling, A&P
Materials and packaging for the Product in the Territory will clearly indicate
that the Trademarks are owned by BMS or its Affiliates.
Section 5.4 Use of BMS Trademark by Xxxxx. BMS consents to the use by
Xxxxx of the Trademarks in connection with the performance of Galen's
obligations under this Agreement; provided, that except as provided in Sections
3.2.2 and 3.3.1, any such use is first approved in writing by BMS or the JEC in
advance. Xxxxx agrees that all use of the Trademarks by Xxxxx as provided in
this Agreement shall inure to the benefit of BMS and its Affiliates. Galen's
right to use the Trademarks with respect to a given Product shall terminate at
such time as Galen's rights to Promote such Product are terminated in accordance
with this Agreement.
Section 5.5 Infringement of Trademark by Third Parties; Trademark
Indemnification. In the event that in-house legal counsel for either Party
becomes aware of actual or threatened infringement of a Trademark in the
Territory, such Party shall promptly notify the other Party in writing. Xxxxx
shall render, at its expense (subject to reimbursement by BMS below), all
assistance reasonably requested in connection with any action taken by BMS or
its Affiliates to prevent such infringement. The control of such action,
including whether to initiate any legal proceeding and/or the settlement
thereof, shall solely be under the control of BMS or its
37
Affiliates; provided, that BMS and its Affiliates shall not, without Galen's
prior written consent, settle any such claim or proceeding in a manner that (a)
materially adversely affects Galen's rights, benefits (including compensation),
and obligations under this Agreement, and/or (b) admits liability on the part of
Xxxxx, and/or (c) which results in any damages incurred by Xxxxx or any monetary
payment by Xxxxx not covered by BMS' indemnity obligation below; and provided,
further, that BMS shall indemnify and hold Xxxxx and its Affiliates, and its and
their directors, employees, contractors, and agents, harmless from and against
any claims, damages, liabilities, costs and expenses that may be incurred by or
levied upon Xxxxx or any of its Affiliates as a result of providing such
cooperation or of BMS using their respective name(s) in any such action or
related proceeding. BMS shall reimburse Xxxxx for reasonable outside attorneys'
fees incurred by Xxxxx at the specific written request, or with the prior
written consent, of BMS in any such action or related proceeding.
Section 5.6 Copyrighted Works. All copyrighted works authored or
otherwise created or developed for use on or as A&P Materials, packaging and
labeling for the Product, whether singly or jointly, by Galen's or BMS'
employees, agents, or other persons acting under their authority in the conduct
of this Agreement, and all rights, title and interests therein, shall to the
extent directly related to the Product be owned by BMS ("BMS Works"). Xxxxx
shall retain all rights to its sole works to the extent that they are not
directly related to the Product, and shall retain co-rights with BMS in any
joint works to the extent that they are not directly related to the Product.
Xxxxx agrees to execute such instruments as may be reasonably requested by BMS
to confirm the assignment and/or ownership of BMS Works in BMS, free and clear
of liens, claims and encumbrances. BMS and its Affiliates shall be free to use
the BMS Works as BMS deems fit. Nothing herein shall be construed as giving
Xxxxx any right or license to use any BMS Works for any purpose other than for
purposes of carrying out its obligations under this Agreement.
With respect to any of Galen's sole works that are not
directly related to the Product and that are provided by Xxxxx for use with the
Product, BMS shall have a nonexclusive, worldwide, sublicensable, fully paid-up
right and license, both during and following the term of this Agreement, under
any intellectual property rights owned or controlled by Xxxxx or its Affiliates
covering such sole works, to use same in connection with the use, sale,
marketing or Promotion of the Product, but not any other product .
ARTICLE 6 - [INTENTIONALLY OMITTED].
ARTICLE 7 - TRAINING OF SALES FORCES.
Section 7.1 Initial Training. The Parties intend that BMS will provide
Galen's trainers for its Sales Force Personnel with the same or substantially
similar training with respect to promotion of the Product as has been given
traditionally to BMS' sales force in the Territory (it being understood that
such training shall be specific to the Product itself, as opposed to general
sales training). BMS and Xxxxx will hold one such training session ("Initial
Training Session"), which shall be held on one mutually convenient date as soon
as practicable after the Execution Date, and which will be held at a location
mutually acceptable to BMS and Xxxxx. BMS will
38
determine the content of such Initial Training Session, and shall review the
Product-related training materials and make recommendations for any revisions
and updates thereto as BMS may deem appropriate; provided, however, BMS shall
determine and be solely responsible for the content and development of all
training materials for the Initial Training Session.
Section 7.2 Subsequent Training. Xxxxx shall have the authority, and
shall be responsible at its cost and expense, for all training to be provided to
its Sales Force personnel following the Initial Training Session; provided, that
such training shall be consistent with the direction of BMS, the Promotion Plan,
and with the Product training materials and program developed by BMS for
training its own sales forces for the promotion of the Product in the Territory,
and that such training shall include training on the proper handling and
reporting of adverse drug experiences encountered for the Product and on timely
reporting of Product inquiries and other requests for information related to
Product.
Section 7.3 Training Materials. BMS will determine the content of the
Product-specific training materials to be used for the Initial Training Session.
Promptly after the Execution Date, BMS will provide to Xxxxx reasonable
quantities of training materials from its existing supplies to enable Xxxxx to
provide the initial training of its Sales Force Personnel and Xxxxx will
reimburse BMS for its out-of-pocket costs incurred to prepare and provide same.
Where available to BMS, BMS shall supply Xxxxx with an electronic version of the
initial training materials (subject to any obligations BMS may have to any Third
Party that may have prepared the materials), so that Xxxxx may use and reproduce
the materials, as needed, in accordance with the terms of this Agreement. BMS
shall use its commercially reasonable efforts, at its sole expense, to obtain
access to an electronic version of the initial training materials for Galen's
use pursuant to this Section 7.3 from any Third Party that prepared the
materials. The JEC may review the Product-related training materials from time
to time and make recommendations for any revisions and updates thereto as the
JEC may deem appropriate. Any Product-specific training materials developed by
Xxxxx must be submitted to BMS for review and approval prior to any use by Xxxxx
and may be used by BMS or XXX for the promotion of the Product. BMS shall inform
Xxxxx of its approval or rejection of such materials within forty-five (45) days
of their receipt by BMS. Such approval by BMS shall be deemed granted, however,
in the absence of notice to the contrary by BMS within the forty-five (45) days
following receipt of such materials by BMS. All Product-specific training
materials may only be used by Xxxxx for training in connection with the Product
and may not be used, copied or adapted for any other product or purpose. BMS
shall grant to Xxxxx a limited, nonexclusive license under any copyrights
controlled by BMS with respect to any training materials provided by BMS solely
to use, copy and adapt the training materials for the above purpose, and Xxxxx
covenants to use the license solely for the above purpose.
Section 7.4 Cost. Xxxxx shall bear the full cost and expense of all of
its trainers who attend the Initial Training Session, as well as all Sales Force
Personnel and management who attend a Product-related training program, without
contribution from BMS. BMS shall bear the costs and expenses of its personnel
provided for the Initial Training Session. It is understood and agreed that any
such initial and subsequent training costs under sections 7.1, 7.2 and 7.3 and
39
general training costs under section 7.5 that are incurred by either Party are
not A&P Costs.
Section 7.5 General Training. Each of Xxxxx and BMS shall be solely
responsible at its expense for general sales training of its Sales Force
Personnel.
ARTICLE 8 - FORCE MAJEURE.
Section 8.1 Force Majeure. If the performance of any obligation under
this Agreement by either Party is prevented, restricted, interfered with or
delayed by reason of any cause beyond the reasonable control of the Party unable
to perform, not due to malfeasance and which could not, with the exercise of due
diligence, have been avoided (including without limitation, as a result of acts
of God, civil disorders or commotions, acts of aggression, fire, accident,
explosions, floods, drought, war, sabotage, embargo, utility failures, material
shortages, failure of supply of Product on the part of XXX, labor disturbances,
strike, riot, delay or errors by shipping companies, a change in Law, a national
health emergency, or appropriations of property), then, the Party so affected
shall not be excused from such performance, but shall merely suspend such
performance during the continuation of Force Majeure. The Party prevented from
performing its obligations or duties because of Force Majeure shall promptly
notify the other Party hereto of the occurrence and particulars of such Force
Majeure and shall provide the other Party, from time to time, with its best
estimate of the duration of such Force Majeure and with notice of the
termination thereof. The affected Party shall use all reasonable efforts to
avoid or remove such causes of non-performance and to ameliorate the effects of
such nonperformance as promptly as practicable thereafter and upon termination
of Force Majeure, the performance of any suspended obligation or duty shall
promptly recommence. Nothing contained herein shall require any Party to settle
on terms unsatisfactory to such Party any strike, lock-out or other labor
difficulty, any investigation or proceeding by any public authority, or any
litigation by any Third Party. When Force Majeure arises, the Parties shall
discuss what, if any, modification of the terms of this Agreement may be
required in order to arrive at an equitable solution. Neither Party shall be
liable to the other Party for any direct, indirect, consequential, incidental,
special, punitive, exemplary or other damages arising out of or relating to the
suspension or termination of any of its obligations or duties under this
Agreement by reason of the occurrence of Force Majeure.
ARTICLE 9 - CERTAIN REGULATORY MATTERS; PRODUCT RECALL.
Section 9.1 General Control in BMS. Except as otherwise specifically
provided herein, all regulatory matters regarding the Product shall remain under
the exclusive control and responsibility of BMS, subject to the participation by
Xxxxx through the JEC. BMS will have the sole responsibility, at its cost and
expense, to respond to Product and medical complaints and to handle all returns
and recalls of the Product. Subject to the terms of this Agreement, within three
(3) months of the Execution Date, BMS and Xxxxx shall discuss and develop
mutually acceptable guidelines and procedures for the receipt, recordation,
communication (as between the Parties) and exchange of adverse event information
and the other matters covered in this Article 9; until such agreement is
executed, the terms of this Article 9 shall apply. It is anticipated that such
guidelines and procedures will include provisions for the direct reporting to
BMS of adverse
40
events by Xxxxx Sales Force Personnel. The Parties shall bear their respective
costs incurred in connection with receiving, recording, reviewing,
communicating, and exchanging with each other regarding and, as applicable,
reporting and responding to adverse events.
Section 9.2 Efficacy and Safety Information. BMS shall xxxxxxx Xxxxx
with efficacy and safety information reasonably requested by Xxxxx to assist it
in promoting the Product in the Territory, including, without limitation,
summaries of relevant clinical and safety data included in the NDA for the
Product and summaries of information related to the efficacy and safety profile
of the Product since its approval by the FDA. In connection therewith, except as
otherwise specifically provided in this Article 9, BMS will provide Xxxxx in a
timely manner with copies of all Medwatch and or CIOMS-I reports submitted by
BMS with respect to the Product, (i.e., within seven (7) days of submission for
Serious Adverse Events and on a monthly basis for Non-Serious Adverse Events.)
Raw data or databases will not be made available to Xxxxx.
Section 9.3 Notification of Adverse Events; Reporting to Governmental
or Regulatory Authorities. Serious Adverse Events for the Product learned by
Xxxxx shall be submitted to BMS in sufficient time to reasonably allow BMS to
comply with applicable regulations. Non-Serious Adverse Events for the Product
that are spontaneously reported to Xxxxx shall be submitted to BMS no more than
one (1) month from the date received by Xxxxx; provided, however, that medical
and scientific judgment should be exercised in deciding whether expedited
reporting is appropriate in other situations, such as important medical events
that may not be immediately life-threatening or result in death or
hospitalization but may jeopardize the patient or may require intervention to
prevent a Serious Adverse Event outcome.
BMS shall have the reporting responsibility for all adverse
events to applicable Governmental or Regulatory Authorities anywhere in the
world. BMS shall inform Xxxxx of all adverse events reported by it to the FDA at
the same time as BMS reports same to the FDA.
Xxxxx shall report all such adverse events involving the
Product learned by it to:
Vice President, Global Pharmacovigilance & Labeling
Xxxxxxx-Xxxxx Squibb Pharmaceutical Research Institute
P.O. Box 5400
Mail Stop HW19-1.01
Xxxxxxxxx, Xxx Xxxxxx 00000-0000
X.X.X.
Facsimile No.: (000) 000-0000
Telephone No.: (000) 000-0000
A CIOMS-I form or a form that contains the data elements of a CIOMS-I form shall
be used.
Adverse events concerning the Product learned by BMS shall be
reported by BMS to Xxxxx at the time that BMS reports such events to the FDA,
and shall be sent to:
00
Xxxxxx Xxxxxxxx, Inc.
000 Xxxxxxxxxx Xxxxx
Xxxxxxxx, XX 00000
Attention: Medical Director
Telephone No.: (000) 000-0000
Facsimile No.: (000) 000-0000
A Party may change its contact at any time for future notices upon written
notice given to the other.
BMS shall create and maintain at its expense a master safety database
which shall cross-reference any adverse drug experience relating to the Product
occurring anywhere in the world.
Section 9.4 Response by Xxxxx to Regulatory Inquiries. Upon being
contacted by the FDA or any other applicable Governmental or Regulatory
Authority for any regulatory purpose directly related to this Agreement or to
the Product, Xxxxx shall immediately notify BMS. To the extent permitted by
applicable Law, Xxxxx will allow BMS to assume control over the timing and
content of the response to such Governmental or Regulatory Authority and will
not respond to the agency until consulting with BMS; provided, that the
foregoing shall not be construed to prevent Xxxxx in any way from complying with
its obligations under applicable Law, including, without limitation, by
permitting unannounced FDA or similar inspections and responding to requests by
FDA inspectors in connection therewith.
Section 9.5 Product Quality Complaint.
9.5.1 Xxxxx shall inform BMS' Office of the Vice President, U.S. Safety &
Surveillance of any Product Quality Complaint received by it within three (3)
business days from the receipt date by Xxxxx. "Product Quality Complaint" is
defined as any complaint that questions the purity, identity, potency or quality
of the Product, its packaging, or labeling, or any complaint that concerns any
incident that causes the drug product or its labeling to be mistaken for, or
applied to, another article or any bacteriological contamination, or any
significant chemical, physical, or other change or deterioration in the
distributed drug product, or any failure of one or more distributed batches of
the drug product to meet the specifications therefor in the NDA for the Product.
Such information shall be sent to the same address as set forth in Section 9.3
above. BMS shall be solely responsible for responding to any such Product
Quality Complaints.
9.5.2 BMS shall inform Xxxxx of any Product Quality Complaint
received by it within three (3) business days from the receipt date by BMS. Such
information shall be sent to Xxxxx as set forth below:
Xxxxx Holdings PLC
000 Xxxxxxxxxx Xxxxx
Xxxxxxxx, Xxx Xxxxxx 00000
Attention: Vice President- Regulatory Affairs
42
Facsimile No.: (000) 000-0000
Telephone No.: (000) 000-0000
Section 9.6 Medical Inquiries. BMS Medical Communications Department
shall have sole responsibility for handling all medical inquiries concerning the
Product in accordance with its normal procedures therefor. Xxxxx shall refer all
routine medical information requests by telephone or in writing to:
Medical Communications P24-17
Xxxxxxx-Xxxxx Squibb Company
Worldwide Medicines Group
XX Xxx 0000
Xxxxxxxxx, XX 00000-0000
Facsimile No.: 000-000-0000
Telephone No.: ____________________________
For urgent medical information requests, health care professionals shall be
referred by telephone to the Customer Contact Center at 000-000-0000.
A Party may change its contact at any time for future notices under this Section
upon written notice given to the other.
BMS shall provide Xxxxx with one copy of all medical documents,
including but not limited to medical responses, written, phone and person
contact inquiries and published literature which BMS believes is useful or
necessary in connection with the activities and duties contemplated of Xxxxx
under this Agreement.
Section 9.7 Definition of Adverse Event. A "Serious Adverse Event" for
the Product shall have the meaning set forth in 21 C.F.R. Section 314.80(a), as
amended from time to time and a "Non-Serious Adverse Event" is defined as an
untoward medical occurrence at any dose for the Product that is not a Serious
Adverse Event.
Section 9.8 Product Recall.
9.8.1 In the event that either Party obtains information that
a Product or any portion thereof should be alleged or proven not to meet the
specifications, the labeling, or the NDA for such Product or to be otherwise
defective in the Territory, such Party shall notify the other Party immediately
and both Parties shall cooperate fully regarding the investigation and
disposition of any such matter. BMS and Xxxxx shall each maintain such
traceability records as are sufficient and as may be necessary to permit a
recall, product withdrawal or field correction of any Product or Product
samples, as the case may be. In the event (i) any applicable Governmental or
Regulatory Authority should issue a request, directive or order that a Product
be recalled or withdrawn or (ii) BMS determines that any Product already in
interstate or international commerce in the Territory presents a risk of injury
or gross deception or is otherwise
43
defective and that a Recall of such Product is appropriate (each of (i) or (ii),
a "Recall"), each Party shall give telephonic notice (to be confirmed in
writing) to the other within 24 hours of the occurrence of such event.
9.8.2 Prior to making a decision to implement any such Recall,
BMS will, where it is reasonably able to do so, consult with Xxxxx as to same,
but BMS shall have sole responsibility for determining all corrective action to
be taken and for carrying out the Recall. Xxxxx will provide full cooperation
and assistance to BMS in connection therewith as may be requested by BMS,
including providing BMS within five (5) business days of receipt by Xxxxx of
notice of the Recall a list of Prescribing Professionals who received any
Product samples subject to the Recall. BMS shall be responsible for all expenses
of effecting any such Recall (including any out-of-pocket expenses incurred by
Xxxxx in connection with such cooperation), except to the extent such Recall is
attributable to a breach by Xxxxx of its obligations hereunder (in which case
Xxxxx shall be responsible for the expenses associated with any such Recall
attributable to such breach).
ARTICLE 10 - COMPLIANCE WITH LAW AND LABELING.
Section 10.1 Compliance with Laws. Each Party shall comply in all
material respects with all Laws applicable to its activities under this
Agreement, including without limitation, any requirements of any product license
applicable to the Product in the Territory. The Parties will reasonably
cooperate with one another with the goal of ensuring full compliance with Laws.
Section 10.2 Maintenance of Authorizations. Each Party shall maintain
in full force and effect at its expense all necessary licenses, permits,
approvals, consents, registrations, and other authorizations required by Law to
carry out its duties and obligations under this Agreement.
Section 10.3 BMS Duties. During the Copromotion Term, BMS will use
Diligent Efforts to maintain at its expense, consistent with applicable legal
requirements, all necessary authorizations, permits, registrations, including
without limitation each IND, drug master file (DMF), and NDA for each Product,
and consents required of any applicable Governmental or Regulatory Authority or
Third Party that are needed to manufacture, package and store the Product
anywhere in the world, and to import, use, offer for sale, and sell the Product
in the Territory, including without limitation filing IND and NDA annual reports
and maintaining such records and filing such reports as may be required under
the FD&C Act, as well as applicable state and federal Laws (collectively,
"Product Registrations"). BMS shall retain all rights, title and interests in
and to such Product Registrations and to any benefits accruing thereto. BMS
shall use Diligent Efforts to make timely filing with applicable Governmental or
Regulatory Authorities in the Territory of all adverse drug experience reports
related to the Product. BMS shall notify Xxxxx promptly in writing as to any
developments (including without limitation filings, notices and correspondence
received from or made by it with the FDA relating to safety or efficacy claims
of, or advertising or promotional claims for, the Product or that relate to
manufacturing problems) that would have a material adverse effect on the Product
Registrations.
44
Subject to the foregoing and the provisions of Article 9, all
such reports or filings made to the FDA and other Governmental or Regulatory
Authorities shall be the sole responsibility of BMS and shall be made at BMS'
discretion, and Xxxxx shall cooperate with BMS with respect to obtaining and/or
maintaining the Product Registrations, shall execute, acknowledge and deliver
such further instruments at BMS' request and expense, and shall use commercially
reasonable efforts to do all such other acts, as promptly as possible, which may
be necessary or appropriate to assist BMS to obtain and maintain the Product
Registrations in the Territory; provided, that nothing herein shall be construed
as restricting Galen's ability to take action that it deems to be appropriate or
required of it under applicable Law. BMS shall have the final decision-making
authority in every case on whether and how to supplement, amend or otherwise
alter the Product Registrations and any other issues in connection with such
Product Registrations (including, but not limited to, decisions to Recall the
Product) and on whether and how to communicate with the FDA and other applicable
Governmental or Regulatory Authorities in connection therewith; provided, that
BMS will not, except where required by, or to fulfill its obligations under,
applicable Law or except where required by a Governmental or Regulatory
Authority acting within the scope of its authority, supplement, amend or
otherwise alter a Product Registration so as to materially adversely affect
Galen's rights, benefits and obligations under this Agreement that are derived
from such Product Registration.
BMS shall notify Xxxxx in writing promptly of any information
that comes to the attention of Product management or its in-house counsel
regarding any threatened or pending action by the FDA or other Governmental or
Regulatory Authority that may materially adversely affect the safety or efficacy
claims of the Product, or the continued marketing of the Product in the
Territory, or the manufacture or supply of the Product for use in the Territory.
Xxxxx shall provide BMS with reasonable assistance with respect to
communications to and from Governmental or Regulatory Authorities in the
Territory, it being understood that all such communications shall be the sole
responsibility of BMS; provided, that nothing herein shall be construed as
restricting Galen's ability to take action that it deems to be appropriate or
required of it under applicable Law.
Section 10.4 No Misrepresentation. Xxxxx shall make no representations
or warranties relative to the Product that conflict or are inconsistent with the
NDA, applicable Law, and the FDA-approved label for the Product. Xxxxx shall be
responsible for any out-of-pocket costs incurred by BMS resulting from
statements made by Galen's sales representatives that relate to the safety or
efficacy of the Product that are not in compliance with applicable Law or have
not been authorized by BMS in advance in writing or as otherwise expressly
permitted in accordance with the terms of this Agreement.
ARTICLE 11 - COPROMOTION PERFORMANCE COMPENSATION.
Section 11.1 Generally. Subject to Sections 11.6, and 13.6.2, as
compensation for Galen's performance of its Promotion obligations under this
Agreement, BMS shall pay Xxxxx, with respect to each Semi-Annual Period,
compensation ("Performance Compensation") equal to the amount determined under
this Section 11.1, less any amount owed by Xxxxx under Section
45
11.2:
11.1.1 For Each Semi-Annual Period in Agreement Year 1: The
sum of (a), plus (b), plus (c) below, multiplied by the Gross Margin Percentage
for such accounting period, where (a), (b) and (c) represent the following:
(a) An amount determined by multiplying (1)
Eighty Percent (80%), times (2) the Retail
Net Sales Difference for such Semi-Annual
Period; provided, that for purposes of this
subsection (a) (but not for purposes of
Section 11.1.1(c)), if the Retail Net Sales
Difference is less than zero, this amount
shall be deemed to be zero; plus
(b) An amount determined by multiplying (1)
Eighty Percent (80%), times (2) the Mail
Order Net Sales Difference for such
Semi-Annual Period; provided, that for
purposes of this subsection (b) (but not for
purposes of Section 11.1.1(c)), if the Mail
Order Net Sales Difference is less than
zero, this amount shall be deemed to be
zero; plus,
(c) If the Retail/MO Net Sales Difference is a
positive number for such Semi-Annual Period,
then an amount determined by multiplying (1)
the Actual Demand-Based Other Net Sales for
such Semi-Annual Period, times (2) a
fraction, the numerator of which is the
Retail/MO Net Sales Difference and the
denominator of which is the total Actual
Demand-Based Retail/MO Net Sales for the
applicable Semi-Annual Period, times (3)
Eighty Percent (80%).
As used in this Section 11.1:
"Mail Order Net Sales Difference" means the sum of the Actual
Demand-Based Mail Order Net Sales less the Baseline Demand-Based Mail Order Net
Sales for the applicable accounting period.
"Retail Net Sales Difference" means, the sum of the Actual Demand-Based
Retail Net Sales less the Baseline Demand Based Retail Net Sales for the
applicable accounting period.
"Retail/MO Net Sales Difference" means the sum of the actual (whether
negative or positive) Retail Net Sales Difference plus the actual (whether
negative or positive) Mail Order Net Sales Difference.
11.1.2 For Each Semi-Annual Period Agreement Year 2: The sum
of (a), plus (b), plus (c) plus (d) below, multiplied by the Gross Margin
Percentage for such accounting period, where (a), (b), (c) and (d) represent the
following:
46
a) Seven Percent (7%) of the Actual
Demand-Based Retail/MO Net Sales for such
Semi-Annual Period, plus seven percent (7%)
of the Actual Demand-Based Other Net Sales
for such Semi-Annual Period; plus
b) An amount determined by multiplying (1)
Sixty-three percent (63%), times (2) the
Retail Net Sales Difference; provided, that
for purposes of this subsection (b) ) (but
not for purposes of Section 11.1.2(d)), if
the Retail Net Sales Difference is less than
zero, this amount shall be deemed to be
zero; plus
c) An amount determined by multiplying (1)
Sixty-three percent (63%), times (2) the
Mail Order Net Sales Difference; provided,
that for purposes of this subsection (c)
(but not for purposes of Section 11.1.2(d)),
if the Mail Order Net Sales Difference is
less than zero, this amount shall be deemed
to be zero; plus,
d) If the Retail/MO Net Sales Difference is a
positive number for such Semi-Annual Period,
then an amount determined by multiplying (1)
the Actual Demand-Based Other Net Sales for
such Semi-Annual Period, times (2) a
fraction, the numerator of which is the
Retail/MO Net Sales Difference and the
denominator of which is the total Actual
Demand-Based Retail/MO Net Sales for the
applicable Semi-Annual Period, times (3)
Sixty-three percent (63%).
11.1.3 For Each Semi-Annual Period in Agreement Years 3, 4 and
5: The sum of (a), plus (b), plus (c) plus (d) below, multiplied by the Gross
Margin Percentage for such accounting period, where (a), (b), (c) and (d)
represent the following:
a) Twelve percent (12%) of the Actual
Demand-Based Retail/MO Net Sales for such
Semi-Annual Period, plus twelve percent
(12%) of the Actual Demand-Based Other Net
Sales for such Semi-Annual Period; plus
b) An amount determined by multiplying (1)
thirty-eight percent (38%), times (2) the
Retail Net Sales Difference; provided, that
for purposes of this subsection (b) (but not
for purposes of Section 11.1.3(d)), if the
Retail Net Sales Difference is less than
zero, this amount shall be deemed to be
zero; plus
c) An amount determined by multiplying (1)
thirty-eight percent (38%), times (2) the
Mail Order Net Sales Difference; provided,
47
that for purposes of this subsection (c)
(but not for purposes of Section 11.1.3(d)),
if the Mail Order Net Sales Difference is
less than zero, this amount shall be deemed
to be zero; plus,
d) If the Retail/MO Net Sales Difference is a
positive number for such Semi-Annual Period,
then an amount determined by multiplying (1)
the Actual Demand-Based Other Net Sales for
such Semi-Annual Period, times (2) a
fraction, the numerator of which is the
Retail/MO Net Sales Difference and the
denominator of which is the total Actual
Demand-Based Retail/MO Net Sales for the
applicable Semi-Annual Period, times (3)
thirty-eight percent (38%).
11.1.4 An exhibit setting forth the Baseline Agreement Year
Prescriptions, the Baseline Semi-Annual Prescriptions and the Baseline Quarterly
Prescriptions for the mail order and retail segments for the Product is set
forth as Exhibit 11.1.5 hereto and an example of the Performance Fee calculation
is attached as Exhibit 11.1.4 hereto.
Section 11.2 Offset. Any amount determined to be owed to Xxxxx for a
given period pursuant to Section 11.1 shall be reduced by any amount determined
to be owing by Xxxxx to BMS under Sections 3.4.4, 3.7.1, 3.7.4, 3.9, 3.10.1, 7.3
and 7.4 with respect to such period.
Section 11.3 Currency; Bank Account; Tax Withholdings. All payments to
a Party under this Agreement shall be made by electronic funds transfer in legal
currency of the United States and shall be delivered to the account of such
Party designated by a Vice President of Finance in writing from time to time.
Any taxes, levies or other duties paid or required to be withheld by a Party on
account of monies payable to the other Party under this Agreement shall be
deducted from the amount of monies otherwise due such other Party under this
Agreement. In such event, paying Party shall secure and send to receiving Party
proof of any such taxes, levies or other duties withheld and paid by the paying
Party for the benefit of the receiving Party, and shall provide reasonable
cooperation to receiving Party in any effort to secure release or refund of
same.
Section 11.4 Payment.
11.4.1 Quarterly Payments. In order for Xxxxx to receive
Performance Compensation under this Article 11 on a quarterly basis during the
Copromotion Term, at the end of the first quarter in each Semi-Annual Period,
BMS will make a good faith calculation of the amount due to Xxxxx for such
quarter and pay, less any amounts owed by Xxxxx under Section 11.2, such balance
within 30 days following the end of such first quarter.
11.4.2 Semi-Annual Reconciliation. A preliminary semi-annual
reconciliation of the Performance Compensation due Xxxxx under Section 11.1 with
respect to each Semi-Annual Period will be completed within sixty (60) days
after the end of such Semi-Annual Period (or, if later, as soon thereafter as
BMS has received all final IMS data required for BMS to compute any
48
adjustment to Performance Compensation calculated in accordance with Section
11.4.1) and reconciled against all amounts previously paid during such
Semi-Annual Period. If the reconciliation shows an amount due by either Party to
the other, the amount due shall be paid within thirty (30) days after the
receipt by Xxxxx of such reconciliation report. The semi-annual reconciliation
report shall set forth the calculation of the Performance Compensation due Xxxxx
for the applicable Semi-Annual Period within such Agreement Year, the
calculation of any amounts owed by Xxxxx to BMS under Section 11.2 for such
Semi-Annual Period, and any reconciliations or adjustments made in accordance
with this Agreement with respect to such final payment for the applicable
Semi-Annual Period.
Since certain deductions required to calculate Performance
Compensation take more than sixty days after a Semi-Annual Period before being
confirmed with Third Parties (e.g., Medicare and Medicaid rebates), a final
reconciliation of the Performance Compensation due Xxxxx under Section 11.1 with
respect to a Semi-Annual Period will be completed nine (9) months after the end
of such period and reconciled against all amounts previously paid with respect
to such Semi-Annual Period. The final semi-annual reconciliation report shall be
prepared in the same manner as the preliminary semi-annual reconciliation
report, and if the final semi-annual reconciliation shows an amount due by
either Party to the other, the amount due shall be paid within thirty (30) days
after the receipt by Xxxxx of such final semi-annual reconciliation report.
Section 11.5 Books and Records. BMS will maintain complete and accurate
books and records in sufficient detail to enable verification of Galen's
Performance Compensation, and Xxxxx will maintain complete and accurate books
and records in sufficient detail to enable verification of its internally
reported PDEs. Not more than twice per Agreement Year, a Party may demand an
audit of the other Party's and its Affiliates' relevant books and records in
order to verify a Party's reports on the aforesaid matters, and vice-versa. Upon
reasonable prior notice (not less than ten (10) business days) to the other
Party and during the other Party's normal business hours, the auditing Party's
independent public accountants shall have access to the relevant books and
records of the other Party in order to conduct a review or audit thereof. Such
review and access shall be permitted only with respect to the two-year period
prior to the Agreement Quarter in which the audit occurs. Each Party may
designate competitively sensitive information which such auditor may see and
review but which it may not disclose to the other Party; provided, however, that
such designation shall not encompass or restrict the auditor's investigation or
conclusions. The accountants shall report its conclusions and calculations to
both Parties at the same time. The accountants shall execute an appropriate
confidentiality agreement (in form and substance reasonably acceptable to the
audited Party) prior to having access to any of its books and records requiring
such auditor to keep any information gathered from the inspection of such
records and books confidential.
The auditing Party shall bear the full cost of the performance
of any such audit except as hereinafter set forth. If, as a result of any
inspection of the books and records of the other Party, it is shown that a
Party's payments to the other under this Agreement were less than the amount
which should have been paid, then the Party owing the amount shall make all
49
payments required to be made to eliminate any discrepancy revealed by said
inspection within 30 days after written notification of same, plus interest on
the amount due from the date that the amount would otherwise have been paid as
part of the interim semi-annual reconciliation payment at an annual rate equal
to prime rate prevailing during such period plus one percent (1%). If the
Performance Compensation payments calculated under Section 11.1 were less than
the amount which should have been paid by an amount in excess of ten percent
(10%) of the payments actually made during the period in question, BMS shall
also reimburse Xxxxx for its out-of-pocket costs of such audit and inspection.
If the A&P and Phase IV Study costs for which Xxxxx claimed credit differed by
more than ten percent (10%) from the amounts which should actually have been
offset or credited during the period in question, Xxxxx shall also reimburse BMS
for its out-of-pocket costs of such audit and inspection. For purposes of the
foregoing, the prime rate shall mean the rate in effect at Citibank in New York,
New York during the relevant period in question. If Xxxxx understated its
internally reported PDEs for a given Agreement Year by five percent (5%) or
more, then Xxxxx shall reimburse BMS for its out-of-pocket costs of such audit
and inspection.
Section 11.6 Adjustment for Manufacturing Shortages. In the event that
supply problems have caused a material shortage in the supply of Product to
retail trade or managed care segments (with or without regard to the application
of Section 8.1) for more than four (4) weeks in any Semi-Annual Period, and so
long as Actual Demand-Based Retail/MO Gross Sales for such Semi-Annual Period
are less than one hundred ten percent (110%) of the Baseline Demand-Based
Retail/MO Gross Sales for such Semi-Annual Period, it shall notify BMS in
writing as promptly as practicable, and the Parties shall promptly meet to
consider an appropriate adjustment, if any, of Baseline Agreement Year
Prescriptions for Semi-Annual Period(s) affected by such material shortage. If
the Parties fail to reach mutual agreement on the appropriate adjustment under
this Section 11.6 within a reasonably period of time (not to exceed sixty (60)
days after BMS receives written notification from Xxxxx to initiate such
negotiations after such an event has occurred), then Xxxxx shall be entitled to
terminate the Copromotion Term upon one hundred eighty (180) days written notice
to BMS.
ARTICLE 12 - DISPUTE RESOLUTION.
Section 12.1 Dispute Resolution. Except for matters for which unanimous
consent of all members of the JEC or of both Parties is specifically required
under this Agreement, in the event of any controversy, claim or dispute arising
out of or relating to this Agreement, the Parties shall try to settle their
differences amicably between themselves first, by referring the disputed matter
to JEC for resolution with assistance from each Party's Vice President for
Alliance Management (or similar executive). If not resolved by JEC, then the
disputed matter shall be referred to the President of BMS U.S. Primary Care and
the President, Pharmaceuticals of Xxxxx, or their respective designees, for
resolution. Either Party may initiate such informal dispute resolution by
sending written notice of the dispute to the other Party requesting attempted
resolution by said executive officers, and, within twenty (20) days after such
notice, such representatives of the Parties shall meet for the purpose of
attempting in good faith to resolve such dispute. Neither Party shall be
precluded from using a court of competent jurisdiction to resolve any dispute
50
arising under this Agreement.
Section 12.2 No Limitation. Notwithstanding the foregoing, nothing in
this Article 12 shall be construed as limiting in any way the right of a Party
to seek injunctive or other equitable relief from a court of competent
jurisdiction with respect to any actual or threatened breach of this Agreement
or to prevent infringement of its intellectual property rights.
ARTICLE 13 - COPROMOTION TERM AND TERMINATION.
Section 13.1 Copromotion Term; Term of Agreement.
13.1.1 Copromotion Term. The Copromotion Term shall begin on
the Effective Date and shall continue until the earlier of: (i) the date that
all Valid Claims of any patents Controlled by BMS or any of its Affiliates
covering the composition or use of the Product in the Territory have terminated
or expired, (ii) the date that the XXX License Agreement terminates; (iii) the
date that the XXX Supply Agreement terminates and BMS has not been able to find
another source of supply within three (3) months thereafter; or (iv) December
31, 2007 (the "Copromotion Term"); provided, that the Copromotion Term is
subject to earlier termination in accordance with Section 2.3.2, 13.2, 13.3, or
13.5 below or by the Parties' mutual agreement.
13.1.2 Term of Agreement. Subject to Section 13.6 and 13.7,
this Agreement shall terminate upon the expiration or earlier termination of the
Copromotion Term.
Section 13.2 Termination by Xxxxx. Xxxxx may terminate the Copromotion
Term upon the occurrence of any of the following:
13.2.1 immediately upon written notice to BMS, if BMS has
ceased marketing and/or XXX has permanently ceased manufacturing and marketing
the Product because of a significant safety problem related to the Product; or
13.2.2 immediately upon written notice of termination given to
BMS, if BMS has breached a material obligation, covenant, or duty under this
Agreement, unless, where such breach is curable, either BMS has cured such
default within sixty (60) days after Xxxxx has advised BMS in writing of the
nature of the breach or default, or, if such breach is not curable within said
60-day period, BMS has taken substantial steps to remedy such breach and
continues to take diligent steps to cure same as promptly as reasonably
practicable thereafter; or
13.2.3 immediately upon written notice of termination given to
BMS, if any of BMS' representations and warranties set forth in Article 16 are
untrue in any material respect provided, that such notice of termination is
given not later than 180 days after Xxxxx has learned of the circumstance(s)
giving rise to this right of termination; or
13.2.4 pursuant to Sections 11.6 or 13.5; or
51
13.2.5 upon sixty (60) days written notice to BMS in the event
that the FDA imposes a "black box" warning requirement on the labeling for the
Product in the Territory;
Section 13.3 Termination by BMS. BMS may terminate the Copromotion Term
upon the occurrence of any of the following:
13.3.1 immediately upon written notice to Xxxxx, if BMS has
ceased marketing and/or XXX has ceased manufacturing and marketing the Product
because of a significant safety problem related to the Product; or
13.3.2 immediately upon written notice of termination given to
Xxxxx, if Xxxxx has breached a material obligation, covenant, or duty under this
Agreement, unless, where such breach is curable, either Xxxxx has cured such
default within sixty (60) days after BMS has advised Xxxxx in writing of the
nature of the breach or default, or, if such breach is not curable within said
60-day period, Xxxxx has taken substantial steps to remedy such breach and
continues to take diligent steps to cure same as promptly as reasonably
practicable thereafter; or
13.3.3 immediately upon written notice of termination given to
Xxxxx, if any of Galen's representations and warranties set forth in Article 16
are untrue in any material respect, provided, that such notice of termination is
given not later than 180 days after BMS has learned of the circumstance(s)
giving rise to this right of termination; or
13.3.4 pursuant to Section 3.5.1.3; or
13.3.5 pursuant to Sections 2.4; or
13.3.6 pursuant to Section 2.5.1; or
13.3.7 pursuant to Sections 13.5 hereof; or
13.3.8 immediately upon written notice, if (i) Xxxxx has acted
illegally in the manner in which it is Promoting a Product in the Territory or
has otherwise not complied in any material respect with applicable Law relating
to the Promotion of a Product, or (ii) Xxxxx has materially breached or
persistently breached this Agreement in its Promotion of a Product, such that,
in any event or events falling within (i) or (ii), Xxxxx materially jeopardizes
or xxxxx BMS' NDA for, or materially xxxxx the commercial value or the
commercial reputation of, the Product. The phrase "jeopardizes or xxxxx" an NDA
includes, but is not limited to, the following serious types of issues:
13.3.8.1 a government seizure of Product;
13.3.8.2 a government injunction upon the sale of
Product;
13.3.8.3 a government indictment of Xxxxx or its
employees based upon
52
Promotion or other conduct of Xxxxx or its employees involving Product;
or
13.3.8.4 a consent decree or assurance of voluntary
discontinuance or similar civil and/or criminal settlement agreement
entered into between Xxxxx and the federal or state government which
involves the Product and relates to conduct of Xxxxx or its employees
which is not in compliance with or alleged by such government not to be
in compliance with federal and/or state Laws impacting drug labeling,
advertising and promotion including, without limitation the PDMA, the
Antifraud and Abuse Amendments, the Omnibus Budget Reconciliation Act,
and the Veteran's Administration Xxxx, and other similar Laws enacted
in the future in the U.S.; or
13.3.9 pursuant to Section 3.7.3.
Section 13.4 [Intentionally omitted].
Section 13.5 Insolvency. Either Party may terminate this Agreement if,
at any time, the other Party shall file in any court or agency pursuant to any
statute or regulation of any state or country, a petition in bankruptcy or
insolvency or for reorganization or for an arrangement or for the appointment of
a receiver or trustee of the Party or of its assets, or if the other Party
proposes a written agreement of composition or extension of its debts, or if the
other Party shall be served with an involuntary petition against it, filed in
any insolvency proceeding, and such petition shall not be dismissed within sixty
(60) days after the filing thereof, or if the other Party shall propose or be a
party to any dissolution or liquidation, or if the other Party shall make an
assignment for the benefit of creditors. In the event that this Agreement is
terminated or rejected by a Party or its receiver or trustee under applicable
bankruptcy Laws due to such Party's bankruptcy, then all rights and licenses
granted under or pursuant to this Agreement by such Party to the other Party
are, and shall otherwise be deemed to be, for purposes of Section 365(n) of the
Bankruptcy Code and any similar Law in any other country, licenses of rights to
"intellectual property" as defined under Section 101(52) of the Bankruptcy Code.
The Parties agree that all intellectual property rights licensed hereunder,
including, without limitation, any patents or patent applications in any country
of a Party covered by the license grants under this Agreement, are part of the
"intellectual property" as defined under Section 101(52) of the Bankruptcy Code
subject to the protections afforded the non-terminating Party under Section
365(n) of the Bankruptcy Code, and any similar Law in any other country.
Section 13.6 Survival of Obligations.
13.6.1 The termination of this Agreement shall not release or
operate to discharge either Party from any liability or obligation that may have
accrued prior to such termination or constitute a waiver or relinquishment of
any cause of action or claim that a Party may have based on events, acts or
omissions occurring prior to such termination date. Any termination of the
Copromotion Term by a Party shall not be an exclusive remedy, but shall be in
addition to any legal or equitable remedies that may be available to a Party and
shall not affect a Party's rights to indemnification that are expressly set
forth in this Agreement. The mere termination of this
53
Agreement or the Copromotion Term in accordance with the terms hereof shall not,
in and of itself, give rise to any damages or liability on the part of the
terminating Party.
13.6.2 Upon termination of the Copromotion Term prior to the
completion of an Agreement Quarter, Xxxxx shall be entitled to receive a pro
rata portion of the Performance Compensation which it would have been entitled
to receive under Article 11 had the Copromotion Term been in effect until the
end of said Quarter (based on the number of days that Xxxxx was responsible for
promoting the Product in the Territory during such Agreement Quarter).
13.6.3 The following provisions shall survive any termination
of this Agreement: Sections 2.4, 3.2.5, 3.4.2, 3.4.4, 3.4.5 (unless Xxxxx
purchases BMS' NDA for the Product), 3.5.3.3, 3.6.4, 3.6.6-3.6.9, 3.7.2.4,
3.7.4, 3.10.1.4, 3.10.1.5, 4.2, 4.3.2, 4.3.5 (unless Xxxxx purchases BMS' NDA
for the Product), 8.1, 10.1, 13.6, 13.7 and Articles 5, 9, 11, 12, 14, 15, 17
and 18, as well as any other provisions, which, by their intent or meaning, are
intended to so survive, except that, if termination is triggered by reason of
the purchase by Xxxxx of BMS' NDA for the Product, (i) BMS shall have no further
obligation with respect to claims alleged or arising after such termination date
with respect to Sections 14.5 and 14.6 and (ii) Sections 14.1 and 14.2 shall
only survive in respect of events, acts or omissions occurring prior to such
termination date.
Section 13.7 Effect of Termination.
13.7.1 Upon the termination or expiration of the Copromotion
Term, unless otherwise agreed in writing by BMS and Xxxxx, Xxxxx shall promptly
(i) cease all of its promotion activities pursuant to this Agreement, (ii)
discontinue any use of the Trademark, (iii) return to BMS at BMS' expense all
sales training, A&P Material, literature, BMS call lists, BMS Confidential
Information (in accordance with Article 15 hereof), (iv) return to BMS at BMS'
expense any remaining Product samples then in Galen's possession, to a site
designated by BMS; and (v) enable BMS to Promote the Product to all physicians
in the Territory thereafter.
13.7.2 Subject to Section 13.7.4, Xxxxx hereby grants to BMS,
effective upon the termination or expiration of the Copromotion Term, a
non-exclusive, perpetual, irrevocable, sublicensable, fully paid-up right and
license under Xxxxx Know-How and Xxxxx Inventions to use same for any purpose
anywhere in the world in connection with the research, manufacture, use, sale,
import, and offer for sale of the Compound, the Product, and any Combination
Product.
13.7.3 During any period after receipt of notice of
termination but preceding the effective date of termination, each Party shall
continue to diligently fulfill all obligations of this Agreement as apply to it
during such period in accordance with the provisions of this Agreement.
13.7.4 All licenses granted by Xxxxx hereunder shall terminate
upon the earlier of the termination of the XXX License Agreement and the sale of
the Product by BMS to Xxxxx; provided, that Xxxxx shall have granted to XXX a
non-exclusive, perpetual, irrevocable, sublicensable, and fully paid-up right
and license under Xxxxx Know-How and Xxxxx Inventions to use same for any
purpose anywhere in the world in connection with the research, manufacture,
54
use, sale, import, and offer for sale of the Compound, the Product, and any
Combination Product, but no other products.
ARTICLE 14 - INDEMNIFICATION AND INSURANCE; INFRINGEMENT PROCEEDINGS.
Section 14.1 Indemnification by BMS. Subject to Section 14.2, BMS shall
defend, indemnify and hold Xxxxx, its Affiliates and their respective employees,
agents, officers and directors (collectively, the "Xxxxx Indemnitees") harmless
from and against any and all losses, liabilities, obligations, claims, fees
(including, without limitation, reasonable attorneys fees and fees of other
professionals), expenses and lawsuits brought against or incurred by a Xxxxx
Indemnitee that are claimed by any Third Party and that result from or arise in
connection with: (i) the breach of any covenant, obligation, representation or
warranty of BMS contained in this Agreement; (ii) any claim of patent,
copyright, trade secret or other intellectual property infringement arising out
of or in connection with any manufacture, use, sale, offer for sale,
importation, or use of the Product; (iii) any product liability claim arising
out of or in connection with the use of the Product by any Third Party; (iv)
injury to any person (including death) arising out of the use of the Product;
(v) negligence or willful misconduct by any employee, representative, contractor
(other than Xxxxx or XXX) or agent of BMS and its Affiliates; and (vi) claims by
Third Parties arising out of any shortfall of the Product in the Territory.
Section 14.2 Indemnification by Xxxxx. Xxxxx shall defend, indemnify
and hold BMS, its Affiliates and their respective employees, agents, officers
and directors (collectively, the "BMS Indemnitees") harmless from and against
any and all losses, liabilities, obligations, claims, fees (including, without
limitation, reasonable attorneys fees and fees of other professionals), expenses
and lawsuits brought against or incurred by an BMS Indemnitee by a Third Party
resulting from or arising in connection with: (i) the breach by Xxxxx of any
covenant, obligation, representation or warranty of Xxxxx contained in this
Agreement; (ii) negligence or willful misconduct by any employee,
representative, contractor (other than BMS) or agent of Xxxxx and its
Affiliates; (iii) any failure of any A&P Materials (as defined in Section 3.2.2)
prepared or proposed by Xxxxx to receive FDA Approval or to comply with the
Product labeling, applicable Law, or applicable FDA approvals received for same;
and/or (iv) any contamination, mislabeling, alteration, or adulteration of any
Product samples or A&P Materials to the extent caused by Xxxxx while such
samples or materials are under the control of any Xxxxx Indemnitee.
Section 14.3 Indemnification Procedure. In order to receive the
benefits of the indemnity under Sections 3.10, 14.1, or 14.2, as applicable, a
Xxxxx Indemnitee or BMS Indemnitee (either, an "Indemnitee") must:
(i) give the indemnifying Party (the "Indemnitor") written notice
of any claim or potential claim promptly after the Indemnitee
receives notice thereof; provided that failure of the
Indemnitee to provide such notice shall not constitute a
waiver of, or result in the loss of, such Party's right to
indemnification under this Agreement, except in the event that
the Indemnitor's rights, and/or its ability to
55
defend against or settle such claim or potential claim, are
materially prejudiced by such failure to notify;
(ii) allow the Indemnitor to assume the control of the defense and
settlement (including all decisions relating to litigation,
defense and appeal) of any such claim, provided, that: (a) the
Indemnitor has confirmed its indemnification obligation to the
Indemnitee under this Article 14, and (b) no such settlement
may materially adversely affect the rights or obligations of
the Indemnitee under this Agreement without the Indemnitee's
prior written consent; and
(iii) reasonably cooperate with the Indemnitor in its defense of the
claim (including, without limitation, making documents and
records available for review and copying and making persons
within the Indemnitee's control available for pertinent
interview and testimony), so long as such cooperation does not
vitiate any legal privilege to which such Indemnitee is
entitled.
If the Indemnitor defends the claim, the Indemnitee may at its expense and using
attorneys of its choice, participate in, but shall not have any control of, the
defense of such claim. An Indemnitor shall have no liability under this Article
14 as to any claim for which settlement or compromise of such claim, or an offer
of settlement or compromise of such claim, is made by an Indemnitee without the
prior written consent of the Indemnitor.
Section 14.4 Insurance. Both BMS and Xxxxx shall maintain an adequate
self-insurance and/or insurance program to protect against potential liabilities
and risk arising out of activities to be performed under this Agreement and upon
such terms (including coverages, deductible limits and self-insured retentions)
as are customary for the activities to be conducted by such Parties under this
Agreement and are appropriate to cover the Parties' respective indemnification
obligations hereunder. Each Party shall furnish to the other evidence of such
insurance and/or self insurance, upon request. Such insurance information shall
be kept in confidence in the same manner as any other confidential information
disclosed by one Party to the other hereunder.
Section 14.5 Infringement Claimed by a Third Party. In the event of the
institution of any suit by a Third Party against Xxxxx or its Affiliates for
patent, copyright or trademark infringement involving the manufacture, use,
sale, license or marketing of the Product in the Territory, Xxxxx shall promptly
notify BMS in writing. BMS shall defend Xxxxx in any such suit with counsel
reasonably satisfactory to Xxxxx at BMS' own expense. BMS may settle any such
action in its sole and absolute discretion through the payment of damages,
royalties, milestones or other fees to such Third Party. Provided that BMS has
acknowledged its indemnification obligations to Xxxxx under Section 14.3 in
writing, Xxxxx shall render, at its expense all assistance reasonably requested
in connection with any action taken by BMS in such suit and permit BMS to use
its name in connection therewith, and the control of such action, including
whether to initiate any legal proceeding and/or the settlement thereof, shall
solely be under the control of BMS; provided, that BMS or its Affiliates shall
not, without Galen's prior written consent (not to be unreasonably withheld),
settle any such claim or proceeding in a manner that (a) materially adversely
affects Galen's rights, benefits or
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obligations under this Agreement, or (b) admits liability on the part of Xxxxx,
or (c) results in any damages payable by Xxxxx that are not covered by BMS'
indemnification herein. BMS shall reimburse Xxxxx for reasonable out-of-pocket
expenses (including attorney's fees and costs of litigation) incurred by Xxxxx
in any such proceeding or at the specific written request of BMS. BMS shall
indemnify and hold Xxxxx and its Affiliates harmless from and against any
claims, damages, liabilities, costs and expenses that may be incurred by or
levied upon Xxxxx or any of its Affiliates as a result of providing such
cooperation or of using their respective name(s) in any such action or related
proceeding.
Section 14.6 Infringement by Third Parties. In the event that in-house
legal counsel for BMS or any of its Affiliates or Xxxxx or any of its Affiliates
becomes aware of actual or threatened infringement of a XXX Patent anywhere in
the Territory, that Party shall promptly notify the other Party in writing of
same. BMS shall have the exclusive right but not the obligation to bring, at its
own expense, an infringement action against any such Third Party, and to use the
name of Xxxxx in connection therewith and to name Xxxxx, as necessary, as a
party thereto; provided, that, BMS shall indemnify and hold Xxxxx and its
Affiliates harmless from and against any claims, damages, liabilities, costs and
expenses that may be incurred by or levied upon Xxxxx or any of its Affiliates
as a result of rendering cooperation to BMS in such action or proceeding or of
using their respective name(s) in any such action or related proceeding. Xxxxx
shall render, at its expense (subject to reimbursement by BMS of Galen's
out-of-pocket costs and expenses incurred in connection therewith), all
assistance reasonably requested in connection with any action taken by BMS to
prevent such infringement. The control of such action, including whether to
initiate any legal proceeding and/or the settlement thereof, shall solely be
under the control of BMS; provided, that BMS may not, without Galen's prior
written consent, settle any such claim or proceeding in a manner that (a)
materially adversely affects Galen's rights, compensation, benefits, or
obligations under this Agreement, or (b) admits liability on the part of Xxxxx,
or (c) which results in any damages payable by Xxxxx, without Galen's consent.
All damages and monetary rewards received from such Third Party shall, after
payment of any amounts due to XXX under the XXX License Agreement, be divided
fifty percent (50%) to BMS and fifty percent (50%) to Xxxxx.
ARTICLE 15 - CONFIDENTIALITY.
Section 15.1 Confidential Information. Each Party acknowledges that it
may receive Confidential Information (as defined below) of the other Party in
the performance of or in furtherance of this Agreement. Each Party shall use
commercially reasonable efforts to hold confidential and not to, directly or
indirectly, disclose or publish to any Third Party or use for the benefit of a
Third Party or itself or its Affiliates, except in carrying out its duties
hereunder, any Confidential Information of the other Party, without first having
obtained the furnishing Party's written consent to such disclosure or use.
"Confidential Information" means know-how, scientific information, pre-clinical
and clinical data, adverse event information, formulas, methods and processes,
specifications, pricing information (including discounts, rebates and other
price adjustments) and other terms and conditions of sales, customer
information, business plans, and all other intellectual property which is not
publicly available and is owned or controlled by a
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Party. These restrictions shall not apply to any Confidential Information which:
15.1.1 is known to the receiving Party or its Affiliates prior
to the time of disclosure to it; or
15.1.2 is independently developed by employees, agents, or
independent contractors of the receiving Party or its Affiliates without aid or
use of the disclosing Party's Confidential Information (and such independent
development can be demonstrated by the receiving Party); or
15.1.3 is disclosed, without restriction as to
confidentiality, to the receiving Party or its Affiliates by a Third Party that
has a right to make such disclosure; or
15.1.4 becomes part of the public domain through no breach by
the receiving Party of its obligations under this Agreement (including without
limitation information that is contained in any written A&P Material prepared by
BMS that is distributed for use in connection with the Product).
Each receiving Party shall disclose Confidential Information of the
disclosing Party only to those employees and contractors of such Party and of
its Affiliates who have reason to know same in furtherance of a Party's duties
under this Agreement and who are bound by a written obligation of
confidentiality to the receiving Party (or its Affiliate) that is no less
stringent than the confidentiality obligations set forth in this Article 15.
Section 15.2 Required Disclosures. The receiving Party shall also be
entitled to disclose the other Party's Confidential Information that is required
to be disclosed (i) to or by Governmental or Regulatory Authorities; (ii) to
comply with applicable Laws (including, without limitation, to comply with SEC,
NASDAQ or stock exchange disclosure requirements), (iii) to comply with judicial
process or an order of any Governmental or Regulatory Authority of competent
jurisdiction, or (iv) to defend or prosecute litigation; provided, however, that
in each case the Party required to disclose such Confidential Information shall
use reasonable efforts to notify the other Party in advance of such disclosure
and shall provide the disclosing Party with reasonable assistance to obtain a
protective order and/or confidential treatment of such Confidential Information,
to the extent available, and thereafter only discloses the minimum Confidential
Information required to be disclosed in order to ensure legal compliance.
Section 15.3 Duration. This obligations set forth in this Article 15
shall survive the termination or expiration of this Agreement for ten (10)
years. Upon expiration or termination of this Agreement, a receiving Party shall
return to the disclosing Party or destroy all Confidential Information provided
to it by the disclosing Party, including all copies, notes and extracts thereof
or other written records containing such Confidential Information, except for
one (1) copy that it may keep in its archives for the sole purpose of verifying
its continuing confidentiality obligations hereunder.
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Section 15.4 Novation. The confidentiality obligations described above
shall supersede the Confidential Disclosure Agreement dated as of January 4,
2001 between the Parties with respect to the disclosure by either Party to the
other of any Confidential Information hereafter that may fall within the terms
of this Agreement and the terms of such Confidential Disclosure Agreement.
Further, said prior Confidential Disclosure Agreement is hereby amended to
incorporate the terms of Section 15.3 hereof.
ARTICLE 16 - REPRESENTATIONS AND WARRANTIES.
Section 16.1 Mutual Representations and Warranties. Xxxxx and BMS each
represent and warrant to the other Party that, as of the Execution Date:
16.1.1 Representations of Authority. It (as well as such
Party's Affiliates with which such Party may agree, contract or otherwise
arrange with to assume or perform any of such Party's rights, obligations,
representations, or warranties hereunder) has full corporate right, power and
authority to enter into this Agreement and to perform its respective obligations
under this Agreement and, subject to Section 16.1.2 hereof, that it has the
right to grant to the other the licenses granted pursuant to this Agreement.
16.1.2 Consents. All necessary consents, approvals and
authorizations of all Governmental or Regulatory Authorities and other persons
required to be obtained by it as of the Execution Date in connection with the
execution, delivery and performance of this Agreement have been or, if
reasonably capable of being obtained prior to the Execution Date, shall be
obtained.
16.1.3 No Conflict. Notwithstanding anything to the contrary
in this Agreement, the execution and delivery of this Agreement, the performance
of such Party's obligations in the conduct of this Agreement and the licenses
and sublicenses to be granted pursuant to this Agreement (a) do not and will not
conflict with or violate any requirement of applicable Laws existing as of the
Execution Date, and (b) do not and will not conflict with, violate, breach or
constitute a default or require any consent under, any contractual obligations
of such Party or any of its Affiliates existing as of the Execution Date, except
for such consents as shall have been obtained prior to the Execution Date.
16.1.4 Enforceability. This Agreement has been duly executed
by it, has been authorized by all necessary corporate action, and is a legal and
valid obligation binding upon it and is enforceable in accordance with its
terms.
ARTICLE 17 - NOTICES.
Section 17.1 Notices. Unless otherwise explicitly set forth herein, any
notice required or permitted to be given hereunder shall be in writing and shall
be delivered personally by hand, or sent by reputable overnight courier,
signature required, to the addresses of each Party set forth below or to such
other address or addresses as shall be designated in writing in the same matter:
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(a) If to BMS:
Xxxxxxx-Xxxxx Squibb U.S. Pharmaceutical Group
000 Xxxxxxxx Xxxx Xxxx
Xxxxxxxxxx, XX 00000
Attention: President - U.S. Pharmaceutical Group
with a copy to the attention of the "Vice President and Senior Counsel - USPG"
at the same address and a copy to the attention of the Vice President - Alliance
Management at Xxxxxxx-Xxxxx Squibb Company, Xxxxx 000 xx Xxxxxxxx Xxxx Xxxx,
Xxxxxxxxx, Xxx Xxxxxx 00000-0000.
(b) If to Xxxxx:
Xxxxx (Chemicals) Limited.
0 Xxxxxxxx Xxxx
Xxx Xxxxxxxxx, Xx. Xxxxxx
Attention: Senior Vice President - Finance
with a copy to the attention of the "Senior Vice President, Corporate
Development and General Counsel" at 000 Xxxxxxxxxx Xxxxx, Xxxxxxxx, Xxx Xxxxxx
00000.
All notices shall be deemed given when received by the addressee.
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ARTICLE 18 - MISCELLANEOUS PROVISIONS.
Section 18.1 Assignment.
18.1.1 Neither Party shall assign or otherwise
transfer this Agreement or any interest herein or right hereunder without the
prior written consent of the other Party, and any such purported assignment,
transfer or attempt to assign or transfer any interest herein or right hereunder
shall be void and of no effect; except that each Party (i) may assign its rights
and obligations hereunder to an Affiliate without the prior consent of the other
Party (although, in such event, the assigning Party shall remain jointly and
severally responsible and liable with such Affiliate for the performance of all
of representations, warranties, obligations and agreements of the assigning
Party set forth herein) and (ii) may assign its rights and obligations to a
successor (whether by merger, consolidation, reorganization or other similar
event) or purchaser of all or substantially all of its business assets relating
to its pharmaceutical business; provided, that such successor or purchaser has
agreed in writing to assume all of such Party's rights and obligations hereunder
and a copy of such assumption is provided to the other Party hereunder.
18.1.2 BMS reserves the right to assign to an
Affiliate or to XXX all rights to the Product (including the IND and NDA), as
and upon such terms as BMS may elect and determine in its sole and absolute
discretion; provided, that such Affiliate or XXX shall have first agreed in
writing with Xxxxx and with BMS that it shall be jointly and severally
responsible and liable with BMS with respect to the performance of BMS'
representations, warranties, covenants, and obligations under this Agreement.
Section 18.2 Non-Waiver. Any failure on the part of a Party to enforce
at any time or for any period of time any of the provisions of this Agreement
shall not be deemed or construed to be a waiver of such provisions or of any
right of such Party thereafter to enforce each and every such provision on any
succeeding occasion or breach thereof.
Section 18.3 Entirety of Agreement. This Agreement contains the entire
understanding of the Parties with respect to the subject matter hereof and
thereof and supersedes all previous and contemporaneous verbal and written
understandings, agreements, representations and warranties with respect to such
subject matter or on which the Parties may have relied. This Agreement (and any
provision or term hereof) may be released, waived, changed or supplemented only
by a written agreement signed by an officer or other authorized representative
of the Party against whom enforcement of any release, waiver, change or
supplement is sought. This Agreement shall not be strictly construed against
either Party hereto. Paragraph headings are for convenience only and shall not
be considered in interpreting this Agreement. Any provisions of this Agreement
that conflict with any subsequently executed agreement between BMS and Xxxxx or
with the Option Agreement among XXX, BMS and Xxxxx entered into concurrently
herewith shall be governed by and be subject to the terms of those agreements.
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Section 18.4 Public Announcements. The form and content of any public
announcement to be made by one Party regarding this Agreement, or the subject
matter contained herein, shall be subject to the prior written consent of the
other Party (which consent may not be unreasonably withheld), except as may be
required by applicable Law (including, without limitation, disclosure
requirements of the SEC, NASDAQ, or any other stock exchange) in which event the
other Party shall endeavor to give the other Party reasonable advance notice and
review of any such disclosure.
Section 18.5 Governing Law. THIS AGREEMENT SHALL BE GOVERNED BY AND
CONSTRUED IN ACCORDANCE WITH THE INTERNAL LAWS OF THE STATE OF NEW YORK
APPLICABLE TO AGREEMENTS MADE AND TO BE PERFORMED ENTIRELY WITHIN SUCH STATE,
WITHOUT REGARD TO THE CONFLICTS OF LAW PRINCIPLES OF SUCH STATE OTHER THAN
SECTIONS 5-1401 OF THE NEW YORK GENERAL OBLIGATIONS LAW.
Section 18.6 Relationship of the Parties. In making and performing this
Agreement, the Parties are acting, and intend to be treated, as independent
entities and nothing contained in this Agreement shall be construed or implied
to create an agency, partnership, joint venture, or employer and employee
relationship between BMS and Xxxxx. Except as otherwise expressly provided
herein, neither Party may act on behalf of the other Party, and neither Party
may make (or has any authority to make) any representation, warranty or
commitment, whether express or implied, on behalf of the other Party or incur
any charges or expenses for or in the name of the other Party. No Party shall be
liable for the act of any other Party unless such act is expressly authorized in
writing by both Parties hereto. The relationship of the Parties under this
AGREEMENT is, and is intended to be, one of independent contractors hereunder.
Neither Party shall have any responsibility for the hiring,
firing, compensation or benefits of the other Party's employees, and all
compensation and benefits to be paid to any employee or representative of a
Party (including without limitation all Sales Force Personnel engaged by a
Party) shall be the responsibility of the Party engaging such individual.
Neither Party may create or impose any contractual or other liability on behalf
of the other Party without said Party's authorized prior written approval.
Section 18.7 Counterparts. This Agreement shall become binding when any
one or more counterparts hereof, individually or taken together, shall bear the
signatures of each of the Parties hereto. This Agreement may be executed in any
number of counterparts, each of which shall be deemed an original as against the
Party whose signature appears thereon, but all of which taken together shall
constitute but one and the same instrument.
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[end of text - signature page to follow]
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IN WITNESS WHEREOF, the Parties hereto have duly executed this
Agreement as of the day and year first above written.
XXXXXXX-XXXXX XXXXXX XXXXX (CHEMICALS) LIMITED
COMPANY
By: _____________________________ By: ___________________________________
Name: Xxxxx X. Xxxxxx Name: Xxxxx X. Xxxxxxxxxxxxx
Title: Senior Vice President, Title: Director
Corporate Development
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