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Exhibit 10.40
Pursuant to 17 CFR 240.24b-2, confidential
information has been omitted in places marked "[* * *]" and has
been filed separately with the Securities and Exchange Commission
pursuant to a Confidential Treatment Application filed with the
Commission.
SUPPLY AND DISTRIBUTION
AGREEMENT
among
GLAXO GROUP LIMITED,
GLAXO WELLCOME MANUFACTURING PTE LIMITED
and
PAR PHARMACEUTICAL, INC.
November 10, 2006
Pursuant to 17 CFR 240.24b-2,
confidential information has been omitted in places marked "[* *
*]" and has been filed separately with the Securities and Exchange
Commission pursuant to a Confidential Treatment Application filed
with the Commission.
SUPPLY AND DISTRIBUTION
AGREEMENT
Table of Contents
Pursuant to 17 CFR 240.24b-2,
confidential information has been omitted in places marked "[* *
*]" and has been filed separately with the Securities and Exchange
Commission pursuant to a Confidential Treatment Application filed
with the Commission.
SUPPLY AND DISTRIBUTION
AGREEMENT
Table of Exhibits, Schedules and Appendices
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GSK Supplied Product Supply Price
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Form of Trading Services Agreement
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Form of Quality Agreement
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GSK Supplied Product and its
Specifications
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GSK Supplied Product and Initial PAR
Estimate
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Initial Quantity
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Form of Pharmacovigilance Agreement
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Press Release
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Pursuant to 17 CFR 240.24b-2,
confidential information has been omitted in places marked "[* *
*]" and has been filed separately with the Securities and Exchange
Commission pursuant to a Confidential Treatment Application filed
with the Commission.
SUPPLY AND DISTRIBUTION
AGREEMENT
PREAMBLE
This SUPPLY AND DISTRIBUTION AGREEMENT dated as of the 10th day
of November, 2006 (the " Execution Date ") by and among
Glaxo Group Limited, a company incorporated in England and Wales,
having its registered office at Glaxo Wellcome House, Berkeley
Avenue, Greenford, Middlesex, England UB6 0NN, and Glaxo Wellcome
Manufacturing PTE Limited, having its registered office at 1
Pioneer Sector 1, Jurong, Singapore 628413 (collectively, "
GSK "), and PAR Pharmaceutical Companies, Inc., a Delaware
corporation having its office at 300 Tice Boulevard, 3
rd Floor, Woodcliff
Lake, NJ 07677 (" PAR "). PAR and GSK are sometimes
collectively referred to herein as the " Parties " and
separately as a " Party ."
WHEREAS, GSK and Spectrum Pharmaceuticals, Inc. ("
Spectrum ") entered into that certain Settlement Agreement
(as that term is hereinafter defined) on November 10,
2006;
WHEREAS, pursuant to such Settlement Agreement, GSK and Spectrum
have agreed to enter into this Agreement under which GSK (or its
Affiliate) has agreed to supply GSK Supplied Products (as that term
is hereinafter defined) to Spectrum for distribution in the
Territory (as that term is hereinafter defined) upon the terms and
conditions set forth herein;
WHEREAS, pursuant to a certain Development and Marketing
Agreement dated February 22, 2006 (as amended), by and between
Spectrum and PAR (the " Marketing Agreement "), Spectrum has
granted PAR a license to market, promote, distribute and sell
certain pharmaceutical products on behalf of Spectrum in the United
States, its territories, possessions, protectorates and the
Commonwealth of Puerto Rico, and under such Marketing Agreement,
PAR is responsible for entering into any commercial supply
agreement that is necessary to allow PAR to obtain adequate
quantities of such pharmaceutical products;
WHEREAS, in order to fulfill its obligations under the Marketing
Agreement PAR and its Affiliates desire to exclusively purchase
certain GSK Supplied Products for resale to its (or their)
distributors and other customers for ultimate sale to consumers in
the Territory, and GSK (or its Affiliate) desires to manufacture
and supply the GSK Supplied Products to PAR and its Affiliates in
such Territory subject to the terms and conditions set forth in
this Agreement; and
WHEREAS, PAR and Spectrum acknowledge and agree that PAR shall
enter into this Agreement on behalf of Spectrum pursuant to the
terms and conditions of the Settlement Agreement, and that PAR
shall purchase the GSK Supplied Products and market, promote,
distribute and sell such GSK Supplied Products in the Territory
subject to the respective rights and obligations of PAR and
Spectrum set forth in the Marketing Agreement.
NOW, THEREFORE, in consideration of the mutual covenants,
agreements and stipulations set forth herein, the receipt and legal
sufficiency of which are hereby mutually acknowledged, the Parties
hereby agree as follows:
1
Pursuant to 17 CFR 240.24b-2,
confidential information has been omitted in places marked "[* *
*]" and has been filed separately with the Securities and Exchange
Commission pursuant to a Confidential Treatment Application filed
with the Commission.
ARTICLE I -
DEFINITIONS
Section 1.1 Definitions . As used in this Agreement,
the following terms, whether used in the singular or plural, shall
have the following meanings:
" A Rated " shall mean that the product in question has
been assigned an "A" rating signifying that the FDA has classified
the product as "therapeutically equivalent" to the particular
product in question, applying the definition of "therapeutically
equivalent" set forth in the preface to the current edition of the
then current FDA publication "Approved Drug Products With
Therapeutic Equivalence Evaluations".
" Affiliate " shall mean any Person which controls, is
controlled by, or is under common control with the applicable
Person. For purposes of this definition, "control" shall mean:
(a) in the case of corporate entities, direct or indirect
ownership of at least fifty percent (50%) of the stock or
shares (or such lesser percentage which is the maximum allowed to
be owned by a foreign corporation in a particular jurisdiction)
entitled to vote for the election of directors, or otherwise having
the power to control or direct the affairs of such Person; and
(b) in the case of non-corporate entities, direct or indirect
ownership of at least 50% of the equity interest or the power to
direct the management and policies of such noncorporate
entities.
" Agreement " shall mean this Supply and Distribution
Agreement including all exhibits, schedules and appendices attached
hereto.
" ANDA " shall mean an Abbreviated New Drug Application
as defined in the U.S. Federal Food, Drug, and Cosmetic Act and all
applicable regulations promulgated thereunder.
" Applicable Law " shall mean all applicable provisions
of all statutes (including the Federal Food, Drug and Cosmetic
Act), laws, rules, regulations, administrative codes, ordinances,
decrees, orders, decisions, guidance documents (including FDA
guidance documents), injunctions, awards, judgments, and permits
and licenses of or from governmental authorities relating to the
use, marketing or regulation of the subject item.
" Auditor " shall have the meaning set forth in
Section 3.9.
" Business Day " shall mean any day other than a day
which is a Saturday, a Sunday or federal bank or federal government
holiday in the United States or the UK.
"cGMP" shall mean the then-current good manufacturing
practices of the FDA, as set forth in 21 C.F.R. Parts 210 and 211
and all applicable rules, regulations, guides and guidances.
" Calendar Quarter " shall mean each of the three
(3) month periods during a calendar year starting on the first
of January, April, July and October.
" Claim " shall have the meaning set forth in
Section 8.1(c)(i).
" COGS Auditor " shall have the meaning set forth in
Section 7.2(e)(ii).
" Commercially Reasonable Efforts " shall mean with
respect to a Party, efforts and diligence in accordance with
business matters in the pharmaceutical industry that are of high
importance to the Party and which are consistent with the subject
Party’s reasonable and sound business and legal judgment.
2
Pursuant to 17 CFR 240.24b-2,
confidential information has been omitted in places marked "[* *
*]" and has been filed separately with the Securities and Exchange
Commission pursuant to a Confidential Treatment Application filed
with the Commission.
" Confidential Information " shall mean
any and all confidential information regarding, related to, or
associated with this Agreement as may be provided by one Party to
the other including (a) the GSK Supplied Product or the Net
Sales Split Reports (and all information contained therein), that
is disclosed by the Disclosing Party to the Recipient, or
(b) this Agreement (including the terms and conditions
hereof). Provided, however, that Confidential Information shall not
include information which (i) at the time of disclosure is in
the public domain, (ii) after disclosure becomes part of the
public domain, except through breach of this Agreement,
(iii) the Recipient can demonstrate by reasonable proof was in
its possession prior to the time of disclosure by the Disclosing
Party hereunder, and was not acquired directly or indirectly from
the Disclosing Party, (iv) becomes available to Recipient free
of an obligation of confidentiality from a Third Party who did not
acquire such information directly or indirectly from the Disclosing
Party and who is not otherwise prohibited from disclosing such
information, or (v) is independently developed by the
Recipient without reference to Confidential Information disclosed
by the Disclosing Party.
" Cost of Goods " shall mean [* * *] the
applicable GSK Supplied Product in finished dosage form labeled and
packaged for use by the ultimate consumer, including, without
limitation, [* * *] calculated in accordance with U.S.
generally accepted accounting principles ("U.S. GAAP") applied in a
consistent manner. GSK’s methods for allocating
[* * *] shall also be consistent with GSK’s then
current practices with respect to GSK products which have similar
requirements to the applicable GSK Supplied Product regarding
[* * *] in finished dosage form.
" Disclosing Party " shall have the meaning set forth in
Section 6.2(a).
" Diverted Product Net Sales Split " shall have the
meaning set forth in Section 3.1(b).
" Effective Date " shall have the meaning set forth in
Section 2.1.
" Execution Date " shall be the date upon which this
Agreement shall be mutually executed by authorized representatives
of each Party, which date shall be that which is set forth in the
Preamble.
" FDA " shall mean the U.S. Food and Drug Administration,
or any successor agency thereto.
" Forecast " shall have the meaning set forth in
Section 4.2(c)(i).
" Generic Equivalent " shall mean the prescription
Sumatriptan injection in the [* * *] presentation for
human use that is supplied or manufactured by or for GSK (or its
Affiliates) under a GSK owned or controlled NDA for sale in the
United States as a generic equivalent to GSK’s Imitrex
® (Sumatriptan)
injection in the [* * *] presentation. For the avoidance
of doubt, Generic Equivalents shall not include any product
marketed and sold under GSK’s Imitrex ® trademark.
" Generic Injection Product " shall mean the generic form
of the prescription Sumatriptan injection [* * *] for use
in humans as further detailed in the applicable Specifications set
forth in Schedule 4.2(b)(iii). For the avoidance of doubt, Generic
Injection Product shall not include the [* * *]
presentation or any other forms, formulations, dosages or
presentations of Product, whether branded or generic; and for the
further avoidance of doubt, Generic Injection Product shall not
include any other forms, formulations dosages or presentations,
whether branded or generic, of GSK’s Imitrex ® products or other products
sold under other GSK owned or controlled trademarks.
3
Pursuant to 17 CFR 240.24b-2,
confidential information has been omitted in places marked "[* *
*]" and has been filed separately with the Securities and Exchange
Commission pursuant to a Confidential Treatment Application filed
with the Commission.
" Generic [* * *] Product "
shall mean the generic form of the prescription Sumatriptan
injection in [* * *] presentation for use in humans as
further detailed in the applicable Specifications set forth in
Schedule 4.2(b). For the avoidance of doubt, Generic
[* * *] Product shall not include the [* * *]
presentation (subject to Section 4.1(d)) or any other forms,
formulations, dosages or presentations of Product, whether branded
or generic; and for the further avoidance of doubt, Generic
[* * *] Product shall not include any other forms,
formulations dosages or presentations, whether branded or generic,
of GSK’s Imitrex ® products or other products
sold under other GSK owned or controlled trademarks.
Sumatriptan
" Generic Injection Net Sales Split " shall have the
meaning set forth in Section 3.1.
" GSK " shall have the meaning set forth in the
Preamble.
" GSK Claim " shall have the meaning set forth in
Section 8.1(b).
" GSK Losses " shall have the meaning set forth in
Section 8.1(b).
" GSK Party " shall have the meaning set forth in
Section 8.1(b).
" GSK Supplied Product " shall mean the Generic Injection
Product and the Generic [* * *] Product for human use
supplied to PAR (and its Affiliates) by GSK (and its Affiliates)
pursuant to the provisions of this Agreement. For the avoidance of
doubt, GSK Supplied Product shall not include any other forms,
formulations, dosages or presentations of Product, whether branded
or generic, including any other forms, formulations, dosages or
presentations, whether branded or generic, of Imitrex
® except that
it may include the [* * *] presentation as provided in
Section 4.1(d).
" Initial Quantity " shall have the meaning set forth in
Section 4.2(d)(i).
" Launch Date " shall mean shall mean [***]
" Labels or Labeling" shall mean all labels and other
written, printed or graphic matter upon (a) the GSK Supplied
Product or any container, carton or wrapper or other packaging
utilized with the GSK Supplied Product or (b) any written
material accompanying the GSK Supplied Product, including, without
limitation, package inserts or outserts or medical information
guides.
" NDA " shall mean a New Drug Application as defined in
the U.S. Federal Food, Drug, and Cosmetic Act and all applicable
regulations promulgated thereunder.
" NDC " shall mean a National Drug Code.
" Net Sales " shall mean the aggregate gross sales ("
Gross Sales ") amount invoiced for GSK Supplied Product by
PAR (and its Affiliates) to its (or their) distributors and
customers (for purposes of this definition, collectively,
"customer") less the following deductions relating to such sales to
the extent
4
Pursuant to 17 CFR 240.24b-2,
confidential information has been omitted in places marked "[* *
*]" and has been filed separately with the Securities and Exchange
Commission pursuant to a Confidential Treatment Application filed
with the Commission.
such deductions are consistent with the normal
practice in the pharmaceutical products industry and are related
solely to GSK Supplied Products:
(a) [***];
(b) [***];
(c) [***];
(d) [***];
(e) [***];
(f) [***];
(g) [***]; and
(h) [***].
The foregoing deductions from Gross Sales shall only be deducted
once and only to the extent not otherwise deducted from Gross
Sales. PAR shall be responsible for payment of rebates or other
price reductions required pursuant to Applicable Law to be made by
PAR (or its Affiliates) based on its sales of GSK Supplied Product
to any governmental or regulatory authority in respect of any state
or federal Medicare, Medicaid or similar programs.
In the event that PAR (or its Affiliates) sells GSK Supplied
Product as part of a bundle or group sale with other products not
covered by this Agreement, and PAR (or its Affiliates) provide a
discount, allowance or rebate to the purchaser of such products
based on the invoiced prices for all products sold, such discount
must be allocated pro-rata based on the selling prices of such
products before taking into account the discount, allowance or
rebate on GSK Supplied Product provided as part of such bundle.
In the event that a GSK Supplied Product is sold or otherwise
commercially exploited by PAR (or its Affiliates) in a manner such
that the above means of calculating Net Sales is not possible or
otherwise is inappropriate, the Parties agree to negotiate in good
faith a reasonable mechanism for fairly calculating the "Net Sales"
resulting from such sales or other commercial exploitation. Net
Sales shall be determined in accordance with the accrual method of
accounting in accordance with USA generally accepted accounting
principles ("GAAP") applied in a consistent manner.
5
Pursuant to 17 CFR 240.24b-2,
confidential information has been omitted in places marked "[* *
*]" and has been filed separately with the Securities and Exchange
Commission pursuant to a Confidential Treatment Application filed
with the Commission.
" Net Sales Split " shall mean,
collectively, the Generic Injection Net Sales Split and the
Diverted Product Net Sales Split.
" Net Sales Split Report " shall have the meaning set
forth in Section 3.3.
" OTC " shall mean the subject pharmaceutical drug is
available for human use without requiring a prescription, i.e., an
‘over-the-counter’ pharmaceutical drug for human
use.
" PAR " shall have the meaning set forth in the
Preamble.
" PAR Claim " shall have the meaning set forth in
Section 8.1(a).
" PAR Losses " shall have the meaning set forth in
Section 8.1(a).
" PAR Party " shall have the meaning set forth in
Section 8.1(a).
" Party or Parties " shall have the meaning set forth in
the Preamble.
" Person " shall mean any natural person, corporation,
unincorporated organization, partnership, association, joint stock
company, joint venture, limited liability company, trust or
government, or any agency or political subdivision of any
government, or any other entity.
" Pharmacovigilance Agreement " shall have the meaning
set forth in Section 4.4.
" Prime Rate " shall mean the rate of interest that
Citibank N.A. lists as its prime lending rate on the last day of
the applicable Calendar Quarter, or if such rate is not available,
the prime lending rate listed in the New York City, USA version of
The Wall Street Journal on the last day of the applicable Calendar
Quarter.
" Products " shall mean all prescription pharmaceutical
drug products in injection form, including all dosages and
presentations thereof, for human use, consisting of or containing
Sumatriptan. Product shall include all Generic Injection Products,
Generic [* * *] Products and GSK Supplied Products. For
the avoidance of doubt, PAR shall only have the rights to GSK
Supplied Product that are explicitly set forth herein.
" Product Action " shall have the meaning set forth in
Section 5.8(b).
" Product Claims " shall mean [***].
" Promotional Materials " shall have the meaning set
forth in Section 4.5.
" Quality Agreement " shall have the meaning set forth in
Section 4.2(b).
" Reasonable Quantity Requirements " shall mean, subject
to Section 4.2(d)(ii), such quantity of Generic Injection
Product and Generic [* * *] Product, that (a) PAR
reasonably believes it requires for sale in the Territory pursuant
to the immediate previously provided forecast consistent with
reasonable market and demand information for Generic Injection
Product and Generic [* * *] Product, and (b) is not
in excess of the applicable non-binding forecast previously
provided to GSK.
6
Pursuant to 17 CFR 240.24b-2,
confidential information has been omitted in places marked "[* *
*]" and has been filed separately with the Securities and Exchange
Commission pursuant to a Confidential Treatment Application filed
with the Commission.
" Recipient " shall have the meaning set
forth in Section 6.2(a).
" Settlement Agreement " shall mean the Settlement
Agreement, entered into by and between GSK and Spectrum, which is
dated as of November 10, 2006, relating to that certain cases
captioned GSK v. Spectrum, Civil Action No. 05-99-GMS and GSK
v. Spectrum, Civil Action No. 06-0558-GMS in the United States
District Court for the District of Delaware.
" Sumatriptan " shall mean sumatriptan succinate, a
selective 5-hydroxytryptamine (5-HT1) receptor subtype agonist
chemically designated as
"3-[2-(dimethylamino)ethyl]-N-methyl-indole-5-methanesulfonamide
succinate (1:1)".
" Supply Price " shall have the meaning set forth in
Section 3.4(a).
" Supply Term " shall mean the period between the Launch
Date and the Supply Termination Date.
" Supply Termination Date " shall mean the earlier of:
(i) the date that is [* * *] ([* * *])
years after the Launch Date, as such date may be extended pursuant
to Section 4.1(b); or (ii) the date upon which this
Agreement terminates for any reason.
" Term " shall have the meaning set forth in
Section 7.1.
" Territory " shall mean the United States of America
(including the Commonwealth of Puerto Rico) its possessions and
territories and U.S. military or U.S. government installations that
are under the purview of the FDA.
" Third Party " shall mean any Person other than PAR or
GSK, or an Affiliate of either of them.
" [***] " shall mean, [***], based on [***] under which
all [***] for each of the [***]. By way of example, if the [***]
has occurred for the [* * *] apply only to the
[* * *] and shall not mean the [* * *].
" Third Party Generic Sumatriptan Product " shall mean
any Third Party’s prescription generic Sumatriptan injection
(e.g., in any of the [* * *]) product for human use that
has received Final Approval from the FDA; and is A-Rated to the
[* * *] approved under GSK’s NDA [* * *];
provided that such Third
7
Pursuant to 17 CFR 240.24b-2,
confidential information has been omitted in places marked "[* *
*]" and has been filed separately with the Securities and Exchange
Commission pursuant to a Confidential Treatment Application filed
with the Commission.
Party Generic Sumatriptan Product is not
licensed, distributed or sold in the United States by (or with) PAR
(or their respective Affiliates) or made from a finished or
semi-finished dosage form formulated for use in the United States
with direct or indirect support provided knowingly by PAR (or their
respective Affiliates). For the avoidance of doubt, Third Party
Generic Sumatriptan Product shall not include GSK Supplied Product
or any Sumatriptan injection product sold under GSK’s
Imitrex ® trademark.
" Trading Services Agreement " shall have the meaning set
forth in Section 3.4(c).
" Trigger Date " shall mean, [***]:
Section 1.2 The word " including " or any variation
thereof means "including without limitation" or any variation
thereof and shall not be construed to limit any general statement
which it follows to the specific or similar items or matters
immediately following it.
ARTICLE II – EFFECTIVE DATE
Section 2.1 Effective Date . This Agreement shall
automatically become effective as of the Execution Date (the "
Effective Date "), subject to termination and becoming null
and void as of the Execution Date pursuant to the provisions of the
Settlement Agreement.
ARTICLE III - PAYMENTS
Section 3.1 Net Sales Split Payments .
(a) In consideration of the supply of GSK Supplied Product by
GSK (and its Affiliates) to PAR (and its Affiliates) under the
terms and conditions of this Agreement during the Term, in addition
to the Supply Price, PAR shall make a Net Sales Split payment to
GSK (or its Affiliate) with respect to the Generic Injection
Product and the Generic [* * *] Product (the " Generic
Injection Net Sales Split ") that is equal to [* * *]
percent ([* * *]%) of Net Sales of GSK Supplied Product
in the Territory.
(b) In the event that it is determined, as evidenced by
reasonable proof, that PAR (or an Affiliate) has knowingly sold,
directly or indirectly to its wholesalers or distributors or other
customers, any GSK Supplied Product outside of the Territory, PAR
shall, in lieu of the foregoing Net Sales Split, pay GSK (or its
Affiliate) a Net Sales Split of [* * *] percent
([* * *]%) of the Net Sales (the " Diverted Product
Net Sales Split ") of such diverted GSK Supplied Product;
provided, however, that the
8
Pursuant to 17 CFR 240.24b-2,
confidential information has been omitted in places marked "[* *
*]" and has been filed separately with the Securities and Exchange
Commission pursuant to a Confidential Treatment Application filed
with the Commission.
calculation of such payment shall exclude any Net
Sales on such diverted GSK Supplied Product that PAR successfully
recalls and recovers within the thirty (30) day period set
forth in Section 4.3(b) (with such recalled GSK Supplied
Product instead being subject to the Net Sales Split as set forth
in Section 3.1(a) above when and if resold by PAR), and
further provided that PAR shall provide GSK with written evidence
that is reasonably satisfactory to GSK as to such successful recall
and recovery. Nothing in this paragraph shall in any way limit
GSK’s remedies that may be available to it pursuant to this
Agreement, and shall in no way be deemed as permission for PAR to
promote or sell, directly or indirectly, GSK Supplied Product
outside the Territory.
Section 3.2. Net Sales Split Obligation Effective and
Termination Dates .
(a) PAR’s Net Sales Split obligation to GSK (or its
Affiliate) for the Product shall automatically become effective in
the Territory as of the Launch Date and shall automatically
terminate as of the Supply Termination Date (except as otherwise
set forth in Section 3.2(b) with respect to post- Supply Term
sales).
(b) Ten (10) days prior to the end of the Supply Term, PAR
shall notify GSK of the amount of the GSK Supplied Product PAR or
its Affiliates then has on hand, the sale of which would, but for
the termination of the Supply Term, be subject to the Net Sales
Split, and PAR and its Affiliates shall thereupon be permitted to
sell that amount of GSK Supplied Product in accordance with the
provisions of this Agreement in the Territory, for as long as it
reasonably takes PAR to deplete the amount of the GSK Supplied
Product PAR or its Affiliates then has on hand, provided that PAR
shall pay to GSK the Net Sales Split that would have accrued but
for the termination of the Supply Term.
Section 3.3 Net Sales Reporting and Payment .
(a) Within [* * *] ([* * *]) days after the
end of each Calendar Quarter in which a sale of GSK Supplied
Product has been made by PAR (or its Affiliates) in the Territory,
PAR shall submit to GSK and Spectrum a written report (the " Net
Sales Split Report ") containing the following information
regarding such preceding Calendar Quarter: an itemized accounting
and calculation of the total Net Sales of GSK Supplied Product sold
by PAR (or its Affiliates) during such preceding Calendar Quarter
in the Territory and the amount of any Net Sales Split due GSK on
such Net Sales, and such report shall include information in
sufficient detail reasonably necessary for GSK to confirm the
accuracy of the amount of the Net Sales Split due GSK, if any,
during such preceding Calendar Quarter. Concurrent with the
submission of a Net Sales Split Report to GSK, PAR shall also remit
payment to GSK of any and all Net Sales Split due GSK (or its
Affiliate) for such preceding Calendar Quarter in the Territory.
Upon request by GSK [***], PAR shall provide GSK with a non-binding
estimate of the gross number of units of GSK Supplied Product sold
[***], to the extent such information has not been already provided
to GSK in a Net Sales Split Report, and for the avoidance of doubt
such estimate shall not in any way bind or commit PAR. All Net
Sales Split Reports shall be considered Confidential Information of
both Parties.
(b) Prior to January 1, 2007, the Parties shall in good
faith develop procedures for the ongoing and timely exchange of the
information necessary for the Parties to comply with the reporting
obligations promulgated under the U.S. Deficit Reduction Act of
2005, including, but not limited to, the "best price" and "AMP"
calculations. In the event that any governmental agency (including,
without limitation, the Center for Medicare and Medicaid Services
or the Department of Health and Human Services Office of Inspector
General) subsequently promulgates regulations or otherwise
provides
9
Pursuant to 17 CFR 240.24b-2,
confidential information has been omitted in places marked "[* *
*]" and has been filed separately with the Securities and Exchange
Commission pursuant to a Confidential Treatment Application filed
with the Commission.
guidance which clarifies the Parties’
obligations under the U.S. Deficit Reduction Act of 2005, which may
be applicable to this Agreement, then the Parties shall meet to
consider whether modifications to this Agreement or the procedures
are appropriate.
(c) PAR agrees, represents and covenants it (and its Affiliates)
shall transport, store distribute, sell and promote GSK Supplied
Product in the Territory in compliance with all Applicable Laws
regarding the promotion and marketing of GSK Supplied Product,
including, but not limited to, with respect to the U.S. Federal
Food, Drug and Cosmetics Act of 1938, as amended, and the
Prescription Drug Marketing Act of 1987. PAR further agrees,
represents and covenants that, as applicable, any calculated prices
or other data or information that are provided to GSK by PAR and/or
its Affiliates for use by GSK for reporting purposes pursuant to
the Deficit Reduction Act of 2005 (DRA), Pub. L. No.109-171, §
6001(c)(3) (2006), the 340B Drug Pricing Program and the
requirements of the Veterans Health Care Act of 1992(Public Law
No. 102-585) Section 602, and Section 1927 of the
Social Security Act, and any other similar federal or state
government programs, shall to its knowledge be current, accurate
and complete and shall comply with applicable laws and
regulations.
Section 3.4 Supply Price .
(a) The per unit supply price for the GSK Supplied Product
purchased by PAR and its Affiliates from GSK pursuant to the terms
of this Agreement is set forth on Schedule 3.4(a) (the "
Supply Price "). The Supply Price for GSK Supplied Product
during any subsequent extension of the Supply Term pursuant to
Section 4.1(b) shall be on such terms and conditions as
negotiated by the Parties in good faith at such time as the Supply
Term is renewed, provided such Supply Price shall be no greater
than as set forth on Schedule 3.4(a) .
(b) PAR shall remit to GSK (or its Affiliate) payment of the
applicable Supply Price (i.e., the Supply Price x units) for the
GSK Supplied Product within [* * *] ([* * *])
days after the date of GSK’s (or its Affiliate’s)
invoice for each shipment of GSK Supplied Product to PAR and its
Affiliates. With respect to the Supply Price relating to the
Initial Quantity, PAR shall remit to GSK (or its Affiliate) payment
of the applicable Supply Price (i.e., the Supply Price x units) for
the GSK Supplied Product within [***] after the Launch Date.
(c) Within thirty (30) days prior to delivery of the
Initial Quantity for GSK Supplied Product to PAR (or any of its
Affiliates) pursuant to Section 4.2(d), PAR (or its applicable
Affiliate) and GSK’s Affiliate "GlaxoSmithKline Trading
Services Limited" shall enter into an agreement in the form set
forth in Schedule 3.4(c) (the " Trading Services
Agreement "). For the avoidance of doubt, in the event of any
inconsistency or conflict between the terms of the Trading Services
Agreement and this Agreement, the terms of this Agreement shall
govern.
Section 3.5 Late Payments . Any payment due GSK (or
its Affiliate) from PAR (or its Affiliate) that is past due under
this Agreement shall bear interest at a rate equal to the lesser of
(i) Prime Rate plus [* * *] percent
([* * *]%) per year, or (ii) the maximum rate
permitted by Applicable Law, calculated based on the number of days
that the payment is delinquent.
Section 3.6 Method of Payment . PAR shall make all
payments to GSK (or its Affiliate) in lawful money of the United
States by electronic transfer to an account designated by GSK (or
its Affiliate) as designated in the Trading Services Agreement, or
by such other means as may be agreed in advance by both
Parties.
10
Pursuant to 17 CFR 240.24b-2,
confidential information has been omitted in places marked "[* *
*]" and has been filed separately with the Securities and Exchange
Commission pursuant to a Confidential Treatment Application filed
with the Commission.
Section 3.7 Taxes .
(a) GSK shall be responsible for and shall pay all taxes payable
on any income or any payments by PAR to GSK. PAR and GSK shall bear
sole responsibility for payment of compensation to their respective
personnel, employees or subcontractors and for all employment taxes
and withholding with respect to such compensation pursuant to
Applicable Law.
(b) PAR shall have the right to withhold taxes in the event that
the revenue authorities in any country require the withholding of
taxes on amounts paid hereunder to GSK (or its Affiliate). Any tax,
duty or other levy paid or required to be withheld by PAR on
account of Net Sales Splits, Supply Price or other payments payable
to GSK under this Agreement shall be deducted from the amount of
Net Sales Splits, Supply Price or other payments due GSK. PAR shall
secure and promptly send to GSK proof of such taxes, duties or
other levies withheld and paid by PAR or its Affiliates for the
benefit of GSK. Each Party agrees to cooperate with the other Party
in claiming exemptions from such deductions or withholdings under
any agreement or treaty from time to time in effect.
Section 3.8 Records . PAR shall keep and require its
Affiliates to keep complete and accurate records of all purchases
and sales of GSK Supplied Product under the terms and conditions of
this Agreement, pursuant to Section 5.6.
Section 3.9 Net Sales Split Audit . Upon the written
request of GSK (but not more frequently than [***]), GSK shall have
the right, within sixty (60) days after receipt of written
confirmation that the Auditor is reasonably satisfactory to PAR (as
set forth below), starting as of the Launch Date and during the
Term of this Agreement [***], to have an independent certified
public accountant, satisfactory to PAR in PAR’s reasonable
discretion (the " Auditor ") inspect PAR’s records
with respect to the transactions contemplated by this Agreement for
the preceding [***] during the Term (but not more than one time for
any period) for the sole purpose of determining the accuracy of
PAR’s Net Sales Split Reports and the associated Net Sales
Split payments made to GSK under this Agreement. PAR shall permit
the Auditor to have reasonable confidential access, during normal
business hours and upon having given reasonable prior notice, to
such records of PAR as may be necessary to verify PAR’s
compliance with the Net Sales Split payments due hereunder for the
[***]. The Auditor shall reach its conclusion as quickly as
possible but in no event more than a period of thirty
(30) days, and notify the Parties and Spectrum of its
conclusion in writing. Under no circumstances shall the Auditor
report to GSK or Spectrum the wholesale prices at which PAR sold
the GSK Supplied Product. In the event the Auditor concludes that
there was an underpayment of the Net Sales Split to GSK, the
underpayment shall be paid by PAR within thirty (30) days
after the date PAR receives such Auditor’s written report. In
the event the Auditor concludes that there was an overpayment of
the Net Sales Split to GSK, the overpayment shall be credited
toward future Net Sales Split payments to be paid by PAR to GSK
under this Agreement; provided, however, that in the event no
further Net Sales Split payments shall become due under this
Agreement, said overpayment shall be paid by GSK to PAR within
thirty (30) days after the date GSK receives such
Auditor’s written report. If the underpayment of the Net
Sales Split is greater than [* * *] percent
([* * *]%) of the Net Sales Split determined by the
Auditor to be payable to GSK, the reasonable fees and expenses
charged by the Auditor shall be paid by PAR, otherwise GSK shall
pay the reasonable fees and expenses charged by such Auditor. The
Auditor shall report to GSK only its conclusions as to whether PAR
is in compliance with the Net Sales Split obligations and the
amount of any underpayment or overpayment. The Auditor inspecting
records of PAR shall sign a written confidentiality agreement
reasonably satisfactory to PAR and GSK.
11
Pursuant to 17 CFR 240.24b-2,
confidential information has been omitted in places marked "[* *
*]" and has been filed separately with the Securities and Exchange
Commission pursuant to a Confidential Treatment Application filed
with the Commission.
ARTICLE IV –
SUPPLY
Section 4.1 Supply Term .
(a) GSK (or its Affiliate) shall use its Commercially Reasonable
Efforts to supply PAR and its Affiliates with their entire
commercial requirements of GSK Supplied Product for sale to
PAR’s (and its Affiliates’) distributors and other
customers solely in the Territory pursuant to the provisions of
this Agreement, including those provisions regarding the timing of
such supply. GSK’s (or its Affiliate’s) supply
obligation for GSK Supplied Product shall be for the duration of
the Supply Term subject to Section 4.1(b).
(b) The Supply Term for the Product may be extended for
additional one (1) year periods beyond its then-applicable
expiry date. In the event either Party wishes to extend the Supply
Term for an additional one (1) year period beyond its
applicable expiry date, such Party shall submit such request in
writing to the other Party at least nine (9) months before the
Supply Term’s then applicable expiry date. Within thirty
(30) days after the receipt of such request, the recipient
Party shall respond to the extension-requesting Party in writing as
to whether or not the recipient Party accepts such request for a
one (1) year extension of the Supply Term; provided, neither
Party shall be bound to such extension until a Supply Price has
been agreed-upon pursuant to Section 3.4(a). For the avoidance
of doubt, GSK shall not be obligated to extend the Supply Term if,
in GSK’s reasonable discretion, the Supply Price for the
extension period should exceed the prices set forth in Schedule
3.4(a) . Notwithstanding anything to the contrary, the Supply
Term shall automatically terminate as of the earlier of the date
upon which this Agreement terminates or expires for any reason.
(c) In the event the Launch Date occurs [***], PAR (and its
Affiliates) hereby acknowledge and agree that [***]. In the event
[***] pursuant to the provisions of this Agreement. [***]
(d) [* * *], such product shall [***]
12
Pursuant to 17 CFR 240.24b-2,
confidential information has been omitted in places marked "[* *
*]" and has been filed separately with the Securities and Exchange
Commission pursuant to a Confidential Treatment Application filed
with the Commission.
shall be deemed to [* * *] provided, if
[***]. For the avoidance of doubt, [* * *].
Section 4.2 Supply Provisions .
(a) Exclusive Supply .
(i) PAR hereby agrees and acknowledges that, subject to the
terms and conditions of this Agreement, PAR and its Affiliates
shall receive one hundred percent (100%) of its (and its
Affiliates’) requirements of Generic Injection Product and
Generic [* * *] Product in the Territory from GSK (or
GSK’s Affiliates) during the Supply Term. PAR hereby agrees
and acknowledges that, during the Supply Term, PAR (and its
Affiliates) shall not, directly or indirectly, purchase, receive,
make, have made, use, sell, offer for sale or import any Product,
as applicable, in the Territory with the sole exception of its
rights to market and sell GSK Supplied Product in the Territory as
explicitly set forth in this Agreement and as permitted in the
Settlement Agreement.
(ii) GSK agrees and acknowledges that from the Execution Date
until the Supply Termination Date (subject to Section 4.1(d),
if applicable) GSK (and its Affiliates) shall not, directly or
indirectly, through a Third Party sell or supply for import/export
any Generic Injection Product or any Generic [* * *]
Product ([* * *]). Notwithstanding the foregoing, PAR
agrees and acknowledges that nothing in this Agreement shall
prohibit GSK and its Affiliates from making, having made, using,
selling to any Person, having sold to any Person, and importing
Products approved by the FDA as of the Execution Date or other
components of Generic Injection Products or the Generic
[* * *] Products (including the Product) in the Territory
in each case under an applicable GSK brand name, label or trademark
(including the Imitrex ®
trademark) with the exception of a Generic
Equivalent of the Imitrex ® [* * *]. Subject to
the first sentence of this Section 4.2(a)(ii), nothing in this
Agreement shall prohibit GSK and its Affiliates from making, or
having made, or using, or selling or having sold or importing
(individually, or as a blend), the components of the Generic
Injection Product or the Generic [* * *] Product for sale
(individually, or as a blend) by GSK or its Affiliates or any Third
Party in the Territory during and after the Supply Term. GSK hereby
represents [* * *].
(iii) Failure to Supply . In the event of
[* * *] prior to the [***] (for any reason except as set
forth below [***] with at least [* * *] that are
consistent with the [* * *]. Further provided in no event
shall
13
Pursuant to 17 CFR 240.24b-2,
confidential information has been omitted in places marked "[* *
*]" and has been filed separately with the Securities and Exchange
Commission pursuant to a Confidential Treatment Application filed
with the Commission.
[* * *] shall be as determined on a
[***] shall use [***] in the event of such a [***].
(b) Specifications and Supply . GSK hereby represents,
warrants and covenants that all GSK Supplied Product shall, with
the exception of information provided to GSK by PAR: (i) not
be misbranded or adulterated under Applicable Law, (ii) be in
fully finished form, labeled and packaged for supply to the
ultimate consumer in accordance with Applicable Law,
(iii) meet the applicable specifications and requirements set
forth in Schedule 4.2(b)(iii) , (iv) be manufactured,
labeled, packaged and stored in accordance with specifications in
the applicable NDA, cGMP, and Applicable Law and (v) be
capable of maintaining conformity to said specifications and
requirements when handled and stored in accordance with the
Labeling until the applicable expiry date of such GSK Supplied
Product. GSK (or its Affiliate) may have manufactured, and supplied
to PAR, GSK Supplied Product from any of GSK’s (or its
Affiliates or its or their supplier’s or
subcontractor’s) FDA approved and registered manufacturing
facilities. All GSK Supplied Product shall be supplied to PAR and
its Affiliates in compliance with Applicable Law, including cGMP
and the Quality Agreement (" Quality Agreement "), which
shall be entered into by the Parties within thirty (30) days
after the Execution Date (but in any event prior to the release of
the Initial Quantity to PAR) and shall be substantially in the form
set forth in Schedule 4.2(b) . GSK shall use commercially
reasonable efforts to promptly respond to any reasonable inquiries
from PAR regarding the supply of GSK Supplied Product.
(c) Ordering/Forecasting.
(i) Except as is set forth below with regard to the Initial
Quantity during the Supply Term, at least [* * *]
([* * *]) days prior to the start of each calendar month,
PAR shall provide GSK (or its Affiliate) with a written firm order
for such upcoming calendar month. By the first of each calendar
month, PAR shall also provide GSK (or its Affiliate) with a written
estimate of the quantities of GSK Supplied Product in the Territory
PAR and its Affiliates require for the next succeeding
[* * *] ([* * *]) months on a monthly basis (in
the forecast format set forth on Schedule 4.2(c) ) (the "
Forecast "). Each of such Forecast shall contain the
applicable [* * *] ([* * *]) calendar months
firm orders and the remaining [* * *] ([* * *])
non-binding monthly estimates for that applicable period. When PAR
shall place a firm order with GSK (or its Affiliate) for its GSK
Supplied Product requirements at least [* * *]
([* * *]) days in advance of the start of each calendar
month, GSK (or its Affiliate) shall respond to PAR within
[* * *] ([* * *]) Business Days after receipt
of such firm order, and in the event GSK (or its Affiliate)
responds other than by accepting the firm order, the Parties shall
cooperate and use good faith efforts to meet as closely as
reasonably possible the Reasonable Quantity Requirements and
schedule for delivery specified in the firm order, subject to the
provisions of subsections (ii) below. Once a firm order is
agreed upon by the Parties, PAR shall amend the firm order to
reflect the quantity and delivery schedule agreed by the Parties
and send to GSK (or its Affiliates) such revised firm order and a
purchase order covering such quantities and delivery date, and GSK
(or its Affiliate) shall have the obligation to supply such
quantity to PAR pursuant to the terms hereof. PAR shall promptly
reimburse GSK for any
14
Pursuant to 17 CFR 240.24b-2,
confidential information has been omitted in places marked "[* *
*]" and has been filed separately with the Securities and Exchange
Commission pursuant to a Confidential Treatment Application filed
with the Commission.
and all documented, reasonable costs and expenses
incurred by GSK (or its Affiliate) that arise from any canceled or
materially modified firm order (without GSK’s prior written
consent) after acceptance thereof by GSK (or its Affiliate),
including all obsolete material that can not be reasonably utilized
by GSK or its Affiliate. The previous sentence shall not limit
GSK’s remedies or damages in the event PAR cancels or
materially modifies any firm order, and PAR shall not modify or
cancel the last firm order in the Supply Term. In the event the
Parties reasonably agree that a Third Party Generic Sumatriptan
Product is likely to in the immediate future, or has, become
available for commercial sale in the Territory, the Parties shall
in good faith review and adjust the then-existing Forecast in light
of the presence of such Third Party Generic Sumatriptan Product in
the Territory, provided the Parties shall use their commercially
reasonable efforts to mitigate all losses and expenses related to
such revisions to the Forecast.
The last firm order and Forecast shall be received and agreed by
GSK not less than [* * *] ([* * *]) days prior
to the Supply Termination Date. The firm orders for the last
[* * *] ([* * *]) months of the Supply Term
shall each not exceed [* * *] percent
([* * *]%) of the average monthly demand for GSK Supplied
Product over the prior twelve (12) month period (determined on
a sku-by-sku basis), unless PAR can provide reasonable evidence to
GSK that there is adequate demand over the remainder of the Supply
Term for GSK Supplied Product in excess of such limits. Upon
termination or expiration of this Agreement, all firm orders and
Forecasts are to be automatically terminated, except to the extent
that backordered firm orders remain unfilled. PAR acknowledges and
agrees that GSK relies on the [* * *] ([* * *]) month firm zone
orders provided by PAR for the purpose of manufacturing planning
and ordering necessary materials and components for the production
of GSK Supplied Product. In the event PAR does not issue purchase
orders in a timely manner (as described in this
Section 4.2(c)) covering any [* * *] ([* * *]) month firm
zone, PAR agrees that in the event GSK decides in its sole
discretion to waive the firm zone requirements set forth herein:
(A) GSK is entitled to reasonably rely upon the applicable [*
* *] month firm zone last provided by PAR in the Forecast for the
purpose of manufacturing planning and ordering necessary materials
and components for the production of GSK Supplied Product and
(B) in the event GSK is unable to reasonably utilize any such
materials and components in the event PAR’s purchase orders
are less than as set forth in the firm orders for such [* * *] ([*
* *]) month firm zone, PAR shall reimburse GSK for all reasonable
out-of-pocket costs incurred by GSK for any such obsolete materials
and components, provided GSK uses its reasonable efforts to
mitigate the costs associated with such obsolete materials and
components. For the avoidance of doubt, GSK shall, in its sole
discretion, decide whether or not it (or its Affiliates) will
supply PAR with GSK Supplied Product absent purchase orders issued
in a timely manner (as described in this Section 4.2(c)) for
any [* * *] ([* * *]) month firm zone, however GSK shall reasonably
consider supplying PAR in such instance, consistent with
GSK’s reasonable ability to do so.
(ii) Each purchase order shall specify a delivery date which
shall be at least [* * *] ([* * *]) days after the date of the
purchase order. Should a purchase order call for shipment of
quantities of GSK Supplied Product in excess of [* * *] percent ([*
* *]%) of the immediately preceding estimated requirements
previously provided to GSK (or its Affiliate) in the Forecast, GSK
(or its Affiliate) will use its Commercially Reasonable Efforts,
but shall not be obligated, to supply that portion of excess by the
dates instructed by PAR; provided, however, in no event shall GSK
(or its Affiliates) have any obligation to forego manufacture of
any GSK (or its Affiliates’) products on common equipment
that would have a material adverse consequence to GSK business in
order to deliver GSK Supplied Product to PAR or its Affiliates in
excess of the preceding Forecast. Notwithstanding anything to the
contrary, PAR’s first firm orders for the [* * *]
([* * *]) month firm zone for GSK Supplied Product from
GSK shall be in the quantities specified in Schedule 4.2(d)
. GSK (and its Affiliates) shall not be obligated to supply to PAR
(or its Affiliates) quantities of GSK Supplied Product in excess of
GSK’s (or
15
Pursuant to 17 CFR 240.24b-2,
confidential information has been omitted in places marked "[* *
*]" and has been filed separately with the Securities and Exchange
Commission pursuant to a Confidential Treatment Application filed
with the Commission.
its Affiliate’s) branded Imitrex
® [* * *]
product ([* * *]presentations) manufacturing capacity (with such
capacity being defined herein as GSK’s [* * *] product ([* *
*] presentations) capacity without regard to individual
presentation capacity – all subject to PAR’s compliance
with the forecasting and firm order requirements in this
Agreement). In no event shall such capacity be less than such
capacity existing as of the Execution Date.
(iii) Delivery of GSK Supplied Product ordered hereunder from
GSK (or its Affiliate) to PAR and its Affiliates shall be [***]
(Incoterms 2000), whereby [***] and [***] shall bear all risk of
loss or damage, and costs of insurance and shipping associated with
the GSK Supplied Product [***].
(iv) Attached hereto as Schedule 4.2(d) , is PAR’s
current good faith non-binding estimate of its (and its
Affiliates’) requirements of GSK Supplied Product for the
Territory for the [* * *] ([* * *]) months (including the
Initial Quantity) following the Launch Date and the remainder of
the Forecast. Following the Execution Date, PAR shall provide GSK
an updated version of the Forecast on a [* * *] basis.
[* * *] ([* * *]) days after the later of
(A) [***] and (B) the date GSK notifies PAR of its
ability (or inability) to supply PAR with the Generic
[* * *] Product in the [* * *], PAR shall
provide GSK with a definitive Forecast (in the form applicable to
such Launch Date) and binding purchase orders for the
[* * *] ([* * *]) months following the Launch Date (such
total to include the Initial Quantity) and such Forecast and
binding purchase orders shall not vary by more than [* * *] percent
([* * *]%) from the last non-binding Forecast provided to GSK (as
determined on a monthly basis) subject to the last sentence of the
first paragraph of Section 4.2(c)(i).
(v) In ordering and delivering GSK Supplied Product, as the case
may be, GSK (or its Affiliates) and PAR may use their respective
standard forms and documents in ordering and delivering the GSK
Supplied Product, provided that nothing in those forms or documents
shall be construed to modify or amend the terms and conditions of
this Agreement, and, in the case of any conflict herewith, the
terms and conditions of this Agreement shall control.
(d) Initial Quantity .
(i) PAR’s good faith estimate of the initial quantity of
GSK Supplied Product that GSK (or its Affiliate) shall supply PAR
and its Affiliates is set forth on Schedule 4.2(d) hereto
(the " Initial Quantity "). So as to allow GSK an
appropriate opportunity to manufacture such Initial Quantity, the
Initial Quantity [* * *]. GSK (or its Affiliate) shall deliver the
Initial Quantity to PAR (pursuant to Section 4.2(c)(iv)) at
least [* * *] days prior to the anticipated Launch Date.
(ii) Title to the Initial Quantity will remain with GSK until
the Launch Date, and upon the Launch Date title to the Initial
Quantity shall automatically transfer to PAR; [***]. [***] will
store the Initial Quantity in one of its facilities until the
Launch Date and shall not, directly or indirectly, make available,
consign, transfer, sell or make available for sale (or any other
conveyance whatsoever) the Initial Quantity until the Launch Date
occurs. On the Launch Date, [***].
16
Pursuant to 17 CFR 240.24b-2,
confidential information has been omitted in places marked "[* *
*]" and has been filed separately with the Securities and Exchange
Commission pursuant to a Confidential Treatment Application filed
with the Commission.
(iii) The Parties shall use their Commercially
Reasonable Efforts to make all reasonable manufacturing
preparations to enable GSK to be able to meet the obligations set
forth in Section 4.2(d)(i) above, and as of the Execution
Date, the Parties shall exercise their reasonable efforts, and
shall co-operate with each other, to obtain all necessary
certifications, permits and other registrations required pursuant
to Applicable Law to enable GSK (or its Affiliate) to manufacture
and supply, and PAR and its Affiliates to import/export, sell and
distribute, the GSK Supplied Product pursuant to the provisions of
this Agreement.
(e) Labeling . All GSK Supplied Products shall bear a
generic label specifying PAR as the distributor and displaying the
logo PAR artwork supplied by PAR to GSK, and as agreed by GSK
pursuant to the remainder of this Section 4.2(e). The label
shall also include any references to Spectrum as conveyed by PAR
and Spectrum to GSK in accordance with the Applicable Law, [***].
All GSK Supplied Product Labels, packaging or trade dress [***]
shall comply with Applicable Law (including the terms of the
applicable NDA), and, subject to the first sentence of this
Section 4.2(f), [***]. Should PAR or GSK desire or be required
pursuant to Applicable Law to make any change in any such Labels or
Labeling, GSK shall be responsible for procuring the updating of
all artwork and text associated with such change and providing such
changes to PAR. Upon approval by GSK, GSK shall make all necessary
arrangements for such changed Labels or Labeling to be printed and
shall provide to PAR agreed artwork documents for PAR’s
review. PAR shall, within one (1) week of receipt of agreed
artwork documents, either provide GSK any necessary corrections
thereto or notify GSK of its approval of such agreed artwork
documents. [***] If a change of Labels or Labeling that was
requested by PAR, required pursuant to Applicable Law, or due to an
assignment of this Agreement by Spectrum pursuant to
Section 9.1 results in obsolete inventory of former Labels or
Labeling that GSK cannot otherwise use, [***]. PAR shall supply GSK
with all of PAR’s necessary artwork, text, SKU numbers and
other necessary items by the dates reasonably requested by GSK, so
that GSK can prepare the Labels and packaging for the Initial
Quantity. GSK’s obligations to supply PAR and its Affiliates
with GSK Supplied Product, including the Initial Quantity by the
specified delivery date, shall be contingent upon GSK’s
timely receipt of the foregoing artwork, text, SKU and NDC numbers
and other necessary items from PAR.
17
Pursuant to 17 CFR 240.24b-2,
confidential information has been omitted in places marked "[* *
*]" and has been filed separately with the Securities and Exchange
Commission pursuant to a Confidential Treatment Application filed
with the Commission.
(f) Manufacturing . PAR and GSK hereby
agree to follow and conduct their respective activities in
accordance with the terms of Applicable Law, the Quality Agreement
and this Agreement. GSK (or its Affiliate) expressly reserves the
right to select, and subsequently change, the manufacturing sites
for the GSK Supplied Product at its sole discretion, and will
provide not less than one hundred eighty (180) days prior
notice to PAR if the manufacturing of the GSK Supplied Product is
to be moved to a site other than those identified in the applicable
NDA provided, however, that GSK shall only use manufacturing sites
registered with FDA and in compliance with Applicable Law, and
shall ensure that its selection or change of manufacturing sites
will not: (i) adversely affect its ability to fulfill its then
current supply obligations to PAR and its Affiliates pursuant to
this Agreement; or (ii) cause PAR or its Affiliates to incur
additional material expenses or costs. In the event that GSK (or
its Affiliate) desires to make a change of manufacturing sites that
will adversely affect the supply obligations described in the
immediately preceding sentence, then GSK shall at its own risk of
loss, use its Commercially Reasonable Efforts to stockpile such
quantities of GSK Supplied Product as may be required to deliver up
to the volume of GSK Supplied Product ordered by PAR and its
Affiliates pursuant to this Agreement. Subject to this
Section 4.2(f), GSK (or its Affiliate) may dual-source the GSK
Supplied Product from any FDA-registered facilities without prior
notice to PAR; provided GSK provides PAR with the ability to
identify the manufacturing facility for each lot.
(g) Delivery . GSK (or its Affiliate) shall use its
Commercially Reasonable Efforts to deliver, pursuant to
Section 4.2(c)(iii), to PAR and its Affiliates all such GSK
Supplied Product as may be ordered by PAR and its Affiliates under
a purchase order issued to GSK (or its Affiliate) pursuant to this
Agreement no earlier than [* * *] ([* * *]) days prior to the
delivery date specified in PAR’s purchase order, and shall
deliver such GSK Supplied Product no later than [* * *] ([* * *])
days after the date specified in PAR’s purchase order unless
otherwise agreed. PAR shall pick-up the GSK Supplied Product on the
applicable delivery date and pursuant to Section 4.2(c)(iii)
and Section 4.2(d)(i) as applicable. Nothing herein shall be
construed as limiting the Parties’ ability to mutually agree
in writing to any adjustment to a delivery date without any
modification to a then outstanding purchase order or Forecast. GSK
(or its Affiliate) shall provide an invoice and a certificate of
conformance (except that with respect to the Initial Quantity such
certificate shall be supplied as set forth in
Section 4.2(d)(i)) to PAR for each lot of GSK Supplied Product
shipped to PAR and its Affiliates which certifies that such GSK
Supplied Product meets cGMP and meets the applicable specifications
set forth in Schedule 4.2(b)(iii) .
(h) Rejection and No Returns to GSK . Within [* * *] ([*
* *]) days of receipt of any GSK Supplied Product, PAR and its
Affiliates may perform appropriate inspections to determine whether
the GSK Supplied Product meets the applicable specifications set
forth in Schedule 4.2(b)(iii) and in accordance with the
Quality Agreement and the requirements of this Agreement. Any GSK
Supplied Product not refused by PAR within [* * *] ([* * *]) days
of receipt of shipment shall be deemed accepted by PAR. If PAR
wishes to refuse acceptance, PAR shall within such
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