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SUPPLY AND DISTRIBUTION AGREEMENT

Requirements Supplier Agreement

SUPPLY AND DISTRIBUTION AGREEMENT | Document Parties: GLAXO GROUP LIMITED | GLAXO WELLCOME MANUFACTURING PTE LIMITED | PAR Pharmaceutical Companies, Inc | PAR PHARMACEUTICAL, INC | SmithKline Beecham Corporation | SPECTRUM PHARMACEUTICALS, INC You are currently viewing:
This Requirements Supplier Agreement involves

GLAXO GROUP LIMITED | GLAXO WELLCOME MANUFACTURING PTE LIMITED | PAR Pharmaceutical Companies, Inc | PAR PHARMACEUTICAL, INC | SmithKline Beecham Corporation | SPECTRUM PHARMACEUTICALS, INC

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Title: SUPPLY AND DISTRIBUTION AGREEMENT
Governing Law: New York     Date: 3/14/2007
Industry: Biotechnology and Drugs     Sector: Healthcare

SUPPLY AND DISTRIBUTION AGREEMENT, Parties: glaxo group limited , glaxo wellcome manufacturing pte limited , par pharmaceutical companies  inc , par pharmaceutical  inc , smithkline beecham corporation , spectrum pharmaceuticals  inc
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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

 

 

     
  • Article I - Definitions

  

2

  • Article II – Effective Date

  

8

  • Article III - Payments

  

8

  • Article IV – Supply

  

12

  • Article V - Representations, Warranties and Covenants

  

21

  • Article VI - Intellectual Property and Confidential Information

  

26

  • Article VII - Term And Termination

  

29

  • Article VIII - Indemnification, Insurance and Dispute Resolution

  

31

  • Article IX - Miscellaneous

  

35



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

 

 

     
  • Schedule 3.4(a)

  

GSK Supplied Product Supply Price

  • Schedule 3.4(c)

  

Form of Trading Services Agreement

  • Schedule 4.2(b)

  

Form of Quality Agreement

  • Schedule 4.2(b)(iii)

  

GSK Supplied Product and its Specifications

  • Schedule 4.2(c)

  

GSK Supplied Product and Initial PAR Estimate

  • Schedule 4.2(d)

  

Initial Quantity

  • Schedule 4.4

  

Form of Pharmacovigilance Agreement

  • Schedule 6.3

  

Press Release



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.

 

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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 [***]

 

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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

 

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[* * *] 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

 

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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

 

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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, [***].

 

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(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.

 

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(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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