Provision Language
Definitions
“NCE Exclusivity” shall mean five years of marketing exclusivity granted by FDA pursuant to its authority under 21 U.S.C. §§ 355(c)(3)(E)(ii) and 355(j)(5)(F)(ii), or similar regulatory exclusivity granted by the appropriate regulatory authority having jurisdiction over the Products.
6. Manufacturing and Commercialization of Product
6.1 Promotion of Sales in the Territory. The parties hereto agree that an important purpose of this Agreement is to increase patient access to the Products licensed under this Agreement in the Territory. Except as otherwise provided in this Agreement, Licensee shall have the sole discretion to manage its own commercial strategy to promote and sell the Product in the Territory, provided, however, that Licensee shall not engage in activities that are inconsistent with the first sentence of this Section 6.1. By means of example and without limitation, Licensee agrees that Licensee shall not accept patient orders that Licensee does not have the capacity to fill, and shall not obtain API or Product without having the means, either directly or through the use of permitted third parties, to manufacture such API into Product and/or distribute such Product to patients within the Territory.
6.2 Manufacturing Requirements [as amended by Amendment 1]
(a) Minimum Standards.
(i) Licensee agrees that it shall manufacture API and Product in a manner consistent with (i) the applicable Indian manufacturing standards; (ii) either World Health Organization (“WHO”) pre–qualification standards, standards of the European Medicines Agency (“EMA”), or United States Food and Drug Administration (“FDA”) tentative approval standards (“Minimum Quality Standards”); and (iii) on a country–by–country basis, any applicable national, regional or local standards as may be required by the specific country where Product is sold.
(ii) As required by MPP, in the event that any of COBI, EVG, TAF or BIC are included in the WHO Consolidated Guidelines on the use of antiretroviral drugs for treating and preventing HIV infection (“WHO Guidelines“) or in the expression of interest for WHO pre–qualification for active pharmaceutical ingredients, Licensee shall apply for WHO pre–qualification or submit such included API’s Drug Master File (or equivalent) to the FDA no later than by the second anniversary of any such inclusion.
(iii) As required by MPP, in the event that any TAF Product or TAF Combination Product, BIC Product or BIC Combination Product, COBI Product or COBI Combination Product, EVG Product or EVG Combination Product, or the TDF Quad are included in WHO Guidelines or in the expression of interest for WHO pre–qualification of medicines, Licensee shall apply for WHO pre–qualification or FDA conditional approval for each such Product so included no later than by the third anniversary of any such inclusion.
(b) Audit Right. Licensee hereby agrees to allow Gilead and MPP reasonable access to Licensee’s books and records, facilities and employees solely for the purpose and to the extent required for Gilead and/or MPP to audit Licensee’s compliance with the requirements of this Section 6.2. Gilead and MPP agree to provide at least thirty (30) days prior notice of the proposed audit, and agree that such audits shall not be conducted more than once a year unless circumstances outside the ordinary course of business warrant such an audit (such as an investigation or other government action). To the extent any such audit relates to EVG, EVG Product, EVG Combination Product, or Quad Product, Gilead will have the right to share reports from any such audit with Japan Tobacco.
(c) Remedy for Failure. If Licensee fails at any time to meet the Minimum Quality Standards with respect to the manufacture of API or Product, Gilead and/or MPP may elect, in their sole discretion and notwithstanding Section 10.2 or 10.3 hereof, to suspend the effectiveness of the licenses granted hereunder until such time as Gilead and/or MPP have determined that Licensee has corrected any such failure to Gilead’s and/or MPP’s reasonable satisfaction. During any such suspension, Gilead and/or MPP and Licensee shall coordinate with each other to provide for the supply of API or Product, as appropriate, to ensure that end–user patient requirements are not disrupted as a result of such suspension.
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(e) Pediatric Formulations. Licensee will have the right to develop a TDF Product, TDF Combination Product, TAF Product, TAF Combination Product, EVG Product, EVG Combination Product, COBI Product or COBI Combination Product as either a liquid or dispersible tablet formulation for use in pediatric patients less than 12 years of age (each, a “Pediatric Formulation”), provided, however, that with respect to EVG Product and EVG Combination Product, Licensee agrees not to develop any such Pediatric Formulation without Gilead’s prior written consent, not to be unreasonably withheld. Licensee may seek regulatory approval for Pediatric Formulations anywhere in the Territory.
(i) If Licensee is granted regulatory approval to market such Pediatric Formulation, then Licensee will use reasonable efforts to make such Pediatric Formulation available (A) if such Pediatric Formulation is a TDF Product, TDF Combination Product, TAF Product or a TAF Combination Product, throughout the TDF–TAF Territory, (B) if such Pediatric Formulation is a COBI Product or a COBI Combination Product, throughout the COBI Territory, or (C) if such Pediatric Formulation is an EVG Product or EVG Combination Product, throughout the EVG–Quad Territory (for purposes of this Section 6.2(e), “Licensee’s Applicable Territory”). Gilead would agree to waive any royalty Gilead otherwise would be entitled to receive for sale of such Pediatric Formulation pursuant to Section 4.1, provided such Pediatric Formulation is sold for use in pediatric populations under age 12 and not in adult populations.
(ii) Licensee will further agree either to license such Pediatric Formulation to Gilead or to other Licensed Product Suppliers or to manufacture and supply such Pediatric Formulation to one or more Gilead Distributors for sale (a) in territories that either are outside the scope of Licensee’s Applicable Territory but within the scope of the licensed territory of such designated Licensed Product Supplier or Gilead Distributor, or (b) in territories that are within Licensee’s Applicable Territory but in which Licensee is not able to make such Pediatric Formulation available. Licensee will be entitled to receive compensation for any such license or sale of such Pediatric Formulation to Gilead, a Licensed Product Supplier or Gilead Distributor that would be commensurate with (and not in excess of) the compensation Licensee would receive if Licensee itself sold such Pediatric Formulation in Licensee’s Applicable Territory.
(iii) If Gilead, in its sole discretion, is interested in pursuing the regulatory approval or marketing of such Pediatric Formulation in countries outside Licensee’s Applicable Territory, or in facilitating access to such Pediatric Formulation to countries within Licensee’s Applicable Territory where Licensee has not made such Pediatric Formulation available, then Gilead and Licensee will negotiate a separate agreement relating to such Pediatric Formulation, with such agreement including appropriate compensation for Licensee for such Pediatric Formulation. Gilead shall have the right to sublicense such Pediatric Formulation to Japan Tobacco for use in Japan in accordance with the Japan Tobacco Agreement.
[Added by Amendment 1] Licensee will have the right to develop a BIC Product or BIC Combination Product as either a liquid or dispersible tablet formulation for use in pediatric patients less than 12 years of age (such formulation shall be a Pediatric Formulation). If Licensee is granted regulatory approval to market such Pediatric Formulation, then Licensee will use reasonable efforts to make such Pediatric Formulation available throughout the BIC Territory (for purposes of Section 6.2(e) of the Agreement, the BIC Territory shall be Licensee’s Applicable Territory with respect to such Pediatric Formulation).
6.3 Regulatory Filings and Inspections. Except as provided otherwise herein, Licensee shall be responsible for obtaining and maintaining all applicable regulatory or other approvals or authorizations to carry out its activities under this Agreement and shall provide Gilead and MPP with a quarterly written report setting forth (a) a list of countries within the Territory for which such regulatory approvals or authorization have been obtained for any Product and (b) a description of activities performed by Licensee, its designee or, to its knowledge any other third party, with respect to the filing, obtaining or maintaining of such regulatory approvals or authorizations within the Territory for any Product (each such report, a “Regulatory Report”). Gilead or its Affiliates may, in its discretion, elect to file, or authorize third parties to file, for regulatory or other approval or authorization to make and sell API and Product anywhere in the Territory. Upon Gilead’s or Licensee’s request, Licensee or Gilead, as applicable, shall provide non–proprietary data that it perceives is reasonably necessary to obtain any such approvals, authorizations, permits or licenses. Licensee shall obtain, have and maintain all required registrations for its manufacturing facilities. Licensee shall allow appropriate regulatory authorities to inspect such facilities to the extent required by applicable law, rule or regulation. Gilead agrees to provide Licensee with NCE Exclusivity or other regulatory exclusivity waivers as may be required by the applicable regulatory authorities in order to manufacture or sell Product in the Territory, provided such manufacture and sale by Licensee is compliant with the terms and conditions of this Agreement. Licensee agrees not to pursue or obtain regulatory exclusivity on any Product in any country within the Territory.
[Added by Amendment 1] To the extent Regulatory Reports relate to EVG, EVG Product, EVG Combination Product, or Quad Product, Gilead will have the right to share such Regulatory Reports with Japan Tobacco, which right shall survive the expiration or termination of the Agreement.
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6.6 Safety Requirements [added by Amendment 1]
(a) Licensee is responsible for all single and periodic reporting to all applicable regulatory authorities for the Products manufactured by or on behalf of Licensee under the Agreement.
(b) Licensee is responsible for all pharmacovigilance activities with respect to such Products, including but not limited to all associated signal detection, risk management and product labelling requirements.
(c) In the event Licensee receives an individual case safety report associated with any Gilead proprietary product, Licensee agrees to forward such reports to Gilead at EMail: SafetyFC@gilead.com Fax: +1–650–522–5477.
(d) Licensee will forward details of any confirmed safety signals or emerging safety issues relating to Products manufactured by or on behalf of Licensee under this Agreement and any supporting documentation to the risk management contact at Gilead: Neda. Shokrai@gilead.com”
7. Representations, Warranties and Covenants
7.2 Diversion of Product and Technology [as amended by Amendment 1].
Licensee covenants and agrees that Licensee and its Affiliates shall not, and shall require its Distributors and Third party Resellers not to: (i) divert or allow the diversion of APl outside of India, China or South Africa, or to third parties that do not constitute Licensed Product Suppliers, (i) divert or allow the diversion of TDF Product, TDF Combination Product, TAF Product or TAF Combination Product outside the TDF–TAF Territory, (ii) divert or allow the diversion of COBI Product or COBI Combination Product outside the COBI Teritory, (iv) divert or allow the diversion of EVG Product, EVG Combination Product or Quad Product outside the EVG–Quad Territory, (v) divert or allow the diversion of BIC Product or BIC Combination Product outside the BIC Territory, (vi) divert or allow the diversion of Licensed Technology to any third party, except as expressly permitted under this Agreement, (vii) take any action that Gilead determines in good faith to be in furtherance of the activities described in clauses (i)-(vi), or (viii) assist or support, directly or indirectly, any third party in the conduct of the activities described in clauses (i)-(vii). The parties agree that it shall not be a breach of Section 3.1 or this Section 7.2 for Licensee or its Affiliate to file marketing approval applications for any Product in a country outside of the Territory as required by applicable regulatory authorities in such country for the commercialization of such Product in such country, or for Licensee or its Affiliate to provide developmental quantities of APl or Product in support of its Own marketing approval applications or a third party’s application for marketing approval, in each case, as required by applicable regulatory authorities in such country, it being understood that this provision shall not be construed as expressly or implicitly granting Licensee any right or license under any Gilead intellectual property rights beyond the licenses granted in Section 2 of this Agreement or otherwise providing any authorization by Gilead to do so, and does not constitute a waiver of any rights of Gilead under law that it may have to contest the filing or granting of such marketing approval applications.
(b) Damages. In the event (i) any Product is diverted (x) by Licensee or its Affiliate sublicensees, or (y) by another party with the assistance of the Licensee or its Affiliate sublicensees, in each case to any country outside the Territory in any manner described in Section 7.2(a), and (i) a patent covering such Product has been granted in such country or in the country(ies) outside the Teritory in which such Product is manufactured (collectively the circumstance described by clause (i) and (ii), a “Diversion Event“), then in addition to any other remedies Gilead may be entitled to at law or in equity, Gilead shall be entitled to injunctive relief and to receive lost profits associated with the Diversion Event, which such lost profits will be determined by taking into consideration the following factors: (1) the quantity of Product that is the subject of such Diversion Event; (2) the average profit Gilead receives from its sale of such Product in the country(ies) outside the Teritory into which such Product was sold or otherwise transferred, and (3) any erosion in Gilead’s market share in such country(ies) outside the Territory as a result of such Diversion Event. This Section 7.2(b) shall survive the expiration or termination of the Agreement with respect to Products sold prior to such expiration or termination.
[Added by Amendment 1] If any party becomes aware of a suspected occurrence of any prohibited activity described in Section 7.2(a)(i)-(vii), such party will notify the other parties promptly, and following such notification, the parties will confer. Gilead (except in the case of Patents relating to EVG, EVG Product, EVG Combination Product or TAF Quad that are subject to the Japan Tobacco Agreement and controlled by Japan Tobacco) will have the right, but not the obligation, to bring an infringement or other action at its own expense, in its own name, and entirely under its own direction and control. Licensee will reasonably assist Gilead (or, where applicable, Japan Tobacco) in such actions or proceedings if so requested, and will lend its name to such actions or proceedings if required by law in order for Gilead (or Japan Tobacco) to bring such an action, which obligations shall survive the expiration or termination of the Agreement.