Provision Language
Definitions
“Customer” shall mean a hospital, government, or alternative site of care that is located in the Territory and properly licensed under local law to receive and dispense Product and that purchases Product pursuant to a written agreement with Licensee or Licensee’s Third Party Reseller requiring Customer to: (a) comply with the applicable terms of this Agreement, (b) purchase Product directly and exclusively from Licensee or Licensee’s Third Party Reseller for use within the Territory, (c) not purchase or accept any such Product from any entity or person other than Licensee or Licensee’s Third Party Reseller, (d) not sell Product to any entity or individual outside of the Territory, and (e) not sell Product to any entity or individual that supports use of the Product outside the Territory.
“Distributor” shall mean a third-party wholesaler or distributor that is not a Gilead Distributor and that is operating under a written agreement with Licensee for the distribution and sale of Product in the Territory.
“Gilead Distributor” shall mean any third-party distributor that is currently operating under an agreement with Gilead for the distribution and sale of Gilead Lenacapavir Product in the Territory. No more frequently than once per calendar year, upon request by Licensee, Gilead will provide Licensee with a list, which may be updated by Gilead from time to time, of the identity of any such Gilead Distributors and their authorized territory(ies) within the Territory.
“Third Party Reseller(s)” shall mean, individually and collectively, Distributor(s) and Gilead Distributor(s).
2. License Grant
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2.5 Licensee Right to Sell
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(e) Terms of Agreements with Third Party Resellers
(ii) Third Party Resellers. Licensee shall require any Third Party Reseller to agree, in a written agreement with Licensee (i) to comply with the applicable terms of this Agreement, (ii) to provide Customer sales data, including name and address of Customer, date of transaction for Product(s), quantity and associated lot numbers and serial numbers (where applicable) sold (on a Customer by Customer basis) (“Customer Sales Data”) (iii) to prohibit Third Party Resellers from selling, offering to sell, or providing Product to another reseller, wholesaler or distributor or any entity other than a Customer providing Product within the Territory and to prohibit Customer via a written agreement between the Third Party Reseller and Customer from reselling the Product and require unsold/unused Product to be returned to the Third Party Reseller, and (iv) to report to Licensee the information described in Section 4.2, and allow Licensee to provide Gilead with such information. Gilead has the right to audit, on no less than thirty (30) days’ advance notice to Licensee, such records of Licensee solely to the extent necessary to verify such compliance. Gilead will bear the full cost of any such audit unless the audit reveals a failure to comply with this Agreement. Licensee shall not enter into any agreement, arrangement, or understanding (including with respect to confidentiality) with any such third party that would hinder the exercise of Gilead’s audit rights. By ensuring the most direct supply for the Product from Licensee to patients or individuals who would benefit medically from PrEP within the Territory, this section is intended to: (i) enable broad access for the Product while helping to ensure the pricing for the Product remains accessible to local patients and (ii) protect patients’ safety by mitigating risks from counterfeits and substandard versions of the Product.
4. Consideration/Payment Terms/Audit
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4.2 Reports
(a) Within thirty (30) days after the end of each calendar month, Licensee shall provide Gilead with a detailed report (the “Monthly Report”) that includes at least the information set forth in this Section 4.2. The Licensee shall be solely responsible for ensuring that all necessary infrastructure (systems, personnel, files, and backup documents) is established and maintained to facilitate the timely and accurate submission of monthly reports, as stipulated in this Agreement.
(i) Product and Lenacapavir Information. In each Monthly Report, Licensee agrees to set forth in reasonable detail the following information on country-by-country basis: (i) amounts of Lenacapavir and Product manufactured by Licensee, (ii) the quantity of Lenacapavir and Product in Licensee’s stock, (iii) the Third Party Resellers or direct Customer, to which Licensee has provided Product by date, including quantities, lot number(s), serial numbers shipping addresses, shipping dates, and the countr(ies) in which the Product provided is to be used (on a Third Party Reseller by Third Party Reseller basis), (iv) aggregated Customer Sales Data as defined in Section 2.5(e)(ii) (on a Third Party Reseller by Third Party Reseller basis), (v) in the case of the sale of any Lenacapavir to Licensed Product Supplier, the identity of such Licensed Product Supplier and the dates and quantities of Lenacapavir sold to each such Licensed Product Supplier and (vi) the volume of Lenacapavir or Product that Licensee intends to manufacture over the course of the following 12-month period, on a month by month basis.
(ii) Monthly Average Net Sales Information. In each Monthly Report, Licensee shall additionally include the following information: (i) monthly average Net Sales, reported on a country-by-country basis, (ii) the countries to which the Product has been sent and in what quantities.
(iii) Regulatory Information. In each Monthly Report, Licensee shall additionally provide Gilead with the following information: (i) a list of countries within the Territory for which Marketing Authorizations have been obtained for Product and (ii) 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 on a country-by-country basis for any Product.
(iv) No Objection Certificates. In each Monthly Report, Licensee shall provide Gilead with the following information: (i) any local regulatory approvals, permits or other similar documents from the country(ies) of manufacture obtained by the Licensee for Product, including the quantity of Product exported, the final destination of the Product and the recipient of the Product; and (ii) any local regulatory approvals, permits or other similar documents from the country of manufacture obtained by third parties for Product for which Licensee provided information, including the quantity of Product exported, the final destination of the Product and the recipient of the Product.
(v) Certifications. Together with each Monthly Report, Licensee shall provide Gilead with a written certification of the accuracy of the contents of the Monthly Report, signed by an appropriate Licensee senior officer. Licensee shall provide Monthly Reports to Gilead at the address set forth in Section 12.4 below and send a copy to Gilead’s Voluntary Licensee Portal. Failure to provide complete, accurate Monthly Reports to Gilead as set forth in this Section 4.3 shall be deemed a breach of the Agreement.
4.4 Records. Licensee shall keep complete and accurate records of Lenacapavir and Product produced and sold in sufficient detail to enable Licensee to determine the parties to whom Product or Lenacapavir was sold, and the countries in which sales occurred.
4.5 Audit. Gilead has the right to engage an independent public accountant to perform, on no less than thirty (30) days’ advance notice to Licensee, an audit, conducted in accordance with generally accepted auditing standards, of such books and records of Licensee that are deemed necessary by such public accountant to report amounts of Lenacapavir and Product produced, gross sales, Net Sales for the periods requested. Gilead will bear the full cost of any such audit.
5. Intellectual Property
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5.3 Reporting of Improvements. Licensee shall provide Gilead with a semi-annual report, in writing and in reasonable detail that sets forth any Improvements, including any patent application claiming Improvements. Licensee shall transfer to Gilead, upon request by Gilead and at Gilead’s expense, any know-how owned or controlled by Licensee relating to such Improvements. Any failure to report any such Improvements to Gilead in accordance with the terms of this Agreement shall constitute a breach of this Agreement and shall provide Gilead with the right to terminate this Agreement pursuant to Section 10.2. Gilead shall not transfer any Improvements obtained from Licensee to any third party, provided, however, that Gilead may transfer Improvements to (i) Licensed Product Suppliers and Licensed Lenacapavir Suppliers and (ii) Gilead’s own Affiliates, licensees and suppliers, provided such Affiliates, licensees and suppliers utilize such Improvements solely for the benefit of Gilead.
5.4 Trademarks, Trade Dress, Packaging, and Approvals
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(b) Prior to making any regulatory submissions for Product, or offering for sale or selling of Product, Licensee shall provide to Gilead exemplary mockups and images of Product and any packaging, labeling information or marketing materials (including, but not limited to, advertisement and promotional materials) to be used with Product via the Voluntary Licensee Portal (located at https://gsf.force.com/vlp, at the time of execution and subject to change), and Licensee shall not sell such Product until Gilead has reviewed such submission. Gilead shall review such submission for compliance with the terms of the Brand Requirements for Licensee concerning the Licensee’s trademarks, product names, tablet and trade dress, labelling, and logos, and text requirements for such Product and its vial design, packaging to determine if such Product or its packaging is likely to be confused with Gilead’s trade dress and trademarks or the Lenacapavir non-proprietary name and the Brand Requirements for Licensees. If Gilead reasonably objects to the trade dress or other aspects of the Product or product packaging based on the requirements set forth in Section (a), the Licensee agrees to make such modifications to Product or packaging as are necessary to address Gilead’s concerns prior to selling such Product.
6. Manufacturing and Commercialization of Product
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6.2 Manufacturing Requirements
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(b) Audit Right. Licensee hereby agrees to allow Gilead reasonable access to Licensee’s books and records, facilities and employees for the purpose and to the extent required for Gilead to audit Licensee’s compliance with the requirements of this Section 6.2. Gilead agrees that it shall limit its access to Licensee’s employees to the extent required to conduct the audit and that such employees shall not be required to disclose to Gilead information that is subject to obligations of confidentiality with third parties unless such third parties have provided consent for such disclosure. Gilead agrees to provide at least thirty (30) days prior notice of the proposed audit and agrees 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).
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6.6 Safety Reporting
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(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 within fifteen (15) calendar days of awareness and in English to E-Mail: Safety_FC@gilead.com Fax: +1-650-522-5477. When sending any such reports by email, to the above address, Licensee will ensure an acknowledgement is received from Gilead (to confirm receipt) and document the acknowledgement. If not received within one (1) business day, the safety report should be resent.
(d) Licensee will forward details of any confirmed safety signals or emerging safety issues relating to Product manufactured by or on behalf of Licensee under this Agreement and any supporting documentation to the risk management contact at Gilead: PSAlliances@gilead.com.
7. Representations, Warranties and Covenants
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7.2 Diversion of Product and Technology
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(b) In furtherance to Section 6.1(a), Licensee will promptly report to Gilead any knowledge or information Licensee or its Affiliates may have concerning (i) any suspected Counterfeit Product or Diverted Product or (ii) any unsolicited offers to Licensee of the Product. Licensee will report to Gilead any incidents of confirmed Counterfeit Product or Diverted Product within 24-hours. Licensee will cooperate with and assist Gilead in investigating incidents of suspected or confirmed Counterfeit Product or Diverted Product pursuant to Section 6.1(a), including efforts to prevent unauthorized exports and resale of Product outside Licensee’s authorized supply chain and outside the applicable country in the Territory and providing Gilead with any applicable Customer information reasonably requested by Gilead.
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(e) Anti-Diversion Audit Right. Upon reasonable notice to Licensee, Gilead shall be entitled, at its own expense, to conduct an audit of Licensee’s orders, books, records, facilities, and other information (including but not limited to Customer transaction information, interviews with employees of Licensee), no more than two (2) times per year. If Gilead becomes aware of any Diversion Event or otherwise forms a reasonable belief that a Diversion Event has occurred in the course of such audit (and such known or suspected Diversion Event was not previously disclosed to Gilead by Licensee), then Licensee shall pay to Gilead all costs of such audit. In addition to the regular audits described elsewhere in this Agreement, in the event of a known or suspected Diversion Event, Gilead shall be entitled to conduct an audit of Licensee’s orders, books, records, facilities, and other information (including but not limited to Customer transaction information, interviews with employees of Licensee) to the extent relating to the Diversion Event at issue which may include the right to request a reassessment of Licensee’s Anti-Diversion Plan during the term of this agreement as necessary to address diversion of Product. All costs of a diversion audit in connection with a known or suspected Diversion Event shall be paid by Licensee.
11. Confidentiality and Publications
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11.2 Limitations on Licensed Know-How
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(f) Upon Gilead’s request, Licensee shall permit Gilead or Gilead’s designee to review and audit the books and records of Licensee to confirm compliance with the use of Licensed Know-How obligations and limitations set forth herein. Any such audit shall be at Gilead’s cost unless any breach of any terms relating to Licensed Know-How are discovered, in which case Licensee shall reimburse Gilead’s costs therefor.