Master Alliance Provisions Guide (MAPGuide)

Gilead, HIV Therapeutic (Lenacapavir) Template License Agreement

  • Equitable access | Territory access commitments

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.

Diversion Event” shall mean an event where any Product is diverted to any country (or sub-jurisdictional unit specifically identified in any Agreement) outside of the applicable prescribed Territory in any manner by any Person (whether Licensee, any Affiliate of Licensee, any trading partner or Customer of the Product or other third party).

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.

Target Countries” shall mean the countries set forth in Part B of Appendix 1 as may be updated from time to time.

Territory” shall mean the countries set forth on Part A of Appendix 1 and also includes the Target Countries unless otherwise specified.

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.

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(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.

6. Manufacturing and Commercialization of Product

6.1 Commercialization of Product in the Territory

(a) Anti-Diversion Programs. Licensee shall provide Gilead with written notice at least three (3) months prior to its anticipated first sale of Product in each country within the Territory. Following Gilead’s receipt of such notice, the Parties shall discuss in good faith programs that Licensee may implement to minimize diversion of Product outside of such country, including by using Commercially Reasonable Efforts in ensuring Product is sold direct to patients and individuals who would benefit medically from PrEP within such country, as may be determined by the Parties. On a country by country basis, if requested by Gilead at any time either prior to Licensee’s sale of Product in such country or at any time thereafter, the Parties shall discuss and agree upon a written anti-diversion plan that Licensee shall implement to ensure Product is not diverted out of such country (for each such country, the “Anti-Diversion Plan”). In all events, Licensee agrees to enact best practices protocols and programs, including, but not limited to, promptly raising all instances of known or suspected Counterfeit Product or Diverted Product to Gilead, conducting thorough investigations to identify the source of diversion and to enforce, in cooperation with Gilead, against parties involved in instances of diversion, adopting trade dress and marketing material practices as described in this Agreement, ensuring compliance with Licensee’s anti-diversion obligations and to otherwise prevent diversion. Licensee shall disclose the content of such protocols and programs to Gilead and shall consult with and implement any additional practices requested by Gilead, such as, where commercially practical, expressly identify on the labeling and packaging of all Product sold or offered for sale under this Agreement the country in which such Product is intended to be used.

(b) Diversion Notice. Gilead shall have the right to prohibit Licensee’s sale of Product to any country (the “Subject Country”) within the Territory if it reasonably believes that material quantities of Product are being sold, transferred or otherwise diverted from such Subject Country outside the Territory by providing written notice thereof to Licensee (each such notice, a “Diversion Notice”). Except as may be necessary for patients within any Subject Country who are already being treated with Product for any indication in the Field (and where there is no sufficient alternative), upon Licensee’s receipt of a Diversion Notice, Licensee shall immediately cease all sales of Product in, and imports of Product to, the Subject Country(ies) that is covered by such Diversion Notice until such time that Gilead and Licensee have developed an Anti-Diversion Plan for such Subject Country(ies). Licensee shall not enter into any contractual arrangements or commitments that would prevent it from fulfilling its obligations under this Section 6.1(b).

(c) Promotion. The Parties hereto agree that an important purpose of this Agreement is to increase patient access (including access for individual who would benefit medically from PrEP) to Product in the Field within the Territory. Subject to the terms of this Agreement, Licensee shall have the sole discretion to manage its own commercial strategy to promote and sell 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(c). 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 Lenacapavir or Product without having the means, either directly or through the use of permitted third parties, to manufacture Product using such Lenacapavir and/or distribute Product within the Territory.

(d) Product Security Features, Serialization, and Traceability. Licensee shall include anti-counterfeiting features on the Product, including, but not limited to, affixing a unique product identifier in the form of a serial number to both the secondary and primary packaging of each individual unit that is produced and intended for sale in the Territory (“Individual Saleable Unit”). Licensee shall implement a process for tracing each Individual Saleable Unit of Product from Licensee to Licensee’s immediate downstream trading partner. Tracking and tracing requirements shall be further enhanced where enactment of local law in the country of manufacture or sale of Product in Territory requires tracking and/or traceability throughout the supply chain, from the manufacturer to end customer responsible for selling or dispensing the Licensee Product to the patient or individual who would benefit medically from PrEP.

7. Representations, Warranties and Covenants

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7.2 Diversion of Product and Technology

(a) Licensee covenants and agrees that Licensee and its Affiliates shall not, and shall require its permitted subcontractors and Third Party Resellers or direct Customers not to directly or indirectly: (i) sell, re-sell, consign, seek to sell, promote or advertise for sale, export, ship, transport, or seek, solicit or distribute to any third party or divert or allow the diversion of Lenacapavir to third parties in a manner inconsistent with this Agreement, (ii) remove, or allow the removal of Products outside of the Territory, (iii) divert or allow the diversion of Licensed Technology to any third party, (iv) take any action that Gilead determines in good faith to be in furtherance of the activities described in Sections 7.2(a)(i) – (iii), or (v) assist or support, directly or indirectly, any third party in the conduct of the activities described in Sections 7.2(a)(i) – (iv). 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 Product in a country outside of the Territory, or for Licensee or its Affiliate to provide developmental quantities of Lenacapavir or Product in support of such 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 right beyond the licenses granted in Article 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) 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.

(c) Agreed Damages. Gilead and Licensee acknowledge and agree that the amount of actual damages sustained by diversion is impossible or extremely difficult to calculate, and that the damage increases on an exponential (and not linear) basis, due to the effect of the product brand and associated goodwill and reputation. If a Diversion Event occurs, 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 damages, calculated in the manner set forth in section (d) below.

(d) Calculation of Liquidated Damages. For each Diversion Event, Gilead shall be entitled to damages, as follows:

(i) If Gilead is able, in good faith, to estimate the net revenues that Gilead would have received had such Diversion Event not occurred (“Estimated Net Revenues”), Licensee shall pay to Gilead an amount equal to the sum of (i) the Estimated Net Revenues plus (ii) (A) all investigative costs, fees, and expenses (including, without limitation, those of private investigators), plus (B) all attorneys’ costs, fees, and expenses (including, without limitation, in connection with investigating such Diversion Event and any litigation, arbitration, or other proceeding arising out of or related to such Diversion Event (including, without limitation, any action to enforce the terms of the Agreement or any License Agreement or to otherwise stop or prevent diversion by the Licensee or any third party)), plus (C) and all other professional costs, fees, and expenses (including of accountants and other advisors), in each case incurred by Gilead in connection with such Diversion Event; or

(ii) If Gilead is not able, in good faith, to ascertain the Estimated Net Revenues, Licensee shall pay to Gilead an amount equal to 2x (two times) the sum of (i) all investigative costs, fees, and expenses (including, without limitation, those of private investigators), plus (ii) all attorneys’ costs, fees, and expenses (including, without limitation, in connection with investigating such Diversion Event and any litigation, arbitration, or other proceeding arising out of or related to such Diversion Event (including, without limitation, any action to enforce the terms of the Agreement or any License Agreement or to otherwise stop or prevent diversion by the Licensee or any third party)), plus (iii) all other professional costs, fees, and expenses (including of accountants and other advisors), in each case incurred by Gilead in connection with Diversion Event.

The obligation of Licensee to pay damages described in this section is (i) absolute and indefeasible adosend (ii) not contingent on any showing of willfulness on the part of any party (including Licensee) in connection with any Diversion Event. All liquidated damages payable to Gilead shall be paid by Licensee promptly and without any counterclaim, set-off, or reduction.

The Parties agree that the payments set forth in this section are not intended to compel the other Party’s performance hereunder or constitute a penalty or punitive damages for any purpose.

(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.

7.3 Compliance

(a) General. Licensee covenants and agrees that it shall perform all activities under this Agreement in accordance with all applicable laws, rules, and regulations, including, without limitation, with respect to privacy, data protection, recalls, safety and reporting requirements and shall obtain, have and maintain all necessary regulatory approvals, Marketing Authorizations, permits and licenses, at Licensee’s expense for the manufacture and sale of the Lenacapavir and/or Product and any other Licensee activities contemplated under this Agreement. In particular, Licensee shall use its best efforts to obtain all applicable Marketing Authorizations for the sale of Products for PrEP in each country in the Territory. If Licensee obtains, and verifies to Gilead that it has obtained, all applicable Marketing Authorizations for each of the eighteen (18) Target Countries within three (3) years of the earlier of the date upon which Gilead receives (a) FDA approval; or (b) WHO PQ for the Product, then Gilead will consider appointing Licensee as a preferred partner (subject to Licensee fulfilling other relevant selection criteria) with respect to any future product formulation of Lenacapavir which Gilead is intending to license.

Appendix 1

PART A – Territory

PART B – Target Countries