Provision Language
Definitions
“Licensed Know-How” shall mean: (a) the know-how actually transferred to Licensee pursuant to the terms of Section 5.5 and (b) any other improvements or modifications to such transferred know-how that are (i) disclosed or transferred to Licensee under this Agreement, (ii) specific to the Product (including Lenacapavir) and (iii) developed and controlled by Gilead during the term of this Agreement. Licensed Know-How specifically excludes any improvements, modifications, methods and other know-how claimed in any patent or patent application.
“Licensed Technology” shall mean the Patents and the Licensed Know-How.
“Patents” (a) the patents and patent applications set forth in Appendix 2 hereto; and (b) any other patents or patent applications (and resulting patents therefrom) that are in the Territory and (i) owned and controlled by Gilead and its Affiliates during the term of this Agreement and (ii) necessary for Licensee to practice the licenses granted in Article 2 hereof, including in each of (a) and (b) solely to the extent the claims in such patents and patent applications cover the manufacture, use or sale of Lenacapavir or Product, and including any substitution, divisional, continuation, continuation in part, reissue, renewal, registration, confirmation or the like of any such patent or patent application, any extension or restoration by existing or future extension or restoration mechanism, including revalidation, reissue, re-examination or extension of any of the foregoing, and any patent term extensions, supplementary protection certificates and equivalents thereof.
2. License Grant
2.1 License Grant to Licensee.
(a) Patent and Licensed Know-How License. Subject to the terms and conditions of this Agreement (including but not limited to the terms of this Article 2 and Article 11.2), Gilead hereby grants to Licensee a royalty-free, non-exclusive, non-sublicensable (other than a sublicense to an Affiliate in accordance with Section 2.2 below), non-transferable license under the Patents and Licensed Know-How to:
(i) make and have made Lenacapavir or Product in the Territory, and to use Lenacapavir for the purposes of making Product, provided that Product is made solely for the purpose of Section 2.1(a)(iii);
(ii) sell or otherwise supply Lenacapavir to Licensed Product Suppliers solely the purposes of such License Product Supplier’s exercise of its license from Gilead in the Territory; and
(iii) sell, have sold, and offer for sale Product in the Territory,
in each case of (i) to (iii) only for use in the Field.
(b) Trademark License. Gilead hereby grants to Licensee a royalty-free, non-exclusive, non-sublicensable (other than a sublicense to an Affiliate in accordance with Section 2.2 below), non-transferable license to use Licensed Gilead Logos in accordance with the requirements set forth in Section 6.5 and Appendix 4 herein, which license is revocable by Gilead with or without cause.
(c) Restrictions on Scope. The licenses granted in this Section 2.1 do not include, expressly or by implication, a license under any Gilead intellectual property right to manufacture, sell, promote or distribute (i) any active pharmaceutical ingredient owned or controlled by Gilead other than Lenacapavir, (ii) any product other than Product or (iii) any Product as standalone oral medication. Licensee covenants not to use Licensed Know-How or other Confidential Information of Gilead for any purpose other than as set out in Sections 11.1 and 11.2, and pursuant to the licenses under this Sections 2.1, and, without limiting the foregoing, in no event may Licensee use any such Licensed Know-How or other Confidential Information of Gilead in support of a generic drug approval application to the FDA that includes any Paragraph IV certification (21 U.S.C. 355(j)(2)(A)(vii)(IV)). For the avoidance of doubt, failure by Licensee to comply with this Section 2.1(c)shall constitute a material breach of this Agreement for the purposes of Section 10.2.
2.2 Affiliates. Licensee may not grant sublicenses under the licenses granted in Section 2.1 except to its Affiliates, in each case, solely upon Gilead’s prior written approval, not to be unreasonably withheld or delayed. Each approved sublicense will be subject to a written agreement between Licensee and the applicable Affiliate that is consistent with the terms and conditions of this Agreement. Licensee shall provide Gilead with a written copy of the proposed sublicense agreement with such Affiliate(s) at the time of requesting Gilead’s approval. Licensee shall name Gilead as a third-party beneficiary in any such sublicense agreement, and accordingly Licensee shall consent and hereby does consent to Gilead’s enforcement of such sublicense agreement to the extent relating to the obligations that Licensee is required hereunder to impose on its Affiliates. Licensee shall ensure that any such Affiliate complies with all the terms of this Agreement as if they were a party to this Agreement, and Licensee will be liable for the activities of such Affiliates as if such activities were performed by Licensee. All notices and copies of sublicensee agreements provided under this Section 2.2 shall be submitted into Gilead’s Voluntary Licensee Portal.
2.3 Subcontractors. Subject to Article 3, Licensee may use third party subcontractors in exercising its rights under Sections 2.1(a)(i), 2.1(a)(ii) and 2.1(a)(iii) soley upon prior written notice to Gilead. Licensee will cause each subcontractor of Licensee to be bound by a written agreement that is consistent with the terms and conditions of this Agreement (including those relating to confidentiality). Licensee will conduct appropriate risk-based due diligence, including risk-based periodic renewal due diligence, to assess the capabilities, compliance, and reputation of subcontractors that it engages in accordance with this Section 2.3. Licensee shall provide Gilead with the written copies of the applicable agreement with such subcontractor(s) at the time Licenseee provides written notice of such subcontracting arranagement. Licensee shall name Gilead as a third-party beneficiary in any such subcontract agreement, and accordingly Licensee shall consent and hereby does consent to Gilead’s enforcement of such subcontract agreement to the extent relating to the obligations that Licensee is required hereunder to impose on its subcontractors. Licensee shall ensure that any such subcontractor complies with all the terms of this Agreement as if they were a party to this Agreement, and Licensee will be liable for the activities of such subcontractor as if such activities were performed by Licensee. All notices and copies of agreements provided under this Section 2.3 shall be sent to Gilead’s Voluntary Licensee Portal.
2.4 License Grant to Gilead.
(a) Improvements License. Licensee hereby grants to Gilead a nonexclusive, royalty-free, worldwide, sublicensable license to all improvements, methods, modifications, processes and other know-how developed by or on behalf of Licensee and relating to Lenacapavir or Product (“Improvements”), subject to the restrictions on further transfer of Licensee’s technology by Gilead as set forth in Section 5.3. Licensee shall, as between Gilead and Licensee, own all such Improvements and shall, as between Licensee and Gilead, have the sole right, but not the obligation, to pursue intellectual property protection with respect to such Improvements.
2.5 Licensee Right to Sell.
(a) Lenacapavir Sales. Licensee agrees that it will not sell or offer to sell Lenacapavir to any entity other than Licensed Product Suppliers that have been approved by Gilead in accordance with Section 2.5(f).
(b) Product Sales. Licensee agrees that it will not sell, offer to sell or provide Product to any entity other than a Third Party Reseller or a direct Customer or as otherwise provided under this Agreement, sales to such entities being exclusively reserved to Gilead. Licensee agrees that neither it, nor its Affiliates, will sell, offer for sale, or permit third parties (including any Third Party Reseller or Customer) to sell or distribute Product in or to any country outside of the Territory or for any use outside the Field, such outside territories and/or fields being exclusively reserved to Gilead. Licensee agrees that it will prohibit its direct trading partners, including Third Party Resellers or Customers, from selling Product (i) to any other reseller, wholesaler or distributor, (ii) outside the Territory, or (iii) for any purpose outside the Field. If Licensee’s direct trading partner is a Customer, Licensee will prohibit its Customer from reselling the Product; unsold/unused Product must be returned to Licensee.
(c) Licensee agrees that it will not sell a Product for PrEP until the earlier of Gilead obtaining a marketing approval for such Product for PrEP from (i) the FDA or (ii) the EMA.
(d) Limitations on Product Combinations. Licensee agrees that it will not make, have made, sell or offer to sell products containing Lenacapavir in the Territory: (i) in combination with other active pharmaceutical ingredients; (ii) in combination or bundled with any other product whatsoever; and / or (iii) for any purpose other than use in the Field.
(e) Terms of Agreements with Third Party Resellers.
(i) Gilead Distributors. Licensee may elect to sell Product in the Territory via a written agreement with any Gilead Distributor, provided, however, that Licensee may only sell and offer for sale Product to Gilead Distributors to sell in the Territory, and may not sell or offer for sale Product outside the Territory, and may not import Product into any country outside the Territory. Licensee shall only allow such Gilead Distributor to sell such Product to Customers in the country(ies) of the applicable Territory for which such Gilead Distributor has the right to sell Gilead Lenacapavir Product.
(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.
(f) Gilead Approval of Third-Party Reseller Agreements and Direct Customer Agreements. Licensee shall not enter into any agreements with Third Party Resellers or direct Customers on terms inconsistent with this Agreement without obtaining Gilead’s prior written approval. Licensee shall notify Gilead in writing of all Third Party Resellers and any direct Customers promptly after entering into such arrangements and shall certify that its arrangement with such Third Party Reseller and/or direct Customer is consistent with the terms and conditions of this Agreement. Licensee shall provide Gilead with written copies of all agreements executed between Licensee and Third Party Resellers and Licensee and direct Customers relating to Lenacapavir or Product at the time it provides notice of such arrangements. Licensee shall name Gilead as a third-party beneficiary in any such agreements, and accordingly Licensee shall consent and hereby does consent to Gilead’s enforcement of such agreements to the extent relating to the obligations that Licensee is required hereunder to impose upon Third Party Resellers and direct Customers. Licensee shall be allowed to redact confidential financial terms from such agreements prior to sharing them with Gilead. Gilead shall have the right to review all such agreements to verify consistency with the terms and conditions of this Agreement. In the event that any inconsistency is found between any such agreement and the terms and conditions of this Agreement which had not been specifically discussed and agreed with Gilead, then Gilead shall have the right to require Licensee to amend or terminate such agreement and upon notice from Gilead to such effect, Licensee shall immediately terminate such agreement. All notices and copies of agreements provided under this Section 2.5(f) shall be sent to Gilead’s Voluntary Licensee Portal.
(g) Termination of Third Party Reseller and Direct Customer Agreements by Licensee. Licensee shall immediately terminate its agreement(s) with a Third Party Reseller or direct Customer in the event that Gilead believes in good faith that such Third Party Reseller has engaged in activities that Licensee is prohibited from performing under this Agreement, or that are inconsistent with Licensee’s covenants under this Agreement, including without limitation the unauthorized use, sale or a Diversion Event by such Third Party Reseller or direct Customer of (i) Lenacapavir in a manner inconsistent with this Agreement or (ii) Product outside the Field or the Territory, or upon Licensee first reasonably believing that such Third Party Reseller or direct Customer has engaged in such activities.
(h) Termination of Third Party Reseller or Direct Customer Agreements by Gilead. Gilead may terminate the right of Licensee to sell Product to any Third Party Reseller or direct Customer pursuant to this Section 2.5, if (i) in Gilead’s reasonable belief the Third Party Reseller or direct Customer is not acting in a way that is consistent with Licensee’s covenants under this Agreement; or (ii) if Licensee does not terminate Licensee’s agreement with such Third Party Reseller or direct Customer under the circumstances described in Section (f) or Section (g).
2.6 License Limitations.
(a) Gilead Retained Rights. Licensee hereby acknowledges that Gilead retains all right, title and interest in Lenacapavir and Product except as explicitly provided in this Agreement, and that Gilead may license or otherwise convey rights with respect to Lenacapavir and Product as it wishes without obligation or other accounting to Licensee.
(b) Gilead Marks. The licenses granted hereunder do not include any license or other right to use any Gilead Mark or any word, logo or any expression that is similar to or alludes to any Gilead Mark, except the Licensed Gilead Logo specified in Section 6.5 and Appendix 4.
(c) No Other Licenses.
(i) Except as expressly set forth in this Agreement, Licensee agrees that it shall not subcontract any of its rights or delegate any of its duties without obtaining Gilead’s prior written consent, or grant any sublicenses hereunder to any other person, company or entity, including third parties and Affiliates.
(ii) Except as expressly set forth in this Agreement, Gilead does not grant any license under any of its intellectual property rights (including, without limitation, patents or rights to any proprietary compounds or drug substances other than Lenacapavir) to Licensee.
(iii) Independent ANDA Filing. Subject to Licensee’s compliance with limitations on the use of Licensed Know-How and other Confidential Information of Gilead hereunder, nothing in this Agreement is intended to restrict Licensee’s submission of a generic application to the FDA with a Paragraph IV certification that Licensee would have been able to submit but for this Agreement, namely without reliance on the Licensed Know-How or any other Confidential Information of Gilead.
5. Intellectual Property
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5.4 Trademarks, Trade Dress, Packaging, and Approvals
(a) Product offered for sale or sold under this Agreement, including sublicenses of this Agreement, shall have a trade dress, consisting of a distinct color, shape, container, packaging, trade name and logo different from and not likely to be confused with, any product sold by or on behalf of Gilead, including Gilead Lenacapavir Product or any Gilead Marks (except for Licensed Gilead Logo) or other restrictions established by Gilead. Gilead from time to time shall provide Licensee with Brand Requirements for Licensees, which Licensee must adhere to prior to offering a product for sale or regulatory submissions under this Agreement. Gilead may amend the Brand Requirements for Licensees at any time and Licensee must comply with such amended Brand Requirements for Licensees from the point which the amendments have been transmitted to Licensee. Licensee’s non-performance of the obligations set forth in this Section 5.4(a) shall constitute a material breach of Licensee’s material obligations under this Agreement.
(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.
(c) Without limiting the requirement with respect to Licensee’s use of a trade dress distinct from any Gilead trade dress as described in Section 5.4(a) above, Licensee further agrees that, Licensee (whether itself, or through an Affiliate or a Third Party Reseller) shall have the right to use no more than one (1) trademark or trade name in the Territory with respect to a Product.
Appendix 1
PART A – Territory
