Provision Language
Definitions
“Distributor” shall mean a third party wholesaler or distributor that is not a Gilead Distributor and that is operating under an agreement with Licensee for the distribution and sale of Product in the Territory.
“Gilead Distributor” shall mean any third party distributor that is operating under an agreement with Gilead for the distribution and sale of Gilead’s branded product in the Territory. Gilead will provide Licensee with a list, which may be updated by Gilead from time to time, of the identity of the Gilead Distributors and their licensed territories.
“Licensed Product Supplier” shall mean (a) an entity located in India (other than Licensee) that is licensed by Gilead, directly or through a sublicense from MPP, to (i) make Product in India and (ii) use, sell, have sold, offer for sale and export such Product in the Field in the Territory; (b) an entity located in China that is licensed by Gilead, directly or through a sublicense from MPP, to (1) make Product in China and (2) use, sell, have sold, offer for sale and export such Product in the Field in the Territory; or (c) an entity located in South Africa that is licensed by Gilead, directly or through a sublicense from MPP, to (x) make Product in South Africa and (y) use, sell, have sold, offer for sale and export such Product in the Field in the Territory.
“Third Party Resellers” shall mean Licensed Product Suppliers, Distributors and Gilead Distributors.
2. License Grants
2.1 API License. Subject to the terms and conditions of this Agreement, MPP hereby grants to Licensee a royalty–free, non–exclusive, non–sublicensable (other than a sublicense to an Affiliate in accordance with Section 2.3 below), non–transferable license under the Licensed Technology to (i) make API in India solely for the purposes of exercising the licenses described in this Section 2.1; (ii) offer for sale and sell such API to Licensed Product Suppliers in India, China and South Africa; (iii) import Licensed API into India for purposes of exercising the license set forth in Section 2.2 or (iv) use API for Licensee’s own internal use. For clarity, the license granted in this Section 2.1 does not include, expressly or by implication, a license under any Gilead intellectual property right to manufacture, sell or distribute any active pharmaceutical ingredient owned or controlled by Gilead other than TAF, TDF, EVG and COBI.
2.2 Product License [as amended by Amendment 1]. Subject to the terms and conditions of this Agreement, MPP hereby grants to Licensee a royalty–bearing, non–exclusive, non–sublicensable (other than a sublicense to an Affiliate in accordance with Section 2.3 below), non–transferable license under the Licensed Technology solely to make Product in India and sell, have sold, offer for sale, export from India and import (i) TAF Product, TAF Combination Product, TDF Product and TDF Combination Products in the Field in the TDE–TAF Territory, (ii) EVG Product, EVG Combination Products and the Quad Products in the Field in the EVG–Quad Territory, (ii) COBI Products and COBI Combination Products in the Field and in the COBI Territory, and (iv) BIC Product and BIC Combination Products in the Field and in the BIC Territory; provided that in each case such Products shall be made only from Licensed API. For clarity, (a) the licenses granted in this Section 2.2 do not include, expressly or by implication, a license under any Gilead intellectual property right to manufacture, sell or distribute any product containing active pharmaceutical ingredients owned or controlled by Gilead other than Products containing TAF, TDF, EVG, COBI, and BIC, and (b) notwithstanding the foregoing, the licenses granted under this Section 2.2 shall not extend to any active pharmaceutical ingredient included within a Product other than TAF, TDF, EVG, COBI, and BIC.
2.3 Affiliates [as amended by Amendment 1]. Licensee may grant sublicenses under the licenses granted in Section 2.1 or Section 2.2 to its Affiliates located in India upon prior written notice to Gilead and MPP. Upon Gilead’s or MPP’s request, Licensee shall provide Gilead and/or MPP (as applicable) with the written copies of the applicable sublicense agreement with such Affiliate(s). Further upon Gilead’s or MPP’s request, Licensee shall name Gilead and/or MPP (as applicable) as a third party beneficiary in any such sublicense agreement, in which case Licensee shall consent and hereby does consent to Gilead’s and/or MPP°s (as applicable) 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 Afifiliate 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.
2.4 License Grant to Gilead and MPP. Licensee hereby grants to Gilead and MPP a nonexclusive, royalty–free, worldwide, sublicensable license to all improvements, methods, modifications and other know–how developed by or on behalf of Licensee and relating to API or a Product (“Improvements”), subject to the restrictions on further transfer of Licensee’s technology by Gilead as set forth in Section 5.2. As between Gilead, MPP and Licensee, Licensee shall own all such Improvements and have the sole right, but not the obligation, to pursue intellectual property protection with respect to such Improvements.
2.5 Licensee Right to Sell Through Third Party Resellers [as amended by Amendment 1].
(a) Licensed Product Suppliers. Licensee agrees that it will not sell or offer to sell API to any entity other than to Licensed Product Suppliers in India, China or South Africa, in each case that have been approved by Gilead in accordance with Section 2.5(e).
(b) Product Sales. Subject to Sections 10.3(c) and 10.3(d) of the Agreement, Licensee agrees that it will not sell, offer for sale, or assist third parties (including Affiliates) in selling Product
except for the sale and offer for sale of (A) TAF Product, TAF Combination, TDF Product and TDF Combination Product for use in the Field in and in the countries of the TDF–TAF Territory, (B) COBI Product and COBI Combination Product for use in the Field and in the countries of the COBI Territory, (C) EVG Product, EVG Combination Product and Quad Product for use in the Field and in the countries of the EVG–Quad Territory, and (D) BIC Product and BIC Combination Product for use in the Field and in the countries of the BIC Territory.
(i) Licensee agrees that during the period in which the Patents are valid and enforceable (on a Product–by–Product basis) it will prohibit its Distributors from selling Product (A) to any other wholesaler or distributor, (B) outside the Territory for which Licensee is licensed for sale of such Product pursuant to Section 2.2, or (C) for any purpose outside the Field.
(ii) Licensee agrees that it will not administer BIC to humans, or sell Products containing BIC until Gilead has obtained marketing approval for a Product containing BIC from the FDA.
(c) Limitations on Product Combinations.
(i) Licensee will be allowed to manufacture and sell TAF or TDF in combination with other active pharmaceutical ingredients in the TDF–TAF Territory, provided in each case (A) Licensee has the legal right to manufacture and sell such other active pharmaceutical ingredients in the applicable country in the TDF–TAF Territory, and (B) such manufacture and sale is in accordance with the licenses granted herein.
(ii) Licensee will be allowed to manufacture and sell COBI in combination with other active pharmaceutical ingredients in the COBI Territory, provided in each case (A) Licensee has the legal right to manufacture and sell such other active pharmaceutical ingredients in the applicable country in the COBI Territory, and (B) such manufacture and sale is in accordance with the licenses granted herein.
(iii) Licensee will be allowed to manufacture and sell EVG in combination with other active pharmaceutical ingredients in the EVG–Quad Territory, provided in each case (A) Licensee has the legal right to manufacture and sell such other active pharmaceutical ingredients in the applicable country in the EVG–Quad Territory, (B) such manufacture and sale is in accordance with the licenses granted herein, and (C) Licensee has obtained Gilead’s prior written consent for the manufacture or sale of such product containing EVG, such consent not to be unreasonably withheld. For clarity, the requirement for Gilead’s prior consent set forth in the preceding clause (C) shall not apply to the Quad Products.
[Added by Amendment 1] Licensee will be allowed to manufacture and sell BIC in combination with other active pharmaceutical ingredients in the BIC Territory, provided in each case (A) Licensee has the legal right to manufacture and sell such other active pharmaceutical ingredients in the applicable country in the BIC Territory, and (B) such manufacture and sale is in accordance with the licenses granted herein.
(d) Terms of Agreements with Third Party Resellers.
(i) Gilead Distributors. Licensee may elect to sell finished Product in the Territory to any Gilead Distributor, provided, however, that (A) Licensee may only sell and offer for sale TAF Product, TAF Combination Product, TDF Product and TDF Combination Product to Gilead Distributors to sell in the TDF–TAF Territory, and may not sell or offer for sale TAF Product, TAF Combination Product, TDF Product or TDF Combination Product outside the TDF–TAF Territory, and may not import TAF Product or TAF Combination Product into any country outside the TDF–TAF Territory, (B) Licensee may only sell and offer for sale COBI Product and COBI Combination Product to Gilead Distributors to sell in the COBI Territory, and may not sell or offer for sale COBI Product or COBI Combination Product outside the COBI Territory, and may not import COBI Product or COBI Combination Product into any country outside the COBI Territory, (C) Licensee may only sell and offer for sale EVG Product, EVG Combination Product and Quad Product to Gilead Distributors to sell in the EVG–Quad Teritory, and may not sell or offer for sale EVG Product, EVG Combination Product or Quad Product outside the EVG–Quad Territory, and may not import EVG Product, EVG Combination Product or Quad Product into any country outside the EVG–Quad Territory, (D) Licensee may only sell and offer for sale BIC Product and BIC Combination Product to Gilead Distributors to sell in the BIC Territory, and may not sell or offer for sale BIC Product or BIC Combination Product outside the BIC Territory, and may not import BIC Product or BIC Combination Product into any country outside the BIC Territory, and (E) Licensee shall only sell to such Gilead Distributor those Products that are bioequivalent to the branded products Gilead has granted such Gilead Distributor the right to sell in such country of the applicable Territory. Licensee shall only allow such Gilead Distributor to sell such Product in the countries within the country of the applicable Territory for which such Gilead Distributor has the right to sell branded Gilead product. For example, Licensee shall not sell to a Gilead Distributor (X) a Product containing TDF, emtricitabine (FTC) and efavirenz in a particular country in the TDF–TAF Territory, unless Gilead has granted such distributor the right to sell a branded product containing TDF, FTC and efavirenz in such country in the TDF–TAF Territory, or (Y) a Product containing both TDF and 3TC or both TAF and 3TC.
(ii) Other 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; and (ii) to report to Licensee such information and allow Licensee to provide Gilead and MPP with the information described in Section 4.3 and Section 6.3 (and also to provide Japan Tobacco with such information to the extent it relates to EVG, EVG Product, EVG Combination Product or Quad Product). 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, and shall have the right to share the outcome of any such audit with Japan Tobacco to the extent such outcome relates to EVG, EVG Product, EVG Combination Product or the Quad Product.
(e) Gilead Approval of Third Party Reseller Agreements. Licensee shall not enter into any agreements with Third Party Resellers on terms inconsistent with this Agreement without obtaining Gilead’s prior written approval. If Licensee enters into an agreement with any Third Party Reseller, then Licensee shall notify Gilead and MPP in writing, and shall certify that its arrangement with such Third Party Reseller is consistent with the terms and conditions of this Agreement. Upon Gilead’s or MPP’s request, Licensee shall provide Gilead and/or MPP (as applicable) with written copies of all agreements executed between Licensee and Third Party Resellers. Further upon Gilead’s or MPP’s request, Licensee shall name Gilead and/or MPP (as applicable) as a third party beneficiary in any such agreements, in which case Licensee shall consent and hereby does consent to Gilead’s and/or MPP’s (as applicable) enforcement of such agreements to the extent relating to the obligations that Licensee is required hereunder to impose upon Third Party Resellers. Gilead and/or MPP 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 which had not been specifically discussed and agreed with Gilead, then Gilead and/or MPP shall have the right to require Licensee to teminate such agreement. To the extent any such agreements relate to EVG, EVG Product, EVG Combination Product, or Quad Product, Gilead shail also have the right to share such agreements with Japan Tobacco.
(f) Termination of Third Party Agreements by Licensee. Licensee shall immediately terminate its agreement(s) with a Third Party Reseller in the event that such Third Party Reseller engages in material 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 diversion by such Third Party Reseller of API or Product outside the Field or the applicable Territory, or upon Licensee first reasonably believing that such Third Party Reseller has engaged in such activities.
(g) Termination of Third Party Agreements by Gilead. Gilead may terminate the right of Licensee to sell Product to any Third Party Reseller pursuant to this Section 2.5, if Gilead believes in good faith that the Third Party Reseller is not acting in a way that is consistent with Licensee’s covenants under this Agreement, or if Licensee does not terminate Licensee’s agreement with
such Third Party Reseller under the circumstances described in Section 2.5(e) or Section 2.5(f).
2.6 License Limitations [as amended by Amendment 1]
(a) Gilead Retained Rights. Licensee hereby acknowledges that Gilead and MPP retain all rights in API and Products except as otherwise provided in this Agreement, and that Gilead and MPP may license or otherwise convey to third parties its rights in API and Products 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 trademark, trade name, logo or service mark (each, a “Gilead Mark”) or any word, logo or any expression that is similar to or alludes to any Gilead Mark, except as provided in Section 6.5. Licensee agrees not to use any Japan Tobacco trademark, trade name, logo or service mark (each, a “JT Mark”), or any word, logo or any expression that is similar to any JT Mark.
(c) Sublicensed Technology. The licenses relating to EVG, EVG Product, EVG Combination Product or Quad Product granted to Licensee under this Agreement include sublicenses of intellectual property rights from Japan Tobacco, and remain subject to the terms and conditions of the Japan Tobacco Agreement. Gilead and Licensee shall not permit any action to be taken or event to occur, in each case to the extent within such party’s reasonable control, that would give Japan Tobacco the right to terminate the Japan Tobacco Agreement. If any party is notified or otherwise becomes aware that Licensee’s activities may constitute a material breach of the Japan Tobacco Agreement, it shall promptly notify the other parties. The parties shall confer regarding an appropriate manner for curing any such alleged breach. Licensee shall cure such alleged breach as promptly as possible, and in any case within the time allotted under the Japan Tobacco Agreement. Gilead shall remain responsible for EVG Product, EVG Combination Product, and Quad Product royalties owed to Japan Tobacco pursuant to the Japan Tobacco Agreement.
(d) No Other Licenses.
(i) Licensee agrees that it shall not use any contract manufacturers without obtaining Gilead’s prior written consent, or grant any sublicenses hereunder.
(ii) Except as expressly set forth in this Agreement, MPP does not grant any license under any of Gilead’s intellectual property rights (including, without limitation, patents or rights to any proprietary compounds or drug substances other than API) to License.
5. Intellectual Property
5.3 Trademarks.
(a) Any Product offered for sale or sold shall have a different trade dress, including a distinct color, shape and trade name, than the comparable product sold by Gilead and, where applicable, the comparable product sold by Japan Tobacco. For clarity, Licensee’s non–performance of the obligations set forth in this Section 5.3(a) shall constitute a material breach of Licensee’s material obligations under this Agreement.
(b) Licensee shall provide to Gilead, prior to any regulatory submissions for any Product, or selling or offering for sale any Product, samples of the Product and any packaging, labeling information or marketing materials (including, but not limited to, advertisement and promotional materials) to be used with the Product to permit Gilead to review and approve the Product and packaging as consistent with the requirements of Section 5.3(a). If Gilead reasonably objects to the trade dress or other aspects of the Product or product packaging based on the requirements of Section 5.3(a), the parties shall discuss in good faith the changes to be made to the Product or packaging to address Gilead’s concerns.
6. Manufacturing and Commercialization of Product
[…]
6.5 Product Labeling. The labeling of all Products sold or offered for sale under this Agreement shall expressly state that the Product is manufactured under a license from the Medicines Patent Pool and Gilead.