Provision Language
Definitions
“Discovered Product” means any product (whether developed or commercialized by Licensee, its Subsidiaries or Discovered Product Licensees) that: [***].
“Harvard Technology Transfer Materials” means the Know-How, including, without limitation, the protocols, materials, data and other information listed in Exhibit C, and described in Harvard Case No. [***], and any progeny, derivatives and modifications of such material made by or on behalf of Licensee, its Subsidiaries, Sublicensees or Strategic Partners.
“Know-How Enabled Product” means any product (whether developed or commercialized by Licensee, its Subsidiaries, its Sublicensees, Strategic Partners or Know-How Enabled Product Licensees) incorporating [***]. A Know-How Enabled Product also includes [***].
“Licensed Product” means, with respect to a given product, that a Valid Claim would (absent a license thereunder or ownership thereof) be infringed (directly, indirectly by contributory infringement or inducement to infringe) by the making, using, selling, offering for sale, importation or other exploitation of such product.
“Royalty-Bearing Products” means Licensed Products, Know-How Enabled Products and Discovered Products.
2. License
2.1 License Grant. Subject to the terms and conditions set forth in this Agreement, Harvard hereby grants to Licensee: (a) an exclusive, worldwide, royalty-bearing license under Harvard’s interests in the Patent Rights and a non-exclusive, worldwide, royalty-bearing license to use the Harvard Technology Transfer Materials, in each case, solely to develop, make, have made, offer for sale, sell, have sold and import Licensed Products and Know-How Enabled Products and (b) a non-exclusive, worldwide, royalty-bearing license to use the Discovery Materials solely to develop, make, have made, offer for sale, sell, have sold and import Discovered Products, in each of (a) and (b), solely for use within the Field; provided, however, that:
2.1.1 Harvard retains the right, for itself and for other not-for-profit research organizations and government agencies, to practice the Patent Rights and to use the Harvard Technology Transfer Materials and Discovery Materials within the scope of the license granted above, solely for research, educational and scholarly purposes. Harvard shall not (x) grant any rights to for-profit collaborators that would be inconsistent with the rights granted to Licensee hereunder, or (y) grant any rights to the Patent Rights in the Field under any form of collaboration or sponsored research agreements with any for-profit collaborators or for-profit collaborators affiliated with a for-profit entity. For clarity, Harvard shall not have the right to conduct clinical trials using Licensed Products without the prior written consent of Licensee; and
2.1.2 the United States federal government retains rights in the Patent Rights pursuant to 35 U.S.C. §§ 200-212 and 37 C.F.R. § 401 et seq., and any right granted in this Agreement greater than that permitted under 35 U.S.C. §§ 200-212 or 37 C.F.R. § 401 et seq. will be subject to modification as may be required to conform to the provisions of those statutes and regulations.
2.2 Global Access.
2.2.1 First Right of Licensee to Sell Licensed Products into Developing Countries. Following [***], Licensee, together with its Subsidiaries and/or Sublicensees, shall have the first right to develop, manufacture, have manufactured, import, have imported, offer for sale, sell, have sold or otherwise distribute or have distributed such Licensed Product or equivalent thereof (e.g., a generic product) to make such Licensed Products generally available at locally-affordable prices in any Developing Country(ies) which are chosen by Licensee and/or its Subsidiaries and Sublicensees in their sole discretion. Sales of such Licensed Products in Developing Country(ies) generally available at locally-affordable prices shall be entitled to the royalty discounts set forth in Section 4.5 of the Agreement.
2.2.2 Step-in Rights for Licensed Products in Developing Countries. At any time after [***] following [***], if Licensee, together with its Subsidiaries and/or Sublicensees, has not chosen to exercise its first rights to make such Licensed Products generally available at locally-affordable prices in accordance with Section 2.2.1 above in any particular Developing Country, Harvard may notify Licensee in writing of a not-for-profit Third Party to whom Harvard would like Licensee to grant a Sublicense under the Patent Rights to develop, manufacture, have manufactured, import, have imported, offer for sale, sell, have sold or otherwise distribute or have distributed such Licensed Product or an equivalent thereof (e.g., a generic product) for use in the Field, solely for sale or other distribution of such Licensed Product or equivalent on a locally-affordable basis in any Developing Countries in which such Licensed Product is not then available on a locally-affordable basis (a “Developing Country Sublicense“). Within [***] after the receipt of such notification from Harvard, Licensee shall either (a) provide a notice to Harvard that reasonably demonstrates how Licensee is already distributing, or intends to distribute (together with a written plan and timeline for so distributing), such Licensed Product in such Developing Country on a locally-affordable basis, or (b) notify Harvard that it wishes to grant the Developing Country Sublicense to such Third Party (in each case, a “Developing Country Compliance Notice“). If Licensee provides Harvard with a Developing Country Compliance Notice, and Harvard approves such Developing Country Compliance Notice (such approval not to be unreasonably withheld, conditioned, or delayed) Licensee (i) shall use Commercially Reasonable Efforts to carry out such distribution plan and provide Harvard with reports in accordance with Section 3.3 showing compliance with such plan, or (ii) shall grant such Developing Country Sublicense to such Third Party within [***] after delivery of such Developing Country Compliance Notice (with a copy of such Developing Country Sublicense delivered to Harvard within [***] upon its execution). To the extent Licensee uses Commercially Reasonable Efforts to carry out such distribution plan reasonably approved by Harvard, or grants such Developing Country Sublicense within the [***] period set forth above, then Harvard shall have no right to grant Third Parties licenses under the Patent Rights to develop, manufacture, have manufactured, import, have imported, offer for sale, sell, have sold or otherwise distribute or have distributed such Licensed Product or equivalent for use, solely for sale or other distribution of such Licensed Product or equivalent on a locally-affordable basis in such Developing Country. If Licensee provides Harvard with a Developing Country Compliance Notice, and Harvard reasonably rejects such Developing Country Compliance Notice or Licensee fails to use Commercially Reasonable Efforts to carry out such distribution plan, then Harvard may [***] to such not-for-profit Third Party to develop, manufacture, have manufactured, import, have imported, offer for sale, sell, have sold or otherwise distribute or have distributed such Licensed Product or an equivalent thereof (e.g., a generic product), in each case solely for sale or other distribution of such Licensed Product or equivalent on a locally-affordable basis in such Developing Country(ies); provided, however, that Harvard may not grant such Third Party any license in or to any of Licensee’s intellectual property.
2.3 Subsidiaries. The license granted to Licensee under Section 2.1(a) and (b) includes the right to have some or all of Licensee’s rights or obligations under this Agreement exercised or performed by one or more of Licensee’s Subsidiaries, solely on Licensee’s behalf; provided, however, that:
2.3.1 prior to any Subsidiary exercising or performing any of Licensee’s rights or obligations under this Agreement, such Subsidiary (an “Exercising Subsidiary“) shall acknowledge and agree in writing, for the benefit of Harvard, to be bound by the terms and conditions of this Agreement as if it were Licensee hereunder, which writing shall state that Harvard is an intended third party beneficiary of such writing, including without limitation for the purpose of enforcing this Agreement directly against such Subsidiary, and including specific written agreement (a) to indemnify, defend and hold the Indemnitees harmless, and carry insurance, under the same terms as Article 9 of this Agreement, and (b) that the Indemnitees are express third party beneficiaries of such writing; and
2.3.2 no such Subsidiary shall be entitled to grant, directly or indirectly, to any other person any right of whatever nature under, or with respect to, or permitting any use or exploitation of, any of the Patent Rights, the Harvard Technology Transfer Materials or the Discovery Materials, including any right to develop, manufacture, market or sell Licensed Products, Know-How Enabled Products or Discovered Products;
2.3.3 any act or omission taken or made by a Subsidiary of Licensee under this Agreement will be deemed an act or omission by Licensee under this Agreement, and Licensee shall be responsible for each of its Affiliates complying with all obligations of Licensee under this Agreement (including without limitation all restrictions placed on Licensee herein);
2.3.4 any assumption of rights or obligations by Subsidiaries of Licensee under this Agreement shall not relieve Licensee of any of its obligations under this Agreement; and
2.3.5 any such Subsidiary of Licensee shall represent in writing, for the benefit of Harvard, that such Subsidiary is not in violation of any Applicable Law.
2.4 Sublicenses; Know-How Enabled Licenses; Discovered Product Licenses.
2.4.1 Sublicense Grant. Licensee and any Sublicensee will be entitled to grant Sublicenses to non-Controlled Affiliates and Third Parties under the license granted pursuant to Section 2.1(a) subject to the terms of this Section 2.3. Licensee may not grant any Sublicense to Harvard Technology Transfer Materials, except where one or more Patent Rights are also sublicensed. The license granted under Section 2.1(b) to Discovery Materials shall not be sublicensable except to Third Parties working solely on behalf of Licensee’s and/or its Subsidiaries’ behalf (subject to Section 2.2 with regard to Subsidiaries). Any such Sublicense shall be on terms and conditions in compliance with and not inconsistent with the terms of this Agreement.
2.4.2 Sublicense Agreements. Licensee and any Sublicensee granting through an additional tier shall grant sublicenses pursuant to written agreements negotiated at arms’ length, which will be subject and subordinate to the terms and conditions of this Agreement. Such Sublicense agreements will contain, among other things, the following:
2.4.2.1 all provisions necessary to ensure Licensee’s ability to perform its obligations under this Agreement;
2.4.2.2 a section substantially the same as Article 9 of this Agreement, which also will state that the Indemnitees (as defined in Section 9.1) are intended third party beneficiaries of such Sublicense agreement for the purpose of enforcing such indemnification;
2.4.2.3 a provision clarifying that, in the event of termination of the license set forth in Section 2.1 (in whole or in part (e.g., termination in a particular country)), any existing Sublicense agreement shall terminate to the extent of such terminated license; and
2.4.2.4 a provision prohibiting the Sublicensee from assigning the Sublicense agreement without the prior written consent of Harvard, except that Sublicensee may assign the Sublicense agreement to a successor in connection with the merger, consolidation or sale of all or substantially all of its assets or that portion of its business to which the Sublicense agreement relates; provided, however, that any permitted assignee agrees in writing to be bound by the terms of such Sublicense agreement.
2.4.3 Delivery of Agreements. Licensee shall furnish Harvard with a fully-executed copy of any Sublicense, Strategic Partnership, Know-How Enabled Product License and Discovered Product License agreement within [***] after its execution. Harvard shall keep all such copies in its confidential files and shall use them solely for the purpose of monitoring Licensee’s and Sublicensees’ compliance with their obligations hereunder and enforcing Harvard’s rights under this Agreement.
2.4.4 Breach. Any act or omission by a Sublicensee, Strategic Partner, Know-How Enabled Product Licensee or Discovered Product Licensee that would have constituted a breach of this Agreement had it been an act or omission by Licensee shall constitute a breach of this Agreement. Licensee shall either (a) cure such breach in accordance with Section 10.2.2 of this Agreement or (b) enforce its rights by terminating such Sublicense agreement in accordance with the terms thereof. Notwithstanding the foregoing or the terms of any Sublicense, Licensee shall remain liable to Harvard for all of Licensee’s duties and obligations contained in this Agreement.
2.5 No Other Grant of Rights. Except as expressly provided herein, nothing in this Agreement will be construed to confer any ownership interest, license or other rights upon Licensee by implication, estoppel or otherwise as to any technology, intellectual property rights, products or biological materials of Harvard, or any other entity, regardless of whether such technology, intellectual property rights, products or biological materials are dominant, subordinate or otherwise related to any Patent Rights.
3. Development and Commercialization
3.1 Diligence.
3.1.1 General. Licensee shall use Commercially Reasonable Efforts and shall cause its Sublicensees to use Commercially Reasonable Efforts: (a) to develop Royalty-Bearing Products in accordance with the Development Plan; (b) to introduce Royalty-Bearing Products into the commercial market; (c) to market Royalty-Bearing Products following such introduction into the market; and (d) to make Royalty-Bearing Products available at locally-affordable prices in Developing Countries. In addition, Licensee, by itself or through its Subsidiaries or Sublicensees, shall cause each of the Development Milestones to be achieved for Licensed Products within the time periods specified in Exhibit A.