Provision Language
2. License
[…]
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.