Common use of Authorized Generics Clause in Contracts

Authorized Generics. 6.5.1. The license granted by AstraZeneca to Impax pursuant to Section 6.1.1 shall include the exclusive (even as to AstraZeneca and its Affiliates) right to Commercialize in the Field in the Territory an Impax Generic Version of each Existing Product mode of administration and dosage strength in reliance on AstraZeneca’s NDA with respect to such Existing Product, subject to the terms and conditions of this Section 6.5 and the other terms and conditions of this Agreement. Any such Impax Generic Version shall be identical to the corresponding branded Existing Product, except that the Impax Generic Version shall not be sold under the Product Trademarks (and Product Labels and Inserts with respect to any Impax Generic Versions shall be modified accordingly). 6.5.2. Impax covenants to AstraZeneca that [***]: (i) in the case of all Impax Generic Versions, Impax may, [***] (a) notify potential customers that it will have the right to sell such Impax Generic Version as of the applicable Generic Launch Date, (b) engage in discussions with or enter into arrangements with customers relating to such Impax Generic Version [***] in accordance with Applicable Law and in accordance with other procedures approved in advance by AstraZeneca, such approval with respect to procedures not to be unreasonably conditioned, withheld or delayed; (ii) in the case of all Impax Generic Versions, Impax may, [***], [***] Product of such Impax Generic Version [***] owned by Impax or any of its Affiliates or by one or more [***] pursuant to the terms of a [***] Agreement to be entered into between AstraZeneca and Impax, and a further Third Party [***] Agreement to be entered into between Impax and one or more [***] for such Impax Generic Version, in each case in the form of agreement to be agreed upon by the Parties in good faith pursuant to Section 6.5.3; (iii) in the case of any Impax Generic Version with respect to a Licensed Product consisting of any [***], in addition to the Impax rights pursuant to clauses (i) and (ii), Impax shall have the right, [***] (a) to [***] pursuant to the terms of a [***] Agreement to be entered into between AstraZeneca and Impax, and a further Third Party [***] Agreement to be entered into between Impax and [***] for such Impax Generic Version, in each case in the form of agreement to be agreed upon by the Parties in good faith pursuant to Section 6.5.3; and (b) to take such other reasonable [***] as are consistent with the terms of this Agreement and Applicable Law, including [***]. Further, in the event a [***], then Impax and AstraZeneca shall in good faith discuss whether [***] activities for the corresponding Impax Generic Version of such Existing Product as provided under this Section 6.5.2(iii) for Impax Generic Versions of [***]. (iv) Except as expressly permitted pursuant to the preceding clauses (i) through (iii), Impax shall not advertise, market, sell, accept orders for sale, ship, or Commercialize any Impax Generic Version to Third Parties prior to [***]. 6.5.3. With respect to each Existing Product, upon (i) [***] of an Existing Product in the Territory or (ii) reasonably in advance of the Anticipated Generic Date, at the request of either Party, (a) the Parties shall coordinate in good faith with respect to the [***] activities with respect to the Impax Generic Version as set forth in Section 6.5.2; and (b) the Parties shall negotiate in good faith to agree upon the form of [***] Agreement that will apply with respect to the applicable Impax Generic Version, and the form of any Third Party [***] Agreement that must be used by Impax in entering into any such [***] agreement with Third Parties, including, as applicable[***] as permitted pursuant to this Section 6.5. Any such [***] Agreement or Third Party [***] Agreement shall provide, among other terms, that (x) [***], and (y) notwithstanding clause (x), subject to Section 8.17.3 and 8.17.4, [***]. 6.5.4. In the event that, following the launch by Impax of such Impax Generic Version, there [***], Impax shall immediately [***] in the Field in the Territory (and [***]). 6.5.5. Impax shall [***] by this Agreement. 6.5.6. Except as provided in this Section 6.5, no Party shall have the right to, and each Party covenants to the other Party that it shall not, and shall cause its Affiliates and Sublicensees not to, directly or indirectly, [***] in the Field in the Territory during the Term, or, [***]. Except with respect to the Exploitation of an Impax Generic Version in accordance with this Section 6.5, Impax covenants to AstraZeneca that neither Impax nor any of its Affiliates or Sublicensees will [***].

Appears in 2 contracts

Sources: Distribution, License, Development and Supply Agreement (Impax Laboratories Inc), Distribution, License, Development and Supply Agreement (Impax Laboratories Inc)