Examples of AVEO Antibodies in a sentence
Without limiting the foregoing, AVEO will deliver to Novartis (or its designee) copies of all manufacturing batch records, Development reports, analytical results, filings and correspondence with any Regulatory Authority (including notes or minutes of any meetings with any Regulatory Authority), raw material and excipient sourcing information, quality audit findings and any other relevant technical information relating to the AVEO Antibodies and/or the Product.
Notwithstanding the foregoing, AVEO will have no obligation to disclose to Novartis any portion of AVEO Know-How consisting of Information pertaining to AVEO’s proprietary products other than the AVEO Antibodies and/or the Product.
Subject to the terms and conditions of this Agreement, AVEO hereby grants to Novartis an exclusive (even as to AVEO and its Affiliates), sub-licensable (pursuant to Section 2.2) license or sublicense, as applicable, under AVEO’s interest in the AVEO Technology to research, Develop, make, have made, use, import, offer for sale, sell, have sold and otherwise Commercialize the AVEO Antibodies and Product in the Field worldwide.
Novartis will have no obligation to reimburse AVEO for the cost of manufacture of any research-grade material; delivery of quantities of AVEO Antibodies and/or Product manufactured in accordance with cGMP will be subject to the payment by Novartis of the amount set forth in Section 8.1(b).
Subject to Section 5.2, Novartis will be responsible for conducting, at its sole expense, such research and preclinical, clinical and other Development of the AVEO Antibodies and/or Product as it determines appropriate in its sole discretion.
Novartis wishes to obtain, and AVEO wishes to grant, rights under the AVEO Technology to develop, make, use and sell biological products incorporating the AVEO Antibodies in the Field (as defined below), as set forth herein.
Within [**] days of the Effective Date, Novartis will provide AVEO with a high level summary development plan setting forth the anticipated Development activities to be conducted by Novartis and its Affiliates and sublicensees related to AVEO Antibodies and Products during the following [**] month period (the “Development Plan”).
Upon the written request of Novartis, which shall be delivered prior to the [**] day following the Effective Date, AVEO will provide to Novartis or its designated Affiliate all (and not, for clarity, a portion of the) AVEO Antibodies and/or Product in AVEO’s possession, for use by Novartis and its Affiliates in connection with Development and Commercialization activities under this Agreement.
Novartis or its designated subcontractor(s) will be solely responsible for the manufacture and supply of the AVEO Antibodies and Products being Developed or Commercialized under this Agreement.
No later [**] days after each anniversary of the Effective Date, until the approval of the first BLA or MAA for a Product, Novartis will provide AVEO an updated Development Plan providing, in reasonable detail, the Development activities conducted by Novartis and its Affiliates and sublicensees related to AVEO Antibodies and Products during the immediately preceding year and its anticipated plans for Development of AVEO Antibodies and Products for next [**] month period.