Examples of GDNF Product in a sentence
The Parties acknowledge that developing and seeking Regulatory Approvals for a GDNF Product may include sequential implementation of clinical trials and intervals between clinical trials for data interpretation and clinical program planning and approval.
The Parties shall work together in good faith for a period of [**] days to transfer to Amgen any GDNF Product developed by AMT prior to the date of such termination, including by transferring Regulatory Filings related to the program and manufacturing of GDNF Products.
Upon the first approval of an NDA with respect to a GDNF Product achieved by AMT and/or its Affiliates (the “Approval Milestone”), AMT shall promptly (and, in any event, no later than [**] days) notify Amgen in writing of such occurrence and the amount received, and Amgen will invoice AMT for a one-time payment in the amount of the greater of (a) ten million US Dollars (US$10,000,000) and (b) [**]% of any milestone payments received by AMT from Third Parties in respect of the Approval Milestone.
Amgen shall have [**] Business Days from receipt of such notice to request from AMT a data package containing such information as Amgen may reasonably request and as may be available regarding such GDNF Product (the “Data Package”).
Amgen acknowledges that in determining whether AMT has met its requirement to use Reasonably Diligent Efforts in accordance with Section 5.1 (Use of Reasonably Diligent Efforts) reference will be made to the totality of AMT’s activities with respect to all GDNF Product(s) (if, in AMT’s sole discretion, it decides to develop more than one GDNF Product) in all countries, not on a country-by-country basis.
AMT, itself or through one or more Third Party contract manufacturers designated by it that have appropriate expertise and are suitably qualified, including holding the requisite permits and having been subject to or available for appropriate audits and inspections by the relevant regulatory bodiesis solely responsible for the manufacture and supply of requirements of GDNF Products (including any GDNF used in a GDNF Product).
For a period of [**] days after the termination of this Agreement under either Section 8.2 (Termination by AMT) or 8.3 (Termination by Amgen), AMT, its Affiliates and Sublicensees shall have the right to sell off any stock of GDNF Product on hand or in-process and provide services relating to GDNF Products, and the provisions of Section 4.2 (Revenue Sharing) and the payment provisions of this Agreement shall apply to such sales.
AMT shall notify Amgen in writing within [**] Business Days after Completion of the first Phase 2 Clinical Trial (whether a stand-alone clinical trial or in combination with another clinical trial, i.e., a phase 1/2 clinical trial or phase 2/3 clinical trial) for the first GDNF Product.
If any GDNF Product Exploited by or under the authority of AMT becomes the subject of a Third Party’s claim or assertion of infringement of a patent relating to the manufacture, use, sale, offer for sale or importation of such GDNF Product, the Party first having notice of the claim or assertion shall promptly notify the other Party, and the Parties shall promptly confer to consider the claim or assertion and the appropriate course of action.
Without limiting the foregoing, Amgen hereby acknowledges that AMTretains the right to Exploit, and authorize (by license or otherwise) Third Parties to Exploit, any product other than a GDNF Product even if such product is covered by a claim within the AMT Licensed Patent Rights.