Examples of Amgen Product in a sentence
On an Amgen Target-by-Amgen Target basis, until the Marketing Approval Milestone Payment set forth in Section 8.1.4 (Milestone Payments) has been made with respect to the first Amgen Product directed against such Amgen Target, on […***…], Amgen shall submit to Kite a report providing a status of Amgen’s and its Affiliates’ and Sublicensees’ activities related to the Exploitation of Amgen Products directed against such Amgen Target during the preceding […***…] period.
For clarity, neither Kite nor any Kite CMO shall be required to (i) develop any process to improve upon the Phase 1 Clinical Trial clinical product manufacturing of any Amgen Product for any Phase 2 Clinical Trial clinical manufacturing of such Amgen Product, or (ii) develop a commercial process for any Amgen Product, and any commercial product sold during such period by Amgen shall be manufactured according to the process used to manufacture clinical product.
In the event that it becomes necessary for one Party to provide the other Party with tangible research or biological materials (other than an Amgen Product for clinical or commercial use), the Parties will enter into an appropriate material transfer agreement related thereto, which agreement will be subject to this Agreement and will be interpreted consistent with the terms hereof.
Working with Amgen, Kite shall prepare the […***…] for the first Amgen Product directed against the first Amgen Target.
On an Amgen Target-by-Amgen Target basis, at any time prior to the Initiation of the first Phase 1 Clinical Trial for the first Amgen Product directed against such Amgen Target, Amgen will have the right to terminate this Agreement with respect to such Amgen Target […***…] after delivery of written notice to Kite thereof.
On an Amgen Target-by-Amgen Target basis, Amgen shall (directly and/or through one or more Affiliates and/or Sublicensees) use Commercially Reasonable Efforts to develop and, if successful, commercialize an Amgen Product directed against such Amgen Target.
To the extent Amgen seeks to have a Third Party contract manufacturing organization perform manufacture of any Amgen Product after the period of Kite’s manufacture (itself or through the Kite CMO) of such Amgen Product under Section 5.1 (Supply and Quality Agreement) or Section 5.1.1 (Kite or Kite CMO Manufactures), it shall first inform Kite of such intent.
On an Amgen Target-by-Amgen Target basis, at any time after the Initiation of the first Phase 1 Clinical Trial for the first Amgen Product to such Amgen Target, Amgen will have the right to terminate this Agreement with respect to such Amgen Target […***…] after delivery of written notice to Kite thereof.
Amgen shall control, itself or through outside counsel reasonably acceptable to Novartis and directed by Amgen, Patent and Trademark Matters with respect to Amgen Patents, Amgen Product Trademarks and Joint Patents (in the case of Joint Patents, the prosecution will be in the name of both Parties), in each case solely in the United States (collectively, the “United States Patents and Trademarks”), as well as preparation and filing for any patent term extensions or similar protections therefor.
Notwithstanding the provisions of Section 6.1 (Amgen Responsibility), with respect to Amgen Products manufactured by Kite, Kite shall assist with the […***…] for any such Amgen Product, with sufficient information to satisfy […***…].