Pre-Clinical Compounds Sample Clauses
Pre-Clinical Compounds. Licensor covenants that, during the Term, it shall not, and shall cause its Affiliates not to, license or otherwise grant, or sell, to any Third Party rights to develop or commercialize any Pre-Clinical Compound for any Licensed Indication in the Licensee Territory. As used herein, “Pre-Clinical Compound” means a Targeted AIM controlled or owned by Licensor or any of its Affiliates which has not at the time of license grant or sale to a Third Party been the subject of any Phase I Clinical Study. In the event that in order to comply with non-competition laws of any jurisdiction, Licensor, upon the advice of counsel, determines that it is required to grant to such Third Party such rights in the Licensed Indications, it shall do so only provided it also obtains from such Third Party a negative covenant that such Third Party shall not directly or indirectly (including by licensing, authorizing, appointing, or otherwise enabling any other Third Party to do so) (i) commercialize any pharmaceutical product containing such Pre-Clinical Compound as an active pharmaceutical ingredient in any country in the Licensee Territory for any Licensed Indication during the Term, (ii) develop any such pharmaceutical product anywhere in the world for the purpose of obtaining or maintaining any regulatory approval for such pharmaceutical product in any country in the Licensee Territory for any Licensed Indication during the Term, or (iii) manufacture or have manufactured any such pharmaceutical product anywhere in the world in support of such commercialization or such development in the Licensed Indications. Nothing in this Section 5.7.5 shall be construed as restricting Licensor’s right to (a) engage Third Party service providers or other vendors to perform research or development activities on behalf of Licensor, such as toxicology studies, chemistry, screening, manufacturing, process development, testing and assays, with respect to any Pre-Clinical Compound; (b) license, sell, or otherwise grant to any Third Party rights in and to any Pre-Clinical Compound for use outside the Licensed Indications, anywhere in the Territory, and (c) license or otherwise grant to any Third Party rights to any Collaboration Compound as to which Licensee has not exercised its Collaboration Candidate Option (subject at all times to the restrictions set forth in Section 5.7.2), or any Targeted AIM described in Section 5.7.4, subject at all times to the terms of Section 5.7.4.
Pre-Clinical Compounds. Licensor covenants that, during the Term, it shall not, and shall cause its Affiliates not to, license or otherwise grant, or sell, to any Third Party rights to develop or commercialize any Pre-Clinical Compound for any Licensed Indication in the Licensee Territory. As used herein, “Pre-Clinical Compound” means a Targeted AIM controlled or owned by Licensor or any of its Affiliates which has not at the time of license grant or sale to a Third Party been the subject of any Phase I Clinical Study. In the event that in order to comply with non-competition laws of any jurisdiction, Licensor, upon the advice of counsel, determines that it is required to grant to such Third Party such rights in the Licensed Indications, it shall do so only provided it also obtains from such Third Party a negative covenant that such Third Party shall not directly or indirectly (including by licensing, authorizing, appointing, or otherwise enabling any other Third Party to do so) (i) commercialize any pharmaceutical product containing such Pre-Clinical Compound as an active pharmaceutical ingredient in any country in the Licensee Territory for any Licensed Indication during the Term,
Pre-Clinical Compounds. 3.1.1 The Joint Research Committee shall notify Amgen in writing when a Joint Research Project Team has recommended a Program Compound for Pre-Clinical Status. Such notification shall (1) identify the Program Compound with specificity, (2) identify the related Program Target and (3) identify the Back-Up Compounds for such Program Compound in accordance with Section 3.5.
1. Such notification shall be accompanied by any pertinent data, information, results and materials relating to the foregoing available to the Joint Research Committee (the “Pre-Clinical Data Package”).
3.1.2 If Amgen reasonably determines that the Pre-Clinical Data Package is complete, it shall approve the Pre-Clinical Data Package and such Program Compound shall be deemed to have achieved Pre-Clinical Status. If Amgen reasonably determines that the Pre-Clinical Data Package is not complete, i.e., it is insufficient to make a determination whether to Develop and Commercialize such Pre-Clinical Compound, it shall promptly, but in no event later than [**] following receipt of the Pre-Clinical Data Package, notify the Joint Research Committee and specifically identify any additional data, information, results or materials that should be provided.
3.1.3 Amgen shall, as soon as possible, but in all cases within [**] after Amgen has approved the Pre-Clinical Data Package as complete (the “Pre-Clinical Notification Period”), provide the Joint Research Committee with written notification of its interest in Developing such Pre-Clinical Compound. If Amgen fails to provide such written notification within the Pre-Clinical Notification Period, Amgen shall be deemed not to be interested in Developing such Pre-Clinical Compound.
3.1.4 Upon the expiration of the Pre-Clinical Notification Period with respect to a particular Pre-Clinical Compound, the Joint Research Committee shall designate such Pre-Clinical Compound as an Amgen Development Compound or Tularik Development Compound, as applicable, in accordance with this Section 3.1.4.