Clinical Manufacturing definition

Clinical Manufacturing or “Clinical Manufacture” means Manufacture of a Licensed Product (including the cost of Manufacturing Licensed Antibody contained in Licensed Product) or acquisition of such Licensed Antibody and Licensed Product from a CMO, in each case, for use in Clinical Trials.

Clinical Manufacturing means the Manufacture of the Compound or any Product (including the cost of Manufacturing the Compound contained in any Product) or acquisition of the Compound or any Product from a CMO, in each case, for use in Clinical Trials. “Clinical Manufacture” shall have a correlative meaning.

Clinical Manufacturing or “Clinical Manufacture” means the Manufacture of a Licensed Product (including Manufacturing the Licensed Compound contained in such Licensed Product) or the acquisition of such Licensed Compound and Licensed Product from a CMO, in each case, for use in Clinical Trials.

Examples of Clinical Manufacturing in a sentence

• Similarly, Sanofi shall [***], as set forth in greater detail in the applicable Clinical Quality Agreement and Clinical Manufacturing and Supply Agreement.

• Subject to the terms and conditions of this Agreement, pursuant to this Agreement and the applicable Clinical Manufacturing and Supply Agreement and Clinical Quality Agreement, which [***] shall [***] the applicable Licensed Compounds and Licensed Products.

• In the event of any inconsistency between this Agreement, on one hand, and the applicable Clinical Manufacturing and Supply Agreement or Clinical Quality Agreement, on the other hand, the terms of this Agreement will prevail except to the extent the Clinical Manufacturing and Supply Agreement or Clinical Quality Agreement, as applicable, expressly references the provisions of this Agreement to be superseded.

• If the Milestone Data Package delivered by IGM pursuant to Section 9.3.2(a) (Immunology Milestone Data Package Review) for a [***] conducted by IGM for any Lead Candidate Directed to an Immunology Target Construct establishes that [***] in accordance with the applicable Clinical Manufacturing and Supply Agreement; provided that Sanofi shall promptly [***].

• However, Oxurion’s reliance on these third parties does not relieve it of its regulatory responsibilities and it continues to be responsible for ensuring that each of its trials is conducted in accordance with the applicable protocol, scientific standards and legal and regulatory obligations, such as Good Laboratory Practice (“GLP”), Good Clinical Practice (”GCP”) and Good Clinical Manufacturing (”cGMP”) regu- lations.

• In the event of any inconsistency between a Global Manufacturing Plan, on one hand, and this Agreement or the applicable Clinical Manufacturing and Supply Agreement, on the other hand, the terms of this Agreement or such Clinical Manufacturing and Supply Agreement, as the case may be, will prevail.

• Any Clinical Manufacturing and Supply Agreement will contain terms and conditions with respect to [***].

• However, Oxurion’s reliance on these third parties does not relieve it of its regulatory responsibilities and it continues to be responsible for ensuring that each of its trials is conducted in accordance with the applicable protocol, scientific standards and legal and regulatory obligations, such as Good Laboratory Practice (GLP), Good Clinical Practice (GCP) and Good Clinical Manufacturing (cGMP) regulations.

• IGM will use Commercially Reasonable Efforts to conduct and to timely complete the Manufacturing activities for which IGM is responsible under each Global Development Plan or Global Manufacturing Plan, or the applicable Clinical Manufacturing and Supply Agreement or Clinical Quality Agreement, in each case, pursuant to the timelines set forth therein (as such timelines may be amended from time to time by the JMC) and under the oversight of the JMC.

• However, Oxurion’s reliance on these third parties does not relieve it of its regulatory responsibilities and it continues to be responsible for ensuring that the KALAHARI trial is conducted in accordance with the applicable protocol, scientific standards and legal and regulatory obligations, such as Good Laboratory Practice (“GLP”), Good Clinical Practice (“GCP”) and Good Clinical Manufacturing (“cGMP”) regulations.