Commercial Supply Agreement. Provided that HMI is still Manufacturing Candidates and Products under the applicable Development Supply Agreement and Development Quality Assurance Agreement, at such time as directed by the JMC prior to the Initiation of the first Pivotal Clinical Trial for such Target, the Parties will negotiate in good faith the terms of a new supply agreement for Candidates and Products (“Commercial Supply Agreement(s)”), along with the associated Commercial Quality Assurance Agreement(s) to cover supply of Candidates and Products for the Pivotal Clinical Trial, Product launch, and NVS’ Commercialization requirements (which Commercial Quality Assurance Agreement will contain terms related to HMI’s rights and obligations as the Manufacturer of such Product(s) as well as terms related to NVS’ rights and obligations as the Regulatory Responsible Party for such Product(s), including each Party’s respective review, comment, and approval rights thereunder). The Commercial Supply Agreement and Commercial Quality Assurance Agreement will provide for customary terms and conditions, including quality requirements, those provisions required under Sections 8.1.3 (Objective Criteria) and 8.6.1 (Manufacturing Related Rights), forecasting, ordering, delivery, technical requirements and criteria to be met, payment, and supply and will be consistent with the terms of this Agreement, [***].
Appears in 4 contracts
Samples: Collaboration and License Agreement (Homology Medicines, Inc.), Collaboration and License Agreement (Homology Medicines, Inc.), Collaboration and License Agreement (Homology Medicines, Inc.)
