Common use of Manufacturing Related Rights Clause in Contracts

Manufacturing Related Rights. Commencing upon NVS’ commencement of Preclinical Development of a Candidate or Product, HMI will grant, or in the case of any Designated CMO, shall procure the granting, to the NVS CMC Sub-Team or NVS Audit Team, as applicable, the rights below for the purposes of enabling NVS to comply fully with its regulatory and quality obligations in relation to such Candidate or Product Manufactured by HMI or a Designated CMO, including the release of such Candidate and Product: (a) access to all information relating to HMI Manufacturing Know-How with respect to such Candidate and Product, including the Manufacturing process for such Candidate or Product and access to CMC data for such Candidates and Products (i.e., cell line history, vector sequences, media composition, summary of animal derived material used during the course of technical Research and Development, details about Manufacturing process and analytical methods applied or under Development, etc.); (b) a right (either itself or through an authorized representative), pursuant to the audit right provided under Section 8.7 below (Audit and Inspection), to inspect and audit any facility in which such Candidate or Product is Manufactured with advance reasonable notice, which inspection or audit shall not occur more than once per Calendar Year per Manufacturing facility, subject to any for-cause audits or any follow-up audit required to ensure compliance with prior audit findings; (c) a right to approve any Designated CMO used by HMI for the Manufacture of such Candidate or Product; (d) a right to access records regarding the selection and engagement of any Third Party supplier of any materials, components, excipients, or processing aids necessary for the Manufacture of such Candidate or Product, including traceability requirements to ensure compliance under pedigree requirements; and (e) access to any other relevant information or materials [***] to satisfy its regulatory or other quality related obligations with respect to such Candidate or Product, including access to and inspection and audit rights for any Third Party subcontractors or suppliers, each as mutually agreed upon in the applicable Development Supply Agreement, Commercial Supply Agreement, or Quality Agreement. Thereafter, on a continuing basis during the Term, HMI shall [***], and at a minimum no less frequently than on a [***] basis, disclose to the NVS CMC Sub-Team all additional HMI Product Know-How relating to such Candidate or Product that comes into existence from time to time. Subject to Section 13.1.3 (Exceptions to Confidentiality), the NVS CMC Sub-Team and NVS Audit Team will not disclose any HMI Manufacturing Know-How to other personnel of NVS or its Affiliates; provided, that the foregoing shall not apply to any [***] of NVS or its Affiliates where the information received is of a general nature regarding the progress of the Development, Manufacturing, or Commercialization activities of any Candidate or Product and does not disclose specific technical information contained within such HMI Manufacturing Know-How. HMI will provide reasonable assistance to NVS, at NVS’ expense, in connection with understanding and using all such HMI Product Know-How to Manufacture Candidates and Products in accordance with the licenses and rights granted to NVS pursuant to this Agreement.