Common use of Objective Criteria Clause in Contracts

Objective Criteria. As part of the Parties’ negotiations of the Development Supply Agreement, Development Quality Assurance Agreement, Commercial Supply Agreement, or Commercial Quality Assurance Agreement, as applicable to such Candidate or Product, the Parties will jointly define a set of criteria that will be used to determine whether HMI or the applicable Designated CMO is able to Manufacture or supply such Candidate or Product (i) [***] or (ii) [***] (the “Objective Criteria”), which Objective Criteria will include the following listed criteria (as applicable, based on the phase of Development or Commercialization of such Candidate or Product): (a) whether HMI or the Designated CMO has [***] to Manufacture such Candidate or Product so as to meet: (i) [***]; (ii) [***]; and (iii) [***]; (b) whether HMI or the Designated CMO has [***] to Manufacture such Candidate or Product so that they will be [***] in materials, ingredients, workmanship, appearance and finish; (c) whether HMI or the Designated CMO has [***] to Manufacture such Candidate or Product in accordance with all applicable authorizations; (d) whether the Manufacturing site (i) has (or is capable of obtaining [***]) all permits, licenses, equipment, approvals, and other authorizations that are required under Applicable Law relating to the performance of Manufacturing and the provision of such Candidate and Product; (ii) has received (or is capable of obtaining [***]) approval to Manufacture Candidates and Products by the applicable Regulatory Authorities; and (iii) has been subject to any warning letters or other regulatory actions; and (e) whether HMI or the Designated CMOs have [***] to supply, and the quantities to be Manufactured and supplied are likely to be capable of meeting [***] requirements.