Common use of Development Compounds Clause in Contracts

Development Compounds. Unless otherwise agreed by the Parties, NovaCal shall have the right and responsibility (itself or through one or more Third Parties) for manufacturing and supplying Development Compounds to Alcon for use in all Development activities up through the initiation of the first Phase II clinical trial for a Licensed Product in the Field incorporating such Development Compound. (a) Subject to the foregoing provisions of this Section 6.1.1, if such Development Compound is a Common Compound, then NovaCal shall have the right and responsibility (itself or through one or more Third Parties) to manufacture and supply such Development Compound to Alcon for use in all other Development activities as well as all Commercialization activities hereunder; provided that Alcon shall reimburse NovaCal for [***] of [***] Confidential treatment has been requested for the bracketed portions. The confidential redacted portion has been omitted and filed separately with the Securities and Exchange Commission. the costs associated with process development, scale-up, quality assurance and quality control testing and monitoring, stability studies, qualification, validation and other similar activities with respect to the manufacture of such Development Compound, such costs to be verified by audit at Alcon’s election and expense. In the event such NovaCal costs are audited and the audit reveals that such costs were overstated by more than ten percent (10%), then the audit expenses shall be paid by NovaCal. (b) Subject to the foregoing provisions of this Section 6.1.1, if such Development Compound is not a Common Compound, Alcon shall have the right and responsibility (itself or through one or more Third Parties) to manufacture and supply such Development Compound for use in all other Development activities as well as all Commercialization activities hereunder. (c) For clarity, NovaCal shall not have any obligation to supply or have supplied any GMP material for a Licensed Compound unless and until such time as such Licensed Compound has been designated a Development Compound in accordance with Section 3.4 above.

Development Compounds. Unless otherwise agreed by the Parties, NovaCal shall have the right and responsibility (itself or through one or more Third Parties) for manufacturing and supplying Development Compounds to Alcon for use in all Development activities up through the initiation of the first Phase II clinical trial for a Licensed Product in the Field incorporating such Development Compound. (a) Subject to the foregoing provisions of this Section 6.1.1, if such Development Compound is a Common Compound, then NovaCal shall have the right and responsibility (itself or through one or more Third Parties) to manufacture and supply such Development Compound to Alcon for use in all other Development activities as well as all Commercialization activities hereunder; provided that Alcon shall reimburse NovaCal for [***] of [***] Confidential treatment has been requested for the bracketed portions. The confidential redacted portion has been omitted and filed separately with the Securities and Exchange Commission. the costs associated with process development, scale-up, quality assurance and quality control testing and monitoring, stability studies, qualification, validation and other similar activities with respect to the manufacture of such Development Compound, such costs to be verified by audit at Alcon’s election and expense. In the event such NovaCal costs are audited and the audit reveals that such costs were overstated by more than ten percent (10%), then the audit expenses shall be paid by NovaCal. (b) Subject to the foregoing provisions of this Section 6.1.1, if such Development Compound is not a Common Compound, Alcon shall have the right and responsibility (itself or through one or more Third Parties) to manufacture and supply such Development Compound for use in all other Development activities as well as all Commercialization activities hereunder. [***] Confidential treatment has been requested for the bracketed portions. The confidential redacted portion has been omitted and filed separately with the Securities and Exchange Commission. (c) For clarity, NovaCal shall not have any obligation to supply or have supplied any GMP material for a Licensed Compound unless and until such time as such Licensed Compound has been designated a Development Compound in accordance with Section 3.4 above.3.4