Common use of Changes to Specifications Clause in Contracts

Changes to Specifications. Orion will not modify any of the Specifications, specifications for any of the raw materials used in producing the Product (including without limitation the Compound), or any process or procedure used to manufacture the same, or change the equipment used in the manufacture of Product (except for repair or replacement of existing equipment), or change any of its suppliers of any raw materials used in producing Product, in each case without obtaining the prior written consent of USL, such consent not to be unreasonably withheld, and any approvals required for purposes of obtaining or maintaining any Regulatory Approval of the Product affected by such modification. Any such change shall be implemented only after all necessary consents and approvals of, and notifications to, the FDA have been obtained or made, and shall be implemented in a manner that does not impact Orion’s ability to supply Product to USL in accordance with the provisions of Section 6. Orion shall be solely responsible for all costs and expenses incurred in making any such changes or modifications, except to the extent such changes or modifications have been requested by USL, in which case such costs shall be borne by USL; provided further that should such changes result in economic benefit for Orion the allocation of such costs and expenses between the Parties shall be separately agreed, as reasonable. The Parties acknowledge that the Specifications for Product attached hereto as Schedule 4 are preliminary and the Parties shall work in good faith to finalize such Specifications at the appropriate time; provided, however, for clarity, such final Specifications shall be subject to FDA approval.