Manufacturing Standards; Changes to Product Specifications. (a) The target Product Specifications with respect to each Product shall be included in the Research Plan for such Product. The Executive Steering Committee shall review and consider in good faith all changes to the target Product Specifications proposed by either Alvotech or Alvogen. No changes may be made to the target Product Specifications without the prior written approval of the Executive Steering Committee, except as a result of the procedures set forth in Section 9.4(b). Alvotech shall manufacture all Products in accordance with the applicable Product Specifications (as may be amended by the Executive Steering Committee or through the procedures set forth in Section 9.4(b)), all applicable cGMP and all Applicable Laws. Alvotech may not make any changes to the Product Specifications except (i) with the prior written approval of the Executive Steering Committee (subject to Section 5.2(b)) or (ii) as required by Applicable Law or other regulatory requirements, including cGMP (each such change described in clause (ii), a “Required Change”). Alvotech shall deliver notice to Alvogen of any Required Change to the Product Specifications promptly after Alvotech becomes aware of such change. Alvotech and Alvogen shall cooperate in promptly making any Required Changes and any changes to the Product Specifications that are required by medical or scientific concerns as to the toxicity, safety and/or efficacy of the Products. If a Required Change is made with respect to a Product, then each Party shall cover its own costs and expenses incurred by such Party related thereto, including all regulatory costs, transition costs, stocking costs and other expenses incurred by such Party related to such change, in such Party’s performance of its obligations hereunder. If, following the date by which the Product Specifications are required to be changed pursuant to a Required Change, Alvogen is in possession of any Products manufactured in accordance with the Product Specifications in effect prior to the amendment thereof pursuant to such Required Change, and, as a result of such Required Change, Alvogen cannot sell such Products without violating an Applicable Law, then Alvotech shall credit Alvogen’s account in an amount equal to fifty percent (50%) of the aggregate purchase price paid by Alvogen to Alvotech for such Products.
