Common use of Manufacturing Specifications Clause in Contracts

Manufacturing Specifications. All Study Materials and commercial supplies of Product shall be manufactured in accordance with the specifications (i) determined by MacroGenics, (ii) subject to Section 5.3, consistent with those Territory specific specifications required by the applicable Regulatory Authority in the Territory provided by Zai to MacroGenics in writing, and (iii) in compliance with all regulatory requirements and all Applicable Laws and Regulations, as further set forth in the supply agreements and related quality agreements.

Manufacturing Specifications. All Study Materials and commercial supplies of Product shall be manufactured in accordance with the specifications (i) determined by MacroGenics, (ii) subject to Section 5.3, consistent with those Territory specific specifications required by the applicable Regulatory Authority in the Territory provided by Zai to MacroGenics in writing, and (iii) in compliance with all regulatory requirements and all Applicable Laws and Regulations, Regulations as further set forth in the clinical supply agreements agreement and related quality agreementsCommercial Supply Agreement to be negotiated by MacroGenics and I-MAB under Section 5.1(b).