Specifications. All API Manufactured and supplied under this Agreement will: # be free from defects in materials and workmanship; # conform to the API Specifications; # have been Manufactured in accordance with the approved batch records and stored in accordance with the requirements specified in Section 5.1 above; # not be adulterated or misbranded within the meaning of the United States Federal Food, Drug and Cosmetic Act or other Regulatory Requirements at, or at any time prior to, delivery in accordance with [Section 4.5] above; # shall have, at the time of delivery of such API to SAVARA, at least ​ of the shelf life approved for API by the applicable Regulatory Authority, unless otherwise agreed in writing by SAVARA on a case-by-case or lot-by-lot basis; and # have been Manufactured, labeled, packaged, stored, tested, documented, released and shipped in accordance with the applicable Regulatory Requirements, the terms of the applicable Quality Technical Agreement and all applicable Laws;

Specifications. All of the Products shall conform strictly to the Specifications attached hereto as Exhibit D, and any other specifications agreed in writing by Raven and AgEagle (collectively “Specifications”) and shall be in accordance with designs, drawing, samples and standards of quality and workmanship approved by or on behalf of Raven, as applicable.

Specifications. The Parties have agreed that the Vessel shall be built to the specifications set forth in the attached [Exhibit A] (the “Specifications”). The Specifications may be changed from time to time during the construction of the Vessel in accordance with the procedures stated below in Article 10, and such changes will be set forth in one or more sequentially numbered Change Orders (as defined below).

The Parties will mutually agree in good faith on the manufacturing and release specifications, including without limitation testing methods and acceptance criteria, for Drug Substance and Drug Product, for each of the First Generation Process and the Second Generation Process (for the Second Generation Process as further specified in [Appendix 8.3].3), in each case as updated by the JSC from time to time (the “Specifications”). Each Party shall be solely responsible for establishing the specifications for packaging and labeling of finished Drug Product in its Respective Territory.

Product Specifications. A certificate of analysis shall accompany each shipment of the [[Pfizer:Organization]] Compound to Ideaya. Upon request, Ideaya shall provide [[Pfizer:Organization]] with a certificate of analysis covering each shipment of Ideaya Compound used in the Study.

Product Specifications. Supplier shall supply all Products according to the Specifications in effect as of the date of this Agreement, with such changes or additions to the Specifications of the Products related thereto as shall be requested by Buyer in accordance with this Section or as otherwise agreed in writing by the Parties. All other Products shall be manufactured with such Specifications as the Parties shall agree in writing. "Specifications" means, with respect to any Product, the design, composition, dimensions, other physical characteristics, chemical characteristics, packaging, unit count and trade dress of such Product. The Specifications hereby incorporate the Laws and all rules and regulations promulgated thereunder by any governmental authority, including but not limited to the Oregon Department of Agriculture and the U.S Agricultural Improvement Act of 2018. The Products shall not contain any substance or chemical prohibited by such Laws, rules and regulations.

Specifications. The Parties have agreed that the Vessel shall be built to the specifications set forth in the attached [Exhibit B] (the “Specifications”). The Specifications may be changed from time to time during the construction of the Vessel in accordance with the procedures stated below, and such changes will be set forth in one or more sequentially numbered Change Orders (as defined below).

Specifications. Supplier shall maintain ongoing quality assurance and testing procedures in accordance with, and sufficient to comply with, the Specifications and [[OUTSET:Organization]]’s quality assurance policies and procedures as mutually agreed under the signed and executed quality agreement.

Specifications. Licensee shall not modify the form, formulation, dosage, or composition of Product, except as is permitted pursuant to [Section 7.5].

Specifications. The Customer Provided Bulk Products and the Supplier Provided Bulk Products shall meet the relevant Bulk Specifications identified in Annex 4. The Customer Provided Bulk Products shall have a bulk holding time of at least ​ from receipt at Supplier’s Facility.