Manufacturing Standards

Manufacturing Standards. Shall mean information that describes the processes, procedures and requirements specifically related to the manufacture of any Product. Without limiting the foregoing, a "Manufacturing Standard" may include assembly machine programs; reflow profiles; assembly aids; process flows; standard assembly instructions; process control plan; overall process definition; work instructions; process and machine capabilities; design review report; first article inspection reports; personnel qualification... requirements, and Quality Improvement Plan. View More

Manufacturing Standards. Shall mean, with respect to any Product, cGMP and such additional manufacturing specifications or standards as may be established by any Regulatory Authority from time to time, it being understood that at the Effective Date, the FDA has not inspected medac's suppliers with respect to their manufacture of the Product. -3- EXECUTION COPY [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS... BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. View More

Manufacturing Standards. Shall mean, with respect to any Product, cGMP and such additional manufacturing specifications or standards as may be established by any Regulatory Authority from time to time, it being understood that at the Effective Date, the FDA has not inspected medac's suppliers with respect to their manufacture of the Product.

Manufacturing Standards. Shall mean, with respect to the Finished Product and Delivery System, cGMP and such additional manufacturing specifications or standards as may be established by mutual agreement of the Parties from time to time.

Manufacturing Standards. Shall mean, with respect to the Compound, cGMP and such additional manufacturing specifications or standards as may be established by mutual agreement of the Parties from time to time, in accordance with Section 8.1(c).

Manufacturing Standards. Means Captisol delivered by CyDex under this Agreement: (i) meets Specifications; (ii) has been manufactured in accordance with the processes set forth in the DMF; (iii) has been manufactured in accordance with GMP and all other applicable laws and regulations; and (iv) is not adulterated within the meaning of the United States Food, Drug and Cosmetic Act, as amended (the "Act"), and shall not be an article which may not, under the provisions of the Act, be introduced into interstate... commerce. LICENSE AND SUPPLY AGREEMENT PAGE 3 Portions of this Exhibit, indicated by the mark "[***]," were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant's application requesting confidential treatment pursuant to Rule 406 of the Securities Act of 1933, as amended. View More

Manufacturing Standards. The specifications for Processing, Packaging, and storing the Product set forth in the Product Specifications, the Master Batch Record, cGMPs, MSDSs, and all other applicable U.S. laws and regulations, to the extent such terms and conditions are not inconsistent with this Agreement