Manufacturing Practices. All manufacturing operations performed by or on behalf of the Company and its subsidiaries are being conducted in all material respects in compliance with the Quality System regulation of the FDA and, to the extent applicable, counterpart regulations in the European Union and all other countries where compliance is required. The Company and its subsidiaries are in compliance in all material respects with all reporting requirements under Applicable Laws, including, but not limited to, medical device reports (as defined by 21 C.F.R. Part 803), reports of corrections and removals (as defined by 21 C.F.R. Part 806), and the reporting and recordkeeping requirements under the Quality System regulation of the FDA, and counterpart regulations and requirements in other countries where compliance is required.
Manufacturing Practices. All manufacturing operations performed by or on behalf of the Company are being conducted in compliance with the Quality System regulation of the FDA and, to the extent applicable, counterpart regulations in the European Union and all other countries where compliance is required, except to the extent that the failure to be in compliance would not reasonably be expected to result in a Material Adverse Effect. The Company and its subsidiaries are in compliance with all reporting requirements under Health Care Laws, including, but not limited to, medical device reports (as defined by 21 C.F.R. Part 803), reports of corrections and removals (as defined by 21 C.F.R. Part 806), and the reporting and recordkeeping requirements under the Quality System regulation of the FDA, and counterpart regulations in other countries where compliance is required, except to the extent that the failure to be in compliance would not reasonably be expected to result in a Material Adverse Effect.
Manufacturing Practices. 7.2.1 Halozyme shall manufacture, or have manufactured, API under this Article 7 in conformity with the API Specifications and in accordance with all applicable laws and regulations. The API Specifications shall not be amended without the prior written consent of both parties.
Manufacturing Practices. (a) The Supplier of an Alliance Product will manufacture (or have manufactured) such Alliance Product in conformity with its written specifications and in accordance with all applicable laws and regulations. If a Supplier is unable to supply pursuant to the terms of this Agreement an FDA-approved or FDA-cleared Alliance Product due to non-compliance with FDA regulations, such event, subject to Sections 6.2(b) and (c), will be deemed [***] indicates material that has been omitted pursuant to a request for confidential treatment. The omitted material has been filed separately with the Securities and Exchange Commission. a material breach of this Agreement and the other Party may terminate this Agreement pursuant to Section 17.4 or 17.5, as the case may be.
Manufacturing Practices. 7.2.1 Halozyme shall manufacture, or have manufactured, API under this Article 7 in conformity with the API Specifications and in accordance with all applicable laws and regulations. The API Specifications shall not be amended without the prior written consent of both parties. Halozyme shall notify Intrexon in the event it agrees to modify the specifications for PH20 Drug being provided to any of its other licensees. Portions herein identified by [*****] have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete copy of this document has been filed separately with the Securities and Exchange Commission.
Manufacturing Practices. Without limiting the generality of any obligations of Rohto hereunder, Rohto agrees to meet or exceed all its manufacturing practices and standards (as of the Effective Date) with respect to all manufacturing activities for the Product. Rohto shall provide OMP with written notice of any material changes in such manufacturing practices. During the term of this Agreement, Rohto agrees that OMP or its agent (reasonably acceptable to Rohto) will be permitted to inspect the Facility annually to assure compliance with such manufacturing practices; and, OMP shall provide Rohto with a copy of the results of such inspection. If such inspection discloses deficiencies in the Facility, OMP may request, and Rohto shall implement, corrective actions, at Rohto’s expense and on a timetable mutually acceptable to the parties. In addition, in such event, OMP shall have the right to conduct reasonably frequent inspections of the Facility. OMP shall have the right to terminate this Agreement if Rohto fails to implement commercially reasonable corrective actions. OMP shall also be permitted, at its own expense, to place a representative at the Facility to monitor Rohto’s performance hereunder for the initial production of each new Licensed Product.
Manufacturing Practices. Except as disclosed in the Registration Statement, the Pricing Disclosure Package and the Prospectus, the manufacture of products by or on behalf of the Company and the Company’s subsidiaries, to the knowledge of the Company, has been and is being conducted in material compliance with all applicable Laws including the FDA’s current Good Manufacturing Practices. In addition, the Company and the Company’s subsidiaries have been and are in material compliance with all other applicable FDA requirements, including, but not limited to, registration and listing requirements set forth in 21 U.S.C. Section 360 and 21 C.F.R. Part 207. For the purposes of this Agreement, “Good Manufacturing Practices” means current good manufacturing practices for drugs, including but not limited to the regulations for drugs and finished pharmaceutical products contained in 21 C.F.R. Part 210 and 211, respectively.
Manufacturing Practices. Except as disclosed in the Registration Statement, the Time of Sale Information and the Prospectus, the manufacture of products by or on behalf of the Company and the Company’s subsidiaries has been and is being conducted in material compliance with all applicable Laws including the FDA’s current Good Manufacturing Practices.
Manufacturing Practices. 10.1 SUNEVA is responsible for ensuring that all Products are designed and manufactured in material compliance with cGMP, including FDA’s Good Manufacturing Practices, which are now codified in the Quality System Regulation (“QSR”), as well as international quality system standards, such as ISO 13485:2003, as necessary.
Manufacturing Practices. When engaged in the design, production or distribution of any products containing moissanite jewels, JN and its agents, sub-manufacturers, or contractors involved in the design, production, or distribution of products containing moissanite jewels shall not engage in the use of child labor, prison or any type of forced labor, or any other labor practices that may violate the sensibilities of the American public. Within 90 days of the execution of this agreement and upon annual renewal, JN shall certify to C&C that it, as well as its agents, sub-manufacturers, or contractors involved in the design, production, or distribution of products containing moissanite jewels does not engage in such labor practices. JN will certify that all rules and regulations, as well as all measures of safety, health, and labor practices, recommended or requested by the relevant authorities of JN's governing municipalities, as well as the governing municipalities of JN's agents, sub-manufacturers, or contractors involved in the design, production, or distribution of products containing moissanite jewels have been complied with, and warrant to C&C that under any circumstance, or for any reason, C&C will not be held responsible for any liability subsequent to any action or omission occurring on JN's, its agents, sub-manufacturer's, or contractor's premises. Furthermore, C&C guarantees that no radioactive process has been utilized by C&C in the manufacturing process of moissanite jewels.
