Supply Matters Clause Samples

Supply Matters. During the Pediatrician Promotion Period, Forest shall keep Replidyne advised of matters regarding the supply of the Oral Suspension in the Territory and shall consult with Replidyne on strategic decisions to be made with respect thereto.

Supply Matters. Any Enhancement Agents supplied by Aegis will be done so in accordance with the Supply Agreement.

Supply Matters. 4.1. TRANSFER OF BULK COMPOUND TO TMC. ASTRAZENECA undertakes to supply to TMC [**] approximately ten (10) kilograms of bulk Compound no later than ninety (90) days after the License Agreement Effective Date. The transport of such entire quantity of bulk Compound shall be entirely at TMC's risk and expense. It is explicitly understood that this quantity of Compound was manufactured by ASTRAZENECA at an earlier date, and was not made for the purpose of the supply now stated, and that ASTRAZENECA gives no guarantee whatsoever as to the characteristics of the Compound or the Compound's fitness for any particular purpose.

Supply Matters. 6.1. The Supply Addendum (Exhibit C to the Agreement) shall continue to apply by its terms except to the extent set forth below: (a) The provisions of Section 4.4 of this Amendment Agreement shall supersede the provisions for payments to Mylan for Compound set forth in Section 3.2(b) of the Supply Addendum. (b) Section 4.5 of the Supply Addendum is hereby deleted in its entirety. (c) Mylan shall not have the rights of inspection and audit provided by Section 6.7 of the Supply Addendum, provided that such rights shall continue to be extended to ▇▇▇▇▇▇▇ to the extent required by the ▇▇▇▇▇▇▇ Agreement or any Quality Agreement (each a "Quality Agreement") between Mylan and ▇▇▇▇▇▇▇ or between Forest and ▇▇▇▇▇▇▇ from time to time in effect. (d) Except to the extent required by the ▇▇▇▇▇▇▇ Agreement or any Quality Agreement, Forest shall not be obligated to notify Mylan of any audit or inspection by the FDA or other Regulatory Authority of Forest’s facilities used in the manufacture of the Product.

Supply Matters. 4.1. TRANSFER OF BULK COMPOUND TO TMC. ASTRAZENECA undertakes to supply to TMC [**] approximately [**] kilograms of bulk Compound no later than ninety (90) days after the Effective Date. The transport of such entire quantity of bulk Compound shall be entirely at TMC's risk and expense. It is explicitly understood that this quantity of Compound was License Agreement - The Medicines Company manufactured by ASTRAZENECA at an earlier date, and was not made for the purpose of the supply now stated, and that ASTRAZENECA gives no guarantee whatsoever as to the characteristics of the Compound or the Compound's fitness for any particular purpose. It is explicitly understood and agreed by the Parties that ASTRAZENECA shall have no obligations whatsoever to transfer or supply, other than as explicitly provided under this Article 4.1, any quantity of Compound or Product to TMC. 4.2. SUPPLY OF COMPOUND AND PRODUCT BY TMC. 4.2.1. TMC undertakes to supply ASTRAZENECA and/or any of its Affiliates, at TMC's [**] ASTRAZENECA's and/or its Affiliates entire need of Product for clinical trials, sale, promotion and marketing in the Excluded Countries, pursuant to the Supply Agreement between TMC and ASTRAZENECA, attached hereto, subject to what is stated in Article 4.2.3, as Schedule F. In addition ASTRAZENECA will reimburse TMC for costs specifically pertaining to the development of a formulation necessary only for the purpose of enabling ASTRAZENECA to obtain NDA Approval in one or more of the Excluded Countries. 4.2.2. TMC further undertakes to supply ASTRAZENECA, subject to Article 15.1 (i), at [**] and otherwise under terms to be as consistent as possible with those under the Supply Agreement, ASTRAZENECA's entire need of Product for clinical trials, sale, promotion and marketing in any country where the license granted under Article 2 has been terminated pursuant to Article 3.8; provided always that such TMC's obligation shall not become effective unless and until TMC has Launched the Product in at least one (1) country of the Territory. 4.2.3. The Supply Agreement has not been entered into on the Effective Date due to the Parties' desire to expeditiously enter into this Agreement, not delaying such procedure by awaiting the completion of the Supply Agreement. The parties acknowledge the substantial need for License Agreement - The Medicines Company ASTRAZENECA to rely on TMC for its supply of the Product for the countries mentioned in Articles 4.2.1 and 4.2.2 and that en...

Supply Matters. Aegis covenants that it will not in the performance of its obligations under this Agreement use the services of any person debarred or suspended under 21 U.S.C. §335(a) or (b). Aegis will not hire, as an officer or an employee any person who has been convicted of a felony under the laws of the United States for conduct relating to the regulation of any drug product under the United States Food, Drug and Cosmetic Act.

Supply Matters. Local materials that are adequate in quality and available in sufficient quantity shall be used for the Project as practical as possible. During implementation of the Project, quality of the locally procured materials shall be examined in a proper manner with sufficient frequency in order to confirm that they satisfy the requirements of the technical specifications of the Project.