Second Source of Supply Sample Clauses

Second Source of Supply. Upon Galderma’s request, NovaBay shall develop a plan and budget for a qualified second source of supply capable of supplying the Collaboration Compounds for Galderma’s approval. The second source supplier shall be under the control of NovaBay and may be an alternative manufacturing facility owned by NovaBay or consist of one or more subcontractor relationships with Third Parties established by NovaBay. Galderma shall be responsible for all reasonable and documented costs and expenses incurred by NovaBay in establishing and maintaining the second source supplier.
Sample 1Sample 2
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Second Source of Supply. Within a reasonable time (which shall not ----------------------- exceed *** plus any delay associated with approval of the site of manufacture by Regulatory Authorities) after Worldwide Annual Net Sales of the Licensed Product attain a level of ***, or if a restriction is imposed upon (i) manufacturing that would prevent Zonagen from meeting its supply obligations hereunder or (b) exporting the Licensed Compound or Licensed Product out of the country where it is manufactured, then, subject to the terms and provisions of the ***, Zonagen shall, at its own cost and expense, qualify a second source of supply of the Licensed Compound and Licensed Product, which second source of supply shall be subject to SP Ltd.'s approval, which approval shall not unreasonably be withheld. SP Ltd., at its sole option, may elect to be qualified as such second source of supply.
Sample 1
Second Source of Supply. In addition to the triggering event in Section 3.6.2, in the event Seller fails to deliver *** percent (***%) of ordered Products for *** business days beyond any Purchase Order Delivery Date, Buyer shall, immediately upon written notice to Seller, have the option of purchasing Products from a second source of supply and Seller shall automatically become a nonexclusive supplier of Products to Buyer for the remainder of the term of this Agreement. Buyer may, at any time after the Effective Date, begin qualifying a second source of supply for producing the Products. In order to assist Buyer in qualifying a second source of supply, Seller shall, upon Buyer's written request, within *** days of receiving the written agreement of Buyer's proposed second source of supply to confidentiality provisions substantially similar to those contained in Section 7 of this Agreement, deliver to Buyer copies of technical, manufacturing, and other written information, including but not limited to process sheets, process specifications, manuals, vendor lists, equipment information, and other writings required in order for Buyer to qualify a second source to manufacture and package Products according to the Current Product Specifications and Current Manufacturing Processes. Notwithstanding the foregoing, Seller shall only be required to deliver materials in its actual possession and shall not be required to produce or create any additional materials. Seller shall also be required to provide such assistance to Buyer or its designees as might be reasonably necessary to instruct Buyer or its designees in the manufacturing technique and procedures to manufacture Products for the validation of the first three (3) lots of Products by the proposed second source supplier. Notwithstanding the foregoing, Seller shall not be required to provide information listed in this Section to Buyer unless a triggering event in either Section 3.6.2, this Section 3.7, or Section 4.5 is implicated.
Sample 1
Second Source of Supply. GENTA, in consultation with and subject to the approval of the SUPPLY CHAIN TEAM, shall use COMMERCIALLY REASONABLE EFFORTS to establish or require its Subcontractors to establish second sources of supply for all KEY RAW MATERIALS, API and FINISHED PRODUCT so as to reasonably ensure GENTA's ability to fulfill its obligations to supply FINISHED PRODUCT to AVENTIS hereunder in a timely manner.
Sample 1
Second Source of Supply. Blueprint will have the right at any time during the Term to request that Xxx serve as a back-up supplier of one or more Licensed Products for use by Blueprint inside or outside of the Territory. Upon Blueprint’s request, and Xxx’s agreement, following completion of the Manufacturing Technology Transfer with respect to a Blueprint Compound and the Licensed Products containing such Blueprint Compound, Zai will supply such Licensed Products to Blueprint for Blueprint’s Exploitation of such Licensed Products outside of the Territory, as a second source of supply, at a price equal to [****].
Sample 1
Second Source of Supply. Upon GALDERMA’s request but provided that worldwide Net Sales for the twelve (12) month period immediately preceding such request exceed [****************], ANIKA within nine (9) months of such request shall develop a plan and budget for a qualified second source of supply capable of supplying Licensed Products (the “Second Source Supplier”) and shall submit such plan and budget to the Steering Committee for its approval. Such Second Source Supplier shall be under the control of ANIKA and may be an alternative Facility owned by ANIKA or consist of one or more sub contractor relationships with Third Parties established by ANIKA. If such Second Source Supplier involves a Third Party, ANIKA’s obligation to establish a second source relationship with such Third Party will be subject to such Third Party agreeing in writing to be bound by the terms of a confidentiality and non-disclosure agreement satisfactory to ANIKA. Upon approval by the Steering Committee of the plan and budget for a Second Source Supplier, GALDERMA shall be responsible for all reasonable and reasonably documented costs and expenses incurred by ANIKA in establishing and maintaining such Second Source Supplier. If such costs exceed the budget approved by the Steering Committee, then such excess shall be borne by (i) GALDERMA, if such excess resulted from a change in the agreed plan requested by GALDERMA or the Steering Committee or requested by ANIKA and agreed to by GALDERMA or (ii) ANIKA, if such excess resulted from any mismanagement of the agreed upon budget.
Sample 1
Second Source of Supply. 22 6.4 [Deleted] ....................................................... 24 6.5 Restrictions on Unipac Competition .............................. 24 6.6 Reserved Capacity; Minimum Load ................................. 25 6.7 Orders .......................................................... 25 6.8 Rejected Goods/Shortages ........................................ 26 6.9 [Deleted] ....................................................... 26 6.10 Modifications; Changes; Substitutions ........................... 26 6.11
Sample 1
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Second Source of Supply. Notwithstanding anything to the contrary herein, in order to insure continued supply of Marketed Product and MERCK Product, ARIAD shall develop, qualify and maintain, on a time table to be agreed upon by the Parties, a second source of supply for Commercial API (the "Second API Manufacturer") in addition to its current Approved Manufacturer for API; provided that ARIAD shall in no event be required to have obtained a qualified Second API Manufacturer prior to [***] ([***]) years after first Commercialization Regulatory Approval in the United States for a Product; provided, further, that the Second API Manufacturer is approved in advance in accordance with Section 2.5(b). Upon such approval by MERCK, the Second API Manufacturer shall be treated as an Approved Manufacturer under this Agreement and its manufacturing facilities shall be "Facilities".
Sample 1

Related to Second Source of Supply

  • Scope of Supply 12.1 The Goods and Related Services to be supplied shall be as specified in the Schedule of Requirements.

  • Supply Agreement Seller and Buyer, or their Affiliates, shall have executed the Supply Agreement.

  • Office of Supplier Diversity The State of Florida supports its diverse business community by creating opportunities for woman-, veteran-, and minority-owned small business enterprises to participate in procurements and contracts. The Department encourages supplier diversity through certification of woman-, veteran-, and minority-owned small business enterprises and provides advocacy, outreach, and networking through regional business events. For additional information, please contact the Office of Supplier Diversity (OSD) at xxxxxxx@xxx.xxxxxxxxx.xxx.

  • Product Supply 5.1 In the event that Eisai notifies Radius of its desire to purchase bulk substance of Compound from Radius, Radius shall supply Eisai with all amount of such bulk substance of Compound, which meets specifications for the Product determined by Radius in the course of its Development activities pursuant to this Agreement, required by Eisai for commercial sales of Product in Japan With respect to Eisai clinical development activities for Product in Japan, upon Eisai’s request, Radius shall supply Eisai the bulk substance of Compound for * Confidential Treatment Requested by the Registrant. Redacted Portion Filed Separately with the Commission. the conduct of the Eisai Development activities in the amounts and at the times determined by the SC, having reference to the quantity of the bulk substance of Compound required for clinical trials in Japan. Radius shall charge [*] for applicable bulk substance of Compound. Radius shall ship such bulk substance of Compound, FOB point of manufacturing. 5.2 In the event that Eisai notifies Radius of its desire to purchase Semi-Product from Radius which meets specifications determined by Radius in the course of its Development activities pursuant to this Agreement, Radius shall supply Eisai with all amount of Semi-Product required by Eisai for commercial sales of Product in Japan. With respect to Eisai clinical development activities for Product in Japan, upon Eisai’s request, Radius shall supply Eisai Semi-Product for the conduct of the Eisai Development activities in the amounts and at the times determined by the SC, having reference to the quantity of Semi-Product required for clinical trials in Japan. Radius shall charge [*] for Semi-Product. Radius shall ship such Semi-Product, FOB point of manufacturing. 5.3 The Parties agree that they shall, in good faith, discuss, negotiate and execute necessary agreements containing mutually acceptable terms, including but not limited to, a supply agreement for either bulk substance of Compound or Semi-Product as well as a quality control agreement of either bulk substance of Compound or Semi-Product, in the event that Eisai notifies Radius as set forth in Article 5.1 or 5.2. 5.4 As manufacturer of the Product, Radius shall be responsible for: (a) the control of the quality of the Product promoted and sold under the Radius trademarks; as provided in Article 2.3; and (b) ensuring that all bulk substance of Compound or Semi-Product supplied to Eisai pursuant to this Article 5 shall be manufactured in accordance with the applicable good manufacturing practices (GMP) and shall meet the then applicable specifications for the bulk substance of Compound or Semi-Product; and Radius warrants that all bulk substance of Compound or Semi-Product supplied to Eisai pursuant to this Article 5 shall be manufactured in accordance with the applicable GMP and * Confidential Treatment Requested by the Registrant. Redacted Portion Filed Separately with the Commission. shall meet the then applicable specifications for the bulk substance of Compound or Semi-Product and will be free from defects in material and workmanship. Radius shall resolve any product liability issues in the Territory relating to the Product and shall resolve any product liability issues in Japan relating to the Product or the bulk substance of Compound or Semi-Product, as the case may be, supplied to Eisai pursuant to this Article 5 in the event and to the extent related to a breach of the warranty set forth in Article 5.4(b) at its own expense and subject to Article 5.5. 5.5 Radius’ obligations with respect to product liability in the Territory and Japan shall include the following responsibilities, each to be taken at Radius’ expense: (a) Radius shall report, at its expense, to appropriate authorities, in accordance with local requirements, all adverse events related to use of the Product in the Territory or Japan. Eisai shall provide to Radius, upon Radius’ request, reasonable assistance in connection with the reporting of all of adverse events, responding to safety queries and assessing safety issues, in each case, to the extent related to the Product in Japan. Adverse events shall be recorded in a single, centralized database, which shall be held and owned by Radius. Radius will provide, upon request by Eisai, any safety information in Radius’ control and reasonably required by Eisai in connection with the development and commercialization of the Product in Japan and all reasonable assistance in responding to safety queries related to the Product and in assessing safety issues related to the Product in Japan. Details of safety reporting activities relating to the Product will be addressed in a pharmacovigilance contract, which the Parties shall enter into after the Effective Date. (b) In the event that (i) Radius determines that an event, incident, or circumstance may result in the need for a recall or other removal of the Product or any lot or lots thereof from the market; (ii) any regulatory authority in the Territory threatens to remove a Product from the market; or (iii) any regulatory authority in the Territory requires distribution of a “Dear Doctor” letter or its equivalent regarding the use of Product, Radius shall promptly advise Eisai in writing, and shall provide Eisai with copies of all relevant correspondence, notices and the like. Notwithstanding anything the contrary herein, Radius shall have final authority to make all decisions relating to any recall, market withdrawal or other corrective action with respect to the Product in the Territory. After establishing SC pursuant to Article 3.5, all decisions relating to any recall, market withdrawal or other corrective action with respect to the Product shall be decided by the SC as set forth in Article 3.6; provided that in the event that the Parties take different positions with respect to recall, market withdrawal or other corrective action with respect to the Product, then Radius shall have the right to cease supplying bulk substance of Compound or Semi-Product to Eisai for Japan if, after good faith discussions with Eisai, Radius reasonably believes that that continued supply to Eisai exposes Radius to liability as a result of its decision with respect to the Territory. If Radius elects to cease supply, it will terminate supply in an orderly manner, as soon as practical and in accordance with a schedule agreed to by Eisai and Radius. In the event of a recall, market withdrawal or other corrective action with respect to the Product in Japan, and at Radius’ request, Eisai shall provide reasonable assistance to Radius, at Radius’ cost and expense, in conducting any such recall, market withdrawal or other corrective action with respect to the Product in Japan. 5.6 THE WARRANTY IN SECTION 5.4(b) IS IN LIEU OF ANY OTHER WARRANTY WITH RESPECT TO THE PRODUCT, BULK SUBSTANCE OF COMPOUND OR SEMI-PRODUCT SUPPLIED BY RADIUS HEREUNDER, WHETHER EXPRESS OR IMPLIED, WRITTEN OR ORAL (INCLUDING, WITHOUT LIMITATION, ANY WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE).

  • PRODUCT MANUFACTURER'S SUPPLIERS Only those dealers/distributors listed by the manufacturer will be considered authorized to act on behalf of the Product Manufacturer.

  • Use of sub-processors (a) The data importer has the data exporter’s general authorisation for the engagement of sub- processor(s) from an agreed list. The data importer shall specifically inform the data exporter in writing of any intended changes to that list through the addition or replacement of sub- processors at least within ten (10) days in advance, thereby giving the data exporter sufficient time to be able to object to such changes prior to the engagement of the sub-processor(s). The data importer shall provide the data exporter with the information necessary to enable the data exporter to exercise its right to object. (b) Where the data importer engages a sub-processor to carry out specific processing activities (on behalf of the data exporter), it shall do so by way of a written contract that provides for, in substance, the same data protection obligations as those binding the data importer under these Clauses, including in terms of third-party beneficiary rights for data subjects. The Parties agree that, by complying with this Clause, the data importer fulfils its obligations under Clause 8.

  • Selection of Subcontractors, Procurement of Materials and Leasing of Equipment The contractor shall not discriminate on the grounds of race, color, religion, sex, national origin, age or disability in the selection and retention of subcontractors, including procurement of materials and leases of equipment. The contractor shall take all necessary and reasonable steps to ensure nondiscrimination in the administration of this contract. a. The contractor shall notify all potential subcontractors and suppliers and lessors of their EEO obligations under this contract. b. The contractor will use good faith efforts to ensure subcontractor compliance with their EEO obligations.

  • Supply Agreements For a period of three years from the consummation of the IPO, Odetics shall not unilaterally terminate or assign its guarantee obligation with respect to any supply agreement pursuant to which it has guaranteed the performance by ATL of ATL's obligations, unless such suppliers have consented to the termination or assignment of such guarantee.

  • Manufacturing and Supply (a) Depomed shall supply Product for use in conducting Depomed’s development activities for Product in the Field and in the Territory as set forth in Exhibit D. (b) During the four-year period beginning on the Effective Date (the “Supply Period”), Depomed shall supply and package (or have supplied and packaged) Product pursuant to this Section 4.8. Depomed will use commercially reasonable efforts to enter into a long-term Product supply agreement with [***] days after the Effective Date (the “Depomed Supply Agreement”) that will be freely assignable to Solvay or its Affiliates, successors or assigns at any time. In addition, Depomed and Solvay will negotiate and enter into a Product supply agreement with business terms substantially similar to the Depomed Supply Agreement concurrently with the execution and delivery by Depomed and [***] of the Depomed Supply Agreement (the “Solvay Supply Agreement”, and, together with the Depomed Supply Agreement, the “Supply Agreements”). The Supply Agreements will, together, contain the following provisions (among others mutually agreeable to the Parties): (i) Under the Solvay Supply Agreement, Depomed will agree to supply Solvay with its requirements of finished, packaged Product during the Supply Period; (ii) All manufacturing and records will be performed and maintained in accordance with specifications, cGMP and Applicable Law; (iii) Depomed will provide reasonable assistance to Solvay in the event Solvay wishes to qualify a backup Product manufacturer; (iv) Depomed shall [***]; (v) Solvay will pay Depomed the following amounts in connection with all activities performed by or on behalf of Depomed associated with Product manufacture and supply (other than activities specified on Exhibit D) (A) [***]% of Depomed’s out-of-pocket costs incurred in connection with such manufacture and supply of Product to Solvay, and (B) a labor charge equal to the FTE Charges for all Depomed employees allocated to the manufacture and supply of Product to Solvay, not to exceed FTE Charges for an aggregate of [***] during any given calendar quarter (and Depomed shall provide to Solvay periodic reports detailing the FTE Charges for which Solvay must pay Depomed hereunder);

  • Continuity of Supply A Service Order will continue until terminated in accordance with this Agreement. A change to a Service Order will not initiate a new Service Order, or cause the existing Service Order to terminate, unless expressly agreed in writing. In particular, a change to a Service Order that is implemented by the LFC electronically and does not require a physical visit to a site or Interconnection Point will not cause the Service Order to terminate.

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