Changes in Manufacture Sample Clauses

Changes in Manufacture. In accordance with the Quality Agreement, Supplier will notify and obtain written approval from Supernus of any and all proposed changes in its manufacture and testing of the Product and will obtain Supernus’ written approval prior to implementation for any such change that would impact the manufacturing process or the Specifications and constitute a reportable change or modification pursuant to any applicable Regulatory Scheme (e.g., Xxxxx 00 Xxxxxx Xxxxxx Code of Federal Regulations Section 211 and 314.70).
Sample 1
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Changes in Manufacture. DOTTIKON shall not alter any processing steps with respect to the Manufacture of each Product, as such steps are set forth in the NDA, DMF (or IND, if appropriate), applicable Manufacturing protocols, Master Batch Records or any other document governing such steps, unless requested in writing by PCYC's authorized [ *** ] representatives designated in the applicable Product Appendix. DOTTIKON may, from time to time, suggest to PCYC changes DOTTIKON may wish to make in the Manufacture of a Product, the location of Manufacture within the Facility, the equipment used to Manufacture such Intermediate or Product or the process used to Manufacture such Intermediate or Product. DOTTIKON shall notify PCYC of any such suggested changes via DOTTIKON's change notice procedure, but shall not implement any such changes until signature approval has been received from PCYC's authorized [ *** ] representatives designated in the applicable Product Appendix. PCYC shall have no obligation to accept any such suggestions. Any such changes shall be made in accordance with both DOTTIKON's and PCYC's change control policies and procedures. In the event that [ *** ], unless otherwise agreed by the Parties in writing: [ *** ] and [ *** ] For clarity, [ *** ] If facility, process, equipment or system changes are required of DOTTIKON as a result of requirements set forth by a Regulatory Authority, regardless of whether such requirements are in force as of the Effective Date, then DOTTIKON shall have sole responsibility of implementing such changes, at DOTTIKON's sole expense.
Sample 1
Changes in Manufacture. EirGenix will provide Bolt with at least [***] prior written notice of any proposed changes in the Specifications (as defined in Schedule A), and neither EirGenix nor any of its contract manufacturers shall implement any such change without Bolt’s prior written approval, except to the extent such change is required by written directive of the FDA, the European Medicines Agency, Japan’s Pharmaceuticals and Medical Devices Agency or Taiwan’s Food and Drug Administration. Any such permitted changes to the Specifications of the Antibody shall be signed by an authorized representative of each of the Parties, and shall be effective for purchase orders of the Antibody placed after the effective date of such changes.
Sample 1
Changes in Manufacture. 6.6.1 Contractor shall not alter any processing steps with respect to the Manufacture of each Drug Product, as such steps are set forth in the NDA, DMF (or IND, if appropriate), applicable Manufacturing protocols, Master Batch Records or any other document governing such steps. Contractor may, from time to time, suggest to PCYC changes Contractor may wish to make in the Manufacture of a Drug Product, the location of Manufacture within the Facility, the equipment used to Manufacture such Drug Product or the process used to Manufacture such Drug Product. Contractor shall notify PCYC of any such suggested changes via Contractor's change notice procedure, but shall not implement any such changes until signature approval has been received from PCYC's authorized quality assurance and manufacturing representatives designated in the applicable Drug Product Appendix. PCYC shall have no obligation to accept any such suggestions.
Sample 1
Changes in Manufacture. EirGenix will provide Bolt with at least [***] prior written notice of any proposed changes in the Specifications, and neither EirGenix nor any of its contract manufacturers shall implement any such change without Bolt’s prior written approval, except to the extent such change is required by written directive of the FDA, the European Medicines Agency, Japan’s Pharmaceuticals and Medical Devices Agency or Taiwan’s Food and Drug Administration. Any such permitted changes to the Specifications of the Antibody shall be signed by an authorized representative of each of the Parties, and shall be effective for purchase orders of the Antibody placed after the effective date of such changes. In addition, EirGenix will provide Bolt with timely written notice of other manufacturing changes as detailed in and in accordance with the timelines set forth in the Quality Agreement.
Sample 1

Related to Changes in Manufacture

  • Product Changes Vocera shall have the right, in its absolute discretion, without liability to End User, to update to provide new functionality or otherwise change the design of any Product or to discontinue the manufacture or sale of any Product. Vocera shall notify End User at least 90 days prior to the delivery of any Product which incorporates a change that adversely affects form, fit or function (“Material Change”). Vocera shall also notify End User at least 90 days prior to the discontinuance of manufacture of any Product. Notification will be made as soon as reasonably practical for changes associated with regulatory or health and safety issues.

  • Supply of Materials The following materials will be supplied by the department Name of Materials Rate. Place of delivery 1.

  • Quality of Materials and workmanship The Contractor shall ensure that the Construction, Materials and workmanship are in accordance with the requirements specified in this Agreement, Specifications and Standards and Good Industry Practice.

  • Solicitations for Subcontracts, Including Procurement of Materials and Equipment In all solicitations either by competitive bidding or negotiation made by the Local Government for work to be performed under a subcontract, including procurement of materials or leases of equipment, each potential subcontractor or supplier will be notified by the Local Government of the Local Government’s obligations under this Agreement and the Acts and Regulations relative to Nondiscrimination on the grounds of race, color, or national origin.

  • Product Recalls (a) If either Party reasonably decides or is required by any government authority or court of competent jurisdiction, to initiate a product recall, withdrawal or field correction with respect to, or if there is any governmental seizure of, the Product, the Party initiating or required to initiate such action will notify the other Party promptly of the details regarding such action, including providing copies of all relevant documentation concerning such action. The Parties will assist each other in investigating any such situation and all regulatory contacts that are made and all activities concerning seizure, recall, withdrawal or field correction will be jointly coordinated by HSL and LMI. (b) If any such recall, withdrawal, field correction or seizure occurs due solely to (i) failure of any Product produced by HSL hereunder to conform to Specifications (including, without limitation, being adulterated or misbranded) or any warranty or other requirement set forth in this Agreement, (ii) the failure of HSL to comply in all material respects with any applicable law, rule, regulation, guideline, standard, court order or decree or (iii) the negligent or intentional wrongful act or omission of HSL in connection with the production of Product hereunder, then HSL shall bear the **** of any such seizure, recall, withdrawal or field correction and shall reimburse LMI for its ****, including any purchase price payments made to HSL and related taxes to the extent related to such recalled Product. To the extent any such recall, withdrawal, field correction or seizure occurs for any reason other than that set forth in the immediately preceding sentence, then LMI shall bear the **** of any such seizure, recall, withdrawal or field correction. If both HSL and LMI contribute to the cause of a seizure, recall, withdrawal or field correction, the cost and expense thereof will be shared in proportion to each Party’s contribution to the problem. For the purposes of this Agreement, the expenses of any recall, withdrawal, field correction or seizure shall include, without limitation, the out-of-pocket expenses of notification and destruction or return of the recalled Product and all other out-of-pocket costs incurred in connection with such recall but shall not include a Party’s lost profits. HSL’s reimbursement for the costs of LMI Materials related to such recall, withdrawal or field correction is limited by Section 5.6(c).

  • Manufacture 2.1. The LED(s) on the LED module shall be equipped with suitable fixation elements. 2.2. The fixation elements shall be strong and firmly secured to the LED(s) and the LED module.

  • 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.

  • Manufacturing (a) The Supplier shall without limitation be responsible, at no additional cost to the Purchaser, for: sourcing and procuring all raw materials for the Products; obtaining all necessary approvals, permits and licenses for the manufacturing of the Products; providing sufficient qualified staff and workers to perform the obligations under this Purchase Agreement; implementing and maintaining effective inventory and production control procedures with respect to the Products; and handling other matters as reasonably requested by the Purchaser from time to time. (b) The Supplier shall not change any process, material, component, packaging or manufacturing location without the Purchaser’s express prior written approval.

  • Labelling The distributor, on behalf of the selected vendor agrees that all supplies of articles should invariably contain the following information on its label and the carton. One information should not be overlapped by any other information needed to be furnished. The label should contain : a. Name of the item as approved b. CMS Cat. No. c. Manufacturing date/Import date for the imported items. d. Expiry Date. (where applicable) e. Name & address of Registered Office of Manufacturers and place of manufacture. f. Manufacturing License Number. (where applicable for Manufactures) g. Batch Number (where applicable) h. Month and Year of supply. i. The label & Carton must invariably marked “W B. GOVT SUPPLY : NOT FOR SALE”. j. All Surgical items quoted/supplied by the tenderer must conform to IS /BIS /CE/USFDA. Pacemker must conform to CE & US FDA norms. In case of Drugs items quoted /supplied by tenderer MUST CONFORM TO IP, BP, or USP norms and N.F.I. –III specification as noted against the item(s) in catalogue as applicable. k. The MRP and Trade Name will not be allowed to be printed in any pack. This will lead to cancellation of candidature straightaway. However, for excisable products, insertion of writing of Govt MRP is allowed as per provision laid down in the order of the Central Excise dept. However, for imported item(s), MRP and Trade name may be allowed in addition to Generic name.

  • Product Specifications (a) Supplier shall manufacture 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. (b) Buyer may request changed or additional Specifications for any Product by delivering written notice thereof to Supplier not less than one hundred twenty (120) days in advance of the first Firm Order for such Product to be supplied with such changed or additional Specifications. Notwithstanding the foregoing, if additional advance time would reasonably be required in order to implement the manufacturing processes for production of a Product with any changed or additional Specifications, and to commence manufacture and delivery thereof, Supplier shall so notify Buyer, and Supplier shall not be required to commence delivery of such Product until the passage of such additional time. (c) Supplier shall be required to accommodate any change of, or additions to, the Specifications for any Product, if and only if (i) in Supplier’s good faith judgment, such changed or additional Specifications would not require Supplier to violate good manufacturing practice, (ii) the representation and warranty of Buyer deemed made pursuant to Subsection (e) below is true and correct, and (iii) Buyer agrees to reimburse Supplier for the incremental costs and expenses incurred by Supplier in accommodating the changed or additional Specifications, including the costs of acquiring any new machinery and tooling. For the avoidance of doubt, such costs and expenses shall be payable by Buyer separately from the cost of Products at such time or times as Supplier shall request. (d) Supplier shall notify Buyer in writing within thirty (30) days of its receipt of any request for changed or additional Specifications (i) whether Supplier will honor such changed or additional Specifications, (ii) if Supplier declines to honor such changed or additional Specifications, the basis therefor and (iii) if applicable, the estimated costs and expenses that Buyer will be required to reimburse Supplier in respect of the requested changes or additions, as provided in Subsection (c) above. Buyer shall notify Supplier in writing within fifteen (15) days after receiving notice of any required reimbursement whether Buyer agrees to assume such reimbursement obligation. (e) By its request for any changed or additional Specifications for any Product, Buyer shall be deemed to represent and warrant to Supplier that the manufacture and sale of the Product incorporating Buyer’s changed or additional Specifications, as a result of such incorporation, will not and could not reasonably be expected to (i) violate or conflict with any contract, agreement, arrangement or understanding to which Buyer and/or any of its Affiliates is a party, including this Agreement and any other contract, agreement, arrangement or understanding with Supplier and/or its Affiliates, (ii) infringe on any trademark, service xxxx, copyright, patent, trade secret or other intellectual property rights of any Person, or (iii) violate any Applicable Law. Buyer shall indemnify and hold Supplier and its Affiliates harmless (including with respect to reasonable attorneys’ fees and disbursements) from any breach of this representation and warranty.

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