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Manufacturing Changes Sample Clauses

Manufacturing Changes. 5.3.1 IMPAX shall not make any changes to the Manufacturing process, the Manufacturing equipment, the Specifications, the Materials, the sources of Materials or the Methods of Analysis without the prior written consent of WCH, which consent shall not be unreasonably withheld. If either Party requests in writing a change in the Manufacturing process, the Manufacturing equipment, the Specifications, the Materials, the source of Materials or Methods of Analysis with respect to any Product that is not the result of a requirement of FDA or any other Regulatory Authority, the other Party shall use Commercially Reasonable Efforts to make or accept such change, as the case may be. The requesting Party shall provide the other Party with a detailed written report of all proposed changes to the Manufacturing process, the Manufacturing equipment, the Specifications, the Materials, the sources of Materials or the Methods of Analysis. 5.3.2 If FDA or any other Regulatory Authority requests or requires any change in the Manufacturing process, the Manufacturing equipment, the Specifications, the Materials, the source of Materials or Methods of Analysis with respect to any Product the Parties shall meet and discuss an implementation plan for such change and use all Commercially Reasonable Efforts to accommodate such change to meet the FDA’s or such other Regulatory Authority’s requirements. Each Party will bear its respective costs associated with, or incurred as a result of, such change. Each Party agrees to promptly forward to the other copies of any written communication received by such Party from the FDA or any other Regulatory Authority that may affect the Manufacture or supply of any Product as contemplated herein. Notwithstanding the foregoing, if after Launch of the D-12 Product IMPAX determines, in the exercise of its reasonable judgment, that a change required by the FDA or other Regulatory Authority creates an unreasonable burden on IMPAX or results in the continuing compliance by IMPAX with this Agreement uneconomical and if, upon IMPAX’s request, WCH does not agree (i) to pay the incremental cost of complying with the changes required by FDA or such other Regulatory Authority (which costs shall not be included in Direct Manufacturing Costs hereunder to the extent paid by WCH), or (ii) to exercise its right to Manufacture pursuant to Section 2.2, then IMPAX may by notice in writing to WCH, given no later than thirty (30) days after such refusal by WCH, termina...
Manufacturing Changes. Corium shall notify Xxxx in the event it desires to make any changes in the manufacturing process as set forth in the applicable ANDA for the Products. No such change shall be made unless Xxxx authorizes such change.
Manufacturing ChangesSeller shall give Buyer not less than sixty (60) days prior, written notice of any specification, design, part number or other identification changes, or any major changes in process or procedure or changes in the location of the manufacturing plant or place where Seller performs any of its obligations under this Order if any such changes may affect the Goods.
Manufacturing Changes. Both TI and Anam understand that the particular TI Product to be provided to TI for initial Product Qualification and as qualified by TI will define the applicable manufacturing process with respect to the manufacture of TI Products. After Product Qualification is successfully completed, Anam shall not make any changes to said manufacturing process(es) or the Specifications without the prior written instruction and consent of TI. Any unauthorized manufacturing changes by Anam which affect the form, fit, function or reliability of the TI Products shall render them unqualified. TI assumes no liability for the manufacture of unqualified TI Products. Any particular TI Product and its manufacture can become unqualified after Product Qualification if such formerly qualified TI Product subsequently falls below applicable Specifications. Changes to a particular TI Product or its manufacture may necessitate re-qualification. TI or Anam shall bear the costs associated with the foregoing as determined under the applicable TAA and this Agreement.
Manufacturing Changes. Kin Yat shall not make any changes to the manufacturing process that may affect the product form, fit, function or safety without receiving prior written approval from iRobot.
Manufacturing ChangesThe supplier must notify Distell of their intention to make any change that may affect the specification, safety, quality, security, shelf-life or functionality of material produced, such as changes in raw materials, services, parts, manufacturing line, manufacturing facility or processes and any change shall be approved by Distell before being implemented. Distell must be notified of such changes in writing. Distell will assess whether a new approval is needed.
Manufacturing ChangesDuring the Term, OXIS shall not make any material changes to its manufacturing operations for Licensed Product without the prior written consent of HAPTOGUARD, which consent shall not be unreasonably withheld.
Manufacturing Changes. BIONICHE may implement commercially reasonable changes in the equipment used for Manufacturing of the Drug Product in the Facility, or the Manufacturing methods, labeling, or packaging of the Drug Product only as expressly provided in the Specifications unless BIONICHE has the prior written consent of CUMBERLAND, which consent shall not be unreasonably withheld or delayed.
Manufacturing Changes. (i) SITE AND RESPONSIBILITY. Xxxxxxx shall not change the site of manufacture of the Products without VisiJet's prior written approval, which shall not be unreasonably withheld or delayed. Xxxxxxx shall not assign or subcontract manufacturing responsibility without VisiJet's prior written approval, which shall not be unreasonably withheld or delayed. For purposes of this Section, the "site of manufacture" and "manufacturing responsibility" shall mean the location and responsibility for the final assembly and quality testing of the Products.
Manufacturing ChangesSupplier shall have the right to make changes to the materials, equipment or methods of production or testing used in the Manufacture of API to be supplied to Customer from time to time, and shall notify Customer thereof in advance no less than three (3) months prior to the first delivery to Customer of API implementing such change(s). Supplier shall first obtain Customer’s prior written consent to any such change (other than a change required by a Regulatory Authority) that would affect Customer’s then pending Regulatory Filing(s) or in-process pre-marketing clinical trial for a Recro Product. Following grant of Regulatory Approval, Supplier shall first obtain Customer’s prior written consent to any such changes (other than a change required by a Regulatory Authority) that would affect Customer’s Regulatory Approval(s), such consent not to be unreasonably withheld. Customer recognizes that change may be necessary to enable Supplier to remain efficient and cost-effective and thus shall be fully supportive of the implementation of such changes where justified.