Recalls, Product Withdrawals and Field Corrections Sample Clauses

Recalls, Product Withdrawals and Field Corrections. If any governmental entity issues a request, directive or order to a Party (or its Affiliate) requiring that any of the Finished Goods or Drug Product be recalled, or detains or destroys or prevents the release of any of the Finished Goods or Drug Product, or if either Party becomes aware of any other facts or circumstances that suggest a recall, withdrawal or field correction may be warranted, such Party shall give the other Party telephonic notice within twenty-four (24) hours (to be confirmed in writing within one (1) Business Day) of the occurrence of such event. In the Second Phase and Third Phase, Bioverativ shall have the sole right to determine whether to implement a recall, product withdrawal or field correction of the Finished Goods or Drug Product, but shall make such decision in accordance with the instructions of the Regulatory Authority of the country where such Finished Goods or Drug Product was distributed and shall reasonably take into consideration Biogen’s comments and concerns in relation to any proposed recall, withdrawal or field correction. If Bioverativ decides that there shall be a recall, withdrawal or field correction, Bioverativ shall have the sole right to control the implementation of such recall, withdrawal or field correction, but shall keep Biogen informed on a regular basis of its progress in planning and implementing the recall, withdrawal or field correction. Biogen shall cooperate with Bioverativ in connection with, and the provisions of Section 11.10 below shall be applicable to, any such action, and Bioverativ shall provide to Biogen all documentation reasonably requested by such other Party.
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Recalls, Product Withdrawals and Field Corrections. If either Party (or its Affiliate or supplier) becomes aware of any facts or circumstances that suggest a recall, product withdrawal or field correction of a quantity of Licensed Product supplied hereunder, it shall promptly notify the other Party in writing. If there is a recall, product withdrawal or field correction of Licensed Product, this will be executed in accordance with Avigen's Product Recall Procedure or other applicable SOP (a copy of the then-current version of which Avigen will supply promptly to SDI from time to time promptly after SDI’s written request). Avigen shall have the right to control all recalls, product withdrawals and field corrections for Licensed Products for the Territory. SDI will provide Avigen with all reasonable assistance during such recall, product withdrawal or field correction. The costs of such recall, product withdrawal or field correction shall be paid by the Party whose negligence or breach of contract caused such recall, or if neither Party was negligent or in breach, by the Party who initiated such recall, product withdrawal or field correction. Initiating a recall, as used here, means bringing to the attention of the other Party facts and circumstances within the notifying Party’s control or area of responsibility, which facts and circumstances lead to the recall, product withdrawal or field correction.
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Recalls, Product Withdrawals and Field Corrections. If either party becomes aware of any facts or circumstances that suggest a recall, product withdrawal or field correction of a quantity of Supply Product supplied under this Supply Agreement, it shall promptly notify the other party in writing. If there is a recall, product withdrawal or field correction of Supply Product for the Territory, it will be executed in accordance with ZKC’s Supply Product recall procedures or other applicable SOP. ZKC shall have the sole right (subject to any instructions from the applicable regulatory authority) to determine whether to implement any recall, product withdrawal or field correction, and Theraclone will provide ZKC with all reasonable assistance. The costs of such recall, product withdrawal or field correction shall be paid by the party whose activity, error, negligence or breach of contract caused such recall, product withdrawal or field correction, or, if neither party’s activity, error, negligence or breach of contract occasioned such recall, product withdrawal or field correction, then by ZKC.
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Related to Recalls, Product Withdrawals and Field Corrections

  • Product Recalls The Company is not aware of any pattern or series of claims against the Company or any of its subsidiaries which reasonably could be expected to result in a generalized product recall relating to products sold by the Company or any of its subsidiaries, regardless of whether such product recall is formal, informal, voluntary or involuntary.

  • Recalls If (i) any governmental or regulatory authority issues a directive, order or, following the issuance of a safety warning or alert about a Product, a written request that any Product be Recalled, (ii) a court of competent jurisdiction orders a Recall, or (iii) Client determines that any Product should be Recalled or that a “Dear Doctor” letter is required relating the restrictions on the use of any Product, Patheon will co-operate as reasonably required by Client, having regard to all applicable laws and regulations.

  • Product Recall (a) If any governmental agency with jurisdiction over the recall of any goods supplied hereunder provides written notice to Buyer or Seller, or Buyer or Seller has a reasonable basis to conclude, that any goods supplied hereunder could possibly create a potential safety hazard or unsafe condition, pose an unreasonable risk of serious injury or death, contain a defect or a quality or performance deficiency, or are not in compliance with any applicable code, standard or legal requirement so as to make it advisable, or required, that such goods be recalled and/or repaired, Seller or Buyer will promptly communicate such relevant facts to each other. Buyer shall determine whether a recall of the affected goods is warranted or advisable, unless Buyer or Seller has received notice to that effect from any governmental agency with jurisdiction over the recalled goods.

  • Product The term “

  • Product Changes IDSI reserves the right to make design and other modifications in the Equipment at any time but shall not be obligated to implement such modifications in Equipment that has previously been delivered.

  • Licensed Products Lessee will obtain no title to Licensed Products which will at all times remain the property of the owner of the Licensed Products. A license from the owner may be required and it is Lessee's responsibility to obtain any required license before the use of the Licensed Products. Lessee agrees to treat the Licensed Products as confidential information of the owner, to observe all copyright restrictions, and not to reproduce or sell the Licensed Products.

  • Product Returns Client will have the responsibility for handling customer returns of the Products. Patheon will give Client any assistance that Client may reasonably require to handle the returns.

  • Product Complaints Subdistributor shall promptly notify Distributor of (but in no event later than 24 hours after receipt), and provide, upon Distributor’s request, reasonable assistance to address and investigate, any complaint or adverse claim about any Product or its use of which Subdistributor becomes aware;

  • Commercialization Intrexon shall have the right to develop and Commercialize the Reverted Products itself or with one or more Third Parties, and shall have the right, without obligation to Fibrocell, to take any such actions in connection with such activities as Intrexon (or its designee), at its discretion, deems appropriate.

  • Supply of Materials Unless the parties otherwise agree in a Work Order, Manufacturer will supply, in accordance with the relevant approved raw material specifications, all materials to be used by Manufacturer in the performance of Services under a Work Order other than the Rhythm Materials specified in such Work Order. Rhythm or its designees will provide Manufacturer with the Rhythm Materials. Manufacturer agrees (a) to account for all Rhythm Materials, (b) not to provide Rhythm Materials to any third party (other than an Affiliate acting as a permitted subcontractor) without the express prior written consent of Rhythm, (c) not to use Rhythm Materials for any purpose other than conducting the Services, including, without limitation, not to analyze, characterize, modify or reverse engineer any Rhythm Materials or take any action to determine the structure or composition of any Rhythm Materials unless required * CONFIDENTIAL TREATMENT REQUESTED. OMITTED PORTIONS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED. pursuant to a signed Work Order, and (d) to destroy or return to Rhythm all unused quantities of Rhythm Materials according to Rhythm’s written directions.

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