Voluntary Product Recalls Sample Clauses

Voluntary Product Recalls. If either Party believes that a voluntary recall or market withdrawal of a Product is necessary, such Party shall notify the other Party within forty-eight (48) hours of its determination and if the Product Party so determines both Parties shall cooperate to allow such recall or market withdrawal to occur under the direction of the Product Party (as set forth in Section 3.9). In the event of a dispute about whether to recall a Product, the Product Party shall have the final authority with respect to such matters, which authority shall be exercised reasonably and in good faith and subject to Section 3.9.
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Voluntary Product Recalls. If ALLERGAN believes that a voluntary recall or market withdrawal of Elestat is necessary, ALLERGAN shall promptly notify INSPIRE and both parties shall cooperate, at ALLERGAN’s sole expense, to allow such recall or market withdrawal to occur under the direction of ALLERGAN (as set forth in Section 3.9.8). In the event of a dispute about whether to recall Elestat, ALLERGAN shall have the final authority with respect to such matters, which authority shall be exercised reasonably and in good faith and subject to Section 3.9.8 and this Section 6.4. In the event of any recall, withdrawal other action on the part of the FDA which results in Elestat being removed from the market, the JCC shall determine the impact of such a recall including, but not limited to, the continued commercial viability of Elestat and, in its discretion, may adjust the applicable annual Net Sales forecast set forth on Schedule B.
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Voluntary Product Recalls. 21 7.10 Regulatory Obligations.......................................................21 7.11 Co-Promotion Responsibilities................................................22
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Voluntary Product Recalls. If either Party believes that a voluntary recall or market withdrawal of Product is necessary, such Party shall notify the other Party within [*] of its determination and both Parties shall cooperate to allow such recall or market withdrawal to occur under the direction of Anesiva (as set forth in Section 2.8(h)). In the event of a dispute about whether to recall Product, Anesiva shall have the final authority with respect to such matters, which authority shall be exercised in good faith.
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Voluntary Product Recalls. If either Party believes that a voluntary recall or market withdrawal of the Product is necessary, such Party shall notify the other Party within forty-eight (48) hours of its determination and both Parties shall cooperate to allow such recall or market withdrawal to occur under the direction of Wyeth-Ayerst (as set forth in Section 7.3). In the event of a dispute about whether to recall a Product, Wyeth-Ayerst shall, after consultation with Aviron, have the final authority with respect to such matters, which authority shall be exercised reasonably and in good faith and subject to Section 7.3. -------- [***]=CONFIDENTIAL TREATMENT REQUESTED
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Related to Voluntary Product Recalls

  • 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.

  • 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 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.

  • 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 The term “

  • Licensed Product “Licensed Product” shall mean any article, composition, apparatus, substance, chemical material, method, process or service whose manufacture, use, or sale is covered or claimed by a Valid Claim within the Patent Rights. For clarity, a “Licensed Product” shall not include other product or material that (a) is used in combination with Licensed Product, and (b) does not constitute an article, composition, apparatus, substance, chemical material, method, process or service whose manufacture, use, or sale is covered or claimed by a Valid Claim within the Patent Rights.

  • Defective Product If Client rejects Products under Section 6.1 and the deviation is determined to have arisen from Patheon’s failure to provide the Manufacturing Services in accordance with the Specifications, cGMPs, or Applicable Laws, Patheon will credit Client’s account for Patheon’s invoice price for the defective Products. If Client previously paid for the defective Products, Patheon will promptly, at Client’s election, either: (i) refund the invoice price for the defective THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH [***] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. Products; (ii) offset the amount paid against other amounts due to Patheon hereunder; or (iii) replace the Products with conforming Products without Client being liable for payment therefor under Section 3.1, contingent upon the receipt from Client of all Active Materials and Client-Supplied Components required for the manufacture of the replacement Products. For greater certainty, Patheon’s responsibility for any loss of Active Materials in defective Product will be captured and calculated in the Active Materials Yield under Section 2.2.

  • Combination Product The term “

  • 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.

  • Marking of Licensed Products To the extent commercially feasible and consistent with prevailing business practices, Company shall xxxx, and shall cause its Affiliates and Sublicensees to xxxx, all Licensed Products that are manufactured or sold under this Agreement with the number of each issued patent under the Patent Rights that applies to such Licensed Product.

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