ALLOCATION OF BURDEN OF PRODUCT RECALL Sample Clauses

ALLOCATION OF BURDEN OF PRODUCT RECALL. In the event (a) any government authority issues a request, directive or order that First Gen FDP and Second Gen FDP prepared from Fermentation Pellets, First Gen PDS and/or Second Gen PDS manufactured by CBSH for SERAGEN be recalled, or (b) a court of competent jurisdiction orders such a recall, or (c) SERAGEN shall reasonably determine that the Product should be recalled, the Parties shall take all appropriate actions to effectuate the recall as determined by SERAGEN and/or by the applicable Regulatory Agency, and shall cooperate in the investigations surrounding the recall. For clarity, as between the Parties, SERAGEN shall have responsibility for and exclusive control of all recall activities. In the event that such recall results from (i) the failure of CBSH personnel or subcontractors to follow cGMP, (ii) the failure of CBSH personnel or subcontractors to follow and execute the Production Record and required MRR documentation as written and approved by both Parties, (iii) the failure of the Facility equipment or utilities, (iv) the failure or non-conformance of the raw materials with SOPs or Specifications, (v) the breach of CBSH's obligations, representations or warranties hereunder or (vi) the acts or omissions of CBSH's subcontractors, CBSH shall (A) promptly replace such Fermentation Pellets, First Gen PDS and/or Second Gen PDS necessary for SERAGEN to replace the recalled Batches of First Gen FDP and Second Gen FDP, at no additional cost to SERAGEN, consistent with directions received from the appropriate Regulatory Agency and (B) promptly reimburse SERAGEN for its reasonable direct costs and third-party expenses documented and actually incurred in recalling the affected Product and replacing such Product at the wholesaler level. In all other cases, SERAGEN shall be responsible for the costs and expenses of recall, including the cost of replacement material for the Product. For the purposes of this Agreement, the expenses of recall shall include, without limitation, the expenses of notification and destruction or return of the recalled Fermentation Pellets, First Gen PDS and/or Second Gen PDS and all other costs incurred in connection with such recall, but shall not include lost profits of either Party.
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ALLOCATION OF BURDEN OF PRODUCT RECALL. In the event (a) any government authority issues a request, directive or order that FDP prepared from PRODUCT supplied by COPHARMA to SERAGEN be recalled, or (b) a court of competent jurisdiction orders such a recall, or (c) SERAGEN or COPHARMA shall reasonably determine that the PRODUCT should be recalled, the parties shall take all appropriate corrective actions, and shall cooperate in the investigations surrounding the recall. In the event that such recall results from any cause or event arising from the manufacture, storage or handling of the PRODUCT by COPHARMA in a manner which does not comply with the Manufacturing and Release Requirements (excluding defects relating to packaging or labeling supplied by or prepared at the direction of SERAGEN), COPHARMA shall be responsible for all expenses of the recall (except that COPHARMA and SERAGEN shall share such expenses equally if such recall is due to a failure by SERAGEN to meet the Manufacturing and Release Requirements during a Process Improvement requested by or approved by SERAGEN) and COPHARMA shall promptly replace such PRODUCT at no additional cost to SERAGEN consistent with directions received from the appropriate governmental authority. In all other cases, SERAGEN shall be responsible for the expenses of recall, including the cost of replacement material for the PRODUCT. For the purposes of this Agreement, the expenses of recall shall include, without limitation, the expenses of notification and destruction or return of the recalled PRODUCT and all other costs incurred in connection with such recall, but shall not include lost profits of either party.

Related to ALLOCATION OF BURDEN OF PRODUCT RECALL

  • Product Recall (a) If a recall is required by applicable Law, or if Buyer or Supplier reasonably determines that a recall is advisable because the goods may create a potential safety hazard, are not in compliance with any applicable code, standard or legal requirement, or contain a defect or non-conformance with the requirements of this Order occurring or likely to occur in multiple goods, which such defects or non-conformances are substantially similar or have substantially similar causes or effects (collectively a “Serial Defect”), the parties shall promptly communicate such facts to each other. At Buyer’s request, Supplier shall promptly develop a corrective action plan satisfactory to Buyer, which shall include all actions required to recall and/or repair the goods and any actions required by applicable Law (“Corrective Action Plan”) for Buyer’s review and approval. At Buyer’s election, Xxxxx may develop the Corrective Action Plan. In no event shall Buyer and Supplier’s failure to agree on the Corrective Action Plan delay the timely notification of a potential safety hazard, non-compliance or Serial Defect to users of the goods, cause either party to be non-compliant with applicable Law or prevent Buyer from taking reasonable actions to prevent injury or damage to persons, equipment or other property. Supplier and Buyer shall cooperate with and assist each other in any corrective actions and/or filings, if applicable. (b) To the extent a recall is required by applicable Law, or due to a potential safety hazard, non-compliance or Serial Defect, which is caused by Supplier, Supplier shall indemnify and hold Buyer harmless from all reasonable costs and expenses incurred in connection with any recall, repair, replacement or refund program, including all costs related to: (i) investigating and/or inspecting the affected goods; (ii) notifying Buyer’s customers; (iii) repairing, or where repair of the goods is impracticable or impossible, repurchasing or replacing the recalled goods; (iv) packing and shipping the recalled goods; and (v) media notification. Each party shall consult the other before making any statements to the public or a governmental agency relating to such recall, potential safety hazard, non- compliance or Serial Defect, except where such consultation would prevent timely notification required by Law.

  • 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).

  • Tests and Preclinical and Clinical Trials The preclinical studies and clinical trials conducted by or, to the Company’s knowledge, on behalf of the Company, that are described in the Registration Statement, the Pricing Disclosure Package and the Prospectus, as applicable, and are intended to be submitted to the U.S. Food and Drug Administration (the “FDA”) or other comparable government entities, were and, if still ongoing, are being conducted in all material respects in accordance with experimental protocols, procedures and controls pursuant to accepted professional scientific standards and all Authorizations and Applicable Laws, including, without limitation, current Good Clinical Practices and Good Laboratory Practices and any applicable rules and regulations of the jurisdiction in which such trials and studies are being conducted; the descriptions of the results of such studies and trials contained in the Registration Statement, the Pricing Disclosure Package and the Prospectus are, to the Company’s knowledge, accurate and complete in all material respects and fairly present the data derived from such studies and trials; except to the extent disclosed in the Registration Statement, the Pricing Disclosure Package and the Prospectus, the Company is not aware of any studies or trials, the results of which the Company believes reasonably call into question the study or trial results described or referred to in the Registration Statement, the Pricing Disclosure Package and the Prospectus when viewed in the context in which such results are described and the clinical stage of development; and, except to the extent disclosed in the Registration Statement, the Pricing Disclosure Package or the Prospectus, the Company has not received any written notices or written correspondence from the FDA or any governmental entity requiring the termination or suspension of any preclinical studies or clinical trials conducted by or on behalf of the Company, other than ordinary course communications with respect to modifications in connection with the design and implementation of such trials, copies of which communications have been made available to you.

  • AUDIT OF LICENSED PRODUCT USAGE Contractor shall have the right to periodically audit, no more than annually, at Contractor’s expense, use of licensed Product at any site where a copy of the Product resides provided that: (i) Contractor gives Licensee(s) at least thirty (30) days advance written notice, (ii) such audit is conducted during such party’s normal business hours, (iii) the audit is conducted by an independent auditor chosen on mutual agreement of the parties. Contractor shall recommend a minimum of three (3) auditing/accounting firms from which the Licensee will select one (1). In no case shall the Business Software Alliance (BSA), Software Publishers Association (SPA), Software and Industry Information Association (SIIA) or Federation Against Software Theft (FAST) be used directly or indirectly to conduct audits, or be recommended by Contractor; (iv) Contractor and Licensee are each entitled to designate a representative who shall be entitled to participate, and who shall mutually agree on audit format, and simultaneously review all information obtained by the audit. Such representatives also shall be entitled to copies of all reports, data or information obtained from the audit; and (v) if the audit shows that such party is not in compliance, Licensee shall be required to purchase additional licenses or capacities necessary to bring it into compliance and shall pay for the unlicensed capacity at the NYS Net Price in effect at time of audit, or if none, then at the Contractor’s U.S. Commercial list price. Once such additional licenses or capacities are purchased, Licensee shall be deemed to have been in compliance retroactively, and Licensee shall have no further liability of any kind for the unauthorized use of the software.

  • Billing and Payment Procedure for Forest Products Delivered The State will compute and forward to Purchaser a billing statement of charges for forest products delivered during the billing period at the delivered rate shown in P- 028.2 clause. After receipt of the billing statement, Purchaser’s payment must be received by the Department of Natural Resources on or before the due date shown on the billing statement. Purchaser agrees to make payment, payable to the Department of Natural Resources. Failure to pay on time for forest products delivered is considered a breach of contract. Included with the billing statement will be a summary report for the billing period compiled by the State or their log and load reporting service. The State will adjust final xxxxxxxx to account for any State approved payment reductions. Advance payments made under P-045 or P-045.2 remaining on account above the value for the charges shall be returned to Purchaser within 30 days following the final report of charges. Refunds not made within the 30 day period will accrue interest at the interest rate, as established by WAC 000-000-000, computed on a daily basis until paid.

  • Allocation of Profit or Loss All Profit or Loss shall be allocated to the Member.

  • Product References a. “Or Equal” In all Solicitations or Bid Specifications, the words “or equal” are understood to apply where a copyrighted, brand name, trade name, catalog reference, or patented Product is referenced. References to such specific Product are intended as descriptive, not restrictive, unless otherwise stated. Comparable Product will be considered if proof of compatibility is provided, including appropriate catalog excerpts, descriptive literature, specifications and test data, etc. The Commissioner’s decision as to acceptance of the Product as equal shall be final. b. Discrepancies in References In the event of a discrepancy between the model number referenced in the Solicitation or Bid Specifications and the written description of the Products that cannot be reconciled, then the written description shall prevail.

  • 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.

  • Penalties for non-conformity of production 9.1. The approval granted in respect of a vehicle type pursuant to this Regulation may be withdrawn if the requirements set forth above are not met. 9.2. If a Contracting Party to the Agreement applying this Regulation withdraws an approval it has previously granted, it shall forthwith so notify the other Contracting Parties applying this Regulation, by means of a communication form conforming to the model in Annex 1 to this Regulation.

  • Technical Feasibility of String While ICANN has encouraged and will continue to encourage universal acceptance of all top-­‐level domain strings across the Internet, certain top-­‐level domain strings may encounter difficulty in acceptance by ISPs and webhosters and/or validation by web applications. Registry Operator shall be responsible for ensuring to its satisfaction the technical feasibility of the TLD string prior to entering into this Agreement.

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