Product Recall Management Sample Clauses

Product Recall Management. Collegium shall have the right to control and/or conduct any Product Recall of any Licensed Product Developed or Commercialized by or for it, any Affiliate thereof, or any Sublicensee in the Territory, subject to Section 12.01. The Product Recall shall be the sole responsibility of Collegium, its Affiliates, or Sublicensees, as applicable, and shall be carried out by Collegium, its Affiliates, or Sublicensees in as reasonable, prudent, and expeditious a manner as possible to preserve the goodwill and reputation of the affected Licensed Products and the goodwill and reputation of the Parties. Collegium, its Affiliates or Sublicensees, as applicable, shall maintain records of all sales and distribution of Licensed Products and customers in the Territory sufficient to reasonably adequately administer a Product Recall, for the period required by Applicable Law, and make such records available to BDSI or any designee thereof immediately upon request.
AutoNDA by SimpleDocs
Product Recall Management. Purdue shall have the right to control and/or conduct any Product Recall of any Licensed Product Commercialized or otherwise distributed by or for Purdue, any Affiliate thereof, or any Sublicensee in the Territory, subject to Section 12.01. Purdue will conduct such Product Recall in a Commercially Reasonable manner determined by Purdue in its sole discretion and in compliance with all Applicable Law. Purdue, its Affiliates or Sublicensees, as applicable, shall maintain records of all sales and distribution of Licensed Products and customers in the Territory sufficient to reasonably adequately administer a Product Recall, for the period required by Applicable Law, and make such records available to BDSI or any designee thereof immediately upon request. BDSI shall cooperate, at, except as otherwise set forth in the Supply Agreement, Purdue’s expense, in the conduct of any Product Recall for such Licensed Product in the Territory as reasonably requested by Purdue. In the event Purdue notifies BDSI, or BDSI otherwise becomes aware, that Purdue, any Affiliate thereof, or any Sublicensee does not intend to undertake a Product Recall (i) in respect of any death or life-threatening Adverse Event associated with any Licensed Product or (ii) to comply with any Applicable Law with respect to any Licensed Product within, in either case, a reasonable period of time, or is unreasonably delayed in undertaking any such Product Recall, BDSI shall be entitled to do so without Purdue’s prior written consent, in which case Purdue shall cooperate (and cause its Affiliates and Sublicensees to cooperate) in the conduct of any such Product Recall as reasonably requested by BDSI.
Product Recall Management. Meda shall have the right to control and/or conduct any Product Recall in the Territory, subject to Section 12.01. The Product Recall shall be the sole responsibility of Meda or its Affiliates and shall be carried out by Meda or its Affiliates in as reasonable, prudent, and expeditious a manner as possible to preserve the goodwill and reputation of the Licensed Products and the goodwill and reputation of the Parties, provided that BDSI shall share any such Product Recall responsibilities to the extent assumed by BDSI pursuant to the Supply Agreement. Meda shall maintain records of all sales and distribution of Licensed Products and customers in the Territory sufficient to reasonably adequately administer a Product Recall, for the period required by Applicable Law, and make such records available to BDSI or any designee thereof immediately upon request.
Product Recall Management. Arius shall have the right to control and/or conduct any Product Recall in the Territory, subject to Section 13.01, with respect to any Product. The Product Recall shall be the sole responsibility of Arius or its Affiliate and shall be carried out by Arius or its Affiliate in as expeditious a manner as reasonably possible to preserve the goodwill and reputation of the Product and the goodwill and reputation of the Parties. Arius shall maintain records of all sales and distribution of Product and customers sufficient to adequately administer a Product Recall, for the period required by Applicable Law and make such records available to Arius Two immediately upon request.
Product Recall Management. Arius shall have the right to control and/or conduct any Product Recall in the Territory, subject to Section 12.01 with respect to any Product. The Product Recall shall be the sole responsibility of Arius or its Affiliate and shall be carried out by Arius or its Affiliate in as expeditious a manner as reasonably possible to preserve the goodwill and reputation of the Product and the goodwill and reputation of the Parties. Arius and Arius Two (if applicable) shall maintain records of all sales and distribution of Product and customers sufficient to adequately administer a Product Recall, for the period required by Applicable Law and make such records available to the other Party immediately upon request.

Related to Product Recall Management

  • Quality Management Grantee will: 1. comply with quality management requirements as directed by the System Agency. 2. develop and implement a Quality Management Plan (QMP) that conforms with 25 TAC § 448.504 and make the QMP available to System Agency upon request. The QMP must be developed no later than the end of the first quarter of the Contract term. 3. update and revise the QMP each biennium or sooner, if necessary. Xxxxxxx’s governing body will review and approve the initial QMP, within the first quarter of the Contract term, and each updated and revised QMP thereafter. The QMP must describe Xxxxxxx’s methods to measure, assess, and improve - i. Implementation of evidence-based practices, programs and research-based approaches to service delivery; ii. Client/participant satisfaction with the services provided by Xxxxxxx; iii. Service capacity and access to services; iv. Client/participant continuum of care; and v. Accuracy of data reported to the state. 4. participate in continuous quality improvement (CQI) activities as defined and scheduled by the state including, but not limited to data verification, performing self-reviews; submitting self-review results and supporting documentation for the state’s desk reviews; and participating in the state’s onsite or desk reviews. 5. submit plan of improvement or corrective action plan and supporting documentation as requested by System Agency. 6. participate in and actively pursue CQI activities that support performance and outcomes improvement. 7. respond to consultation recommendations by System Agency, which may include, but are not limited to the following: i. Staff training; ii. Self-monitoring activities guided by System Agency, including use of quality management tools to self-identify compliance issues; and iii. Monitoring of performance reports in the System Agency electronic clinical management system.

  • Quality Management System Supplier hereby undertakes, warrants and confirms, and will ensue same for its subcontractors, to remain certified in accordance with ISO 9001 standard or equivalent. At any time during the term of this Agreement, the Supplier shall, if so instructed by ISR, provide evidence of such certifications. In any event, Supplier must notify ISR, in writing, in the event said certification is suspended and/or canceled and/or not continued.

  • 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).

  • 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.

  • STATEWIDE CONTRACT MANAGEMENT SYSTEM If the maximum amount payable to Contractor under this Contract is $100,000 or greater, either on the Effective Date or at any time thereafter, this section shall apply. Contractor agrees to be governed by and comply with the provisions of §§00-000-000, 00-000-000, 00-000-000, and 00- 000-000, C.R.S. regarding the monitoring of vendor performance and the reporting of contract information in the State’s contract management system (“Contract Management System” or “CMS”). Contractor’s performance shall be subject to evaluation and review in accordance with the terms and conditions of this Contract, Colorado statutes governing CMS, and State Fiscal Rules and State Controller policies.

  • Quality Assurance Program An employee shall be entitled to leave of absence without loss of earnings from her or his regularly scheduled working hours for the purpose of writing examinations required by the College of Nurses of Ontario arising out of the Quality Assurance Program.

  • PRODUCT MANUFACTURER'S SUPPLIERS Only those dealers/distributors listed by the manufacturer will be considered authorized to act on behalf of the Product Manufacturer.

  • Safety Boots Each employee, after 3 months’ continuous service, will be reimbursed (on production of a receipt), the cost of one pair of safety boots (approved by the employer), in each year, to a maximum of $110.00. All protective clothing such as wet weather jackets, safety helmets, welding jackets, welding xxxxxxx, welding gauntlets, rubber boots, etc, (which remain the property of the Company), will be supplied on all occasions deemed necessary.

  • API If the Software offers integration capabilities via an API, your use of the API may be subject to additional costs or Sage specific policies and terms and conditions (which shall prevail in relation to your use of the API). You may not access or use the API in any way that could cause damage to us or the Software, or in contravention of any applicable laws. We reserve the right in our sole discretion, to: (i) update any API from time to time; (ii) place limitations around your use of any API; and (iii) deny you access to any API in the event of misuse by you or to otherwise protect our legitimate interests.

  • Safety Glasses Section 1. The City shall supply prescription safety glasses with plastic lenses to employees who are required to wear safety glasses and who are members of the classifications contained in Appendix C to this contract. Safety glasses which are authorized must be industrial grade safety glasses which meet or exceed the requirements of ANSI Specification Z87. 1. All employees who are required to wear safety glasses shall also be required to wear side xxxxxxx, either permanent or snap-on, whenever an eye hazard exists. Solid tinted glasses will not be approved unless required by prescription. Photogray, progressive, scratch coating and/or anti-glare lenses may be considered for those employees who primarily work outdoors or as prescribed. In the event that additional classes are identified as needing either prescription safety glasses or protective eyewear, such classes may be added to the classification list in Appendix C upon approval of PAGE and the City. Section 2. The City agrees to pay the full cost of required prescription safety glasses, with frames not to exceed $75.00. This excludes the cost of the eye examination which will be the responsibility of the employee. The effected employees will be allowed one (1) replacement of safety glasses every two (2) years. In the event the safety glasses become lost, unserviceable, or broken on the job, the employee must present a written request for replacement to the Department Head and Human Resources Director. If the employee breaks his safety glasses while on the job, the Department shall replace the glasses at no cost to the employee. The replacement of lost glasses or glasses that are broken off the job will be at the discretion of the Department Head and Human Resources Director. If an employee has been provided safety glasses by the City, the employee shall be permitted to retain possession of the glasses after separation from the City without reimbursing the City for any costs associated with the glasses. Section 3. An employee who is required to wear prescription safety glasses must present a written request to his department head or designated representative. Section 4. The employee must obtain a current prescription and the employee is authorized the use of sick leave not to exceed two (2) hours to accomplish this examination. The employee will obtain a purchase order from the Department Head prior to ordering the safety glasses. The employee will present the purchase order to the appropriate vendor when ordering. The vendor will contact the appropriate Department Head when the glasses are ready for delivery. The Department Head will then notify the employee who will present himself at the vendor for fitting and pickup. Section 5. In the event a probationary employee has been issued safety glasses and terminates his employment with the City for any reason during the probationary period, he shall be required to reimburse the City for any expenses incurred in the purchase of safety glasses.

Draft better contracts in just 5 minutes Get the weekly Law Insider newsletter packed with expert videos, webinars, ebooks, and more!