Recall Responsibilities Clause Samples

Recall Responsibilities. Customer will handle all discussions with regulatory agencies regarding manufacturing defects or safety issues related to any Product and will be solely responsible for deciding the necessity, scope, and procedures for any Product recall. SCS will support Product recalls based on the Ad-Hoc rates stated in Exhibit B. 9.1 Customer will be responsible for notifying SCS of any recalls or market withdrawals of their products to be handled by SCS. 9.2 Customer will be responsible for drafting product recall customer communications. Customer is responsible for all recall communications to customer. Customer can request in writing for SCS to perform the recall customer communications, and negotiate the service fee based on handling requirements. No amendment to this schedule is required for this service.
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Recall Responsibilities. Each party will have written procedures covering field corrective actions and recall activities, and employees will have appropriate training on these procedures. Each party will promptly notify the other party of any recall or field correction affecting the Product. If a recall or field correction results from a defect in a Seller Product, Seller will be responsible for: (i) the investigation to determine the cause and extent of the problem, while Spacelabs will be responsible for: (iv) locating the Products in question; (v) communications with Customers; (vi) in the event of a recall, requiring that the recalled Products are returned; (vii) in the event of a Product shipment hold, initiating a shipment hold immediately upon notice by Seller; and (viii) requiring and performing field upgrades and/or repairs. If the Product provided by Seller is a finished medical device Product, Seller will be responsible for all regulatory authority contacts and (overall coordination of any corrective activities involving the Products. The Parties will cooperate fully with each other in effecting any recall of a Product. Seller will bear all costs and expenses of such field correction or recall, including, without limitation, the cost of notifying Spacelabs’ Customers and costs associated with sending a service engineer to perform field correction and/or shipment of recalled Products from Spacelabs’ Customers to Seller, as well as the costs associated with providing Spacelabs’ Customers with replacement or modified Products.
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Recall Responsibilities. Haemacure shall conduct product recalls, withdrawals or quarantines as required by the FDA, or such voluntary recalls initiated by Haemacure's reasonable belief that the Products violate any provision of applicable law. BPL shall assist Haemacure in all recalls, withdrawals or quarantines relating to the Product. Haemacure and BPL shall share equally all expenses incurred in any such recall, provided however, (a) if such action is taken due to BPL's failure to manufacture the Products in accordance with the Specifications or in breach of its warranties pursuant to Section 6.5, then BPL shall bear all such expenses, including the cost of replacement Product, and (b) if such action is taken due to Haemacure's failure to comply with the Act or the breach of its responsibilities pursuant to this Agreement, then Haemacure shall bear all such expenses, including the cost of replacement Product.
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Recall Responsibilities. (a) In accordance with the Quality Assurance Agreement to be entered into by the Parties according to Section 10.14, Delcath shall be the primary point of contact with FDA with respect to any recall of the PHP Systems incorporating the Product. The Parties agree, however, that any recall would be conducted and coordinated in full consultation with the other Party, with Delcath handling the logistics of such recall. The Parties agree that the cost of any recall (including without limitation the costs of notifying the customers, Product recovery, Product destruction, replacement Product and applicable freight, insurance, taxes, customs and duties for all of the above) shall be borne by Delcath unless and to the extent such recall relates to (i) Synerx/Bioniche’s breach of their representations, warranties, or obligations under this Agreement or applicable laws, (ii) Synerx/Bioniche’s negligence or willful misconduct, or (iii) the manufacturing and supply of the Product, in which case, to the extent the recall is related to or results from the events set forth in clauses (i), (ii) or (iii) above, the costs of such recall (including without limitation the costs of notifying the customers, Product recovery, Product destruction, replacement Product and applicable freight, insurance, taxes, customs and duties for all of the above) shall be borne by Synerx/Bioniche. For purposes of this Section, “recall” means any action by Delcath or any Affiliate of ▇▇▇▇▇▇▇ CONFIDENTIAL TREATMENT [***] Indicates that text has been omitted which is the subject of a confidential treatment request. This text has been separately filed with the Securities and Exchange Commission. to recover title to or possession of any PHP System incorporating the Product sold or shipped including, but not limited to, market withdrawal. (b) Each Party shall keep the other fully informed in writing of any notification or other information, whether received directly or indirectly, that might (i) affect the marketability, safety or effectiveness of any PHP System, (ii) result in liability issues or otherwise necessitate action on the part of either Party or (iii) result in recall or seizure of any PHP System. Delcath shall be responsible for assuring that such recall is closed-out with the FDA, unless the FDA shall otherwise require. For purposes of this Section, “seizure” means any action by any governmental authority to detain or destroy any PHP System.
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Related to Recall Responsibilities

  • Additional Responsibilities This paragraph applies to all phases of Architect's work. (a) Architect shall be responsible for the professional quality, technical accuracy, timely completion and coordination of all of Architect's work, including that performed by Architect's consultants, and including designs, Drawings, Specifications, reports and other services, irrespective of Owner's approval or acquiescence in same. Architect shall, without additional compensation, correct or revise any errors, omissions or other deficiencies in his work. (b) Architect shall be responsible, in accordance with applicable law, to Owner for all loss or damage to Owner caused by Architect's negligent act or omission; except that Architect hereby irrevocably waives and excuses Owner and its attorneys from compliance with any requirement to obtain a certificate of review as a condition precedent to commencement of an action, including any such requirements set forth in Section ▇▇-▇▇-▇▇▇, C.R.S. or similar statute. (c) Architect's professional responsibility shall comply with the standard of care applicable to the type of engineering and architectural services provided, commensurate with the size, scope and nature of the Project. (d) Architect shall be completely responsible for the safety of Architect's employees in the execution of work under this Agreement, shall provide all necessary safety equipment for said employees, and shall hold harmless and indemnify and defend Owner from any and all claims, suits, loss or injury to Architect's employees. (e) Architect acknowledges that, due to the nature of architectural and related professional services and the impact of same on the Project, the Owner has a substantial interest in the personnel and consultants to whom Architect assigns principal responsibility for services performed under this Agreement. Consequently, Architect represents that Architect has selected and intends to employ or assign the key personnel and consultants identified in Appendix C - "Identification of Personnel, Subcontractors and Task Responsibility", attached hereto for the Project assignments and areas of responsibility stated therein. Within 10 days of execution of this Agreement, Owner shall have the right to object in writing to employment on the Project of any such key person, consultant or assignment of principal responsibility, in which case Architect will employ alternate personnel for such function or reassign such responsibility to another to whom Owner has no reasonable objection. Thereafter, Architect shall not assign or reassign Project work to any person to whom Owner has reasonable objection. Within 5 days of execution of this Agreement, Architect shall designate in writing a Project representative who shall have complete authority to bind Architect, and to whom Owner should address communications. (f) Promptly after execution of this Agreement and upon receipt of authorization from Owner to proceed, Architect shall submit to Owner for approval a schedule showing the order in which Architect proposes to accomplish his work, with dates on which he will commence and complete each major work item. The schedule shall provide for performance of the work in a timely manner so as to not delay Owner's time table for achievement of interim tasks and final completion of Project work, provided however, the Architect will not be responsible for delays beyond his control. (g) Before undertaking any work which Architect considers beyond or in addition to the scope of work and services which Architect has contractually agreed to perform under the terms of this Agreement, Architect shall advise Owner in writing (i) that Architect considers the work beyond the scope of this Agreement, (ii) the reasons the Architect believes the out of scope or additional work should be performed, and (iii) a reasonable estimate of the cost of such work. Architect shall not proceed with such out of scope or additional work until authorized in writing by Owner. The compensation for such authorized work shall be negotiated, but in the event the parties fail to negotiate or are unable to agree as to compensation, then Architect shall be compensated for his direct costs and professional time at the rates set forth in Appendix B - "Fee Schedule".

  • School Responsibilities 1. The School shall have the total responsibility for planning and determining the adequacy of the educational experience of students in theoretical background, basic skill, professional ethics, attitude and behavior, and will assign to the Facility only those students who have satisfactorily completed the prerequisite didactic portion of the School’s curriculum. 2. The School shall provide proof to the Facility, of professional liability insurance policy of at least One Million Dollars ($1,000,000.00) per occurrence or claim and Three Million Dollars ($3,000,000.00) in the aggregate covering the acts of such student while participating in the program at the Facility.

  • General Responsibilities Issuer hereby engages Distributor to act as exclusive distributor of the shares of each class of the Funds. The Funds subject to this Agreement as of the date hereof are identified on SCHEDULE A, which may be amended from time to time in accordance with Section 11 below. Sales of a Fund's shares shall be made only to investors residing in those states in which such Fund is registered. After effectiveness of each Fund’s registration statement, Distributor will hold itself available to receive, as agent for the Fund, and will receive by mail, telex, telephone, or such other method as may be agreed upon between Distributor and Issuer, orders for the purchase of Fund shares, and will accept or reject such orders on behalf of the Fund in accordance with the provisions of the applicable Fund’s prospectus. Distributor will be available to transmit orders, as promptly as possible after it accepts such orders, to the Fund’s transfer agent for processing at the shares’ net asset value next determined in accordance with the prospectuses.

  • Professional Responsibilities Other activities to support the delivery of the ▇▇▇▇▇▇ ▇▇▇▇▇▇ Business Plan and ▇▇▇▇▇▇ Mission Strategic Plan, as requested by your manager • As an employee, be responsible under the Work Health & Safety Act for the health and safety of all persons they come into contact with, during employment • All hazards and injuries must be reported through the normal process as set out in ▇▇▇▇▇▇ Mission’s Work Health, Safety and Rehabilitation Quality Management System and site procedures • Participate in the review and maintenance of industry specific and internal audit processes, as per ▇▇▇▇▇▇ Mission’s standard policy and procedures • In relation to ▇▇▇▇▇▇ Mission and the Uniting Church in Australia, attend such functions, meetings, seminars, training courses as directed by your supervisor • In relation to ▇▇▇▇▇▇ Mission attend worship services as encouraged by your supervisor • Participate on a quarterly basis in ▇▇▇▇▇▇ Mission’s Employee contribution and development process • Take responsibility for personal career development and training • Participate in ▇▇▇▇▇▇ Mission’s Orientation program, so as to gain an understanding of, and • promote, the application of the EEO, Affirmative Action, Privacy Act, Work Health & Safety Act and other relevant legislation • Administer ▇▇▇▇▇▇ Mission’s philosophy of care and other relevant policy documents as appropriate • Demonstrate responsible stewardship of all resources, and willingness to report impropriety in keeping with the values of ▇▇▇▇▇▇ Mission • Ensure the reputation and integrity of ▇▇▇▇▇▇ Mission is maintained at all times • Maintain confidentiality

  • Financial Responsibilities The acceptance of a Project Agreement creates a legal duty on the part of the Grantee’s organization to use the funds made available in accordance with the terms and conditions of the Grant. Note: Authority cited: Sections 5001.5 and 5003, Public Resources Code. Reference: Sections 5090.32 and 5090.50, Public Resources Code.