COMPLAINTS, QUALITY RECORDS AND RECALLS Sample Clauses

COMPLAINTS, QUALITY RECORDS AND RECALLS. 19.1 Distributor will notify, in writing, AMS's quality assurance department of all Product complaints or any regulatory/conformance issues that may affect the marketability of Products. AMS shall notify the appropriate regulatory agent(s) if required and shall conduct any safety investigations or other necessary follow-up activities. Distributor will provide any information essential to such activities. AMS will promptly notify Distributor if corrective action is necessary in the Territory. 19.2 Distributor shall keep records of the names and addresses of customers and Product serial numbers for the active Product life to enable Distributor to notify customers of Product safety information. Distributor shall maintain the following information when distributing AMS's Products: - Name and address of initial consignee - Identification of device and quantity of devices shipped - Date of shipment 19.3 Upon request, Distributor will supply AMS a quarterly report of repairs, maintenance or service activity for Products. The report will include the product number, serial number, fault found, action taken and date of the activity. 19.4 In the event of any recall of a Product required by a governmental agency for safety or efficacy reasons, or requested by Aspect at its sole discretion, which is the result of AMS's failure to supply Products that (1) conform in all material respects to the applicable published specifications or (2) are free from defects in material and workmanship (when given normal, proper and intended usage), AMS agrees to repair or replace at its own costs all Products subject to the recall and previously delivered to Distributor. AMS also agrees to consult with Distributor to establish a reasonable process for managing the recall and Aspect shall be responsible for all reasonable out-of-pocket expenditures incurred by Distributor (including, but not limited to shipping costs, labor and travel costs) that are consistent with the recall process agreed to by the Parties.. In the event the recall is not required by a governmental agency for safety or efficacy reasons, but is instead requested by AMS at its sole discretion, AMS will be responsible for determining the scope of the recall, including the number of units, timeframe for the recall, and criteria for completion. Distributor agrees to maintain all necessary sales records to facilitate the recall. MEDICAL PRODUCTS DISTRIBUTION AGREEMENT
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COMPLAINTS, QUALITY RECORDS AND RECALLS. All regulatory compliance obligations of the parties are set forth in the Purchase Agreement.
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COMPLAINTS, QUALITY RECORDS AND RECALLS. 17.1 DISTRIBUTOR will notify, in writing, MANUFACTURER's quality assurance department of all Product complaints or any regulatory/conformance issues known to DISTRIBUTOR that are likely to affect the marketability of Products or Accessories. MANUFACTURER shall notify the appropriate regulatory agent(s) if required and shall conduct any safety investigations or other necessary follow-up activities. DISTRIBUTOR will provide any requested information in its possession essential to such activities. MANUFACTURER will promptly notify DISTRIBUTOR if corrective action is necessary in the Territory.
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COMPLAINTS, QUALITY RECORDS AND RECALLS. 16.1 PSS will notify, in writing, Cutera’s quality assurance department of all Product complaints or any regulatory/conformance issues that may affect the marketability of Products. Cutera shall notify the appropriate regulatory agent(s) if required and shall conduct any safety investigations or other necessary follow-up activities. PSS will provide any information essential to such activities. Cutera will promptly notify PSS if corrective action is necessary in the Territory. 16.2 In the event of any recall of a Product required by a governmental agency for safety or efficacy reasons, or requested by Cutera at its sole discretion, Cutera agrees to repair or replace at its own costs and expense all Products subject to the recall and previously delivered to PSS or PSS customers. Cutera also agrees to consult with PSS to establish a reasonable process for managing the recall. Cutera shall be responsible for all reasonable expenditures incurred by PSS (including, but not limited to shipping, labor and travel costs) consistent with the recall process agreed to by the Parties, and consistent with HIDA and HDMA industry guidelines. In the event the recall is not required by a governmental agency for safety or efficacy reasons, but is instead requested by Cutera at its sole discretion, Cutera will be responsible for determining the scope of the recall, including the number of units, timeframe for the recall, and criteria for completion, at no cost or expense to PSS.
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COMPLAINTS, QUALITY RECORDS AND RECALLS 
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Related to COMPLAINTS, QUALITY RECORDS AND RECALLS

  • Production of Witnesses; Records; Cooperation (a) After the Effective Time, each Party shall use its commercially reasonable efforts to make available to the other Party, upon written request, the former, current and future directors, officers, employees, other personnel and agents of the members of its respective Group as witnesses and any books, records or other documents within its control or which it otherwise has the ability to make available without undue burden, to the extent that any such Person (giving consideration to business demands of such directors, officers, employees, other personnel and agents) or books, records or other documents may reasonably be required in connection with any Action in which the requesting Party (or member of its Group) may from time to time be involved, regardless of whether such Action is a matter with respect to which indemnification may be sought hereunder. The requesting Party shall bear all costs and expenses in connection therewith. (b) If an Indemnifying Party chooses to defend or to seek to compromise or settle any Third-Party Claim, the other Party shall make available to such Indemnifying Party, upon written request, the former, current and future directors, officers, employees, other personnel and agents of the members of its respective Group as witnesses and any books, records or other documents within its control or which it otherwise has the ability to make available without undue burden, to the extent that any such Person (giving consideration to business demands of such directors, officers, employees, other personnel and agents) or books, records or other documents may reasonably be required in connection with such defense, settlement or compromise, or such prosecution, evaluation or pursuit, as the case may be, and shall otherwise cooperate in such defense, settlement or compromise, or such prosecution, evaluation or pursuit, as the case may be. (c) Without limiting the foregoing, the Parties shall cooperate and consult to the extent reasonably necessary with respect to any Actions. (d) Without limiting any provision of this Section 6.7, each of the Parties agrees to cooperate, and to cause each member of its respective Group to cooperate, with each other in the defense of any infringement or similar claim with respect any Intellectual Property and shall not claim to acknowledge, or permit any member of its respective Group to claim to acknowledge, the validity or infringing use of any Intellectual Property of a third Person in a manner that would hamper or undermine the defense of such infringement or similar claim. (e) The obligation of the Parties to provide witnesses pursuant to this Section 6.7 is intended to be interpreted in a manner so as to facilitate cooperation and shall include the obligation to provide as witnesses inventors and other officers without regard to whether the witness or the employer of the witness could assert a possible business conflict (subject to the exception set forth in the first sentence of Section 6.7(a)).

  • Environmental, Health and Safety Matters (a) Comply in all material respects with all applicable Environmental Laws, including, without limitation, obtaining and complying with and maintaining any and all licenses, approvals, notifications, registrations or permits required by applicable Environmental Laws. For purposes of this Section 5.12(a), material noncompliance by the Company, any of its Subsidiaries or any tenant or subtenant, with any applicable Environmental Law shall be deemed not to constitute a breach of this covenant provided that, upon learning of any actual or suspected material noncompliance, the Company and the relevant Subsidiaries shall promptly undertake all reasonable efforts to achieve material compliance (or contest in good faith by appropriate proceedings the alleged violation or applicable Environmental Law at issue and (to the extent required by GAAP) provide on the books of the Company or any of its Subsidiaries, as the case may be, reserves in accordance with GAAP with respect thereto), and provided further that, in any case, such noncompliance, and any other noncompliance with applicable Environmental Law, individually or in the aggregate, could not reasonably be expected to have a Material Adverse Effect. (b) Promptly comply in all material respects with all lawful orders and directives of all Governmental Authorities regarding applicable Environmental Laws, except to the extent that the validity thereof is currently being contested in good faith by appropriate proceedings and (to the extent required by GAAP) reserves in accordance with GAAP with respect thereto have been provided on the books of the Company or any of its Subsidiaries, as the case may be. (c) Defend, indemnify and hold harmless the Administrative Agent and the Lenders, and their respective parents, subsidiaries, affiliates, employees, agents, officers and directors, from and against any claims, demands, penalties, fines, liabilities, settlements, damages, costs and expenses of whatever kind or nature, known or unknown, contingent or otherwise, arising out of, or in any way relating to the violation of, noncompliance with or liability under any Environmental Laws applicable to the Company or any of its Subsidiaries or any of their respective operations or properties, or any orders, requirements or demands of Governmental Authorities related thereto, including, without limitation, attorney’s and consultant’s fees, investigation and laboratory fees, response costs, court costs and litigation expenses, except to the extent that any of the foregoing arise out of the gross negligence or willful misconduct of (or, as determined pursuant to a claim initiated by the Company, breach in bad faith of its express obligations under the applicable Loan Documents by) the party seeking indemnification therefor, in each case, as determined by a final non-appealable judgment by a court of competent jurisdiction. This indemnity shall continue in full force and effect regardless of the termination of this Agreement.

  • Environmental Compliance and Reports Borrower shall comply in all respects with any and all Environmental Laws; not cause or permit to exist, as a result of an intentional or unintentional action or omission on Borrower’s part or on the part of any third party, on property owned and/or occupied by Borrower, any environmental activity where damage may result to the environment, unless such environmental activity is pursuant to and in compliance with the conditions of a permit issued by the appropriate federal, state or local governmental authorities; shall furnish to Lender promptly and in any event within thirty (30) days after receipt thereof a copy of any notice, summons, lien, citation, directive, letter or other communication from any governmental agency or instrumentality concerning any intentional or unintentional action or omission on Borrower’s part in connection with any environmental activity whether or not there is damage to the environment and/or other natural resources. Additional Assurances. Make, execute and deliver to Lender such promissory notes, mortgages, deeds of trust, security agreements, assignments, financing statements, instruments, documents and other agreements as Lender or its attorneys may reasonably request to evidence and secure the Loans and to perfect all Security Interests.

  • Access to Public Records No records of District shall be made available for public inspection or copying by NWRDC, NWESD, or ▇▇▇▇▇ without express written authorization of District. Requests pursuant to RCW 42.17 for inspection or copying of public records of District, held or maintained by NWRDC shall be referred to District.

  • Health and Safety Representatives The Employer and its Employees will comply with Part 7 of the OHS Act – Representation of Employees in relation to the establishment of designated work groups and the election of Health and Safety Representatives.