Quality and Regulatory Matters Sample Clauses

Quality and Regulatory Matters. In conjunction with the execution of this Manufacturing Agreement, the Parties shall execute a Quality Agreement in the form of Exhibit C attached hereto.
View SourceView Similar (2)
Quality and Regulatory Matters. 7.1 MAKO shall have the right to perform a quality assurance audit of the manufacturing facility of PDEX during normal business hours. MAKO will provide at least five (5) business days advance written notice and arrange the audit at the convenience of both parties in a non-disruptive manner. During the term of this Agreement, PDEX will maintain ISO 13485, or equivalent, certification and comply with all applicable FDA regulations and Applicable Laws. 7.2 PDEX shall permit the FDA and other Regulatory Agencies to conduct inspections of PDEX’s facilities as they may request, including pre-approval inspections, and shall cooperate with Regulatory Agencies with respect to the inspections and any related matters. PDEX shall give MAKO prior notice, to the extent practicable, of any such inspections related to the Services, the Products, or otherwise affecting MAKO hereunder, and shall keep MAKO informed about the results and conclusions of each regulatory inspection, including actions taken by PDEX to remedy conditions cited in the inspections. PDEX shall permit MAKO or its representative to be present at such inspections related exclusively to the Services, the Products, or otherwise affecting MAKO hereunder and as permitted by the FDA or other such Regulatory Agency. PDEX shall provide MAKO with copies of any written inspection reports issued by a Regulatory Agency and all correspondence between PDEX and the Regulatory Agency, including, but not limited to, FDA Form 483, Notice of Observation, and all related correspondence, in each case relating exclusively to the Services and Products. PDEX shall promptly notify and provide MAKO copies of any request, directive, or other communication of the FDA or other Regulatory Agency relating exclusively to the Services or Products and shall consult with MAKO in responding to such requests, directives, and communications. [***] Confidential treatment has been requested for portions of this exhibit. The copy filed herewith omits the information subject to the confidentiality request. Omissions are designated as [***]. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission. 7.3 PDEX shall provide upon request from MAKO, at a reasonable cost, all available information in PDEX’s control necessary or useful for MAKO to apply for, obtain, and maintain regulatory approvals for Products in any country, including without limitation information relating to the facilities, process,...
View Source
Quality and Regulatory Matters. 6.1. Novartis shall operate its facilities, process equipment, software and programs such as environmental monitoring, calibration, validation, compliance, cGMP training and maintenance in accordance with cGMPs, Novartis’ Standard Operating Procedures, Novartis’ applicable regulatory licenses and requirements, and the relevant terms of the Quality Agreement.
View Source
Quality and Regulatory Matters. 4.1 ORGANON will maintain in-process quality control procedures in accordance with FDA cGMPs and will otherwise comply in all respects with the Quality Agreement. 4.2 AMPHAST AR shall have the right, but not the obligation, to inspect ORGANON's quality control procedures and records and to obtain specimens of PRODUCT from ORGANON's production for analysis to confirm quality. Any AMPHASTAR employees who inspect ORGANON's facilities shall abide by all of ORGANON's policies, procedures and rules and shall enter into an appropriate confidentiality agreement. AMPHAST AR shall assume all risk of loss and indemnify and hold ORGANON harmless from all liability and expenses (including legal fees and expenses) directly and proximately resulting from their presence at ORGANON's facilities. Section 12.4 of the Asset Sale Agreement shall apply to such indemnification. 4.3 ORGANON shall be responsible for all communications with any governmental entity relating to its manufacturing and packaging activities, including facility inspections, and AMPHASTAR shall be responsible for all communications with any governmental entity concerning the marketing, sale and distribution of the PRODUCT in the United States. Notwithstanding the foregoing, communications concerning the NDA shall be submitted by AMPHASTAR as owner of the NDA. 4.4 ORGANON will, at its sole expense, comply with all laws applicable to production, packaging, testing, storage, shipment and recordkeeping by ORGANON of the PRODUCT and its performance of its obligations hereunder, including all applicable laws or requirements under any applicable product registrations or manufacturing facility registrations. As long as ORGANON manufactures PRODUCT for AMPHAST AR, it will pay any fees necessary to obtain and maintain manufacturing facility registrations and any other licenses, registrations, permits, exemptions, allowances, authorizations, or approvals from a government entity which are applicable to its facilities used to manufacture and package the PRODUCT.
View Source
Quality and Regulatory Matters. 5.3.1 The Parties have entered into, as of the date hereof, the Quality Agreement referenced as Annex 4. The terms of the Quality Agreement, as may be amended by the parties from time to time, are incorporated by reference into this Amendment; provided, that, except as provided in Article 2.1 hereof, in the event of a conflict between the terms herein and the Quality Agreement, the terms of this Amendment shall apply unless prohibited by law or regulation. 5.3.2.1 DexCom agrees to promptly notify Distributor of any safety, efficacy or stability field actions related to the Transmitter regardless of where in the world those field actions occur. Additionally, DexCom agrees to provide Distributor a quarterly summary report of all product complaints (not inquiries) and all regulatory reporting (MDV, MDR, AEs, etc.), on a worldwide basis, related to the Transmitter. 5.3.2.2 The parties agree that Distributor shall be responsible for securing in-country registration in the member states of the European Union (for example, in France, the placing into service communication for medical devices in conformity with Articles L.5211-4 and R.5211-66) of the Pump and Transmitter, and DexCom shall be responsible for securing in-country registration of the Sensor, in each relevant country prior to commencing commercial launch of the Integrated System. (i) In the event of a product recall, withdrawal or field action relating to the Integrated System or a component thereof, the parties shall follow the guidelines set forth in Section 16 of the Quality Agreement. (ii) In the event any governmental agency having jurisdiction shall request or order, or if Distributor shall determine to undertake, any corrective action with respect to the Integrated System (or the Enabled Pump separately), including any recall, corrective action or market action, all costs associated with such recall or action shall be borne by Distributor unless, and only to the extent that, the cause or basis of such recall or action is attributable to a breach by DexCom of any of its warranties, guarantees, representations, obligations or covenants contained in the OUS Commercialization Agreement, in which case DexCom shall be liable, and shall bear the costs of such recall or action including the cost of any product which is so recalled. (iii) In the event any governmental agency having jurisdiction shall request or order, or if Distributor, after consultation with DexCom, shall determine to undertake, any co...
View Source
Quality and Regulatory Matters. In conjunction with the execution of this Agreement, the parties shall execute a Quality Agreement in the form of Exhibit C attached hereto.
View Source
Quality and Regulatory Matters 
View SourceView Similar (18)

Related to Quality and Regulatory Matters

  • Tax and Regulatory Matters No Buyer Entity or, to the Knowledge of Buyer, any Affiliate thereof has taken or agreed to take any action, and Buyer does not have any Knowledge of any agreement, plan or other circumstance, that is reasonably likely to (i) prevent the Merger from qualifying as a “reorganization” within the meaning of Section 368(a) of the Internal Revenue Code, or (ii) materially impede or delay receipt of any of the Requisite Regulatory Approvals.

  • Clinical Data and Regulatory Compliance The preclinical tests and clinical trials, and other studies (collectively, “studies”) that are described in, or the results of which are referred to in, the Registration Statement or the Prospectus were and, if still pending, are being conducted in all material respects in accordance with the protocols, procedures and controls designed and approved for such studies and with standard medical and scientific research procedures; each description of the results of such studies is accurate and complete in all material respects and fairly presents the data derived from such studies, and the Company and its subsidiaries have no knowledge of any other studies the results of which are inconsistent with, or otherwise call into question, the results described or referred to in the Registration Statement or the Prospectus; the Company and its subsidiaries have made all such filings and obtained all such approvals as may be required by the Food and Drug Administration of the U.S. Department of Health and Human Services or any committee thereof or from any other U.S. or foreign government or drug or medical device regulatory agency, or health care facility Institutional Review Board (collectively, the “Regulatory Agencies”); neither the Company nor any of its subsidiaries has received any notice of, or correspondence from, any Regulatory Agency requiring the termination, suspension or modification of any clinical trials that are described or referred to in the Registration Statement or the Prospectus; and the Company and its subsidiaries have each operated and currently are in compliance in all material respects with all applicable rules, regulations and policies of the Regulatory Agencies.

  • Regulatory Matters The parties will negotiate in good faith to resolve regulatory criticisms or concerns expressed by the Office of the Comptroller of the Currency or other U.S. federal or state banking Regulators that can reasonably be addressed through a modification of the Agreement or adoption of mutually agreeable policies or procedures to prevent or resolve a Material Default described by clause (iii) of such definition, subject to applicable legal requirements including restrictions on disclosing confidential supervisory information.

  • Statutory and Regulatory Compliance Contractor shall comply with all laws and regulations applicable to the Community Development Block Grant-Disaster Recovery funds appropriated by the Disaster Relief Appropriations Act, 2013 (Pub. L. 113-2), including but not limited to the applicable Office of Management and Budget Circulars, which may impact the administration of funds and/or set forth certain cost principles, including the allowability of certain expenses.

  • Financial Viability and Regulatory Compliance 2.6.1 Contractor warrants and represents that its corporate entity is in good standing with all applicable federal, state, and local licensing authorities and that it possesses all requisite licenses to perform the services required by this contract. Contractor further warrants and represents that it owes no outstanding delinquent federal, state or local taxes or business assessments. 2.6.2 Contractor agrees to promptly disclose to the MPHA any IRS liens or licensure suspension or revocation that may adversely affect its capacity to perform the services outlined within this contract. The failure by Contractor to disclose such issue to the MPHA in writing within 5 days of such notification received will constitute a material breach of this contract. 2.6.3 Contractor further agrees to promptly disclose to the MPHA any change of more than 50% of its ownership and/or any declaration of bankruptcy that Contractor may undergo during the term(s) of this contract. The failure of Contractor to disclose any change of more than 50% of its ownership and/or its declaration of bankruptcy within 5 days of said actions shall constitute a material breach of this contract. 2.6.4 All disclosures made pursuant to this section of the contract shall be made in writing and submitted to MPHA within the time periods required herein.