Quality; Regulatory Sample Clauses

Quality; Regulatory. 6.1 LTS warrants that all Products supplied pursuant to this Agreement shall on the date of delivery have been manufactured in accordance with the Product Specifications, Packaging Specifications and all legal and regulatory requirements at the place of manufacture (including, but not limited to, those included in applicable Governmental Approvals) and GMP. The Product Specifications may be amended only with the prior written consent of LTS which shall not unreasonably be withheld.
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Quality; Regulatory. 13.1 Encision agrees to maintain a quality system that is in substantial compliance with USA FDA Quality System Regulations, Canadian Medical Device Regulations, European Union Medical Devices Directives, ISO 13485: 2003 and Japan GQP (Good Quality Practices). Intuitive understands that Japan GQP is currently in process but not completed.
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Quality; Regulatory. 6.1 Supplier warrants that all Supplied API supplied pursuant to this Agreement shall (i) be manufactured in accordance with current GMP and (ii) comply with the Specifications and all Applicable Laws (including but not limited to FDA regulations and requirements included in the Product Approvals), provided that Specifications may be amended as (a) reasonably requested by Cempra and agreed upon by Supplier, such agreement not to be unreasonably withheld, or (b) necessary to conform such Specifications to the regulatory requirements necessary to obtain and maintain Product Approvals with respect to Cempra Products, including but not limited to the approval of alternative dosages or indications of Cempra Products. In the event any change in the Specifications materially increases or decreases the Manufacturing Costs, then the parties will meet and negotiate in good faith an increase or decrease in the Price.
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Quality; Regulatory. 5.1 BDSI warrants that all Products supplied pursuant to this Agreement shall on the date of delivery (i) comply with the Product Specifications and all applicable regulatory requirements (including but not limited to those included in applicable Governmental Approvals and GMP); (ii) not, in the case of Commercial Products, be misbranded or adulterated (as such terms are defined by Applicable Laws); and (iii) be packaged according to the Packaging Specifications and all regulatory requirements (including but not limited to those included in applicable Governmental Approvals and GMP), provided that Product Specifications and Packaging Specifications may be amended as (a) reasonably requested by Meda and agreed upon by BDSI, (b) necessary to conform such Product Specifications and Packaging Specifications to the regulatory requirements necessary to obtain and maintain Governmental Approvals with respect to the Products in the reasonable discretion of BDSI, or (c) or otherwise effected in accordance with Section 5.2 below. BDSI shall, at Meda’s option, immediately replace (without additional cost) or refund to Meda the amount actually paid by Meda for any such Products which do not meet the foregoing warranty. Replacement or refund, as elected by BDSI in its sole discretion, shall be Meda’s sole remedy for breach of such warranty unless such breach is the result of BDSI’s gross negligence or willful misconduct.
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Quality; Regulatory. 5.1 BDSI warrants that all Products supplied pursuant to this Agreement shall on the date of delivery (i) materially comply with the Product Specifications and all applicable regulatory requirements (including but not limited to those included in applicable Governmental Approvals and GMP) and (ii) be packaged according to the Packaging Specifications and all regulatory requirements (including but not limited to those included in applicable Governmental Approvals and GMP), provided that Product Specifications and Packaging Specifications may be amended as (a) reasonably requested by Meda and agreed upon by BDSI or (b) necessary to conform such Product Specifications and Packaging Specifications to the regulatory requirements necessary to obtain and maintain Governmental Approvals with respect to the Products in the reasonable discretion of BDSI. BDSI shall, at Meda’s option, immediately replace (without additional cost) or refund to Meda the amount actually paid by Meda for any such Products which do not meet the foregoing warranty. Replacement or refund, as elected by BDSI in its sole discretion, shall be Meda’s sole remedy for breach of such warranty unless such breach is the result of BDSI’s gross negligence or willful misconduct.
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Quality; Regulatory. 8.1 Aveva warrants that all Products supplied pursuant to this Agreement shall on the date of delivery (i) be manufactured in accordance with cGMP, (ii) comply with the Product Specifications and all applicable regulatory requirements (including but not limited to all FDA regulations and those regulatory requirements included in or related to the Product Approvals) and (iii) be packaged according to the Packaging Specifications and all regulatory requirements (including but not limited to all FDA regulations and those regulatory requirements included in or related to the Product Approvals), provided that Product Specifications and Packaging Specifications may be amended as (a) reasonably requested by Arius or (b) necessary to conform such Product Specifications and Packaging Specifications to the regulatory requirements necessary to obtain and maintain Product Approvals with respect to the Products in the reasonable discretion of Arius, including but not limited to the approval of alternative dosages or indications, or Product Approvals in foreign jurisdictions, with respect to Products. Aveva shall, at Arius’ option, immediately replace (without additional cost) or refund to Arius ***CONFIDENTIAL TREATMENT REQUESTED*** Note: The portions hereof for which confidential treatment are being requested are denoted with “*****”. the Purchase Price of any such Products which do not meet the foregoing warranty. Replacement or refund shall be Arius’ sole remedy for breach of warranty.
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Related to Quality; Regulatory

  • 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.

  • Quality Standards Each Party agrees that the nature and quality of its products and services supplied in connection with the other Party's Marks will conform to quality standards set by the other Party. Each Party agrees to supply the other Party, upon request, with a reasonable number of samples of any Materials publicly disseminated by such Party which utilize the other Party's Marks. Each Party will comply with all applicable laws, regulations, and customs and obtain any required government approvals pertaining to use of the other Party's marks.

  • Quality Specifications SANMINA-SCI shall comply with the quality specifications set forth in its Quality Manual, incorporated by reference herein, a copy of which is available from SANMINA-SCI upon request.

  • Regulatory Compliance Cooperation (a) CIT/VC agrees to use commercially reasonable best efforts to avoid the occurrence of a Regulatory Problem. In the event that CIT/VC determines that it has a Regulatory Problem, the Company agrees to use commercially reasonable efforts to take all such actions as are reasonably requested by CIT/VC in order (A) to effectuate and facilitate any transfer by CIT/VC of any Securities of the Company then held by CIT/VC to any Person designated by CIT/VC (subject, however, to compliance with Section 3 of this Agreement), (B) to permit CIT/VC (or any Affiliate of CIT/VC) to exchange all or any portion of the voting Securities of the Company then held by such Person on a share-for-share basis for shares of a class of non-voting Securities of the Company, which non-voting Securities shall be identical in all respects to such voting Securities, except that such new Securities shall be non-voting and shall be convertible into voting Securities on such terms as are requested by CIT/VC in light of regulatory considerations then prevailing, and (C) to continue and preserve the respective allocation of the voting interests with respect to the Company arising out of CIT/VC's ownership of voting Securities of the Company and/or provided for in this Agreement before the transfers and amendments referred to above (including entering into such additional agreements as are requested by CIT/VC to permit any Person(s) designated by CIT/VC to exercise any voting power which is relinquished by CIT/VC upon any exchange of voting Securities for nonvoting Securities of the Company); and the Company shall enter into such additional agreements, adopt such amendments to this Agreement, the Company's Charter and the Company's By-laws and other relevant agreements and taking such additional actions, in each case as are reasonably requested by CIT/VC in order to effectuate the intent of the foregoing. If CIT/VC elects to transfer Securities of the Company to a Regulated Holder in order to avoid a Regulatory Problem, the Company shall enter into such agreements with such Regulated Holder as it may reasonably request in order to assist such Regulated Holder in complying with applicable laws, and regulations to which it is subject. Such agreements may include restrictions on the 39. redemption, repurchase or retirement of Securities of the Company that would result or be reasonably expected to result in such Regulated Holder holding more voting securities or total securities (equity and debt) than it is permitted to hold under such laws and regulations.

  • Quality Requirements Performance Indicator Heading Indicator (specific) Threshold Method of Measurement Frequency of monitoring Consequence of Breach QUALITY Patient Safety - Incidents I1 Number of incidents Adverse incidents include the following: clinical or non clinical adverse events that have potential to cause avoidable harm to a patient, including medical errors or adverse events related to medical devices or other equipment. Clinical or non- clinical accidents, accidental injuries to staff and members of the public, verbal, physical or psychological abuse or harassment, unusual or dangerous occurrences, damage to trust property, plant or equipment, fire or flood, security, theft or loss, near misses are identified as any event where under different circumstances significant injury or loss may have occurred Number of recorded incidents in the contract month Monthly Remedial Action Plan brought to Performance Meeting following breach; action under Module C Clause 32 if needed I2 Number of Sis Definition of SUI according to trust policy and national guidance Number of Serious Untoward Incidents reported in contract month Monthly Remedial Action Plan brought to Performance Meeting following breach; action under Module C Clause 32 if needed S1 Percentage of eligible staff received child safeguarding training at level 2 (as identified in LSCB training strategy) 95% Number received training/ Number of identified staff requiring training Monthly S2 Percentage of eligible staff received adult safeguarding awareness training at level 2 ( as identified in K&M Safeguarding Vulnerable Adults training strategy) 95% Number of staff trained/ Number of identified staff requiring training Monthly

  • Product Recalls The Company is not aware of any pattern or series of claims against the Company or any of its subsidiaries which reasonably could be expected to result in a generalized product recall relating to products sold by the Company or any of its subsidiaries, regardless of whether such product recall is formal, informal, voluntary or involuntary.

  • 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, Registration Statement, the Pricing Disclosure Package or the Prospectus were and, if still pending, are being conducted in all material respects in accordance with applicable laws, rules, regulations and policies of the Food and Drug Administration of the U.S. Department of Health and Human Services (the “FDA”) or any committee thereof or of any other U.S. or foreign government or drug or medical device regulatory agency, or health care facility Institutional Review Board; 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 materially inconsistent with, or otherwise call into question, the results described or referred to in the Registration Statement, the Pricing Disclosure Package or the Prospectus; for such studies that have been or are being conducted, the Company and its subsidiaries have made all such filings and obtained all such approvals as may be required by foreign government or drug or medical device regulatory agencies, or foreign health care facility Institutional Review Boards; and no investigational new drug application filed by or on behalf of the Company or any of its subsidiaries with the FDA has been terminated or suspended by the FDA, and neither the FDA nor any applicable foreign regulatory agency has commenced, or, to the knowledge of the Company, threatened to initiate, any action to place a clinical hold order on, or otherwise terminate, delay or suspend, any proposed or ongoing studies conducted or proposed to be conducted by or on behalf of the Company or any of its subsidiaries.

  • Packaging and Labeling Seller shall properly xxxx, xxxx, and ship Goods and provide Buyer with shipment documentation showing the Order number, Seller’s identification number for the subject Goods, the quantity of goods in shipment and the number of cartons or containers in the shipment.

  • Product Specifications The Company agrees that all Products sold to Xxxx hereunder shall conform to the respective specifications set forth on Schedule A or to such other specifications as are from time to time agreed upon by the Parties.

  • Regulatory Compliance a. Monitor compliance with the 1940 Act requirements, including:

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