Compliance of Products. (a) Each Loan Party:
(i) except as set forth on Schedule 6.26(a), has been operating in compliance in all material respects with all reporting and regulatory requirements imposed upon it as well as the Specified Laws, including reporting to FDA and other agencies, to include state government agencies of product deviations, contamination or of device malfunctions and/or device-related serious injuries or deaths and reporting to FDA of Corrections or Removals, when and as required under the FDCA;
(ii) has not, and none of its officers, directors, employees, shareholders, their agents or affiliates have, made an untrue statement of material fact or fraudulent statement to the FDA or failed to disclose a material fact required to be disclosed to the FDA, committed an act, made a statement, or failed to make a statement that could reasonably be expected to provide a basis for the FDA to invoke its policy respecting “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities,” set forth in 56 Fed. Regulation 46191 (September 10, 1991);
(iii) has not received any notice that any Governmental Authority, including the FDA, the Office of the Inspector General of HHS, the United States Department of Justice or any equivalent foreign agency, has commenced or threatened to initiate any action to enjoin a Loan Party, or any of its officers, directors, employees, shareholders, agents or Affiliates, from conducting their respective businesses at any facility owned or used by any of them, or for any material civil penalty, injunction, seizure or criminal action, or which would result in the revocation, transfer, surrender, suspension or other material impairment of any material portion of the Required Permits;
(iv) is not a participant in any federal program whereby any federal, state or local government or quasi-governmental body, agency, board or other authority may have the right to recover funds by reason of the advance of federal funds, including those authorized under the Xxxx-Xxxxxx Act (42 U.S.C. 291, et seq.);
(v) has not been threatened to be (A) excluded from United States health care programs pursuant to 42 U.S.C. §1320a7 and related regulations, (B) “suspended” or “debarred” from selling products to the United States government or its agencies pursuant to the Federal Acquisition Regulation, relating to debarment and suspension applicable to federal government agencies generally (48 C.F.R. Subpart 9.4), or other applicable Laws or regulations, ...
Compliance of Products. (a) The Issuer and its Subsidiaries have obtained all required Regulatory Authorizations necessary for compliance with all Laws for its respective business as presently conducted and all such Regulatory Authorizations are in full force and effect except to the extent the failure to do so could not reasonably be expected to have a material adverse effect on the Businesses or Product Development and Commercialization Activities concerning any Product. All Regulatory Authorizations held by the Credit Parties and their respective Subsidiaries are (i) legally and beneficially owned exclusively by Credit Parties or their respective Subsidiaries, free and clear of all Liens other than Permitted Liens, and (ii) validly registered and on file with the applicable Regulatory Agency, in compliance with all filing and maintenance requirements (including any fee requirements) thereof, and are in good standing, valid and enforceable with the applicable Regulatory Agency except to the extent the failure to do so could not reasonably be expected to have a material adverse effect on the Businesses or Product Development and Commercialization Activities concerning any Product. All required notices, registrations and listings, supplemental applications or notifications, reports (including reports of adverse experiences) and other required filings with respect to the Products for which Issuer or its Subsidiaries have such filing responsibility or control over have been filed with the FDA, the DEA, and all other applicable Regulatory Agencies when due, except where the failure to do so could not reasonably be expected to result in (x) a material adverse effect on any Product Development and Commercialization Activities or (y) a Material Adverse Effect.
(b) Except where the failure to do so could not reasonably be expected to result in the termination or restriction of a Material Regulatory Authorization, all applications, notifications, submissions, information, claims, reports and statistics and other data and conclusions derived therefrom, utilized as the basis for or submitted in connection with any and all requests made by, on behalf of, or for the benefit of the Issuer or any of its Subsidiaries for a Regulatory Authorization from the FDA or other Regulatory Agency relating to the Issuer’s or any Subsidiary’s business operations and Products, when submitted to the FDA or other
(c) Except as could not reasonably be expected to result in a material adverse effect on any Prod...
Compliance of Products. (a) Each Credit Party:
(i) has obtained all Required Permits, or has contracted with third parties holding Required Permits, necessary for compliance with all Laws, including the FDCA, and all such Required Permits are current;
(ii) has been operating in compliance with the FDCA, including but not limited to, reporting to FDA of device malfunctions and/or device-related serious injuries or deaths pursuant to 21 C.F.R. 803 and reporting to FDA of corrections or removals pursuant to 21 C.F.R. 806;
(iii) warrants and represents that none of its officers, directors, employees, shareholders, their agents or affiliates has made an untrue statement of material fact or fraudulent statement to the FDA or failed to disclose a material fact required to be disclosed to the FDA, committed an act, made a statement, or failed to make a statement that could reasonably be expected to provide a basis for the FDA to invoke its policy respecting "Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities," set forth in 56 Fed. Regulation 46191 (September 10, 1991); and
(iv) has not received any written notice that any Governmental Authority, including without limitation the FDA, the Office of the Inspector General of HHS or the United States Department of Justice has commenced any action against a Credit Party, any action to enjoin a Credit Party, their officers, directors, employees, shareholders or their agents and Affiliates, from conducting their businesses at any facility owned or used by them or to seek any material civil penalty, injunction, seizure or criminal action.
(b) None of the Credit Parties, their Affiliates or any of their respective agents acting or benefiting in any capacity in connection with the transactions contemplated by this Agreement is (i) in violation of any Anti-Terrorism Law, (ii) engages in or conspires to engage in any transaction that evades or avoids, or has the purpose of evading or avoiding, or attempts to violate, any of the prohibitions set forth in any Anti-Terrorism Law, or (iii) is a Blocked Person. No Credit Party nor, to the knowledge of any Credit Party, any of its Affiliates or agents acting or benefiting in any capacity in connection with the transactions contemplated by this Agreement, (x) conducts any business or engages in making or receiving any contribution of funds, goods or services to or for the benefit of any Blocked Person, or (y) deals in, or otherwise engages in any transaction relating to, any propert...
Compliance of Products. In addition to Retailer’s representations and warranties and obligations set forth in Section 2 of the Agreement (“General Product Policy”), Retailer further represents and warrants that (i) it has valid legal title to all Inventory and all necessary rights to perform under this WFS Agreement; (ii) all Inventory and its packaging complies with applicable Laws for marking, labeling, and other requirements; (iii) the Inventory has been produced in compliance with applicable Laws; and (iv) the Inventory complies with Xxxxxxx.xxx restricted products policies.
Compliance of Products. 5.2.1 XXXXXX shall have the right to ensure that all Products comply with the Specifications during the period of fifteen (15) working days following the date of BARRIER's delivery of such Products. In the event XXXXXX finds that the Products do not conform to the Specifications, XXXXXX shall send a notice to BARRIER within the fifteen (15) working day period following delivery. If BARRIER has not received any notice from XXXXXX within such fifteen (15) working days following delivery, XXXXXX shall be deemed to have accepted the Products as is. Such limitations shall not apply as per latent defects. For clarity, XXXXXX shall not have the right to return Products which conform to the applicable Specifications .
5.2.2 If XXXXXX receives Products from BARRIER that do not comply with the Specifications ("non-conforming"), BARRIER shall replace such non-conforming Products with an equal quantity of Product that conforms to the Specifications at no additional cost to XXXXXX. If a shortage exists with respect to a shipment of Products, XXXXXX shall so inform BARRIER, and BARRIER shall make-up such shortage at no additional cost to XXXXXX. The remedies set forth in this Section 5.2.2 shall be the sole and exclusive remedies of XXXXXX with regard to a shortage or non-conforming Products.
5.2.3 If the analysis or assay of a sample of the Products performed by or for XXXXXX indicates that the batch of Products does not meet Specifications and ** Certain information in this exhibit has been omitted and will be filed separately with the Securities and Exchange Commission pursuant to a confidential treatment request. BARRIER's analysis or assay of its sample from the same batch indicates that the batch does meet Specifications, BARRIER will so advise XXXXXX and a joint investigation will be conducted to determine the cause of the failure.
5.2.4 If the Products are proven to meet Specifications, then XXXXXX shall be responsible for the cost of the joint investigation and any independent Third Party testing of Products.
5.2.5 If the Products are proven not to meet Specifications in a material way that is likely to affect the Products, BARRIER shall be responsible for the cost of the joint investigation and any independent Third Party testing of Products, and shall replace such Products at its own cost.
Compliance of Products. The Company undertakes to deliver products that comply with the specifications of the order in terms of measures and quality of the net and in compliance with the provisions in force. In case of default, contact us via the email address xxxxxxx@xxxx.xxxxxxxxxxxxxxxxx.xxx to review the alternatives. The product does not constitute a defect of conformity as a result of non-compliance with the instructions for use listed in the Product Information Sheet available prior to purchase under the "Description" of the product.
Compliance of Products. The provisions of this Clause 4 shall at all times be subject to the provisions of the Research Agreement.
4.1. The Licensee shall ensure that all Products supplied by or on behalf of the Licensee or any Sub-licensee:-
4.1.1. are safe, non-hazardous and comply with all regulatory requirements applying to such Products in the relevant country within the Territory.
4.2. The Licensor makes no representations or warranties that the Products will be safe or non-hazardous. The Licensee will be responsible for any product liability claims relating to the Products licensed to the Licensee hereunder and their use and the Licensor, its officers, employees and agents will have no liability to the Licensee or any Sub-Licensee whether in contract, tort, negligence or otherwise for any loss or damage arising out of or in connection with the manufacture, supply or development of any Products by or on behalf of the Licensee or any Sub-Licensee which are not safe or are hazardous.
4.3. The Licensee shall indemnify the Licensor and keep the Licensor fully indemnified against any and all liability, losses damages, costs, claims and expenses (including legal expenses) actually incurred by the Licensor, the Medical School and the Trust and arising out of or in connection with:-
4.3.1. any manufacture, use, distribution or supply of the Products by or on behalf of the Licensee or any Sub-licensee; or
4.3.2. any use by a third party of any Products manufactured and/or supplied by or on behalf of the Licensee or any Sub-licensee where such liability, damages, losses, costs, claims or expenses are suffered, incurred or experienced by the Licensor (or Medical School or Trust) as a result of the negligence, breach of statutory duty or breach of any of the provisions of this Agreement on the part of the Licensee, its directors, officers, employees, agents or any Sub- licensee.
