Compliance of Products. (a) Each Credit Party:
Compliance of Products. (a) The Loan Parties represent and warrant:
Compliance of Products. (a) Each Loan Party:
Compliance of Products. (a) The Borrower and its Subsidiaries have obtained all Material Regulatory Authorizations required for the conduct of their business as currently conducted, and all such Material Regulatory Authorizations are in full force and effect, without restriction, and all such Regulatory Authorizations held by the Loan Parties and their respective Subsidiaries or their licensees are (i) legally and beneficially owned exclusively by one of the Loan Parties and their respective Subsidiaries or licensees, free and clear of all Liens other than Liens permitted pursuant to Section 8.01, and (ii) validly registered and on file with the applicable Regulatory Agency, in compliance in all material respects with all filing and maintenance requirements (including any fee requirements) thereof, and are in good standing (to the extent applicable), valid and enforceable with the applicable Regulatory Agency. All required notices, registrations and listings, supplemental applications or notifications, reports (including reports of adverse experiences) and other required filings with respect to all material Products 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 a material adverse effect on any Product Development and Commercialization Activities.
Compliance of Products. (a) Super Holdings and its Subsidiaries have obtained all required Regulatory Authorizations necessary for compliance with all Laws and all such Regulatory Authorizations are in full force and effect. All Regulatory Authorizations held by the Credit Parties and their respective Subsidiaries are (i) legally and beneficially owned exclusively the 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. 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 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 a Material Adverse Effect.
Compliance of Products. (a) Each Borrower and each Subsidiary:
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
Compliance of Products. (a) The Borrowers:
Compliance of Products. (a) The Loan Parties and their Subsidiaries, either directly or through their Product Distributors, have obtained all Regulatory Authorizations necessary to conduct the business as presently conducted, except where the lack of such Regulatory Authorizations could not reasonably be expected to have, individually or in the aggregate, a material adverse effect on any Product Development and Commercialization Activities. All Regulatory Authorizations with respect to Material Products that are held by the Loan Parties and their respective Subsidiaries and Product Distributors are legally and beneficially owned exclusively by one of the Loan Parties or their respective Subsidiaries or Product Distributors, free and clear of all Liens other than Permitted Liens. All Regulatory Authorizations held by the Loan Parties are valid and in full force and effect, except where the failure of any Regulatory Authorization to be valid or in full force and effect, individually or in the aggregate, could not be reasonably expected to have a material adverse effect on any Product Development and Commercialization Activities.
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 .
