Common use of Compliance of Products Clause in Contracts

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) The Borrower and its Subsidiaries have obtained all Material required Regulatory Authorizations required necessary for the conduct of their business as currently conducted, compliance with all Laws and all such Material Regulatory Authorizations are in full force and effect, without restriction, and all such . All Regulatory Authorizations held by the Loan Parties and their respective Subsidiaries or their licensees are (i) legally and beneficially owned exclusively the by one of the Loan Parties and or their respective Subsidiaries or licenseesSubsidiaries, free and clear of all Liens other than Liens permitted pursuant to Section 8.01Permitted Liens, 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)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 all material 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 on any Product Development and Commercialization ActivitiesMaterial Adverse Effect.