|PERNIX THERAPEUTICS HOLDINGS, INC. filed this Form 8-K on 02/19/2019|
"Prepetition DDTL Loan Documents" means the "Loan Documents", as defined in the Prepetition DDTL Agreement.
"Prepetition DDTL Obligations" means the "Obligations", as defined in the Prepetition DDTL Agreement.
"Product Approvals" means the Regulatory Approvals for each Product, together with all supporting documents, submissions, correspondence, reports and clinical studies relating to such Regulatory Approvals (including, without limitation, documentation of pharmacovigilance, good clinical practice, good laboratory practice and good manufacturing practice).
"Product Intellectual Property" means all Intellectual Property owned, licensed, used or held for use by or on behalf of a Seller with respect to the Products, including all Intellectual Property listed on Section 1.1(d) of the Disclosure Letter, but excluding (a) the Pernix Marks and (b) any Intellectual Property that is an Excluded Asset.
"Product Marketing Materials" means to the extent related to the Business, all advertising, promotional, selling and marketing materials in written or electronic form existing as of the Closing and owned or controlled by a Seller.
"Product Regulatory Materials" means (a) all adverse event reports and other data, information and materials relating to adverse experiences with respect to each Product; (b) all written notices, filings, communications or other correspondence between any Seller, on the one hand, and any Governmental Authority, on the other hand, relating to each Product, including any safety reports or updates, complaint files and product quality reviews, and clinical or pre-clinical data derived from clinical studies conducted or sponsored by a Seller, which data relates to each Product; and (c) all other information regarding activities pertaining to each Product's compliance with any law or regulation of any jurisdiction, including audit reports, corrective and preventive action documentation and reports, and relevant data and correspondence, maintained by or otherwise in the possession of any Seller as of the Closing Date.
"Product Working Capital Assets" means the assets identified as the Product Working Capital Assets in the Reference Statement.
"Product Working Capital Liabilities" means (i) the liabilities identified as the Product Working Capital Liabilities in the Reference Statement and (ii) without duplication of any amount included in the calculation of prong (i), all Cure Costs required to be paid by Buyer under this Agreement in respect of any Designated Contract (other than any Royalty Contract).
"Products" means those products listed in Section 1.1(e) of the Disclosure Letter. Notwithstanding the foregoing, (i) if the Treximet Assets are Excluded Assets pursuant to Section 2.2(o), then "Products" shall exclude the Treximet Products and (ii) if any other products listed in Section 1.1(e) of the Disclosure Letter (or a material portion of the assets (including the Product Approvals) related to any such product) are designated as Excluded Assets pursuant to Section 2.1(b), then "Products" shall exclude such product(s).