a request for Confidential Treatment filed separately with the Commission. concepts, data, processes, procedures, methods, techniques, protocols, formulae, trade secrets, Inventions (whether or not patentable), media, research tools, compositions, software, hardware, instruments, documents, works of authorship, formulations, and other physical, chemical or biological materials and information, including, without limitation, clinical and regulatory strategies, test data (including pharmacological, toxicological and clinical test data), analytical and quality control data, manufacturing, patent, marketing and legal data or descriptions, apparatus, prototypes, devices, chemical formulations, compound compositions of matter, product samples, assays and similar information and Inventions. 1.24. "Regulatory Approval" means, with respect to a country in the Territory, all approvals, licenses, registrations, or authorizations by an applicable Regulatory Authority necessary to import, commercialize, transport, store, market and sell Treated Integra Product and/or Partially Treated Integra Product in such country, including labeling, pricing, or reimbursement approvals. 1.25. "Regulatory Authority" means the FDA in the United States, and the equivalent regulatory authority or governmental entity having the responsibility, jurisdiction, and authority to approve the to importation, commercialization, transport, storage, marketing and sale of the Treated Integra Product or Partially Treated Integra Product in any country or jurisdiction outside of the United States. 1.26. "Sale" or "Sales" or "Sell" or "Sold" means the transfer or disposition by Integra or its Affiliates of a Treated Integra Product or a Partially Treated Integra Product for value to Integra Customers in the Territory 1.27. "Territory" means worldwide, during the thirty six (36) month period following Notice of Initial Acceptance of First Product Order. Thereafter, "Territory" may exclude the People's Republic of China ("PRC"), to the extent that Integra has had no sales of Treated Integra Products in that country. In the event that Integra has had no such sales, PcoMed shall give sixty (60) days advance written notice of PcoMed's