Marketing Approval. None of the Company’s product candidates have received marketing approval from any Regulatory Authority.
Marketing Approval. You may be approved as a Solution Provider under a remarketer relationship or under a complementary marketing relationship, or both, if we approve you to market the same Products and Services under both remarketer and complementary marketing terms, all transactions will be under remarketer terms. You may unilaterally elect not to participate under remarketer terms for a specific transaction or business segment by providing us a signed IBM Business Partner Statement of Election. if you meet the requirements of the Marketing Approval section of the Complementary Marketing Terms Attachment, you may participate under those terms.
Marketing Approval. TRANSMEDICS shall be solely responsible for completing and maintaining all marketing applications required by the regulatory authorities in order to allow the marketing and sale of the Products including but not limited to, all changes to the regulatory filings and dossiers as a result of a change in manufacturing site or modifications to the production process that were approved by TRANSMEDICS prior to implementation.
Marketing Approval. You are approved as a Reseller for Workstation Software under remarketer terms for workstation software to market Programs and Services.
Marketing Approval. Vertex shall have sole authority to obtain and maintain Regulatory Approval to Commercialize Licensed Products and Combination Products in the Major Market Countries and any other country where Vertex determines to Commercialize Licensed Products and/or Combination Products. Vertex will promptly send to Alios copies of all Regulatory Approvals of any Licensed Product or Combination Product (including English translations thereof, if Vertex has in its possession such an English translation) and any material related correspondence with any Governmental Authority in Major Market Countries relating to the marketing of any Licensed Products or Combination Products.
Marketing Approval. Marketing Approval means, with respect to any Agreement Product in a particular jurisdiction, all approvals, licenses, registrations or authorizations necessary for the Commercialization of such Agreement Product in such jurisdiction, including, with respect to the United States, approval of an Approval Application for such Agreement Product by the FDA, with respect to the European Union, approval of an Approval Application for such Agreement Product by the European Commission, and with respect to Japan, approval of an Approval Application for such Agreement Product by the Ministry of Health, Labour and Welfare.
Marketing Approval. You may be approved as a Distributor under a remarketer relationship or under a complementary marketing relationship, or both. If we approve you to market the Products and Services under both remarketer and complementary marketing term transactions will be under remarketer terms. You may unilaterally elect not to participate under remarketer terms for a specific transaction or business segment by providing signed IBM Business Partner Statement of Election. If you meet the requirements o Marketing Approval section of the Complementary Marketing Terms Attachment for Distributors, you may participate under those terms. You are approved to market Products and Services to Business Partners (but not to IBM approved Distributors unless we specify otherwise in your Profile) and to End Users. Your Profile will specify to whom you may market Products and Services.
Marketing Approval. (a) EMMAUS shall obtain MARKETING APPROVAL for CAOMECS in the TERRITORY according to the schedule set out in the section (c) below, and shall maintain quality assurance and pharmacovigilance systems required by the competent authorities and/or under the applicable laws and regulations.
(b) In addition to the PACKAGE, CELLSEED shall provide to EMMAUS all necessary information which has been generated by or for CELLSEED to enable EMMAUS to make MAA filing for CAOMECS in the TERRITORY, if necessary. CELLSEED will provide support to EMMAUS in answering questions from authorities during the regulatory procedure and for post approval regulatory maintenance activities in the TERRITORY.
(c) EMMAUS shall use commercially reasonable efforts to perform its obligation hereunder according to the time schedule for the MARKETING APPROVAL for CAOMECS as set forth in Appendix 2 attached hereto (“PROJECT SCHEDULE”).
Marketing Approval. (a) Forty Million Dollars (US $40,000,000) upon Marketing Approval by the FDA or EMEA of Chondrogen with a label that allows Chondrogen to be marketed as a Pain Therapeutic; and
(b) Forty Million Dollars (US $40,000,000) upon Marketing Approval by the FDA or EMEA of Chondrogen with a label that allows Chondrogen to be marketed for Disease Modification.
(c) For clarity, if the FDA or EMEA grants Marketing Approval that allows Chondrogen to be marketed both as a Pain Therapeutic and for Disease Modification, then both payments in Sections 6.4.2(a) and (b) above shall be payable by Genzyme to Osiris.
Marketing Approval. The Distributor and Somnus shall mutually ------------------ agree who is responsible for costs associated with preparation and filing of all regulatory documents, product clinical trials, registering, licensing and permits required to comply with the laws of regulations of the Territory for sale and distribution of Products. If either party determines that these costs are prohibitive to doing business within the Territory then the contract would be terminated.
