“Regulatory Documentation” means all applications, registrations, licenses, authorizations and approvals (including all INDs and Regulatory Approvals), all correspondence submitted to or received from Regulatory Authorities (including minutes and official contact reports relating to any communications with any Regulatory Authority) and all supporting documents and all clinical studies and tests, solely relating to a Product, and all data contained in any of the foregoing, including all INDs, drug approval applications, regulatory drug lists, advertising and promotion documents, clinical data, adverse event files and complaint files but excluding Drug Master Files.
Public Health Laws means all Requirement of Law relating to the procurement, development, clinical and non-clinical evaluation or investigation, product approval or clearance, manufacture, production, analysis, distribution, dispensing, importation, exportation, use, handling, quality, reimbursement, sale, labeling, advertising, promotion, or post-market requirements of any medical device (including any ingredient or component of, or accessory to, the foregoing products) subject to regulation under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. et seq.) and similar state or foreign laws, controlled substances laws, pharmacy laws, or consumer product safety laws.
and exclusively by itself, # and the Change in Control party shall adopt reasonable procedures to be agreed upon in writing to prevent disclosure of Confidential Information of [[Organization A:Organization]], and # if has not exercised its Co-Promotion Option as of the date of such Change in Control, terminate the Co-Promotion Option, and if has exercised its Co-Promotion Option as of the date such Change in Control, terminate s right to co-promote any Co-Promotion Products in the Co-Promotion Territory.
oversee at a high level all Commercialization activities in the Co-Promotion Territory with respect to the Co-Promotion Products;
subject to Section 4.8, upon exercise by of the Co-Promotion Option, a non-exclusive, royalty-free license or sublicense (as the case may be), without the right to grant sublicenses, under the [[Organization A:Organization]] Patents and [[Organization A:Organization]]s interests in the Joint Patents and license grants set forth in Sections 5.2.1, 5.2.2 and 5.2.3, solely for the purposes of performing its obligations as set forth in the Co-Promotion Plan for the Co-Promotion Products in the Co-Promotion Territory, all in accordance with the Co-Promotion Agreement.
Detail means, with respect to a Co-Promotion Product in the Co-Promotion Territory, a face-to-face contact between a sales representative and a physician or other medical professional, during which a primary position detail (as will be defined in the Co-Promotion Agreement) or a secondary position detail (as will be defined in the Co-Promotion Agreement) is made to such Person, in each case as measured by each Partys internal recording of such activity in accordance with the Co-Promotion Agreement; provided, that such meeting is consistent with and in accordance with the requirements of Applicable Law and the Co-Promotion Agreement. When used as a verb, Detail means to engage in a Detail.
Party A shall be responsible for the internal publishing of the internet advertising, including check of vacancy, arrangement of advertising space, and supervision of advertising exposure.
Party B may not return or replace any advertising space for prime time once it determines the date of placement, and shall pay Party A the advertising charges in full according to the execution order. For other advertising space, if Party B is unable to place the advertising on the specified date, it must notify Party A ten natural days before such date. Meanwhile, if Party B fails to place the advertising on the specified date, Party A has the right to dispose of the advertising space.
[Schedule 2.26(a)] of the Company Schedules sets forth the development and testing phase for each Company Product. To the Company’s knowledge, all Company Products are being and have been researched, developed, designed, manufactured, tested, prepared, assembled, packaged, labeled, stored, processed, distributed, and marketed in material compliance with all applicable Health Care Regulatory Laws, including those rules and regulations enacted by any federal, state, or foreign Governmental Entity relating to investigational use, premarket clearance or approval, good laboratory practice, good tissue practice, good clinical practice, good manufacturing practice, labeling, advertising, promotion, recordkeeping, filing of reports, and security.
Regulatory Documentation means all # applications (including all INDs and Drug Approval Applications and other regulatory filings), registrations, licenses, authorizations, and approvals (including Regulatory Approvals), # correspondence and reports submitted to or received from Regulatory Authorities (including minutes and official contact reports relating to any communications with any Regulatory Authority) and all supporting documents with respect thereto, including all regulatory drug lists, advertising and promotion documents, adverse event files, and complaint files, and # Clinical Data and data contained or relied upon in any of the foregoing, in each case ((i), (ii), and (iii)) relating to a Licensed Compound or Licensed Product.
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