Manuscript in relation to a work, means the original document embodying the work whether written by hand or not;
Accepted Author Manuscripts An accepted author manuscript is the manuscript of an article that has been accepted for publication and which typically includes author- incorporated changes suggested during submission, peer review and editor-author communications. Published journal article (JPA): A published journal article (PJA) is the definitive final record of published research that appears or will appear in the journal and embodies all value-adding publishing activities including peer review co-ordination, copy-editing, formatting, (if relevant) pagination and online enrichment.
Biosimilar Application has the meaning set forth in Section 7.3.3.
Approval Application means a BLA, NDA or similar application or submission for a Product filed with a Regulatory Authority in a country or group of countries to obtain marketing approval for a biological or pharmaceutical product in that country or group of countries.
Submitted Order has the meaning specified in Section 11.10(d)(i) below.
Advertising Materials means all advertising, merchandising, promotional and display materials of or concerning the Licensed Products.
Unproven/ Experimental treatment means the treatment including drug experimental therapy which is not based on established medical practice in India.
Meeting Materials means the notice of meeting, the Circular and the form of proxy in respect of the Meeting which accompanies the Circular.
Drug Approval Application means an application for Regulatory Approval required before commercial sale of a Product as a pharmaceutical product in a regulatory jurisdiction.
Peer-reviewed medical literature means a scientific study published only after having been critically
FDA means the United States Food and Drug Administration and any successor agency thereto.
MFDA means the Mutual Fund Dealers Association of Canada;
Brochure means the current Course brochure in which the Course was advertised;
Artwork has the meaning set forth in Section 1.6(a).
Printed Materials means all artwork and mechanicals set forth on the disc label of the PlayStation Disc relating to any of the Licensed Products and on or inside any Packaging for the Licensed Product, and all instructional manuals, liners, inserts, trade dress and other user information to be inserted into the Packaging.
Protocols means written directions and orders, consistent with the department’s standard of care, that are to be followed by an emergency medical care provider in emergency and nonemergency situations. Protocols must be approved by the service program’s medical director and address the care of both adult and pediatric patients.
Request for Proposals or “RFP” means all documents, including those attached or incorporated by reference, used for soliciting proposals.
Promotional Material means all material used in the promotion of, or otherwise in connection with, the Business (whether written or recorded in any other medium) and includes artwork, advertising materials (irrespective of the medium in which they are recorded), display materials, packaging materials, brochures, posters and internal and external signage.
Specifications means the Specifications of the Works included in the Contract and any modification or addition made or approved by the Project Manager.
Request for Proposal or “RFP” means all documents, including those attached or incorporated by reference, used for soliciting proposals.
Regulatory Submissions means any filing, application or submission with any Regulatory Authority, including authorizations, approvals or clearances arising from the foregoing, including Regulatory Approvals and any pricing or reimbursement approvals, as applicable, and all correspondence or communication with or from the relevant Regulatory Authority, as well as minutes of any material meetings, telephone conferences or discussions with the relevant Regulatory Authority, in each case, with respect to a Licensed Product.
Request for Proposals (RFP means all documents, including those attached or incorporated by reference, used for soliciting proposals.
Responsive Proposal means a Proposal that complies with the material provisions of this RFP.
Regulatory Approval Application means any application submitted to an appropriate Regulatory Authority seeking any Regulatory Approval.
Material safety data sheet or "MSDS" means the chemical, physical, technical, and safety information document supplied by the manufacturer of the coating, solvent, or other chemical product, usually through the distribution network or retailers.
Promotional Materials means all sales representative training materials and all written, printed, graphic, electronic, audio or video matter, including, without limitation, journal advertisements, sales visual aids, formulary binders, reprints, direct mail, direct-to-consumer advertising, internet postings and sites and broadcast advertisements intended for use or used by either Party or its Affiliates or sublicensees in connection with any promotion of a Product.