1.29 Product Labeling shall mean (a) the FDA full prescribing information for the applicable Product, including any required patient information, and (b) all labels and other written, printed or graphic matter upon any container, wrapper or any package insert or outsert utilized with or for such Product. Product Labeling for AcelRx Products will be referred to as AcelRx Product(s) Labeling, and Product Labeling for Tetraphase Products will be referred to as Tetraphase Product(s) Labeling.
1.30 Product Party shall mean, with respect to any AcelRx Product, AcelRx, and, with respect to any Tetraphase Product, Tetraphase.
1.31 Promotional Materials shall mean sales representative training materials and all written, printed, graphic, electronic, audio or video matter, including but not limited to journal advertisements, sales visual aids, leave items, formulary binders, reprints, direct mail, direct-to-consumer advertising, internet postings, and broadcast advertisements, in each case created by the Product Party or on its behalf and used or intended for use by the Parties in connection with the co-promotion of the applicable Product to the Target Audience in the Field hereunder, but excluding any Product Labeling.
1.32 Regulatory Approvals shall mean any approvals (including, but not limited to, NDA approval, labeling, pricing and reimbursement approvals), product, biologic and/or establishment licenses, registrations or authorizations of any federal, state or local regulatory agency, department, bureau or other governmental entity, necessary for the commercial manufacture, use, storage, importation, export, transport or sale of Products in the Territory.
1.33 Sales Force shall mean the AcelRx Sales Force and the Tetraphase Sales Force.
1.34 Secondary Presentation shall mean a Call during which key product attributes of a Product are verbally promoted and detailed in the second position on such Call.
1.35 Target Audience shall mean the appropriate health care provider that may be a user or purchaser of a Product at an institution identified in the applicable Marketing Plan or otherwise approved by the JMSC (such institution being a Target Institution).
1.36 Territory shall mean the United States and its territories and possessions.
1.37 Tetraphase Patents shall mean any patent or patent application in the Territory owned or controlled by Tetraphase during the term of this Agreement relating to Tetraphase Products, including the method of manufacture or the use thereof.
1.38 Tetraphase Product Rights shall have the meaning ascribed in Section 8.3 hereof.
1.39 Tetraphase Products shall mean the proprietary pharmaceutical products of Tetraphase set forth in Schedule A-2.