Product Label and Insert definition

Product Label and Insert means (a) all labels and other written, printed or graphic matter affixed to any container, packaging or wrapper utilized with the Product, or (b) any written material physically accompanying the Product, including Product package inserts.
Product Label and Insert means (i) any display of written, printed or graphic matter upon the immediate container, outside container, wrapper or other packaging of the Licensed Product or (ii) any written, printed or graphic material on or within the package from which the Licensed Product is to be dispensed and is reviewed and approved from time to time by a Regulatory Authority from time to time.
Product Label and Insert means, with respect to a Licensed Product for use in the Field, (a) any display of written, printed or graphic matter upon the container in which the Licensed Product is immediately contained, outside container, wrapper or other packaging of the Licensed Product, and (b) any written, printed or graphic material on or within the package from which the Licensed Product is to be dispensed, including any package insert or other patient information provided with the Licensed Product.

Examples of Product Label and Insert in a sentence

  • Xxxxxxx may revise, update or develop additional Promotional Materials from time to time during the Term, as deemed necessary and appropriate by Xxxxxxx, including based on: (i) changes in the Product Label and Insert; (ii) requirements or mandates of the FDA or other Regulatory Authorities or any Laws; or (iii) changes in the Promotion Rules.

  • Any statement, claim or comment that is contained in the Promotional Materials or the Product Label and Insert, in each case, as in effect when such statement, claim or comment is made, shall be deemed not to violate this Section 11.5.1.

  • Any resulting filing with respect to the Product Label and Insert for the Combination Product shall be governed by Section 4.4(b) and any documentation required in connection with such filing shall be exchanged to the extent and in the manner set forth in Section 4.3.

  • For clarity, a Party shall not be required to obtain the other Party’s prior written approval for the use of the approved Product Label and Insert for the Combination Product, notwithstanding the fact that such Product Label and Insert may contain such other Party’s name, company logo/identifiers or the Trademark for such other Party’s Stand-Alone Product.

  • Company shall use only the Promotional Materials provided by Xxxxxxx and the Product Label and Insert in its Promotion of the Product in the Territory.

  • The Core Promotional Materials shall also be subject to revision by MLNM during the Co-Promotion Term as deemed necessary and appropriate by MLNM based on (a) changes in the Product Label and Insert or (b) suggestions, requirements or mandates of the FDA or other Governmental Authorities and/or Applicable Law.

Related to Product Label and Insert

  • Product Labeling means, with respect to a Licensed Product in a country or other jurisdiction in the Territory, (a) the Regulatory Authority‑approved full prescribing information for such Licensed Product for such country or other jurisdiction, including any required patient information, and (b) all labels and other written, printed, or graphic matter upon a container, wrapper, or any package insert utilized with or for such Licensed Product in such country or other jurisdiction.

  • Product brand name means the name of the product exactly as it appears on the principal display panel of the product.

  • Product Know-How means Know-How to the extent related to the properties, manufacture or use of any products.

  • Brand Features means the trade names, trademarks, service marks, logos, domain names, and other distinctive brand features of each party, respectively, as secured by such party from time to time.

  • Product name means the name of the commercial feed which identifies it as to kind, class, or specific use.

  • Fully Burdened Manufacturing Cost means, with respect to any Licensed Product supplied by or on behalf of NVCR to Zai hereunder if such Licensed Product (or any precursor or intermediate thereof) is manufactured by a Third Party manufacturer [***].

  • 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.

  • Switched Access Detail Usage Data means a category 1101xx record as defined in the EMI Telecordia Practice BR 000-000-000.

  • Product Category means the applicable category which best describes the product as listed in this Section 94508.

  • Product Manufacturer means the entity that assembles the component parts to manufacture the final Product;

  • Licensing Site means xxxx://xxx.xxxxxxxxx.xxx/licensing/contracts or a successor site.

  • Existing Product means any formulation of the same product category and form sold, supplied, manufactured, or offered for sale in California prior to the following dates, or any subsequently introduced identical formulation:

  • CREFC® Intellectual Property Royalty License Fee Rate With respect to each Mortgage Loan, a rate equal to 0.0005% per annum.

  • Vehicle protection product means a vehicle protection device, system, or service that is:

  • Custom Products Products, preliminary, final or otherwise, which are created or developed by Contractor, its subcontractors, partners, employees or agents for Authorized User under the Contract.

  • Tobacco product manufacturer means an entity that after the date of enactment of this Act directly (and not exclusively through any affiliate):

  • Existing Products Tangible Products and intangible licensed Products that exist prior to the commencement of work under the contract. Existing Products must be identified on the Product prior to commencement of work or else will be presumed to be Custom Products.

  • Product Group or “the Group” means a group of lotteries that has joined together to offer a product pursuant to the terms of the Multi-State Lottery Agreement and the Product Group’s own rules.

  • Non-Microsoft Product means any third-party-branded software, data, service, website or product, unless incorporated by Microsoft in a Product.

  • Licensed Trademarks means the trademarks, service marks, trade dress, logos and other icons or indicia designated by SCEA in the SourceBook 2 or other Guidelines for use on or in connection with Licensed Products. Nothing contained in this Agreement shall in any way grant Publisher the right to use the trademark "Sony" in any manner. SCEA may amend such Licensed Trademarks from time to time in the SourceBook 2 or other Guidelines or upon written notice to Publisher.

  • Manufacturing Site means the facilities where a Compound is Manufactured by or on behalf of a Party, as such Manufacturing Site may change from time to time in accordance with Section 8.7.

  • Program Materials means the documents and information provided by the Program Administrator specifying the qualifying EEMs, technology requirements, costs and other Program requirements, which include, without limitation, program guidelines and requirements, application forms and approval letters.

  • Brand Name Drug means a Prescription Drug that has been given a name by a manufacturer or distributor to distinguish it as produced or sold by a specific manufacturer or distributor and may be used and protected by a trademark.

  • Off-label use means the prescription and use of drugs for indications other than those stated in the labeling approved by the federal Food and Drug Administration.[PL 1997, c. 701, §1 (NEW).]

  • SONIA Compounded IndexStart means, with respect to an Interest Accrual Period, the SONIA Compounded Index determined in relation to the day falling the Relevant Number of London Banking Days prior to the first day of such Interest Accrual Period; and

  • Manufacturing Know-How means all information, techniques, inventions, discoveries, improvements, practices, methods, knowledge, skill, experience and other technology, whether or not patentable or copyrightable, and any copyrights based thereon, relating to or necessary or useful for the production, purification, packaging, storage and transportation of Collaboration Products, including without limitation specifications, acceptance criteria, manufacturing batch records, standard operating procedures, engineering plans, installation, operation and process qualification protocols for equipment, validation records, master files submitted to the FDA, process validation reports, environmental monitoring processes, test data including pharmacological, toxicological and clinical test data, cost data and employee training materials.