Product Profile definition

Product Profile means any of the following:

Product Profile means the Product profile described in Schedule 1.114 hereto.

Product Profile means the recommendations for and limitations upon use of a pharmaceutical product that must be included in product labeling and packaging pursuant to any Regulatory Approval for such product.

Examples of Product Profile in a sentence

• Use of either the USDA or BOC’s seal is voluntary and not required by the NOP.Attach a Single Ingredient Product Profile to list all single ingredient products and/or an Organic Product Profile for each multi-ingredient product requested for certification.

• Impax shall use commercially reasonable efforts to use its proprietary technology in existence as of the Effective Date to formulate a product that meets or approaches the Target Product Profile and to perform standard in vitro analytic testing upon such resulting New Product to determine whether it meets the Target Product Profile criteria.

• Without limiting the generality of the foregoing, Impax shall perform no more than three (3) in vivo pharmacokinetic studies upon such New Product to determine whether it meets the Target Product Profile criteria.

• Target Product Profile: Table summary of the candidate development goals – description of the aspirational product not the specific goals of your proposal (template provided).

• The FDA released the draft guidance document “Guidance for Industry and Review Staff: Target Product Profile – A Strategic Development Process Tool” which may be a helpful resource for developing a TPP.

• It is understood and agreed that the Target Product Profile is aspirational in nature, and that any given Development Candidate may not meet all targeted features and requirements of a given TPP, and that certain features of the TPP may only apply to later stages of Development of a given Development Candidate (such as development of a sustained release formulation, etc.).

• Target Product Profile: Point-of-Care Malaria Infection Detection Test.

• Attach a Single-Ingredient Product Profile (SIPP) listing all single-ingredient products to be certified.

• Attach an Organic Product Profile (OPP) for each multi-ingredient product.

• Within [***] of the designation of an Elected Candidate, Merck shall update, if required, the Target Product Profile from which such Elected Candidate was selected by providing written notice to Moderna of [***].

More Definitions of Product Profile

Product Profile means any of the following: (a) an appropriate dose regimen in C-IBS phase III study showing the efficacy which is not materially less than shown in phase II study (SPI\0211SIB-022) and (b) evidence of the clinical activity in both men and women. “Proprietary Product Information” shall mean (a) all information and data now or hereafter contained in any Drug Approval Application or otherwise submitted in support of any Regulatory Approval to which either Party shall have the right under applicable law, regulations and administrative decisions to refer to, to authorize third parties to refer to and to prohibit third parties from referring to the Initial Indications and, if applicable, Additional Indications and/or New Formulations in the Initial Territory; (b) all data concerning any serious or unexpected adverse events, side effects and contra-indications of the Product which may come to the attention of either Party, its Affiliates or any sublicensee; (c) all data and information in the possession of either Party, its Affiliates or any permitted sublicensee of a Party relating to (i) the pharmacological or toxicological properties of a Product, (ii) pre-clinical or clinical testing and experience in relation to a Product which is not included in any Drug Approval Application and (iii) to the extent reasonably required for purposes of any application for Drug Approval Application, the chemical composition, manufacturing processes and quality control testing of a Product and (d) all other information and data now or hereafter in existence and not in the public domain, which is in the possession of either Party and its Affiliates and which relates in any way to the development, testing, manufacture, marketing, use or sale of the Products, including, without limitation, all such information or data that is developed as a result of the Development and/or Commercialization of the Products hereunder. Notwithstanding the foregoing, any data and information developed or obtained by a Party or its Affiliates or any sublicensee that is not based upon the other Party’s confidential or proprietary information shall not be deemed to be Proprietary Product Information. “Regulatory Approval” shall mean any approvals (including pricing and reimbursement approvals), product and/or establishment licenses, registrations or authorizations of any federal, state or local regulatory agency, department, bureau or other governmental entity, necessary for the manufacture, use, stora...

Product Profile means the Quality Specifications established by Hershey and the Product Recipe for each Product in each Product Category. The Product Profiles are accessible via the Hershey Vendor Portal and may be amended by the Parties from time to time in writing.

Product Profile means, in Case's discretion, all relevant criteria --------------- pertaining to engines of the applicable Case equipment in the applicable region, including, without limitation, the following criteria: (i) engine performance criteria, (ii) availability of the engine, (iii) delivery of the engine, (iv) local content needs, (v) finance terms, and (vi) if a Cummins engine model meets one of the conditions set forth in clause (i) or (ii) of Section 2.3(a) of the ---------- ---- -------------- Engine Supply Agreement, Installed Target Cost.

Product Profile the analysis made by Monex with respect to each type of Financial Product based on public information, pursuant to the general Provisions applicable to brokers and credit institutions regarding investment services.