Product Profile definition

Product Profile means the Product profile described in Schedule 1.114 hereto.
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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.
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Product Profile means any of the following:
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Examples of Product Profile in a sentence

  • 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.

  • 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.).

  • 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 [***].

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

  • Using the Target Product Profile as a guide in its decision making, ChemoCentryx shall conduct all studies it determines appropriate, applying at all times its Diligent Efforts, and shall select such Collaboration Compound it determines has met the Development Candidate Criteria and is appropriate for nomination by the JSC as a Development Candidate, and shall propose to the JSC such Collaboration Compound as a Development Candidate.

  • The Early Development Plan with respect to a Development Candidate, including each Target Product Profile and the design of any PoC Trials, will be reviewed as necessary at each meeting of the JPS, and at any other time upon the request of either Party, and may be modified by the JPS or JSC as appropriate to reflect material scientific or commercial developments, subject to Section 3.6.4 and all other applicable provisions of this Agreement.

  • The JSC shall review and approve such Target Product Profile for Collaboration Compounds directed against each Collaboration Target.

  • In the event of a disagreement at the JSC, GSK shall have the final say on the content of the Target Product Profile.

  • For each Collaboration Target, GSK shall establish and submit an aspirational Target Product Profile for adoption by the JSC.


More Definitions of Product Profile

Product Profile. The analysis made by Monex with respect to each type of Financial Product based on the disclosed public information, under the terms of the General provisions applicable to brokerage firms and credit institutions on investment services matters.
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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.
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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...
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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.
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Related to Product Profile

  • DNA profile means a letter or number code which represents a set of identification characteristics of the non-coding part of an analysed human DNA sample, i.e. the particular molecular structure at the various DNA locations (loci);

  • DRS/Profile means the system for the uncertificated registration of ownership of securities pursuant to which ownership of ADSs is maintained on the books of the Depositary without the issuance of a physical certificate and transfer instructions may be given to allow for the automated transfer of ownership between the books of DTC and the Depositary. Ownership of ADSs held in DRS/Profile is evidenced by periodic statements issued by the Depositary to the Holders entitled thereto.

  • Milk product or "dairy product" means cottage cheese, dry curd cottage cheese, reduced fat cottage cheese, lowfat cottage cheese, cream, light cream, light whipping cream, heavy cream, heavy whipping cream, whipped cream, whipped light cream, sour cream, acidified sour cream, cultured sour cream, half-and-half, sour half-and-half, acidified sour half-and-half, cultured sour half-and-half, reconstituted or recombined milk and milk products, concentrated milk, concentrated milk products, skim milk, lowfat milk, frozen milk concentrate, flavored milk, eggnog, buttermilk, cultured milk, cultured lowfat milk, cultured skim milk, yogurt, lowfat yogurt, nonfat yogurt, acidified milk, acidified lowfat milk, acidified skim milk, low-sodium milk, low-sodium lowfat milk, low-sodium skim milk, lactose-reduced milk, lactose-reduced lowfat milk, lactose-reduced skim milk, aseptically processed and packaged milk, milk products with added safe and suitable microbial organisms, and any other milk product made by the addition or subtraction of milkfat or addition of safe and suitable optional ingredients for protein, vitamin, or mineral fortification. Unless a product is considered a milk product under this subdivision, milk product does not include dietary products, infant formula, ice cream or other desserts, cheese, or butter. Milk products include the following:

  • Feed ingredient means each of the constituent materials making up a commercial feed.

  • Disinfection profile means a summary of daily Giardia lamblia inactivation through the treatment plant. The procedure for developing a disinfection profile is contained in s. NR 810.32.