Material Use definition

Material Use means, with respect to Clinical Data, the inclusion of such Clinical Data in a core report of an NDA filed by ARCHEMIX as evidenced by (i) the use of a bridging study to utilize such Clinical Data, (ii) the elimination for the need to duplicate such Clinical Data, or (iii) the ability to reduce the number of patients enrolled in a clinical trial due to the use of such Clinical Data.
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Material Use means, with respect to Shared Clinical Trial Data, (a) the inclusion of such Shared Clinical Data in a core report of an NDA filed by a Party (as evidenced by (i) the use of a bridging study to utilize such Shared Clinical Data, (ii) the elimination for the need to [***] such Shared Clinical Data through a clinical trial within such Party's respective geographic territory, or (iii) such other reference use of such Shared Clinical Data consistent with clauses (i)-(ii) above), or (b) the use of such Shared Clinical Data by a Party in a manner substantially similar to that contained in a full Clinical Study Report (CSR), as described in ICH Harmonized Guideline E3 (Structure and Content of Clinical Study Reports), and including the appendices specified in Section 16 of such guideline that are applicable to such Party’s NDA. For purposes of clarity, it shall not be deemed to be a Material Use of clinical data if such clinical data is used only to support an NDA filing.
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Material Use means ***.
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Examples of Material Use in a sentence

  • On and after the date of exercise by ImmunoGen of its Co-Development Option for a Co-Developed Product and continuing for the Term of this Agreement, each Party shall provide written notice to the other Party to the extent it intends to make Material Use of any Shared Clinical Trial Data.

  • Preparation Conditions: Site of conjugation Antibody preparation for conjugation: Conjugation reaction conditions Formulation PBS Recommended Storage Conditions 4ºC Material Use For Research Use Only Prepared by: Submitter Name (Last, First) Date prepared Date purified Notebook & Page ***Certain information contained herein has been omitted and filed separately with the Securities and Exchange Commission.

  • MPI will deposit information in escrow pursuant to Section 2.20 identifying each Program Clone of which it elects to make Material Use in research and development activities within ***** after MPI or any of its Affiliates initiates such activities.

  • Preparation Conditions: Site of conjugation Antibody preparation for conjugation: Conjugation reaction conditions Formulation PBS Recommended Storage Conditions 4ºC Material Use For Research Use Only Prepared by: Submitter Name (Last, First) Date prepared Date purified Notebook & Page ***Certain information contained herein has been omitted pursuant to Regulation S-K 601(b)(10).

  • The following exhibits and addendums are attached and hereby made a part of this Lease: X Exhibit "A" Building Floor Plan --- X Exhibit "B" Detailed Floor Plan or Blueprint --- X Exhibit "C" Landlord's Finishing Schedule --- X Exhibit "D" TENANT's and/or Guarantor(s) --- Financial Statement Rider X Exhibit "E" Material Use Rider --- Exhibit "F" Personal Guaranty --- The signatories below warrant that they are duly authorized to enter into this Lease representing the parties hereto.

  • Promptly following the submission of each Regulatory Filing, and any amendments or supplements thereto, the Party making such submission shall provide a full and complete copy of such filing to the other Party for purposes of determining whether the submitting Party has made Material Use of the other Party’s Shared Clinical Trial Data without having paid in full its applicable Shared Clinical Trial Cost Sharing Percentage associated with such Shared Clinical Trial Data.

  • Assumptions Pricing - Prices are USD - Pricing includes raw materials Material Use - The material is GMP and is suitable for use in human clinical trials Timelines - Project start date Jan, 2005.

  • Material Use & Recycling Alcoa is one of the largest and most fully integrated aluminum companies in the world, which means that we have the capabilities to extract raw materials, process them into aluminum, convert the metal into end-use products or make them available to others for further processing, and recycle aluminum products at the end of their useful life.

  • Such final accounting shall also include a reasonably detailed calculation of the net amount that one Party may owe the other Party for such costs in the case of Material Use, as applicable.

  • Upon Material Use of a Program Clone, MPI will promptly deposit the name of such Program Clone in the escrow account in accordance with Lexicon's current labeling method.


More Definitions of Material Use

Material Use means, with respect to Shared Clinical Trial Data, (a) the inclusion of such Shared Clinical Data in a core report of an NDA filed by a Party (as evidenced by (i) the use of a bridging study to utilize such Shared Clinical Data, (ii) the elimination for the need to [***] such Shared Clinical Data through a clinical trial within such Party's respective geographic territory, or (iii) such other reference use of such Shared Clinical Data consistent with clauses (i)-
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Material Use has the meaning set forth in Section 1.1(mm) of the Counterparty License Agreement.
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Material Use means any use of a Lexicon Sequence in a Material Activity by or on behalf of MPI and/or its Affiliates.
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Material Use means [***].
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Material Use means, with respect to Shared Clinical Trial Data, (a) the inclusion of such Shared Clinical Data in a core report of an NDA filed by a Party (as evidenced by (i) the use of a bridging study to utilize such Shared Clinical Data, (ii) the elimination for the need to [***] such Shared Clinical Data through a clinical trial within such Party's respective geographic territory, or (iii) such other reference use of such Shared Clinical Data consistent with clauses (i)- Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934.
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Related to Material Use

  • Industrial use means the use of natural gas, electricity, heat, coal, fuel oil, or other fuels:

  • Material date means the date of publication of notification of various controlled area declared as under:-

  • Industrial User means a nondomestic discharger, as identified in 40 CFR Part 403, introducing pollutants to a POTW.

  • Residential use means the use in or around a home, apartment building, sleeping quarters, and similar facilities or accommodations.

  • Commercial Use means the use to which the material can commercially be put.

  • Medical use means the intentional internal or external administration of radioactive material or the radiation from radioactive material to patients or human research subjects under the supervision of an authorized user.

  • material hoist means a hoist used to lower or raise material and equipment, excluding passengers; "medical certificate of fitness" means a certificate contemplated in regulation 7(8);

  • Alcohol use means the consumption of any beverage, mixture, or preparation, including any medication, containing alcohol.

  • Material Deviation refers to any contents or characteristics of the proposal that is significantly different from an essential aspect or requirement of the RFP, and : (i) substantially alters the scope and quality of the requirements; (ii) limits the rights of UNDP and/or the obligations of the offeror; and (iii) adversely impacts the fairness and principles of the procurement process, such as those that compromise the competitive position of other offerors.

  • Principal use means the use other than one which is wholly incidental or accessory to another use on the same premises.

  • Municipal use means all those uses of water common to the municipal water supply of a city, town, or other similar population group, including uses for domestic purposes, uses for the purposes of commerce, trade or industry, and any other use incidental thereto for any beneficial purpose.

  • Material Intellectual Property means Intellectual Property owned by or licensed to a Grantor and material to the conduct of any Grantor’s business.

  • Material Document Defect As defined in Section 2.03(a) of this Agreement.

  • Material Permit shall have the meaning ascribed to such term in Section 3.1(n).

  • 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).]

  • Conditional use means a land use that, because of its unique characteristics or potential impact on the municipality, surrounding neighbors, or adjacent land uses, may not be compatible in some areas or may be compatible only if certain conditions are required that mitigate or eliminate the detrimental impacts.

  • Material Agreement means any material contract, commitment, agreement (written or oral), instrument, lease or other document, license agreement and agreements relating to intellectual property, to which the Corporation or any Subsidiary are a party or to which any of their property or assets are otherwise bound;

  • Internal Use means use of the Sprinklr Services for Customer’s and/or Customer Affiliates’ general business use, solely for the benefit of Customer and/or Customer Affiliates, but does not include use of the Sprinklr Services to provide any services for the benefit of third parties.

  • Material Permits shall have the meaning ascribed to such term in Section 3.1(m).

  • Material Information means information for which there is a substantial likelihood that a reasonable investor would consider it important in making investment decisions, or information that is reasonably certain to have a substantial effect on the price of a company’s securities. Examples of material information include information regarding dividend changes, earnings estimates, changes in previously released earnings estimates, significant merger or acquisition proposals or agreements, major litigation, liquidity problems, and extraordinary management developments.

  • Material Terms means (i) for Designated FX Transactions, the Settlement Date, amounts of each currency to be delivered by each party, and any other terms considered material in the market, (ii) for Designated Option Transactions, the amounts of each currency, the style (e.g., American or European) of option, the strike price, premium, expiration date, and any other terms considered material in the market, (iii) for Designated Bullion Trade Transactions, the Trade Date, Purchaser, Seller, Bullion, number of Ounces, Contract Price, Value Date, and any other material terms and (iv) for Designated Bullion Option Transactions, Trade Date, Buyer, Seller, Bullion, number of Ounces, style, type, Strike Price, Expiration Date, Settlement Date, Premium, Premium Payment Date, and any other material terms (terms used in subsection (iii) and (iv) in this definition have the means set forth in the 2005 ISDA Commodity Definitions).

  • General Use Free Writing Prospectus means any Issuer Free Writing Prospectus that is identified on Schedule B to this Agreement.

  • Material Company means, at any time:

  • Material Property means all Real Property owned in fee in the United States by any Credit Party, in each case, with a fair market value of $7,425,000 (as determined by the Borrower in good faith) or more, as determined (i) with respect to any Real Property owned by any Credit Party on the Closing Date, as of the Closing Date, and (ii) with respect to any Real Property acquired by a Credit Party after the Closing Date, as of the date of such acquisition.

  • Institutional use means use within the lines of, or on property necessary for the operation of buildings such as hospitals, schools, libraries, auditoriums, and office complexes.

  • Residential Uses means lands, Buildings or structures or portions thereof used, or designed or intended for use as a home or residence of one or more individuals, and shall include Single Detached Dwelling, Semi-Detached Dwelling, Multiple Dwelling, Apartment Dwelling, and the residential portion of a mixed-use Building or structure;