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 ***.

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)-

Examples of Material Use in a sentence

• Material: Use the most suitable material obtained from stripping operations and borrow when required.

• The Sub-recipient shall utilize the WRF’s Material Use Permission Request Form located at ▇▇▇▇://▇▇▇.▇▇▇▇▇▇▇.▇▇▇//funding/Pages/Project-report-guidelines.aspx for securing the foregoing required permission for WRF.

• The Sub-recipient shall utilize the WRF’s Material Use Permission Request Form located at ▇▇▇▇://▇▇▇.▇▇▇▇▇▇▇.▇▇▇//funding/Pages/project-report-guidelines.aspx for securing the foregoing required permission for WRF.

• 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.

• 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.

• Sublessee shall not cause or permit any Hazardous Material Use without the prior written consent of Master Lessor and Sublessor, and in any event Sublessee shall not cause or permit any Hazardous Material Release.

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

• 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.

• 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.

• 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)-(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.

Material Use means any use of a Lexicon Sequence in a Material Activity by or on behalf of MPI and/or its Affiliates.

Material Use has the meaning set forth in Section 1.1(mm) of the Counterparty License Agreement.

Material Use means [***].