Common use of Expense Limitations Clause in Contracts

Expense Limitations. The expenses charged by either Party to its R&D Account in accordance with Section 5.3.2 shall not, subject to Section 7.1.4, be an amount in excess of [***] the amount included for such expenses in the then current Annual Research Budget, Annual Development Budget or Post BLA Filing Annual Budget, as appropriate, unless the JSC recommends and each Party approves such excess expenses. Additionally, the Parties hereby agree that efforts of the employees of a Party or its Affiliates in performing its activities hereunder shall be charged to such Party's R&D Account at the applicable FTE rate set forth in the applicable Annual Research Budget or Annual Development Budget; provided, however, that only those efforts that are contemplated by the Annual Research Plan and the Annual Development Plan shall be chargeable by a Party to its R&D Account, except as otherwise approved in writing by the JSC. The FTE rates set forth in any Annual Research Budget or Annual Development Budget shall be based upon [***]. All payments made by a Party to a Third Party in connection with the performance of its activities under an Annual Research Plan or Annual Development Plan shall be charged to such Party's R&D Account at such Party's actual out-of-pocket cost. Expenses incurred by each Party for equipment, materials and supplies utilized in performing its activities under an Annual Research Plan or Annual Development Plan shall not be separately charged to such Party's R&D Account, except for those expenses incurred by a Party, with the prior written consent of the JSC, [***], which expenses shall be charged to such Party's R&D Account at such Party's actual out-of-pocket expense incurred in purchasing or making such equipment, materials or supplies. Notwithstanding the foregoing, in the case of materials supplied to the Parties by either Party for use in clinical trials of R&D Candidates or Collaboration Products, the supplying Party shall charge to its R&D Account its Cost of Goods Manufactured for Clinical Supplies for such materials, as adjusted to account for customary and usual manufacturing cost variances allocable to such materials.

Appears in 1 contract

Samples: Development and Commercialization Agreement (Cambridge Antibody Technology Group PLC)

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Expense Limitations. The expenses charged by either Party to its R&D Account in accordance with Section 5.3.2 shall not, subject to Section 7.1.4, be an amount in excess of [***] the amount included for such expenses in the then current Annual Research Budget, Annual Development Budget or Post BLA Filing Annual Budget, as appropriate, unless the JSC recommends and each Party approves such excess expenses. Additionally, the Parties hereby agree that efforts of the employees of a Party or its Affiliates in performing its activities hereunder shall be charged to such Party's R&D Account at the applicable FTE rate set forth in the applicable Annual Research Budget or Annual Development Budget; provided, however, that only those efforts that are contemplated by the Annual Research Plan and the Annual Development Plan shall be chargeable by a Party to its R&D Account, except as otherwise approved in writing by the JSC. The FTE rates set forth in any Annual Research Budget or Annual Development Budget shall be based upon [***]. All payments made by a Party to a Third Party in connection with the performance of its activities under an Annual Research Plan or Annual Development Plan shall be charged to such Party's R&D Account at such Party's actual out-of-pocket cost. Expenses incurred by each Party for equipment, materials and supplies utilized in performing its activities under an Annual Research Plan or Annual Development Plan shall not be separately charged to such Party's R&D Account, except ex- cept for those expenses incurred by a Party, with the prior written consent of the JSC, [***], which expenses shall be charged to such Party's R&D Account at such Party's actual out-of-pocket expense incurred in purchasing or making such equipment, materials or supplies. Notwithstanding the foregoing, in the case of materials supplied to the Parties by either Party for use in clinical trials of R&D Candidates or Collaboration Products, the supplying Party shall charge to its R&D Account its Cost of Goods Manufactured for Clinical Supplies for such materials, as adjusted to account for customary and usual manufacturing cost variances allocable to such materials.

Appears in 1 contract

Samples: Development and Commercialization Agreement (Cambridge Antibody Technology Group PLC)

Expense Limitations. The expenses charged by either Party to its R&D Account in accordance with Section 5.3.2 4.3.2, shall not, subject to Section 7.1.4, not be in an amount in excess of [***] * of the amount included for such expenses in the then current Annual Research Budget, Plan or Annual Development Budget or Post BLA Filing Annual BudgetPlan, as appropriate, unless the JSC recommends and each Party approves such excess expenses. Additionally, the Parties hereby agree that efforts of the employees of a Party or its Affiliates in performing its activities hereunder shall be charged to such Party's ’s R&D Account at the applicable FTE rate set forth in the applicable Annual Research Budget Plan or Annual Development Budget; Plan, provided, however, that only those efforts that are contemplated by the Global Research and Development Plan and/or the applicable Annual Research Plan and the or Annual Development Plan shall be chargeable by a Party to its R&D Account, except as otherwise approved in writing by the JSC. The FTE rates set forth in any Annual Research Budget Plan or Annual Development Budget Plan shall be based upon [***]direct costs plus a minimum overhead allocation established by the JSC. All payments made by a Party to a Third Party in connection with the performance of its activities under an Annual Research Plan or Annual Development Plan shall be charged to such Party's ’s R&D Account at such Party's ’s actual out-of-pocket cost. Expenses incurred by each Party for equipment, materials and supplies utilized in performing its activities under an Annual Research Plan or Annual Development Plan shall not be separately charged to such Party's ’s R&D Account, except for those expenses incurred by a Party, with the prior written consent of the JSC, [***]in the purchase or making of equipment, materials or supplies (other than common laboratory supplies, e.g., pipettes, test tubes, petri dishes, reagents, and the like) that are to be used exclusively in connection with the performance of such Party’s activities under an Annual Research Plan or Annual Development Plan (e.g., laboratory animals, compounds that are R&D Candidates, Products, placebo supplies, etc.), which expenses shall be charged to such Party's ’s R&D Account at such Party's ’s actual out-of-pocket expense incurred in purchasing or making such equipment, materials or supplies. Notwithstanding the foregoing, in the case of materials supplied to the Parties by either Party for use in clinical trials of R&D Candidates or Collaboration Products, the supplying Party shall charge to its R&D Account its Fully Absorbed Standard Cost of Goods Manufactured for Clinical Supplies for such materials, as adjusted to account for customary and usual manufacturing cost variances allocable to such materials.

Appears in 1 contract

Samples: Development and Commercialization Agreement (Elan Corp PLC)

Expense Limitations. The expenses charged by either Party to its R&D Account in accordance with Section 5.3.2 4.6.3, shall not, subject to Section 7.1.4, not be in an amount in excess of [***] ********** of the amount included for such expenses in the then current Annual Research Budget, Annual Development Plan and Budget or Post BLA Filing Annual Budget, as appropriate, unless the JSC recommends and the respective R&D management of each Party approves such excess expenses. Additionally, the Parties hereby agree that efforts of the employees of a Party or its Affiliates in performing its activities hereunder obligations under the Research Program shall be charged to such Party's R&D Account at the applicable FTE rate set forth of *******************, or such other amount as may be agreed to from time to time in writing by the Parties, for efforts in support of preclinical studies of a Compound or otherwise performed in the applicable Annual Screening Phase or the Research Budget Phase of the Research Program and ***********************, or Annual such other amount as may be agreed to from time to time in writing by the Parties, for efforts in support of clinical studies of a Compound or Product or otherwise performed as part of the Development Budget; Phase of the Research Program, provided, however, that only those efforts that are contemplated by the Annual Global Research and Development Plan and and/or the applicable Annual Development Plan and Budget shall be chargeable by a Party to its R&D Account, except as otherwise approved in writing by the JSC. The FTE rates set forth in any Annual Research Budget or Annual Development Budget shall be based upon [***]. All payments made by a Party to a Third Party in connection with the performance of its activities obligations under an Annual the Research Plan or Annual Development Plan Program shall be charged to such Party's R&D Account at such Party's actual out-of-pocket cost. Expenses incurred by each Party for equipment, materials and supplies utilized in performing its activities obligations under an Annual the Research Plan or Annual Development Plan Program shall not be separately charged to such Party's R&D Account, except for those expenses incurred by a Party, with the prior written consent of the JSC, [***]in the purchase or making of equipment, materials or supplies (other than common laboratory supplies, e.g., pipettes, test tubes, petri dishes, reagents, and the like) that are to be used exclusively in connection with the performance of such Party's obligations under the Research Program (e.g., laboratory animals, compounds that are Development Candidates, Products, placebo supplies, etc.), which expenses shall be charged to such Party's R&D Account at such Party's actual out-of-pocket expense incurred in purchasing or making such equipment, materials or supplies. Notwithstanding the foregoing, in the case of materials supplied to the Parties by either Party AHPC for use in clinical trials of R&D Candidates Compounds or Collaboration Products, the supplying Party AHPC shall charge to its R&D Account its Fully Absorbed Standard Cost of Goods Manufactured for Clinical Supplies for such materials, as adjusted to account for customary and usual manufacturing cost variances allocable to such materials.

Appears in 1 contract

Samples: Collaboration and License Agreement (Viropharma Inc)

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Expense Limitations. The expenses charged by either Party to its R&D Account in accordance with Section 5.3.2 4.6.3, shall not, subject to Section 7.1.4, not be in an amount in excess of [***] ************ of the amount included for such expenses in the then current Annual Research Budget, Annual Development Plan and Budget or Post BLA Filing Annual Budget, as appropriate, unless the JSC recommends and the respective R&D management of each Party approves such excess expenses. Additionally, the Parties hereby agree that efforts of the employees of a Party or its Affiliates in performing its activities hereunder obligations under the Research Program shall be charged to such Party's R&D Account at the applicable FTE rate set forth of *************************************, or such other amount as may be agreed to from time to time in writing by the Parties, for efforts in support of preclinical studies of a Compound or otherwise performed in the applicable Annual Screening Phase or the Research Budget Phase of the Research Program and ************************************, or Annual such other amount as may be agreed to from time to time in writing by the Parties, for efforts in support of clinical studies of a Compound or Product or otherwise performed as part of the Development Budget; Phase of the Research Program, provided, however, that only those efforts that are contemplated by the Annual Global Research and Development Plan and and/or the applicable Annual Development Plan and Budget shall be chargeable by a Party to its R&D Account, except as otherwise approved in writing by the JSC. The FTE rates set forth in any Annual Research Budget or Annual Development Budget shall be based upon [***]. All payments made by a Party to a Third Party in connection with the performance of its activities obligations under an Annual the Research Plan or Annual Development Plan Program shall be charged to such Party's R&D Account at such Party's actual out-of-pocket cost. Expenses incurred by each Party for equipment, materials and supplies utilized in performing its activities obligations under an Annual the Research Plan or Annual Development Plan Program shall not be separately charged to such Party's R&D Account, except for those expenses incurred by a Party, with the prior written consent of the JSC, [***]in the purchase or making of equipment, materials or supplies (other than common laboratory supplies, e.g., pipettes, test tubes, petri dishes, reagents, and the like) that are to be used exclusively in connection with the performance of such Party's obligations under the Research Program (e.g., laboratory animals, compounds that are Development Candidates, Products, placebo supplies, etc.), which expenses shall be charged to such Party's R&D Account at such Party's actual out-of-pocket expense incurred in purchasing or making such equipment, materials or supplies. Notwithstanding the foregoing, in the case of materials supplied to the Parties by either Party Wyeth for use in clinical trials of R&D Candidates Compounds or Collaboration Products, the supplying Party Wyeth shall charge to its R&D Account its Fully Absorbed Standard Cost of Goods Manufactured for Clinical Supplies for such materials, as adjusted to account for customary and usual manufacturing cost variances allocable to such materials.

Appears in 1 contract

Samples: Collaboration and License Agreement (Viropharma Inc)

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