Expense Limitations. The expenses charged by either Party to its R&D Account in accordance with Section 4.6.3, shall not be in an amount in excess of *************** of the amount included for such expenses in the then current Annual Development Plan and Budget 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 obligations under the Research Program shall be charged to such Party's R&D Account at the rate 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 Screening Phase or the Research Phase of the Research Program and ************************************, or 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 Phase of the Research Program, provided, however, that only those efforts that are contemplated by the Global Research and Development Plan 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. All payments made by a Party to a Third Party in connection with the performance of its obligations under the Research 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 obligations under the Research 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 Wyeth for use in clinical trials of Compounds or Products, Wyeth shall charge to its R&D Account its Fully Absorbed Standard Cost for such materials, as adjusted to account for manufacturing cost variances allocable to such materials.
Appears in 1 contract
Sources: Collaboration and License Agreement (Viropharma Inc)
Expense Limitations. The expenses charged by either Party to its R&D Account in accordance with Section 4.6.35.3.2 shall not, shall not subject to Section 7.1.4, 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 obligations under the Research Program activities hereunder shall be charged to such Party's R&D Account at the applicable FTE rate 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 set forth in the Screening Phase applicable Annual Research Budget or the Research Phase of the Research Program and ************************************, or 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 Annual Development Phase of the Research Program, Budget; provided, however, that only those efforts that are contemplated by the Global Annual Research Plan and Development Plan 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 obligations activities under the an Annual Research Program 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 obligations activities under the an Annual Research Program 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, 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 Wyeth either Party for use in clinical trials of Compounds R&D Candidates or Collaboration Products, Wyeth 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
Sources: Research and Development (Cambridge Antibody Technology Group PLC)
Expense Limitations. The expenses charged by either Party to its R&D Account in accordance with Section 4.6.34.3.2, shall not be in an amount in excess of *************** of the amount included for such expenses in the then current Annual Research Plan or Annual Development Plan and Budget Plan, 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 obligations under the Research Program activities hereunder shall be charged to such Party's ’s R&D Account at the applicable FTE rate 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 set forth in the Screening Phase applicable Annual Research Plan or the Research Phase of the Research Program and ************************************, or 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 Annual Development Phase of the Research ProgramPlan, provided, however, that only those efforts that are contemplated by the Global Research and Development Plan and/or the applicable Annual Research Plan or 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 Plan or Annual Development 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 obligations activities under the an Annual Research Program 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 obligations activities under the an Annual Research Program 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 obligations ’s activities under the an Annual Research Program Plan or Annual Development Plan (e.g., laboratory animals, compounds that are Development 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 Wyeth either Party for use in clinical trials of Compounds R&D Candidates or Products, Wyeth the supplying Party shall charge to its R&D Account its Fully Absorbed Standard Cost for such materials, as adjusted to account for manufacturing cost variances allocable to such materials.
Appears in 1 contract
Expense Limitations. The expenses charged by either Party to its R&D Account in accordance with Section 4.6.3, shall not be in an amount in excess of *************** of the amount included for such expenses in the then current Annual Development Plan and Budget 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 obligations under the Research Program shall be charged to such Party's R&D Account at the rate 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 Screening Phase or the Research Phase of the Research Program and ************************************, or 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 Phase of the Research Program, provided, however, that only those efforts that are contemplated by the Global Research and Development Plan 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. All payments made by a Party to a Third Party in connection with the performance of its obligations under the Research 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 obligations under the Research 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 Wyeth AHPC for use in clinical trials of Compounds or Products, Wyeth AHPC shall charge to its R&D Account its Fully Absorbed Standard Cost for such materials, as adjusted to account for manufacturing cost variances allocable to such materials.
Appears in 1 contract
Sources: Collaboration and License Agreement (Viropharma Inc)
Expense Limitations. The expenses charged by either Party to its R&D Account in accordance with Section 4.6.35.3.2 shall not, shall not subject to Section 7.1.4, 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 obligations under the Research Program activities hereunder shall be charged to such Party's R&D Account at the applicable FTE rate 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 set forth in the Screening Phase applicable Annual Research Budget or the Research Phase of the Research Program and ************************************, or 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 Annual Development Phase of the Research Program, Budget; provided, however, that only those efforts that are contemplated by the Global Annual Research Plan and Development Plan 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 obligations activities under the an Annual Research Program 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 obligations activities under the an Annual Research Program 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, 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 Wyeth either Party for use in clinical trials of Compounds R&D Candidates or Collaboration Products, Wyeth 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
Sources: Research, Development and Commercialization Agreement (Cambridge Antibody Technology Group PLC)