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 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.

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.

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.

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 activities hereunder related to Development, supply or Commercialization of the Research Program shall Product in the Territory will be charged to such Party's R&D Account accrued and reported at the rate of *************************************, or such other amount as may be agreed to from time to time applicable FTE Rate then 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, effect; provided, however, that only those efforts that relate to the Development or Commercialization of the Product and 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 Accountor Commercialization Plan, except as otherwise or are activities approved in writing hereunder by the JSCJOC or by mutual agreement of the Parties for purposes of Developing or Commercializing the Product in the Territory or under the Supply Agreement for such purposes, will be so accrued and reported. All payments made by a Party (or its Affiliates) to a Third Party in connection with the performance Development and Commercialization of its obligations the Product in the Territory consistent with the [**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission. Development Plan, the Commercialization Plan or activities approved hereunder or under the Research Program shall Supply Agreement for purposes of Developing or Commercializing the Product in the Territory will be charged to such Party's R&D Account at such Party's actual out-of-pocket costaccrued and reported [**]. Expenses incurred by each Party for equipment, materials and supplies utilized [**] in performing its obligations activities under the Research Program shall not be separately charged to such Party's R&D Account, except for those expenses incurred by a Party, Development Plan or Commercialization Plan [**] (with the prior written consent of the JSCJDC or JCC, as applicable, or as expressly provided for in the Development Plan or Commercialization Plan) [**] and to the extent to be used [**] the Commercialization Plan or in procuring Clinical Trial Material or Product for purposes of Development or Commercialization of the Product, as applicable, in the purchase or making Territory, which expenses will be [**]. In the event of equipment, materials or supplies (other than common laboratory supplies, e.g., pipettes, test tubes, petri dishes, reagents, a conflict between this Section 4.2.4 and the like) definition of Supply Price, the definition of Supply Price shall control and in no event is this Section 4.2.4 intended to expand or modify the manner in which Supply Price is calculated. For clarity, a Party may be reimbursed for a cost hereunder and under the Supply Agreement only once for such cost and in no event can an amount be taken as both a deduction under Net Sales and as a reimbursable expense under this Agreement (i.e., no double counting). In no event may a Party include in its Program Expenses any amounts that are constitute an inter-company xxxx-up or profit to be used exclusively in connection with the performance an Affiliate of such Party's obligations under , nor may a Party include any costs incurred prior to the Research Program (e.g.Effective Date. All Third Party contracts executed by a Party for purposes of Development, laboratory animals, compounds that are Development Candidates, Products, placebo supplies, etc.), which expenses supply or Commercialization hereunder shall be charged negotiated on an arm’s length basis. In no event may Ironwood structure its contractual arrangements with Third Parties in a manner designed 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 benefit countries outside the foregoing, in Territory over those within 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 materialsTerritory.

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.

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.