Common use of Conduct of the Research Program Clause in Contracts

Conduct of the Research Program. 2.5.1 ImmunoGen shall use Commercially Reasonable Efforts to perform its obligations under the Research Program in accordance with the Annual Research Plan. As part of such efforts, during the Research Program Term, ImmunoGen shall [***]the [***]and [***]necessary to carry out its obligations under the Annual Research Plan, and shall make available the [***]of [***]in each year of the Research Program Term as set forth in Section 2.5.3. In furtherance of the foregoing, the Annual Research Plan shall set forth the [***]of [***]and by Calendar Quarter (or partial Calendar Quarter, as the case may be) and shall set a [***]related to the use of Approved Subcontractors by project and by Calendar Quarter (or partial Calendar Quarter, as the case may be). If, at any time during the Research Program Term, ImmunoGen determines that either the [***]of [***]for a particular Calendar Quarter or the costs related to the use by ImmunoGen of Approved Subcontractors for a particular Calendar Quarter or for the Contract Year is expected to exceed the number or costs set forth in the Annual Research Plan for such Calendar Quarter or for the Contract Year by [***]([***]) or more, ImmunoGen shall convene a special meeting of the Joint Research Committee. The Joint Research Committee shall then determine whether to [***]the use of such [***]or such additional Approved Subcontractor services or whether to [***]the [***]to be[***], such that such [***]or [***]related to the use by ImmunoGen of Approved Subcontractors are[***]. Such determination of the Joint Research Committee shall be set forth in a revised Annual Research Plan as a revised work plan or budget, as the case may be. To the extent agreed to by the Joint Research Committee, [***]may be allocated by the Joint Development Committee to Development activities relating to Collaboration Products or Licensed Products. Subject to ImmunoGen’s right to receive the funding described in Section 2.5.3 below, ImmunoGen shall have the responsibility, at its sole cost and expense, of paying the [***]and [***]of its[***], including any [***]conducting [***]under the Research Program. Except as otherwise provided herein, Aventis shall have no liability as a result of its [***]hereunder to [***]for any[***], [***], [***], [***], [***]and [***]and [***]and [***]incurred by [***]and [***]with the[***]. 2.5.2 During the Research Program Term, Aventis shall use Commercially Reasonable Efforts to perform its obligations under the Research Program in accordance with the Research Plan. 2.5.3 Pursuant to the terms of this Agreement, Aventis will pay to ImmunoGen funds in the amount of [***]in [***]and [***]and [***]in [***]and for any [***]for which the Research Program Term is extended. ImmunoGen shall invoice Aventis for, and Aventis shall fund, a minimum of [***]([***]) [***]in[***], and [***]([***]) [***]in each of [***]and[***]. Subject to Aventis’ right to be reimbursed pursuant to Section 2.5.6 for any excess amounts paid by Aventis, all such payments made pursuant to this Section 2.5.3 shall be non-refundable and non-creditable against any other payments owed by Aventis to ImmunoGen hereunder. The Parties shall mutually agree on the number of [***]to be used for any extension term, based upon the scope of activities to be performed in the Research Program as so extended; provided, however, that Aventis may determine not to exercise its option to extend the Research Program Term in its sole discretion and for any reason including, without limitation, the failure of the Parties to agree on the number of[***]. 2.5.4 Within [***]([***]) [***]after the [***]of [***]during the Research Program Term and the [***]following the expiration or termination of the Research Program Term, [***]will provide to [***]a [***]and [***]the [***]of [***]to the Research Program during each [***]in such[***], along with [***]and[***], together with an [***]of the [***]between such [***]and the [***]of [***]for that[***]. Within [***]([***]) days from the date of its [***]of each such[***], [***]will pay to [***]the [***]as [***]for the [***]by the[***]. For purposes of clarity and pursuant to the [***]set forth in Section 2.5.3, but subject to Sections 2.5.6, 12.2.3, 12.2.7 and 15.6 of this Agreement, or except as otherwise permitted under this Agreement, the [***]to be [***]in [***] will be no less than[***]; the [***]to be [***]in [***]will be no less than [***]and the [***]to be [***]in [***]will be no less than[***]. 2.5.5 Within [***]([***]) [***]after the end of each [***]during the Research Program Term and the [***]following the expiration or termination of the of the Research Program Term, ImmunoGen will provide to Aventis a report setting forth the names of the Approved Subcontractors actually applied to the Research Program during each month in such Calendar Quarter, together with an accounting of the difference between the budgeted costs and the actual costs for Approved Subcontractors for that Calendar Quarter. Within [***]([***]) [***]from the end of each Calendar Quarter, ImmunoGen shall provide to Aventis an invoice setting forth the names of such Approved Subcontractors and the costs incurred and invoiced by such Approved Subcontractors during such Calendar Quarter. Within [***]([***]) [***]from the date of its receipt of each such invoice, Aventis will pay to ImmunoGen any invoice amount due as reimbursement for the work performed by such Approved Subcontractors to the extent such Approved Subcontractors are eligible to be used by ImmunoGen in accordance with Section 2.13 of this Agreement. 2.5.6 During the Research Program Term and for a period of [***]([***]) [***]thereafter, ImmunoGen shall keep and maintain, and shall require its Affiliates and Approved Subcontractors to keep and maintain, accurate and complete laboratory books and other records of activities performed by [***]in performing[***], and by each Approved Subcontractor in performing Approved Subcontractor services, under the Research Program. In furtherance of the foregoing, ImmunoGen shall keep track of the activities of [***]on a [***]as determined by [***]in a manner mutually agreed to by the Parties; it being agreed and understood that [***]to [***]of [***]shall [***]a [***]of the Research Program. ImmunoGen shall [***]this [***]with respect to all of its [***]and[***]. Not more than [***]per[***], [***]shall have the right to engage an independent certified public accounting firm of nationally recognized standing and reasonably acceptable to ImmunoGen, which shall have the right to examine in confidence the relevant books, records or other relevant reports, of ImmunoGen and its respective Affiliates and Approved Subcontractors as may be reasonably necessary to determine and/or [***]of the [***]to [***]and the [***]of [***]applied to the [***]of [***]under the Research Program. For clarity, such examination shall include, without limitation, the right of the certified public accounting firm to examine in confidence reports relating to [***]for all [***]with respect to the Research Program and all of [***]and[***], for the sole purpose of [***]the [***]of the [***]of [***]applied to the [***]of [***]under the Research Program and such accounting firm may not reveal to Aventis any information with respect to [***]and[***]. Such examination shall be conducted, and ImmunoGen shall make its records available, during normal business hours, after at least [***]([***]) [***]prior written notice shall have been provided by Aventis to ImmunoGen, as applicable, and shall take place at the Facility(ies) where such records are maintained. Each such examination shall be limited to pertinent books, records or reports for any year ending not more than [***]([***]) months prior to the date of request; provided, that, Aventis shall not be permitted to audit the same period of time more than once. Before permitting such independent accounting firm to have access to such books and records, ImmunoGen may require such independent accounting firm and its personnel involved in such audit, to sign a confidentiality agreement (in form and substance reasonably acceptable to each of the Parties) as to any confidential information which is to be provided to such accounting firm or to which such accounting firm will have access, while conducting the audit under this paragraph. The accounting firm shall provide both ImmunoGen and Aventis with a written report stating whether the reports submitted by ImmunoGen are correct or incorrect and the specific details concerning any discrepancies. Such accounting firm may not reveal to Aventis any information learned in the course of such audit other than the amount of any such discrepancies. Aventis agrees that all such information shall be Confidential Information of ImmunoGen and further agrees to hold in strict confidence all information disclosed to it in accordance with Article 11 of this Agreement, except to the extent necessary for Aventis to enforce its rights under this Agreement or if disclosure is required by law. If the actual [***]in the [***]of the [***]is [***]than that [***]by ImmunoGen, ImmunoGen shall [***](but in no event [***]than [***]([***])[***] after ImmunoGen’s receipt of the independent auditor’s report so correctly concluding) [***]Aventis for any [***]by [***]to [***]pursuant to Section 2.5.3. Aventis shall bear the full cost of such audit unless such audit [***]the [***]in the [***]of [***]under the [***]to be [***]than that [***]by [***]by [***]([***]) or[***], in which case ImmunoGen shall [***]for all [***]by [***]in connection with such audit. 2.5.7 During the period commencing on the Effective Date and continuing for the longer of the termination or expiration of this Agreement and [***]([***]) [***]from the date of filing of any patent application pursuant to Article 10 covering any Product, each Party shall use Commercially Reasonable Efforts to keep and maintain accurate and complete lab notebooks reflecting the screening and other research and development activities performed by such Party under the Research Program. Upon [***]([***]) [***]prior written notice from a Party, the other Party shall permit a Third Party patent expert selected by the first Party and reasonably acceptable to the other Party to examine (at the first Party’s sole cost and expense) the relevant lab notebooks of the other Party, as applicable; provided, that, any such Third Party patent expert shall be required to execute and deliver to the other Party an appropriate confidentiality agreement covering the information contained in the lab notebooks to be examined. 2.5.8 Each Party shall have caused or shall cause each participant in the Research Program to execute such Party’s standard non-disclosure and invention assignment agreement. 2.5.9 Each Party shall identify one of its representatives to serve as a program coordinator with responsibility for overseeing that Party’s day-to-day activities relating to the Research Program and to serve as a contact person for coordinating Research Program activities between the Parties. 2.5.10 Each Party shall identify one of its representatives to serve as a program manager with overall responsibility for achievement of the objectives of the Research Program. Such program manager shall serve as a member of the Joint Research Committee and the Joint Development Committee.

Appears in 1 contract

Sources: Collaboration and License Agreement (Immunogen Inc)

Conduct of the Research Program. 2.5.1 ImmunoGen shall use Commercially Reasonable Efforts to perform its obligations under the Research Program in accordance with the Annual Research Plan. As part of such efforts, during the Research Program Term, ImmunoGen shall [***]** the [***]** and [***]** necessary to carry out its obligations under the Annual Research Plan, and shall make available the [***]** of [***]** in each year of the Research Program Term as set forth in Section 2.5.3. In furtherance of the foregoing, the Annual Research Plan shall set forth the [***]** of [***]** and by Calendar Quarter (or partial Calendar Quarter, as the case may be) and shall set a [***]** related to the use of Approved Subcontractors by project and by Calendar Quarter (or partial Calendar Quarter, as the case may be). If, at any time during the Research Program Term, ImmunoGen determines that either the [***]** of [***]** for a particular Calendar Quarter or the costs related to the use by ImmunoGen of Approved Subcontractors for a particular Calendar Quarter or for the Contract Year is expected to exceed the number or costs set forth in the Annual Research Plan for such Calendar Quarter or for the Contract Year by [***]** ([***]**) or more, ImmunoGen shall convene a special meeting of the Joint Research Committee. The Joint Research Committee shall then determine whether to [***]** the use of such [***]** or such additional Approved Subcontractor services or whether to [***]** the [***]** to be[be ***]**, such that such [***]** or [***]** related to the use by ImmunoGen of Approved Subcontractors are[are ***]**. Such determination of the Joint Research Committee shall be set forth in a revised Annual Research Plan as a revised work plan or budget, as the case may be. To the extent agreed to by the Joint Research Committee, [***]** may be allocated by the Joint Development Committee to Development activities relating to Collaboration Products or Licensed Products. Subject to ImmunoGen’s right to receive the funding described in Section 2.5.3 below, ImmunoGen shall have the responsibility, at its sole cost and expense, of paying the [***]** and [***]** of its[its ***]**, including any [***]** conducting [***]** under the Research Program. Except as otherwise provided herein, Aventis shall have no liability as a result of its [***]** hereunder to [***]** for any[any ***]**, [***]**, [***]**, [***]**, [***]** and [***]** and [***]** and [***]** incurred by [***]** and [***]** with the[the ***]**. 2.5.2 During the Research Program Term, Aventis shall use Commercially Reasonable Efforts to perform its obligations under the Research Program in accordance with the Research Plan. 2.5.3 Pursuant to the terms of this Agreement, Aventis will pay to ImmunoGen funds in the amount of [***]** in [***]** and [***]and [** and***]** in [***]** and for any [***]** for which the Research Program Term is extended. ImmunoGen shall invoice Aventis for, and Aventis shall fund, a minimum of [***]** ([***]**) [***]in[** in ***]**, and [***]** ([***]**) [***]** in each of [***]and[** and ***]**. Subject to Aventis’ right to be reimbursed pursuant to Section 2.5.6 for any excess amounts paid by Aventis, all such payments made pursuant to this Section 2.5.3 shall be non-refundable and non-creditable against any other payments owed by Aventis to ImmunoGen hereunder. The Parties shall mutually agree on the number of [***]** to be used for any extension term, based upon the scope of activities to be performed in the Research Program as so extended; provided, however, that Aventis may determine not to exercise its option to extend the Research Program Term in its sole discretion and for any reason including, without limitation, the failure of the Parties to agree on the number of[of ***]**. 2.5.4 Within [***]([** after the ***]) [** of ***]after the [***]of [***]* during the Research Program Term and the [***]** following the expiration or termination of the Research Program Term, [***]** will provide to [***]** a [***]** and [***]** the [***]** of [***]** ***** to the Research Program during each [***]** in such[such ***]**, along with [***]and[** and ***]**, together with an [***]** of the [***]** between such [***]** and the [***]** of [***]** for that[that ***]**. Within [***]** ([***]**) days from the date of its [***]** of each such[such ***]**, [***]** will pay to [***]** the [***]** as [***]** for the [***]** by the[the ***]**. For purposes of clarity and pursuant to the [***]** set forth in Section 2.5.3, but subject to Sections 2.5.6, 12.2.3, 12.2.7 and 15.6 of this Agreement, or except as otherwise permitted under this Agreement, the [***]** to be [***]** in [***] ** will be no less than[***]** ; the [***]** to be [***]** in [***]** will be no less than [***]** and the [***]** to be [***]** in [***]** will be no less than[than ***]**. 2.5.5 Within [***]** ([***]**) [***]** after the end of each [***]** during the Research Program Term and the [***]** following the expiration or termination of the of the Research Program Term, ImmunoGen will provide to Aventis a report setting forth the names of the Approved Subcontractors actually applied to the Research Program during each month in such Calendar Quarter, together with an accounting of the difference between the budgeted costs and the actual costs for Approved Subcontractors for that Calendar Quarter. Within [***]** ([***]**) [***]** from the end of each Calendar Quarter, ImmunoGen shall provide to Aventis an invoice setting forth the names of such Approved Subcontractors and the costs incurred and invoiced by such Approved Subcontractors during such Calendar Quarter. Within [***]** ([***]**) [***]** from the date of its receipt of each such invoice, Aventis will pay to ImmunoGen any invoice amount due as reimbursement for the work performed by such Approved Subcontractors to the extent such Approved Subcontractors are eligible to be used by ImmunoGen in accordance with Section 2.13 of this Agreement. 2.5.6 During the Research Program Term and for a period of [***]** ([***]**) [***]** thereafter, ImmunoGen shall keep and maintain, and shall require its Affiliates and Approved Subcontractors to keep and maintain, accurate and complete laboratory books and other records of activities performed by [***]** in performing[performing ***]**, and by each Approved Subcontractor in performing Approved Subcontractor services, under the Research Program. In furtherance of the foregoing, ImmunoGen shall keep track of the activities of [***]** on a [***]** as determined by [***]** in a manner mutually agreed to by the Parties; it being agreed and understood that [***]** to [***]** of [***]** shall [***]** a [***]** of the Research Program. ImmunoGen shall [***]** this [***]** with respect to all of its [***]** and[***]**. Not more than [***]per[** per ***]**, [***]** shall have the right to engage an independent certified public accounting firm of nationally recognized standing and reasonably acceptable to ImmunoGen, which shall have the right to examine in confidence the relevant books, records or other relevant reports, of ImmunoGen and its respective Affiliates and Approved Subcontractors as may be reasonably necessary to determine and/or [***]** of the [***]** to [***]** and the [***]** of [***]** applied to the [***]** of [***]** under the Research Program. For clarity, such examination shall include, without limitation, the right of the certified public accounting firm to examine in confidence reports relating to [***]** for all [***]** with respect to the Research Program and all of [***]and[** and ***]**, for the sole purpose of [***]** the [***]** of the [***]** of [***]** applied to the [***]** of [***]** under the Research Program and such accounting firm may not reveal to Aventis any information with respect to [***]and[** and ***]**. Such examination shall be conducted, and ImmunoGen shall make its records available, during normal business hours, after at least [***]** ([***]**) [***]** prior written notice shall have been provided by Aventis to ImmunoGen, as applicable, and shall take place at the Facility(ies) where such records are maintained. Each such examination shall be limited to pertinent books, records or reports for any year ending not more than [***]** ([***]**) months prior to the date of request; provided, that, Aventis shall not be permitted to audit the same period of time more than once. Before permitting such independent accounting firm to have access to such books and records, ImmunoGen may require such independent accounting firm and its personnel involved in such audit, to sign a confidentiality agreement (in form and substance reasonably acceptable to each of the Parties) as to any confidential information which is to be provided to such accounting firm or to which such accounting firm will have access, while conducting the audit under this paragraph. The accounting firm shall provide both ImmunoGen and Aventis with a written report stating whether the reports submitted by ImmunoGen are correct or incorrect and the specific details concerning any discrepancies. Such accounting firm may not reveal to Aventis any information learned in the course of such audit other than the amount of any such discrepancies. Aventis agrees that all such information shall be Confidential Information of ImmunoGen and further agrees to hold in strict confidence all information disclosed to it in accordance with Article 11 of this Agreement, except to the extent necessary for Aventis to enforce its rights under this Agreement or if disclosure is required by law. If the actual [***]** in the [***]** of the [***]** is [***]** than that [***]** by ImmunoGen, ImmunoGen shall [***]** (but in no event [***]** than [***]** ([***])[**) ***] ** after ImmunoGen’s receipt of the independent auditor’s report so correctly concluding) [***]** Aventis for any [***]** by [***]** to [***]** pursuant to Section 2.5.3. Aventis shall bear the full cost of such audit unless such audit [***]** the [***]** in the [***]** of [***]** under the [***]** to be [***]** than that [***]** by [***]** by [***]** ([***]**) or[or ***]**, in which case ImmunoGen shall [***]** for all [***]** by [***]** in connection with such audit. 2.5.7 During the period commencing on the Effective Date and continuing for the longer of the termination or expiration of this Agreement and [***]** ([***]**) [***]** from the date of filing of any patent application pursuant to Article 10 covering any Product, each Party shall use Commercially Reasonable Efforts to keep and maintain accurate and complete lab notebooks reflecting the screening and other research and development activities performed by such Party under the Research Program. Upon [***]** ([***]**) [***]** prior written notice from a Party, the other Party shall permit a Third Party patent expert selected by the first Party and reasonably acceptable to the other Party to examine (at the first Party’s sole cost and expense) the relevant lab notebooks of the other Party, as applicable; provided, that, any such Third Party patent expert shall be required to execute and deliver to the other Party an appropriate confidentiality agreement covering the information contained in the lab notebooks to be examined. 2.5.8 Each Party shall have caused or shall cause each participant in the Research Program to execute such Party’s standard non-disclosure and invention assignment agreement. 2.5.9 Each Party shall identify one of its representatives to serve as a program coordinator with responsibility for overseeing that Party’s day-to-day activities relating to the Research Program and to serve as a contact person for coordinating Research Program activities between the Parties. 2.5.10 Each Party shall identify one of its representatives to serve as a program manager with overall responsibility for achievement of the objectives of the Research Program. Such program manager shall serve as a member of the Joint Research Committee and the Joint Development Committee.

Appears in 1 contract

Sources: Collaboration and License Agreement (Immunogen Inc)

Conduct of the Research Program. 2.5.1 ImmunoGen ViroPharma and AHPC shall each use its respective Commercially Reasonable Efforts to perform its obligations under the Research Program in accordance with the Global Research and Development Plan and the then current Annual Research PlanDevelopment Plan and Budget and each Party shall perform such obligations in accordance with applicable GLPs and GCPs. As part of such efforts, during All activities to be undertaken in the Research Program Term, ImmunoGen shall [***]the [***]and [***]necessary to carry out its obligations under the Annual Research Plan, and shall make available the [***]of [***]in each year performance of the Research Program Term as set forth in Section 2.5.3. In furtherance shall be carried out by employees of the foregoingParties and/or their respective Affiliates, the Annual Research Plan shall set forth the [***]of [***]and by Calendar Quarter (or partial Calendar Quarter, as the case may be) and shall set a [***]related to the use of Approved Subcontractors by project and by Calendar Quarter (or partial Calendar Quarter, as the case may be). If, at any time during the Research Program Term, ImmunoGen determines that either the [***]of [***]for a particular Calendar Quarter or the costs related to the use by ImmunoGen of Approved Subcontractors for a particular Calendar Quarter or for the Contract Year is expected to exceed the number or costs set forth in the Annual Research Plan for such Calendar Quarter or for the Contract Year by [***]([***]) or more, ImmunoGen shall convene a special meeting of the Joint Research Committee. The Joint Research Committee shall then determine whether to [***]the use of such [***]or such additional Approved Subcontractor services or whether to [***]the [***]to be[***], such that such [***]or [***]related to the use by ImmunoGen of Approved Subcontractors are[***]. Such determination of the Joint Research Committee shall be set forth in a revised Annual Research Plan as a revised work plan or budget, as the case may be. To the extent agreed to by the Joint Research Committee, [***]may be allocated by the Joint Development Committee to Development activities relating to Collaboration Products or Licensed Products. Subject to ImmunoGen’s right to receive the funding described in Section 2.5.3 below, ImmunoGen shall have the responsibility, at its sole cost and expense, of paying the [***]and [***]of its[***], including any [***]conducting [***]under the Research Program. Except as otherwise provided herein, Aventis shall have no liability as a result of its [***]hereunder to [***]for any[***], [***], [***], [***], [***]and [***]and [***]and [***]incurred by [***]and [***]with the[***]. 2.5.2 During the Research Program Term, Aventis shall use Commercially Reasonable Efforts to perform its obligations under the Research Program in accordance with the Research Plan. 2.5.3 Pursuant to the terms of this Agreement, Aventis will pay to ImmunoGen funds in the amount of [***]in [***]and [***]and [***]in [***]and for any [***]for which the Research Program Term is extended. ImmunoGen shall invoice Aventis for, and Aventis shall fund, a minimum of [***]([***]) [***]in[***], and [***]([***]) [***]in each of [***]and[***]. Subject to Aventis’ right to be reimbursed pursuant to Section 2.5.6 for any excess amounts paid by Aventis, all such payments made pursuant to this Section 2.5.3 shall be non-refundable and non-creditable against any other payments owed by Aventis to ImmunoGen hereunder. The Parties shall mutually agree on the number of [***]to be used for any extension term, based upon the scope of activities to be performed in the Research Program as so extended; provided, however, that Aventis may determine not if either Party is able to exercise its option reasonably demonstrate, and the JSC agrees, that it would be in the best interests of both Parties to extend contract with one (1) or more Third Parties to perform certain tasks under the Research Program Term in its sole discretion and for any reason including, without limitationProgram, the failure Party responsible for such task may enter into a contract with a Third Party to perform such task, which contract shall be subject to the prior written approval of the Parties JSC. In determining whether to agree on utilize the number of[***]. 2.5.4 Within [***]([***]) [***]after the [***]services of [***]during any Third Party in conducting activities under the Research Program Term Program, the Parties shall consider, inter alia, what would be the most efficient and cost-effective means for accomplishing the [***]following proposed activity, any relevant intellectual property issues that may impede a Third Party's ability to perform the expiration proposed activity or termination that may warrant limiting the performance of the Research Program Term, [***]will provide proposed activity to [***]a [***]and [***]the [***]of [***]to the Research Program during each [***]in such[***], along with [***]and[***], together with an [***]one of the [***]between such [***]Parties, and the [***]of [***]other relevant factors. The responsibility for that[***]. Within [***]([***]) days from the date of its [***]performing clinical studies of each such[***]Product will be assigned to AHPC and/or Third Party contractors selected by the JSC in accordance with this Section 4.5. Notwithstanding the foregoing, [***]will pay ViroPharma shall be given the opportunity to [***]perform three (3) clinical studies in the [***]as [***]for Development of Products in the [***]by the[***]. For purposes of clarity and pursuant to the [***]set forth in Section 2.5.3, but subject to Sections 2.5.6, 12.2.3, 12.2.7 and 15.6 of this Agreement, or except as otherwise permitted Copromotion Territory under this Agreement, the [which clinical studies shall consist of one (1) Phase I Clinical Study, one (1) Phase II Clinical Study and one (1) Phase III Clinical Study ***]to be [***]in [***] will be no less than[***]; the [***]to be [***]in [. Within thirty (30) days of the JSC's deciding that a clinical study on a Product is warranted, ***]will be no less than [***]and the [***]to be [***]in [***]will **. If the JSC agrees, in writing, such agreement not to be no less than[unreasonably withheld, ***]. 2.5.5 Within [***]([***]) [***]after the end of each [***]during the Research Program Term and the [***]following the expiration or termination of the of the Research Program Term, ImmunoGen will provide to Aventis a report setting forth the names of the Approved Subcontractors actually applied to the Research Program during each month in such Calendar Quarter, together with an accounting of the difference between the budgeted costs and the actual costs for Approved Subcontractors for that Calendar Quarter. Within [***]([**, the Annual Development Plan and Budget for the calendar year in which such clinical study is to take place shall assign responsibility for such clinical study to ViroPharma, or be amended to reflect such assignment of responsibility. ***]) [***]from the end of each Calendar Quarter, ImmunoGen shall provide to Aventis an invoice setting forth the names of such Approved Subcontractors and the costs incurred and invoiced by such Approved Subcontractors during such Calendar Quarter. Within [***]([***]) [***]from the date of its receipt of each such invoice, Aventis will pay to ImmunoGen any invoice amount due as reimbursement for the work performed by such Approved Subcontractors to the extent such Approved Subcontractors are eligible to be used by ImmunoGen in accordance with Section 2.13 of this Agreement. 2.5.6 During the Research Program Term and for a period of [***]([***]) [***]thereafter, ImmunoGen shall keep and maintain, and shall require its Affiliates and Approved Subcontractors to keep and maintain, accurate and complete laboratory books and other records of activities performed by [***]in performing[***], and by each Approved Subcontractor in performing Approved Subcontractor services, under the Research Program. In furtherance of * Notwithstanding the foregoing, ImmunoGen shall keep track of the activities of [***]on a [***]as determined by [***]in a manner mutually agreed JSC may assign to by the Parties; it being agreed and understood that [***]to [***]of [***]shall [***]a [***]of the Research Program. ImmunoGen shall [***]this [***]with respect to all of its [***]and[***]. Not more than [***]per[***], [***]shall have the right to engage an independent certified public accounting firm of nationally recognized standing and reasonably acceptable to ImmunoGen, which shall have the right to examine in confidence the relevant books, records or other relevant reports, of ImmunoGen and its respective Affiliates and Approved Subcontractors as may be reasonably necessary to determine and/or [***]of the [***]to [***]and the [***]of [***]applied to the [***]of [***]under the Research Program. For clarity, such examination shall include, without limitation, the right of the certified public accounting firm to examine in confidence reports relating to [***]for all [***]with respect to the Research Program and all of [***]and[***], for the sole purpose of [***]the [***]of the [***]of [***]applied to the [***]of [***]under the Research Program and such accounting firm may not reveal to Aventis any information with respect to [***]and[***]. Such examination shall be conducted, and ImmunoGen shall make its records available, during normal business hours, after at least [***]([***]) [***]prior written notice shall have been provided by Aventis to ImmunoGen, as applicable, and shall take place at the Facility(ies) where such records are maintained. Each such examination shall be limited to pertinent books, records or reports for any year ending not more than [***]([***]) months prior to the date of request; provided, that, Aventis shall not be permitted to audit the same period of time more than once. Before permitting such independent accounting firm to have access to such books and records, ImmunoGen may require such independent accounting firm and its personnel involved in such audit, to sign a confidentiality agreement (in form and substance reasonably acceptable to each of the Parties) as to any confidential information which is to be provided to such accounting firm or to which such accounting firm will have access, while conducting the audit under this paragraph. The accounting firm shall provide both ImmunoGen and Aventis with a written report stating whether the reports submitted by ImmunoGen are correct or incorrect and the specific details concerning any discrepancies. Such accounting firm may not reveal to Aventis any information learned in the course of such audit other than the amount of any such discrepancies. Aventis agrees that all such information shall be Confidential Information of ImmunoGen and further agrees to hold in strict confidence all information disclosed to it in accordance with Article 11 of this Agreement, except to the extent necessary for Aventis to enforce its rights under this Agreement or if disclosure is required by law. If the actual [***]in the [***]of the [***]is [***]than that [***]by ImmunoGen, ImmunoGen shall [***](but in no event [***]than [***]([***])[***] after ImmunoGen’s receipt of the independent auditor’s report so correctly concluding) [***]Aventis for any [***]by [***]to [***]pursuant to Section 2.5.3. Aventis shall bear the full cost of such audit unless such audit [***]the [***]in the [***]of [***]under the [***]to be [***]than that [***]by [***]by [***]([***]) or[***], in which case ImmunoGen shall [***]for all [***]by [***]in connection with such audit. 2.5.7 During the period commencing on the Effective Date and continuing for the longer of the termination or expiration of this Agreement and [***]([***]) [***]from the date of filing of any patent application pursuant to Article 10 covering any Product, each Party shall use Commercially Reasonable Efforts to keep and maintain accurate and complete lab notebooks reflecting the screening and other research and development activities performed by such Party under the Research Program. Upon [***]([***]) [***]prior written notice from a Party, the other Party shall permit a Third Party patent expert selected by the first Party and reasonably acceptable to the other Party to examine (at the first Party’s sole cost and expense) the relevant lab notebooks of the other Party, as applicable; provided, that, any such Third Party patent expert shall be required to execute and deliver to the other Party an appropriate confidentiality agreement covering the information contained in the lab notebooks to be examined. 2.5.8 Each Party shall have caused or shall cause each participant in the Research Program to execute such Party’s standard non-disclosure and invention assignment agreement. 2.5.9 Each Party shall identify one of its representatives to serve as a program coordinator with ViroPharma responsibility for overseeing that Party’s day-to-day activities relating to conducting additional clinical trials beyond the Research Program and to serve as a contact person for coordinating Research Program activities between the Partiesthree (3) described above in this Section 4.5. 2.5.10 Each Party shall identify one of its representatives to serve as a program manager with overall responsibility for achievement of the objectives of the Research Program. Such program manager shall serve as a member of the Joint Research Committee and the Joint Development Committee.

Appears in 1 contract

Sources: Collaboration and License Agreement (Viropharma Inc)