Commercialization Plan. On a Collaboration Product-by-Collaboration Product basis, not later than [***] after commencement of the first Phase III Clinical Trial of a R&D Candidate in the Territory, ELAN shall prepare and the JSC shall review, and after due consideration by ELAN of any suggestions or comments, accept ELAN's rolling multi-year (being not less than[***]) plan for Commercializing the Collaboration Product in the Territory (the "Commercialization Plan"), which plan shall include without limitation [***]. The Commercialization Plan shall be updated by the ELAN at least once each calendar year. Not later than [***] after the filing of the first BLA for an R&D Candidate in the Territory and thereafter on or before August 31 of each calen dar year, ELAN shall prepare and the JSC shall review, and after due consideration by ELAN of any suggestions or comments, accept a long term plan (the "Post BLA Filing Plan"), which plan shall be based on and shall supersede the then current Commercialization Plan and which shall include [***]. The Post BLA Filing Budget shall be based on and shall supersede the relevant Commercialization Budget. The Post BLA Filing Plan will specify [***]. In preparing and updating the Commercialization Plan, Commercialization Budget, each Post BLA Filing Plan and each Post BLA Filing Budget, ELAN will take into consideration factors such as market conditions, regulatory issues and competition. If in any year of a Post BLA Filing Plan the aggregate expenses incurred by the Parties are in excess of [***] of the amounts set out in the Post BLA Filing Budget for that year (a "Post BLA Excess Year") then each Party shall charge to its R&D Account [***] of such [***] and, in addition, ELAN shall charge to its R&D Account any amounts in excess of such [***] (the "Post BLA Excess Charge"). All expenses incurred by the Parties in respect of any Post BLA Filing Budget and charged to their respective R&D Accounts shall be shared equally by the Parties in accordance with Section 5.3.1 and Section 5.3.4; provided, however, in any years following a Post BLA Excess Year CAT shall, in addition to any sums which may be due to ELAN under Section 5.3.4 for that year in respect of the then current Post BLA Filing Budget, pay to ELAN [***] of any Post BLA Excess Charges charged by ELAN to is R&D Account in each Post BLA Excess Year provided always that CAT's liability hereunder in any year shall not exceed [***] of [***] of the relevant Post BLA Filing Budget. If CAT's liability hereunder in any year does exceed [***] of [***] of the relevant Post BLA Filing Budget then this Section shall apply mutatis mutandis thereto.
Appears in 1 contract
Samples: Research and Development (Cambridge Antibody Technology Group PLC)
Commercialization Plan. On The strategy and budget for the Commercialization of, the Product in the Territory will be described in a Collaboration Productcomprehensive plan (the “Commercialization Plan”) and in a budget (the “Incremental Cost Budget”), each developed by EPI Health based on good faith assumptions regarding the then-by-Collaboration current forecast for the Product basisin the Field in the Territory, in consultation with MC2, and each shall be subject to final approval by MC2, such approval not later to be unreasonably withheld; provided that, notwithstanding the foregoing or anything to the contrary herein, (i) the Incremental Cost Budget as it pertains to the EPI Health Sales Representatives must be mutually agreed by MC2 and EPI Health; (ii) neither Party shall be permitted to decrease the number of EPI Health Sales Representatives to less than [***] after commencement or increase the number of the first Phase III Clinical Trial of a R&D Candidate in the Territory, ELAN shall prepare and the JSC shall review, and after due consideration by ELAN of any suggestions or comments, accept ELAN's rolling multi-year (being not less thanEPI Health Sales Representatives to more than [***], and (iii) plan MC2 may, in its sole discretion and acting in good faith, increase the Incremental Cost Budget relative to the then-current Incremental Cost Budget by no more than ten percent (10%) or decrease the Incremental Cost Budget relative to the then-current Incremental Cost Budget by no more than fifty percent (50%) solely with respect to increases or decreases in the Incremental Costs for Commercializing non-inventory and non-personnel costs, provided that MC2 may not reduce the Collaboration Incremental Cost Budget for noncancellable expenses so long as EPI Health uses Commercially Reasonable Efforts to cancel or reduce such expenses (including in accordance with the terms of any contract therefor) as soon as practicable following a request to do so by MC2 ((i) through (iii), the “Agreed Budget Limitations”). The Commercialization Plan for Calendar Year 2022 is attached hereto as Exhibit 7.2 A, and the Incremental Cost Budget for Calendar Year 2022 (including the Incremental Costs actually incurred by EPI Health since the Amendment Effective Date until the date on which the Condition Precedent is satisfied) is attached hereto as Exhibit 7.2 B. The Commercialization Plan and Incremental Cost Budget shall be updated and may be amended during the Term in accordance with Section 7.3 and Section 9.3. The Commercialization Plan will be used as the basis for the Commercialization activities to be undertaken under this Agreement and shall specifically describe the (a) Commercialization activities for the Product in the Territory (the "Commercialization Plan"including messaging, branding, list price and rebating strategy, pricing, advertising, education, planning, marketing, promotion, product sampling and sales force training and allocation), which plan (b) key tactics for implementing those activities, (c) specific resource commitments required of the Parties, including number and location of EPI Sales Territories, number of EPI Health Sales Representatives, number of Details by position, and marketing spend, (d) the Field Force Detailing Plan, (e) a three (3)-year sales forecast and (f) any other information necessary or useful for the successful Commercialization of the Product in the Field in the Territory. In the event of any inconsistency between either the Commercialization Plan or Incremental Cost Budget, on the one hand, and this Agreement, on the other hand, the terms of this Agreement shall include without limitation [***]govern and control. The Notwithstanding anything to the contrary in this Agreement, the Commercialization Plan shall specify and account for the performance of EPI Commercialization Activities by EPI Health and MC2 Commercialization Activities by MC2. In no event shall EPI Health be updated required to perform any function or activity or to purchase inventory set forth in the Commercialization Plan the cost of which is not covered by the ELAN at least once each calendar year. Not later than [***] after the filing of the first BLA for an R&D Candidate in the Territory and thereafter on or before August 31 of each calen dar year, ELAN shall prepare and the JSC shall review, and after due consideration by ELAN of any suggestions or comments, accept a long term plan (the "Post BLA Filing Plan"), which plan shall be based on and shall supersede the then then-current Commercialization Plan and which shall include [***]. The Post BLA Filing Budget shall be based on and shall supersede the relevant Commercialization Incremental Cost Budget. The Post BLA Filing Plan will specify [***]. In preparing and updating the Commercialization Plan, Commercialization Budget, each Post BLA Filing Plan and each Post BLA Filing Budget, ELAN will take into consideration factors such as market conditions, regulatory issues and competition. If in any year of a Post BLA Filing Plan the aggregate expenses incurred by the Parties are in excess of [***] of the amounts set out in the Post BLA Filing Budget for that year (a "Post BLA Excess Year") then each Party shall charge to its R&D Account [***] of such [***] and, in addition, ELAN shall charge to its R&D Account any amounts in excess of such [***] (the "Post BLA Excess Charge"). All expenses incurred by the Parties in respect of any Post BLA Filing Budget and charged to their respective R&D Accounts shall be shared equally by the Parties in accordance with Section 5.3.1 and Section 5.3.4; provided, however, in any years following a Post BLA Excess Year CAT shall, in addition to any sums which may be due to ELAN under Section 5.3.4 for that year in respect of the then current Post BLA Filing Budget, pay to ELAN [***] of any Post BLA Excess Charges charged by ELAN to is R&D Account in each Post BLA Excess Year provided always that CAT's liability hereunder in any year shall not exceed [***] of [***] of the relevant Post BLA Filing Budget. If CAT's liability hereunder in any year does exceed [***] of [***] of the relevant Post BLA Filing Budget then this Section shall apply mutatis mutandis thereto.
Appears in 1 contract
Samples: Promotion and Collaboration Agreement (Novan, Inc.)
Commercialization Plan. On a Collaboration Product(a) If PGx has exercised the Co-by-Collaboration Product basisDevelopment Option, not no later than [***] after commencement sixty (60) days prior to the anticipated initiation of the first Phase III 3 Clinical Trial of a R&D Candidate in the TerritoryTrial, ELAN CRXX shall prepare and deliver to the JSC shall review, for its review and after due consideration by ELAN of any suggestions or comments, accept ELAN's rolling multi-year (being not less than[***]) comment a draft written Commercialization plan for Commercializing the Collaboration setting forth anticipated Commercialization activities to be performed with respect to Product in the Territory by CRXX or on its behalf by Third Parties (including without limitation market studies, launch plans, detailing and promotion), as well as projected timelines for such activities (the "“Commercialization Plan"”). CRXX shall implement all such reasonable comments received from the JSC and shall submit such revised document to the JSC for review.
(b) CRXX shall thereafter update the Commercialization Plan on an annual basis as follows: CRXX shall provide the JSC with a draft update to the Commercialization Plan no later than the thirtieth (30th) of January of each year. CRXX shall implement all such comments received from the JSC and shall submit such revised document to the JSC for review. CRXX may, which plan shall include without limitation [***]. at its election, update the Commercialization Plan between annual updates by following this same procedure.
(c) The Commercialization Plan shall include, without limitation: (i) a description of CRXX’s anticipated marketing activities (both pre- and post-launch), including the plans to use key opinion leaders and focus groups; (ii) five (5) year sales projections, broken down by calendar quarter; (iii) any requirements for additional marketing studies; (iv) competitive analysis including specific actions to mitigate competitive threats; and (v) planned promotional material and sales/detailing protocols.
(d) It is understood that the initial Commercialization Plan delivered pursuant to Section 6.2(a) will likely include only a summary of the anticipated marketing activities and that, reasonably in advance of the First Commercial Sale of a Product, a more detailed version of the Commercialization Plan containing the items described in Section 6.2(c) will be updated prepared by CRXX and delivered to the ELAN at least once each calendar yearJSC pursuant to Section 6.2(b). Not Without limiting the generality of the foregoing, no later than [***] after the filing of an NDA and/or MAA for a particular Product, provided that PGx has exercised the first BLA Co-Development Option, CRXX shall provide the JSC with a Commercialization Plan containing a country-by-country marketing plan for an R&D Candidate such Product in the Territory and thereafter on or before August 31 of each calen dar year, ELAN shall prepare and top six (6) targeted markets.
(e) In the JSC shall review, and after due consideration by ELAN event of any suggestions or comments, accept a long term plan (inconsistency between the "Post BLA Filing Plan"), which plan shall be based on and shall supersede the then current Commercialization Plan and which this Agreement, the terms of this Agreement shall include [***]. The Post BLA Filing Budget shall be based on and shall supersede the relevant Commercialization Budget. The Post BLA Filing Plan will specify [***]. In preparing and updating the Commercialization Plan, Commercialization Budget, each Post BLA Filing Plan and each Post BLA Filing Budget, ELAN will take into consideration factors such as market conditions, regulatory issues and competition. If in any year of a Post BLA Filing Plan the aggregate expenses incurred by the Parties are in excess of [***] of the amounts set out in the Post BLA Filing Budget for that year (a "Post BLA Excess Year") then each Party shall charge to its R&D Account [***] of such [***] and, in addition, ELAN shall charge to its R&D Account any amounts in excess of such [***] (the "Post BLA Excess Charge"). All expenses incurred by the Parties in respect of any Post BLA Filing Budget and charged to their respective R&D Accounts shall be shared equally by the Parties in accordance with Section 5.3.1 and Section 5.3.4; provided, however, in any years following a Post BLA Excess Year CAT shall, in addition to any sums which may be due to ELAN under Section 5.3.4 for that year in respect of the then current Post BLA Filing Budget, pay to ELAN [***] of any Post BLA Excess Charges charged by ELAN to is R&D Account in each Post BLA Excess Year provided always that CAT's liability hereunder in any year shall not exceed [***] of [***] of the relevant Post BLA Filing Budget. If CAT's liability hereunder in any year does exceed [***] of [***] of the relevant Post BLA Filing Budget then this Section shall apply mutatis mutandis theretoprevail.
Appears in 1 contract
Commercialization Plan. On a Collaboration Product-by-Collaboration Product basis, not later than [***] after commencement of * the first Phase III Clinical Trial of a R&D Candidate in the Territory, ELAN JSC shall prepare and the JSC shall review, and after due consideration by ELAN of any suggestions or comments, accept ELAN's approve a rolling multi-year (being not less than[multiyear ( ***]* ) plan for Commercializing the Collaboration such Product in the Territory (the "“Commercialization Plan"”), which plan shall include without limitation [***]includes a comprehensive market development, marketing, sales, supply and distribution strategy for such Product in the Territory. The Commercialization Plan shall be updated by the ELAN JSC at least once each calendar yearyear such that it addresses no less than the *** . Not later than [***] thirty (30) days after the filing of the first BLA application for an R&D Candidate Regulatory Approval of a Product in the Territory and thereafter on or before August 31 September 30 of each calen dar calendar year, ELAN shall prepare and the JSC shall review, and after due consideration by ELAN of any suggestions or comments, accept a long term prepare an annual commercialization plan (the "Post BLA Filing “Annual Commercialization Plan"”), which plan shall be is based on and shall supersede the then current Commercialization Plan and includes a comprehensive market development, marketing, customer support, sales, supply and distribution strategy, including an overall budget for anticipated marketing, promotion and sales efforts in the upcoming calendar year (the first such Annual Commercialization Plan shall cover the remainder of the calendar year in which shall include [***]such Product is anticipated to be approved plus the first full calendar year thereafter). The Post BLA Filing Budget shall be based on and shall supersede the relevant Annual Commercialization Budget. The Post BLA Filing Plan will specify [***]which audiences and distribution channels each Party shall devote its respective Promotion efforts towards, the personnel and other resources to be devoted by each Party to such efforts, the number and positioning of Details to be performed by each Party (which as much as is reasonably possible shall represent an equal effort on the part of each Party), as well as market and sales forecasts and related operating expenses, for the Product in each country of the Territory, and budgets for projected Pre-Marketing Expenses, Distribution Expenses, Third Party License Fees, Assigned Sales Force Adjustment Payment, Working Capital Charges, Sales and Marketing Expenses and Post- Approval Research and Regulatory Expenses. In preparing and updating the Commercialization Plan, Commercialization Budget, each Post BLA Filing Plan and each Post BLA Filing BudgetAnnual Commercialization Plan, ELAN the JSC will take into consideration factors such as market conditions, regulatory issues and competition. If in any year The number of Details assigned to a Post BLA Filing Plan the aggregate expenses incurred Party by the Parties are in excess of [***] of the amounts set out in the Post BLA Filing Budget for that year (a "Post BLA Excess Year") then each Party shall charge to its R&D Account [***] of such [***] and, in addition, ELAN shall charge to its R&D Account any amounts in excess of such [***] (the "Post BLA Excess Charge"). All expenses incurred by the Parties in respect of any Post BLA Filing Budget and charged to their respective R&D Accounts shall be shared equally by the Parties JSC in accordance with Section 5.3.1 and Section 5.3.4; provided, however, in any years following a Post BLA Excess Year CAT shall, in addition to any sums which may be due to ELAN under Section 5.3.4 for that year in respect of the then current Post BLA Filing Budget, pay to ELAN [***] of any Post BLA Excess Charges charged by ELAN to is R&D Account in each Post BLA Excess Year provided always that CAT's liability hereunder in any year shall not exceed [***] of [***] of the relevant Post BLA Filing Budget. If CAT's liability hereunder in any year does exceed [***] of [***] of the relevant Post BLA Filing Budget then this Section shall apply mutatis mutandis theretobe such Party’s Assigned Sales Force Effort.
Appears in 1 contract
Commercialization Plan. On a 7.2.1 With respect to each Collaboration Product-by-, in connection with the determination to file the first Drug Approval Application for such Collaboration Product, the LCP shall prepare and provide to the JCC a commercialization plan (the “Commercialization Plan”) for such Collaboration Product. The LCP shall provide the initial Commercialization Plan for each Collaboration Product to the JCC [***]. Each such initial Commercialization Plan shall include, (a) [***]; (b) [***]; (c) [***]; (e) [***]; and (f) [***].
(a) With respect to the initial Commercialization Plan (including the associated Commercialization Budget) [***], the JCC shall review and approve such Commercialization Plan and shall submit such Commercialization Plan to the JSC for the JSC to review and approve, with the exception of the portion relating to plans for Commercial Manufacture and supply for Commercialization, which shall be submitted to the JMC for review and approval prior to submission to the JSC for review and approval. If the JSC cannot agree on the Commercialization Plan submitted by the JCC within [***] after being submitted by the JCC or the JMC, whichever is later, then such dispute shall be resolved in accordance with Section 3.9.2. Each initial Commercialization Plan and associated Commercialization Budget [***] will go into effect once approved by the JSC in accordance with Section 3.9.
(b) With respect to the initial Commercialization Plan (including the associated Commercialization Budget) [***], the JCC and the JSC shall review and discuss, and [***].
7.2.2 The LCP shall prepare and submit to the JCC for review and approval, on an annual basis, not any material changes to each Commercialization Plan, including any updates to the Commercialization Budget for each Collaboration Product, no later than [***] after commencement of each Calendar Year.
(a) With respect to the first Phase III Clinical Trial of a R&D Candidate in Commercialization Plan (including the Territory, ELAN shall prepare and the JSC shall review, and after due consideration by ELAN of any suggestions or comments, accept ELAN's rolling multi-year (being not less thanassociated Commercialization Budget) [***]) plan , the JCC shall review and approve such annual updates and shall submit such updates to the JSC for Commercializing review and approval. If the Collaboration Product in JSC cannot agree on such updates submitted by the Territory (the "Commercialization Plan"), which plan shall include without limitation JCC within [***]. The Commercialization Plan , then such dispute shall be updated by resolved in accordance with Section 3.9.2. Upon the ELAN at least once JSC’s preliminary approval, such updates shall be submitted to each calendar year. Not Party for its internal budgeting process with a target for final approval no later than [***] after the filing of the first BLA for an R&D Candidate in the Territory and thereafter on or before August 31 of each calen dar yearCalendar Year, ELAN shall prepare and the JSC shall review, and after due consideration by ELAN of at which time any suggestions or comments, accept a long term plan (the "Post BLA Filing Plan"), which plan such approved update shall be based on and shall supersede appended to the then current Commercialization Plan and which shall include [***], provided that, [***]. The Post BLA Filing Budget Any material updates to the Commercialization Plans, including any updates to the associated Commercialization Budgets, for the Antibody Products and Functional Genomics Products shall not be based on effective without the approval of the JSC, subject to the terms and shall supersede conditions of Section 3.9.
(b) With respect to the relevant Commercialization Plan (including the associated Commercialization Budget. The Post BLA Filing Plan will specify ) [***]. In preparing , the JCC and updating the JSC shall review and discuss all annual updates to such Commercialization PlanPlans, Commercialization Budget, each Post BLA Filing Plan and each Post BLA Filing Budget, ELAN will take into consideration factors such as market conditions, regulatory issues and competition. If in any year of a Post BLA Filing Plan the aggregate expenses incurred by the Parties are in excess of [***] of the amounts set out in the Post BLA Filing Budget for that year (a "Post BLA Excess Year") then each Party shall charge to its R&D Account [***] of such [***] and, in addition, ELAN shall charge to its R&D Account any amounts in excess of such [***] (the "Post BLA Excess Charge"). All expenses incurred by the Parties in respect of any Post BLA Filing Budget and charged to their respective R&D Accounts shall be shared equally by the Parties in accordance with Section 5.3.1 and Section 5.3.4; provided, however, in any years following a Post BLA Excess Year CAT shall, in addition to any sums which may be due to ELAN under Section 5.3.4 for that year in respect of the then current Post BLA Filing Budget, pay to ELAN [***] of any Post BLA Excess Charges charged by ELAN to is R&D Account in each Post BLA Excess Year provided always that CAT's liability hereunder in any year shall not exceed [***] of [***] of the relevant Post BLA Filing Budget. If CAT's liability hereunder in any year does exceed [***] of [***] of the relevant Post BLA Filing Budget then this Section shall apply mutatis mutandis thereto].
Appears in 1 contract
Commercialization Plan. On a Collaboration Product-by-Collaboration Product basis, not (a) No later than [***] after commencement of the first Phase III Clinical Trial of a R&D Candidate in the Territory], ELAN subject to Sections 9.3(d) and 9.3(e), Astellas shall prepare and provide to the JSC shall review, JCC for review and after due consideration by ELAN of any suggestions or comments, accept ELAN's rolling multi-year (being not less than[***]) discussion a written plan for Commercializing the Commercialization of such Collaboration Product in the Territory an Astellas’ fiscal year (the "“Commercialization Plan"”), which plan shall include without limitation [***]. The Commercialization Plan shall be updated by include a reasonably detailed description of and anticipated timeline for the ELAN at least once each calendar yearParties’, their respective Affiliates’ and sublicensees’ Commercialization activities with respect to such Collaboration Product, including pre-launch plans, launch plans, market analytics, product forecasts, pricing assumptions and competitive intelligence. Not later than It is the Parties’ understanding that, [**] Astellas will be the Party primarily responsible for the conduct of the Commercialization activities under the Commercialization Plan. Each Party shall use Diligent Efforts to [*] after the filing of the first BLA for an R&D Candidate in collaboration under the Territory and thereafter on or before August 31 of each calen dar year, ELAN shall prepare and Commercialization Plan (including [*]). The Parties agree that the JSC shall review, and after due consideration by ELAN of any suggestions or comments, accept a long term plan (the "Post BLA Filing Plan"), which plan shall be based on and shall supersede the then current Commercialization Plan and the applicable Commercialization strategy shall be consistent.
(b) If Cytokinetics exercises its Co-Promotion option for a Collaboration Product, the Commercialization Plan shall also include a reasonably detailed description of and anticipated timeline for Cytokinetics’ Co-Promotion activities as well as a budget therefor, which shall include be consistent with Section 9.6 below.
(c) Subject to Sections 9.3(d) and 9.3(e)(ii), Astellas shall periodically (at least on an annual basis) prepare updates and amendments to its Commercialization Plan to reflect changes in its plans, including in response to changes in the marketplaces and related product forecasts, relative success of the Collaboration Products and other relevant factors influencing such plans and activities. Subject to Sections 9.3(d) and 9.3(e)(ii), Astellas shall submit all updates and amendments to its Commercialization Plan to the JCC for review and discussion. For clarity, the Commercialization budget is subject to the final determination by the JCC, subject to [***], subject to Section 9.8. The Post BLA Filing Budget shall be based on and shall supersede the relevant Commercialization Budget. The Post BLA Filing Plan will specify Cytokinetics may perform [***]. In preparing and updating ] activities within the scope of its responsibilities under the Commercialization Plan, [*].
(d) The Commercialization BudgetPlan (and any amendment thereto) for any Collaboration Product (i) for a [*] Indication, each Post BLA Filing (ii) for [*] Indication for which Cytokinetics exercises the Cytokinetics Co-Funding Option [*], and (iii) subject to Section 9.3(e) and Section 9.8, for [*] Indication, must be agreed by the JCC by [*]. Neither Party shall conduct any Commercialization activities that are inconsistent with such agreed-upon Commercialization Plan and each Post BLA Filing Budget, ELAN will take into consideration factors such as market conditions, regulatory issues and competition. If in any year Co-Promotion Agreement.
(e) With respect to the Commercialization of a Post BLA Filing Collaboration Product in [*] Indication, subject to Section 9.8, then:
(i) If Cytokinetics has an Established Commercial Infrastructure, Cytokinetics shall have [*] for the Commercialization strategy for such Collaboration Product for such Indication in the Shared Territory (but not for the Commercialization strategies with respect to such Collaboration Product as a whole), provided however, such Commercialization strategy and the overall Commercialization Plan the aggregate expenses incurred by the Parties are in excess shall be consistent.
(ii) Regardless of [**] as relates to the portions of the Commercialization Plan for such Collaboration Product that are specific to such Indication for the Shared Territory, as well as any update and/or amendment thereof. The Commercialization strategy with respect to [*] of Indications includes the amounts set out in the Post BLA Filing Budget for that year (a "Post BLA Excess Year") then each Party shall charge to its R&D Account following [**].
(iii) [*] the Shared Territory and the [*] Astellas and Cytokinetics as well as the [*] such Collaboration Product for such Indication, subject to the discussion and final determination by the JCC, taking into account [*].
(iv) Notwithstanding anything to the contrary, the [*] for such Collaboration Product in such Indication in a particular country will have the decision making authority with respect [*] and other terms of sale for such Collaboration Product in such Indication for such country, provided that the other Party may conduct, [*].
(v) If [*] the Collaboration Product(s) in such [**] Indication, but the Parties have not determined which Party will [*] and, for the Collaboration Product(s) in addition, ELAN shall charge to its R&D Account any amounts in excess of such [*] Indication under Section 9.8(b), then [*] shall be responsible for the pre-commercialization activities for the Collaboration Product in such [*] Indication.
(f) Subject to Section 9.3(c), Astellas shall be solely responsible for all costs incurred by or on behalf of either Party in performing their respective obligations under the Commercialization Plan except [*] (the "Post BLA Excess Charge"). All expenses incurred or [*] determined by the Parties in respect of any Post BLA Filing Budget and charged to their respective R&D Accounts JCC), which shall be shared equally by agreed between the Parties acting reasonably and in accordance with Section 5.3.1 good faith and Section 5.3.4; provided, however, in any years following a Post BLA Excess Year CAT shall, in addition to any sums which may be due to ELAN under Section 5.3.4 for that year in respect of the then current Post BLA Filing Budget, pay to ELAN [***] of any Post BLA Excess Charges charged by ELAN to is R&D Account ], for its Co-Promotion activities as set forth in each Post BLA Excess Year provided always that CAT's liability hereunder in any year shall not exceed [***] of [***] of the relevant Post BLA Filing Budget. If CAT's liability hereunder in any year does exceed [***] of [***] of the relevant Post BLA Filing Budget then this Section shall apply mutatis mutandis theretoCo-Promotion Agreement.
Appears in 1 contract
Samples: License and Collaboration Agreement (Cytokinetics Inc)