Commercialization Plans. (a) The strategy for the Commercialization of Product to Physician Targets in the Field in the Territory during the term of this Agreement shall be described in one or more comprehensive plans that describe the pre-launch, launch and subsequent Commercialization activities (including estimated Shared Expenses, advertising, education, planning, marketing, sales force training and allocation) (each, a “Commercialization Plan”). (b) Attached hereto as Exhibit 6.2(b) is a forecast of the prescriptions for Product in the in the Field in the Territory during each of the [***] following First Commercial Sale (the “Signing Date TRx Forecast”). (c) No later than ninety (90) days following the Effective Date, the JCC shall have agreed upon and presented to the JSC an initial Commercialization Plan setting forth the pre-launch and launch year Commercialization activities and a preliminary Net Sales forecast and budget for Product in the in the Field in the Territory during the Product Launch Period. The amounts set forth in such Commercialization Plan (including without limitation, Net Sales forecast and budget, and other costs and expenses) will be based upon the prescription forecasts in the Signing Date TRx Forecast, and the prescription forecasts in such Commercialization Plan shall not vary from the Signing Date TRx Forecast without the mutual written consent of both MAP and ALLERGAN. (d) Thereafter, on or before May 1 of each Calendar Year during the term of this Agreement, the JCC shall present to the JSC for its approval an updated Commercialization Plan including a budget for Shared Expenses in accordance with the then-current Annual Forecast And Budget for Product in the Field in the Territory for the next two (2) Calendar Years. On or before September 1 of such Calendar Year, the JSC shall have approved such Commercialization Plan, including the Annual Forecast And Budget contained therein. Notwithstanding anything contained herein, without the mutual written consent of both Parties, neither Party shall have the right to xxxx the other Party or include in Shared Expenses any direct or indirect Commercialization expenses other than those expressly provided for in the Annual Forecast and Budget, unless agreed to by the other Party. (e) All Commercialization Plans developed in accordance with this Agreement shall generally conform to the level of detail utilized by ALLERGAN in preparation of its own product commercialization plans, with the overall objective of maximizing the economic value of Product in the Field in the Territory. Without limiting the foregoing, all Commercialization Plans shall include but not be limited to: (i) details regarding demographics, market dynamics, and market strategies for Product and patient population, estimated launch dates, and sales and expense forecasts; (ii) a marketing plan (including plans related to the prelaunch, launch, promotion, reimbursement and sales of Product, which shall include pricing strategy, sampling plans, public relations and promotional communications and a reasonably descriptive overview of the marketing and advertising campaigns proposed to be conducted; (iii) health economics and/or quality of life studies to be performed or other payor related activities required to determine placement of product with payors, and other payor related studies to establish prices for Product; (iv) sales force forecasts and allocation, physician training and education, detail frequency, Physician Target Detail plans and allocations of percentages of Details and identities of Physician Targets to be provided or contacted by the Parties, and sales incentive compensation programs for Commercialization of Product to Physician Targets in the Field in the Territory; and (v) Phase IV Clinical Trial activities. Each Commercialization Plan shall include an associated budget for Commercialization of Product, including without limitation the Third Parties to be utilized in such activities and the arrangements with them that have been or are proposed to be agreed upon and a budget of the costs and expenses expected to be incurred in connection with performing the Commercialization Plan.
Appears in 2 contracts
Samples: Collaboration Agreement (Allergan Inc), Collaboration Agreement (MAP Pharmaceuticals, Inc.)
Commercialization Plans. (a) The strategy for the Commercialization of Product to Physician Targets in the Field in the Territory during the term of this Agreement Incyte shall be described in one or more comprehensive plans that describe the pre-launch, launch and subsequent conduct its Commercialization activities with respect to any Profit-Share Product under a rolling three (including estimated Shared Expenses, advertising, education, planning, marketing, sales force training 3) year commercialization plan and allocation) associated budget (each, a “Commercialization Plan”).
(b) Attached hereto as Exhibit 6.2(b) is a forecast that will describe the proposed overall program of the prescriptions for Commercialization of such Product in the in Field. An initial Commercialization Plan for each Profit-Share Product shall be prepared no later than the Field in the Territory during each earlier of the [***] following First Commercial Sale (Initiation of the “Signing Date TRx Forecast”).
(c) No later than ninety (90) days following second Phase 2 Clinical Trial of such Product or the Effective DateInitiation of the first Phase 3 Clinical Trial of such Product. Each Commercialization Plan shall be updated annually by Incyte, the JCC shall have agreed upon in consultation with Agenus, and presented submitted to the JSC an initial Commercialization Plan setting forth the pre-launch for review and launch year Commercialization activities and a preliminary Net Sales forecast and budget for Product in the in the Field in the Territory during the Product Launch Period. The amounts set forth in such Commercialization Plan (including without limitation, Net Sales forecast and budget, and other costs and expenses) will be based upon the prescription forecasts in the Signing Date TRx Forecast, and the prescription forecasts in such Commercialization Plan shall approval not vary from the Signing Date TRx Forecast without the mutual written consent of both MAP and ALLERGAN.
(d) Thereafter, on or before May 1 later than October 31 of each Calendar Year during the term of this Agreement, the JCC shall present to the JSC for its approval an Term. Each such updated Commercialization Plan including shall include (i) an overall Commercialization plan for the applicable Profit-Share Product that sets forth all major Commercialization tasks remaining to be accomplished prior to First Commercial Sale, (ii) a detailed description for the Commercialization activities proposed for the following three (3) Calendar Years, and (iii) a detailed, rolling three (3) year financial forecast containing a good faith estimated revenue forecast and a committed budget for Shared Expenses in accordance with the then-current Annual Forecast And Budget for Product in first Calendar Year and good faith estimates of the Field in the Territory budget for the next following two (2) Calendar Years. On or before September 1 While minor adjustments to the Commercialization Plan may be made from time to time in Incyte’s discretion, any changes in budgeted funding exceeding [**] of the then-total amount budgeted in any Calendar Year for such Calendar YearProfit-Share Product must be approved by the JSC, in the JSC absence of which approval the most recently approved Commercialization Plan and budget shall have approved such Commercialization Plan, including the Annual Forecast And Budget contained thereinremain in effect. Notwithstanding anything contained herein, without the mutual written consent of both Parties, neither Party shall have the right to xxxx the other Party or include in Shared Expenses any direct or indirect Commercialization expenses other than those expressly provided for in the Annual Forecast and Budget, unless agreed to by the other Party.
(e) All Commercialization Plans developed in accordance with this Agreement shall generally conform to the level of detail utilized by ALLERGAN in preparation of its own product commercialization plans, with the overall objective of maximizing the economic value of Product in the Field in the Territory. Without limiting the foregoing, all Commercialization Plans if the JSC does not approve the budget increase, and (1) such increase is for an activity to be conducted by Agenus for a Co-Promotion Product, Incyte may, in its sole discretion, fund such activity and such expenditure shall include but be an Allowable Expense hereunder, or (2) subject to clause (1), Incyte may fund such amounts itself, and such expenditures shall not be limited to: (i) details regarding demographics, market dynamics, and market strategies for Product and patient population, estimated launch dates, and sales and expense forecasts; (ii) a marketing plan (including plans related to the prelaunch, launch, promotion, reimbursement and sales of Product, which shall include pricing strategy, sampling plans, public relations and promotional communications and a reasonably descriptive overview of the marketing and advertising campaigns proposed to be conducted; (iii) health economics and/or quality of life studies to be performed or other payor related activities required to determine placement of product with payors, and other payor related studies to establish prices for Product; (iv) sales force forecasts and allocation, physician training and education, detail frequency, Physician Target Detail plans and allocations of percentages of Details and identities of Physician Targets to be provided or contacted by the Parties, and sales incentive compensation programs for Commercialization of Product to Physician Targets in the Field in the Territory; and (v) Phase IV Clinical Trial activities. Each Commercialization Plan shall include an associated budget for Commercialization of Product, including without limitation the Third Parties to be utilized in such activities and the arrangements with them that have been or are proposed to be agreed upon and a budget of the costs and expenses expected to be incurred in connection with performing the Commercialization PlanAllowable Expense hereunder.
Appears in 2 contracts
Samples: License, Development and Commercialization Agreement (Incyte Corp), License, Development and Commercialization Agreement (Agenus Inc)
Commercialization Plans. (a) The strategy for the Commercialization of Product to Physician Targets in the Field in JCC will review and discuss the Territory during Commercialization Plan and the term of this Agreement shall be described in one or more comprehensive plans that describe the pre-launch, launch and subsequent Commercialization activities (including estimated Shared Expenses, advertising, education, planning, marketing, sales force training and allocation) (each, a “North American Commercialization Plan”).
(b) Attached hereto as Exhibit 6.2(b) is a forecast of the prescriptions for Product in the in the Field in the Territory during , each of which will be provided to the JCC by Xxxxxxx or Vertex, respectively, no later than [***] following First Commercial Sale prior to the projected commercial launch for the Product in the United States (with respect to the “Signing Date TRx Forecast”North American Commercialization Plan) or the European Union (with respect to the Territory Commercialization Plan).
(c) No later than ninety (90) days following . [***] The responsible Party will also provide to the Effective DateJCC, for review and discussion, any subsequent material amendments to the most recent Commercialization Plan that it provided to the JCC and in any event shall submit an updated plan on an annual basis. [***] prior to the projected commercial launch for the Product in either the United States or the European Union, the JCC shall have agreed upon and presented to the JSC an initial Commercialization Plan setting forth the pre-launch and launch year will consider plans for sharing certain global Commercialization activities (i.e., activities that benefit the Product in both the Vertex’ and a preliminary Net Sales forecast Xxxxxxx’x territories, including without limitation such activities that relate to [***] and the appropriate allocation of responsibilities and budget for Product in the in the Field in the Territory during the Product Launch Periodsuch activities. The amounts set forth in Any such Commercialization Plan plan (including without limitation, Net Sales forecast the allocation of responsibilities and budget, and other costs and expenses) recommended by the JCC will be based upon the prescription forecasts in the Signing Date TRx Forecast, and the prescription forecasts in such Commercialization Plan shall not vary from the Signing Date TRx Forecast without the mutual written consent of both MAP and ALLERGAN.
(d) Thereafter, on or before May 1 of each Calendar Year during the term of this Agreement, the JCC shall present referred to the JSC for its approval an and if approved, will be reviewed and updated annually thereafter by the JSC upon referral from the JCC. The Territory Commercialization Plan will contain the annual Commercialization plans and budgets for [***] with sufficient detail with respect to Commercialization, including but not limited to details [***] to enable the JCC to conduct a budget meaningful review of such plans. Comparable information will be provided for Shared Expenses in accordance with the then-current Annual Forecast And Budget Territory as a whole and on a regional basis. Amendments and updates to the Territory Commercialization Plan and particularly the Commercialization plans for [***] shall not be effective without review and discussion by the JCC. Notwithstanding the foregoing, Xxxxxxx shall be solely responsible for all decisions regarding the prices charged for the Product in the Field in the Territory for the next two (2) Calendar Years. On or before September 1 of such Calendar YearTerritory, the JSC shall have approved such Commercialization Planas well as discounts, including the Annual Forecast And Budget contained therein. Notwithstanding anything contained herein, without the mutual written consent of both Parties, neither Party shall have the right to xxxx the rebates and all other Party or include in Shared Expenses any direct or indirect Commercialization expenses other than those expressly provided for in the Annual Forecast and Budget, unless agreed to by the other Partydeductions from Net Sales allowed under Section 1.77.
(e) All Commercialization Plans developed in accordance with this Agreement shall generally conform to the level of detail utilized by ALLERGAN in preparation of its own product commercialization plans, with the overall objective of maximizing the economic value of Product in the Field in the Territory. Without limiting the foregoing, all Commercialization Plans shall include but not be limited to: (i) details regarding demographics, market dynamics, and market strategies for Product and patient population, estimated launch dates, and sales and expense forecasts; (ii) a marketing plan (including plans related to the prelaunch, launch, promotion, reimbursement and sales of Product, which shall include pricing strategy, sampling plans, public relations and promotional communications and a reasonably descriptive overview of the marketing and advertising campaigns proposed to be conducted; (iii) health economics and/or quality of life studies to be performed or other payor related activities required to determine placement of product with payors, and other payor related studies to establish prices for Product; (iv) sales force forecasts and allocation, physician training and education, detail frequency, Physician Target Detail plans and allocations of percentages of Details and identities of Physician Targets to be provided or contacted by the Parties, and sales incentive compensation programs for Commercialization of Product to Physician Targets in the Field in the Territory; and (v) Phase IV Clinical Trial activities. Each Commercialization Plan shall include an associated budget for Commercialization of Product, including without limitation the Third Parties to be utilized in such activities and the arrangements with them that have been or are proposed to be agreed upon and a budget of the costs and expenses expected to be incurred in connection with performing the Commercialization Plan.
Appears in 2 contracts
Samples: License, Development, Manufacturing and Commercialization Agreement (Vertex Pharmaceuticals Inc / Ma), License, Development, Manufacturing and Commercialization Agreement (Vertex Pharmaceuticals Inc / Ma)
Commercialization Plans. (a) The strategy Upon filing by Fovea for Regulatory Approval for the Commercialization of Product to Physician Targets in the Field in the Territory during the term of this Agreement shall be described in one or more comprehensive plans that describe the pre-launch, launch and subsequent Commercialization activities (including estimated Shared Expenses, advertising, education, planning, marketing, sales force training and allocation) (each, a “Commercialization Plan”).
(b) Attached hereto as Exhibit 6.2(b) is a forecast of the prescriptions for Product in the Fovea Territory, Fovea shall develop an annual Commercialization plan (including a budget) for the Product in the Field Fovea Territory. Such Commercialization plan shall include, without limitation, a strategy for obtaining Product pricing and reimbursement approvals in the Territory during each of the [***] following First Commercial Sale (the “Signing Date TRx Forecast”).
(c) No later than ninety (90) days following the Effective Date, the JCC Fovea Territory. Fovea shall have agreed upon and presented submit its Commercialization plan to the JSC an initial for review, discussion and commentary. The Commercialization Plan setting forth plan of Fovea, and particularly the pre-launch plans and launch year budgets for the Major European Countries, shall contain sufficient detail with respect to Commercialization activities tactics and other matters to enable the JSC to conduct a preliminary Net Sales forecast and budget meaningful review of such plan. Upon filing by Dyax for Regulatory * Confidential Treatment Requested. Omitted portions filed with the Commission. Approval for the Product in the in Dyax Territory, Dyax shall submit a Commercialization plan for the Field in Dyax Territory to the Territory during the Product Launch PeriodJSC for review and discussion. The amounts set forth in such Such Commercialization Plan (including plan shall include, without limitation, Net Sales forecast a strategy for obtaining Product pricing and budget, and other costs and expenses) will be based upon the prescription forecasts reimbursement approvals in the Signing Date TRx ForecastDyax Territory. The JSC shall review, discuss and comment on the prescription forecasts Commercialization plan of each Party and on each Party’s Commercialization program and activities for the Product under such Party’s Commercialization plan but the JSC shall have no authority to approve or disapprove of either Party’s Commercialization plan or the Commercialization program and activities of either Party under such Party’s Commercialization plan and neither Party shall have any obligation to make any changes to its Commercialization plan or to its Commercialization program or activities in such Commercialization Plan shall not vary response to any comments from the Signing Date TRx Forecast without the mutual written consent of both MAP and ALLERGAN.
(d) Thereafter, on or before May 1 of each Calendar Year during the term JSC. Notwithstanding any other provision of this Agreement, Fovea shall be solely responsible for all decisions regarding the JCC shall present to prices charged for the JSC for its approval an updated Commercialization Plan including a budget for Shared Expenses in accordance with the then-current Annual Forecast And Budget for Product in the Field in Fovea Territory, and Dyax shall be solely responsible for all decisions regarding the Territory prices charged for the next two (2) Calendar Years. On or before September 1 of such Calendar Year, the JSC shall have approved such Commercialization Plan, including the Annual Forecast And Budget contained therein. Notwithstanding anything contained herein, without the mutual written consent of both Parties, neither Party shall have the right to xxxx the other Party or include in Shared Expenses any direct or indirect Commercialization expenses other than those expressly provided for in the Annual Forecast and Budget, unless agreed to by the other Party.
(e) All Commercialization Plans developed in accordance with this Agreement shall generally conform to the level of detail utilized by ALLERGAN in preparation of its own product commercialization plans, with the overall objective of maximizing the economic value of Product in the Field in the Dyax Territory. Without limiting the foregoing, all Commercialization Plans shall include but not be limited to: (i) details regarding demographics, market dynamics, and market strategies for Product and patient population, estimated launch dates, and sales and expense forecasts; (ii) a marketing plan (including plans related to the prelaunch, launch, promotion, reimbursement and sales of Product, which shall include pricing strategy, sampling plans, public relations and promotional communications and a reasonably descriptive overview of the marketing and advertising campaigns proposed to be conducted; (iii) health economics and/or quality of life studies to be performed or other payor related activities required to determine placement of product with payors, and other payor related studies to establish prices for Product; (iv) sales force forecasts and allocation, physician training and education, detail frequency, Physician Target Detail plans and allocations of percentages of Details and identities of Physician Targets to be provided or contacted by the Parties, and sales incentive compensation programs for Commercialization of Product to Physician Targets in the Field in the Territory; and (v) Phase IV Clinical Trial activities. Each Commercialization Plan shall include an associated budget for Commercialization of Product, including without limitation the Third Parties to be utilized in such activities and the arrangements with them that have been or are proposed to be agreed upon and a budget of the costs and expenses expected to be incurred in connection with performing the Commercialization Plan.
Appears in 1 contract
Samples: License Agreement (Dyax Corp)
Commercialization Plans. (a) The strategy for [****] Zai will develop and provide an initial draft of the Commercialization of Plan for such Licensed Product to Physician Targets in the Field JPT for its review and discussion. The Commercialization Plan for a Licensed Product will contain [****] Commercialization activities to be undertaken (including [****]) for such Licensed Product in the Territory during and the term estimated timelines for achieving such activities. The JPT will have the right to comment on each such Commercialization Plan and Zai will consider such comments [****] and incorporate such comments [****] prior to finalizing each such Commercialization Plan. Thereafter, from time to time, [****] Zai will propose updates to the Commercialization Plan for each Licensed Product in consultation with the JPT to reflect changes in such plans, including those in response to changes in the marketplace, relative commercial success of this Agreement shall be described in one or more comprehensive plans the applicable Licensed Product, and other relevant factors that describe may influence such plan and the pre-launch, launch and subsequent Commercialization activities set forth therein. Zai will submit each proposed updated Commercialization Plan for a Licensed Product to the JPT for review and discussion and will consider [****] and incorporate [****] any comments thereon provided by the JPT before finalizing any such update. Zai submit each initial Commercialization Plan and each such proposed updated Commercialization Plan to the JSC. The JSC will review, discuss, and determine whether to approve each initial Commercialization Plan for each Licensed Product and each update thereto. Once approved by the JSC, each update to a Commercialization Plan for a Licensed Product will become effective and supersede the then-current Commercialization Plan for such Licensed Product. Each Commercialization Plan for a Licensed Product (including estimated Shared Expenseseach update thereto) must be consistent with Blueprint’s global brand strategy and global key messaging, advertising, education, planning, marketing, sales force training and allocation) Global Brand Elements for such Licensed Product (each, a “Commercialization PlanGlobal Brand Strategy”).
(b) Attached hereto , if and as Exhibit 6.2(b) provided to Zai by Blueprint from time to time during the Term; provided, however, that if the JSC agrees upon brand strategy for a Licensed Product that is a forecast of the prescriptions for Product in the in the Field in specific to the Territory during each of (or any region therein) and that is inconsistent with the [***] following First Commercial Sale Global Brand Strategy for such Licensed Product (the “Signing Date TRx Forecast”).
(c) No later than ninety (90) days following the Effective Date, the JCC shall have agreed upon and presented to the JSC an initial Commercialization Plan setting forth the pre-launch and launch year Commercialization activities and a preliminary Net Sales forecast and budget including any product positioning or messaging for Product in the in the Field in the Territory during the Product Launch Period. The amounts set forth in such Commercialization Plan (including without limitationor any region therein), Net Sales forecast and budget, and other costs and expenses) then Zai will be based upon the prescription forecasts in the Signing Date TRx Forecast, and the prescription forecasts in such Commercialization Plan shall not vary from the Signing Date TRx Forecast without the mutual written consent of both MAP and ALLERGAN.
(d) Thereafter, on or before May 1 of each Calendar Year during the term of this Agreement, the JCC shall present to the JSC for its approval an updated Commercialization Plan including a budget for Shared Expenses in accordance with the then-current Annual Forecast And Budget for Product in the Field in the Territory for the next two (2) Calendar Years. On or before September 1 of such Calendar Year, the JSC shall have approved such Commercialization Plan, including the Annual Forecast And Budget contained therein. Notwithstanding anything contained herein, without the mutual written consent of both Parties, neither Party shall have the right to xxxx implement such Territory-specific brand strategy within the other Party or include in Shared Expenses any direct or indirect Commercialization expenses other than those expressly provided for Territory and to incorporate such inconsistent strategies in the Annual Forecast and Budget, unless agreed to by the other Party.
(e) All Commercialization Plans developed in accordance with this Agreement shall generally conform to the level of detail utilized by ALLERGAN in preparation of its own product commercialization plans, with the overall objective of maximizing the economic value of Product in the Field in the Territory. Without limiting the foregoing, all Commercialization Plans shall include but not be limited to: (i) details regarding demographics, market dynamics, and market strategies for Product and patient population, estimated launch dates, and sales and expense forecasts; (ii) a marketing plan (including plans related to the prelaunch, launch, promotion, reimbursement and sales of Product, which shall include pricing strategy, sampling plans, public relations and promotional communications and a reasonably descriptive overview of the marketing and advertising campaigns proposed to be conducted; (iii) health economics and/or quality of life studies to be performed or other payor related activities required to determine placement of product with payors, and other payor related studies to establish prices for Product; (iv) sales force forecasts and allocation, physician training and education, detail frequency, Physician Target Detail plans and allocations of percentages of Details and identities of Physician Targets to be provided or contacted by the Parties, and sales incentive compensation programs for Commercialization of Product to Physician Targets in the Field in the Territory; and (v) Phase IV Clinical Trial activities. Each Commercialization Plan shall include an associated budget for Commercialization of such Licensed Product, including without limitation the Third Parties to be utilized in such activities and the arrangements with them that have been or are proposed to be agreed upon and a budget of the costs and expenses expected to be incurred in connection with performing the Commercialization Plan.
Appears in 1 contract
Commercialization Plans. (a) The strategy During the Income Option Period, on an Income Share Product-by-Income Share Product basis:
4.2.1 By no later than [**] of each Calendar Year, Ultragenyx will submit to the JSC a plan for the Commercialization of Product to Physician Targets in the Field in the Territory during the term of this Agreement shall be described in one or more comprehensive plans that describe the pre-launch, launch and subsequent Commercialization activities (including estimated Shared Expenses, advertising, education, planning, marketing, sales force training and allocation) (each, a “Commercialization Plan”).
(b) Attached hereto as Exhibit 6.2(b) is a forecast to be undertaken by or on behalf of Ultragenyx with respect to the prescriptions for relevant Income Share Product in the in the Field in the Option Territory during each of the [**] (each such plan, a “Option Territory Commercialization Plan” and the activities described therein, the “Option Territory Commercialization Activities”); provided that Ultragenyx will submit a preliminary Option Territory Commercialization Plan by [**] following First Commercial Sale of each Calendar Year. Each Option Territory Commercialization Plan will include a [**] budget of estimated costs for Option Territory Commercialization Activities (the “Signing Date TRx ForecastOption Territory Commercialization Budget”).
(c) No later than ninety (90) days following and, if requested by Solid in writing, [**]. If the Effective Date, activities under the JCC shall have agreed upon and presented to the JSC an initial Option Territory Commercialization Plan setting forth exceed the pre-launch and launch year corresponding Option Territory Commercialization activities and a preliminary Net Sales forecast and budget for Product in Budget, each Party will continue to share the in the Field in the Territory during the Product Launch Period. The amounts set forth in such Commercialization Plan (including without limitation, Net Sales forecast and budget, and other costs and expenses) will be based upon the prescription forecasts in the Signing Date TRx Forecast, and the prescription forecasts in such Commercialization Plan shall not vary from the Signing Date TRx Forecast without the mutual written consent of both MAP and ALLERGAN.
(d) Thereafter, on or before May 1 of each Calendar Year during the term of this Agreement, the JCC shall present to the JSC for its approval an updated Commercialization Plan including a budget for Shared Expenses therefor in accordance with the then-current Annual Forecast And Exhibit B; provided, however, that [**]. The Option Territory Commercialization Budget will be for Product in the Field in the information and planning purposes only. Each Option Territory for the next two (2) Calendar Years. On or before September 1 of such Calendar Year, the JSC shall have approved such Commercialization Plan, including the Annual Forecast And Budget contained therein. Notwithstanding anything contained herein, without the mutual written consent of both Parties, neither Party shall have the right to xxxx the other Party or include in Shared Expenses any direct or indirect Commercialization expenses other than those expressly provided for in the Annual Forecast and Budget, unless agreed and each update thereto, will be prepared by Ultragenyx based on Ultragenyx’s good faith estimation of the probable Option Territory Commercialization Activities to by be conducted during the other Partyrelevant time period. Ultragenyx’s obligations under this Section 4.2.1 will terminate on the last day of the relevant Income Option Period.
(e) All Commercialization Plans developed in accordance with this Agreement shall generally conform 4.2.2 Either Party may, through its representatives on the JSC, propose amendments to the level of detail utilized by ALLERGAN in preparation of its own product commercialization plans, with the overall objective of maximizing the economic value of Product in the Field in the Territory. Without limiting the foregoing, all Commercialization Plans shall include but not be limited to: (i) details regarding demographics, market dynamics, and market strategies for Product and patient population, estimated launch dates, and sales and expense forecasts; (ii) a marketing plan (including plans related to the prelaunch, launch, promotion, reimbursement and sales of Product, which shall include pricing strategy, sampling plans, public relations and promotional communications and a reasonably descriptive overview of the marketing and advertising campaigns proposed to be conducted; (iii) health economics and/or quality of life studies to be performed or other payor related activities required to determine placement of product with payors, and other payor related studies to establish prices for Product; (iv) sales force forecasts and allocation, physician training and education, detail frequency, Physician Target Detail plans and allocations of percentages of Details and identities of Physician Targets to be provided or contacted by the Parties, and sales incentive compensation programs for Commercialization of Product to Physician Targets in the Field in the Territory; and (v) Phase IV Clinical Trial activities. Each any Option Territory Commercialization Plan shall include an associated budget for until such time as no further Commercialization of Product, including without limitation the Third Parties to be utilized in such activities and the arrangements with them that have been or are proposed to be agreed upon and a budget of the costs and expenses expected to be incurred in connection with performing the Commercialization Plan.are
Appears in 1 contract
Samples: Collaboration and License Agreement (Solid Biosciences Inc.)