Commercialization Budget. (a) For the purpose of determining "commercialization costs" (to be reimbursed to Chiron as permitted in Section 8.5 of the Agreement), Chiron shall submit to Gen-Probe a commercialization budget, promptly following any termination of this Ultrio Addendum for breach in accordance with Section 8.2 or an unilateral withdrawal by a party in accordance with Section 8.4, and the timely election by a Continuing Party to continue the Ultrio Development Program, as described in this Section 6.4.
(b) Chiron shall submit to Gen-Probe a commercialization budget, setting forth the programs and anticipated costs, including applicable costs and overhead for internal sales, marketing, distribution, training, technical support, instrument service and field service engineering, product support, quality assurance, regulatory affairs and clinical affairs all as required to commercialize the Ultrio Assay. Such commercialization budget shall also include out-of pocket costs associated with each such program and initiative plus costs associated with any third party support and allocated costs of instrumentation on a per unit or other reasonable allocation method applicable to the commercialization of the Ultrio Assay Product.,The detail and basis provided in the proposed budget shall be commensurate with the information supplied by Gen-Probe to support Gen-Probe's calculation of Manufacturing Cost.
(c) Gen-Probe will deliver to Chiron either a written acceptance of the proposed commercialization budget or a detailed written statement specifying the basis for rejection. Chiron may, in response to a rejection, revise the proposed commercialization budget to reflect the discussions of the parties, and redeliver the revised commercialization budget for further review, until the parties agree upon the final commercialization budget. Either party may, in its discretion and with notice to the other party, determine that the parties have reached an impasse with respect to the proposed commercialization budget and deliver a request to the Supervisory Board for determination.
(d) If a party delivers the request to the Supervisory Board for determination of the commercialization budget, the Supervisory Board shall promptly, but not later than the later of (i) [***], or (ii) the [***], meet and discuss the proposed commercialization budget.
(e) If the Supervisory Board has met and consulted without resolution, then either party may, in its discretion, determine that the parties have reache...
Commercialization Budget. The Commercialization Budget will be included in the Commercialization Plan and will be a written budget setting forth the budgeted amounts for costs with respect to activities set forth in the Commercialization Plan during the then-current calendar year and [***], broken down by calendar quarter for the then current calendar year. The Commercialization Budget also will include a breakout of costs by functional area or category (and may set forth budgets for commercialization activities in the Territory on a regional basis, rather than a country-by-country basis, defining the regions in a manner consistent with Licensee’s internal procedures).
Commercialization Budget. Alimera shall have sole responsibility for implementing Commercialization based on Alimera’s commercially reasonable expectations of the resources and expenses required to Commercialize each Product in the Territory, taking into account industry standards and the competitive environment in effect from time to time with regard to each Product. Alimera shall prepare a budget (“Commercialization Budget”) that shall set forth, on a rolling two (2) year basis, the projected sales and the projected Direct Commercialization Costs broken down on a calendar quarter-by-quarter and Product-by-Product basis. Alimera shall prepare semi-annual updates to the Commercialization Budget prior to June 30 and December 31 of each year in which Alimera has a Commercialization Budget or engages in Commercialization of any Products, and shall provide CDS with copies of such semi-annual
Commercialization Budget. Except for Joint Commercialization Activities, Licensee shall be responsible for Commercialization in the Licensee Territory at its own cost and expense. The budget for Joint Commercialization Activities shall be set forth in the Commercialization Plan, as provided in Section 3.2.1.
Commercialization Budget. Alimera shall have sole responsibility for implementing Commercialization based on Alimera’s commercially reasonable expectations of the resources and expenses required to Commercialize each Product in the Territory, taking into account industry standards and the competitive environment in effect from time to time with regard to each Product. Alimera shall prepare a budget (“Commercialization Budget”) that shall set forth, on a rolling two (2) year basis, the projected sales and the projected Direct Commercialization Costs broken down on a calendar quarter-by-quarter and Product-by-Product basis. Alimera shall prepare semi-annual updates to the Commercialization Budget prior to June 30 and December 31 of each year in which Alimera has a Commercialization Budget or engages in Commercialization of any Products, and shall provide CDS with copies of such semi-annual updates. Prior to finalizing the initial Commercialization Budget and prior to finalizing each subsequent updated Commercialization Budget due by December 31, Alimera shall arrange for the Parties to have an in-person meeting (or, at CDS’ option, a meeting by telephone, videoconference or other means), during which an executive from Alimera shall present in reasonable detail its planned Commercialization activities and Commercialization Budget for the time period covered in the subject Commercialization Budget and CDS shall have opportunities to ask questions and to present its comments on the applicable Commercialization Budget. It is understood and agreed that Alimera shall have sole decision-making authority with respect to the Commercialization Budget, consistent with its other obligations under this Agreement. Alimera shall provide an initial draft Commercialization Budget to CDS on the Amendment Effective Date.
Commercialization Budget. At such times as the JCC will deem appropriate, and concurrently with the preparation of the initial Commercialization Plan, each Lead Party (after good faith consultation with the non-Lead Party) will prepare its portion of an initial Commercialization budget (collectively, the “Commercialization Budget”), and the JCC will review and approve such initial Commercialization Budget; it being understood and agreed that, pursuant to Section 6.3, Celgene shall specify the form and contents of the Commercialization Budget for the ROW Territory. Thereafter, the applicable Lead Party (after good faith consultation with the non-Lead Party) will update its portion of the Commercialization Budget at least once in each Calendar Year, (but in any event no later than November 30 of each Calendar Year during the Term) and the JCC will review and approve any such update or any other amendment to the Commercialization Budget. In addition, either Party may request at any time that the JCC consider and approve other updates to the Commercialization Budget.
Commercialization Budget. 24 4.3 Diligence.................................................................. 25 4.4
Commercialization Budget. Alimera shall have sole responsibility for implementing Commercialization based on Alimera's commercially reasonable expectations of the resources and expenses required to Commercialize each Product in the Territory, taking into account industry standards and the competitive environment in effect from time to time with regard to each Product. Alimera shall prepare a budget ("Commercialization Budget") and consider in good faith incorporating into the Commercialization Budget any comments made by CDS prior to finalizing such budget. The Commercialization Budget shall set forth, on a rolling two (2) year basis, the projected sales and the projected Direct Commercialization Costs broken down on a calendar quarter-by-quarter and Product-by-Product basis. Alimera shall prepare semi-annual updates to the Commercialization Budget prior to June 30 and December 31 of each year in which Alimera has a Commercialization Budget or engages in Commercialization of any Products, and shall provide CDS with copies of such semi-annual updates. Prior to finalizing the initial Commercialization Budget and prior to finalizing each subsequent semi-annual updated Commercialization Budget, Alimera shall arrange for the Parties to have an in-person meeting (or, at CDS' option, a meeting by telephone, videoconference or other means), during which an executive from Alimera shall present in reasonable detail its planned Commercialization [*] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE SECURITIES AND EXCHANGE ACT OF 1934, AS AMENDED. activities and Commercialization Budget for the time period covered in the subject Commercialization Budget and CDS shall have opportunities to ask questions and to present its comments on the applicable Commercialization Budget. It is understood and agreed that [*] shall have the right and ability to [*]. Alimera shall provide an initial draft Commercialization Budget to CDS for its review as soon as it is available, but in no event later than the earlier of (a) [*] prior to [*] or (b) [*] prior to incurring Direct Commercialization Costs estimated to be in excess of [*] in the aggregate.
Commercialization Budget. Commercialization of the Product in the Field in the Territory shall be conducted in accordance with a comprehensive Commercialization Budget, which the Parties shall agree upon [*] of the Product in the Territory (or such other time as mutually agreed by the Parties). From time to time, but at least each Calendar Year, the Parties shall update the Commercialization Budget to reflect any new planned Commercialization activities or changes in Commercialization activities with respect to the Product. The updated Commercialization Budget shall be subject to JCC review, discussion and approval. If the Parties (directly or through the JCC) cannot agree, even after the escalation steps in Section 2.2.4 (Decision Making), on a Commercialization Budget or certain Commercialization Costs within the Commercialization Budget, then for any proposed Commercialization Costs which have not been agreed upon, a Party may incur (at its own risk and cost) such Commercialization Costs to Commercialize the Product in the Field in its applicable Licensed Territories and such costs shall [*].
Commercialization Budget. Each Commercialization Budget will set forth the detailed costs to be incurred with respect to Commercialization of the applicable Cost Share Product for the [***] of such Commercialization Budget and will set forth high-level estimates for each of (i) the [***] period immediately following such [***] and (ii) the [***] period immediately following the [***] described in subsection (i) to the extent Astellas has prepared such an estimate for internal purposes. Each Commercialization Budget shall be updated least [***] with the corresponding Commercialization Plan in accordance with Section 6.7.4(b).
