Common use of Commercialization Plan and Budget Clause in Contracts

Commercialization Plan and Budget. ORTHO, after taking --------------------------------- into consideration CTI's comments, shall develop and the JCC shall review, to the extent reasonably practical given the stage of development of each Collaboration Product and consistent with ORTHO's reasonable business practice, a commercialization plan ("Commercialization Plan") for each Collaboration Product for the Co-Promotion Territory, which shall include but not be limited to (i) market dynamics, market strategies, estimated launch dates in the Co- Promotion Territory, a sales and expense forecast (including at least ***** of estimated sales and expenses) in the Co-Promotion Territory, manufacturing plans and expected product profile based upon the Development Plan, (ii) a market plan (including Advertising forecasts and pricing strategies pertaining to discounts, samples and nominal price sales) for the Co-Promotion Territory; it being understood that such market plan will evolve over time and shall be similar to existing market plans developed at such time by ORTHO within the Co-Promotion Territory, (iii) a commercialization budget ("Commercialization Budget") for each Collaboration Product, initially for the Development Indications, for the Co-Promotion Territory, including the Third Parties to be utilized and the arrangements with them that have been or are proposed to be agreed upon. Each Commercialization Budget shall include a budget of the expenses expected to be incurred in connection with performing the Commercialization Plan, including Pre-Marketing Expenses and Allowable Operating Expenses in the Co-Promotion Territory. (The information below marked by ***** has been omitted by a request for confidential treatment. The omitted portion has been separately filed with the Commission.) The first Commercialization Plan shall be in the form of an initial outline and the first Commercialization Budget shall be in the form of an estimated budget. ORTHO shall submit such outline of the first Commercialization Plan and an estimated Commercialization Budget for a Collaboration Product for a BMT Indication to the JCC for review and approval by a date to be established by the JCC taking into account ORTHO's and CTI's annual budget planning calendars. It is understood that such outlines may contain open issues and identify areas wherein more information is needed to complete the outlines (The information below marked by ***** has been omitted by a request for confidential treatment. The omitted portion has been separately filed with the Commission.) and estimated Commercialization Budgets and to prepare a more complete Commercialization Plan and Budget for Collaboration Products for such Development Indications. Thereafter, by ***** of each subsequent year, ORTHO, after taking into consideration CTI's comments, including CTI's notice regarding its contribution to the dedicated field force, will prepare a more complete Commercialization Plan and Commercialization Budget for submission to the JCC for its review and approval. The Commercialization Plan and Commercialization Budget shall be approved by the JCC no later than ***** of each year. It is understood that each Commercialization Plan and Commercialization Budget will become more comprehensive as the project evolves. For any subsequent Collaboration Products, ORTHO shall prepare and submit to the JCC an outline of an initial Commercialization Plan and an estimated Commercialization Budget for the Co-Promotion Territory for each such Collaboration Product for review and approval. Such Commercialization Plan and Commercialization Budget shall be updated and refined on each subsequent ***** as described above in connection with Collaboration Products for a BMT Indication. ORTHO shall make all final decisions with respect to Commercialization Plans and Budgets except as is provided in Section 7.01(b). Any significant change in a Commercialization Plan or Commercialization Budget during the course of the year will be communicated promptly to the JCC. In addition, ORTHO shall provide an update on each Commercialization Plan and Commercialization Budget to the JCC in a manner consistent (with respect to timing and content) with such updates as are reported internally by ORTHO on its existing products at such time. (The information below marked by ***** has been omitted by a request for confidential treatment. The omitted portion has been separately filed with the Commission.)

Commercialization Plan and Budget. ORTHO, after taking --------------------------------- into consideration CTI's comments, (a) The Lead Marketing Party shall develop a comprehensive written plan and budget for the JCC shall review, to direct development and commercialization of the extent reasonably practical given the stage of development of each Collaboration Product in the Field (a “Commercialization Plan and consistent Budget”). The Commercialization Plan and Budget will set forth in detail the marketing, sale and distribution activities to be undertaken with ORTHO's reasonable business practice, a commercialization plan ("Commercialization Plan") for each respect to such Collaboration Product (including advertising, education, planning, marketing, sales force training and distribution), as well as the activities required for the Co-Promotion Territorymanufacture of such Collaboration Products following commercial launch, which in each case whether such activities are undertaken before or after Regulatory Approval. The Commercialization Plan and Budget shall include but not be limited to to: (i) demographics, market dynamics, dynamics and market strategies, estimated country launch dates in the Co- Promotion Territorydates, a sales and expense forecast (including at least ***** three (3) years of estimated sales and expenses) in the Co-Promotion Territorysales), manufacturing plans and expected product profile based upon the Development Plan, Plan and Budget; and (ii) a market plan (including Advertising forecasts and pricing strategies pertaining to discounts, samples and nominal price sales) for the Co-Promotion Territory; samples), it being understood that such the market plan will evolve over time time. (b) The Commercialization Plan and shall be similar to existing market plans developed at such time by ORTHO within the Co-Promotion Territory, (iii) a commercialization budget ("Commercialization Budget") for each Collaboration Product, initially for the Development Indications, for the Co-Promotion Territory, including the Third Parties to be utilized and the arrangements with them that have been or are proposed to be agreed upon. Each Commercialization Budget shall include a budget of the expenses expected to be incurred in connection with performing the Commercialization Plan, including Pre-Marketing Expenses and Allowable Operating Expenses in the Co-Promotion Territory. (The information below marked by ***** has been omitted by a request for confidential treatment. The omitted portion has been separately filed with the Commission.) The first Commercialization Plan shall be in the form of an initial outline and the first Commercialization Budget shall be in the form of an estimated budget. ORTHO shall submit such outline of the first Commercialization Plan and an estimated Budget, and shall set forth the maximum Allowable Commercialization Budget for Expenses to be incurred in each calendar year (although some of such expenses may be expressed as a percentage of revenue or other mutually-agreed formulas). In those territories where the Collaboration Product for a BMT Indication to will be sold through Third Party licensees, the JCC for review and approval by a date to be established by the JCC taking into account ORTHO's and CTI's annual budget planning calendars. It is understood that such outlines may contain open issues and identify areas wherein more information is needed to complete the outlines (The information below marked by ***** has been omitted by a request for confidential treatment. The omitted portion has been separately filed with the Commission.) and estimated Commercialization Budgets and to prepare a more complete Commercialization Plan and Budget may be limited to solely those activities for Collaboration Products for such Development Indications. Thereafter, by ***** which the Lead Marketing Party will be responsible. (c) By September 1 of each subsequent calendar year, ORTHO, after taking into consideration CTI's comments, including CTI's notice regarding its contribution to the dedicated field force, will prepare a more complete Commercialization Plan and Commercialization Budget for submission to the JCC for its review and approval. The Commercialization Plan and Commercialization Budget shall be approved by the JCC no later than ***** of each year. It is understood that each Commercialization Plan and Commercialization Budget will become more comprehensive as the project evolves. For any subsequent Collaboration Products, ORTHO Lead Marketing Party shall prepare and submit to the JCC an outline of an initial JSC a draft Commercialization Plan and an estimated Commercialization Budget for the Co-Promotion Territory for each forthcoming year. The Party other than the Lead Marketing Party shall submit its comments on such Collaboration Product for review draft plan and approval. Such budget within 30 days after its receipt, and the JSC shall thereafter meet and confer, with the objective of approving such Commercialization Plan and Commercialization Budget shall be updated as soon as practicable, and refined on each subsequent ***** as described above in connection with Collaboration Products for a BMT Indicationno later than November 15. ORTHO shall make all final decisions with respect to It is understood that Commercialization Plans and Budgets except as is provided in Section 7.01(b). Any significant may need to change in a Commercialization Plan or Commercialization Budget during the course of a calendar year, and if the year will Lead Marketing Party determines that such a change may be communicated necessary, it shall promptly to inform the JCC. In addition, ORTHO JSC and the JSC shall provide an update on each Commercialization Plan and Commercialization Budget to the JCC in a manner consistent (with respect to timing and content) with promptly decide such updates as are reported internally by ORTHO on its existing products at such time. (The information below marked by ***** has been omitted by a request for confidential treatment. The omitted portion has been separately filed with the Commissionmatter.)

Commercialization Plan and Budget. ORTHO(a) The Commercialization Plan shall (i) be developed on a country-by-country basis and, after taking --------------------------------- into consideration CTI's commentswith respect to Territory Centralized Expenses and related activities, a Territory-wide basis, (ii) specify any Territory-wide activities and country-specific activities to be conducted in each country in the Territory, which country-specific activities shall develop and be mutually agreed by the JCC shall review, parties to the extent reasonably practical given applicable Co-Promotion Agreement, if any, in accordance with such agreement, subject to any applicable provisions of this Agreement, and (iii) cover only activities for commercialization of Territory Combination Product that shall be conducted by or on behalf of one Party or its applicable Affiliate or that must be coordinated between the stage Parties or their respective Affiliates hereunder or under any Co-Promotion Agreement, which activities shall conform to the other terms of development this Agreement, including the provisions of each Collaboration Product this Section 5 and consistent with ORTHO's reasonable business practice, a commercialization plan ("Commercialization Plan") for each Collaboration Product for the Co-Promotion Agreement, if any, for the applicable country. Such plan shall specify (A) such activities and (B) the Party that shall take the lead role with respect to such activities on a country-by-country basis (or Territory-wide basis, if applicable). [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. CONFIDENTIAL TREATMENT REQUESTED UNDER 17 C.F.R. §§ 200.80 (b)(4) AND 230.406 (b) The initial Commercialization Plan attached hereto as Annex F covers Calendar Years 2006, 2007 and 2008 (such plan, as updated from time to time in accordance with this Section 5.8, the “Commercialization Plan”) for certain countries in the Territory. From time to time, the Parties or the JEC shall amend the Commercialization Plan to include each other country in the Territory prior to the anticipated date of Launch in such country. The Commercialization Plan and any update thereto shall contain a budget for each Party’s out-of-pocket expenses for such Party’s activities set forth therein (such budget, the “Commercialization Budget”), which budget shall include but not be limited set forth on a country-by-country basis (for the countries included in the Commercialization Plan) and with respect to Territory Centralized Expenses, on a Territory-wide basis. The initial Commercialization Plan covers, and any updates thereto shall cover (i) unit volume and market dynamics, market strategies, estimated launch dates share forecasts for the Combination Product in each country in the Co- Territory that is included in the Commercialization Plan for the foregoing period, (ii) certain Marketing and other commercialization activities for the Combination Product that are required to be conducted in each such country by or on behalf of one Party or its applicable Affiliate or that must be coordinated between the Parties or their respective Affiliates hereunder or under the applicable Co-Promotion TerritoryAgreement, a sales (iii) the total minimum number of Details by each Party in each country in the Territory in each Calendar Quarter (or part thereof); provided, however, that, without limitation of the obligations of each Party set forth in Section 5.3 to use Commercially Reasonable Efforts to perform such Party’s Commercialization Activities and expense forecast to Promote the Territory Combination Product, no minimum number of Details are required for any country in Territory A; and (including iv) any other matters or activities determined by the EUOC. With respect to each country, except as otherwise agreed by the JEC or by the Parties in writing, the total amount included in the Country-Specific Commercialization Budget for the Initial Launch Period for such country shall be at least ***** the amount of estimated sales the Initial Launch Period Financial Commitment for such country. (c) For each Calendar Year commencing with Calendar Year 2009 (other than (i) any such Calendar Year for which the Parties agree that there shall be no Commercialization Plan or Commercialization Budget or (ii) any such Calendar Year that follows a Calendar Year in which the Commercialization Budget is zero), the Parties shall jointly prepare, based on country-by-country plans and expenses) in budgets developed by the JLOCs pursuant to the Co-Promotion TerritoryAgreements or as otherwise agreed by the Parties, manufacturing plans and expected product profile based upon the Development Plan, (ii) a market plan (including Advertising forecasts and pricing strategies pertaining to discounts, samples and nominal price sales) for the Co-Promotion Territory; it being understood that such market plan will evolve over time and shall be similar to existing market plans developed at such time by ORTHO within the Co-Promotion Territory, (iii) a commercialization budget ("Commercialization Budget") for each Collaboration Product, initially for the Development Indications, for the Co-Promotion Territory, including the Third Parties to be utilized and the arrangements with them that have been or are any proposed to be agreed upon. Each Commercialization Budget shall include a budget of the expenses expected to be incurred in connection with performing the Commercialization Plan, including Pre-Marketing Expenses and Allowable Operating Expenses in the Co-Promotion Territory. (The information below marked by ***** has been omitted by a request for confidential treatment. The omitted portion has been separately filed with the Commission.) The first Commercialization Plan shall be in the form of an initial outline and the first Commercialization Budget shall be in the form of an estimated budget. ORTHO shall submit such outline of the first Commercialization Plan and an estimated Commercialization Budget for a Collaboration Product for a BMT Indication updates to the JCC for review and approval by a date to be established by the JCC taking into account ORTHO's and CTI's annual budget planning calendars. It is understood that such outlines may contain open issues and identify areas wherein more information is needed to complete the outlines (The information below marked by ***** has been omitted by a request for confidential treatment. The omitted portion has been separately filed with the Commission.) and estimated Commercialization Budgets and to prepare a more complete Commercialization Plan and Budget for Collaboration Products for such Development Indications. Thereafter, by ***** of each subsequent year, ORTHO, after taking into consideration CTI's comments, including CTI's notice regarding its contribution to the dedicated field force, will prepare a more complete Commercialization Plan and Commercialization Budget for submission (which updates shall be prepared in sufficient time to permit Gilead Sub to submit, in a timely manner, such updates to the JCC EUOC and the JFC in accordance with this Section 5.8(c)). Gilead Sub shall submit to the EUOC and the JFC, not less than sixty (60) days prior to the start of each Calendar Year for its review and approval. The such Calendar Year, any jointly-agreed proposed updates to the Commercialization Plan and Budget. In the event that Gilead Sub and BMS fail to reach agreement with respect to any such proposed updates, each Party shall submit its proposed updates to the EUOC and the JFC by the deadline set forth in the immediately preceding sentence. The JFC shall provide its comments on any Commercialization Budget submitted to the JFC to the EUOC, for its consideration, within ten (10) Business Days following such submission. Following review, discussion and appropriate revision of such proposed update, no later than forty-five (45) days prior to the start of the applicable Calendar Year, the EUOC shall be (A) agree upon an update to propose to the JEC and submit such proposed update to the JEC, or (B) in the event the EUOC cannot reach agreement on such any such proposed update, to submit to the JEC the proposed update submitted by Gilead Sub (or each Party) to the EUOC pursuant to this Section 5.8(c) and any other relevant materials, including any comments that the JFC and either Party’s EUOC members may have on such proposed update, so as to enable the JEC to reach agreement with respect to such an update. [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. CONFIDENTIAL TREATMENT REQUESTED UNDER 17 C.F.R. §§ 200.80 (b)(4) AND 230.406 (d) Without limitation to the annual updates covered by Section 5.8(c), either Party, directly or through its representatives on the EUOC, as the case may be, may propose interim updates to the Commercialization Plan and the Commercialization Budget to the EUOC from time to time as appropriate in light of changed circumstances. The EUOC shall review, discuss and revise, as appropriate, any such proposed update at its next quarterly meeting. In the event that any such proposed update would cause the updated Commercialization Budget to exceed one hundred and five percent (105%) of the Commercialization Budget most recently approved by the JCC no later than ***** of each year. It is understood that each Commercialization Plan and Commercialization Budget will become more comprehensive as JEC pursuant to Section 5.8(c) (a “Significant Interim Update”), the project evolves. For any subsequent Collaboration ProductsEUOC shall forward such proposed update, ORTHO shall prepare and submit with its recommendation, if any, with respect to such proposed update, to the JCC an outline of an initial Commercialization Plan and an estimated Commercialization Budget for the Co-Promotion Territory for each such Collaboration Product JEC for review and approval. Such Commercialization Plan and In the event that such proposed update is not a Significant Interim Update, including in the case in which the proposed update would reallocate funds between or among two or more countries in the Territory, but not increase the Commercialization Budget beyond the foregoing threshold, the EUOC shall determine whether or not to approve such proposed update, which determination shall be updated final and refined on each subsequent ***** as described above in connection with Collaboration Products for not subject to dispute resolution pursuant to Section 2.6. (e) Subject to Section 2.2(c) and Section 2.7, if a BMT Indication. ORTHO shall make all final decisions with respect proposed update to Commercialization Plans and Budgets except as is provided in Section 7.01(b). Any significant change in a the Commercialization Plan or Commercialization Budget during is not approved by the course of JEC (or if applicable, the year will be communicated promptly to the JCC. In additionEUOC), ORTHO shall provide an update on each then such Commercialization Plan or Commercialization Budget, as the case may be, shall continue in effect as approved and Commercialization Budget most recently updated pursuant to the JCC in a manner consistent (with respect to timing and content) with such updates as are reported internally by ORTHO on its existing products at such time. (The information below marked by ***** has been omitted by a request for confidential treatment. The omitted portion has been separately filed with the Commissionthis Section 5.8.)