Commercialization Plan. As further described in this section 7.4, the strategy for the commercial launch of, and subsequent Commercialization of, each Joint Product in each Commercialization Territory shall be described in a comprehensive plan (each such plan, and any revisions thereto, a “ Commercialization Plan ”) for such Commercialization Territory that describes: (a) the pre-launch, launch and subsequent Commercialization activities for such Joint Product in the Commercialization Territory Specific terms in this Exhibit have been redacted because such terms are both not material and are of the type that the Company treats as private or confidential. These redacted terms have been marked in this Exhibit with three asterisks [***]. (including promotional messaging, branding (including Product Trademarks), pricing, advertising, planning, marketing, sales force training); (b) key tactics for implementing those activities; (c) the responsibilities for implementing those activities assigned to each of the Parties; (d) the Detailing plan (including the number of Sales Representatives to be provided by the Parties and the number of PDEs required to be performed by the Parties in each applicable country in the Commercialization Territory during each Calendar Quarter); (e) Phase IV Studies and Medical Affairs Activities; (f) the brand elements for such Joint Product throughout the Profit Share Region, including the applicable key distinctive colors, logos, images, and symbols, and Trademarks (including the Product Trademarks) to be used in connection therewith (consistent with Section 7.9); and (g) a comprehensive budget of the projected costs for executing such activities for such Joint Product in the Commercialization Territory (which budget shall include required amounts of promotional funds to be expended by the Parties). The Parties may agree on a single Commercialization Plan to cover multiple Joint Products. Each Commercialization Plan and all subsequent revisions thereto shall contain the information described above in this Section 7.4(a) and any other information the JMC believes is necessary or useful for the successful commercial launch and subsequent Commercialization of such Joint Product. The Parties acknowledge that certain items of the Commercialization Plan may not be amenable to determination at the time the Commercialization Plan is initially drafted. In such event, the Parties shall amend such plan pursuant to Section 7.4(b) to include such items when appropriate. In the event of any inconsistency between a Commercialization Plan and this Agreement, the terms of this Agreement shall control.
Appears in 1 contract
Sources: Collaboration Agreement (Reata Pharmaceuticals Inc)
Commercialization Plan. As further described in this section 7.4, the strategy for the commercial launch of, and subsequent Commercialization of, each Joint Product in each Commercialization Territory shall be described in a comprehensive plan (each such plan, and any revisions thereto, a “ Commercialization Plan ”) for such Commercialization Territory that describes: (a) No later than [*], subject to Sections 9.3(d) and 9.3(e), Astellas shall prepare and provide to the JCC for review and discussion a written plan for the Commercialization of such Collaboration Product in an Astellas’ fiscal year (the “Commercialization Plan”). The Commercialization Plan shall include a reasonably detailed description of and anticipated timeline for the Parties’, their respective Affiliates’ and sublicensees’ Commercialization activities with respect to such Collaboration Product, including pre-launchlaunch plans, launch plans, market analytics, product forecasts, pricing assumptions and subsequent competitive intelligence. It is the Parties’ understanding that, [*] Astellas will be the Party primarily responsible for the conduct of the Commercialization activities for such Joint Product in under the Commercialization Territory Specific terms in this Exhibit have been redacted because such terms are both not material and are Plan. Each Party shall use Diligent Efforts to [*] of the type that collaboration under the Company treats as private or confidential. These redacted terms have been marked in this Exhibit with three asterisks Commercialization Plan (including [***]. (including promotional messaging, branding (including Product Trademarks), pricing, advertising, planning, marketing, sales force training); (b) key tactics for implementing those activities; (c) the responsibilities for implementing those activities assigned to each of the Parties; (d) the Detailing plan (including the number of Sales Representatives to be provided by the Parties and the number of PDEs required to be performed by the Parties in each applicable country in the Commercialization Territory during each Calendar Quarter); (e) Phase IV Studies and Medical Affairs Activities; (f) the brand elements for such Joint Product throughout the Profit Share Region, including the applicable key distinctive colors, logos, images, and symbols, and Trademarks (including the Product Trademarks) to be used in connection therewith (consistent with Section 7.9); and (g) a comprehensive budget of the projected costs for executing such activities for such Joint Product in the Commercialization Territory (which budget shall include required amounts of promotional funds to be expended by the Parties). The Parties may agree that the 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 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 a single an annual basis) prepare updates and amendments to its Commercialization Plan to cover multiple Joint Productsreflect 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. Each 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. Cytokinetics may perform [*] activities within the scope of its responsibilities under the Commercialization Plan, [*].
(d) The Commercialization Plan (and any amendment thereto) for any Collaboration Product (i) for a [*] Indication, (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 all subsequent revisions thereto any Co-Promotion Agreement.
(e) With respect to the Commercialization of a Collaboration Product in [*] Indication, subject to Section 9.8, then:
(i) If Cytokinetics has an Established Commercial Infrastructure, Cytokinetics shall contain the information described above in this Section 7.4(a) and any other information the JMC believes is necessary or useful have [*] for the successful commercial launch 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 subsequent the overall Commercialization Plan shall be consistent.
(ii) Regardless of such Joint Product. The Parties acknowledge that certain items [*] 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 [*] Indications includes the 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 [*] for the Collaboration Product(s) in such [*] Indication under Section 9.8(b), then [*] shall be amenable responsible for the pre-commercialization activities for the Collaboration Product in such [*] Indication.
(f) Subject to determination at the time 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 is initially drafted. In such eventexcept [*] (or [*] determined by the JCC), which shall be agreed between the Parties shall amend such plan pursuant to Section 7.4(b) to include such items when appropriate. In acting reasonably and in good faith and [*], for its Co-Promotion activities as set forth in the event of any inconsistency between a Commercialization Plan and this Co-Promotion Agreement, the terms of this Agreement shall control.
Appears in 1 contract
Sources: License and Collaboration Agreement (Cytokinetics Inc)
Commercialization Plan. As further described in this section 7.4, the strategy Partner shall be responsible for the commercial launch creation and implementation of an annual plan and budget for the commercialization of Products in the Field in the Territory, which will include any Post Marketing Studies (as defined below) of Products in the Field in the Territory (the “Commercialization Plan”), which Commercialization Plan shall include, without limitation, identification of, and subsequent Commercialization ofproposed plans to address, each Joint Product potential challenges with respect to commercialization of Products in each Commercialization Territory the Field in the Territory. Partner shall be described in a comprehensive plan (each such plan, prepare and any revisions thereto, a “ submit to Optimer the initial Commercialization Plan ”) no later than […***…] after the first submission of a MAA for such Commercialization Territory that describes: (a) the pre-launch, launch and subsequent Commercialization activities for such Joint Product in the Territory for review and discussion through the JSC. Subsequent updated Commercialization Territory Specific terms in this Exhibit have been redacted because such terms are both not material Plans shall be submitted by Partner to Optimer on an annual basis on or before the end of February each Calendar Year for review and are of discussion through the type that JSC. Through the Company treats as private or confidential. These redacted terms have been marked in this Exhibit JSC, Partner shall regularly consult with three asterisks [***]. (including promotional messaging, branding (including Product Trademarks), pricing, advertising, planning, marketing, sales force training); (b) key tactics for implementing those activities; (c) and provide updates to Optimer regarding the responsibilities for implementing those activities assigned to each of the Parties; (d) the Detailing plan (including the number of Sales Representatives to be provided by the Parties commercialization strategy and the number commercialization of PDEs required to be performed by the Parties in each applicable country Products in the Field in the Territory. Partner shall consider in good faith Optimer’s input regarding such commercialization strategy and the Commercialization Territory during each Calendar Quarter)Plan; (e) Phase IV Studies and Medical Affairs Activities; (f) provided, however, that Partner shall have final decision-making authority with respect to commercialization of Products in the brand elements for such Joint Product throughout Field in the Profit Share RegionTerritory, including the applicable right to set the terms of sales and book all sales of Products in the Field in the Territory, subject to Section 5.1(c) below. Partner shall provide Optimer with access to KOLs as may reasonably be requested by Optimer, where “KOLs” means all healthcare providers in the Territory that have administered a Product in clinical trials, have published academic articles relating to a Product, or are otherwise regarded by Partner, its Affiliates and Sublicensees, as the case may be, as a key distinctive colors, logos, images, and symbols, and Trademarks (including the Product Trademarks) to be used in connection therewith (consistent with Section 7.9); and (g) opinion leader for a comprehensive budget of the projected costs for executing such activities for such Joint Product in the Commercialization Territory. Optimer shall provide Partner with access to KOLs as may reasonably be requested by Partner, where “KOLs” means all healthcare providers outside the Territory (which budget shall include required amounts of promotional funds and ▇▇▇▇ Territory that have administered a Product in clinical trials, have published academic articles relating to be expended a Product, or are otherwise regarded by Optimer, its Affiliates and Sublicensees, as the Parties). The Parties case may agree on be, as a single Commercialization Plan to cover multiple Joint Products. Each Commercialization Plan key opinion leader for a Product outside the Territory and all subsequent revisions thereto shall contain the information described above in this Section 7.4(a) and any other information the JMC believes is necessary or useful for the successful commercial launch and subsequent Commercialization of such Joint Product. The Parties acknowledge that certain items of the Commercialization Plan may not be amenable to determination at the time the Commercialization Plan is initially drafted. In such event, the Parties shall amend such plan pursuant to Section 7.4(b) to include such items when appropriate. In the event of any inconsistency between a Commercialization Plan and this Agreement, the terms of this Agreement shall control▇▇▇▇ Territory.
Appears in 1 contract
Sources: Collaboration and License Agreement (Optimer Pharmaceuticals Inc)
Commercialization Plan. As further described (a) Agendia shall use Commercially Reasonable Efforts to Commercialize CMPBP in this section 7.4the Territory pursuant to a plan approved by the JSC in accordance with Section 3.6 (“Commercialization Plan”). Such plan shall include:
(i) a reasonably detailed description of the key elements of its Commercialization strategy (including messaging, the strategy for the commercial launch ofbranding, marketing, advertising, sales force positioning, and subsequent Commercialization ofpricing); and
(ii) a reasonably detailed description and commercially reasonable timeline of its implementation tactics (including sales force training, each Joint Product in each Commercialization Territory shall be described in a comprehensive plan (each such planpromotional activities, distribution channels, and any revisions thereto, a “ Commercialization Plan ”customer service) for such Commercialization Territory that describes: strategy for the next Annual Period.
(ab) the pre-launch, launch and subsequent Commercialization activities for such Joint Product in In connection with the Commercialization Territory Specific terms in this Exhibit have been redacted because such terms are both not material Plan, the Parties agree and are of the type that the Company treats acknowledge as private or confidential. These redacted terms have been marked in this Exhibit with three asterisks follows:
(i) Agendia shall be solely responsible [***]. for specific aspects of the commercial strategy for CMPBP including positioning and messaging, publications, generation of marketing materials, pricing and payor contracts, Third Party non-provider relationships (including promotional messaging, branding (including Product Trademarksbut not limited to pharmaceutical companies), pricingand distributor selection.
(ii) Agendia shall also be solely responsible [***]for the commercial strategy for CMPBP including geographic market selection, advertisingtarget market segments and accounts, planningmarketing and publicity. Agendia shall collaborate with Paige [***]in other aspects of commercial operations such as account-level engagement, marketingcontracting with clinical providers, sales force training); and service and support for ordering physicians.
(biii) key tactics If and when the Parties elect to expand the sale and distribution of CMPBP [***], Agendia and Paige shall be jointly responsible for implementing those activities; specific aspects of the commercial strategy for CMPBP including geographic market selection, regulatory jurisdictions, regulatory strategy, target market segments, account-level strategy, contracting with clinical providers, marketing and publicity. Within the geographies that may be selected by the JSC for commercialization outside of the initial Territory, as of the Effective Date of this Agreement, Paige shall have a non-exclusive right to distribute CMPBP directly to Third Parties via the Paige Platform. Notwithstanding the foregoing, if either Party determines that it is not commercially reasonable for such Party to sell or distribute CMPBP in a proposed country or territory, that Party will notify the other Party in writing, and the Parties agree that such Party will not be in material breach of this Agreement for being unable to sell or distribute such CMPBP in the proposed country or territory.
(c) [***]before the responsibilities for implementing those activities assigned to each anticipated date of the Parties; First Commercial Sale hereunder, Agendia shall prepare and present to the JSC the initial Commercialization Plan for such CMPBP. Following such presentation, Agendia will consider the JSC’s comments regarding the Commercialization Plan and adopt them as Agendia determines in its sole discretion.
(d) Prior to any commercial CMPBP launch and/or the Detailing plan (including the number of Sales Representatives to be provided by the Parties and the number of PDEs required to be performed by the Parties in each applicable country in the Commercialization Territory during each Calendar Quarter); (e) Phase IV Studies and Medical Affairs Activities; (f) the brand elements for such Joint Product throughout the Profit Share Regionfiling with any Governmental Authority, including the applicable key distinctive colors, logos, images, and symbols, and Trademarks (including the Product Trademarks) to be used in connection therewith (consistent with Section 7.9); and (g) a comprehensive budget of the projected costs for executing such activities for such Joint Product in the Commercialization Territory (which budget shall include required amounts of promotional funds to be expended by the Parties). The Parties may agree on a single Commercialization Plan to cover multiple Joint Products. Each Commercialization Plan and all subsequent revisions thereto shall contain the information described above in this Section 7.4(a) and any other information the JMC believes is necessary or useful for the successful commercial launch and subsequent Commercialization of such Joint Product. The Parties acknowledge that certain items as part of the Commercialization Plan may not be amenable to determination at the time the Commercialization Plan is initially drafted. In such eventstrategy, the Parties shall amend such plan pursuant enter into a quality agreement in connection with CMPBP and in accordance with the applicable Laws, including but not limited to Section 7.4(bthe International Standards Organization (“ISO”), the In Vitro Diagnostic Medical Device Regulation (“IVDR”) and the U.S. FDA.
(e) [***], Agendia shall prepare updates and amendments, as appropriate, to include such items when appropriate. In the event of any inconsistency between a then-current Commercialization Plan and present such updates and amendments to the JSC. Any material amendments to the Commercialization Plan (including any acceleration of the First Commercial Sale date for CMPBP, any changes to Product Trademarks, or other material changes) must be approved by the JSC in accordance with Section 3.6. Upon such approval, each amended Commercialization Plan will be effective and supersede the previous Commercialization Plan as of the date of such approval.
(f) For clarity, Agendia has full control and decision-making authority for the day-to-day conduct of activities implementing the Commercialization Plan [***], unless expressly reserved in this Agreement for the JSC’s determination or approval; provided that all such decisions must be consistent with the Collaboration’s purpose and objectives, the terms and conditions of this Agreement, the terms of this Agreement shall controland applicable Law.
Appears in 1 contract
Sources: Commercial and Development Collaboration Agreement (Agendia N.V.)
Commercialization Plan. As further described in this section 7.4, the strategy for the commercial launch of, and subsequent Commercialization of, each Joint Product in each Commercialization Territory shall be described in a comprehensive plan (each such plan, and any revisions thereto, a “ Commercialization Plan ”) for such Commercialization Territory that describes: (a) No later than [ * ] prior to the pre-launch, launch and subsequent Commercialization activities anticipated filing of an application for such Joint Regulatory Approval for a Product in the U.S., Endo shall deliver to the JSC a draft written commercialization plan setting forth anticipated material commercialization activities to be performed with respect to such Product in the U.S. by Endo or on its behalf, as well as projected timelines for such activities (the “Commercialization Territory Specific terms in this Exhibit have been redacted because Plan”). The JSC shall promptly review such terms are both not material draft initial Commercialization Plan and are may provide commercially reasonable comments to Endo for its consideration. Endo shall give good faith consideration to such comments and may revise such draft Commercialization Plan to implement such of the type JSC’s comments that it shall deem necessary or advisable to include in the Company treats draft. Endo shall, thereafter, submit the Commercialization Plan with such changes, revisions and modifications that it shall deem advisable to the JSC, and the Commercialization Plan, together with such changes, revisions and modifications, as private or confidential. These redacted terms have been marked in this Exhibit with three asterisks [***]. (including promotional messagingapplicable, branding (including Product Trademarks), pricing, advertising, planning, marketing, sales force training); shall be deemed final.
(b) key tactics for implementing those activities; No later than [ * ] prior to the anticipated launch of a Product in the U.S., Endo shall update the Commercialization Plan, and shall thereafter update the Commercialization Plan on an annual basis as follows: Endo shall provide the JSC with a draft update to the Commercialization Plan no later than December 1 of each year. Endo shall give good faith consideration to any comments provided by the JSC and may revise such Commercialization Plan to implement such of the JSC’s comments that it shall deem necessary or advisable to include in the Commercialization Plan, after which the update to the Commercialization Plan shall be deemed to be finalized. Endo shall deliver a final version of the updated Commercialization Plan no later than January 31 of the following year.
(c) The Commercialization Plan shall include a marketing plan for the responsibilities Product for implementing those activities assigned which Regulatory Approval is being sought or obtained in the U.S. that includes plans related to each the anticipated promotion and sale of such Product in the Parties; (d) U.S., competitive analysis, including information regarding actions intended to mitigate competitive threats, a non-binding sales forecast for the Detailing plan (following year and the marketing, promotion and advertising campaigns proposed to be conducted, including the number of Sales Representatives to be provided by the Parties detailing representatives, level of promotion and the number of PDEs required to be performed by the Parties in each applicable country in the Commercialization Territory during each Calendar Quarter); (e) Phase IV Studies and Medical Affairs Activities; (f) the brand elements for such Joint Product throughout the Profit Share Region, including the applicable key distinctive colors, logos, images, and symbols, and Trademarks (including the Product Trademarks) to be used in connection therewith (consistent with Section 7.9); and (g) a comprehensive budget of the projected costs for executing such activities for such Joint Product in the Commercialization Territory (which budget shall include required amounts of promotional funds to be expended by the Parties). The Parties may agree on a single Commercialization Plan to cover multiple Joint Products. Each Commercialization Plan and all subsequent revisions thereto shall contain the information described above in this Section 7.4(a) and any other information the JMC believes is necessary or useful for the successful commercial launch and subsequent Commercialization of such Joint Product. The Parties acknowledge that certain items of the Commercialization Plan may not be amenable to determination at the time the Commercialization Plan is initially drafted. In such event, the Parties shall amend such plan pursuant to Section 7.4(b) to include such items when appropriate. In the event of any inconsistency between a Commercialization Plan and this Agreement, the terms of this Agreement shall controlEndo’s medical education activities.
Appears in 1 contract
Sources: License, Development and Supply Agreement (Alexza Pharmaceuticals Inc.)
Commercialization Plan. As further described in this section 7.4, the strategy for the commercial launch of, and subsequent Commercialization of, each Joint Product in each Commercialization Territory shall be described in a comprehensive plan (each such plan, and any revisions thereto, a “ Commercialization Plan ”) for such Commercialization Territory that describes: (a) Without limiting the pregenerality of Licensee’s sole responsibility and decision-launch, launch and subsequent Commercialization activities making authority for such Joint Commercializing the Product in the Field in the Licensee Territory as set forth in Section 4.2, Licensee will use its Commercially Reasonable Efforts to carry out the Commercialization Territory Specific terms in this Exhibit have been redacted because such terms are both not material and are of the type Product in accordance with a written Commercialization Plan, as such may be amended or revised by Licensee from time to time, that describes the Company treats as private or confidential. These redacted terms have been marked in this Exhibit with three asterisks [***]. (including promotional messaging, branding (including Product Trademarks), pricing, advertising, planning, marketing, sales force training); (b) key tactics for implementing those activities; (c) the responsibilities for implementing those anticipated Commercialization activities assigned to each of the Parties; (d) the Detailing plan (including the number of Sales Representatives to be provided by the Parties and the number of PDEs required to be performed by the Parties in each applicable country in the Commercialization Territory during each Calendar Quarter); (e) Phase IV Studies and Medical Affairs Activities; (f) the brand elements for such Joint Product throughout the Profit Share Region, including the applicable key distinctive colors, logos, images, and symbols, and Trademarks (including the Product Trademarks) with respect to be used in connection therewith (consistent with Section 7.9); and (g) a comprehensive budget of the projected costs for executing such activities for such Joint Product in the Licensee Territory by Licensee or on its behalf by permitted Third Parties (the “Commercialization Territory (which budget shall include required amounts of promotional funds to be expended by the PartiesPlan”). The Parties may agree on a single Commercialization Plan to cover multiple Joint Products. Each Commercialization Plan shall address, in reasonable detail, to the extent applicable, ***.
(b) Within *** of the Effective Date, Licensee shall deliver to VIVUS a Commercialization Plan covering activities to be conducted in preparation of any Product Launch in the Licensee Territory on a country-by-country basis and all subsequent revisions thereto during the first full calendar year following such Product Launch.
(c) Licensee shall contain thereafter update the information Commercialization Plan (together with the Medical Affairs Plan described above in this Section 7.4(a4.7) and any other information on an annual basis as follows: Licensee shall provide the JMC believes is necessary JSC (or useful for VIVUS in the successful commercial launch and subsequent Commercialization absence of such Joint Product. The Parties acknowledge that certain items a JSC) with preliminary drafts of the Commercialization Plan may not be amenable to determination at and Medical Affairs Plan no later than *** of each year for the time JSC’s (or VIVUS’ in the absence of a JSC) review and comment and Licensee shall provide the JSC (or VIVUS in the absence of a JSC) with the final Commercialization Plan and Medical Affairs Plan no later than *** of the year immediately following such year. In preparing the updated versions of the Commercialization Plan is initially draftedand Medical Affairs Plan, Licensee shall ***. In such eventLicensee agrees to give due consideration to the input provided by the JSC (or VIVUS in the absence of a JSC) but Licensee at all times will retain responsibility and decision-making authority for the Commercialization of the Product in the Field in the Licensee Territory. Licensee may, at its
(d) Each Party shall use Commercially Reasonable Efforts in performing its obligations under this Section 4.3 concerning (as applicable) the Parties shall amend such plan pursuant to Section 7.4(bCommercialization Plan and Medical Affairs Plan.
(e) to include such items when appropriate. In the event of any inconsistency between a between, on the one hand, the Commercialization Plan and or Medical Affairs Plan and, on the other hand, this Agreement, the terms of this Agreement shall controlprevail.
Appears in 1 contract
Sources: License and Commercialization Agreement (Vivus Inc)
Commercialization Plan. As further described in this section 7.4, the strategy for the commercial launch of, and subsequent Commercialization of, each Joint Product in each Commercialization Territory shall be described in a comprehensive plan (each such plan, and any revisions thereto, a “ Commercialization Plan ”) for such Commercialization Territory that describes: (a) No later than [ * ], subject to Sections 9.3(d) and 9.3(e), Astellas shall prepare and provide to the JCC for review and discussion a written plan for the Commercialization of such Collaboration Product in an Astellas’ fiscal year (the “Commercialization Plan”). The Commercialization Plan shall include a reasonably detailed description of and anticipated timeline for the Parties’, their respective Affiliates’ and sublicensees’ Commercialization activities with respect to such Collaboration Product, including pre-launchlaunch plans, launch plans, market analytics, product forecasts, pricing assumptions and subsequent competitive intelligence. It is the Parties’ understanding that, [ * ] Astellas will be the Party primarily responsible for the conduct of the Commercialization activities for such Joint Product in under the Commercialization Territory Specific terms in this Exhibit have been redacted because such terms are both not material and are Plan. Each Party shall use Diligent Efforts to [ * ] of the type that collaboration under the Company treats as private or confidential. These redacted terms have been marked in this Exhibit with three asterisks [***]. Commercialization Plan (including promotional messaging, branding (including Product Trademarks), pricing, advertising, planning, marketing, sales force training); (b) key tactics for implementing those activities; (c) the responsibilities for implementing those activities assigned to each of the Parties; (d) the Detailing plan (including the number of Sales Representatives to be provided by the Parties and the number of PDEs required to be performed by the Parties in each applicable country in the Commercialization Territory during each Calendar Quarter); (e) Phase IV Studies and Medical Affairs Activities; (f) the brand elements for such Joint Product throughout the Profit Share Region, including the applicable key distinctive colors, logos, images, and symbols, and Trademarks (including the Product Trademarks) to be used in connection therewith (consistent with Section 7.9); and (g) a comprehensive budget of the projected costs for executing such activities for such Joint Product in the Commercialization Territory (which budget shall include required amounts of promotional funds to be expended by the Parties[ * ]). The Parties may agree that the 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 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 a single an annual basis) prepare updates and amendments to its Commercialization Plan to cover multiple Joint Productsreflect 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. Each 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. Cytokinetics may perform [ * ] activities within the scope of its responsibilities under the Commercialization Plan, [ * ].
(d) The Commercialization Plan (and any amendment thereto) for any Collaboration Product (i) for a [ * ] Indication, (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 all subsequent revisions thereto any Co-Promotion Agreement.
(e) With respect to the Commercialization of a Collaboration Product in [ * ] Indication, subject to Section 9.8, then:
(i) If Cytokinetics has an Established Commercial Infrastructure, Cytokinetics shall contain 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 shall be consistent. [ * ] = Certain confidential information described above contained in this Section 7.4(adocument, marked by brackets, has been omitted because it is both (i) not material and any other information (ii) would likely cause competitive harm if publicly disclosed.
(ii) Regardless of [ * ] as relates to the JMC believes is necessary or useful for the successful commercial launch and subsequent Commercialization of such Joint Product. The Parties acknowledge that certain items 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 [ * ] Indications includes the 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 [ * ] for the Collaboration Product(s) in such [ * ] Indication under Section 9.8(b), then [ * ] shall be amenable responsible for the pre-commercialization activities for the Collaboration Product in such [ * ] Indication.
(f) Subject to determination at the time 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 is initially drafted. In such eventexcept [ * ] (or [ * ] determined by the JCC), which shall be agreed between the Parties shall amend such plan pursuant to Section 7.4(b) to include such items when appropriate. In acting reasonably and in good faith [ * ], for its Co-Promotion activities as set forth in the event of any inconsistency between a Commercialization Plan and this Co-Promotion Agreement, the terms of this Agreement shall control.
Appears in 1 contract
Sources: License and Collaboration Agreement (Cytokinetics Inc)
Commercialization Plan. As further described in this section 7.4, the The strategy for the commercial launch of, and subsequent Commercialization of, of each Joint Licensed Product in each Commercialization Territory shall be described in a comprehensive plan (each such plan, and any revisions thereto, a “ Commercialization Plan ”) for such Commercialization Territory that describes: (a) describes the pre-launch, launch and subsequent Commercialization activities for such Joint Licensed Product in the Commercialization Territory Specific terms Territory, which shall include, without limitation, (i) the annual anticipated number of details to be conducted in this Exhibit have been redacted because such terms are both not material and are each country within the Territory, (ii) the annual anticipated marketing expenses to be incurred in each of the type that countries within the Company treats as private or confidential. These redacted terms have been marked Territory, (iii) the annual anticipated number of FTEs to be assigned to Commercialize in this Exhibit with three asterisks [***]. each of the countries within the Territory, and (including promotional messaging, branding (including Product Trademarks), iv) a report on pricing, advertising, education, planning, marketing, and sales force trainingtraining (the “Commercialization Plan”); . An initial Commercialization Plan for Biovance shall be prepared by Alliqua and presented to the JSC as soon as practicable, but in any event, within ninety (b90) key tactics for implementing those activities; (c) the responsibilities for implementing those activities assigned to each days of the Parties; (d) the Detailing plan (including the number of Sales Representatives Effective Date or such other time agreed to be provided by the Parties and JSC. In addition, Alliqua shall submit an initial Commercialization Plan for ECMs to the number of PDEs required JSC no later than ninety (90) days prior to be performed by the Parties anticipated 510(k) or other Regulatory Clearance and/or Approval in each applicable country in relevant jurisdiction within the Commercialization Territory during each Calendar Quarter); (e) Phase IV Studies and Medical Affairs Activities; (f) the brand elements for such Joint Product throughout the Profit Share Region, including the applicable key distinctive colors, logos, images, and symbols, and Trademarks (including the Product Trademarks) to be used in connection therewith (consistent with Section 7.9); and (g) a comprehensive budget of the projected costs for executing such activities for such Joint Product in the Commercialization Territory (which budget shall include required amounts of promotional funds to be expended by the Parties)Territory. The Parties may agree on shall, and shall cause their respective members of the JSC to, cooperate with each other in good faith to promptly finalize a single mutually acceptable Commercialization Plan to cover multiple Joint Productsfor each Licensed Product. Each Alliqua shall deliver an updated Commercialization Plan and all subsequent revisions thereto shall contain the information described above in this Section 7.4(a) and any other information the JMC believes is necessary or useful for the successful commercial launch and subsequent Commercialization of such Joint each Licensed Product. The Parties acknowledge that certain items , as applicable, at each meeting of the Commercialization Plan may not be amenable JSC or at such times as agreed to determination at by the time the Commercialization Plan is initially draftedJSC. In such eventTHE COMPANY HAS REQUESTED AN ORDER FROM THE SECURITIES AND EXCHANGE COMMISSION (THE “COMMISSION”) PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, the Parties shall amend such plan pursuant to Section 7.4(b) to include such items when appropriateAS AMENDED, GRANTING CONFIDENTIAL TREATMENT TO SELECTED PORTIONS. In the event of any inconsistency between a Commercialization Plan and this AgreementACCORDINGLY, the terms of this Agreement shall controlTHE CONFIDENTIAL PORTIONS HAVE BEEN OMITTED FROM THIS EXHIBIT, AND HAVE BEEN FILED SEPARATELY WITH THE COMMISSION. OMITTED PORTIONS ARE INDICATED IN THIS EXHIBIT WITH “*****”.
Appears in 1 contract
Sources: License, Marketing and Development Agreement (Alliqua, Inc.)