Common use of Co-Promotion Clause in Contracts

Co-Promotion. Thera Europe or any of its Affiliates shall have the exclusive option, exercisable at any time after an applicable Marketing Authorisation of the Initial Product is obtained, to co-promote with Xxxxxx (or, if applicable, its approved Affiliates, sublicensees or distributors) a Product in one or more Countries (the “Co-Promoted Product”). If Thera Europe desires to exercise its option with respect to the Co-Promoted Product in the UK, France and/or Germany, Thera Europe shall notify Xxxxxx in writing at least [REDACTED: Term] prior to the date on which it intends to begin such co-promotion of the Co-Promoted Product and Xxxxxx agrees that upon the expiry of such time period the licenses granted hereunder shall become sole to the extent necessary to allow Thera Europe to so co-promote the Co-Promoted Product during the Co-Promotion Period (as hereinafter defined) in such Countries. In any Country other than the UK, France and/or Germany (where the UK, France and Germany shall be the “Excluded Countries”) in which Thera Europe desires to exercise its option to co-promote a Co-Promoted Product, Thera Europe shall notify Xxxxxx in writing at least [REDACTED: Term] prior to the date on which it intends to begin the co-promotion of the Co-Promoted Product in such Country other than the Excluded Countries and with such notice shall provide its proposed co-promotion strategy therein. In any Country other than an Excluded Country, the Parties will use Commercially Reasonable Efforts to finalise a co-promotion strategy within such [REDACTED: Term] period prior to the date on which Thera Europe intends to begin the co-promotion of the Co-Promoted Product in such Country. Xxxxxx agrees that upon the expiry of such [REDACTED: Term] period and during the Co-Promotion Period (as hereinafter defined) in any Country the licenses granted hereunder shall become sole to the extent necessary to allow Thera Europe to so co-promote the Co-Promoted Product in such Country. The foregoing option to co-promote in a Country or any of them may be exercised more than once throughout the Term (with each period during which Thera Europe is co-promoting the Co-Promoted Product in a Country being referred to as a “Co-Promotion Period”) provided that Thera Europe shall notify Xxxxxx in writing at least [REDACTED: Term] prior to the date on which it either intends to begin the co-promotion of the Co-Promoted Product or [REDACTED: Term] written notice to Xxxxxx to cease the same. During a Co-Promotion Period, Xxxxxx will book all sales of the Co-Promoted Product whether promoted by Xxxxxx or Thera Europe, and all such sales of the Co-Promoted Product shall be included for purposes of computing the Net Selling Price hereunder. All costs and expenses incurred by Thera Europe during a Co-Promotion Period in connection with the co-promotion activities for the Co-Promoted Product (including, but not limited to, employee costs and marketing expenses), together with any incremental expenses incurred by Xxxxxx as a result of Thera Europe’s co-promotion activities (provided these expenses have been identified by the CPC ahead of time and agreed in writing by Thera Europe), shall be the sole responsibility of Thera Europe, except that Xxxxxx shall reimburse Thera Europe for those costs and expenses that would have otherwise been paid by Xxxxxx according to Xxxxxx’x latest Commercialization Plan submitted to Thera Europe under Section 5.2 (i.e., all costs and expenses that customarily would be incurred by Xxxxxx in connection with the promotion and detailing of, or otherwise in connection with a sales force for, a pharmaceutical product in the ordinary course of Xxxxxx’x business). Notwithstanding the above, the Parties acknowledge that Xxxxxx shall have no obligation to amend the Commercialization Plan (except pursuant to Section 5.2) and that Thera Europe’s Commercialization efforts are independent of those of Xxxxxx hereunder. During a Co-Promotion Period, Thera Europe or any of its Affiliates will be involved in the decision-making process related to all aspects of the co-promotion of the Co-Promoted Product through a co-promotion committee (the “Co-Promotion Committee” or “CPC”). As a general principle, the CPC will operate by consensus with each Party collectively having one vote; provided, however, that at least [REDACTED: Number] representative for each of Thera Europe and Xxxxxx must be present (whether in person or by telephone or videoconference) for a meeting of the CPC to take place and for any decision to be made. The CPC will be comprised of [REDACTED: Number] representatives from Thera Europe or any Affiliates thereof and [REDACTED: Number] representatives from Xxxxxx. In the event that the CPC representatives do not reach consensus with respect to a matter that is within the purview of the CPC (each within [REDACTED: Term] after they have met and attempted to reach such consensus, the matter shall be referred for resolution to the Chief Executive Officer of Thera Europe and the Chief Executive Officer of Xxxxxx for their consideration and agreement. If the executive officers of such Parties are unable to agree after negotiation in good faith, or either Party’s Chief Executive Officer does not participate, within [REDACTED: Term] of the submission of such matter to each Party’s Chief Executive Officer, then the matter shall be subject to review pursuant to ARTICLE 15.

Appears in 1 contract

Samples: Distribution and Licensing Agreement (Theratechnologies Inc.)

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Co-Promotion. Thera Europe or any of its Affiliates With respect to each country within the Joint Commercialization Territory, Maxygen shall have the exclusive option, exercisable at any time after an applicable Marketing Authorisation of the Initial Product is obtained, option to co-promote with Xxxxxx (or, if applicable, its approved Affiliates, sublicensees or distributors) a Product in one or more Countries (the “Co-Promoted Product”). If Thera Europe desires to exercise its option with respect Promote each Product for Co-Development Indications in each such country within the Joint Commercialization Territory according to the Co-Promoted Product terms and conditions set forth in the UK, France and/or Germany, Thera Europe shall notify Xxxxxx in writing at least [REDACTED: Term] prior to the date on which it intends to begin such co-promotion of the Co-Promoted Product and Xxxxxx agrees that upon the expiry of such time period the licenses granted hereunder shall become sole to the extent necessary to allow Thera Europe to so co-promote the Co-Promoted Product during the Co-Promotion Period (as hereinafter defined) in such Countries. In any Country other than the UK, France and/or Germany (where the UK, France and Germany shall be the “Excluded Countries”) in which Thera Europe desires to exercise its option to co-promote a Co-Promoted Product, Thera Europe shall notify Xxxxxx in writing at least [REDACTED: Term] prior to the date on which it intends to begin the co-promotion of the Co-Promoted Product in such Country other than the Excluded Countries and with such notice shall provide its proposed co-promotion strategy therein. In any Country other than an Excluded Country, the Parties will use Commercially Reasonable Efforts to finalise a co-promotion strategy within such [REDACTED: Term] period prior to the date on which Thera Europe intends to begin the co-promotion of the Co-Promoted Product in such Country. Xxxxxx agrees that upon the expiry of such [REDACTED: Term] period and during the Co-Promotion Period (as hereinafter defined) in any Country the licenses granted hereunder shall become sole to the extent necessary to allow Thera Europe to so co-promote the Co-Promoted Product in such Country. The foregoing option to co-promote in a Country or any of them may be exercised more than once throughout the Term (with each period during which Thera Europe is co-promoting the Co-Promoted Product in a Country being referred to as a “Co-Promotion Period”) provided that Thera Europe shall notify Xxxxxx in writing at least [REDACTED: Term] prior to the date on which it either intends to begin the co-promotion of the Co-Promoted Product or [REDACTED: Term] written notice to Xxxxxx to cease the same. During a Co-Promotion Period, Xxxxxx will book all sales of the Co-Promoted Product whether promoted by Xxxxxx or Thera Europe, and all such sales of the Co-Promoted Product shall be included for purposes of computing the Net Selling Price hereunder. All costs and expenses incurred by Thera Europe during a Co-Promotion Period in connection with the co-promotion activities for the Co-Promoted Product (including, but not limited to, employee costs and marketing expenses), together with any incremental expenses incurred by Xxxxxx as a result of Thera Europe’s co-promotion activities (provided these expenses have been identified by the CPC ahead of time and agreed in writing by Thera Europe), shall be the sole responsibility of Thera Europe, except that Xxxxxx shall reimburse Thera Europe for those costs and expenses that would have otherwise been paid by Xxxxxx according to Xxxxxx’x latest Commercialization Plan submitted to Thera Europe under this Section 5.2 (i.e., all costs and expenses that customarily would be incurred by Xxxxxx in connection with the promotion and detailing of, or otherwise in connection with a sales force for, a pharmaceutical product in the ordinary course of Xxxxxx’x business). Notwithstanding the above, the Parties acknowledge that Xxxxxx shall have no obligation to amend the Commercialization Plan (except pursuant to Section 5.2) and that Thera Europe’s Commercialization efforts are independent of those of Xxxxxx hereunder. During a Co-Promotion Period, Thera Europe or any of its Affiliates will be involved in the decision-making process related to all aspects of the co-promotion of the Co-Promoted Product through a co-promotion committee (the “Co-Promotion Committee” or “CPCOption”). As a general principle, provided that, for the avoidance of doubt, the CPC will operate option to Co-Promote in this Section 5.2 shall not apply to Products for which Maxygen has exercised the Maxygen Opt Out Right in accordance with Section 4.1.4. Maxygen may exercise the Co-Promotion Option for a Product for Co-Development Indications in * Certain information on this page has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. any countries within the Joint Commercialization Territory by consensus providing written notice to Astellas (the “Co-Promotion Notice”) no later than [****]days from the later of (i) Astellas notifying Maxygen that it has filed a MAA for such Product in such country and (ii) Astellas providing to Maxygen (in English, or together with each Party collectively having one vote; provided, however, that English translations thereof) the information of its internal projections and plans for the period through at least the [REDACTED: Number****] representative after the launch of such Product regarding Commercialization of such Product for Co-Development Indications within the Joint Commercialization Territory and other related information, in each case which is customarily or actually prepared by Astellas for presentation to, and including pre-meeting materials and information which is actually made available to, Astellas’ applicable executive committee(s) regarding Commercialization of Thera Europe such Product, including in any event projected Cost for Commercialization (including launch Costs), commercial assessments for such Product, and Xxxxxx must forecasts for sales and number and type of details, in each case on a country-by-country basis with respect to each country in the Joint Commercialization Territory. During such [****] day period, Astellas shall (i) promptly (and in any event within [****] days) provide such additional information as Maxygen may reasonably request regarding aspects of Commercialization of the applicable Product, to the extent Controlled by Astellas and available (for the avoidance of doubt, “available” shall mean that such information and materials already exist and that Astellas has already prepared or obtained them for its own internal use, and Astellas is not under any obligation to prepare, create or modify any such information or materials for Maxygen but instead need only provide them in their existing form, other than making applicable redactions as described in the following clause), excluding know-how and techniques proprietary to Astellas that are utilized in developing or obtaining such information but including information resulting therefrom to the extent applied to the applicable Product (and provided that if documents or materials contain both such proprietary know-how or techniques as well as information that is otherwise to be present provided hereunder, Astellas shall provide such documents or materials, but may redact such proprietary know-how or techniques), including (whether A) the activities that would be undertaken in person or by telephone or videoconferencepromoting such Product in the applicable countries, including plans for product positioning, key message delivery, market segmentation, target population identification, competitor analysis and other key promotional activities (including background market research and analysis as applied specifically to the Product at issue) in support thereof, (B) projections of applicable Costs (including Manufacturing Costs, Sales Costs and Marketing Costs, Phase IV commitments and other necessary post-approval activities) related to the applicable Product with respect to such countries, (C) projections of sales and market penetration of such Product in such countries, including forecast data and assumptions related to sales growth, peak sales, time to peak and Commercialization personnel required, brandswitch strategy, pricing and reimbursement assumptions, target market sizes and unit volume projections, and (D) such other information regarding commercial potential of such Product in such country as is material to a decision to launch such Product in each country within the Joint Commercialization Territory on a country-by-country basis, and (ii) be available (promptly, and in any event within [****] following the applicable request) for a meeting of consultation as reasonably requested by Maxygen regarding information provided under this or the CPC to take place and for any decision to be made. The CPC will be comprised of [REDACTED: Number] representatives from Thera Europe or any Affiliates thereof and [REDACTED: Number] representatives from Xxxxxxpreceding sentence. In the event that Maxygen exercises the CPC representatives do not reach consensus Co-Promotion Option with respect to a matter that is within the purview of the CPC particular Product (each within [REDACTED: Term] after they have met and attempted to reach such consensuseach, a “Co-Promot ion Product”), the matter provisions of this Section 5.2 shall apply with respect thereto. For the avoidance of doubt, all information and * Certain information on this page has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. materials provided by Astellas under this Section 5.2 are provided “AS IS” without representation or warranty of any kind (and no assurances are provided hereunder that any particular piece of information described above in subsections A through D will be available for provision to Maxygen) and Maxygen shall be referred solely responsible for resolution its decision as to whether or not to exercise the Chief Executive Officer of Thera Europe and the Chief Executive Officer of Xxxxxx for their consideration and agreement. If the executive officers of such Parties are unable to agree after negotiation in good faith, or either Party’s Chief Executive Officer does not participate, within [REDACTED: Term] of the submission of such matter to each Party’s Chief Executive Officer, then the matter shall be subject to review pursuant to ARTICLE 15Co-Promotion Option hereunder.

Appears in 1 contract

Samples: Co Development and Commercialization Agreement (Maxygen Inc)

Co-Promotion. Thera Europe or any of its Affiliates Cytokinetics shall have the exclusive option, exercisable at any time after an applicable Marketing Authorisation of the Initial Product is obtained, right to coelect to Co-promote with Xxxxxx (or, if applicable, its approved Affiliates, sublicensees or distributors) a Promote each Collaboration Product in one or more Countries (the “Co-Promoted Product”). If Thera Europe desires to exercise its option with respect to the Co-Promoted Product Promotion Territory as set forth in the UKthis Section 8.6. (a) On a Collaboration Product-by-Collaboration Product, France and/or GermanyIndication-by-Indication, Thera Europe shall notify Xxxxxx in writing and country-by-country basis, at least [REDACTED: Term*] prior to the date on which it intends to begin [*] such coCollaboration Product in such Indication in such country as set forth in the then-promotion of current Development Plan (the Co-Promoted “[*] Date”), Astellas shall provide Cytokinetics with a written notification setting forth the following: (i) the [*]; (ii) [*] for such Collaboration Product for such Indication in such country [*]; and Xxxxxx agrees that upon (iii) [*] Astellas and Cytokinetics for such Collaboration Product for such Indication in such country [*] (the expiry of such time period the licenses granted hereunder shall become sole to the extent necessary to allow Thera Europe to so co-promote the Co-Promoted Product during the “Astellas Co-Promotion Period (as hereinafter defined) in Notice”). Within [*] after receiving such Countries. In any Country other than Astellas Co-Promotion Notice, Cytokinetics shall have the UK, France and/or Germany (where the UK, France and Germany shall be the “Excluded Countries”) in which Thera Europe desires right to exercise its option to co-promote a Co-Promoted ProductPromote such Collaboration Product for such Indication in such country by written notice to Astellas. If Cytokinetics fails to provide such written notice within such [*] period, Thera Europe then Cytokinetics shall be deemed to have elected not to exercise its Co-Promotion option for such Collaboration Product for such Indication in such country. In the event [*] determines that there is a reasonable likelihood that [*] for such Collaboration Product for such Indication in such country [*] shall promptly notify Xxxxxx [*] in writing at least after such determination together with [REDACTED: Term*] prior therefor, and the [*] obligation to provide the date [*] (and the period during which [*]) shall be extended accordingly based on which it intends to begin the cosuch [*]. (b) If Cytokinetics exercises its Co-promotion Promotion option for a Collaboration Product for a particular Indication in a particular country of the Co-Promoted Promotion Territory, unless Cytokinetics terminates the Co-Promotion in accordance with Section 8.6(c) below, its Co-Promotion efforts for such Collaboration Product (the “Cytokinetics Co-Promotion Effort”) shall be determined by the JCC on a Collaboration Product-by-Collaboration Product, Indication-by-Indication and country-by-country basis, but in any event shall be [*] particular Collaboration Products for a particular Indication and in a particular country of the Co-Promotion Territory, unless otherwise agreed in writing by the Parties. It is the Parties’ understanding that Cytokinetics Co-Promotion Effort for the first Indication approved for any Collaboration Product in the Co-Promotion Territory as a whole shall not be required to [*]. (c) If Cytokinetics exercises its Co-Promotion option for a Collaboration Product for a particular Indication in a particular country of the Co-Promotion Territory, it shall have the right to continue to Co-Promote such Country other than Collaboration Product for as long as the Excluded Countries and Collaboration Product is being sold for such Indication in such country. Cytokinetics shall have the right to relinquish its Co-Promotion rights for such Collaboration Product for such Indication in such country with [*] written notification to Astellas, in which case the Parties shall reasonably cooperate to transition to Astellas all of Cytokinetics’ Co-Promotion activities with respect to such notice shall provide its proposed co-promotion strategy thereinCollaboration Product for such Indication in such country, so as to minimize disruption to sales activity. In any Country such event, Cytokinetics shall withdraw its sales representatives from such [ * ] = 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. Co-Promotion activities in a professional manner. If Cytokinetics does not exercise its Co-Promotion option for a Collaboration Product for the first Indication for which Marketing Approval is obtained or in the first country such Marketing Approval is obtained, but such Collaboration Product is later approved for a separate Indication and/or in another country, then Cytokinetics shall have the right to exercise its Co-Promotion option solely with respect to such other than an Excluded CountryIndication and/or in such other country for which Marketing Approval may be obtained for such Collaboration Product. (d) If Cytokinetics exercises its Co-Promotion option for a Collaboration Product, Astellas shall [*] in the Co-Promotion Territory based on the Cytokinetics Co-Promotion Efforts. However, if [*] for a particular Indication and/or in a particular country, [*] shall so notify [*] in the applicable [*], and the Parties will discuss in good faith through the JCC [*] Cytokinetics’ exercise of its Co-Promotion option applicable to such Collaboration Product for such Indication in such country. In addition, Astellas shall [*] sales force, such as [*], in each case [*]. (e) Promptly after Cytokinetics exercises its Co-Promotion option for a Collaboration Product in a particular country of the Co-Promotion Territory, the Parties will use Commercially Reasonable Efforts to finalise shall commence negotiations in good faith and enter into a co-promotion strategy within such [REDACTED: Term] period prior to the date on which Thera Europe intends to begin the co-promotion of the Co-Promoted Product in such Country. Xxxxxx agrees that upon the expiry of such [REDACTED: Term] period and during the Co-Promotion Period (as hereinafter defined) in any Country the licenses granted hereunder shall become sole to the extent necessary to allow Thera Europe to so co-promote the Co-Promoted Product in such Country. The foregoing option to co-promote in a Country or any of them may be exercised more than once throughout the Term (with each period during which Thera Europe is co-promoting the Co-Promoted Product in a Country being referred to as a “Co-Promotion Period”) provided that Thera Europe shall notify Xxxxxx in writing at least [REDACTED: Term] prior to the date on which it either intends to begin the co-promotion of the Co-Promoted Product or [REDACTED: Term] written notice to Xxxxxx to cease the same. During a Co-Promotion Period, Xxxxxx will book all sales of the Co-Promoted Product whether promoted by Xxxxxx or Thera Europe, and all such sales of the Co-Promoted Product shall be included for purposes of computing the Net Selling Price hereunder. All costs and expenses incurred by Thera Europe during a Co-Promotion Period in connection with the co-promotion activities for the Co-Promoted Product (including, but not limited to, employee costs and marketing expenses), together with any incremental expenses incurred by Xxxxxx as a result of Thera Europe’s co-promotion activities (provided these expenses have been identified by the CPC ahead of time and agreed in writing by Thera Europe), shall be the sole responsibility of Thera Europe, except that Xxxxxx shall reimburse Thera Europe for those costs and expenses that would have otherwise been paid by Xxxxxx according to Xxxxxx’x latest Commercialization Plan submitted to Thera Europe under Section 5.2 (i.e., all costs and expenses that customarily would be incurred by Xxxxxx in connection with the promotion and detailing of, or otherwise in connection with a sales force for, a pharmaceutical product in the ordinary course of Xxxxxx’x business). Notwithstanding the above, the Parties acknowledge that Xxxxxx shall have no obligation to amend the Commercialization Plan (except pursuant to Section 5.2) and that Thera Europe’s Commercialization efforts are independent of those of Xxxxxx hereunder. During a Co-Promotion Period, Thera Europe or any of its Affiliates will be involved in the decision-making process related to all aspects of the co-promotion of the Co-Promoted Product through a co-promotion committee agreement (the “Co-Promotion Committee” or “CPCAgreement). As a general principle) in accordance with the terms and conditions set forth in Exhibit I attached hereto for such Collaboration Product in such country, the CPC will operate by consensus with each Party collectively having one vote; provided, however, that at least [REDACTED: Number] representative for each of Thera Europe and Xxxxxx must be present (whether in person or by telephone or videoconference) for a meeting of the CPC to take place and allowing for any decision future exercise by Cytokinetics of its Co-Promotion option for the same Collaboration Product in other Indications in the same country subject to be madedifferent allocation of Cytokinetics Co-Promotion efforts as applicable. The CPC will be comprised of [REDACTED: Number] representatives from Thera Europe or any Affiliates thereof Parties shall use Diligent Efforts to enter into and [REDACTED: Number] representatives from Xxxxxx. In execute the event that the CPC representatives do not reach consensus with respect to a matter that is within the purview of the CPC (each applicable Co-Promotion Agreement within [REDACTED: Term*] after they have met and attempted to reach such consensus, the matter shall be referred for resolution to the Chief Executive Officer following Cytokinetics’ exercise of Thera Europe and the Chief Executive Officer of Xxxxxx for their consideration and agreement. If the executive officers of such Parties are unable to agree after negotiation in good faith, or either Party’s Chief Executive Officer does not participate, within [REDACTED: Term] of the submission of such matter to each Party’s Chief Executive Officer, then the matter shall be subject to review pursuant to ARTICLE 15its Co-Promotion option.

Appears in 1 contract

Samples: License and Collaboration Agreement (Cytokinetics Inc)

Co-Promotion. Thera Europe or any of its Affiliates shall have the exclusive option, exercisable at any time after an applicable Marketing Authorisation of the Initial Product is obtained, to co-promote with Xxxxxx (or, if applicable, its approved Affiliates, sublicensees or distributors) a Product in one or more Countries (the “Co-Promoted Product”). If Thera Europe desires to exercise its option with respect to the Co-Promoted Product in the UK, France and/or Germany, Thera Europe shall notify Xxxxxx in writing at least [REDACTED: Term] prior to the date on which it intends to begin such co-promotion of the Co-Promoted Product and Xxxxxx agrees that upon the expiry of such time period the licenses granted hereunder shall become sole to the extent necessary to allow Thera Europe to so co-promote the Co-Promoted Product during the Co-Promotion Period (as hereinafter defined) in such CountriesOption. In any Country other than the UK, France and/or Germany (where the UK, France and Germany shall be the “Excluded Countries”) in which Thera Europe desires to exercise its option to co-promote a Co-Promoted Product, Thera Europe shall notify Xxxxxx in writing at least [REDACTED: Term] prior to the date on which it intends to begin the co-promotion of the Co-Promoted Product in such Country other than the Excluded Countries and with such notice shall provide its proposed co-promotion strategy therein. In any Country other than an Excluded Country, the Parties will use Commercially Reasonable Efforts to finalise a co-promotion strategy within such [REDACTED: Term] period prior to the date on which Thera Europe intends to begin the co-promotion of the Co-Promoted Product in such Country. Xxxxxx agrees that upon the expiry of such [REDACTED: Term] period and during the Co-Promotion Period (as hereinafter defined) in any Country the licenses granted hereunder shall become sole to the extent necessary to allow Thera Europe to so co-promote the Co-Promoted Product in such Country. The foregoing option to co-promote in a Country or any of them may be exercised more than once throughout the Term (with each period during which Thera Europe is co-promoting the Co-Promoted Product in a Country being referred to as a “Co-Promotion Period”) provided that Thera Europe shall notify Xxxxxx in writing at least [REDACTED: Term] prior to the date on which it either intends to begin the co-promotion of the Co-Promoted Product or [REDACTED: Term] written notice to Xxxxxx to cease the same. During a Co-Promotion Period, Xxxxxx will book all sales of the Co-Promoted Product whether promoted by Xxxxxx or Thera Europe, and all such sales of the Co-Promoted Product shall be included for purposes of computing the Net Selling Price hereunder. All costs and expenses incurred by Thera Europe during a Co-Promotion Period in connection with the co-promotion activities for the Co-Promoted Product (including, but not limited to, employee costs and marketing expenses), together with any incremental expenses incurred by Xxxxxx as a result of Thera Europe’s co-promotion activities (provided these expenses have been identified by the CPC ahead of time and agreed in writing by Thera Europe), shall be the sole responsibility of Thera Europe, except that Xxxxxx shall reimburse Thera Europe for those costs and expenses that would have otherwise been paid by Xxxxxx according to Xxxxxx’x latest Commercialization Plan submitted to Thera Europe under Section 5.2 (i.e., all costs and expenses that customarily would be incurred by Xxxxxx in connection with the promotion and detailing of, or otherwise in connection with a sales force for, a pharmaceutical product in the ordinary course of Xxxxxx’x business). Notwithstanding the above, the Parties acknowledge that Xxxxxx ARIAD shall have no obligation to amend the Commercialization Plan (except pursuant to Section 5.2) and that Thera Europe’s Commercialization efforts are independent of those of Xxxxxx hereunder. During a Co-Promotion Period, Thera Europe or any of its Affiliates will be involved in the decision-making process related to all aspects of the co-promotion of the Co-Promoted Product through a co-promotion committee an option (the “Co-Promotion Committee” Option”) to co-promote Product in the Field in [***] and [***] in accordance with the remainder of this Article 16. The Co-Promotion Option shall be exercisable at any time between the [***] of the First Commercial Sale in [***] or [***] (as applicable) and the expiration of the Full Royalty Term in such country (the CPCOption Exercise Period”). As a general principle, the CPC will operate by consensus with each Party collectively having one vote; provided, however, that the Co-Promotion Option shall only be exercisable in [***] if co-promotion of pharmaceutical products is permitted pursuant to Applicable Laws in [***] and is authorized under Otsuka’s (or its relevant Sublicensee’s) and ARIAD’s (or its Affiliate’s) operating licenses and permits in [***]. Upon Otsuka’s receipt of written notice from ARIAD that ARIAD in good faith intends to exercise its Co-Promotion Option, Otsuka shall use commercially reasonable efforts, and shall cause its relevant Sublicensee, if any, to use commercially reasonable efforts, to obtain authorization to co-promote pharmaceutical products under its operating licenses and permits in [***]. ARIAD may exercise the Co-Promotion Option (with respect to [***], if permitted and authorized) by giving Otsuka at least [REDACTED: Number***] representative for each ([***]) [***] prior written notice (each, a Portions of Thera Europe this Exhibit, indicated by the xxxx “[***],” were omitted and Xxxxxx must be present (whether in person or by telephone or videoconference) for a meeting have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the CPC Securities Exchange Act of 1934, as amended. “Co-Promotion Notice”), with such Co-Promotion Notice to take place and effect no earlier than the first day of the Option Exercise Period for any decision to be made. The CPC will be comprised of [REDACTED: Number] representatives from Thera Europe or any Affiliates thereof and [REDACTED: Number] representatives from Xxxxxxthe relevant country. In the event that ARIAD exercises the CPC representatives do not reach consensus Co-Promotion Option in [***] (if permitted and authorized), Otsuka shall invoice ARIAD for [***] percent ([***]%) of all out-of-pocket costs incurred by Otsuka and/or its Sublicensees in connection with respect development and Registration of Product in [***], and ARIAD shall pay the invoiced amount to a matter that is within the purview of the CPC (each Otsuka within [REDACTED: Term***] after they have met and attempted to reach such consensus, the matter shall be referred for resolution to the Chief Executive Officer ([***]) days of Thera Europe and the Chief Executive Officer of Xxxxxx for their consideration and agreement. If the executive officers receipt of such Parties are unable to agree after negotiation in good faith, or either Party’s Chief Executive Officer does not participate, within [REDACTED: Term] of the submission of such matter to each Party’s Chief Executive Officer, then the matter shall be subject to review pursuant to ARTICLE 15invoice.

Appears in 1 contract

Samples: Collaboration Agreement (Ariad Pharmaceuticals Inc)

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Co-Promotion. Thera Europe or any of its Affiliates Subject to Section 5.11(e)(i), in the Shared Territory, Medivation shall participate with Partner in Detailing (but not selling), promoting and marketing each Product to Specialists on the terms and conditions set forth in this Section 5.10 and Section 5.11 and shall have the exclusive option, exercisable at any time after an applicable Marketing Authorisation right to provide between [*] and [*] of the Initial Product is obtained, to co-promote with Xxxxxx (or, if applicable, its approved Affiliates, sublicensees or distributors) a Specialty Detail Effort for each Product in one or more Countries the Shared Territory, with the exact percentage to be determined within such range by Medivation (the “Co-Promoted ProductMedivation Promotional Share”). If Thera Europe desires to exercise its option Medivation shall initially specify the level of Medivation Promotional Share on or before [*] of the [*] for the applicable Product. Unless otherwise requested by Medivation and approved by the JCC, such level of Medivation Promotional Share shall remain in effect for [*] of the [*] in which the First Commercial Sale of the Product in the Shared Territory occurs, and the [*] thereafter. Commencing with the [*] [ * ] = 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. following the First Commercial Sale of the Product in the Shared Territory, and [*] thereafter, Medivation may change the level of Medivation Promotional Share with respect to such Product, by not more than [*] of the CoSpecialty Detail Effort from the prior [*] provided that it remains within the range of [*] to [*] of the Specialty Detail Effort for the then-Promoted current [*] for such Product in the UK, France and/or Germany, Thera Europe shall notify Xxxxxx in writing at least Shared Territory and it provides the JCC with [REDACTED: Term*] days prior to the date on which it intends to begin such co-promotion of the Co-Promoted Product and Xxxxxx agrees that upon the expiry written notice of such time period change. Medivation may change the licenses granted hereunder shall become sole to the extent necessary to allow Thera Europe to so co-promote the Co-Promoted Product during the Co-Promotion Period (as hereinafter defined) in such Countries. In level of Medivation Promotional Share at any Country other than the UKtime, France and/or Germany (where the UK, France and Germany shall be the “Excluded Countries”) in which Thera Europe desires to exercise its option to co-promote a Co-Promoted Product, Thera Europe shall notify Xxxxxx in writing at least [REDACTED: Term] prior to the date on which it intends to begin the co-promotion of the Co-Promoted Product in such Country other than the Excluded Countries and with such notice shall provide its proposed co-promotion strategy therein. In any Country other than an Excluded Country, the Parties will use Commercially Reasonable Efforts to finalise a co-promotion strategy within such [REDACTED: Term] period prior to the date on which Thera Europe intends to begin the co-promotion of the Co-Promoted Product in such Country. Xxxxxx agrees that upon the expiry of such [REDACTED: Term] period and during the Co-Promotion Period (as hereinafter defined) in any Country the licenses granted hereunder shall become sole other amount up to the extent necessary to allow Thera Europe to so co-promote the Co-Promoted Product in such Country. The foregoing option to co-promote in a Country or any of them may be exercised more than once throughout the Term (with each period during which Thera Europe is co-promoting the Co-Promoted Product in a Country being referred to as a “Co-Promotion Period”) provided that Thera Europe shall notify Xxxxxx in writing at least [REDACTED: Term] prior to the date on which it either intends to begin the co-promotion of the Co-Promoted Product or [REDACTED: Term] written notice to Xxxxxx to cease the same. During a Co-Promotion Period, Xxxxxx will book all sales of the Co-Promoted Product whether promoted by Xxxxxx or Thera Europe, and all such sales of the Co-Promoted Product shall be included for purposes of computing the Net Selling Price hereunder. All costs and expenses incurred by Thera Europe during a Co-Promotion Period in connection with the co-promotion activities for the Co-Promoted Product (including, but not limited to, employee costs and marketing expenses), together with any incremental expenses incurred by Xxxxxx as a result of Thera Europe’s co-promotion activities (provided these expenses have been identified by the CPC ahead of time and agreed in writing by Thera Europe), shall be the sole responsibility of Thera Europe, except that Xxxxxx shall reimburse Thera Europe for those costs and expenses that would have otherwise been paid by Xxxxxx according to Xxxxxx’x latest Commercialization Plan submitted to Thera Europe under Section 5.2 (i.e., all costs and expenses that customarily would be incurred by Xxxxxx in connection with the promotion and detailing of, or otherwise in connection with a sales force for, a pharmaceutical product in the ordinary course of Xxxxxx’x business). Notwithstanding the above, the Parties acknowledge that Xxxxxx shall have no obligation to amend the Commercialization Plan (except pursuant to Section 5.2) and that Thera Europe’s Commercialization efforts are independent of those of Xxxxxx hereunder. During a Co-Promotion Period, Thera Europe or any of its Affiliates will be involved in the decision-making process related to all aspects of the co-promotion of the Co-Promoted Product through a co-promotion committee (the “Co-Promotion Committee” or “CPC”). As a general principle, the CPC will operate by consensus with each Party collectively having one vote; provided, however, that at least [REDACTED: Number] representative for each of Thera Europe and Xxxxxx must be present (whether in person or by telephone or videoconference) for a meeting of the CPC to take place and for any decision to be made. The CPC will be comprised maximum of [REDACTED: Number] representatives from Thera Europe or any Affiliates thereof and [REDACTED: Number] representatives from Xxxxxx. In the event that the CPC representatives do not reach consensus with respect to a matter that is within the purview of the CPC (each within [REDACTED: Term] after they have met and attempted to reach such consensus, the matter shall be referred for resolution to the Chief Executive Officer of Thera Europe and the Chief Executive Officer of Xxxxxx for their consideration and agreement. If the executive officers of such Parties are unable to agree after negotiation in good faith, or either Party’s Chief Executive Officer does not participate, within [REDACTED: Term*] of the submission then-current Specialty Detail Effort, with the prior approval of such matter to each Party’s Chief Executive Officer, then the matter shall be subject to review pursuant to ARTICLE 15JCC.

Appears in 1 contract

Samples: Collaboration Agreement (Medivation, Inc.)

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