Common use of Promotional Materials and Activities Clause in Contracts

Promotional Materials and Activities. Subject to the provisions of Section 3.02(b) below, Distributor shall be solely responsible, at its sole expense and under its sole control for conducting all promotional activities and for designing, preparing and distributing all materials, advertisements and activities used in the promotion, advertising and marketing of the Licensed Products within the Territory. Distributor shall Ensure that all materials, advertisements and promotional activities comply with, and Distributor shall be solely responsible and liable for any failure of such materials and activities to comply with, the applicable labeling and Licensed Product Registration for any of the Licensed Products and with Applicable Laws and regulations, notwithstanding any prior review or approval of such materials or activities by MPL and notwithstanding that such materials or activities may have been previously reviewed, used or conducted by MPL. Distributor shall be solely responsible for fulfilling regulatory requirements pertaining to its promotional materials and activities, including, without limitation, sole responsibility for submitting to FDA all promotional and advertising materials prepared by or for Distributor at the time of initial dissemination, by way of a Form FDA-2253, consistent with 21 CFR Part 314.81. To this effect, MPL shall, upon the Effective Date, or as soon thereafter as is reasonably practicable, place a letter on file with DDMAC with respect to the Licensed Products advising DDMAC that Distributor shall be the sole marketer and promoter of the Licensed Products in the Territory and requesting that DDMAC address regulatory inquiries and concerns regarding Distributor's promotional activities solely with Distributor. Distributor shall promptly, but in no event less than one (1) Business Day after Distributor's receipt thereof, provide a copy to MPL of any correspondence from a government agency with respect to any of the Licensed Products, including, but not limited to, the FDA, reflecting any purported legal or regulatory violations or legal or regulatory action being considered or taken by such government agency, including without limitation, copies of FDA NOV's and Warning Letters. Unless otherwise required, Distributor shall not provide MPL with copies of any promotional materials or advertising or notify MPL of any promotional activities unless pursuant to a written request by MPL. Distributor shall absorb and be solely responsible for any and all lost profits, lost revenues, damages, losses, expenses and costs incurred by Distributor, its Affiliates, and any CSO retained by Distributor pursuant to the terms of this Agreement, arising from the failure of any promotional materials or advertising used, or activities conducted by, Distributor to comply with the applicable labeling, the Licensed Product Registrations and/or with Applicable Laws. Without limiting the rights MPL may have under the indemnification provisions of this Agreement, Distributor shall promptly reimburse MPL and its Affiliates for any and all damages, losses, expenses and costs suffered or incurred by MPL and its Affiliates arising from (i) the failure of any promotional materials or advertising used or activities conducted by Distributor to comply with the applicable labeling, the applicable Licensed Product Registrations, Applicable Laws, and/or any comments, guidance or direction given by FDA or DDMAC in the Pre-Clearance Process pursuant to Section 3.02(b)(ii) or (ii) the failure of Distributor or its representatives or any CSO selected pursuant to the terms of this Agreement to promote the Licensed Products in compliance with the applicable labeling, the applicable Licensed Product Registrations and/or with Applicable Laws. MPL shall use Commercially Reasonable Efforts to mitigate or limit its losses, expenses and costs incurred in connection with any matter described in (i) or (ii) above and for purposes of the preceding sentence, it is understood and agreed that the losses, expenses and costs incurred by MPL shall include, without limitation, the losses, expenses and costs incurred by MPL to so mitigate or limit the effect or impact of (i) or (ii) above, on MPL and its Affiliates products or corporate image (including, but not limited to, the costs of any remedial action undertaken by MPL to communicate with physicians or customers (including, but not limited to so-called "dear doctor letters"). If Distributor (or MPL) shall receive a Warning Letter from FDA which relates to marketing, promotion, advertisement, sale or distribution of the Licensed Products after the Effective Date, or Distributor (or MPL) shall receive two (2) NOV's from the FDA which relate to marketing, promotion, advertisement, sale or distribution of the Licensed Products after the Effective Date, MPL shall have the right to call, and Distributor shall participate/or attend at its own expense, a meeting of Distributor (which shall include senior level marketing and sales management of Distributor) and MPL, to be held in Los Angeles, CA. The purpose of such meeting shall be to discuss the promotional pieces or practices which led to the issuance of the Warning Letter or the NOV's, as the case may be, and to discuss, if appropriate, appropriate corrective or remedial measures to Distributor's promotional review process. Subsequent to any such meeting or in lieu of such meeting (if such meeting is not held as a result of the mutual agreement of the Parties or as a result of Distributor's failure or refusal to attend), MPL may, in its sole and absolute discretion, at any time after the issuance of a Warning Letter or a second NOV from FDA related to the Licensed Products after the Effective Date, decide to invoke the promotional review procedures set forth in Section 3.02(b)(ii) below by sending written notice thereof to Distributor (hereinafter, a "Promotional Review Notice"). In the event that MPL sends a Promotional Review Notice to Distributor, Distributor shall comply with the procedures set forth in this Section 3.02(b)(ii). Distributor shall ensure that all marketing and advertising materials and activities comply with the applicable labeling and the applicable Licensed Product Registration for any of the Licensed Products and with Applicable Laws, including, without limitation, addressing any concerns which were the subject of such FDA letter(s). For a period of twelve (12) months after the Promotional Review Notice (the "Pre-Clearance Period"), Distributor shall submit all of the following for review and approval by DDMAC (the "Pre-Clearance Process") prior to use or dissemination; any and all marketing, advertising, promotional and related materials and activities (including, without limitation, detail aids, letters, brochures, reprints and other printed materials shown to or left with healthcare providers, letters, brochures and other printed materials intended for consumers, website content, materials for use in promotional programs, and any print, television, radio, and other media advertising materials intended for healthcare providers or consumers), labeling, press materials, updates and corrections to the Physicians Desk Reference with respect to the Licensed Products, speaker training materials (including slides and slide kits), sales training materials and other materials and communications originating from home offices, regional offices, local offices or hub offices and sent to the sales force regarding promotional messages or strategies for the Licensed Products. Distributor shall not use any materials or make any claims in advertising, promoting or selling the Licensed Products which have not gone through the Pre-Clearance Process and received specific and entire written approval by DDMAC; provided, however, that in the case of materials not accepted for review by DDMAC, Distributor shall ensure that all such materials and the claims and promotional messages therein; (a) are consistent with the materials and claims that have gone through the Pre-Clearance Process and received written approval by DDMAC and (b) comply with all comments, direction and guidance given by DDMAC during the Pre-Clearance Period. Distributor shall ensure that all promotional programs and activities of all sales representatives promoting the Licensed Products comply with any and all comments, direction or guidance given by DDMAC during the Pre-Clearance Period. Upon expiration of the Pre-Clearance Period, Distributor shall continue to promote, detail, sell and advertise the Licensed Products in a manner consistent with, and in full compliance with, all comments, directions and guidance received from DDMAC. Distributor shall be solely responsible for submitting all promotional and advertising materials prepared by or for it to the FDA by way of a Form 2253 or otherwise. MPL shall have the right to immediately terminate this Agreement if; (i) Distributor shall fail to fully comply with the requirements of this Section 3.02(b)(ii) or (iii) FDA issues a Warning Letter or NOV with respect to any of the Licensed Products at any time during or after the Pre-Clearance Period. Distributor acknowledges that MPL has advised Distributor that MPL is not currently actively promoting any of the Licensed Products in the Territory and has never promoted its products in the Territory, and that MPL does not have current materials designed for advertising or promoting the Licensed Products in the Territory. MPL shall provide Distributor with copies of any advertising, promotional or training materials in its possession and previously used by MPL relating to the Licensed Products, and shall permit Distributor, subject to compliance by Distributor with Applicable Laws, to update, adapt and use such materials in the Territory in developing new promotional materials (subject to any copyrights or other rights reserved to MPL, its Affiliates and to Third Parties in such materials). MPL reserves and retains title and all rights, including copyright rights, in and to all written, visual and electronic works and other materials (including without limitation training materials, promotion materials, brochures and other detail literature) provided by it to Distributor under this Agreement. Subject to the foregoing, Distributor is granted the nonexclusive right under this Section to use, copy, modify, and distribute such materials only for the purposes of this Agreement and in furtherance of the rights granted to Distributor hereunder, for the Term for any of the Licensed Products to which such works and materials relate. Distributor shall ensure that all copyright notices and this permission notice appear on all copies of the written materials provided by MPL and all adaptations and derivative works thereof. Any and all new promotional material developed by Distributor, including that which adapts or utilizes materials supplied to Distributor by MPL, shall be filed with FDA at the time of initial dissemination via Form FDA-2253. Distributor shall have sole authority and responsibility, at its sole expense, for conducting independent and non-independent symposia, speaker training and engagement programs, advisory board meetings and other consulting arrangements, scientific exhibits and other types of scientific exchange, and other such events or programs as Distributor, in its sole discretion, deems to be appropriate with respect to the Licensed Products within the Territory; provided, however, that any and all such events and programs must comply in all respects with Applicable Laws and relevant FDA policies, including without limitation, the FDA's Guidance on Industry-Supported Educational and Scientific Activities.

Promotional Materials and Activities. Subject During the Copromotion Period, and in compliance with Law, Esprit shall have the sole right to create and develop the Promotional Materials with, during the Copromotion Period, input and participation from the Marketing Committee, subject to Section 5.6(a). During the Copromotion Period, prior to finalizing such Promotional Materials and promotional activities, each Party shall include the other Party in its internal circulation of information regarding such promotional materials and activities during the development of such Promotional Materials and any event related materials and upon the finalization of such materials. (a) Neither Party shall produce (other than as concepts for consideration by the other Party), distribute or otherwise use any Promotional Materials that have not been approved in advance by the Development Committee for purposes of determining compliance with Law and agreed upon standard operating procedures of each Party. Prior to the provisions of Section 3.02(b) belowNDA Transfer Date, Distributor Promotional Materials shall be submitted to Indevus’ internal regulatory compliance personnel for timely review pursuant to applicable internal standard operating procedures, for an assessment of compliance with Law and shall be subject to Indevus’ approval solely with respect to compliance with Law. Such assessment shall be provided to both Parties. Each Party shall limit its statements, discussions and claims regarding Products, including those as to safety and efficacy, to those that are consistent with the Product Labeling and the Promotional Materials. Neither Party shall add, delete, modify or distort claims of safety or efficacy in the Detailing of Products, nor shall it make any changes (including underlining or otherwise highlighting any language or adding any notes thereto) or alter the presentation order or format in the Promotional Materials. (b) Esprit shall own all right, title and interest in and to the copyrights in all marketing, sales, advertising or Promotional Materials relating to the Products in the Field in the Territory (“Territory Copyrighted Works”). Indevus shall execute all documents and take all actions as are reasonably requested by Esprit to vest title to such Territory Copyrighted Works in Esprit. Esprit shall be responsible, at its sole expense expense, for searching, clearing and under its sole control filing applications for conducting registration of all promotional activities and for designing, preparing and distributing all materials, advertisements and activities used in such Territory Copyrighted Works. To the promotion, advertising and marketing of the Licensed Products within the Territory. Distributor shall Ensure that all materials, advertisements and promotional activities comply with, and Distributor shall be solely responsible and liable for any failure of extent such materials and activities include or incorporate original works of authorship created by Indevus prior to comply with, the applicable labeling and Licensed Product Registration for any of the Licensed Products and with Applicable Laws and regulations, notwithstanding any prior review or approval of such materials or activities by MPL and notwithstanding that such materials or activities may have been previously reviewed, used or conducted by MPL. Distributor shall be solely responsible for fulfilling regulatory requirements pertaining to its promotional materials and activities, including, without limitation, sole responsibility for submitting to FDA all promotional and advertising materials prepared by or for Distributor at the time of initial dissemination, by way of a Form FDA-2253, consistent with 21 CFR Part 314.81. To this effect, MPL shall, upon the Effective Date, Indevus shall not use, or make any proprietary claim with regard to, those pre-existing materials separate and apart from their use and inclusion in Territory Copyrighted Works relating to Products. (c) Subject to Section 5.6(b), Esprit and Indevus shall retain all rights, including all copyrights and trademarks, to all of their respective programs and materials existing as soon thereafter as is reasonably practicable, place a letter on file with DDMAC with respect to the Licensed Products advising DDMAC that Distributor shall be the sole marketer and promoter of the Licensed Effective Date in all formats (including print, video, audio, digital, and computer formats) regarding sales training, patient education and disease management programs owned or licensed by each at the time such materials are shared with the other Party, as well as any modifications of such programs each may develop in the future that are not specific to Products in the Territory Field. Esprit and requesting Indevus shall, from time to time, each notify the other as to the identity of such proprietary programs. In addition, all new programs that DDMAC address regulatory inquiries are not specific to Products in the Field that are jointly developed by Esprit and concerns regarding Distributor's promotional activities solely with Distributor. Distributor shall promptly, but in no event less than one (1) Business Day after Distributor's receipt thereof, provide a copy to MPL of any correspondence from a government agency with respect to any of the Licensed Products, including, but not limited to, the FDA, reflecting any purported legal or regulatory violations or legal or regulatory action being considered or taken by such government agency, including without limitation, copies of FDA NOV's and Warning Letters. Unless otherwise required, Distributor shall not provide MPL with copies of any promotional materials or advertising or notify MPL of any promotional activities unless Indevus pursuant to a written request this Agreement shall be jointly owned by MPL. Distributor shall absorb Esprit and be solely responsible for any and all lost profits, lost revenues, damages, losses, expenses and costs incurred by Distributor, its AffiliatesIndevus, and any CSO retained by Distributor pursuant to the terms of this Agreement, arising from the failure of any promotional materials or advertising used, or activities conducted by, Distributor to comply with the applicable labeling, the Licensed Product Registrations and/or with Applicable Laws. Without limiting the rights MPL may have under the indemnification provisions of this Agreement, Distributor shall promptly reimburse MPL and its Affiliates for any and all damages, losses, expenses and costs suffered or incurred by MPL and its Affiliates arising from (i) the failure of any promotional materials or advertising used or activities conducted by Distributor to comply with the applicable labeling, the applicable Licensed Product Registrations, Applicable Laws, and/or any comments, guidance or direction given by FDA or DDMAC in the Pre-Clearance Process pursuant to Section 3.02(b)(ii) or (ii) the failure of Distributor or its representatives or any CSO selected pursuant to the terms of this Agreement to promote the Licensed Products in compliance with the applicable labeling, the applicable Licensed Product Registrations and/or with Applicable Laws. MPL shall use Commercially Reasonable Efforts to mitigate or limit its losses, expenses and costs incurred in connection with any matter described in (i) or (ii) above and for purposes of the preceding sentence, it is understood and agreed that the losses, expenses and costs incurred by MPL shall include, without limitation, the losses, expenses and costs incurred by MPL to so mitigate or limit the effect or impact of (i) or (ii) above, on MPL and its Affiliates products or corporate image (including, but not limited to, the costs of any remedial action undertaken by MPL to communicate with physicians or customers (including, but not limited to so-called "dear doctor letters"). If Distributor (or MPL) shall receive a Warning Letter from FDA which relates to marketing, promotion, advertisement, sale or distribution of the Licensed Products after the Effective Date, or Distributor (or MPL) shall receive two (2) NOV's from the FDA which relate to marketing, promotion, advertisement, sale or distribution of the Licensed Products after the Effective Date, MPL each Party shall have the right to call, and Distributor shall participate/or attend at its own expense, a meeting use such jointly developed programs free of Distributor charge after the expiration of the Agreement Term. (which shall include senior level marketing and sales management of Distributord) and MPL, to be held in Los Angeles, CA. The purpose of such meeting Esprit shall be to discuss the promotional pieces or practices which led primary Party responsible for preparing all submissions with the FDA regarding approval of all Promotional Materials that require FDA approval; provided that prior to the issuance NDA Transfer Date Indevus shall be responsible for filing all such submissions and participating with Esprit in any interactions with the FDA regarding such matters. After the NDA Transfer Date, Esprit shall be responsible for all submissions and interactions with the FDA regarding approval of all Promotional Materials that require FDA approval. (e) Except as otherwise prohibited by Law, during the Warning Letter Copromotion Period, all Promotional Materials used by Indevus in connection with the Promotion of Products under this Agreement shall be only those supplied by Esprit. Indevus may display on such Promotional Materials the Indevus Logo; provided that the trademark of and specified by Esprit (or the NOV's, as the case may be, and any person or entity to discuss, if appropriate, appropriate corrective which Esprit assigns or remedial measures to Distributor's promotional review process. Subsequent to any such meeting or in lieu of such meeting (if such meeting is not held as a result of the mutual agreement of the Parties or as a result of Distributor's failure or refusal to attend), MPL may, in its sole and absolute discretion, at any time after the issuance of a Warning Letter or a second NOV from FDA related sublicenses rights hereunder) shall appear to the Licensed Products after left of and/or above the Effective Date, decide to invoke the promotional review procedures set forth in Section 3.02(b)(ii) below by sending written notice thereof to Distributor (hereinafter, a "Promotional Review Notice")Indevus Logo. In the event that MPL sends a Promotional Review Notice to Distributor, Distributor shall comply with the procedures set forth in this Section 3.02(b)(ii). Distributor shall ensure that all marketing and advertising materials and activities comply with the applicable labeling and the applicable Licensed Product Registration for any of the Licensed Products and with Applicable Laws, including, without limitation, addressing any concerns which were the subject of such FDA letter(s). For a period of twelve (12) months after the Promotional Review Notice (the "Pre-Clearance Period"), Distributor shall submit all of the following for review and approval by DDMAC (the "Pre-Clearance Process") prior to use or dissemination; any and all marketing, advertising, promotional and related materials and activities (including, without limitation, detail aids, letters, brochures, reprints and other printed materials shown to or left with healthcare providers, letters, brochures and other printed materials intended for consumers, website content, materials for use in promotional programs, and any print, television, radio, and other media advertising materials intended for healthcare providers or consumers), labeling, press materials, updates and corrections to the Physicians Desk Reference with respect to the Licensed Products, speaker training materials (including slides and slide kits), sales training materials and other materials and communications originating from home offices, regional offices, local offices or hub offices and sent to the sales force regarding promotional messages or strategies for the Licensed Products. Distributor Indevus shall not use any representations of any xxxx of Esprit other than those supplied by Esprit in Promotional Materials. Solely to the extent required by Law, all Promotional Materials used by Esprit will indicate that a Product is sold under license from Indevus and promoted by Esprit or any such Affiliate, as directed by Esprit. All promotional materials used by Indevus in connection with the Promotion of Products under this Agreement shall indicate that the Trademarks (except for the Indevus Logo) are owned by Esprit or make any claims such Affiliate, as directed by Esprit. Notwithstanding anything to the contrary in advertisingthis Section 5.6(e), promoting except to the extent required by Law, in no event shall any packaging, trade dress, journal advertising and sales aids, or selling FDA approved Product Labeling display any xxxx of Indevus. (f) Within ninety (90) days after the Licensed Products which have not gone through expiration or termination of this Agreement, each Party shall return (unless prohibited by Law), or otherwise dispose of in accordance with instructions from the Pre-Clearance Process other Party, all remaining Promotional Materials provided by the other Party and received specific and entire written approval by DDMAC; provided, however, that in will provide the case of materials not accepted for review by DDMAC, Distributor shall ensure other Party with a certified statement that all such materials and the claims and promotional messages therein; (a) are consistent with the materials and claims that remaining Promotional Materials have gone through the Pre-Clearance Process and received written approval by DDMAC and (b) comply with all comments, direction and guidance given by DDMAC during the Pre-Clearance Period. Distributor shall ensure that all promotional programs and activities been returned or otherwise properly disposed of all sales representatives promoting the Licensed Products comply with any and all comments, direction or guidance given by DDMAC during the Pre-Clearance Period. Upon expiration of the Pre-Clearance Period, Distributor shall continue to promote, detail, sell and advertise the Licensed Products in a manner consistent with, and in full compliance with, all comments, directions and guidance received from DDMAC. Distributor shall be solely responsible for submitting all promotional and advertising materials prepared by or for it to the FDA by way of a Form 2253 or otherwise. MPL shall have the right to immediately terminate this Agreement if; (i) Distributor shall fail to fully comply with the requirements of this Section 3.02(b)(ii) or (iii) FDA issues a Warning Letter or NOV with respect to any of the Licensed Products at any time during or after the Pre-Clearance Period. Distributor acknowledges that MPL has advised Distributor that MPL is not currently actively promoting any of the Licensed Products in the Territory and has never promoted its products in the Territory, and that MPL does not have current materials designed for advertising the Party is no longer in possession or promoting the Licensed Products in the Territory. MPL shall provide Distributor with copies control of any advertising, promotional such Promotional Materials in any form or training materials in its possession and previously used by MPL relating to the Licensed Products, and shall permit Distributor, subject to compliance by Distributor with Applicable Laws, to update, adapt and use such materials in the Territory in developing new promotional materials (subject to any copyrights or other rights reserved to MPL, its Affiliates and to Third Parties in such materials). MPL reserves and retains title and all rights, including copyright rights, in and to all written, visual and electronic works and other materials (including without limitation training materials, promotion materials, brochures and other detail literature) provided by it to Distributor under this Agreement. Subject to the foregoing, Distributor is granted the nonexclusive right under this Section to use, copy, modify, and distribute such materials only for the purposes of this Agreement and in furtherance of the rights granted to Distributor hereunder, for the Term for any of the Licensed Products to which such works and materials relate. Distributor shall ensure that all copyright notices and this permission notice appear on all copies of the written materials provided by MPL and all adaptations and derivative works thereof. Any and all new promotional material developed by Distributor, including that which adapts or utilizes materials supplied to Distributor by MPL, shall be filed with FDA at the time of initial dissemination via Form FDA-2253. Distributor shall have sole authority and responsibility, at its sole expense, for conducting independent and non-independent symposia, speaker training and engagement programs, advisory board meetings and other consulting arrangements, scientific exhibits and other types of scientific exchange, and other such events or programs as Distributor, in its sole discretion, deems to be appropriate with respect to the Licensed Products within the Territory; provided, however, that any and all such events and programs must comply in all respects with Applicable Laws and relevant FDA policies, including without limitation, the FDA's Guidance on Industry-Supported Educational and Scientific Activitiesfashion.

Promotional Materials and Activities. Subject to the terms of this Section 5.4, during the Detail Requirements Period, and in compliance with applicable Law, the Marketing Committee shall create and develop, subject to approval by the Steering Committee of the Promotion Plan, the Promotional Materials with input and participation from both Parties, following the general guidelines established by the Marketing Committee and consistent with the then current Promotion Plan. After expiration of the Detail Requirements Period, the Marketing Committee shall create and develop, subject to review by the Steering Committee of the Promotion Plan, the Promotional Materials as described in the foregoing sentence. Promotional activities may include programs sponsored and controlled by a Party to disseminate or obtain information relating to Product. During the Detail Requirements Period, prior to finalizing such Promotional Materials and promotional activities, each Party shall include the other Party in its internal circulation of information regarding such promotional materials and activities during the development of such Promotional Materials and any event related materials and upon the finalization of such materials. (a) Promotional Materials shall be submitted to Indevus’s internal regulatory compliance personnel for timely review pursuant to applicable internal standard operating procedures, for an assessment of compliance with applicable Law. Such assessment shall be provided to both Parties. No Promotional Materials shall be used that have not been approved by both Parties’ internal regulatory compliance personnel. As holder of the NDA for Product in the Territory, Indevus shall be responsible for all submissions and interactions with the FDA regarding approval of all Promotional Materials regarding Product that require FDA approval. During the Agreement Term, such submissions shall occur after approval of the Promotional Material by both Parties. (b) Subject to the other provisions of this Section 3.02(b) below5.4, Distributor Odyssey shall own all right, title and interest in and to the copyrights in all marketing, sales, advertising or Promotional Materials relating to the Product in the United States (“U.S. Copyrighted Works”). Indevus shall execute all documents and take all actions as are reasonably requested by Odyssey to vest title to such Promotional Materials in Odyssey. Odyssey shall be solely responsible, at its sole expense expense, for searching, clearing and under its sole control filing applications for conducting registration of all promotional activities and for designing, preparing and distributing all materials, advertisements and activities used in such copyrights. To the promotion, advertising and marketing of the Licensed Products within the Territory. Distributor shall Ensure that all materials, advertisements and promotional activities comply with, and Distributor shall be solely responsible and liable for any failure of extent such materials and activities include or incorporate original works of authorship created by one Party prior to comply with, the applicable labeling and Licensed Product Registration for any of the Licensed Products and with Applicable Laws and regulations, notwithstanding any prior review or approval of such materials or activities by MPL and notwithstanding that such materials or activities may have been previously reviewed, used or conducted by MPL. Distributor shall be solely responsible for fulfilling regulatory requirements pertaining to its promotional materials and activities, including, without limitation, sole responsibility for submitting to FDA all promotional and advertising materials prepared by or for Distributor at the time of initial dissemination, by way of a Form FDA-2253, consistent with 21 CFR Part 314.81. To this effect, MPL shall, upon the Effective Date, the other Party shall not use, or make any proprietary claim with regard to, those pre-existing materials separate and apart from their use and inclusion in U.S. Copyrighted Works relating to Product. (c) Odyssey and Indevus shall retain all rights, including without limitation all copyrights and trademarks, to all of their respective existing programs and materials in all formats (print, video, audio, digital, computer, etc.) regarding sales training, patient education and disease management programs owned or licensed by each at the time such materials are shared with the other Party, as soon thereafter well as is reasonably practicableany modifications of such programs each may develop in the future which are not specific to Product. Odyssey and Indevus shall, place a letter on file with DDMAC with respect from time to time, each notify the other as to the Licensed Products advising DDMAC identity of such proprietary programs. In the event that Distributor Indevus desires after the expiration or termination of this Agreement to use any Odyssey program which has been specifically adapted for, or directed to, Product, the Parties shall negotiate to conclude an appropriate agreement for such use. In addition, all such new programs jointly developed by Odyssey and Indevus pursuant to this Agreement shall be jointly owned by Odyssey and Indevus, and each Party shall have the sole marketer and promoter right to use such jointly developed programs free of charge after the expiration of the Licensed Products Agreement Term. (d) Neither Party shall produce (other than as concepts for consideration by the other Party), distribute or otherwise use any Promotional Materials which have not been approved in advance for purposes of determining compliance with applicable Law and agreed upon standard operating procedures of each Party, by the Marketing Committee. Each Party shall limit its statements, discussions and claims regarding Product, including those as to safety and efficacy, to those which are consistent with the Product Labeling and the Promotional Materials. Neither Party shall add, delete, modify or distort claims of safety or efficacy in the Territory and requesting that DDMAC address regulatory inquiries and concerns regarding Distributor's promotional activities solely with Distributor. Distributor Detailing of Product, nor shall promptlyit make any changes (including underlining or otherwise highlighting any language or adding any notes thereto) or alter the presentation order or format in the Promotional Materials. (e) Except as otherwise prohibited by applicable Law, but in no event less than one (1) Business Day after Distributor's receipt thereof, provide a copy to MPL of any correspondence from a government agency with respect to any of the Licensed Productsall Promotional Materials, including, but not limited to, all packaging, trade dress, journal advertising and sales aids, as well as FDA approved Product Labeling shall display the FDAlogos of Odyssey (or any Affiliate of Odyssey or Parent to which Odyssey assigns or sublicenses its rights hereunder) and Indevus, reflecting with the logo of Odyssey or any purported legal such Affiliate appearing to the left and/ or regulatory violations above the Indevus logo. The Product Labeling shall display the logos of Odyssey or legal any such Affiliate and Indevus in a manner consistent with Schedule 5.4(e). Except as otherwise prohibited by applicable Law, and further to the extent reasonably practicable, all Promotional Materials will indicate that Product is sold under license from Indevus and promoted by Odyssey or regulatory action being considered any such Affiliate, as directed by Odyssey and Indevus and that the Trademarks (except for the Indevus Logo) are owned by Odyssey or taken any such Affiliate, as directed by such government agencyOdyssey. All applicable logos shall, including without limitationsubject to compliance with applicable Law, copies of FDA NOV's and Warning Letters. Unless otherwise requiredduring the Detail Requirements Period, Distributor shall not provide MPL be prominently displayed in accordance with copies of any promotional materials or advertising or notify MPL of any promotional activities unless pursuant to a written request by MPL. Distributor shall absorb each Party’s specifications and be solely responsible for of similar size to each other on all such materials. After expiration of the Detail Requirements Period (or any and all lost profitslonger period in which Indevus continues to conduct Primary Position Details of Product), lost revenuesit will not be required to include Indevus’ name or logo on Promotional Material, damages, losses, expenses and costs incurred except as required by Distributor, its Affiliates, and any CSO retained by Distributor pursuant to Law. (f) Within thirty (30) days after the terms expiration or termination of this Agreement, arising each Party shall return (unless prohibited by applicable Law), or otherwise dispose of in accordance with instructions from the failure other Party, all remaining Promotional Materials provided by the other Party and will provide the other Party with a certified statement that all remaining Promotional Materials have been returned or otherwise properly disposed of and that the Party is no longer in possession or control of any promotional materials such Promotional Materials in any form or advertising used, or activities conducted by, Distributor to comply with the applicable labeling, the Licensed Product Registrations and/or with Applicable Laws. Without limiting the rights MPL may have under the indemnification provisions of this Agreement, Distributor shall promptly reimburse MPL and its Affiliates for any and all damages, losses, expenses and costs suffered or incurred by MPL and its Affiliates arising from (i) the failure of any promotional materials or advertising used or activities conducted by Distributor to comply with the applicable labeling, the applicable Licensed Product Registrations, Applicable Laws, and/or any comments, guidance or direction given by FDA or DDMAC in the Pre-Clearance Process pursuant to Section 3.02(b)(ii) or (ii) the failure of Distributor or its representatives or any CSO selected pursuant to the terms of this Agreement to promote the Licensed Products in compliance with the applicable labeling, the applicable Licensed Product Registrations and/or with Applicable Laws. MPL shall use Commercially Reasonable Efforts to mitigate or limit its losses, expenses and costs incurred in connection with any matter described in (i) or (ii) above and for purposes of the preceding sentence, it is understood and agreed that the losses, expenses and costs incurred by MPL shall include, without limitation, the losses, expenses and costs incurred by MPL to so mitigate or limit the effect or impact of (i) or (ii) above, on MPL and its Affiliates products or corporate image (including, but not limited to, the costs of any remedial action undertaken by MPL to communicate with physicians or customers (including, but not limited to so-called "dear doctor letters"). If Distributor (or MPL) shall receive a Warning Letter from FDA which relates to marketing, promotion, advertisement, sale or distribution of the Licensed Products after the Effective Date, or Distributor (or MPL) shall receive two (2) NOV's from the FDA which relate to marketing, promotion, advertisement, sale or distribution of the Licensed Products after the Effective Date, MPL shall have the right to call, and Distributor shall participate/or attend at its own expense, a meeting of Distributor (which shall include senior level marketing and sales management of Distributor) and MPL, to be held in Los Angeles, CA. The purpose of such meeting shall be to discuss the promotional pieces or practices which led to the issuance of the Warning Letter or the NOV's, as the case may be, and to discuss, if appropriate, appropriate corrective or remedial measures to Distributor's promotional review process. Subsequent to any such meeting or in lieu of such meeting (if such meeting is not held as a result of the mutual agreement of the Parties or as a result of Distributor's failure or refusal to attend), MPL may, in its sole and absolute discretion, at any time after the issuance of a Warning Letter or a second NOV from FDA related to the Licensed Products after the Effective Date, decide to invoke the promotional review procedures set forth in Section 3.02(b)(ii) below by sending written notice thereof to Distributor (hereinafter, a "Promotional Review Notice"). In the event that MPL sends a Promotional Review Notice to Distributor, Distributor shall comply with the procedures set forth in this Section 3.02(b)(ii). Distributor shall ensure that all marketing and advertising materials and activities comply with the applicable labeling and the applicable Licensed Product Registration for any of the Licensed Products and with Applicable Laws, including, without limitation, addressing any concerns which were the subject of such FDA letter(s). For a period of twelve (12) months after the Promotional Review Notice (the "Pre-Clearance Period"), Distributor shall submit all of the following for review and approval by DDMAC (the "Pre-Clearance Process") prior to use or dissemination; any and all marketing, advertising, promotional and related materials and activities (including, without limitation, detail aids, letters, brochures, reprints and other printed materials shown to or left with healthcare providers, letters, brochures and other printed materials intended for consumers, website content, materials for use in promotional programs, and any print, television, radio, and other media advertising materials intended for healthcare providers or consumers), labeling, press materials, updates and corrections to the Physicians Desk Reference with respect to the Licensed Products, speaker training materials (including slides and slide kits), sales training materials and other materials and communications originating from home offices, regional offices, local offices or hub offices and sent to the sales force regarding promotional messages or strategies for the Licensed Products. Distributor shall not use any materials or make any claims in advertising, promoting or selling the Licensed Products which have not gone through the Pre-Clearance Process and received specific and entire written approval by DDMAC; provided, however, that in the case of materials not accepted for review by DDMAC, Distributor shall ensure that all such materials and the claims and promotional messages therein; (a) are consistent with the materials and claims that have gone through the Pre-Clearance Process and received written approval by DDMAC and (b) comply with all comments, direction and guidance given by DDMAC during the Pre-Clearance Period. Distributor shall ensure that all promotional programs and activities of all sales representatives promoting the Licensed Products comply with any and all comments, direction or guidance given by DDMAC during the Pre-Clearance Period. Upon expiration of the Pre-Clearance Period, Distributor shall continue to promote, detail, sell and advertise the Licensed Products in a manner consistent with, and in full compliance with, all comments, directions and guidance received from DDMAC. Distributor shall be solely responsible for submitting all promotional and advertising materials prepared by or for it to the FDA by way of a Form 2253 or otherwise. MPL shall have the right to immediately terminate this Agreement if; (i) Distributor shall fail to fully comply with the requirements of this Section 3.02(b)(ii) or (iii) FDA issues a Warning Letter or NOV with respect to any of the Licensed Products at any time during or after the Pre-Clearance Period. Distributor acknowledges that MPL has advised Distributor that MPL is not currently actively promoting any of the Licensed Products in the Territory and has never promoted its products in the Territory, and that MPL does not have current materials designed for advertising or promoting the Licensed Products in the Territory. MPL shall provide Distributor with copies of any advertising, promotional or training materials in its possession and previously used by MPL relating to the Licensed Products, and shall permit Distributor, subject to compliance by Distributor with Applicable Laws, to update, adapt and use such materials in the Territory in developing new promotional materials (subject to any copyrights or other rights reserved to MPL, its Affiliates and to Third Parties in such materials). MPL reserves and retains title and all rights, including copyright rights, in and to all written, visual and electronic works and other materials (including without limitation training materials, promotion materials, brochures and other detail literature) provided by it to Distributor under this Agreement. Subject to the foregoing, Distributor is granted the nonexclusive right under this Section to use, copy, modify, and distribute such materials only for the purposes of this Agreement and in furtherance of the rights granted to Distributor hereunder, for the Term for any of the Licensed Products to which such works and materials relate. Distributor shall ensure that all copyright notices and this permission notice appear on all copies of the written materials provided by MPL and all adaptations and derivative works thereof. Any and all new promotional material developed by Distributor, including that which adapts or utilizes materials supplied to Distributor by MPL, shall be filed with FDA at the time of initial dissemination via Form FDA-2253. Distributor shall have sole authority and responsibility, at its sole expense, for conducting independent and non-independent symposia, speaker training and engagement programs, advisory board meetings and other consulting arrangements, scientific exhibits and other types of scientific exchange, and other such events or programs as Distributor, in its sole discretion, deems to be appropriate with respect to the Licensed Products within the Territory; provided, however, that any and all such events and programs must comply in all respects with Applicable Laws and relevant FDA policies, including without limitation, the FDA's Guidance on Industry-Supported Educational and Scientific Activitiesfashion.

Promotional Materials and Activities. Subject During the Copromotion Period, and in compliance with Law, Esprit shall have the sole right to create and develop the Promotional Materials with, during the Copromotion Period, input and participation from the Marketing Committee, subject to Section 5.6(a). During the Copromotion Period, prior to Confidential treatment has been requested for portions of this document. This copy of the document filed as an Exhibit omits the confidential information subject to the provisions confidentiality request. Omissions are designated by the symbol [...***...]. A complete version of Section 3.02(bthis document has been provided separately to the Securities and Exchange Commission. finalizing such Promotional Materials and promotional activities, each Party shall include the other Party in its internal circulation of information regarding such promotional materials and activities during the development of such Promotional Materials and any event related materials and upon the finalization of such materials. (a) belowNeither Party shall produce (other than as concepts for consideration by the other Party), Distributor distribute or otherwise use any Promotional Materials that have not been approved in advance by the Development Committee for purposes of determining compliance with Law and agreed upon standard operating procedures of each Party. Prior to the NDA Transfer Date, Promotional Materials shall be submitted to Indevus’ internal regulatory compliance personnel for timely review pursuant to applicable internal standard operating procedures, for an assessment of compliance with Law and shall be subject to Indevus’ approval solely with respect to compliance with Law. Such assessment shall be provided to both Parties. Each Party shall limit its statements, discussions and claims regarding Products, including those as to safety and efficacy, to those that are consistent with the Product Labeling and the Promotional Materials. Neither Party shall add, delete, modify or distort claims of safety or efficacy in the Detailing of Products, nor shall it make any changes (including underlining or otherwise highlighting any language or adding any notes thereto) or alter the presentation order or format in the Promotional Materials. (b) Esprit shall own all right, title and interest in and to the copyrights in all marketing, sales, advertising or Promotional Materials relating to the Products in the Field in the Territory (“Territory Copyrighted Works”). Indevus shall execute all documents and take all actions as are reasonably requested by Esprit to vest title to such Territory Copyrighted Works in Esprit. Esprit shall be responsible, at its sole expense expense, for searching, clearing and under its sole control filing applications for conducting registration of all promotional activities and for designing, preparing and distributing all materials, advertisements and activities used in such Territory Copyrighted Works. To the promotion, advertising and marketing of the Licensed Products within the Territory. Distributor shall Ensure that all materials, advertisements and promotional activities comply with, and Distributor shall be solely responsible and liable for any failure of extent such materials and activities include or incorporate original works of authorship created by Indevus prior to comply with, the applicable labeling and Licensed Product Registration for any of the Licensed Products and with Applicable Laws and regulations, notwithstanding any prior review or approval of such materials or activities by MPL and notwithstanding that such materials or activities may have been previously reviewed, used or conducted by MPL. Distributor shall be solely responsible for fulfilling regulatory requirements pertaining to its promotional materials and activities, including, without limitation, sole responsibility for submitting to FDA all promotional and advertising materials prepared by or for Distributor at the time of initial dissemination, by way of a Form FDA-2253, consistent with 21 CFR Part 314.81. To this effect, MPL shall, upon the Effective Date, Indevus shall not use, or make any proprietary claim with regard to, those pre-existing materials separate and apart from their use and inclusion in Territory Copyrighted Works relating to Products. (c) Subject to Section 5.6(b), Esprit and Indevus shall retain all rights, including all copyrights and trademarks, to all of their respective programs and materials existing as soon thereafter as is reasonably practicable, place a letter on file with DDMAC with respect to the Licensed Products advising DDMAC that Distributor shall be the sole marketer and promoter of the Licensed Effective Date in all formats (including print, video, audio, digital, and computer formats) regarding sales training, patient education and disease management programs owned or licensed by each at the time such materials are shared with the other Party, as well as any modifications of such programs each may develop in the future that are not specific to Products in the Territory Field. Esprit and requesting Indevus shall, from time to time, each notify the other as to the identity of such proprietary programs. In addition, all new programs that DDMAC address regulatory inquiries are not specific to Products in the Field that are jointly developed by Esprit and concerns regarding Distributor's promotional activities solely with Distributor. Distributor shall promptly, but in no event less than one (1) Business Day after Distributor's receipt thereof, provide a copy to MPL of any correspondence from a government agency with respect to any of the Licensed Products, including, but not limited to, the FDA, reflecting any purported legal or regulatory violations or legal or regulatory action being considered or taken by such government agency, including without limitation, copies of FDA NOV's and Warning Letters. Unless otherwise required, Distributor shall not provide MPL with copies of any promotional materials or advertising or notify MPL of any promotional activities unless Indevus pursuant to a written request this Agreement shall be jointly owned by MPL. Distributor shall absorb Esprit and be solely responsible for any and all lost profits, lost revenues, damages, losses, expenses and costs incurred by Distributor, its AffiliatesIndevus, and any CSO retained by Distributor pursuant to the terms of this Agreement, arising from the failure of any promotional materials or advertising used, or activities conducted by, Distributor to comply with the applicable labeling, the Licensed Product Registrations and/or with Applicable Laws. Without limiting the rights MPL may have under the indemnification provisions of this Agreement, Distributor shall promptly reimburse MPL and its Affiliates for any and all damages, losses, expenses and costs suffered or incurred by MPL and its Affiliates arising from (i) the failure of any promotional materials or advertising used or activities conducted by Distributor to comply with the applicable labeling, the applicable Licensed Product Registrations, Applicable Laws, and/or any comments, guidance or direction given by FDA or DDMAC in the Pre-Clearance Process pursuant to Section 3.02(b)(ii) or (ii) the failure of Distributor or its representatives or any CSO selected pursuant to the terms of this Agreement to promote the Licensed Products in compliance with the applicable labeling, the applicable Licensed Product Registrations and/or with Applicable Laws. MPL shall use Commercially Reasonable Efforts to mitigate or limit its losses, expenses and costs incurred in connection with any matter described in (i) or (ii) above and for purposes of the preceding sentence, it is understood and agreed that the losses, expenses and costs incurred by MPL shall include, without limitation, the losses, expenses and costs incurred by MPL to so mitigate or limit the effect or impact of (i) or (ii) above, on MPL and its Affiliates products or corporate image (including, but not limited to, the costs of any remedial action undertaken by MPL to communicate with physicians or customers (including, but not limited to so-called "dear doctor letters"). If Distributor (or MPL) shall receive a Warning Letter from FDA which relates to marketing, promotion, advertisement, sale or distribution of the Licensed Products after the Effective Date, or Distributor (or MPL) shall receive two (2) NOV's from the FDA which relate to marketing, promotion, advertisement, sale or distribution of the Licensed Products after the Effective Date, MPL each Party shall have the right to call, and Distributor shall participate/or attend at its own expense, a meeting use such jointly developed programs free of Distributor charge after the expiration of the Agreement Term. (which shall include senior level marketing and sales management of Distributord) and MPL, to be held in Los Angeles, CA. The purpose of such meeting Esprit shall be to discuss the promotional pieces or practices which led primary Party responsible for preparing all submissions with the FDA regarding approval of all Promotional Materials that require FDA Confidential treatment has been requested for portions of this document. This copy of the document filed as an Exhibit omits the confidential information subject to the issuance confidentiality request. Omissions are designated by the symbol [...***...]. A complete version of the Warning Letter or the NOV's, as the case may be, and to discuss, if appropriate, appropriate corrective or remedial measures to Distributor's promotional review process. Subsequent to any such meeting or in lieu of such meeting (if such meeting is not held as a result of the mutual agreement of the Parties or as a result of Distributor's failure or refusal to attend), MPL may, in its sole and absolute discretion, at any time after the issuance of a Warning Letter or a second NOV from FDA related this document has been provided separately to the Licensed Products after Securities and Exchange Commission. approval; provided that prior to the Effective NDA Transfer Date Indevus shall be responsible for filing all such submissions and participating with Esprit in any interactions with the FDA regarding such matters. After the NDA Transfer Date, decide to invoke the promotional review procedures set forth in Section 3.02(b)(ii) below by sending written notice thereof to Distributor (hereinafter, a "Promotional Review Notice"). In the event that MPL sends a Promotional Review Notice to Distributor, Distributor Esprit shall comply be responsible for all submissions and interactions with the procedures set forth FDA regarding approval of all Promotional Materials that require FDA approval. (e) Except as otherwise prohibited by Law, during the Copromotion Period, all Promotional Materials used by Indevus in this Section 3.02(b)(ii). Distributor shall ensure that all marketing and advertising materials and activities comply connection with the applicable labeling Promotion of Products under this Agreement shall be only those supplied by Esprit. Indevus may display on such Promotional Materials the Indevus Logo; provided that the trademark of and the applicable Licensed Product Registration for specified by Esprit (or any of the Licensed Products and with Applicable Laws, including, without limitation, addressing any concerns person or entity to which were the subject of such FDA letter(s). For a period of twelve (12Esprit assigns or sublicenses rights hereunder) months after the Promotional Review Notice (the "Pre-Clearance Period"), Distributor shall submit all of the following for review and approval by DDMAC (the "Pre-Clearance Process") prior to use or dissemination; any and all marketing, advertising, promotional and related materials and activities (including, without limitation, detail aids, letters, brochures, reprints and other printed materials shown to or left with healthcare providers, letters, brochures and other printed materials intended for consumers, website content, materials for use in promotional programs, and any print, television, radio, and other media advertising materials intended for healthcare providers or consumers), labeling, press materials, updates and corrections appear to the Physicians Desk Reference with respect to left of and/or above the Licensed Products, speaker training materials (including slides and slide kits), sales training materials and other materials and communications originating from home offices, regional offices, local offices or hub offices and sent to the sales force regarding promotional messages or strategies for the Licensed ProductsIndevus Logo. Distributor Indevus shall not use any representations of any mxxx of Esprit other than those supplied by Esprit in Promotional Materials. Solely to the extent required by Law, all Promotional Materials used by Esprit will indicate that a Product is sold under license from Indevus and promoted by Esprit or any such Affiliate, as directed by Esprit. All promotional materials used by Indevus in connection with the Promotion of Products under this Agreement shall indicate that the Trademarks (except for the Indevus Logo) are owned by Esprit or make any claims such Affiliate, as directed by Esprit. Notwithstanding anything to the contrary in advertisingthis Section 5.6(e), promoting except to the extent required by Law, in no event shall any packaging, trade dress, journal advertising and sales aids, or selling FDA approved Product Labeling display any mxxx of Indevus. (f) Within ninety (90) days after the Licensed Products which have not gone through expiration or termination of this Agreement, each Party shall return (unless prohibited by Law), or otherwise dispose of in accordance with instructions from the Pre-Clearance Process other Party, all remaining Promotional Materials provided by the other Party and received specific and entire written approval by DDMAC; provided, however, that in will provide the case of materials not accepted for review by DDMAC, Distributor shall ensure other Party with a certified statement that all such materials and the claims and promotional messages therein; (a) are consistent with the materials and claims that remaining Promotional Materials have gone through the Pre-Clearance Process and received written approval by DDMAC and (b) comply with all comments, direction and guidance given by DDMAC during the Pre-Clearance Period. Distributor shall ensure that all promotional programs and activities been returned or otherwise properly disposed of all sales representatives promoting the Licensed Products comply with any and all comments, direction or guidance given by DDMAC during the Pre-Clearance Period. Upon expiration of the Pre-Clearance Period, Distributor shall continue to promote, detail, sell and advertise the Licensed Products in a manner consistent with, and in full compliance with, all comments, directions and guidance received from DDMAC. Distributor shall be solely responsible for submitting all promotional and advertising materials prepared by or for it to the FDA by way of a Form 2253 or otherwise. MPL shall have the right to immediately terminate this Agreement if; (i) Distributor shall fail to fully comply with the requirements of this Section 3.02(b)(ii) or (iii) FDA issues a Warning Letter or NOV with respect to any of the Licensed Products at any time during or after the Pre-Clearance Period. Distributor acknowledges that MPL has advised Distributor that MPL is not currently actively promoting any of the Licensed Products in the Territory and has never promoted its products in the Territory, and that MPL does not have current materials designed for advertising the Party is no longer in possession or promoting the Licensed Products in the Territory. MPL shall provide Distributor with copies control of any advertising, promotional such Promotional Materials in any form or training materials in its possession and previously used by MPL relating to the Licensed Products, and shall permit Distributor, subject to compliance by Distributor with Applicable Laws, to update, adapt and use such materials in the Territory in developing new promotional materials (subject to any copyrights or other rights reserved to MPL, its Affiliates and to Third Parties in such materials). MPL reserves and retains title and all rights, including copyright rights, in and to all written, visual and electronic works and other materials (including without limitation training materials, promotion materials, brochures and other detail literature) provided by it to Distributor under this Agreement. Subject to the foregoing, Distributor is granted the nonexclusive right under this Section to use, copy, modify, and distribute such materials only for the purposes of this Agreement and in furtherance of the rights granted to Distributor hereunder, for the Term for any of the Licensed Products to which such works and materials relate. Distributor shall ensure that all copyright notices and this permission notice appear on all copies of the written materials provided by MPL and all adaptations and derivative works thereof. Any and all new promotional material developed by Distributor, including that which adapts or utilizes materials supplied to Distributor by MPL, shall be filed with FDA at the time of initial dissemination via Form FDA-2253. Distributor shall have sole authority and responsibility, at its sole expense, for conducting independent and non-independent symposia, speaker training and engagement programs, advisory board meetings and other consulting arrangements, scientific exhibits and other types of scientific exchange, and other such events or programs as Distributor, in its sole discretion, deems to be appropriate with respect to the Licensed Products within the Territory; provided, however, that any and all such events and programs must comply in all respects with Applicable Laws and relevant FDA policies, including without limitation, the FDA's Guidance on Industry-Supported Educational and Scientific Activitiesfashion.

Promotional Materials and Activities. (a) Subject to the provisions of Section 3.02(b) below, Distributor FUSA shall be solely responsible, at its sole expense and under its sole control control, subject to review by Luitpold/AR, for conducting all promotional activities and for designing, preparing and distributing all materials, advertisements and activities used in the promotion, advertising and marketing of Iron Products for the Licensed Products Field within the Territory. Distributor FUSA shall Ensure ensure that all materials, advertisements and promotional activities comply with, and Distributor FUSA shall be solely responsible and liable for any failure of such materials and activities to comply with, the applicable labeling and Licensed Product Registration for any of the Licensed Iron Products and with Applicable Laws and regulations, notwithstanding unless, Luitpold/AR shall not have conducted any prior review or approval of such materials or activities by MPL and notwithstanding that or such materials or activities may have been previously reviewed, used or conducted by MPLLuitpold/AR. Distributor FUSA shall be solely responsible for fulfilling regulatory requirements pertaining to its promotional materials and activities, including, without limitation, sole responsibility for submitting to FDA all promotional and advertising materials prepared by or for Distributor FUSA at the time of initial dissemination, by way of a Form FDA-2253, consistent with 21 CFR C.F.R. Part 314.81. To this effect, MPL Luitpold/AR shall, upon the Effective Date, or as soon thereafter as is reasonably practicable, place a letter on file with DDMAC with respect to the Licensed Products advising DDMAC that Distributor FUSA shall be the sole marketer and promoter of the Licensed Products for the Field in the Territory and requesting that DDMAC address regulatory inquiries and concerns regarding Distributor's FUSA’s promotional activities solely with Distributorto FUSA as well as Luitpold/AR. Distributor FUSA shall promptly, but in no event less than one ten (110) Business Day Days after Distributor's FUSA’s receipt thereof, provide a copy to MPL Luitpold/AR of any correspondence from a government agency Governmental Authority with respect to any of the Licensed Iron Products, including, but not limited to, the FDA, reflecting any purported legal or regulatory violations or legal or regulatory action being considered or taken by such government agencyGovernmental Authority, including without limitation, copies of FDA NOV's ’s and Warning Letters. Unless otherwise required, Distributor FUSA shall not provide MPL Luitpold/AR with copies a written request for approval of any promotional materials or advertising or notify MPL of any promotional activities unless pursuant to and Luitpold/AR shall review and approve the same. In the event that FUSA receives no objection within ten (10) Business Days after a written request for approval, the promotional materials or advertising shall be deemed to have been reviewed and approved by MPLLuitpold/AR. Distributor FUSA will incorporate any reasonable changes requested by Luitpold/AR in its review of materials and Luitpold/AR will provide its reasons for any required changes. FUSA will provide Luitpold/AR in writing with its reasons for not incorporating any changes requested by Luitpold/AR. FUSA shall absorb and be solely responsible for any and all lost profits, lost revenues, damages, losses, expenses and costs incurred by Distributor, FUSA and its Affiliates, and any CSO retained by Distributor Affiliates pursuant to the terms of this Agreement, Agreement arising from the failure of any promotional materials or advertising used, or activities conducted by, Distributor FUSA to comply with the applicable labeling, the Licensed Product Registrations and/or with Applicable Laws. Without limiting the rights MPL may have under the indemnification provisions of this Agreement, Distributor shall promptly reimburse MPL and its Affiliates for any and all damages, losses, expenses and costs suffered or incurred by MPL and its Affiliates arising from . (ib) the failure of any promotional materials or advertising used or activities conducted by Distributor to comply with the applicable labeling, the applicable Licensed Product Registrations, Applicable Laws, and/or any comments, guidance or direction given by FDA or DDMAC in the Pre-Clearance Process pursuant to Section 3.02(b)(ii) or (ii) the failure of Distributor or its representatives or any CSO selected pursuant to the terms of this Agreement to promote the Licensed Products in compliance with the applicable labeling, the applicable Licensed Product Registrations and/or with Applicable Laws. MPL shall use Commercially Reasonable Efforts to mitigate or limit its losses, expenses and costs incurred in connection with any matter described in (i) or (ii) above and for purposes of the preceding sentence, it is understood and agreed that the losses, expenses and costs incurred by MPL shall include, without limitation, the losses, expenses and costs incurred by MPL to so mitigate or limit the effect or impact of (i) or (ii) above, on MPL and its Affiliates products or corporate image (including, but not limited to, the costs of any remedial action undertaken by MPL to communicate with physicians or customers (including, but not limited to so-called "dear doctor letters"). If Distributor FUSA (or MPLLuitpold/AR) shall receive a Warning Letter from FDA which relates to manufacturing, marketing, promotion, advertisement, sale or distribution of the Licensed Iron Products after the Effective Date, or Distributor FUSA (or MPL9 Luitpold/AR) shall receive two (2) NOV's an NOV from the FDA which relate to manufacturing, marketing, promotion, advertisement, sale or distribution of the Licensed Iron Products after the Effective Date, MPL either FUSA or Luitpold/AR shall have the right to call, and Distributor the other Party shall participate/or attend at its own expense, a meeting of Distributor the Parties (which shall include include, but not be limited to senior level operational, manufacturing, regulatory affairs, marketing and sales management of Distributoreach Party) and MPL, to be held in Los AngelesBoston, CAMassachusetts and New York, New York, on an alternate basis. The purpose of such meeting shall be to discuss the actions or missions, promotional pieces or practices which led to the issuance of the Warning Letter or the NOV's’s, as the case may be, and to discuss, if appropriate, appropriate corrective or remedial measures to Distributor's the Party’s promotional review process. Subsequent to any such meeting or in lieu of such meeting . (if such meeting c) Luitpold/AR acknowledges that it is not held as a result of actively promoting the mutual agreement of the Parties or as a result of Distributor's failure or refusal to attend), MPL may, in its sole and absolute discretion, at any time after the issuance of a Warning Letter or a second NOV from FDA related to the Licensed Products after the Effective Date, decide to invoke the promotional review procedures set forth in Section 3.02(b)(ii) below by sending written notice thereof to Distributor (hereinafter, a "Promotional Review Notice"). In the event that MPL sends a Promotional Review Notice to Distributor, Distributor shall comply with the procedures set forth in this Section 3.02(b)(ii). Distributor shall ensure that all marketing and advertising materials and activities comply with the applicable labeling and the applicable Licensed Product Registration for any of the Licensed Products and with Applicable Laws, including, without limitation, addressing any concerns which were the subject of such FDA letter(s). For a period of twelve (12) months after the Promotional Review Notice (the "Pre-Clearance Period"), Distributor shall submit all of the following for review and approval by DDMAC (the "Pre-Clearance Process") prior to use or dissemination; any and all marketing, advertising, promotional and related materials and activities (including, without limitation, detail aids, letters, brochures, reprints and other printed materials shown to or left with healthcare providers, letters, brochures and other printed materials intended for consumers, website content, materials for use in promotional programs, and any print, television, radio, and other media advertising materials intended for healthcare providers or consumers), labeling, press materials, updates and corrections to the Physicians Desk Reference with respect to the Licensed Products, speaker training materials (including slides and slide kits), sales training materials and other materials and communications originating from home offices, regional offices, local offices or hub offices and sent to the sales force regarding promotional messages or strategies for the Licensed Products. Distributor shall not use any materials or make any claims in advertising, promoting or selling the Licensed Products which have not gone through the Pre-Clearance Process and received specific and entire written approval by DDMAC; provided, however, that in the case of materials not accepted for review by DDMAC, Distributor shall ensure that all such materials and the claims and promotional messages therein; (a) are consistent with the materials and claims that have gone through the Pre-Clearance Process and received written approval by DDMAC and (b) comply with all comments, direction and guidance given by DDMAC during the Pre-Clearance Period. Distributor shall ensure that all promotional programs and activities of all sales representatives promoting the Licensed Products comply with any and all comments, direction or guidance given by DDMAC during the Pre-Clearance Period. Upon expiration of the Pre-Clearance Period, Distributor shall continue to promote, detail, sell and advertise the Licensed Products in a manner consistent with, and in full compliance with, all comments, directions and guidance received from DDMAC. Distributor shall be solely responsible for submitting all promotional and advertising materials prepared by or for it to the FDA by way of a Form 2253 or otherwise. MPL shall have the right to immediately terminate this Agreement if; (i) Distributor shall fail to fully comply with the requirements of this Section 3.02(b)(ii) or (iii) FDA issues a Warning Letter or NOV with respect to any of the Licensed Products at any time during or after the Pre-Clearance Period. Distributor acknowledges that MPL has advised Distributor that MPL is not currently actively promoting any of the Licensed Products Field in the Territory and has never promoted its products in the Territory, and that MPL does not have current materials designed for advertising or promoting the Licensed Products in the Territory. MPL shall provide Distributor provided FUSA with copies of any advertising, promotional or training materials in its possession and previously used by MPL Luitpold/AR relating to the Licensed ProductsProduct, and shall permit DistributorFUSA, subject to compliance by Distributor FUSA with Applicable Laws, to update, adapt and use such materials for the Field in the Territory in developing new promotional materials (subject to any copyrights or other rights reserved to MPL, its Affiliates and to of Third Parties in such materials). MPL Luitpold/AR reserves and retains title and all rights, including copyright rights, in and to all written, visual and electronic works and other materials (including without limitation training materials, promotion materials, brochures and other detail literature) provided by it to Distributor FUSA under this Agreement. Subject to the foregoing, Distributor FUSA is granted the nonexclusive right under this Section to use, copy, modify, and distribute such materials only for the purposes of this Agreement and in furtherance of the rights granted to Distributor FUSA hereunder, for the Term for any of the Licensed Iron Products to which such works and materials relate. Distributor FUSA shall ensure that all copyright notices and this permission notice appear on all copies of the written materials provided by MPL Luitpold/AR and all adaptations and derivative works thereof. Any and all new promotional material developed by DistributorFUSA, including that which adapts or utilizes materials supplied to Distributor FUSA by MPLLuitpold/AR, shall be filed with FDA at the time of initial dissemination via Form FDA-2253. Distributor Luitpold/AR represents and warrants to FUSA that any promotional or training materials or advertising used or activities provided by it to FUSA hereunder complies with the applicable labeling, the applicable Product Registrations, Applicable Laws, and/or any comments, guidance or direction given by FDA or DDMAC in the Pre-Launch Process, including without limitation, the FDA’s Guidance on Industry-Supported Educational and Scientific Activities and the OIG Guidance. (d) FUSA shall have strategic responsibility and sole authority and responsibility, at its sole expense, for conducting independent and non-independent symposia, speaker training and engagement programs, advisory board meetings and other consulting arrangements, scientific exhibits and other types of scientific exchange, and other such events or programs as DistributorFUSA, in its sole discretion, deems to be appropriate with respect to marketed and approved Iron Products for the Licensed Products Field within the Territory; provided, however, that any and all such events and programs must comply in all respects with Applicable Laws and relevant FDA policies, including without limitation, the FDA's ’s Guidance on Industry-Supported Educational and Scientific ActivitiesActivities and the OIG Guidance.