Common use of Promotional Materials Clause in Contracts

Promotional Materials. Oncogenerix shall provide samples of Promotional Materials to Rosemont not less than ten (10) days prior to the time of first using or distributing such Promotional Materials in the Territory and shall obtain Rosemont’s written approval before using or distributing such Promotional Material; such approval not to be unreasonably delayed, conditioned or denied. Rosemont will approve the Promotional Materials within five (5) business days of receipt of such Promotional Materials from Oncogenerix. If Rosemont does not provide its approval or notice that it does not approve the Promotional Materials within the timescale in this Section 4.3, the Promotional Materials will be deemed to be approved. Oncogenerix will use Reasonable Diligence to make such amendments to the Promotional Materials as requested by Rosemont under this Section 4.3. Oncogenerix shall own all right, title and interest in and to any Promotional Materials created by Oncogenerix relating to the Licensed Products, but excluding the Licensed Trademark(s); provided that, the Promotional Materials shall be used exclusively in connection with the Licensed Products in accordance with the terms of this Agreement. Where required by law, Oncogenerix shall submit Promotional Materials to the FDA (DDMAC) for review and approval. In the event that the FDA issues a letter objecting to any Promotional activities by Oncogenerix that require corrective actions (e.g. issuance of Dear Healthcare Professional letters, recall of Promotional Materials and/or dissemination of corrected Promotional Material), Oncogenerix will bear all the cost related to these corrective activities except to the extent that any such costs are caused by changes requested by Rosemont, in which case Rosemont shall bear the costs of such corrective activities.

Promotional Materials. Oncogenerix Amgen shall provide samples be responsible for the creation, preparation, production and reproduction of all Promotional Materials relating to the Collaboration Products and for filing, as appropriate, such Promotional Materials with all Regulatory Authorities. (A) To the extent permitted by law, regulation or Regulatory Authorities, each Collaboration Product will be marketed as a joint product of ViaCell and Amgen and references to ViaCell and ViaCell's logo shall be included on all Product Labeling in a manner that is substantially similar in terms of prominence and in all other respects as the references to Amgen and Amgen's logo included in such Product Labeling and in a manner that complies with the terms and conditions of this Agreement (including without limitation Section 10.5 hereof). Amgen shall use Commercially Reasonable Efforts in designing and producing Promotional Materials to Rosemont not less than ten (10) days prior promote the Collaboration Products and shall use Commercially Reasonable Efforts to the time of first using or distributing use ViaCell's name and logo in such Promotional Materials with reasonably similar prominence as Amgen's name and logo, and pursuant to the terms of Section 6.4(b), shall consider in good faith the Territory comments and shall obtain Rosemont’s written approval before using or distributing suggestions of ViaCell in relation to such Promotional Material; such approval not to be unreasonably delayedMaterials, conditioned or denied. Rosemont will approve the Promotional Materials within five (5) business days of receipt of such Promotional Materials from Oncogenerix. If Rosemont does not provide its approval or notice that it does not approve the Promotional Materials within the timescale in this Section 4.3, the Promotional Materials will be deemed to be approved. Oncogenerix will use Reasonable Diligence to make such amendments including with respect to the Promotional Materials as requested by Rosemont under this Section 4.3. Oncogenerix use of ViaCell's logo. (B) Prior to the use thereof, Amgen shall own all right, title and interest in and provide to ViaCell a prototype of any Promotional Materials created by Oncogenerix relating to or Product Labeling which contains ViaCell's corporate name and/or logo, so that ViaCell may review the Licensed Productsmanner in which its corporate name and/or logo are used therein. ViaCell shall notify Amgen within [**] after delivery of such prototype, but excluding whether ViaCell approves or disapproves of the Licensed Trademark(s); provided thatmanner of such use and, in the case of disapproval, the Promotional Materials shall be used exclusively in connection with the Licensed Products in accordance with the terms of this Agreement. Where required by law, Oncogenerix shall submit Promotional Materials to the FDA (DDMAC) for review specific reasons therefor and approvalan acceptable alternative. In the event that ViaCell fails to so notify Amgen within such [**] period, ViaCell shall be deemed to have approved the FDA issues a letter objecting manner of such use. In the event that (i) the Promotional Materials and Product Labeling comply with Section 6.4(a), but ViaCell disapproves of the manner of such use and (ii) the Parties are unable to any Promotional activities by Oncogenerix that require corrective actions (e.g. issuance reach agreement regarding the manner of Dear Healthcare Professional letters, recall such use before an applicable regulatory or other legal deadline for submission of Promotional Materials and/or dissemination of corrected Promotional Material)Materials, Oncogenerix will bear all then Amgen shall retain the cost related right to these corrective activities except print and use, and ViaCell agrees to use, to the extent applicable, such Promotional Materials and Product Labeling without ViaCell's corporate name and/or logo. Amgen and ViaCell shall continue efforts to reach agreement on approving Promotional Materials with ViaCell's corporate name and/or logo that comply with Section 6.4(a). (C) Compliance with Laws, Regulations and Guidelines. Each Party agrees to comply with all applicable laws, rules and regulations (e.g., the FD&C Act, the PHS Act, the U.S. Foreign Corrupt Practices Act and any amendments thereto and the regulations promulgated thereunder, and the equivalent laws, rules and regulations in the Territory) and in all material respects to conform its practices and procedures with, as applicable, the Pharmaceutical Research and Manufacturers of America ("PhRMA") Code of Pharmaceutical Marketing Practices and the American Medical Association ("AMA") Guidelines on Gifts to Physicians from Industry, as the same may be amended from time to time, and equivalent guidelines in the Territory with respect to the Commercialization of Collaboration Products. Each Party shall conduct its business operations and cause each of its employees, representatives and agents to do nothing which such costs are caused by changes requested by RosemontParty knows or reasonably should know would jeopardize the good will or reputation of the other Party or the Cell Therapy Products or Collaboration Products. Neither Party shall be required to undertake any activity relating to the Commercialization of Cell Therapy Products or Collaboration Products that it believes, in which case Rosemont good faith, may violate any law or regulations. Each Party shall bear promptly notify the costs other Party of and provide to that other Party a copy of any correspondence or other reports with respect to the Promoting or Detailing of Collaboration Products submitted to or received from PhRMA or the AMA or equivalent organizations in the Territory and Amgen shall be responsible for responding to such corrective activitiescorrespondence or other [**] Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed with the Commission. reports. Each Party shall in all material respects conform its practices and procedures relating to educating the medical community in the U.S. with respect to Collaboration Products to the Accreditation Council for Continuing Medical Education ("ACCME") Standards for Commercial Support of Continuing Medical Education and any applicable FDA regulations or guidelines, as the same may be amended from time to time, and, as applicable, equivalent guidelines in the Territory and each Party shall promptly notify the other Party of and provide to the other Party a copy of any correspondence or other reports submitted to or received from the ACCME with respect to Collaboration Products and Amgen shall be responsible for responding to such correspondence or other reports.

Promotional Materials. Oncogenerix (a) All uses of the Transcept Trademarks and Purdue Trademarks shall provide samples comply with all Applicable Laws in the U.S. Territory. Unless otherwise agreed by the Parties or required by the FDA, Purdue shall sell the Product in the U.S. Territory under the Transcept Assigned Trademark Intermezzo™. Purdue may include its company name and associated logos on all Product packaging and Promotional Materials for the U.S. Territory. (b) Purdue shall be responsible, at its expense, for preparing and producing the Promotional Materials, which will be reviewed by the JCC. All Promotional Materials produced by Purdue for use in Detailing the Product in the U.S. Territory shall include Transcept’s name, and shall display the names and logos of Purdue and Transcept in equal prominence to the extent practical; provided, however, that upon the Co-Promotion Commencement Date, Purdue itself shall have the continued right to use any stock of Promotional Materials to Rosemont not less than ten (10) days prepared prior to the time exercise of first using the Psychiatrist Co-Promotion Option until such stock is exhausted. Except as specifically permitted by this Section 8.7, neither Party shall distribute or distributing have distributed any materials bearing the name or any trademarks of the other Party without the prior written approval of such other Party. To the extent that Transcept disagrees with Promotional messages or tactics proposed by Purdue, it may raise such issues with the JCC for discussion and resolution. Purdue and Transcept will be bound by the decision of the JCC with respect to any activities of Transcept that flow or result from the JCC decision. (c) Upon the Co-Promotion Commencement Date, Purdue shall provide Transcept with the Promotional Materials then used by the Purdue Sales Force to Promote the Product, at no charge to Transcept, in quantities specified in the Marketing Plan and sufficient for Transcept to satisfy its obligations under this Agreement and the Marketing Plan. Transcept shall be responsible for distributing the Promotional Materials to the Transcept Sales Force. Except for Transcept Licensed Trademarks, Purdue shall own all right, title and interest in the Promotional Materials, including all intellectual property rights appurtenant thereto. Purdue hereby grants to Transcept a royalty-free license to use the Promotional Materials during the Term solely in connection with its Promotion of the Product in the U.S. Territory and in accordance with this Agreement and Applicable Laws, subject to Transcept’s payment of costs as provided in this Section. Transcept may sublicense such license only to its contract sales force under Section 6.12(a). (d) Transcept may propose to the JCC that the Parties develop Promotional Materials specifically for use by the Parties in Detailing the Product to Psychiatrists (the “Psychiatrist Promotional Materials”), which materials Transcept shall obtain Rosemont’s written create and develop in accordance with Applicable Laws, subject to prior review and approval before using or distributing such Promotional Material; by Purdue, such approval not to be unreasonably delayedwithheld, conditioned or denieddelayed, and Purdue shall print and produce the Psychiatrist Promotional Materials. Rosemont will approve Transcept shall reimburse Purdue for all out-of-pocket costs incurred by Purdue to produce the Psychiatrist Promotional Materials; provided, however, that if Purdue orders any Psychiatrist Promotional Materials within five for use by the Purdue Sales Force, then Purdue shall be responsible for a proportionate share (5based on the number of units ordered by Purdue) business days of receipt the out-of-pocket costs incurred by both Parties to develop and print the Psychiatrist Promotional Materials. Except for any Purdue Trademarks and any portion of such the Psychiatrist Promotional Materials from Oncogenerix. If Rosemont does not provide its approval or notice that it does not approve is the same as Promotional Materials within the timescale in this Section 4.3produced by Purdue, the Promotional Materials will be deemed to be approved. Oncogenerix will use Reasonable Diligence to make such amendments to the Promotional Materials as requested by Rosemont under this Section 4.3. Oncogenerix Transcept shall own all right, title and interest in and to the Psychiatrist Promotional Materials, including all intellectual property rights appurtenant thereto. Transcept hereby grants to Purdue a royalty-free license to use Psychiatrist Promotional Materials during the Term in connection with its Promotion of the Product to Psychiatrists in accordance with this Agreement and Applicable Laws, subject to Purdue’s payment of costs as provided in this Section. (e) Neither Party shall use or distribute in connection with Detailing the Product in the U.S. Territory any promotional materials other than the Promotional Materials and the Psychiatrist Promotional Materials in the form(s) prepared and approved in accordance with this Section 8.7. Purdue shall be solely responsible for timely submitting, as applicable, any Promotional Materials created by Oncogenerix relating and Psychiatrist Promotional Materials to the Licensed ProductsFDA’s Division of Drug Marketing, but excluding Advertising and Communications and to any applicable state Governmental Authorities in the Licensed Trademark(sU.S. Territory. Transcept shall not be required to distribute any Promotional Materials that: (i) do not mention the Product (except for non-branded materials provided by Purdue if approved by the JCC); provided thator (ii) Transcept believes, in its sole discretion, to be false or misleading. Each Party shall distribute the Promotional Materials shall be used exclusively in connection with the Licensed Products and Psychiatrist Promotional Materials in accordance with the Marketing Plan and the terms of this Agreement. Where required by law, Oncogenerix Neither Party shall submit distribute any out-dated Promotional Materials to the FDA (DDMAC) for review and approvalor Psychiatrist Promotional Materials. In the event that the FDA issues a letter objecting to any Promotional activities by Oncogenerix that require corrective actions (e.g. issuance of Dear Healthcare Professional letters, recall of Promotional Materials and/or dissemination of corrected Promotional Material), Oncogenerix will bear all the cost related to these corrective activities except to the extent Transcept shall certify that any such costs are caused by changes requested by Rosemontout-dated Materials have been returned to Purdue or its designee or destroyed, in which case Rosemont shall bear accordance with Purdue’s written policy delivered on the costs of Co-Promotion Commencement Date, as such corrective activitiespolicies may be updated from time to time by Purdue.

Promotional Materials. Oncogenerix (a) During the Term, the JMC shall provide samples of determine which Promotional Materials, including positioning and key messages, are necessary or appropriate to be distributed in the Co-Promotion Region under the JMP. Allergan shall create and develop such Promotional Materials, and such Promotional Materials shall be subject to review by the JMC. The Parties shall establish a tracking system or utilize Allergan’s tracking system (if appropriate and mutually agreed) for Promotional Materials to Rosemont not less than ten (10) days prior to the time of first using or distributing ensure that all such Promotional Materials are accurately tracked and submitted to the FDA. Allergan will file all Promotional Materials with the FDA if, and as required, by FDA regulations. (b) Spectrum shall not create, develop or distribute any sales, promotional content or other similar materials (including Labeling) relating to the Licensed Product in the Territory Co-Promotion Region except as set forth in this Section. All oral communications that Spectrum or its Sales Force has with Third Parties relating to the Licensed Product shall conform to the pre-approved talking points (which shall be the same for the Sales Force of both Parties) as agreed to within the JMC and provided by Allergan in writing. Spectrum shall not be required to distribute any Promotional Materials prepared after the Effective Date which: (i) do not mention the Licensed Product; (ii) are inaccurate or misleading; or (iii) were not approved by the JMC and Allergan. Spectrum shall distribute Promotional Materials of the type identified in this subsection in accordance with the JMP and with the terms of this Agreement. Print marketing materials produced by Allergan for use for the Target Audience shall include Spectrum’s name, and shall obtain Rosemont’s display the names and logos of Allergan and Spectrum in equal prominence. Except as specifically permitted by this Section or under the License Agreement, neither Party shall distribute or have distributed any materials bearing the name or any Trademarks of the other Party without the prior written approval before using or distributing such Promotional Material; such approval not to be unreasonably delayed, conditioned or denied. Rosemont will approve of the Promotional Materials within five other. (5c) business days of receipt of such Promotional Materials from Oncogenerix. If Rosemont does not provide its approval or notice that it does not approve the Promotional Materials within the timescale in this Section 4.3, the Promotional Materials will be deemed to be approved. Oncogenerix will use Reasonable Diligence to make such amendments to the Promotional Materials as requested by Rosemont under this Section 4.3. Oncogenerix Allergan shall own all right, title and interest in and to the Promotional Materials, including all Intellectual Property Rights and all Trademarks appurtenant thereto but excluding any rights in or to the Spectrum name (the “Allergan Trademarks”). Allergan hereby grants to Spectrum the right, during the Term, to use Promotional Materials created by Oncogenerix relating generated pursuant to the Licensed Products, but excluding JMP in connection with its promotion of the Licensed Trademark(s); provided that, Product and in accordance with this Agreement. Spectrum shall only be able to use the Promotional Materials shall be used exclusively Allergan Trademarks in connection with the Licensed Products Product as required by law. In addition, Spectrum shall be able to use the Allergan Trademarks that are used in accordance connection with the terms Licensed Product on its website and in press releases with the prior written consent of Allergan. All rights of Allergan in and to the Allergan Trademarks not expressly granted under this Article 2 are reserved by Allergan. (d) Spectrum shall promptly notify Allergan of any apparent infringement by a Third Party of any of the Allergan Trademarks. (e) Spectrum acknowledges and agrees that Allergan is the owner of all rights in the Allergan Trademarks, that all use of the Allergan Trademarks shall inure to the benefit of Allergan, that Spectrum will not take any action which is inconsistent with Allergan’s ownership of the Allergan Trademarks, and that upon termination or expiration of this Agreement. Where required by law, Oncogenerix all rights in the Allergan Trademarks shall submit Promotional Materials to remain the FDA (DDMAC) for review and approval. In the event that the FDA issues a letter objecting to any Promotional activities by Oncogenerix that require corrective actions (e.g. issuance property of Dear Healthcare Professional letters, recall of Promotional Materials and/or dissemination of corrected Promotional Material), Oncogenerix will bear all the cost related to these corrective activities except to the extent that any such costs are caused by changes requested by Rosemont, in which case Rosemont shall bear the costs of such corrective activitiesAllergan.

Promotional Materials. Oncogenerix (a) During the Term of this Agreement, CONCEPTUS shall provide samples of Promotional Materials to Rosemont not less than ten (10) days prior to the time of first using create or distributing co-create and develop with GYNECARE such Promotional Materials solely relating to Essure as are determined by the JMC to be necessary or appropriate under the Marketing Plan for distribution in the Territory and Territory, it being understood that the costs thereof shall obtain Rosemont’s written approval before using or distributing be included in Promotion Expenses hereunder. CONCEPTUS shall provide GYNECARE with such Promotional Material; such approval not to Materials, in amounts which the Parties jointly determine are reasonable under the terms of the Marketing Plan. CONCEPTUS shall be unreasonably delayed, conditioned or denied. Rosemont will approve responsible for complying with all regulatory requirements in the Promotional Materials within five (5) business days of receipt creation of such Promotional Materials from Oncogenerix. If Rosemont does not provide its approval and complying with any applicable government filing requirements. (b) During the Term of this Agreement, GYNECARE shall create or notice that it does not approve the co-create and develop with CONCEPTUS such Promotional Materials within solely relating to Thermachoice as are determined by the timescale JMC to be necessary or appropriate under the Marketing Plan for distribution of the Product Lines in the Territory, it being understood that the costs thereof shall be included in Promotion Expenses hereunder. GYNECARE shall provide CONCEPTUS with such Promotional Materials, in amounts which the Parties jointly determine are reasonable under the terms of the Marketing Plan. GYNECARE shall be responsible for complying with all regulatory requirements in the creation of such promotional materials and complying with any applicable government filing requirements. (c) Other than with the advice and prior written consent of CONCEPTUS, GYNECARE shall not create or develop sales, promotional or other similar materials relating to the Essure for distribution to Third Parties. (d) Other than with the advice and prior written consent of GYNECARE, CONCEPTUS shall not create or develop sales, promotional or other similar materials relating to Thermachoice for distribution to Third Parties. (e) All co-promotional materials, sales materials or other similar materials and materials using a Party’s trademarks, trade names and/or trade dress shall be reviewed by such Party’s Copy Review/Sign-Off Committee prior to release for use by the other Party. [ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately. (f) Notwithstanding anything to the contrary herein, neither Party shall be required to distribute any Promotional Materials prepared after the Effective Date which it believes in good faith are inaccurate or misleading. The Parties shall distribute Promotional Materials of the type identified in this Section 4.3, 3.7 in accordance with the Promotional Materials will be deemed to be approvedterms of this Agreement and the Marketing Plan. Oncogenerix will use Reasonable Diligence to make such amendments to the Promotional Materials Except as requested specifically permitted by Rosemont under this Section 4.3. Oncogenerix 3.7, neither Party shall distribute or have distributed any materials bearing the name of the other without the prior written approval of the other. (g) CONCEPTUS shall own all right, title and interest in and to any Promotional Materials created by Oncogenerix relating to the Licensed Products, but excluding the Licensed Trademark(s); provided that, the Promotional Materials shall be used exclusively relating solely to Essure, including all copyrights appurtenant thereto but excluding any rights in or to the GYNECARE trademark. CONCEPTUS hereby grants to GYNECARE the limited, revocable right, during the Term of this Agreement, to use Promotional Materials generated pursuant to the Marketing Plan solely in connection with the Licensed Products its promotion of Essure hereunder in accordance with the terms of this Agreement. Where required by lawAgreement and the Marketing Plan. (h) GYNECARE shall own all right, Oncogenerix shall submit title and interest in and to the Promotional Materials relating solely to Thermachoice, including all copyrights appurtenant thereto but excluding any rights in or to the FDA (DDMAC) for review and approvalCONCEPTUS trademark. In GYNECARE hereby grants to CONCEPTUS the event that limited, revocable right, during the FDA issues a letter objecting Term of this Agreement, to any Promotional activities by Oncogenerix that require corrective actions (e.g. issuance of Dear Healthcare Professional letters, recall of use Promotional Materials and/or dissemination of corrected Promotional Material), Oncogenerix will bear all the cost related to these corrective activities except generated pursuant to the extent that Marketing Plan solely in connection with its promotion of Thermachoice hereunder in accordance with the terms of this Agreement and the Marketing Plan. (i) The Parties shall jointly own all right, title and interest in and to the Promotional Materials relating to both Product Lines, including all copyrights appurtenant thereto but excluding any such costs are caused rights in or to the other Party’s trademarks, trade names and/or trade dress. [ * ] = Certain confidential information contained in this document, marked by changes requested by Rosemontbrackets, in which case Rosemont shall bear the costs of such corrective activitieshas been omitted and filed separately.

Promotional Materials. Oncogenerix (a) Licensee shall provide samples of be responsible, at its expense, for preparing and producing the then current Promotional Materials. Up to two (2) times per year Licensee shall make its core Promotional Materials to Rosemont not less than ten (10) days prior available to the time JSC (or VIVUS in the absence of first using or distributing such a JSC) for its review. The Promotional Materials used by Licensee or its Affiliates or sublicensees in a particular market in the Licensee Territory shall be consistent with the Regulatory Approval in the Licensee Territory and shall obtain Rosemont’s written approval before using or distributing such Promotional Material; such approval not to be unreasonably delayed, conditioned or deniedin any event comply in all material respects with Applicable Law. Rosemont will approve Licensee shall use and distribute the Promotional Materials within five (5) business days of receipt of such Promotional Materials from Oncogenerix. If Rosemont does not provide its approval or notice that it does not approve the Promotional Materials within the timescale in this Section 4.3, the Promotional Materials will be deemed to be approved. Oncogenerix will use Reasonable Diligence to make such amendments to the Promotional Materials as requested by Rosemont under this Section 4.3. Oncogenerix shall own all right, title and interest in and to any Promotional Materials created by Oncogenerix relating to the Licensed Products, but excluding the Licensed Trademark(s); provided that, the Promotional Materials shall be used exclusively in connection with the Licensed Products in accordance with the terms of this Agreement. Where required To the extent that VIVUS disagrees with Promotional message or tactics proposed by lawLicensee for Product in the Licensee Territory, Oncogenerix it may raise such issues with the JSC (or VIVUS in the absence of a JSC) for discussion. Licensee shall submit be solely responsible for timely submitting, as applicable, any Promotional Materials to the FDA FDA’s Office of Prescription Drug Promotion (DDMAC) for review and approval. In the event that the FDA issues a letter objecting “OPDP”), or to any Promotional activities by Oncogenerix equivalent Regulatory Authority elsewhere in the Licensee Territory (including to any applicable state governmental authorities therein). Promptly following the Effective Date, VIVUS will take such actions necessary to confirm with OPDP that require corrective actions Licensee is responsible for such submissions on behalf of VIVUS. (e.g. issuance b) Licensee shall not use or distribute in connection with Promotion of Dear Healthcare Professional letters, recall of the Product any materials bearing VIVUS’ name or trademarks without VIVUS’ prior written approval. (c) All Promotional Materials and/or dissemination of corrected Promotional Material)used or intended for use in the United States shall include MTPC’s name in a form that references MTPC as the licensor, Oncogenerix will bear all the cost related to these corrective activities except to the extent that permitted by Applicable Law and is customary for such materials in the United States. Licensee shall directly provide MTPC with copies of all such Promotional Materials used or intended for use in the United States as soon as reasonably practicable after such Promotional Materials are first used. For all other countries (except for the United States) in the Licensee Territory, Licensee shall, on a country-by-country basis, first request and obtain written confirmation from VIVUS as to whether (and how) the Promotional Materials used or intended for use in each such country shall include MTPC’s name, before using any such costs are caused by changes requested by Rosemont, Promotional Materials in which case Rosemont shall bear the costs of such corrective activitiescountry.

Promotional Materials. Oncogenerix The Parties and their Affiliates shall provide samples only use JOC approved Promotional Materials and only conduct marketing and promotional activities for the IL-1 Products which, in each case, are provided for in the relevant approved Country Co-Commercialization Plan. The Parties will jointly prepare Promotional Materials for the IL-1 Products which are intended for use within the Co-Commercialization Countries. Novartis will have primary responsibility, with Regeneron's participation, for the preparation of Promotional Materials to Rosemont not less than ten (10) days prior to the time of first using or distributing intended for use in a Co-Commercialization Country, and shall ensure that all such Promotional Materials are consistent with the approved Consolidated Co-Commercialization Plan and Country Co-Commercialization Plan, and comply with all applicable Laws. Novartis shall be responsible for the distribution of Promotional Materials for use in the Territory Co-Commercialization Country, shall ensure that Regeneron's local Affiliates have equal access to all Promotional Materials for use in the Co-Commercialization Country, and shall obtain Rosemont’s written approval before using or distributing such Promotional Material; such approval not to be unreasonably delayed, conditioned or denied. Rosemont will approve the Promotional Materials within five (5) business days treat its own Affiliates and those of receipt of such Promotional Materials from Oncogenerix. If Rosemont does not provide its approval or notice that it does not approve the Promotional Materials within the timescale in this Section 4.3, the Promotional Materials will be deemed to be approved. Oncogenerix will use Reasonable Diligence to make such amendments to the Promotional Materials as requested by Rosemont under this Section 4.3. Oncogenerix shall own all right, title and interest in and to any Promotional Materials created by Oncogenerix relating to the Licensed Products, but excluding the Licensed Trademark(s); provided that, the Promotional Materials shall be used exclusively Regeneron equally in connection with the Licensed Products distribution of Promotional Materials in accordance with the terms of this Agreementapproved Country Co-Commercialization Plan. Where required by law, Oncogenerix shall submit Promotional Materials which constitute Detail handouts for distribution to Professionals shall be allotted according to each Party's (or its local Affiliate's) Detail requirements under the approved Country Co-Commercialization Plan. Promotional Materials for use in Detail presentations and retained by the Qualified Sales Representatives shall be allotted according to the FDA number of Qualified Sales Representatives to be engaged by each Party (DDMACor their respective local Affiliates) under the approved Country Co-Commercialization Plan for review and approvalthe relevant country. In the event that the FDA issues a letter objecting The Parties shall jointly own all rights to any all Promotional activities by Oncogenerix that require corrective actions (e.g. issuance of Dear Healthcare Professional lettersMaterials, recall of including all copyrights thereto. All locally generated Promotional Materials and/or dissemination of corrected Promotional Material)for a Co-Commercialization Country shall be maintained in confidence and shall not be disclosed or distributed to Third Parties, Oncogenerix will bear all until such time as they have been reviewed and approved under a core review process to be established by the cost related to these corrective activities except to the extent that any such costs are caused by changes requested by Rosemont, in which case Rosemont shall bear the costs of such corrective activitiesJoint Operating Committee.

Promotional Materials. Oncogenerix shall provide samples of All written sales, promotion and advertising materials relating to Ivory (collectively “Promotional Materials”) (including translations) will be produced by Amgen in accordance with the Brand Plan developed by the JBT and reviewed and approved by the JSC. Any Promotional Materials will include, if permitted by Applicable Law, the Amgen Housemarks and the GSK Housemarks (provided, however, that Amgen will be entitled a reasonable transition period after any required legal approval is obtained to Rosemont design, order, receive and implement Promotional Materials revised to include the GSK Housemarks). Materials that include the GSK Housemarks will use such GSK Housemarks in accordance with any reasonable usage guidelines provided by GSK, and any usage not less than conforming with such guidelines will require GSK’s prior approval as to the use of such GSK Housemarks. GSK will respond to any such requests for approval within ten (10) days prior to business days. In the time of first using or distributing such Promotional Materials in the Territory and shall obtain Rosemont’s written approval before using or distributing such Promotional Material; such approval not to be unreasonably delayed, conditioned or denied. Rosemont will approve the Promotional Materials within five (5) business days of receipt absence of such Promotional Materials from Oncogenerix. If Rosemont does not provide its approval or notice that it does not approve the Promotional Materials response within the timescale in this Section 4.3such period, the Promotional Materials request will be deemed to be approved. Oncogenerix Unless otherwise determined by the JSC, Amgen will use Reasonable Diligence be responsible for the printing and delivery to make such amendments to the GSK of Promotional Materials for use in GSK’s Detailing obligations hereunder, and costs therefor will be included as requested Amgen Costs for purposes of Collaboration Profit (Loss). Other than GSK’s use and distribution of Promotional Materials that are approved by Rosemont under this Section 4.3the JSC and used and distributed in connection with GSK’s Detailing of Ivory within the Collaboration Scope, GSK will not produce or modify (other than as concepts for consideration by Amgen), or distribute or otherwise use any promotional or communications material relating to Ivory. Oncogenerix shall If so instructed by Amgen, GSK will immediately cease to use any Promotional Materials and will collect and destroy any such materials from its sales representatives (and record and document such collection and destruction (and provide a copy of such documentation to Amgen upon request)). Amgen will own all right, title and interest in and to any and all Promotional Materials created by Oncogenerix relating to the Licensed Products, but excluding the Licensed Trademark(s); provided that, the Promotional Materials shall be used exclusively in connection including applicable Copyrights and trademarks (except with the Licensed Products in accordance with the terms of this Agreement. Where required by law, Oncogenerix shall submit Promotional Materials to the FDA (DDMAC) for review and approval. In the event that the FDA issues a letter objecting respect to any GSK Housemarks included in any Promotional activities by Oncogenerix that require corrective actions (e.g. issuance of Dear Healthcare Professional letters, recall of Promotional Materials and/or dissemination of corrected Promotional MaterialMaterials), Oncogenerix and GSK will bear execute all the cost related to these corrective activities except to the extent that any such costs documents and take all actions as are caused by changes reasonably requested by RosemontAmgen to vest title to such Promotional Materials, Copyrights and trademarks in which case Rosemont shall bear the costs of such corrective activitiesAmgen.

Promotional Materials. Oncogenerix shall provide samples (a) Bayer will be responsible, consistent with the guidelines agreed upon by the JSC, for the creation, preparation, production and reproduction of all Promotional Materials and for filing, as appropriate, all Promotional Materials with all Regulatory Authorities in the Bayer Territory. Upon request, Nuvelo will have the right to Rosemont not less than review and comment on all major Promotional Materials for use in a Major Country, Canada or Japan prior to their distribution by Bayer for use in such Major Country, Canada or Japan, as applicable. Nuvelo will be responsible, consistent with the guidelines agreed upon by the JSC, for the creation, preparation, production and reproduction of all Promotional Materials and for filing, as appropriate, all Promotional Materials with all Regulatory Authorities in the Nuvelo Territory. Upon request, Bayer will have the right to review and comment on all major Promotional Materials prior to their distribution by Nuvelo. (b) Each Party shall use its own corporate name and/or logo on Promotional Materials and Licensed Product labels in connection with Commercialization of Licensed Product in such Party’s portion of the Territory, unless otherwise mutually agreed by the Parties. (c) In order to maintain the value of each Party’s Product Trademarks and each Party’s corporate name and logo, when using the other Party’s Product Trademarks, corporate name or logo, each Party will maintain the reasonable quality standards as it maintains for its own corporate name and/or logo and will comply with the other Party’s then-current policies regarding use of its Product Trademarks, corporate name and logo. Prior to a Party’s use thereof in the United States, a Major Country, Canada or Japan, such Party will provide to the other Party a prototype of any Promotional Materials or product labeling for use in the United States, a Major Country, Canada or Japan which contains the other Party’s Product Trademarks, corporate name or logo, so that the other Party may review the manner in which they are used therein. Within ten (10) business days prior to after delivery of such prototype, the time other Party will notify such Party whether the other Party approves or disapproves of first using or distributing such the manner of use and, in the case of disapproval, the specific reasons therefor and an acceptable alternative. All Promotional Materials used in the Bayer Territory and shall obtain Rosemont’s written approval before using or distributing such Promotional Material; such approval not to be unreasonably delayed, conditioned or denied. Rosemont will approve the Promotional Materials within five (5) business days of receipt of such Promotional Materials state that Licensed Product is sold under license from Oncogenerix. If Rosemont does not provide its approval or notice that it does not approve the Promotional Materials within the timescale in this Section 4.3, the Promotional Materials will be deemed to be approved. Oncogenerix will use Reasonable Diligence to make such amendments to the Promotional Materials as requested by Rosemont under this Section 4.3. Oncogenerix shall own all right, title and interest in and to any Promotional Materials created by Oncogenerix relating to the Licensed Products, but excluding the Licensed Trademark(s); provided that, the Promotional Materials shall be used exclusively in connection with the Licensed Products in accordance with the terms of this Agreement. Where required by law, Oncogenerix shall submit Promotional Materials to the FDA (DDMAC) for review and approval. In the event that the FDA issues a letter objecting to any Promotional activities by Oncogenerix that require corrective actions (e.g. issuance of Dear Healthcare Professional letters, recall of Promotional Materials and/or dissemination of corrected Promotional Material), Oncogenerix will bear all the cost related to these corrective activities except to the extent that any such costs are caused by changes requested by Rosemont, in which case Rosemont shall bear the costs of such corrective activitiesNuvelo.

Promotional Materials. Oncogenerix shall provide samples Except as set forth in the Co-Promotion Agreement: (a) Each Party will be responsible, consistent with the guidelines agreed upon by the Parties (if any), for the creation, preparation, production and reproduction of all Promotional Materials and for filing, as appropriate, all Promotional Materials with all Regulatory Authorities in such Party’s portion of the Territory. (b) Each Party shall use its own corporate name and/or logo on Promotional Materials and Licensed Product labels in connection with Commercialization of Licensed Product in such Party’s portion of the Territory, and shall not use the other Party’s corporate name or logo unless agreed upon by the other Party. (c) In order to Rosemont maintain the value of each Party’s Product Trademarks and each Party’s corporate name and logo, when using the other Party’s Product Trademarks, corporate name or logo (if agreed upon by the other Party), each Party will maintain quality standards comparable to those it maintains for its own Product Trademarks, corporate name or logo, which, in any event, shall not be less than ten (10) days prior reasonable, and each Party will use the other Party’s Product Trademarks consistent with Product Trademark usage guidelines agreed upon by the Parties, if any. Prior to a Party’s first use in its portion of the Territory of any Promotional Materials or product labeling that contains the other Party’s Product Trademarks, corporate name or logo, such first Party will provide to the time of first using or distributing such Promotional Materials in the Territory and shall obtain Rosemont’s written approval before using or distributing such Promotional Material; such approval not to be unreasonably delayed, conditioned or denied. Rosemont will approve the Promotional Materials within five (5) business days of receipt other Party a prototype of such Promotional Materials from Oncogenerixso that the other Party may approve or disapprove the use of the other Party’s Product Trademarks, corporate name or logo or the manner in which they are used therein. If Rosemont does not provide its approval or notice that it does not approve the Promotional Materials within the timescale in this Section 4.3Within [ * ] after delivery of such prototype, the Promotional Materials other Party will be deemed to be approved. Oncogenerix will notify such Party whether the other Party approves or disapproves of the use Reasonable Diligence to make such amendments to or manner of use of the Promotional Materials as requested by Rosemont under this Section 4.3. Oncogenerix shall own all rightother Party’s Product Trademarks, title and interest corporate name or logo and, in and to any Promotional Materials created by Oncogenerix relating to the Licensed Products, but excluding the Licensed Trademark(s); provided thatcase of disapproval, the Promotional Materials reasons therefor and an acceptable alternative, if any. After the other Party approves such prototype or labeling, the first Party shall be used exclusively in connection with the Licensed Products in accordance with the terms of this Agreement. Where required by law, Oncogenerix shall submit have no obligation to provide such Promotional Materials to the FDA (DDMAC) other Party for review and approval. In except in the event that the FDA issues a letter objecting first Party makes material modifications to any such Promotional activities by Oncogenerix that require corrective actions (e.g. issuance of Dear Healthcare Professional letters, recall of Materials. All Promotional Materials and/or dissemination of corrected Promotional Material)used in the Bayer Territory will state that Licensed Product is sold and, Oncogenerix will bear all the cost related to these corrective activities except to the extent that any such costs are caused by changes requested by Rosemontif applicable, in which case Rosemont shall bear the costs of such corrective activitiesmanufactured under license from ZGEN.

Promotional Materials. Oncogenerix 2.1 The Parties shall provide samples of Promotional Materials liaise with each other on a regular basis during the Term to Rosemont not less than ten (10) days prior discuss and seek to agree and co-ordinate in advance the time of first using strategies or distributing such Promotional Materials in the Territory and shall obtain Rosemont’s written approval before using or distributing such Promotional Material; such approval not plans to be unreasonably delayed, conditioned applied in relation to any marketing or deniedpromotion of the Services which is intended to feature DB or include any Promotional Materials. Rosemont will approve The Parties shall then discuss in good faith the Promotional Materials within five (5) business days of receipt development and creation of such Promotional Materials from Oncogenerix. If Rosemont does not provide its approval and the most effective way of using DBs time and services in relation thereto. 2.2 Before commencing or notice that it does not approve authorizing third parties to commence the manufacture, production, distribution or publication of any Promotional Materials, the Company must send such Promotional Materials within to Provider for approval together with details of the timescale in this Section 4.3, the channels such Promotional Materials will be deemed used in or through. Any production or use of such Promotional Materials shall be subject to the written approval (which may be provided via email) of Provider. Where Provider gives it written approval to any Promotional Materials in accordance with this Clause such Promotional Materials may be used by the Company during the Term only. Any such Promotional Materials or other items that require the approval of Provider under this Agreement shall initially be submitted by the Company to Provider at the following email address (or such other email address as Provider may from time to time specify for this purpose): xxxx@xxxxxxxxxxxx.xxx. 2.3 The Company acknowledges and agrees that it shall procure that: (a) any Promotional Materials shall be of a high quality and produced to a first class standard consistent with the prestige and reputation of DB and shall comply with all applicable laws and shall not contain any images, text or other materials that are indecent or are likely to offend public morals or otherwise damage the reputation or goodwill of Provider or DB; (b) it shall provide advice and guidance to Provider regarding any applicable laws, regulations, industry standards or codes of practice (including any standards, codes of practice or regulations published by a relevant government authority in a jurisdiction in the Company or any its subsidiaries operates) which may apply to any Social Media Posts or other public statements Provider or DB may make or be required to make pursuant to this Agreement and the Company agrees that it shall arrange for any such posts or statements and all Promotional Materials to be approved. Oncogenerix checked before they are produced or made publicly available in order to ensure that they are compliant with any such applicable laws. 2.4 Provider acknowledges and agrees that Company will use Reasonable Diligence to make such amendments to the Promotional Materials as requested by Rosemont under this Section 4.3. Oncogenerix shall own all right, title title, and interest in and to any Promotional Materials created by Oncogenerix and all advertising, marketing, and promotional materials or content relating to the Licensed Products, but excluding the Licensed Trademark(s); provided thatServices which are produced pursuant to this Agreement (together, the “Promotional Materials shall be used exclusively in connection with the Licensed Products in accordance with the terms of this Agreement. Where required by law, Oncogenerix shall submit Promotional Materials to the FDA (DDMAC) for review and approval. In the event that the FDA issues a letter objecting to any Promotional activities by Oncogenerix that require corrective actions (e.g. issuance of Dear Healthcare Professional letters, recall of Promotional Materials and/or dissemination of corrected Promotional MaterialMaterials”), Oncogenerix will bear all the cost related to these corrective activities except to the extent that any such costs are caused materials contain any intellectual property owned by changes requested DB, Provider or any entity affiliated with Provider (including, without limitation, any rights in respect of DB’s name, image, likeness or other personal attributes). Notwithstanding the forgoing, Company acknowledges that it shall have no right, title or interest in or to any entertainment content into which Provider elects to include Company promotional material. 2.5 Save for the mutually agreed press release referred to in Clause 1.1(g) and save to the extent required by Rosemontany applicable law, in which case Rosemont neither Party shall bear without the costs prior approval of such corrective activitiesthe other Party directly or indirectly make or cause to be made any press release or public announcement relating to this Agreement or the relationship between the Parties or any related matter.

Promotional Materials. Oncogenerix (a) AstraZeneca, at its expense, shall produce and provide to MDCO (at a single point of delivery in the Territory designated by MDCO) all Promotional Materials. AstraZeneca shall, in its sole discretion, determine the form and content of such Promotional Materials, including the messaging with respect to the Product. AstraZeneca warrants and represents that all Promotional Materials, including such messaging, is and shall be in compliance with all Applicable Laws at the time they are provided by AstraZeneca to MDCO. AstraZeneca shall promptly notify MDCO if at any time AstraZeneca determines, or if at any time AstraZeneca receives written notice from OPDP that it has made a final determination, that any Promotional Materials, including such messaging, are not in compliance with Applicable Laws. (b) AstraZeneca shall provide samples MDCO the amount and type of Promotional Materials to Rosemont not less than ten (10) days prior determined by AstraZeneca at the times determined by AstraZeneca. MDCO's storage of Promotional Materials and distribution thereof to the time members of first the Sales Force shall be at MDCO's expense. (c) MDCO shall determine the method and means of using the Promotional Materials, subject to compliance with Applicable Law and the MDCO Policies. In performing Details, MDCO shall use only Promotional Materials provided by AstraZeneca and the Product Labels and Inserts. MDCO shall promptly cease the use of any Promotional Materials when instructed by AstraZeneca in writing to do so. MDCO shall use the Promotional Materials only for the purposes contemplated by this Agreement. Upon termination or distributing expiration of this Agreement, at AstraZeneca's election and expense, MDCO either shall (i) return to AstraZeneca or (ii) destroy and certify to AstraZeneca such destruction, all Promotional Materials not distributed to Target Hospital Personnel and in the possession of, or under the control of, MDCO. MDCO shall not change the Promotional Materials in any way (including by (A) underlining or otherwise highlighting any text or graphics, (B) adding any notes thereto or (C) using any electronic materials (e.g., PDFs) on any electronic devices other than the specific electronic devices on which, and in the specific format as, AstraZeneca indicates such electronic material are intended for use). (d) If any Promotional Materials provided to MDCO by AstraZeneca are lost or destroyed while in the possession of MDCO, MDCO shall promptly notify AstraZeneca of such loss or destruction and AstraZeneca may, in AstraZeneca's sole discretion and at MDCO's sole expense, replace some or all of such lost or destroyed Promotional Materials. (e) To the extent any Promotional Materials are required by Applicable Law to be submitted to the FDA, AstraZeneca shall make such submissions, and AstraZeneca shall be the FDA liaison for both Parties on all marketing, advertising, Promotional and Detailing matters for the Product. (f) If any Promotional Materials provided to MDCO by AstraZeneca need to be withdrawn from use for any reason, AstraZeneca shall promptly notify MDCO of such withdrawal and MDCO shall cooperate with AstraZeneca in effectuating any such withdrawal. AstraZeneca shall reimburse MDCO for any reasonable and documented out-of-pocket costs incurred by MDCO in connection with conducting such withdrawal, except to the extent such withdrawal is attributable to (i) the breach of this Agreement by MDCO or (ii) the negligence or intentional misconduct of MDCO, in which event MDCO shall (A) bear its own costs in connection with taking such actions and (B) reimburse AstraZeneca for any reasonable and documented out-of-pocket costs incurred by AstraZeneca in connection with conducting such withdrawal, in each case ((A) and (B)) to the extent that such withdrawal is attributable to such breach, negligence or intentional misconduct. (g) Notwithstanding anything herein to the contrary, MDCO shall not be required to use any Promotional Materials provided by AstraZeneca if MDCO reasonably and in good faith believes that the use of such Promotional Materials in the Territory Promotion of the Product would violate Applicable Law or the MDCO Policies, provided, that MDCO promptly shall notify AstraZeneca of such belief and the Parties shall obtain Rosemont’s written approval before using or distributing promptly engage in good faith discussions to attempt to resolve such Promotional Materialsituation; such approval not to be unreasonably delayedprovided, conditioned or denied. Rosemont will approve further, that MDCO acknowledges and agrees that it shall use the Promotional Materials within five (5) business days identified on Exhibit G in the Promotion of receipt of such Promotional Materials from Oncogenerix. If Rosemont does not provide its approval or notice that it does not approve the Promotional Materials within the timescale in this Section 4.3, the Promotional Materials will be deemed to be approved. Oncogenerix will use Reasonable Diligence to make such amendments to the Promotional Materials as requested by Rosemont under this Section 4.3. Oncogenerix shall own all right, title and interest in and to any Promotional Materials created by Oncogenerix relating to the Licensed Products, but excluding the Licensed Trademark(s); provided that, the Promotional Materials shall be used exclusively in connection with the Licensed Products in accordance with the terms of this Agreement. Where required by law, Oncogenerix shall submit Promotional Materials to the FDA (DDMAC) for review and approval. In the event that the FDA issues a letter objecting to any Promotional activities by Oncogenerix that require corrective actions (e.g. issuance of Dear Healthcare Professional letters, recall of Promotional Materials and/or dissemination of corrected Promotional Material), Oncogenerix will bear all the cost related to these corrective activities except to the extent that any such costs are caused by changes requested by Rosemont, in which case Rosemont shall bear the costs of such corrective activitiesProduct.

Promotional Materials. Oncogenerix Host and Producer shall provide samples cooperate with each other in the promotion of Promotional Materials the Pageant. Host shall have the non-exclusive right to Rosemont use the Producer Marks (as defined in Paragraph 3 of the Standard Terms and Conditions attached hereto as Appendix II) in advertising, publicity, promotional and marketing materials in any and all media, during the Term of this Agreement, for purposes only of promoting the Pageant and CITY OF DORAL as the site of the Pageant (but not less than ten as an endorsement of any product or service). In this regard, Host shall have the non-exclusive right to manufacture and use commemorative items (10i.e., t-shirts etc.) days with Producer’s logo at the CITY OF DORAL during the Term of this Agreement in connection with its advertising and promotion of the Pageant, provided that such items also bear Host’s trademarks, and to place non-permanent replicas of Producer’s logo on such items at the CITY OF DORAL during the Term of this Agreement in connection with its advertising and promotion of the Pageant, provided that such items also bear Host’s trademarks. All such materials shall be subject to Producer’s prior written approval and to the time terms and conditions set forth in Paragraph 3 of first using the Standard Terms and Conditions attached hereto as Appendix I; it being expressly agreed that Producer shall have the right to approve any preprinted promotional material, audio or distributing such Promotional Materials in video materials, or the Territory and shall obtain Rosemont’s written approval before using like produced by Host or distributing such Promotional Material; such approval not sought to be unreasonably delayed, conditioned or denied. Rosemont will approve the Promotional Materials within five (5) business days of receipt of such Promotional Materials from Oncogenerix. If Rosemont does not provide its approval or notice that it does not approve the Promotional Materials within the timescale in this Section 4.3, the Promotional Materials will be deemed to be approved. Oncogenerix will use Reasonable Diligence to make such amendments to the Promotional Materials as requested by Rosemont under this Section 4.3. Oncogenerix shall own all right, title and interest in and to any Promotional Materials created by Oncogenerix relating to the Licensed Products, but excluding the Licensed Trademark(s); provided that, the Promotional Materials shall be used exclusively in connection with the Licensed Products Pageant. If Host manufactures or causes to be manufactured any commemorative items, Host represents and warrants that such items shall be free from defects and merchantable and fit for their particular purpose. Producer shall have the right to use the Host Marks (as defined in accordance Paragraph 3 of the Standard Terms and Conditions attached hereto as Appendix I) in advertising, publicity, promotional, souvenir pageant merchandising and marketing materials in any and all media, throughout the world in perpetuity, for purposes of promoting the Pageant, any future Miss Universe Pageants and Universe’s pageant-related business activities. Host shall have the right to retain 75% of gross revenues (the remaining 25% to Producer) in connection with the terms sale of this Agreement. Where required by law, Oncogenerix shall submit Promotional Materials to the FDA (DDMAC) for review and approval. In the event that the FDA issues a letter objecting to any Promotional activities by Oncogenerix that require corrective actions (e.g. issuance of Dear Healthcare Professional letters, recall of Promotional Materials and/or dissemination of corrected Promotional Material), Oncogenerix will bear all the cost related to these corrective activities except to the extent that any such costs are caused by changes requested by Rosemontitems discussed herein. Host must notify producer no later than November 1, in 2014 of its intention to manufacture any such items, the approval of which case Rosemont shall bear be at the costs sole discretion of such corrective activitiesProducer.

Promotional Materials. Oncogenerix (a) Licensee shall provide samples be responsible for the preparation of Promotional Materials to Rosemont not less than ten (10) days prior marketing, advertising and promotional core materials, training manuals and educational materials for Collaboration Product for use in the Licensed Territory, in accordance with the Commercialization Plan and Budget for such Collaboration Product. Such manuals and materials shall be consistent with the Parties’ internal policies and procedures and applicable Law. Except with respect to the time of first using or distributing such Promotional Materials in the Territory and shall obtain Rosemont’s written approval before using or distributing such Promotional Material; such approval not to be unreasonably delayedProduct Trademarks, conditioned or denied. Rosemont will approve the Promotional Materials within five (5) business days of receipt of such Promotional Materials from Oncogenerix. If Rosemont does not provide its approval or notice that it does not approve the Promotional Materials within the timescale in this Section 4.3, the Promotional Materials will be deemed to be approved. Oncogenerix will use Reasonable Diligence to make such amendments to the Promotional Materials as requested by Rosemont under this Section 4.3. Oncogenerix Licensee shall own all right, title and interest in and to all such manuals and materials and intellectual property rights therein. Licensee shall provide core promotional materials and manuals, as determined by the JCC, to Seres reasonably in advance of finalization thereof by Licensee, its Affiliates and Sublicensees, so that Seres has a reasonable period of time to review and provide comments thereon for consideration. Licensee shall consider in good faith any Promotional Materials created reasonable comments thereon provided by Oncogenerix relating Seres. Licensee shall be responsible for any submissions to the Licensed Productsapplicable Regulatory Authorities of marketing, but excluding the Licensed Trademark(s); provided that, the Promotional Materials advertising or promotional materials that may be required under applicable Law and communications with such Regulatory Authorities in connection therewith. Seres shall be used exclusively provide to Licensee such assistance as Licensee may reasonably request in connection with such submissions and communications. (b) All materials and other information used in connection with Commercialization activities in the Licensed Territory, including Collaboration Product labeling, package inserts and informational materials distributed for use in promoting Collaboration Products, oral presentations, direct-to-consumer advertising, patient information materials and patient benefit programs, that identify a Party in connection with a Collaboration Product, shall 41 display the Seres and Licensee Corporate Names with equal prominence, and shall identify both Parties as jointly promoting the Collaboration Product, in each case to the extent permitted by applicable Law. (c) Each Party shall, and shall cause its Sales Representatives and other personnel performing Commercialization activities for Collaboration Products to, (i) use and distribute only the materials prepared in accordance with Section 5.6(a); and (ii) not modify, alter, amend, adjust or mask any portion of such materials in any way. Each Party will promptly notify the terms of this Agreement. Where required by law, Oncogenerix shall submit Promotional Materials to the FDA (DDMAC) for review other Party and approval. In take all necessary corrective action in the event that the FDA issues a letter objecting to any Promotional activities by Oncogenerix that require corrective actions (e.g. issuance of Dear Healthcare Professional letters, recall of Promotional Materials and/or dissemination of corrected Promotional Material), Oncogenerix will bear all the cost related to these corrective activities except to the extent such Party learns that any such costs are caused modification, alteration, amendment, adjustment or masking, or any such use or distribution of unapproved marketing materials for Collaboration Products has taken place by changes requested by Rosemont, in which case Rosemont shall bear the costs of such corrective activitiesit or its Sales Representatives.

Promotional Materials. Oncogenerix (a) The “Initial Promotional Materials” are those certain promotional materials described in Exhibit N. AstraZeneca shall provide samples of use Commercially Diligent Efforts to []*, in each case as promptly as practicable after the Effective Date. (b) In addition to the Initial Promotional Materials, AstraZeneca, []*, shall be responsible for developing and producing Promotional Materials to Rosemont not less than ten (10) days prior hereunder []*, as and to the extent set forth herein. []*. Subject only to Section 3.9(e), Cubist shall use the Promotional Materials in connection with the Promotion of the Product until such time as such Promotional *Confidential Treatment Requested. Omitted portions filed separately with the Commission. Materials expire or AstraZeneca directs in writing to Cubist that such Promotional Materials shall no longer be used. []*. (For clarity, (A) AstraZeneca’s obligation set forth in the immediately preceding sentence constitutes AstraZeneca’s sole obligation to []* Promotional Materials, and (B) without limitation of first using or distributing AstraZeneca’s foregoing obligation []*, AstraZeneca shall have the right to direct Cubist to no longer use any given Promotional Materials.) AstraZeneca shall, in its sole discretion (but in compliance with Applicable Law), determine the content of such Promotional Materials, including the messaging with respect to the Product, []*; provided that AstraZeneca shall include the Cubist Trademarks in such Promotional Materials in a form and manner to be mutually agreed upon by the Territory and shall obtain Rosemont’s written approval before using or distributing parties (such Promotional Material; such approval agreement not to be unreasonably delayedwithheld, conditioned or denied. Rosemont will approve the Promotional Materials within five (5) business days of receipt of such Promotional Materials from Oncogenerix. If Rosemont does not provide its approval or notice that it does not approve the Promotional Materials within the timescale in this Section 4.3, the Promotional Materials will be deemed to be approved. Oncogenerix will use Reasonable Diligence to make such amendments to the Promotional Materials as requested by Rosemont under this Section 4.3. Oncogenerix shall own all right, title and interest in and to any Promotional Materials created by Oncogenerix relating to the Licensed Products, but excluding the Licensed Trademark(sdelayed); provided that, the Promotional Materials shall be used exclusively in connection with the Licensed Products in accordance with the terms of this Agreement. Where required by law, Oncogenerix shall submit Promotional Materials to the FDA (DDMAC) for review and approval. In the event that Cubist desires AstraZeneca to develop and produce Promotional Materials in addition to the FDA issues Promotional Materials previously provided to Cubist by AstraZeneca, Cubist may propose such additional Promotional Materials to AstraZeneca’s Alliance Manager for consideration by AstraZeneca; provided that, without limitation of Cubist’s rights under Section 3.5(k), AstraZeneca shall have the sole right to determine whether to develop or produce such Promotional Materials. (c) All Promotional Materials, whether provided by AstraZeneca or its Affiliates or printed by Cubist, shall be the property of AstraZeneca. (d) Cubist shall be responsible, at its expense, for (i) the storage of all Promotional Materials received from AstraZeneca or printed by Cubist hereunder, and (ii) the distribution of all Promotional Materials to the Representatives. (e) AstraZeneca shall be solely liable and responsible for the content of all Promotional Materials (excluding any Cubist Trademark) and for ensuring that such Promotional Materials comply with Applicable Law, []* (to the extent consistent with Applicable Law and this Agreement) and the requirements of this Agreement. []* provided that, at a letter objecting minimum, AstraZeneca shall review any given Promotional Material within []* from the date on which AstraZeneca last reviewed such Promotional Material. AstraZeneca shall notify Cubist in writing of any materials that have been approved by AstraZeneca for use as Promotional Materials and that such materials have been so approved, promptly following such approval. (f) Cubist shall determine []* the Promotional Materials, subject to compliance with Applicable Law with respect to the use of such Promotional Materials in connection with the Product, the terms of this Agreement and the Business Policies (to the extent consistent with Applicable Law and this Agreement). Cubist shall immediately cease the use of any Promotional activities Materials (i) when instructed to do so by Oncogenerix that require corrective actions AstraZeneca or (e.g. issuance ii) as of Dear Healthcare Professional letters, recall the expiration date of such Promotional Materials and/or dissemination (as such expiration date is provided to Cubist by AstraZeneca). Cubist shall use the Promotional Materials only for the purposes contemplated by this Agreement and only in connection with the Promotion of corrected the Product. (g) Without limiting any of AstraZeneca’s obligations under this Agreement, Cubist may reproduce any Promotional MaterialMaterials that have not expired in connection with its Promotion of the Product under this Agreement; provided that such reproduction is (i) in the same form, and of the same nature and quality, as the original Promotional Materials, or (ii) done in a manner agreed by AstraZeneca in writing (provided that *Confidential Treatment Requested. Omitted portions filed separately with the Commission. if AstraZeneca’s Alliance Manager receives a written request from Cubist, AstraZeneca shall notify Cubist in writing within ten (10) business days after AstraZeneca’s Alliance Manager receives such request as to whether or not AstraZeneca approves the proposed reproduction and if AstraZeneca does not respond within such ten (10) business day period, then AstraZeneca shall be deemed to have approved such reproduction). Cubist shall not change or otherwise alter the Promotional Materials in any way (including by underlining or otherwise highlighting any text or graphics or adding any notes thereto). AstraZeneca hereby grants Cubist a non-exclusive, Oncogenerix will bear royalty-free license under all copyrights owned or controlled by AstraZeneca or its Affiliates that cover the cost related Promotional Materials and all other materials provided by AstraZeneca or its Affiliates to these corrective activities except Cubist in connection with the Product solely for the purpose of copying, displaying and distributing such Promotional Materials or other materials, to the extent that such copying, displaying and distributing is permitted hereunder, for the purpose of satisfying Cubist’s obligations hereunder, which license shall automatically and immediately terminate upon the expiration or earlier termination of this Agreement for any reason and shall be non-transferable (except through a permitted assignment of this Agreement) and non-sublicensable. (h) If any member of the Sales Force leaves the Sales Force, Cubist shall use reasonable efforts to retrieve from such Person, or have destroyed, all Promotional Materials in his or her possession and for any Promotional Materials retrieved from such departing member of the Sales Force that have not yet expired, Cubist shall provide such Promotional Materials to another member of the Sales Force. (i) Notwithstanding anything in this Section 3.5 to the contrary, AstraZeneca shall have the sole right and responsibility []* to develop, produce and provide to Cubist reminder items with respect to the Product (and AstraZeneca shall ensure that such reminder items comply with Applicable Law, []* (to the extent consistent with Applicable Law and this Agreement) and the requirements of this Agreement), for distribution to Target Prescribers in quantities that are determined by AstraZeneca in its sole discretion. (j) Cubist shall not use any written, printed, electronic or graphic material to Promote the Product during a Detail other than (i) the Product Labels and Inserts, (ii) Promotional Materials (including reminder items) (as provided by AstraZeneca or its Affiliates, or, if applicable, reproduced by Cubist) or (iii) other materials approved by AstraZeneca in writing for use in Details (provided that if Cubist submits any such costs are caused materials to AstraZeneca’s Alliance Manager for AstraZeneca’s review and approval, AstraZeneca shall notify Cubist in writing within ten (10) business days after AstraZeneca’s Alliance Manager receives such submission as to whether or not AstraZeneca approves such materials and if AstraZeneca does not respond within such ten (10) business day period, then AstraZeneca shall be deemed to have approved such materials). The parties acknowledge and agree that any such materials shall be subject to review and approval through the AZAP Review Team []*. (k) If Cubist plans to conduct any Promotion activity with respect to the Product in the Territory other than Detailing and Cubist Speaker Programs (e.g., an exhibit at a tradeshow or similar Promotional or scientific event), Cubist may do so if AstraZeneca approves such activity in writing (provided that if Cubist submits any such proposed activity to AstraZeneca’s Alliance Manager for AstraZeneca’s review and approval, AstraZeneca shall *Confidential Treatment Requested. Omitted portions filed separately with the Commission. notify Cubist in writing within ten (10) business days after AstraZeneca’s Alliance Manager receives such submission as to whether or not AstraZeneca approves such activity and if AstraZeneca does not respond within such ten (10) business day period, then AstraZeneca shall be deemed to have approved such activity). In connection with any such activity, Cubist shall not use any written, printed, electronic or graphic material to Promote the Product during such activity other than (i) the Product Labels and Inserts, (ii) Promotional Materials (including reminder items) (as provided by changes requested AstraZeneca or its Affiliates, or, if applicable, reproduced by RosemontCubist) or (iii) other materials approved by AstraZeneca in writing for use in conducting such activity (provided that if Cubist submits any such materials to AstraZeneca’s Alliance Manager for AstraZeneca’s review and approval, AstraZeneca shall notify Cubist in writing within ten (10) business days after AstraZeneca’s Alliance Manager receives such submission as to whether or not AstraZeneca approves such materials and if AstraZeneca does not respond within such ten (10) business day period, then AstraZeneca shall be deemed to have approved such materials). The parties acknowledge and agree that any such materials shall be subject to review and approval through the AZAP Review Team []*. (l) Cubist shall not distribute any Product reminder items after December 31, 2008, and shall destroy any Product reminder items in Cubist’s possession that have not been distributed, on or prior to December 31, 2008, in which case Rosemont accordance with this Agreement, provided that Cubist shall bear not be required to destroy de minimis quantities of reminder items in the costs possession of such corrective activitiesits employees that are retained for personal or internal use.

Promotional Materials. Oncogenerix ENDO shall provide samples be responsible for developing and disseminating all promotional, advertising, communication and educational materials relating to the Commercialization of the Licensed Products hereunder (collectively, “Promotional Materials”). All Promotional Materials shall comply with Applicable Law and must comply with the Product Trademark, Product Brand Equity and NCH’s Voltaren® gel style and branding guidelines that were sent to Rosemont not less than ten (10) days prior ENDO by NCH on March 4, 2008. As between the NOVARTIS Parties and ENDO, but subject to the time of first using or distributing Section 2.4, ENDO shall own all right, title, and interest in and to any such Promotional Materials Materials, including applicable copyrights and trademarks. SANDOZ shall have the right to review all Promotional Materials. ENDO shall consider all comments of SANDOZ in good faith and SANDOZ shall have final approval rights with respect to matters involving Product Trademark or Product Brand Equity. However, creative concepts that are used in the Territory advertising and promotion for the Licensed Products shall obtain Rosemont’s written require approval before using or distributing such Promotional Materialof the Parties, and in the event the Parties do not agree, the concept that tests higher in Third Party concept-testing shall be the concept that is adopted; provided, that the Parties have jointly developed the concepts to be tested and have approved the action standards, such approval not to be unreasonably withheld or delayed. For the avoidance of doubt, conditioned neither SANDOZ nor any other of the NOVARTIS Parties shall be responsible for any Out-of-Pocket Costs incurred with respect to jointly developed creative concepts so long as any such costs incurred by or deniedon behalf of SANDOZ have been reviewed and approved by ENDO before they are incurred. Rosemont will approve Further, no Promotional Materials to be submitted to OPDP under the Licensed Product NDA shall be used if NOVARTIS reasonably objects based on legal, medical or regulatory grounds. SANDOZ shall review and submit comments to Promotional Materials promptly. If the Parties reasonably disagree as to the approval or compliant execution of a Promotional Material, they shall convene the heads of regulatory, legal and compliance from each of SANDOZ and ENDO to conduct a joint executive review of the Promotional Materials Material and to decide on the approval, rejection or otherwise of such Promotional Material. Unless otherwise subject to the aforementioned joint executive review and subject to the next sentence, if ENDO has not received comments within five (5) business days of receipt of such Business Days for Promotional Materials from Oncogenerix. If Rosemont does not provide its approval which, in the aggregate including all pieces under review at the same time, are under ten (10) pages in length or notice that it does not approve the within ten (10) Business Days for longer Promotional Materials within the timescale in this Section 4.3Materials, the such Promotional Materials will be deemed to be approvedhave been approved by SANDOZ. Oncogenerix will use Reasonable Diligence to make such amendments to the Promotional Materials as requested by Rosemont under this Section 4.3. Oncogenerix shall own all right, title and interest in and to any Promotional Materials created by Oncogenerix relating to the Licensed Products, but excluding the Licensed Trademark(s); provided that, the All Promotional Materials shall be used exclusively provided to SANDOZ sufficiently in connection advance of first use so as to enable it to file such materials with the Licensed Products in accordance OPDP and otherwise comply with the terms of this Agreement. Where required by law, Oncogenerix shall submit Promotional Materials to the FDA (DDMAC) for review and approval. In the event that the FDA issues a letter objecting to any Promotional activities by Oncogenerix that require corrective actions (e.g. issuance of Dear Healthcare Professional letters, recall of Promotional Materials and/or dissemination of corrected Promotional Material), Oncogenerix will bear all the cost related to these corrective activities except to the extent that any such costs are caused by changes requested by Rosemont, in which case Rosemont shall bear the costs of such corrective activitiesits reporting obligations.

Promotional Materials. Oncogenerix 8.1 During the term of this Agreement, TEAMM shall create and develop, with the assistance and cooperation of Exaeris, sales and Promotional Materials relating to the Product for distribution to independent third parties. TEAMM shall provide samples Exaeris with such materials, in amounts which are reasonable under the terms of the Marketing Plan. Other than with the advice and written consent of TEAMM, Exaeris shall not create or develop sales, promotional or other similar material relating to the Product for distribution to independent third parties, including members of the medical and health professions. Exaeris shall reimburse TEAMM for the costs incurred by TEAMM to produce such all such sales and Promotional Material supplied to Exaeris relating to the Product. The costs to Exaeris will be the direct pass through costs incurred by TEAMM for the printing and shipping of sales and Promotional Materials in quantities requested by Exaeris. Exaeris will be responsible for agency costs only for material that have been requested by Exaeris and for their sole use. 8.2 Exaeris shall provide TEAMM with a list of Promotional Materials it agrees to Rosemont utilize in the promotion of the Product and a schedule setting forth Exaeris’ request for such materials and their delivery dates, all of which shall be reasonable under then existing marketing conditions and subject to approval by TEAMM. TEAMM shall promptly inform Exaeris whether it can deliver such materials in accordance with such schedule. If TEAMM cannot less than ten meet the delivery schedule, Exaeris, at its option, shall have the right to have prepared, at its own expense, additional supplies of such material, provided that such additional supplies conform in all respects with the material produced by TEAMM. If requested by Exaeris, TEAMM shall use its best efforts to provide Exaeris, free of charge, with mechanical and other items necessary to prepare such additional supplies. 8.3 Exaeris shall not be required to distribute any sales and Promotional Material prepared after the date of this Agreement which (10i) days prior does not mention the Product, or (ii) includes a reference to another TEAMM pharmaceutical product in addition to the time of first using or distributing such Promotional Materials in the Territory and Product. In no event shall obtain Rosemont’s written approval before using or distributing such Promotional Material; such approval not TEAMM be required to be unreasonably delayed, conditioned or denied. Rosemont will approve the Promotional Materials within five distribute any material which contains a reference (5i) business days of receipt of such Promotional Materials from Oncogenerix. If Rosemont does not provide its approval or notice that it does not approve the Promotional Materials within the timescale in this Section 4.3, the Promotional Materials will be deemed to be approved. Oncogenerix will use Reasonable Diligence to make such amendments to the Promotional Materials as requested by Rosemont under this Section 4.3. Oncogenerix shall own all right, title and interest in and to any Promotional Materials created by Oncogenerix relating to the Licensed Products, but excluding the Licensed Trademark(s); provided that, the Promotional Materials shall be used exclusively Exaeris (other than in connection with the Licensed Products Detailing of the Product in accordance with the terms of this Agreement) or (ii) any Exaeris pharmaceutical. Where required by law, Oncogenerix shall submit Exaeris is not obligated to utilize all Promotional Materials to the FDA (DDMAC) for review and approval. In the event that the FDA issues a letter objecting to any Promotional activities developed by Oncogenerix that require corrective actions (e.g. issuance of Dear Healthcare Professional letters, recall of Promotional Materials and/or dissemination of corrected Promotional Material), Oncogenerix will bear all the cost related to these corrective activities except to the extent that any such costs are caused by changes requested by Rosemont, in which case Rosemont shall bear the costs of such corrective activitiesTEAMM.

Promotional Materials. Oncogenerix ENDO shall provide samples be responsible for developing and disseminating all promotional, advertising, communication and educational materials relating to the Commercialization of the Licensed Product hereunder, other than Launch materials developed by NOVARTIS which shall be provided in electronic format by NOVARTIS, at no additional cost to ENDO, by the Effective Date (collectively, “Promotional Materials”). All Promotional Materials shall comply with applicable Law and must comply with the Product Trademark, Product Brand Equity and NOVARTIS’ Voltaren® gel style and branding guidelines that were sent to Rosemont not less than ten (10) days prior ENDO by NOVARTIS on March 4, 2008. As between NOVARTIS and ENDO, NOVARTIS shall own all right, title, and interest in and to the time of first using or distributing any such Promotional Materials Materials, including applicable copyrights and trademarks. NOVARTIS shall have the right to review all Promotional Materials. ENDO shall consider all comments of NOVARTIS in good faith and NOVARTIS shall have final approval rights with respect to matters involving Product Trademark or Product Brand Equity. However, creative concepts that are used in the Territory advertising and promotion for the Licensed Product shall obtain Rosemont’s written require approval before using or distributing such Promotional Materialof both Parties, and in the event both Parties do not agree, the concept that tests higher in Third Party concept-testing shall be the concept that is adopted; provided, that both Parties have jointly developed the concepts to be tested and have approved the action standards, such approval not to be unreasonably withheld or delayed. For the avoidance of doubt, conditioned NOVARTIS shall not be responsible for any Out-of-Pocket Costs incurred with respect to jointly developed creative concepts so long as any such costs incurred by or deniedon behalf of NOVARTIS have been reviewed and approved by ENDO before they are incurred. Rosemont will approve the Further, no Promotional Materials within five (5) business days of receipt of such to be submitted to DDMAC under the Licensed Product NDA shall be used if NOVARTIS reasonably objects based on legal, medical or regulatory grounds. NOVARTIS shall review and submit comments to Promotional Materials from Oncogenerixpromptly. If Rosemont does Subject to the next sentence, if ENDO has not provide its approval or notice that it does not approve the received comments within *** Business Days for Promotional Materials which, in the aggregate including all pieces under review at the same time, are under *** pages in length or within the timescale in this Section 4.3*** Business Days for longer Promotional Materials, the such Promotional Materials will be deemed to be approvedhave been approved by NOVARTIS. Oncogenerix will use Reasonable Diligence to make such amendments to the Promotional Materials as requested by Rosemont under this Section 4.3. Oncogenerix shall own all right, title and interest in and to any Promotional Materials created by Oncogenerix relating to the Licensed Products, but excluding the Licensed Trademark(s); provided that, the All Promotional Materials shall be used exclusively provided to NOVARTIS sufficiently in connection advance of first use so as to enable it to file such materials with the Licensed Products in accordance DDMAC and otherwise comply with the terms of this Agreement. Where required by law, Oncogenerix shall submit Promotional Materials to the FDA (DDMAC) for review and approval. In the event that the FDA issues a letter objecting to any Promotional activities by Oncogenerix that require corrective actions (e.g. issuance of Dear Healthcare Professional letters, recall of Promotional Materials and/or dissemination of corrected Promotional Material), Oncogenerix will bear all the cost related to these corrective activities except to the extent that any such costs are caused by changes requested by Rosemont, in which case Rosemont shall bear the costs of such corrective activitiesits reporting obligations.

Promotional Materials. Oncogenerix ENDO shall provide samples be responsible for developing and disseminating all promotional, advertising, communication and educational materials relating to the Commercialization of the Licensed Product hereunder, other than Launch materials developed by NOVARTIS which shall be provided in electronic format by NOVARTIS, at no additional cost to ENDO, by the Effective Date (collectively, “Promotional Materials”). All Promotional Materials shall comply with applicable Law and must comply with the Product Trademark, Product Brand Equity and NOVARTIS’ Voltaren® gel style and branding guidelines that were sent to Rosemont not less than ten (10) days prior ENDO by NOVARTIS on March 4, 2008. As between NOVARTIS and ENDO, NOVARTIS shall own all right, title, and interest in and to the time of first using or distributing any such Promotional Materials Materials, including applicable copyrights and trademarks. NOVARTIS shall have the right to review all Promotional Materials. ENDO shall consider all comments of NOVARTIS in good faith and NOVARTIS shall have final approval rights with respect to matters involving Product Trademark or Product Brand Equity. However, creative concepts that are used in the Territory advertising and promotion for the Licensed Product shall obtain Rosemont’s written require approval before using or distributing such Promotional Materialof both Parties, and in the event both Parties do not agree, the concept that tests higher in Third Party concept-testing shall be the concept that is adopted; provided, that both Parties have jointly developed the concepts to be tested and have approved the action standards, such approval not to be unreasonably withheld or delayed. For the avoidance of doubt, conditioned NOVARTIS shall not be responsible for any Out-of-Pocket Costs incurred with respect to jointly developed creative concepts so long as any such costs incurred by or deniedon behalf of NOVARTIS have been reviewed and approved by ENDO before they are incurred. Rosemont will approve the Further, no Promotional Materials to be submitted to DDMAC under the Licensed Product NDA shall be used if NOVARTIS reasonably objects based on legal, medical or regulatory grounds. NOVARTIS shall review and submit comments to Promotional Materials promptly. Subject to the next sentence, if ENDO has not received comments within five (5) business days of receipt of such Business Days for Promotional Materials from Oncogenerix. If Rosemont does not provide its approval which, in the aggregate including all pieces under review at the same time, are under ten (10) pages in length or notice that it does not approve the within ten (10) Business Days for longer Promotional Materials within the timescale in this Section 4.3Materials, the such Promotional Materials will be deemed to be approvedhave been approved by NOVARTIS. Oncogenerix will use Reasonable Diligence to make such amendments to the Promotional Materials as requested by Rosemont under this Section 4.3. Oncogenerix shall own all right, title and interest in and to any Promotional Materials created by Oncogenerix relating to the Licensed Products, but excluding the Licensed Trademark(s); provided that, the All Promotional Materials shall be used exclusively provided to NOVARTIS sufficiently in connection advance of first use so as to enable it to file such materials with the Licensed Products in accordance DDMAC and otherwise comply with the terms of this Agreement. Where required by law, Oncogenerix shall submit Promotional Materials to the FDA (DDMAC) for review and approval. In the event that the FDA issues a letter objecting to any Promotional activities by Oncogenerix that require corrective actions (e.g. issuance of Dear Healthcare Professional letters, recall of Promotional Materials and/or dissemination of corrected Promotional Material), Oncogenerix will bear all the cost related to these corrective activities except to the extent that any such costs are caused by changes requested by Rosemont, in which case Rosemont shall bear the costs of such corrective activitiesits reporting obligations.