Provision Language
Definitions
“Licensed Rights” means:
(a) the patents and patent applications owned or Controlled by Shionogi in the Territory related to the Licensed Compound or Licensed Product or their Manufacturing or use listed on Schedule B. Should it appear that Shionogi or its Affiliates own or Control other patents or patents applications in the Territory that are necessary for GARDP or its Sublicensees to exercise the licenses granted pursuant to this Agreement, GARDP may request that such be added to Schedule B by amendment, and Shionogi shall not unreasonably refuse such request; for clarity, any changes to Schedule B must be documented in a written amendment to this License Agreement signed by both Parties;
(b) any continuation, continuation–in–part (but only to the extent that such application includes new data in support of claims previously submitted in a prior originally filed application), divisional, and continued–prosecution applications of any patent applications included in paragraph (a); and
(c) any patents issuing from any patent applications included in the paragraphs (a) and (b),
in each case, including any renewals, extensions, patents of addition, supplementary protection certificates, revivals, re–examinations, and reissues thereof; and
(d) the data, information, and documentation that are owned or Controlled by Shionogi that are necessary to Develop, obtain regulatory approvals for, Manufacture and Commercialize the Licensed Product in the Field in the Territory, all as set forth in Schedule D, which Schedule may be updated from time to time by mutual agreement of the Parties. For clarity, the Licensed Rights include the Licensed Manufacturing Know-How.
“Licensed Manufacturing Know-How” means all technical information and know–how owned and/or Controlled by Shionogi or its Affiliates as of the Effective Date (including all manufacturing data, the percentages and specifications of ingredients, the manufacturing process, specifications, assays, quality control, and testing procedures) that is identified by Shionogi, in its good faith judgment, as reasonably necessary for the Manufacture of the Licensed Compound and/or Licensed Product in substantially the same manner that such Licensed Compound and/or Licensed Product have been Manufactured by or for Shionogi as of the Effective Date.
“License Results” means any results and know–how and inventions, patentable or not, developed or generated by or for GARDP and/or a Sublicensee in the performance of any activities conducted pursuant to this License Agreement and/or a Sublicense Agreement. This includes all Process Results and all Development Results.
“Product Trademark” means the trademarks set out in Schedule E.
“Territory” means the countries listed in Schedule C and such other or different countries as the Parties may agree in writing.
2. LICENSE GRANT
2.1 Licensed Rights and Licensed Manufacturing Know-How
(a) The Parties have agreed on a Market Access Plan (the Market Access Plan, the initial version of which is set forth in a schedule to the Collaboration Agreement), which plans and tracks the various activities to be conducted by GARDP and Shionogi (and CHAI, where applicable) pursuant to the Collaboration Agreement in pursuit of the Access and Stewardship Objectives, including notably the activities of GARDP and Shionogi (and CHAI, where applicable) to enable and facilitate the Sublicensees to supply, develop, register, and distribute the Licensed Product in countries in the Territory. Each of Shionogi and GARDP shall use reasonable best efforts to conduct the activities and achieve the objectives for which it is responsible in the Market Access Plan. The Market Access Plan shall be managed and updated from time to time in accordance with the Collaboration Agreement, which provides that either Party (or CHAI) may propose changes to the Market Access Plan, and that all such changes shall require the approval of both Parties and, if applicable, of CHAI except as otherwise specifically set forth in the Collaboration Agreement.
(b) Upon the terms and subject to the conditions set out in this License Agreement, Shionogi hereby grants to GARDP, and GARDP hereby accepts, a non–exclusive, non–transferable license, with the right to grant sublicenses (subject to Shionogi’s consent rights pursuant to the provisions of this License Agreement) under the Licensed Rights and the Licensed Manufacturing Know-How, to: (i) register, or have registered, the Licensed Product in the Field in the Territory, and (ii) Commercialize, or have Commercialized, the Licensed Product in the Field in the Territory, together with a non–exclusive, non–transferable, and sublicensable (subject to Shionogi’s consent rights and limited to the agreed scope of the Sublicense Agreement), license to use and practice the Licensed Rights and Licensed Manufacturing Know-How, (iii) Develop, or have Developed, the Licensed Product, as may be approved by Shionogi, and (iv) to Manufacture, or have Manufactured, the Licensed Compound and Licensed Product for distribution in the Territory, in each case (i) through (iv) strictly in accordance with the requirements of and as otherwise contemplated by this License Agreement and, for GARDP, the Collaboration Agreement and the Market Access Plan, and for each Sublicensee, the relevant Sublicense Agreement and Sublicense Access Plan. For clarity, the license to Manufacture, or have Manufactured, the Licensed Compound and Licensed Product for distribution in the Territory may include the right to Manufacture, or have Manufactured, the Licensed Compound and Licensed Product in a country outside the Territory, so long as the Manufactured Licensed Compound and Licensed Product are Commercialized exclusively in the Territory; for the purposes of this Manufacturing license, the Parties shall discuss and agree whether any licenses to any patents or patent applications owned or Controlled by Shionogi are necessary for such Manufacture in the relevant country(ies) of Manufacture outside the Territory, and if agreed, shall enter into an amendment to this License Agreement to include a nonexclusive license to such patent in the Manufacturing license granted hereunder.
(c) The license granted by Shionogi to GARDP includes a license to use and practice the Licensed Rights as may be required for GARDP to conduct all the activities for which it is responsible under this License Agreement or the Collaboration Agreement. The License Rights granted to GARDP pursuant to this License Agreement shall be strictly limited to conducting the activities contemplated in this License Agreement and to those set out in the Market Access Plan. GARDP will not have any right to practice the license granted under this Section 2.1 or otherwise exploit the Licensed Rights and Licensed Manufacturing Know-How for any other purpose.
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2.3 Sublicenses
(a) Shionogi shall, for so long as GARDP is expending reasonable best efforts to pursue the Access and Stewardship Objectives in accordance with the Market Access Plan, refer to GARDP all enquiries received by Shionogi from potential partners for countries in the Territory, and such potential partners shall be evaluated by GARDP in accordance with the Market Access Plan. Notwithstanding the foregoing, should the Parties agree, or Shionogi reasonably determine after consulting with GARDP, that it would be preferable for the Access and Stewardship Objectives to grant a Third Party a direct license to the Licensed Product for one or more countries in the Territory where access is not being addressed by GARDP or its Sublicensees, Shionogi shall be free to grant such license directly to the Third Party.
(b) The Parties shall evaluate in good faith the capacities and proposals of each potential Third–Party Sublicensee to perform its obligations in accordance with the Access and Stewardship Objectives in countries within the Territory. Each Sublicensee shall be approved by Shionogi prior to the grant of any Sublicense, and Shionogi shall have the right to withhold approval of any Sublicensee proposed by GARDP for reasonable concerns.
(c) The Parties acknowledge and agree that potential Sublicensees of the license granted by Shionogi to GARDP in Section 2.1 shall be identified by GARDP and/or CHAI in accordance with the Collaboration Agreement. These Sublicensees may be involved in Manufacturing the Licensed Product (and/or Licensed Compound), in Commercializing the Licensed Product, or both. GARDP shall grant sublicenses to these Sublicensees according to the terms of a sublicense agreement to be entered into with at least the provisions attached as Schedule F to this License Agreement except to the extent these provisions are not relevant for the Sublicensee given the nature of the rights granted to them (each such executed sublicense agreement being a Sublicense Agreement, the sublicense granted pursuant thereto being a Sublicense, and each Third Party with which a Sublicense Agreement is entered into being a Sublicensee).
(d) Each Sublicense Agreement will include an agreed Commercialization plan (the Sublicense Access Plan), including specific target dates for Commercialization objectives in the portion of the Territory covered by such Sublicense Agreement and means by which the Sublicensee will adhere to, and promote Third Party adherence to, the Access and Stewardship Objectives. The Sublicensee shall have an obligation to devote commercially reasonable efforts to achieving the objectives and target dates of their Sublicense Access Plan. The Sublicense Access Plan for each Sublicensee shall be agreed to by Shionogi, and progress under the Sublicense Access Plan for each Sublicense Agreement will be routinely discussed with Shionogi in the License Management Subcommittee. Shionogi shall also have the right to review and approve each Sublicense Agreement to ensure that it is consistent with the terms and conditions of this License Agreement (including the provisions attached as Schedule F), and may refuse to approve any proposed Sublicense Agreement that is not consistent. Shionogi shall promptly provide its feedback to any first and final draft of each Sublicense Agreement proposed by GARDP.
(e) GARDP may include in each Sublicense Agreement a covenant by GARDP not to seek another market access partner for the country(ies) covered by such agreement, together with a confirmation that Shionogi has agreed to refer to GARDP all enquiries from potential market access partners for such country(ies), in each case for so long as the Sublicensee is complying with its diligence obligations. For the avoidance of doubt, the license granted herein is non–exclusive and nothing herein shall restrict Shionogi or its agents’ Development, Manufacture, or Commercialization (including registration) of any product containing cefiderocol within the Territory.
(f) Any Sublicense Agreement will be entered into subject to the following:
(i) it will refer to this License Agreement and will be subject to and subordinate to this License Agreement;
(ii) the Sublicensees will confirm in writing that it has reviewed the terms and conditions of this License Agreement and agree to not perform any acts or omissions that would place GARDP in breach of this License Agreement;
(iii) the sublicense rights granted to each Sublicensee will be non–sublicensable and non–transferable except as may be expressly provided under the Sublicense Agreement;
(iv) each Sublicensee will be entitled, limited to the activities described in its Sublicensee Access Plan and subject to the express rights granted as set forth in the applicable Sublicense Agreement, to make, have made, offer for sale, have sold, export or import the Licensed Compound, whether inside or outside of the Territory, exclusively for use in the Field in the Territory;
(v) each Sublicensee shall be required to enter into a Safety Data Exchange Agreement, as contemplated by Section 6.1;
(vi) the Sublicensees will be entitled, limited to the activities described in its Sublicensee Access Plan and subject to the express rights granted as set forth in the applicable Sublicense Agreement, to offer for sale, sell, and have sold the Licensed Product to customers outside of the Territory solely to the extent that such Licensed Product will be exclusively imported (as applicable) and used in the Field in the Territory and not exported outside of the Territory; and
(vii) before entering into a Sublicense Agreement, GARDP and/or CHAI, as applicable in accordance with the Collaboration Agreement, will perform due diligence of the proposed Sublicensees in order to ensure compliance with applicable laws relating to corruption (including anti–bribery laws and the U.S. Foreign Corrupt Practices Act and the Unfair Competition Prevention Act and Penal Code Act in Japan); and if applicable relevant national and international quality and good manufacturing practices. No Sublicense Agreement may be entered into before the satisfactory completion of such due diligence by GARDP and/or CHAI, and the approval of such proposed Sublicensee by Shionogi.
(g) GARDP will procure that:
(i) each applicable Sublicensee has demonstrated capability to Manufacture the Licensed Product it intends on Manufacturing; and
(ii) each applicable Sublicensee will file for registration of the Licensed Product in at least one country in the Territory within four (4) years of the start of technical transfer pursuant to Section 4.2 to the Sublicensee, or if there is no technical transfer to the Sublicensee, within four (4) years of the Effective Date of the applicable Sublicense Agreement.
(h) GARDP will coordinate execution of the Sublicense Agreement between GARDP and each Sublicensee.
(i) GARDP will not modify the terms and conditions of any executed Sublicense Agreement (including the provisions as attached as Schedule F) without Shionogi’s prior written consent. Shionogi may refuse to consent to any proposed Sublicense Agreement amendment that is not consistent with the terms of this License Agreement (including the provisions as attached as Schedule F). Shionogi shall promptly provide its feedback to any draft Sublicense Agreement amendment proposed by GARDP.
(j) GARDP will remain jointly and severally liable with any Sublicensee to Shionogi for any failure by any Sublicensee to comply with the terms and conditions of this License Agreement applicable to the Sublicensee or with the terms and conditions of its Sublicense Agreement that would cause GARDP to be in breach of its obligations pursuant to this License Agreement or that would otherwise cause damages to Shionogi.
(k) GARDP will diligently monitor and enforce each Sublicensee’s compliance with its Sublicense Agreement, including, without limitation, diligently reviewing the progress reports received from such Sublicensee, and monitoring compliance with the applicable Sublicense Access Plan. GARDP shall provide unredacted copies of any and all such progress reports to Shionogi within ten (10) Business Days of receipt.
(l) If GARDP becomes aware of any act or omission of a Sublicensee which constitutes a breach of the relevant Sublicense Agreement, GARDP will:
(i) if the breach is capable of correction and does not give rise to an immediate right of termination under the Sublicense Agreement, direct the relevant Sublicensee in writing to cure the breach, with a copy of that writing to Shionogi; and
(ii) if the breach remains uncured at the end of the specified period, or if there are otherwise grounds for termination under the Sublicense Agreement, in consultation with Shionogi, take all actions to procure the termination of the relevant Sublicense Agreement in accordance with its terms.
(m) GARDP agrees that it will not grant sublicenses to entities other than Sublicensees approved by Shionogi and will not enter into any Sublicense Agreement under this License Agreement without the prior written consent of Shionogi. Any purported sublicense not entered into in compliance with the foregoing will be null and void ab initio and without effect. Notwithstanding the foregoing, licenses contemplated in Section 2.1 may be further sublicensed by Sublicensees through multiple tiers (each further tier sublicensee also being considered a Sublicensee for the purposes hereof) for the purpose of Commercializing the Licensed Product in the Territory that is Manufactured by or for the relevant Sublicensee; provided that all such further tier Sublicensees shall be subject (i) to the approval of both Shionogi and GARDP; and (ii) to all other applicable conditions applicable to Sublicensees. For the avoidance of doubt, Third Parties selling finished product Manufactured and Commercialized under the principal Sublicensee’s name shall not be considered further tier Sublicensees.
(n) The Sublicense Agreements will prohibit Sublicensees from Manufacturing and selling the Licensed Compound and/or Licensed Product in combination with other active pharmaceutical ingredients in the Territory or outside of the Territory.
(o) Without limiting the foregoing, Shionogi has the right to review and comment on any and all proposed Development activities (other than Development relating to Manufacturing / chemistry, Manufacturing and controls (CMC) / process development conducted as part of the technical transfer described in Section 4.2(a)) to be conducted by any Sublicensee (or GARDP, as applicable) relating to the Licensed Product or the Licensed Compound, and whether to conduct, and the design and performance of, all such Development activities by any Sublicensee (or GARDP, as applicable) shall be subject to Shionogi’s prior approval. Shionogi shall use its reasonable best efforts to promptly respond to any such proposed Development activities. For the avoidance of doubt, GARDP and/or Sublicensees would be responsible for the cost of any such Development work, including clinical trials.
(p) Each Sublicensee shall be solely responsible at its expense for making or procuring from a Sublicensee that Manufactures Licensed Product, as applicable, all of its respective requirements for the Licensed Compound and Licensed Product in conformity with all applicable specifications in the countries of the Territory where it Commercializes the Licensed Product and will hold all relevant authorizations and permits required by the applicable Regulatory Authority(ies) in this respect. In addition, each Sublicensee shall adhere to, and promote Third Party adherence with, the obligations relating to the Access and Stewardship Objectives set forth in the applicable Sublicense Agreement.
(q) Each Sublicensee that will Manufacture the Licensed Compound and Licensed Product for use and sale in the Territory will (i) do so in strict conformity with the applicable conditions specified in this License Agreement and their Sublicense Agreement, and (ii) use commercially reasonable efforts in accordance with the applicable Sublicense Access Plan to provide a sufficient supply thereof to meet the needs in the countries of the Territory. Without limiting the foregoing and to the extent applicable, each Sublicense Agreement with a Sublicensee that Manufactures Licensed Product shall require the Sublicensee to Manufacture the Licensed Product: (a) in a manner consistent with and in accordance with standards validated by a World Health Organization prequalification (WHO PQ) or by any applicable Stringent Regulatory Authority (if the manufacturing site has already been approved by a Stringent Regulatory Authority) or, if neither WHO PQ or an SRA has assessed and confirmed compliance with such manufacturing standards, by a Third Party audit (including relative to GMP) to confirm adherence with WHO PQ and/or SRA standards, such third party to be agreed by both Parties; and (b) any applicable industry standards for responsible Manufacture of antibiotics.
2.4 No trademark license
(a) No right or license, express or implied, is granted to GARDP or the Sublicensees either under this License Agreement or the Sublicense Agreement to use the Product Trademark or any trademark, trade name, logo, trade dress, or service mark owned or Controlled by Shionogi or any of its Affiliates. Notwithstanding the above, if GARDP or any Sublicensee, as applicable, believes applicable law or regulation would require that GARDP or such Sublicensee use or reference any Product Trademark or any trademark, trade name, logo, trade dress, or service mark owned or Controlled by Shionogi or any of its Affiliates, GARDP shall provide Shionogi with documentation supporting its interpretation of the applicable law or regulation, and Shionogi and GARDP shall discuss in good faith the matter and use reasonable best efforts to reach an amicable resolution thereof.
(b) The relevant Sublicensee(s) shall, at their sole cost and expense, be responsible for the selection, registration, and maintenance of all trademarks and trade dress which they employ in connection with their activities conducted pursuant to their Sublicense Agreement, and will own and control such trademarks and trade dress.
(c) Shionogi shall have the right to review all trademarks and trade dress used in the Commercialization of the Licensed Product in the Territory, and shall have the right to refuse all trademarks and trade dress for reasonable concerns, in particular, if it considers the proposed trademarks or trade dress may be confusingly similar with any Product Trademark or other trademarks or trade dress, or if the proposed trademarks or trade dress are immoral, deceptive, or scandalous, or if the proposed trademarks or trade dress disparage or falsely suggest a connection with persons, living or dead, institutions, beliefs, or national symbols, or bring them into contempt or disrepute. Shionogi shall provide its feedback for any proposed trademark or trade dress promptly following receipt of all information requested in order to fully evaluate such request. If Shionogi reasonably objects to the Sublicensee’s proposal within the foregoing time period, the Parties and the Sublicensee shall discuss in good faith Shionogi’s concerns, and the Sublicensee will agree to make such modifications to the Sublicensee’s proposed trademark, trade dress or product markings as are necessary to address Shionogi’s concerns.
(d) Without limiting the foregoing, GARDP and its Sublicensees will not use (or allow their distributors to use) the Product Trademark or any trademark or trade dress or product marking used by Shionogi or any of its Affiliates or licensees in any manner or any trademark or trade dress that is confusingly similar to the Product Trademark or any trademark or trade dress used by Shionogi or any of its Affiliates.
(e) GARDP will require that its Sublicensees cause the product markings, packaging and related features of each Licensed Product to be distinctive from that which is used by Shionogi with cefiderocol products.
2.5 No implied license
No license or other right is or will be created or granted under this License Agreement by implication, estoppels, or otherwise. All licenses and rights are or will be granted only as expressly provided in this License Agreement. For the avoidance of doubt, Shionogi has entered into this License Agreement subject to the express understanding between the Parties that GARDP would not obtain any licenses or rights other than those expressly provided in this License Agreement.
2.6 Retained rights
(a) All rights not expressly granted under this License Agreement are reserved by Shionogi and Shionogi’s use thereof for any purpose is not restricted by this License Agreement.
(b) Without limiting the foregoing, Shionogi retains any and all rights under the Licensed Rights and Licensed Manufacturing Know-How to make, have made, use, offer for sale, sell, have sold, export, import, license, or exploit: (i) the Licensed Compound and any product containing the License Compound for any use whether within or outside the Territory and whether within or outside the Field; and (ii) compounds other than the Licensed Compound covered by one or more claims in the patents included in the Licensed Rights, for any use.
(c) Shionogi also expressly reserves and retains the right to make or have made, and use, the Licensed Compound and any product containing the Licensed Compound for any internal research purpose.
8. INVENTIONS, PATENT MAINTENANCE, INFRINGEMENT
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8.2(c) The Process Results shall be considered Confidential Information of the party who owns the results, provided in any case that each of Shionogi, GARDP and the Sublicensee that developed or generated the Process Results shall have the right to access and use all Process Results in accordance with the licenses set forth in Section 8.4.
8.3 Development Activity License Results
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(a)(iv) GARDP shall have the right to use all Development Results not owned by it only for regulatory filings, or otherwise to enable or facilitate access to Licensed Product, in the Territory, including by granting Sublicenses to such Development Results, all in accordance with the requirements of this License Agreement.
(v) Each Sublicensee shall have the right to use Clinical Data developed or generated by the Sublicensee only for Development, Manufacture or Commercialization in the country(ies) in the Territory for which it has a license, as applicable, all in accordance with this License Agreement and the applicable Sublicense Agreement.
(vi) Shionogi shall have the sublicensable right to use all Development Results, including any and all Clinical Data, not owned by it for development, regulatory filings, manufacturing, commercialization or otherwise to enable or facilitate access to cefiderocol, or any product containing cefiderocol, worldwide.
8.4 General Conditions Applicable to all License Results
(a) Each Party, including any Sublicensees, shall grant the other Party a free, nonexclusive, nontransferable, sublicensable license to use its License Results and any intellectual property rights thereon to conduct the activities for which they are responsible pursuant to the Collaboration Agreement.
(b) GARDP and the Sublicensees shall grant Shionogi a free, perpetual, nonexclusive, sublicensable (including to all Sublicensees in the Territory) license to use License Results, including any and all Clinical Data, owned by them (including any intellectual property rights thereon) for the development, regulatory filings, manufacture, commercialization or otherwise to enable or facilitate access to cefiderocol, or any product containing cefiderocol, worldwide.
(c) Each Sublicensee shall grant GARDP a free, nonexclusive, sublicensable (including to all Sublicensees in the Territory) license to use License Results owned by them (including any intellectual property rights thereon) for the Development, Manufacture, and Commercialization of the Licensed Product in the Territory pursuant to the License Agreement.
(d) All License Results owned by Shionogi (including any intellectual property rights thereon) shall be included in the sublicensable License Rights granted to GARDP for the Territory pursuant to this License Agreement.
Schedule F: Provisions for Sublicense Agreement
6. Intellectual Property
Manufacturing Process Results
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(c) The Process Results be considered confidential information of the party who owns the results, provided that each of Licensor, Sublicensor and Sublicensee shall have the right to access and use all Process Results in accordance with the licenses set forth in this Sublicense Agreement and the License Agreement.
(d) Licensor shall have the sublicensable right to use all Process Results not owned by it for development, regulatory filings, manufacturing, commercialization or otherwise to enable or facilitate access to any product containing cefiderocol worldwide.
Development Activity Sublicense Results
(a) With respect to any inventions, know–how or results (whether or not patentable) developed or generated by or for Sublicensor and/or Sublicensee in the performance of any Development activities conducted pursuant to this Sublicense Agreement other than Development activities relating to Manufacturing (the results of which are Process Results governed by the terms above) (Development Results):
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(iv) Sublicensee shall have the right to use Clinical Data developed or generated by them only for regulatory filings, Commercialization, or otherwise to enable or facilitate access to Licensed Product, in the country(ies) in the Territory for which it has a license.
(v) Licensor shall have the sublicensable right to use all Development Results, including any and all Clinical Data, not owned by it for development, regulatory filings, manufacturing, commercialization or otherwise to enable or facilitate access to any product containing cefiderocol worldwide.
General Conditions Applicable to all Sublicense Results
(a) Sublicensee grants Licensor a free, perpetual, nonexclusive, sublicensable license to use Sublicense Results owned by Sublicensee (including any intellectual property rights thereon) for the Development, Manufacture, and Commercialization of the Licensed Product worldwide.
(b) Sublicensee grants Sublicensor a free, nonexclusive, sublicensable license to use Sublicense Results owned by Sublicensee (including any intellectual property rights thereon) for the Development, Manufacture, and Commercialization of the Licensed Product in the Territory pursuant to the License Agreement.
(c) All Sublicense Results owned by Licensor (including any intellectual property rights thereon) shall be included in the License Rights licensed to Sublicensor pursuant to the License Agreement and sublicensed to Sublicensee pursuant to this Sublicense Agreement.
16. Licensed Product Trademarks
Subject to any limitations set forth herein, Sublicensee shall own all right, title, and interest to the Licensed Product Trademarks in the Territory, and shall be responsible for the registration, prosecution, and maintenance thereof. All costs and expenses of registering, prosecuting, and maintaining the Licensed Product Trademarks shall be borne solely by Sublicensee. Notwithstanding the foregoing, (i) each Licensed Product Trademark must have color, markings and other presentation to be distinctive from the Licensor’s Licensed Product; and (ii) Sublicensee must obtain Licensor’s prior written approval (such approval not to be unreasonably withheld) for Sublicensee’ proposed Licensed Product Trademarks, trade dress or product markings. Licensor shall provide its feedback for any proposed trademark or trade dress promptly following its receipt of all information requested in order to fully evaluate such request. If Licensor reasonably objects to such request within the foregoing time–period, the Parties shall discuss in good faith Licensor’s concerns, and Sublicensee will agree to make such modifications to Sublicensee’s proposed trademark, trade dress or product markings as are necessary to address Licensor’s concerns. For the purposes of this Agreement, “Licensed Product Trademarks” means the trademark(s) to be used by Sublicensee or its Affiliates for the Commercialization of the Licensed Product in the countries covered by the Sublicense and any registrations thereof or any pending applications relating thereto in such countries (excluding, in any event, any trademarks that include any corporate name or logo of the Parties or their Affiliates, including Licensor’s corporate names).