Master Alliance Provisions Guide (MAPGuide)

Merck – MPP, Molnupiravir License Agreement

  • Intellectual Property | License Grants
  • Intellectual Property | Ownership of IP

<p><b><i>Definitionsi>b>p>
<p><span style=”fontweight: 400;”>“span><b>Authorized Supplierb><span style=”fontweight: 400;”>” shall mean a Third Party that has entered into a written agreement with MSD regarding the right to supply Substance and/or Product to other (receiving) third parties who have also entered into a written license agreement with MSD regarding the right to supply Substance and/or Product.span>p>
<p><span style=”fontweight: 400;”>“span><b>MSD Know-Howb><span style=”fontweight: 400;”>” shall mean all <a href=”#kt“>Know-Howa>span><span style=”fontweight: 400;”>, that: (i) directly relate to use in the Field of the Substance and/or the Product, (ii) are controlled by MSD or its Affiliates as of the execution date of this Agreement and, (iii) are not in the public domain or otherwise generally known. For avoidance of doubt, MSD Know-How shall not include any Know-How to the extent solely and directly related to any other MSD compound. Also, MSD Know-How includes only that Know-How, designated by MSD in its sole discretion, necessary for the manufacture, registration, and commercialization of the Substance and/or the Product for use in the Field.span>p>
<p><span style=”fontweight: 400;”>“span><b>Public Purchasersb><span style=”fontweight: 400;”>” shall mean with respect to a country in the Territory (a) the following organizations to the extent that they are not for profit organizations and operate in such countries: (i) NonGovernmental Organizations to the extent that they are recognized by the applicable local government ministries from such country; (ii) UNrelated organizations span><span style=”fontweight: 400;”>working for or in such country, including but not limited to UNDP and UNICEF; (iii) Notforprofit organizations including without limitation, Médecins Sans Frontières, SavetheChildren, OXFAM and the International Committee of the Red Cross (ICRC) to the extent that they are recognized by span><span style=”fontweight: 400;”>the applicable local government ministries from such countries; (iv) programs funded by funding mechanisms, including without limitation, UNITAID, PEPFAR, USAID, and Global Fund; and agencies based outside of the Territory to the extent that they are supporting implementation of the organisations described in clauses (i) through (iii) above locally in such country, and (b) nominally for profit procurement organisations but only to the span><span style=”fontweight: 400;”>extent that such procurements are supporting notforprofit programs in such country as described in (a) of this definition within the Territory.span>p>
<p><span style=”fontweight: 400;”>“span><b>NonTerritory Patentsb><span style=”fontweight: 400;”>” shall mean any Patents, granted or pending, in any country that is not included in the Territory (as hereinafter defined). For the avoidance of doubt, to the extent international and regional patent applications are included in Patents, such international and regional patent applications are span><span style=”fontweight: 400;”>NonTerritory Patents only with respect to countries not included in the Territory.span>p>
<p><span style=”fontweight: 400;”>“span><b>Territory Patentsb><span style=”fontweight: 400;”>” means Territory Patents shall mean any Patents, granted or pending, in any country within the Territory. For the avoidance of doubt, to the extent international and span><span style=”fontweight: 400;”>regional patent applications are included in Patents, such international and regional patent applications are Territory Patents only with respect to countries within the Territory.span>p>
<p><span style=”fontweight: 400;”>“span><b>Vendb><span style=”fontweight: 400;”>” shall mean sale, import, or export of the Substance by the Sublicensee to another Sublicensee or an Authorized Supplier for the purpose of manufacturing the Product for its Own Use. (“span><b>Own Useb><span style=”fontweight: 400;”>” shall mean the act of Commercialization and/or the act of registration of the Product in the Territory for use in the Field.)span>p>
<p><b><i>MSDMPP Agreement i>b>p>
<p><span style=”textdecoration: underline;”><b>2. Scope Of The Grantb>span>p>
<p><b>2.1 Within the Territory.b><span style=”fontweight: 400;”> Subject to the terms and conditions of this Agreement, MSD hereby grants to MPP a nonexclusive, nontransferable license under the Territory Patents and MSD Know-How to enter into Sublicences with Sublicensees for the latter to manufacture the Product at a facility that is in the Territory (excluding any Sanctions Targets as defined in Section 4.5) and that is approved by a span><span style=”fontweight: 400;”>SRAspan><span style=”fontweight: 400;”> or prequalified by the World Health Organization:span>p>
<p style=”paddingleft: 25px;”><span style=”fontweight: 400;”>(a) To <a href=”#kt“>Commercializea>span><span style=”fontweight: 400;”> the Product by itself or through its Affiliates in the Territory for use in the Field;span>p>
<p style=”paddingleft: 25px;”><span style=”fontweight: 400;”>(b) To Retail the Product to other Sublicensees or Authorized Suppliers for their Own Use within the Territory;span>p>
<p style=”paddingleft: 25px;”><span style=”fontweight: 400;”>(c) to register the Product in the Territory for use by itself or through its Affiliates in the Field for (a) and (d); andspan>p>
<p style=”paddingleft: 25px;”><span style=”fontweight: 400;”>(d) to sell the Product to Public Purchasers for the sole purpose of enabling the Public Purchasers to supply the Product in the Territory for use in the Field.span>p>
<p><b>2.2 Within the Territory.b><span style=”fontweight: 400;”> Subject to the terms and conditions of this Agreement, MSD hereby grants to MPP a nonexclusive, nontransferrable license under the Territory Patents and MSD Know-How to enter into Sublicences with Sublicensees for the latter to manufacture the Substance at a facility that is in the Territory (excluding any Sanctions Targets as defined in Section 4.5) and that is approved by a <a href=”#kt“>SRAa> or prequalified by the World Health Organization;span>p>
<p style=”paddingleft: 25px;”><span style=”fontweight: 400;”>(a) to manufacture the Product in accordance with Section 2.1; andspan>p>
<p style=”paddingleft: 25px;”><span style=”fontweight: 400;”>(b) to Vend the Substance.span>p>
<p><b>2.3 Outside the Territory.b><span style=”fontweight: 400;”> Subject to the terms and conditions of this Agreement, MSD hereby grants to MPP a nonexclusive, nontransferable license under the NonTerritory Patents and MSD Know-How to enter into Sublicences with Sublicensees for the latter to manufacture the Product at a facility that is in a nonTerritory country (excluding any Sanctions Targets as defined in Section 4.5) and that is approved by a SRA or prequalified by the World Health Organization;span>p>
<p style=”paddingleft: 25px;”><span style=”fontweight: 400;”>(a) to export the Product to the Territory for its Own Use;span>p>
<p style=”paddingleft: 25px;”><span style=”fontweight: 400;”>(b) to Retail the Product in the Territory to other Sublicensees or Authorized Suppliers for their Own Use; andspan>p>
<p style=”paddingleft: 25px;”><span style=”fontweight: 400;”>(c) to sell the Product to Public Purchasers for the sole purpose of enabling the Public Purchasers to supply the Product in the Territory for use in the Field.span>p>
<p><b>2.4 Outside the Territory.b><span style=”fontweight: 400;”> Subject to the terms and conditions of this Agreement, MSD hereby grant to MPP a nonexclusive, nontransferrable license under the NonTerritory Patents and MSD Know-How to enter into Sublicences with Sublicensees for the latter to manufacture the Substance at a facility that is in a nonTerritory country (excluding any Sanctions Targets as defined in Section 4.5) and that is approved by a SRA or prequalified by the World Health Organization;span>p>
<p style=”paddingleft: 25px;”><span style=”fontweight: 400;”>(a) to manufacture the Product in accordance with Section 2.3; andspan>p>
<p style=”paddingleft: 25px;”><span style=”fontweight: 400;”>(b) to Vend the Substance.span>p>
<p><b>2.5b><span style=”fontweight: 400;”> No rights are hereby granted for any other purpose, and MPP agrees that it will not use the Patents or MSD Know-How itself or grant sublicenses: (i) to entities other than Sublicensees; and/or (ii) other than in the form of the Sublicense. No license or right is granted by implication or otherwise with respect to the Substance and/or Product, except as expressly granted herein. Subject to the above and except as permitted by statute, the Sublicensee shall not be entitled to manufacture, use, Commercialize, Retail, Vend, register with regulatory agencies, and/or sell the Substance and/or the Product for any other purpose or in combination with any other substance, product, intermediate, and/or active pharmaceutical ingredient (whether copackaged, coformulated or otherwise) (“span><b><i>Combinationi>b><span style=”fontweight: 400;”>”) unless prior written approval had been provided by MSD in its sole discretion.span>p>
<p><span style=”fontweight: 400;”>For the avoidance of doubt, Parties agree that any approval of the Combination by MSD shall be subject to separate terms and conditions which shall be negotiated independently of this Agreement.span>p>
<p><b>2.6b><span style=”fontweight: 400;”> No rights are hereby granted for any other purpose, and MPP agrees that it will not use the Patents or MSD Know-How itself or grant sublicenses: (i) to entities other than Sublicensees; and/or (ii) other than in the form of the Sublicense. No license or right is granted by implication or otherwise with respect to the Substance and/or Product, except as expressly granted herein. Subject to the above and except as permitted by statute, the Sublicensee shall not be entitled to manufacture, use, Commercialize, Retail, Vend, register with regulatory agencies, and/or sell the Substance and/or the Product for any other purpose or in combination with any other substance, product, intermediate, and/or active pharmaceutical ingredient (whether copackaged, coformulated or otherwise) unless prior written approval had been provided by MSD in its sole discretion.span>p>
<p><b>2.7b><span style=”fontweight: 400;”> For the avoidance of doubt, nothing in this Agreement or in the Sublicence shall be construed to prevent Sublicensees from engaging in activities inside or outside the Territory where such activities would not (1) infringe the Patents and/or any other intellectual property rights; and/or (2) misappropriate MSD Know-How. MSD expressly reserves all its rights under the Patents, except as expressly set forth herein, and under any additional patents and/or patent applications owned or controlled by MSD. MSD does not waive any applicable statutory and/or regulatory exclusivities owned or controlled by MSD, except as expressly set forth herein. Nothing in this Agreement or the Sublicense shall provide a right to commercialize outside the Territory.span>p>
<p><b>2.8b><span style=”fontweight: 400;”> MPP acknowledges that the license granted pursuant to Sections 2.1, 2.2, 2.3 and 2.4 is nonexclusive and that MSD retains the right in its sole discretion to:span><span style=”fontweight: 400;”>(i) grant additional licenses or distribution rights for the Substance and/or the Product to third parties; and (ii) make, use, and sell the Substance and/or the Product (or any other pharmaceutical product containing the Substance) on its own behalf.span>p>
<p><b>2.9b><span style=”fontweight: 400;”> MSD shall provide, upon MPP&#8217;s request, a Sublicensee with regulatory exclusivity waivers to the extent required by the applicable regulatory authorities in order to manufacture or sell Product in the Territory in accordance with the terms of the Sublicense. MPP shall require that Sublicensees will agree not to seek any further regulatory exclusivity. For avoidance of doubt, MSD will not be required to represent that any Product is equivalent to any product containing Substance which is manufactured or sold by MSD, and no regulatory exclusivity waiver granted by MSD pursuant to this Section will be deemed as including any such representation.span>p>
<p><b>2.10b><span style=”fontweight: 400;”> Except as expressly set forth in this Agreement, MSD does not grant any license to MPP under any of its intellectual property rights (including, without limitation, Patents or rights to any proprietary compounds or drug substances) other than Substance.span>p>
<p><b>2.11b><span style=”fontweight: 400;”> No rights in any MSD Trademarks are granted to MPP or Sublicensees under this Agreement. MPP shall require that Sublicensees do not, appropriate or otherwise use or register any MSD Trademarks in connection with the Product in the Territory, including without limitation in connection with any sale, distribution, promotion, or marketing of the Product. MPP will require that a complete description of any trademark to be used by Sublicensees in connection with the sale of the Product in the Territory shall be submitted to MPP to be transmitted to MSD for written approval prior to use or filing an application to register such trademark. Such written approval shall be given within 30 days of receipt by MSD from MPP of all the relevant documentation necessary to consider the Sublicensees request. Such approval may be withheld if the subject trademark is determined by MSD, in its sole discretion, to be identical to or confusingly similar to any MSD Trademark, however, any such approval shall not waive any rights with respect to the MSD Trademarks. In addition to the foregoing, for the avoidance of doubt, MPP shall require that Sublicensees do not: (i) register or, in connection with the sale of any Product, use any trademark or trade name which is identical to or confusingly similar (as MSD shall determine in its sole discretion) to any MSD Trademark; (ii) use trade dress, packaging (both internal and external) or labeling which is the same as or similar (as MSD shall determine in its sole discretion) to that of MSD or any Affiliate of MSD in connection with the sale of any Product; and (iii) give the impression to the public, to physicians or to the trade that the Product is manufactured by or in any way connected with MSD or any of its Affiliates.span>p>
<p><b>2.12b><span style=”fontweight: 400;”> Notwithstanding anything to the contrary herein, MPP acknowledges that the license granted under this Section 2 is granted solely under and with respect to Patents and MSD Know-How for the purposes of final supply of the Products in the Territory.span>p>
<p><span style=”textdecoration: underline;”><b>3. Sublicensesb>span>p>
<p><b>3.1 Form of Sublicense.b><span style=”fontweight: 400;”> MPP shall not grant sublicenses other than in the form of the Sublicense and otherwise in accordance with this Section 3.span>p>
<p><b>3.2 Identification of Sublicensees.b><span style=”fontweight: 400;”> Subject to Sections 3.3 and 4.5, MPP may grant Sublicenses to any entity with demonstrated commitment, ability and readiness to develop and commercialize Product and/or Substance in the form of Sublicense. The Parties agree to meet and confer promptly following the Effective Date to agree on the criteria by which MPP will make such assessment.span>p>
<p><b>3.3 MSDs consent.b><span style=”fontweight: 400;”> MSD shall have the right of approval over any proposed Sublicensee, such approval not to be unreasonably withheld based on the criteria agreed to in Section 3.2. MSDs response will be provided within 30 days of MPPs initial written notice of intent to sign a Sublicense with a proposed Sublicensee, such notice to include reasonably adequate information regarding the proposed Sublicensee to permit MSD to assess the proposed Sublicensees compliance with the criteria defined in Section 3.2. In the event that MSD does not provide consent, MSD shall put forth in writing setting forth specific reasons for MSDs withholding of consent.span>p>
<p><span style=”textdecoration: underline;”><b>4. MPP Obligationsb>span>p>
<p><b>4.2 Improvements.b>p>
<p><span style=”fontweight: 400;”>(a) MPP shall require Sublicensees to disclose promptly to MSD in English, without charge, any span><a href=”#kt“><span style=”fontweight: 400;”>Improvementsspan>a><span style=”fontweight: 400;”>. As to any such <a href=”#kt“>Improvementsa> (including any patents or patent applications that may be filed by Sublicensee relating to such Improvements), MPP shall require that Sublicensees grant to MSD, its Affiliates, and MPP a worldwide, royaltyfree, nonexclusive, sublicensable license to any Improvements (“span><b><i>Improvement Licensei>b><span style=”fontweight: 400;”>”) for any and all purposes in the Field, including the rights to make, have made, use, and/or sell the Substance and/or the Product or any other pharmaceutical product using the Substance. For the avoidance of doubt, the Improvement License shall not affect the Sublicensees ownership of any Improvements. MPP shall not sublicense the Improvement License to any Third Party or to another Sublicensee without the consent of the Sublicensee.span>p>
<p><span style=”fontweight: 400;”>(b) Further to Section 4.2 (a), MSD or its Affiliates shall have the right to sublicense the Improvement License to a Third Party (“span><b><i>ThirdParty Sublicensei>b><span style=”fontweight: 400;”>”) as follows and shall negotiate and agree with Sublicensee in good faith a royalty and development fee to be paid to the Sublicensee for such ThirdParty Sublicense:span>p>
<p style=”paddingleft: 25px;”><span style=”fontweight: 400;”>(i) contractspan> <span style=”fontweight: 400;”> manufacturersspan> <span style=”fontweight: 400;”>for use in connection with the commercialization of MSD products; orspan>p>
<p style=”paddingleft: 25px;”><span style=”fontweight: 400;”>(ii) a Third Party in compliance with any contractual obligations that MSD or its Affiliates has with such Third Party.span>p>
<p><span style=”fontweight: 400;”>(c) MPP shall further require that Sublicensees grant to MSD and its Affiliates an option and right of first refusal to obtain a sole, sublicensable, worldwide, royaltybearing license to the Improvements in the Field, for any use outside the Field (“span><b><i>OutofField Licensei>b><span style=”fontweight: 400;”>”) including the rights to make, have made, use, and/or sell the Substance and/or the Product or any other pharmaceutical product using the Substance outside the Field. MSD shall negotiate and agree with Sublicensee in good faith a royalty and development fee to be paid to the Sublicensee for the OutofField License. For the avoidance of doubt, the OutofField License shall not affect the Sublicensees ownership of any Improvements to the Products.span>p>
<p><b><i>Form of Sublicense Agreementi>b>p>
<p><span style=”textdecoration: underline;”><b>2. Scope Of The Grantb>span>p>
<p><b>2.1 Within the Territory.b><span style=”fontweight: 400;”> Subject to the terms and conditions of this Agreement, MPP hereby grants to Licensee a nonexclusive, nontransferable, nonsublicensable license under the Territory Patents and MSD Know-How to manufacture the Product at a facility that is in the Territory (excluding any Sanctions Targets as defined in Section 6.3) and that is approved by a SRA or prequalified by the World Health Organization:span>p>
<p style=”paddingleft: 25px;”><span style=”fontweight: 400;”>(a) To Commercialize the Product by itself or through its Affiliates in the Territory for use in the Field;span>p>
<p style=”paddingleft: 25px;”><span style=”fontweight: 400;”>(b) To Retail the Product to other MPP Licensees or Authorized Suppliers for their Own Use within the Territory;span>p>
<p style=”paddingleft: 25px;”><span style=”fontweight: 400;”>(c) to register the Product in the Territory by itself or through its Affiliates for use in the Field for (a) and (d); andspan>p>
<p style=”paddingleft: 25px;”><span style=”fontweight: 400;”>(d) to sell the Product to Public Purchasers for the sole purpose of enabling the Public Purchasers to supply the Product in the Territory for use in the Field.span>p>
<p><b>2.2 Within the Territory.b><span style=”fontweight: 400;”> Subject to the terms and conditions of this Agreement, MPP hereby grants to Licensee a nonexclusive, nontransferrable, nonsublicensable span><span style=”fontweight: 400;”>license under the Territory Patents and MSD Know-How to manufacture the Substance at a facility that is in the Territory (excluding any Sanctions Targets as defined in Section 6.3) and that is approved by a SRA or prequalified by the World span><span style=”fontweight: 400;”>Health Organization;span>p>
<p style=”paddingleft: 25px;”><span style=”fontweight: 400;”>(a) to manufacture the Product in accordance with Section 2.1; andspan>p>
<p style=”paddingleft: 25px;”><span style=”fontweight: 400;”>(b) to Vend the Substance.span>p>
<p><b>2.3 Outside the Territory.b><span style=”fontweight: 400;”> Subject to the terms and conditions of this Agreement, MPP hereby grants to Licensee a nonexclusive, nontransferable, nonsublicensable license under the NonTerritory Patents and MSD Know-How manufacture the Product at a facility that is in a nonTerritory country (excluding any Sanctions Targets as defined in Section 6.3) and that is approved by a SRA or prequalified by the World Health Organization;span>p>
<p style=”paddingleft: 25px;”><span style=”fontweight: 400;”>(a) to export the Product to the Territory for its Own Use;span>p>
<p style=”paddingleft: 25px;”><span style=”fontweight: 400;”>(b) to Retail the Product in the Territory to other MPP Licensees or Authorized Suppliers for their Own Use; andspan>p>
<p style=”paddingleft: 25px;”><span style=”fontweight: 400;”>(c) to sell the Product to Public Purchasers for the sole purpose of enabling the Public Purchasers to supply the Product in the Territory for use in the Field.span>p>
<p><b>2.4 Outside the Territory.b><span style=”fontweight: 400;”> Subject to the terms and conditions of this Agreement, MPP hereby grants to Licensee a nonexclusive, nontransferrable, nonsublicensable license under the NonTerritory Patents and MSD Know-How to span><span style=”fontweight: 400;”>manufacture the Substance at a facility that is in a nonTerritory country (excluding any Sanctions Targets as defined in Section 6.3.) and that is approved by a SRA or span><span style=”fontweight: 400;”>prequalified by the World Health Organization;span>p>
<p style=”paddingleft: 25px;”><span style=”fontweight: 400;”>(a) to manufacture the Product in accordance with Section 2.3; andspan>p>
<p style=”paddingleft: 25px;”><span style=”fontweight: 400;”>(b) to Vend the Substance.span>p>
<p><b>2.5b><span style=”fontweight: 400;”> No license or right is granted by implication or otherwise with respect to the Substance and/or Product, except as expressly granted herein. Subject to the above and except as permitted by statute, the Licensee shall not be entitled to manufacture, use, Commercialize, Retail, Vend, register with regulatory agencies, and/or sell the Substance and/or the Product for any other purpose or in combination with anspan><span style=”fontweight: 400;”>other substance, product, intermediate, and/or active pharmaceutical ingredient (whether copackaged, coformulated or otherwise) (“Combination”) unless prior written approval had been provided by MSD in its sole discretion. For the avoidance of doubt, Parties agree that any approval of the Combination by MSD shall be subject to separate terms and conditions which shall be negotiated span><span style=”fontweight: 400;”>independently of this Agreement.span>p>
<p><b>2.6b><span style=”fontweight: 400;”> For the avoidance of doubt, nothing in this Agreement shall be construed to prevent the Licensee from engaging in activities inside or outside the Territory where such activities would not (1) infringe the Patents and/or any other intellectual property rights; and/or (2) misappropriate MSD Know-How. Licensee acknowledges that MSD has expressly reserved all its rights under the Patents, except as expressly set span><span style=”fontweight: 400;”>forth in the MSDMPP Agreement, and under any additional patents and/or patent applications owned or controlled by MSD. Licensee also acknowledges that MSD span><span style=”fontweight: 400;”>does not waive any applicable statutory and/or regulatory exclusivities owned or controlled by MSD, except as expressly set forth in the MSDMPP Agreement. Nothing in this Agreement shall provide a right to commercialize outside the span><span style=”fontweight: 400;”>Territory.span>p>
<p><b>2.7b><span style=”fontweight: 400;”> Except as otherwise provided and solely in the manner permissible under this Agreement, the license granted is solely for the stated Territory. Licensee and its Affiliates agree not to sell the Substance and/or the Product to any Third Party span><span style=”fontweight: 400;”>outside the Territory or to sell Substance and/or Product to any Third Party that Licensee or its Affiliates have reason to believe will resell the Substance and/or the Product outside of the Territory in breach of this Agreement. Licensee shall (a) span><span style=”fontweight: 400;”>include language on the packaging of such Product indicating that such Product is &#8220;not for resale&#8221; outside of the initial country of sale and (b) implement a system of batch control and tracing which will enable the identification and batch tracing of any such Product which are subsequently reexported outside the Territory. In addition, Licensee shall use its best efforts, including but not limited to including provisions in its customer contracts and purchase orders, to ensure that all of its customers and any subsequent purchasers of the Product in all countries of the Territory shall not sell the Product or offer the Product for sale outside of the initial country of sale. If MPP or MSD becomes aware of any Commercialization of Product outside the Territory in breach of this Agreement, MPP or MSD (through MPP) shall provide the relevant information to Licensee, and Licensee shall promptly take all possible steps to prevent any further reexports through the distribution channel or channels identified in such information.span>p>
<p><b>2.8b><span style=”fontweight: 400;”> If Licensee wishes to Commercialize or sell the Product through an Affiliate of the Licensee acting on Licensees behalf, Licensee shall first provide prior written notification to MPP and MSD. Upon MPPs or MSDs request, Licensee will span><span style=”fontweight: 400;”>provide MPP or MSD with a written copy of Licensees agreement(s) with such Affiliate and will certify to MPP and MSD in writing that such agreement(s) is/are consistent with the terms and conditions of this Agreement. MPP and MSD have the right to review all such agreements to verify consistency with the terms and conditions of this Agreement. In the event that any inconsistency is found which had not been specifically discussed with, and agreed to in writing by MSD, MPP or MSD shall have the right to require Licensee to amend such agreement with such Affiliate to be consistent with the terms and conditions of this Agreement. Licensee shall be held responsible for the actions of any of its Affiliates or any other permitted assignees/transferees in connection with this Agreement, and all obligations of Licensee under this Agreement in connection with the sale and Commercialization of the Product in the Territory will be deemed to apply to such span><span style=”fontweight: 400;”>activities conducted by any of its Affiliates and permitted assignees/transferees.span>p>
<p><b>2.9b><span style=”fontweight: 400;”> The license granted under Sections 2.1 to 2.4 above does not include a license to other intellectual property that MSD may possess with respect to the Substance and/or the Product, other than the Territory Patents, the NonTerritory Patents, and MSD Know-How, as expressly provided herein. For clarity, license granted under Sections 2.1 to 2.4 above does not include a license to processes or procedures for span><span style=”fontweight: 400;”>the manufacture, production, packaging, labeling, warehousing, and quality control testing of the Substance and/or the Product that are not included in the Patents and/or MSD Know-How.span>p>
<p><b>2.10b><span style=”fontweight: 400;”> Except as expressly set forth in this Agreement, (1) MPP does not grant any license to Licensee under any of MSD intellectual property rights (including, without limitation, patents or rights to any MSD proprietary compounds or drug substances other than the Substance), and (2) Licensee shall other than the Substance), and (2) Licensee shall not take any action which would constitute an infringement of any of the Patents.span>p>
<p><span style=”textdecoration: underline;”><strong>3A. Trademarksstrong>span>p>
<p><b>3A.1b><span style=”fontweight: 400;”> No rights in any MSD Trademarks are granted to Licensee under this Agreement, and Licensee shall not appropriate or otherwise use or register any MSD Trademarks in connection with the Product in the Territory, including without limitation in connection with the sale, distribution, promotion, or marketing of the Product. A complete description of any trademark proposed to be used or registered by Licensee span><span style=”fontweight: 400;”>in connection with the sale of the Product in the Territory shall be submitted to MPP for MSDs written approval prior to use or filing an application to register such trademark. MPP shall promptly review such request and refer it to MSD. The Licensee shall provide any additional information required by MPP in relation to such request. The response to the Licensee for any request for approval shall be given within 30 days span><span style=”fontweight: 400;”>of receipt by MSD from MPP of all relevant documentation necessary to consider the Licensees request. Such approval may be withheld if the subject trademark is determined by MSD, in its sole discretion, to be identical to or confusingly similar to any MSD Trademark, however any such approval shall not waive any rights with respect to the MSD Trademarks.span>p>
<p><b>3A.2b><span style=”f