Provision Language
Definitions
“Authorized Supplier” 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.
“MSD Know-How” shall mean all Know-How, 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.
“Public Purchasers” 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) Non–Governmental Organizations to the extent that they are recognized by the applicable local government ministries from such country; (ii) UN–related organizations working for or in such country, including but not limited to UNDP and UNICEF; (iii) Not–for–profit organizations including without limitation, Médecins Sans Frontières, Save–the–Children, OXFAM and the International Committee of the Red Cross (ICRC) to the extent that they are recognized by 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 extent that such procurements are supporting not–for–profit programs in such country as described in (a) of this definition within the Territory.
“Non–Territory Patents” 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 Non–Territory Patents only with respect to countries not included in the Territory.
“Territory Patents” 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 regional patent applications are included in Patents, such international and regional patent applications are Territory Patents only with respect to countries within the Territory.
“Vend” 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. (“Own Use” shall mean the act of Commercialization and/or the act of registration of the Product in the Territory for use in the Field.)
MSD–MPP Agreement
2. Scope Of The Grant
2.1 Within the Territory. Subject to the terms and conditions of this Agreement, MSD hereby grants to MPP a non–exclusive, non–transferable 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 SRA or prequalified by the World Health Organization:
(a) To Commercialize the Product by itself or through its Affiliates in the Territory for use in the Field;
(b) To Retail the Product to other Sublicensees or Authorized Suppliers for their Own Use within the Territory;
(c) to register the Product in the Territory for use by itself or through its Affiliates in the Field for (a) and (d); and
(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.
2.2 Within the Territory. Subject to the terms and conditions of this Agreement, MSD hereby grants to MPP a non–exclusive, non–transferrable 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 SRA or prequalified by the World Health Organization;
(a) to manufacture the Product in accordance with Section 2.1; and
(b) to Vend the Substance.
2.3 Outside the Territory. Subject to the terms and conditions of this Agreement, MSD hereby grants to MPP a non–exclusive, non–transferable license under the Non–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 a non–Territory 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;
(a) to export the Product to the Territory for its Own Use;
(b) to Retail the Product in the Territory to other Sublicensees or Authorized Suppliers for their Own Use; and
(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.
2.4 Outside the Territory. Subject to the terms and conditions of this Agreement, MSD hereby grant to MPP a non–exclusive, non–transferrable license under the Non–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 a non–Territory 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;
(a) to manufacture the Product in accordance with Section 2.3; and
(b) to Vend the Substance.
2.5 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 co–packaged, co–formulated 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 independently of this Agreement.
2.6 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 co–packaged, co–formulated or otherwise) unless prior written approval had been provided by MSD in its sole discretion.
2.7 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.
2.8 MPP acknowledges that the license granted pursuant to Sections 2.1, 2.2, 2.3 and 2.4 is non–exclusive and that MSD retains the right in its sole discretion to:(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.
2.9 MSD shall provide, upon MPP’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.
2.10 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.
2.11 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 Sublicensee’s 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.
2.12 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.
3. Sublicenses
3.1 Form of Sublicense. MPP shall not grant sublicenses other than in the form of the Sublicense and otherwise in accordance with this Section 3.
3.2 Identification of Sublicensees. 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.
3.3 MSD’s consent. 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. MSD’s response will be provided within 30 days of MPP’s 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 Sublicensee’s 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 MSD’s withholding of consent.
4. MPP Obligations
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4.2 Improvements
(a) MPP shall require Sublicensees to disclose promptly to MSD in English, without charge, any Improvements. As to any such Improvements (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 world–wide, royalty–free, non–exclusive, sublicensable license to any Improvements (“Improvement License”) 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 Sublicensee’s 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.
(b) Further to Section 4.2 (a), MSD or its Affiliates shall have the right to sublicense the Improvement License to a Third Party (“Third–Party Sublicense”) 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 Third–Party Sublicense:
(i) contract manufacturers for use in connection with the commercialization of MSD products; or
(ii) a Third Party in compliance with any contractual obligations that MSD or its Affiliates has with such Third Party.
(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, world–wide, royalty–bearing license to the Improvements in the Field, for any use outside the Field (“Out–of–Field License”) 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 Out–of–Field License. For the avoidance of doubt, the Out–of–Field License shall not affect the Sublicensee’s ownership of any Improvements to the Products.
Form of Sublicense Agreement
2. Scope Of The Grant
2.1 Within the Territory. Subject to the terms and conditions of this Agreement, MPP hereby grants to Licensee a non–exclusive, non–transferable, non–sublicensable 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:
(a) To Commercialize the Product by itself or through its Affiliates in the Territory for use in the Field;
(b) To Retail the Product to other MPP Licensees or Authorized Suppliers for their Own Use within the Territory;
(c) to register the Product in the Territory by itself or through its Affiliates for use in the Field for (a) and (d); and
(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.
2.2 Within the Territory. Subject to the terms and conditions of this Agreement, MPP hereby grants to Licensee a non–exclusive, non–transferrable, non–sublicensable 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 Health Organization;
(a) to manufacture the Product in accordance with Section 2.1; and
(b) to Vend the Substance.
2.3 Outside the Territory. Subject to the terms and conditions of this Agreement, MPP hereby grants to Licensee a non–exclusive, non–transferable, nonsublicensable license under the Non–Territory Patents and MSD Know-How manufacture the Product at a facility that is in a non–Territory 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;
(a) to export the Product to the Territory for its Own Use;
(b) to Retail the Product in the Territory to other MPP Licensees or Authorized Suppliers for their Own Use; and
(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.
2.4 Outside the Territory. Subject to the terms and conditions of this Agreement, MPP hereby grants to Licensee a non–exclusive, non–transferrable, nonsublicensable license under the Non–Territory Patents and MSD Know-How to manufacture the Substance at a facility that is in a non–Territory 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;
(a) to manufacture the Product in accordance with Section 2.3; and
(b) to Vend the Substance.
2.5 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 another substance, product, intermediate, and/or active pharmaceutical ingredient (whether co–packaged, co–formulated 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 independently of this Agreement.
2.6 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 forth in the MSD–MPP Agreement, and under any additional patents and/or patent applications owned or controlled by MSD. Licensee also acknowledges that MSD does not waive any applicable statutory and/or regulatory exclusivities owned or controlled by MSD, except as expressly set forth in the MSD–MPP Agreement. Nothing in this Agreement shall provide a right to commercialize outside the Territory.
2.7 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 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) include language on the packaging of such Product indicating that such Product is “not for resale” 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 re–exports through the distribution channel or channels identified in such information.
2.8 If Licensee wishes to Commercialize or sell the Product through an Affiliate of the Licensee acting on Licensee’s behalf, Licensee shall first provide prior written notification to MPP and MSD. Upon MPP’s or MSD’s request, Licensee will provide MPP or MSD with a written copy of Licensee’s 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 activities conducted by any of its Affiliates and permitted assignees/transferees.
2.9 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 Non–Territory 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 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.
2.10 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.
3A. Trademarks
3A.1 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 in connection with the sale of the Product in the Territory shall be submitted to MPP for MSD’s 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 of receipt by MSD from MPP of all relevant documentation necessary to consider the Licensee’s 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.
3A.2 In addition to the foregoing, for the avoidance of doubt, Licensee agrees that it shall 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 to (as MSD shall determine in its sole discretion) 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.
5. Intellectual Property
5.1 Licensee shall disclose, promptly and in English, to MPP and MSD, without charge, any Improvements. As to any such Improvements (including any patents or patent applications that may be filed by Licensee relating to such Improvements), Licensee shall grant to MSD, its Affiliates, and MPP a world–wide, royalty–free, non–exclusive, sublicensable license to any Improvements (“Improvement License”) 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 Licensee’s ownership of any Improvements. MPP shall not sublicense the Improvement License to any Third Party or to another MPP Licensee without the consent of the Licensee.
5.2 Further to Section 5.1, Licensee shall grant to MSD and/or its Affiliates the right to sublicense the Improvement License to a Third Party (“Third–Party Sublicense”) as follows, and Licensee shall negotiate and agree with MSD and/or its Affiliates in good faith a royalty and development fee to be paid to the Licensee for such Third–Party Sublicense:
(iii) contract manufacturers for use in connection with the commercialization of MSD products; or
(iv) a Third Party in compliance with any contractual obligations that MSD or its Affiliates has with such Third Party.
5.3 Licensee shall grant to MSD and its Affiliates an option and right of first refusal to obtain a sole, sublicensable, world–wide, royalty–bearing license to the Improvements in the Field, for any use outside the Field (“Out–of–Field License”) 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 Licensee in good faith a royalty and development fee to be paid to the Licensee for the Out–of–Field License. For the avoidance of doubt, the Out–of–Field License shall not affect the Licensee’s ownership of any Improvements to the Products.