Provision Language
Definitions
“Licensed Know-How” shall mean all Know-How that (a) is owned or controlled by Ferring and/or its Affiliates as of the Effective Date and (b) is reasonably necessary in the development or manufacture of the Licensed Product as reasonably determined by Ferring.
“Licensed Patent(s)” shall mean those patents and patent applications (as set forth in Appendix B) covering the Licensed Product, and any additions, divisions, continuation, continuation-in-part, substitutions, and reissues claiming priority thereto, as well as any re-examinations, extensions, registrations, patent term extensions, supplemental protection certificates, renewals and the like with respect to any of the foregoing and foreign equivalents thereof.
“Licensed Product” shall mean a pharmaceutical product containing the ICH zone IV stable formulation of 100mcg/mL carbetocin for intramuscular administration, packaged in ampoules.
MOU
2. Description of Proposed Collaboration
a) If and when each of the following criteria are met, the Parties agree to execute the License Agreement (attached hereto as Annexure A), to cover the Public Sector in the Target Countries:
i) HSC for the treatment of PPH is included in the relevant WHO guidelines on PPH; and
ii) at least one Stringent Regulatory Authority (defined in the License Agreement) has approved an extension of the HSC product label to include the treatment of PPH; and
iii) Ferring and/or its authorized distributors receive confirmed orders of at least ten (10) million ampoules (in aggregate and less any returns) of HSC for use in prevention and treatment of PPH (“Field”) in the Public Sector of the Target Countries as calculated on a rolling twelve (12) month basis during the Term, and as evidenced in writing by order reports provided by Ferring to MPP on a quarterly basis, which details the monthly orders.
(1) MPP acknowledges that Ferring uses an authorized third-party distributor to distribute HSC packaged in ampoules to the Public Sector of the Target Countries (except India) and the data from such countries shall be based on reports provided by Ferring’s authorized distributor. Ferring supplies HSC directly in India and MPP acknowledges that the data provided by Ferring for orders of HSC packaged in ampoules for the Public Sector in India shall be from reports provided by a Ferring affiliate in India.
(2) The Parties shall have quarterly business meetings to review and discuss the order reports, to evaluate then-current market conditions, Ferring’s forecasts, and assess trends or performance towards the demand threshold set forth above.
(3) The records provided directly by Ferring and/or its third-party authorized distributor in support of its calculation of the demand threshold set forth in Section 2a)iii) above may be subject to an audit by MPP upon reasonable advance written notice to Ferring, during Ferring’s normal business hours and at mutually agreed upon times. The audit shall be subject to a mutually agreed upon confidentiality agreement and any applicable laws pertaining to confidentiality of personal data that may be contained in such records. The audit shall be performed by MPP’s external auditors (provided that such external auditors shall be a reputable international firm of accountants). The audits may occur no more than once every twenty-four (24) months during the Term. The audits shall be limited to a conclusion of whether or not the calculation of the volume threshold reported during the previous twenty-four (24) month period was accurate. This conclusion shall be used solely for the purpose of determining whether the criterion for in-licensing as set forth in Section 2a)iii) above has been met and, if not, what adjustment is necessary to correct the calculations for the purpose of determining whether the criterion in Section 2a)iii) above is met. The audits shall be conducted at MPP’s sole cost and expense.
b) Once the criteria in Section 2a) above are met, the Parties shall memorialize in writing, their agreement that the criteria have been met and shall promptly execute the License Agreement in furtherance thereof.
c) MPP will identify appropriate generic manufacturing or other partners that have the R&D, manufacturing and/or commercial capabilities to produce and supply the Licensed Product (defined in the License Agreement), in accordance with the terms of the License Agreement, and will provide to Ferring such list of potential sublicensees for approval, prior to executing any sublicense agreements with such firms.
d) The terms of this MOU and any License Agreement (including any applicable sublicense agreements) executed in connection herewith are limited to the Public Sector of Target Countries.
i) “Public Sector” is defined as a government, or a department or agency thereof, or a non-profit non-governmental organization or other entity recognized by the government, procuring and/or distributing reproductive health products for and/or in the Target Countries, including WHO and any other organization within the United Nations system.
ii) “Target Country(ies)” is/are defined as: (a) low-income and lower middle-income countries; and (b) upper middle-income countries, if and to the extent such upper middle-income countries have an elevated incidence of maternal mortality, defined as being greater than 140 per 100,000 live births, and such countries fulfil one of the following additional criteria: (i) capability to maintain cold chain is an issue; or (ii) the normal commercial price for HSC would constitute an impediment to access in the Public Sector (it being understood that low income, lower-middle income and upper-middle income countries will be determined based on then-current World Bank classifications).
A list of the Target Countries will be established, based on the criteria set out above, and will be included as an exhibit/schedule to the executed License Agreement. Ferring and the MPP will agree on an appropriate mechanism to update this list on a regular basis, as set forth in the License Agreement.
e) Any license granted under the License Agreement will be a non-exclusive, non-transferable, royalty-free license for sales in the Public Sector of the Target Countries and will cover the Field. This MOU shall not be construed as a waiver of any Ferring rights anywhere in the world, nor shall it be construed as a grant of rights to MPP or any other party to use any Ferring intellectual property rights anywhere in the world for any purpose other than as explicitly provided in this MOU and the License Agreement. Requests for sublicenses pursuant to the License Agreement shall be submitted to Ferring and shall require Ferring’s written approval (not to be unreasonably withheld) and the License Agreement to be executed prior to any such sublicense being granted.
Annexure A: License Agreement
2. GRANT OF LICENSE
2.1. Subject to the terms and conditions of this Agreement, Ferring hereby grants to MPP a non-exclusive, non-transferable, royalty-free license under the Licensed Patents and Licensed Know-How to enter into Sublicenses with Sublicensees solely to Exploit the Licensed Product and solely for use in the Field in the Territory. No rights are hereby granted for any other purpose and MPP agrees that it will not use the Licensed Patents and/or Licensed Know-How itself or grant sublicenses: (i) to entities other than Sublicensees; and/or (ii) other than in the form of the Sublicense.
3. SUBLICENSE
3.1. The Parties intend that MPP will identify potential manufacturers of pharmaceutical products with a view to enter into Sublicenses. Upon identification of such a manufacturer, in each case, MPP shall provide notice to Ferring of the identity of the manufacturer (including the name, address, principal place of business, list of affiliated entities) and provide Ferring with (i) the information contemplated by Section 3.2, (ii) the complete development, manufacturing and commercialization plans proposed by the manufacturer, including without limitation the proposed supply chain of the Licensed Product; and (iii) any additional information that may be at the time reasonably requested by Ferring to enable Ferring to evaluate a proposed Sublicensee.
3.2. MPP shall only enter into Sublicenses with entities that have produced reasonable evidence demonstrating their intent and capability to: (i) comply with applicable laws relating to corruption (including but not limited to: anti-bribery laws and the U.S. Foreign Corrupt Practices Act and the UK Bribery Act), where certification to this effect, absent other contrary evidence, shall constitute reasonable evidence under this Section 3.2; (ii) manufacture and distribute Licensed Product in a manner consistent with GDP and GMP, and either WHO pre-qualification standards or the standards of any Stringent Regulatory Authority; and (iii) make the Licensed Product available in the Territory at terms that will facilitate access to the Licensed Product solely for use in the Field within the Territory.
3.3. MPP shall not enter into a Sublicense with a party without Ferring’s prior written consent with respect to that party. Ferring’s consent shall not be withheld, except as reasonably based upon the Sublicensee requirements set forth in this Section 3 not being met. Ferring’s consent shall be understood as granted unless otherwise notified by Ferring in writing within thirty (30) days of MPP’s initial written notice to Ferring pursuant to this Section 3.3. Ferring’s consent to a Sublicense pursuant to this Section 3.3 shall not waive or derogate from any other obligation of MPP under this Agreement. If Ferring reasonably objects to a Sublicense being granted pursuant to this Section 3.3, the Parties shall discuss in good faith Ferring’s concerns and any potential mitigations necessary to address Ferring’s concerns and if not appropriately mitigated as reasonably determined by Ferring, such sublicense shall not be granted.
3.4. MPP shall not grant sublicenses other than in the form of the Sublicense (after receiving Ferring’s prior written consent as set forth above).
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3.6. MPP acknowledges that the number of Sublicenses entered into with Sublicensees pursuant to this Agreement must be commensurate to the need for Licensed Product for use in the Field in the Territory or in specific Target Countries within the Territory.
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4. MONITORING AND COMPLIANCE
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4.8. Ferring shall provide MPP the Trade Dress Guidance and shall keep it up to date, and any additional new and/or future Ferring trade dress as soon as practicable after Ferring considers such information no longer to be confidential.
4.9. Ferring does not grant any rights to MPP or Sublicensees under this Agreement to use or register any trademark, service mark, trade dress, symbol, device, company name or domain name (or any confusingly similar trademark, service mark, trade dress, symbol, device, company name or domain name) that is used or registered by Ferring and/or its Affiliates. MPP shall require that Sublicensees do not use or seek to register (or, where it is possible to do so, apply to use or register) any trademark, service mark, trade dress (where applicable), symbol, device, company name or domain name in relation to any Licensed Product or any of their packaging (whether external, intermediate or internal) or promotional material which incorporates or is identical with or confusingly similar to any trademark, service mark, trade dress, symbol, device, company name or domain name used or registered by Ferring and/or its Affiliates anywhere in the world.
Annexure A, Schedule 2
LIST OF COUNTRIES FORMING THE TARGET COUNTRIES
Below is the initial list of Target Countries. The Parties shall consult at least every three years [(starting in INSERT CALENDAR YEAR)] in order to update and include in or delete from the then-current version of Schedule 2 any country, territory or area that, as relevant: (1) has been or ceases to be classified as low income or lower-middle income by the World Bank, or (2) has been or ceases to be classified as upper middle income by the World Bank and meets or ceases to meet the criteria set out in Section 1)(s)(2) of this Agreement. As part of the aforementioned consultation between the Parties, to the extent that a country, territory or area is to be deleted from the then-current version of Schedule 2, and Sublicensee has sold the Licensed Product in such country, territory or area in compliance with the terms and conditions of the Sublicence, the Parties shall consider and agree on a case-by-case basis, in good faith, on a transition plan for the continued sale of the Licensed Product and any limitations thereto, in such country, territory or area, as appropriate.
Any update of the list included in this Schedule 2 shall be added to this Agreement via a signed written amendment and shall replace the preceding list. All references to Schedule 2 shall be deemed to refer to the then-current version of this Schedule.
Annexure A, Schedule 3: Form of Sublicense
2. GRANT OF LICENSE
2.1 Subject to the terms and conditions of this Agreement and to the extent to which the Licensor has the right to grant a license in respect of the Licensed Patents and the Licensed Know-How, the Licensor hereby grants to the Licensee a non-exclusive, non-sublicensable, non-transferable, royalty-free license under the Licensed Patents and Licensed Know-How solely to Exploit the Licensed Product and solely for use in the Field in the Territory.
2.2 Notwithstanding anything contained in this Agreement, nothing in this Agreement shall be construed to prevent the Licensee from engaging in any activities that would not infringe a Licensed Patent granted and in force, including, without limitation, where a country has issued a compulsory license on a Licensed Patent.
2.3 The Licensee shall only supply Licensed Product pursuant to and in accordance with this Agreement for use in the Territory and pursuant to a procurement process of any Public Sector entity in or for the benefit of the Target Countries, only if the supply contemplated by that procurement is approved in writing by the Licensor, with such approval to be provided no later than five (5) Business Days after receipt of the request for approval, unless the Licensor has expressly indicated that approval is not granted (an “Approved Public Market Procurement”).
2.4 Other than as set forth in Section 2.1, no rights are granted to the Licensee under this Agreement to Exploit the Licensed Product inside or outside the Target Countries. Notwithstanding any other provision of this Sublicense Agreement, Ferring and MPP make no representation or warranty of non-infringement or any representation or warranty that the Licensed Patent Rights or Licensed Know-How is suitable for any purpose for which it may be used by the Licensee.
2.5 The Licensee’s license to have manufactured by a Third-Party, Licensed Product in accordance with Section 2.1 shall be limited solely to manufacture on behalf of the Licensee of Licensed Product for supply to the Licensee. Section 2.1 shall not be construed as conferring any right for a Third-Party to manufacture Licensed Product for supply to any party other than the Licensee (as applicable). Such Third-Party manufacturer must be approved in writing by the Licensor prior to engaging in any development or manufacturing activities on behalf of Licensee.
2.6 For the avoidance of doubt, this Agreement confers no rights on the Licensee to sublicense its rights hereunder, which is expressly prohibited. The Licensee shall procure that any Third-Party manufacturer shall comply with the terms of this Agreement as if it was the Licensee, and the Licensee shall remain fully liable for the acts or omissions of such Third-Party manufacturer.
2.7 The Licensee shall, acting in compliance with this Agreement and all applicable laws and regulations, use its best endeavours to maximize access to the Licensed Product for use in the Field in the Territory.
2.8 It is expressly acknowledged by the Licensee that this Agreement confers no intellectual property rights whatsoever on the Licensee other than those expressly granted in Section 2.1 for the Term of this Agreement. Without prejudice to the generality of the foregoing, other than as expressly granted in Section 2.1, no license is granted to the Licensee:
(a) to perform any acts or omissions which infringe any rights (including, but not limited to, patent and/or intellectual property rights) of the Licensor, Ferring and/or any of their Affiliates and/or their sublicensees within or outside the Target Countries;
(b) to perform any acts or omissions which infringe any rights of any Third-Party (including, without limitation, Ferring) within or outside the Target Countries; or
(c) in relation to the Licensed Patents and Licensed Know-How, to Exploit the Licensed Product where such Licensed Product would be supplied directly or indirectly to (i) the Private Sector within or outside the Target Countries or (ii) the Public Sector outside the Target Countries, or (iii) for use outside the Field within our outside the Territory and/or for any indication or patient population other than as set forth on the Licensed Product’s approved label.
2.9 Nothing in this Agreement shall be deemed to constitute a license for the Licensee to manufacture, import, use or supply any active ingredient other than those identified in the Licensed Know-How.
2.10 Notwithstanding the Effective Date of this Agreement, the Licensee undertakes not to sell or offer for sale a Licensed Product in a Target Country in the Territory prior to (i) the relevant Approval Date for that Licensed Product for that Target Country and (ii) WHO prequalification or approval by a Stringent Regulatory Authority (or, as a provisional measure, the review of the Licensed Product by a WHO Expert Review Panel and a notification of no-objection from that WHO Expert Review Panel for time-limited use of the Licensed Product).
2.11 Where this Agreement requires the Licensee to obtain approval from Ferring, the Licensee shall request such approval through the Licensor.
8. INTELLECTUAL PROPERTY
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8.2 Licensee hereby grants to Licensor and Ferring a perpetual, irrevocable, worldwide, royalty free, non-exclusive license to use any Improvement, Improvement Patent and related know-how (and shall promptly execute such document as Ferring may reasonably request accordingly). Licensor shall not sub-license such rights to any Third-Party, provided, however, that should Licensor desire to sub-license any such rights, Licensee and Licensor agree to enter into good-faith negotiations regarding such sub-license. Ferring shall be entitled to grant sub-licenses (without further right to sub-license) under such license only to its Affiliates and/or contract manufacturers, distributors and service providers solely for use in connection with their engagement of commercialising Ferring products.
8.3 In the event that Licensee develops a new formulation of the Licensed Product, Licensee will grant to Ferring an option and right of first refusal to negotiate further mechanisms to make the new formulation available in countries outside the Target Countries, including but not limited to licensing or purchase of such new formulations by Ferring.
9. TRADEMARKS AND NON-PROPRIETARY NAMES
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9.2 The Licensee shall not use or seek to register (or, where it is possible to do so, apply to use or register) any trademark, service mark, trade dress (where applicable), symbol, device, company name or domain name in relation to any Licensed Product or any of their packaging (whether external, intermediate or internal) or promotional material which incorporates or is identical with or confusingly similar to any trademark, service mark, trade dress, symbol, device, company name or domain name used or registered by the Licensor, Ferring and/or any of their Affiliates anywhere in the world. This Section shall be without prejudice to any legal rights the Licensee may have in relation to the use of a trademark, service mark, trade dress, symbol, device, company name or domain name which is identical with or confusingly similar to any trademark, service mark, trade dress, symbol, device, company name or domain name used by the Licensor, Ferring and/or any of their Affiliates anywhere in the world where that use by the Licensee would not infringe the rights of the Licensor, Ferring and/or any of their Affiliates. If the Licensor and/or Ferring become aware that the Licensee is in breach of this Section 9.2, the Licensee shall immediately stop any such use and withdraw any such trademark application and/or registration upon request by the Licensor and/or Ferring.
9.3 The Licensee shall obtain the prior written approval in accordance with the procedures set out in the Trade Dress Guidance, such approval not to be unreasonably withheld or conditioned, of the Licensor and Ferring for all trademark, service mark, trade dress (where applicable), symbols, devices, company names or domain names which the Licensee proposes to use in relation to the Licensed Product or any of their packaging (whether external, intermediate or internal) or promotional material before seeking to register any such trademarks, before offering to sell, selling or otherwise disposing of any Licensed Product, and before applying for government or relevant regulatory authorization to do so. The Licensor and Ferring shall respond to any request for approval from the Licensee within thirty (30) days of receipt by Ferring (from the Licensor) of all the relevant documentation necessary to consider the Licensee’s request, with an approval or a written statement of why the request is not being approved by Ferring. For the avoidance of doubt, the Trade Dress Guidance does not limit in any way the Licensor and/or Ferring’s right to refuse to provide approval under this Section 9.3, and the basis of Ferring’s refusal to provide approval under this Section 9.3 shall not be limited to breaches of Section 9.2.
9.4 For the avoidance of doubt, any approval provided by the Licensor and/or Ferring under Section 9.3 is not to be interpreted as acquiescence by the Licensor and/or Ferring that any packaging and/or labelling complies with any local legal or regulatory requirements, which remains the Licensee’s responsibility.
9.5 If Licensee wishes to use the Ferring name (or use of the Ferring name is required by a local regulatory authority or for any other reason) on packaging or in promotional materials, a request for prior written approval will be made through the Trade Dress Guidance submission process in accordance with Section 9.3.