Provision Language
MOU
2. Description of Proposed Collaboration
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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.
Annexure A: License Agreement
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
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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”).
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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.
7. NON-DIVERSION
7.1 Save as provided under this Agreement, and to the extent that such restrictions comply with applicable law, the Licensee shall not, directly or indirectly, sell or supply Licensed Product outside the Territory, or sell or supply Licensed Product to any Third-Party that the Licensee knows, believes or ought reasonably to suspect will sell or supply Licensed Product outside the Territory.
7.2 The Licensee shall ensure that packaging (whether external, intermediate or internal), data sheets and promotional materials for the Licensed Product to be sold or otherwise supplied by the Licensee under this Agreement shall carry clear statements in bold type that:
(a) the Licensed Product has been manufactured under a license from the Licensor; and
(b) any other statements stipulated in the Trade Dress Guidance.
These obligations are further elaborated in the Trade Dress Guidance.
7.3 The Licensee agrees that any Licensed Product sold pursuant to this Agreement will be visually differentiated from any ICH zone IV stable carbetocin product or other product sold by Ferring in a manner further elaborated under the Trade Dress Guidance. Licensee will submit trade dress documents required by the Trade Dress Guidance to Licensor (through the designated trade dress portal of the Licensor) for the Licensor’s and Ferring’s approval. Licensee agrees not to manufacture batches of Licensed Product or to sell Licensed Product pursuant to this Agreement until the Licensor and Ferring have approved the brand name, packaging and presentation of the trial batches, such approval will not be unreasonably withheld, delayed or conditioned. Once Licensor and Ferring have approved the brand name, packaging and presentation of the trial batches (i) the Licensor agrees not to make any additional requests for differentiation (except as provided in Section 7.4 below), and (ii) the Licensee agrees only to sell Licensed Product that conforms to the brand name, packaging and presentation of the trial batch approved by the Licensor and Ferring pursuant to this Section 7.3.
7.4 Without prejudice to Section 7.3, Licensee agrees to comply with such additional requirements for differentiation of the packaging of Licensed Product as Ferring may reasonably request and agrees to use its reasonable endeavours to ensure timely registration of the variation with all Relevant Regulatory Authorities as they may require.
7.5 The Licensee shall give written notice, of the restrictions contained in this Section 7 to any Third-Party to which it sells the Licensed Product, prior to any sale of the Licensed Product to such Third-Party, and the Licensee shall use its best endeavours, without prejudice to any other provision of this Agreement, to ensure that such Third-Party(ies) will undertake to abide by the restrictions contained in this Section 7 and will assist the Licensor and Ferring in securing compliance with this Section 7 and the restrictions which it contemplates.