Provision Language
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:
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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.
Annexure A: License Agreement
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.
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4. MONITORING AND COMPLIANCE
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4.2. MPP agrees to monitor the compliance with each Sublicense by each Sublicensee, including but not limited to by:
4.2.1. Using reasonable endeavours to ensure that Sublicensees provide reports to MPP in accordance with the Sublicense, and reviewing with all reasonable skill and care any such reports;
4.2.2. within thirty (30) days following the end of each Agreement Quarter, reporting to Ferring which Sublicensees (if any) have not complied with their reporting obligations under the Sublicense and what action MPP has taken to facilitate compliance of such Sublicensees;
4.2.3. within thirty (30) days following the end of each Agreement Quarter, sending to Ferring a copy of any reports provided to MPP under the Sublicense;
4.2.4. fully exercising the audit right set out in the Sublicense at MPP’s own cost as soon as MPP has reasonable cause to believe (and/or as soon as Ferring has notified MPP that Ferring has reasonable cause to believe) an audit is necessary (including without limitation where such a party has reasonable grounds for suspecting non-compliance with the Sublicense); and
4.2.5. assessing with all reasonable skill and care whether any requests for prior written approval for trademarks, service marks, trade dress (where applicable), symbols, devices, company names or domain names provided to MPP by Sublicensees under the Sublicense comply with the Trade Dress Guidance, and submitting to Ferring for written approval, those (and only those) requests which MPP considers meet the criteria provided in the Trade Dress Guidance. Ferring shall respond to any request for approval within thirty (30) days of receipt by Ferring of all the relevant documentation necessary to consider the Licensees’ request.
4.3. Ferring agrees to treat any information of Sublicensees provided to it under this Section 4 as Confidential Information and the confidentiality obligations of the Sublicense shall apply, mutatis mutandis, to Ferring with respect to such information.
4.4. Where the Sublicense requires the Sublicensee to obtain approval from Ferring, MPP shall facilitate the provision of such approval in accordance with the Sublicense.
4.5. If MPP becomes aware of any act or omission of a Sublicensee which constitutes a breach of the relevant Sublicense, MPP shall immediately notify Ferring and (i) if the breach is capable of correction and does not give rise to an immediate right of termination under the Sublicense, direct the relevant Sublicensee in writing to cure the breach, with a copy of that writing to Ferring; and (ii) if the breach remains uncured at the end of the specified period, or if there are otherwise grounds for termination under the relevant Sublicense, and in each case if so requested by Ferring, procure the termination of the relevant Sublicense in accordance with its terms.
Annexure A, Schedule 3: Form of Sublicense
3. COMMERCIALISATION AND REGISTRATION
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3.7 Within ten (10) Business Days following the end of each Agreement Quarter, the Licensee shall provide the Licensor with a quarterly written report on the status of development of, and any planned, as well as any filed and/or obtained, regulatory filing, and/or submissions for WHO prequalification and/or WHO Expert Review Panel review regarding the Licensed Product in relation to that Agreement Quarter. Such reporting shall be made in accordance with the Reporting Guidance issued by the Licensor and should cover (a) status of development of the Licensed Product, (b) regulatory filing plan for the Licensed Product, and (c) a list of countries for which such regulatory approvals or authorizations have been filed and/or obtained for the Licensed Product. The Parties agree to confer on a quarterly basis regarding such reports and also review development and filing status of the Licensed Product. Licensor shall provide Ferring with a copy of the reports produced pursuant to this Section 3.7 in accordance with the Head License. For avoidance of doubt, Ferring and the Licensor agree that information contained in quarterly and other such reports shall be treated as Confidential Information.
8. INTELLECTUAL PROPERTY
8.1 If at any time during the term of this Agreement the Licensee and/or its Affiliates (or any of their employees, agents, or other persons acting under its authority) makes, develops, conceives, acquires, reduces to practice, becomes entitled to or secures control over any Improvement it shall communicate such Improvement to Licensor and Ferring in full together with all available information concerning the mode of working and using the same. Licensor and Ferring shall treat this information as Confidential Information.
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10. STATEMENTS AND REMITTANCES
10.1 At all times the Licensee shall, to the extent permitted by law, keep, and shall require its Affiliates and any Third-Party manufacturers and Third-Parties making sales on its behalf, to keep complete and accurate records for at least seven (7) years of all quantities of the Licensed Product manufactured and/or sold under the licenses granted by this Agreement, together with that information contemplated by Section 10.2. The Licensor and Ferring shall each have the right (and the Licensee shall procure such right), at its expense, through a certified public accountant or like person appointed by it, to examine such records during regular business hours during the Term of this Agreement and for one (1) year after its termination or expiry; provided, however, that such examination shall not take place more often than twice in any calendar year and shall not cover such records for more than the preceding two (2) calendar years and provided further that such accountant or like person shall report to Ferring only as to:
(a) the accuracy of the manufacturing and sales of the Licensee (and/or its Affiliates and/or its Third-Party manufacturers contemplated by this Agreement) in relation to such manufacture and sales;
(b) the appropriateness of quantities of Licensed Product imported, exported or manufactured pursuant to this Agreement by reference to what quantities of Licensed Product would reasonably be required to meet demand for actual sales made and sales forecasted by the Licensee;
(c) verification that all sales and other supplies of Licensed Product made by the Licensee have been made in the Territory and otherwise in accordance with Section 7; and
(d) verification that all sales and other supplies of Licensed Product made by Third-Party manufacturers contemplated by this Agreement have been made to the Licensee in accordance with this Agreement.
10.2 Within ten (10) Business Days following the end of each Agreement Quarter, the Licensee shall provide the Licensor with a quarterly written report of all Licensed Product (in terms of smallest units and patient packs for each formulation) sold or supplied by the Licensee under this Agreement during such Agreement Quarter. Such accounting shall be made in accordance with the Reporting Guidance issued by the Licensor and show smallest unit, pack size, gross sales and Net Sales Value in US Dollars on a Product-by-Product, country-by-country, month-by-month and purchaser-by-purchaser basis. Such a statement shall include copies of the relevant Public Sector procurement documentation in relation to which Approved Public Market Procurement the relevant Licensed Product were supplied.