Provision Language
Definitions
“Relevant Regulatory Authority” shall mean, in relation to a particular Target Country in the Territory, the local regulatory authority having jurisdiction over the manufacture and/or commercialisation of the Licensed Product in that Target Country.
Annexure A: License Agreement
5. COMPLIANCE WITH APPLICABLE LAWS
[…]
5.3 The responsibilities of the Parties for reporting of adverse drug experiences related to the Licensed Product to regulatory authorities in the Territory shall be performed in accordance with local laws and regulations as applicable to such Party. The responsibilities of the Parties for safety related or Licensed Product related inquiries shall be performed in accordance with local laws and regulations as applicable to such Party. MPP hereby undertakes to: (a) monitor the activities and duties of the Sublicensees with respect to pharmacovigilance obligations set out in the Sublicense, and (b) otherwise ensure compliance by the Sublicensees with such terms.
Annexure A, Schedule 3: Form of Sublicense
3. COMMERCIALISATION AND REGISTRATION
[…]
3.4 The Licensee will obtain from the relevant authorities in the Target Countries and maintain in force, as appropriate, all health registrations, permissions, consents and regulatory authorizations relating to the importation, manufacture and sale of the Licensed Product which are necessary to enable the Licensed Product to be sold or supplied in the Territory in accordance with this Agreement.
3.5 Licensee shall file for (i) regulatory approval of the Licensed Product before at least one Relevant Regulatory Authority or (ii) WHO pre-qualification of the Licensed Product or approval by a Stringent Regulatory Authority no later than thirty-six (36) months from the Effective Date.
[…]
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.
3.8 If upon review of a Licensee’s regulatory filing plan (per Section 3.7), Ferring reasonably determines that such regulatory filing plan prejudices or could prejudice Ferring’s contractual obligations to register and supply Ferring’s ICH zone IV stable carbetocin product in the Territory, Ferring shall, no later than thirty (30) Business Days of receiving such report from Licensor, provide written notification to Licensor, including any reasonable requests for modification to such regulatory filing plan. Licensor shall in turn, provide written notice of such request for modification to Licensee no later than thirty (30) Business Days of receiving such request for modification from Ferring, to ensure that the requested modifications are promptly implemented by Licensee. Upon receipt, Licensee agrees to make the requested modifications to its regulatory filing plans and shall send an updated regulatory filing plan to Licensor for Ferring’s review and approval. Such approval shall be deemed provided if Ferring does not provide its disapproval of the submitted updated regulatory filing plan to Licensor within thirty (30) Business Days of its receipt from Licensor.
4. SUPPLY, DISTRIBUTION AND LABELLING
4.1 The Licensee shall be solely responsible for providing its own clinical, promotional and commercial infrastructure to support the manufacture and sale of the Licensed Product in the Territory. The Licensee agrees, where applicable and to the extent that it is able: (a) to not seek; and (b) to waive, regulatory exclusivity in the Target Countries in relation to any data relating to the Licensed Product.
6. ADVERSE EXPERIENCE REPORTING
6.1 The responsibilities of the Parties for reporting of adverse drug experiences related to the Licensed Product to regulatory authorities in the Target Countries shall be performed in accordance with local laws and regulations. The responsibilities of the Parties for safety related or Licensed Product related inquiries shall be performed in accordance with local laws and regulations.
6.2 Without prejudice to Section 6.1:
(a) Licensee undertakes that it will maintain until the termination or expiration of this Agreement (or, as applicable, until the rights and obligations intended to survive termination of this Agreement have been fulfilled), pharmacovigilance and risk management systems, procedures and documentation needed to perform and comply with its regulatory obligations and its related obligations under this Agreement.
(b) Licensee undertakes that it will ensure that it will comply with all applicable laws and regulations regarding the Licensed Product in the Target Countries including without limitation those laws and regulations relating to risk management, drug safety and pharmacovigilance.
(c) Licensee will hold and maintain a safety database regarding the Licensed Product sold in the Territory.
(d) Licensee will be responsible for fulfilling all pharmacovigilance activities in accordance with the local regulations and requirements for the Licensed Product in the Target Countries (this includes but is not limited to collating Adverse Events and expedited and periodic reporting to regulatory agencies in the Target Countries, literature review, performing safety evaluation and signal detection on all available Adverse Events, etc.).
(e) Licensee shall provide Licensor and Ferring with a report containing information regarding Adverse Events which are associated with the Licensed Product, and which have been received by Licensee, from both spontaneous reporting and clinical trial sources. Such report shall be provided annually and otherwise on reasonable request by the Licensor and/or Ferring.
(f) Licensee shall notify the Licensor and Ferring forthwith of the receipt of an enquiry from a regulatory authority in the Target Countries relating to the Licensed Product that concerns any safety issue. If Licensee becomes aware of action that may or will be or has been taken by a regulatory authority for a safety reason connected with the Licensed Product, it shall immediately and in any event no later than twenty-four (24) hours after receiving such notice from a regulatory authority notify Licensor and Ferring in writing (including, but not limited to email communications) with available details regarding the same.