Provision Language
MEDIGEN – MPP AGREEMENT
4. KNOWLEDGE AND MATERIALS TRANSFER
4.1. MEDIGEN shall, subject to any applicable technology export control regulations or policies in any applicable jurisdiction, make the transfer of Licensed Know-how and Material to each of the Sublicensees, in accordance with the scope, quantities and timelines set out in Schedule 2 hereto. The technology transfer hereunder shall be considered successful with respect to each Sublicensee when such Sublicensee has accomplished vaccine production, meeting the requirements of this Agreement and the associated transfer plan to be agreed by MPP and MEDIGEN with each Sublicensee. MEDIGEN will also provide the Sublicensee with applicable regulatory exclusivity waivers, to the extent required by the Relevant Regulatory Authorities for national registration of the Products).
FORM OF SUBLICENSE
4. DEVELOPMENT AND REGISTRATION
4.1 The Sublicensee agrees that it will manufacture the Product in a manner consistent with (i) WHO pre-qualification standards; or (ii) the standards of any Stringent Regulatory Authority, defined as a regulatory authority which was a member or observer of the International Council on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (“ICH”), or associated with an ICH member through a legally-binding, mutual recognition agreement, in each case as before 23 October 2015. Where such standards are not yet available, the Sublicensee will obtain temporary approval through a WHO Expert Review Panel, as appropriate and if applicable.
4.2 The Sublicensee shall:
i. obtain from the relevant authorities in each country and maintain in force, as appropriate, all health registrations, permissions, consents and regulatory authorisations relating to the importation, manufacture and sale of the Products which are necessary to enable the Products to be sold or supplied in each country in accordance with this Agreement.
ii. file for WHO Pre-qualification or any Stringent Regulatory Authority approval as soon as possible and in any event not later than within 24 months from the Effective Date in each case using the fastest approval route possible and will diligently pursue such applications following submission.
iii. manufacture and sell the Products in accordance with all laws and regulations relevant to the manufacture and sale of the Products and in accordance with good industry practice.
4.3 If the Sublicensee manufactures, sells, supplies or otherwise disposes of any Product but has not obtained the necessary compliance with laws or approvals as per this Agreement, MPP shall be entitled to immediately terminate this Agreement by providing written notice to the Sublicensee.
5. KNOWLEDGE AND MATERIAL TRANSFER
5.1 MEDIGEN shall, subject to any applicable technology export control regulations or policies in any applicable jurisdiction, make the transfer of Licensed Know-How and Material to the Sublicensee, in accordance with the scope, quantities and timelines set out in Annex 2 hereto or as otherwise agreed between MEDIGEN and the Sublicensee. The technology transfer hereunder shall be considered successful when the Sublicensee has accomplished vaccine production, meeting the requirements of this Agreement and the associated transfer plan to be agreed among MPP, MEDIGEN and the Sublicensee. MEDIGEN will provide the Sublicensee with applicable regulatory exclusivity waivers, to the extent required by the Relevant Regulatory Authorities for national registration of the Products).
12. PHARMACOVIGILANCE
The Sublicensee shall comply with the following Pharmacovigilance obligations.
12.1 The Sublicensee shall, upon the request of any health authority, pharmacovigilance regulator, MPP, WHO C-TAP or MEDIGEN, provide information required with respect to any adverse event as follows (or within any such shorter period as may be required by law):
(i) Within 48 hours of notification or first awareness by employee or contracted worker (“Known Time”) in case of death or life-threatening event;
(ii) Within 7 calendar days of Known Time by employee or contract worker in case of:
– Persistent or significant Disability/incapacity
– Congenital Anomaly / Birth defect
– Hospitalization or prolongation of existing Hospitalization
– Other medically important condition
12.2 If Sublicensee discovers any potential Emerging Safety Issue which may lead to an Urgent Safety Measure (USM) or Urgent Safety Restrictions (USR), Sublicensee shall report to MPP and MEDIGEN what measures will/have been taken and the reasons why via pmpv@medigenvac.com within 48 hours of Known Time.
12.3 Sublicensee shall provide MPP and MEDIGEN a Periodic Benefit Risk Evaluation Report (formerly known as Periodic Safety Update Report). Every 6 months for the first 2 years from date of [emergency use authorisation] in each country and then annually for the following 3 years.
12.4 Should Emergency Use Authorization be discontinued by regulatory authorities in any country in which the Product is sold, or WHO no longer declares COVID-19 a Public Health Emergency (PHE), the Sublicensee shall mutually agree with MEDIGEN or on reporting schedule per the strictest schedule imposed upon MEDIGEN by any regulatory authority for which MEDIGEN must report Adverse Events.