Provision Language
Definitions
“Licensed Know-how” means know-how, information, data and other technical knowledge owned and/or controlled by MEDIGEN, that are useful or otherwise relevant for the development and/or manufacturing of COVID 19 vaccines as described in Schedule 2.
“Licensed Technology” means the Patent Rights, Material, and Licensed Know-how from MEDIGEN including without limitation MEDIGEN New Developments actually licenced to a Sublicensee as contemplated hereby.
“Material” means materials useful for the development and/or manufacturing of COVID 19 vaccines owned and/or controlled by MEDIGEN as described in Schedule 2.
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).
4.2 The Material will be provided at cost (including manufacturing and direct overhead) which costs will be disclosed to MPP and Sublicensees upon request in advance. Risk of loss shall pass to the Sublicensee Ex-Factory, factory location as defined by MEDIGEN at time of shipment. All transportation from MEDIGEN designated factory and all matters related to import into country of destination shall be for the account, and at the risk, of each Sublicensee.
4.3 MPP shall cause each Sublicensee to agree to:
i. accept remote (telephone, e-mail, on-line, etc.) assistance where applicable; and
ii. allocate a sufficient and technically capable workload to knowledge transfer activities and ensuring that its contract manufacturer does the same.
4.4 Save as expressly provided above, in Schedule 2 or in Clause 3 and ANNEX 2 of Schedule 3, each of MPP, the Sublicensee and MEDIGEN will carry its own costs related to knowledge and materials transfer under this clause 4.
4.5 Without prejudice to the foregoing, prior to entering into the first Sublicence contemplated hereby, the Parties shall, in collaboration with WHO C-TAP agree on the need of a “train the trainer” program, according to the number of interested manufacturers, under which WHO C-TAP and MEDIGEN will prepare an implementation plan to better assist and facilitate the transfer of Licensed Technology to multiple Sublicensees.
SCHEDULE 2: TRANSFER OF MATERIAL AND LICENSED KNOW-HOW
I. Initial Know-how transfer:
Medigen shall provide all documents in accordance with Appendix 1 of the up-to-date WHO guidelines on technology transfer in pharmaceutical manufacturing, set out following this link (“The Guidelines”): https://cdn.who.int/media/docs/default-source/essential-medicines/norms-and-standards/qas20-869-transfer-of-technology.pdf?sfvrsn=2a4723bc_5 provided that if any change to the Appendix 1 after February 1, 2023 increases Medigen’s cost for providing such documents, such increase cost should be borne by the Sublicensee. In such event, Medigen shall undertake all reasonable efforts to minimize the cost of providing any additional documents.
Above documents shall be delivered within approximately 3 months after Effective Date of each Sublicense.
II. Initial Material Transfer
Transfer of Licensed Know-how will consist of the following items (Quantities to be as separately agreed between MEDIGEN and each Sublicensee):
i. Cell line or working cell bank;
ii. stable clone expressing the stabilised prefusion spike protein of COVID-19, its variants thereof and adjuvanted to produce COVID-19 vaccine MVC-COV1901 and its derivatives for intramuscular injection delivery, including related production technology, clinical data, technical dossiers, Standard Operating Procedures (SOPs) and documentation;
iii. Reference product in reasonable quantities to support analytical characterisation and non-clinical/clinical studies within [x] months from the Stringent Regulatory Authority approval of MEDIGEN’s Product;
iv. Critical impurities, standards etc.;
v. Each transfer shall be made directly from MEDIGEN to each Sublicensee within a time period to be agreed between MEDIGEN and such Sublicensee;
vi. All Material shall be provided at cost (including manufacturing and direct overhead). Delivery and risk of loss shall be Ex-Factory, factory location as defined by MEDIGEN at time of shipment. All transportation from MEDIGEN designated factory and all matters related to import into country of destination shall be for the account, and at the risk, of each Sublicensee.
III. Initial Technical Support and Training:
- Basic Support and Training: MEDIGEN will provide up to 200 hours of remote assistance (150 of such hours to be available during the six-month period commencing on the Effective Date of the relevant Sublicence) and up to 50 hours of training at MEDIGEN’s facilities (available within the one-year period commencing on such Effective Date) as follows:
i. Hours for remote assistance will be documented by MEDIGEN and shall include answering emails, document preparation and audio and video calls;
ii. Training at MEDIGEN’s facilities shall be arranged and made available at MEDIGEN’s discretion and coordinated by Sublicensee with MEDIGEN. Travel, lodging, meals and like expenses shall be borne by Sublicensee.
- Additional Training and Support: Remote training and support beyond Basic Training and Support will be charged at US$250 per hour. Onsite training and support at a Sublicensee’s facilities will be charged at US$500 per hour with travel, lodging, meals and similar costs to be covered by the Sublicensee.
IV. Activities and transfers related to additional components required by WHO guidelines on technology transfer in pharmaceutical manufacturing, set in The Guidelines. Any costs beyond those set out under Section I, II and III of this Schedule 2 shall not be borne by Medigen and shall be discussed with the Sublicensee in advance.
V. Transfers Related to MEDIGEN New Development:
The contents, process and timing of any transfer of know-how and Materials (if any) related to a MEDIGEN New Development which a Sublicensee elects to Sublicence shall be as agreed among the parties at the time of such transfer.
VI. Sublicensee Obligations
Each Sublicensee shall, at its own cost, carry out all activities contemplated to be carried out by the Receiving Unit (“RU”) under The Guidelines.
FORM OF SUBLICENSE
3. FEES and ROYALTIES
3.1 Technology fees. The Sublicensee shall pay directly to MEDIGEN by bank transfer to the account indicated on the invoice the following technology fees:
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iii. a one-time fee of 100,000 US Dollars for Sublicensees from LIE and LMIEs, or a onetime fee of 200,000 US Dollars for the Sublicensees from UMIEs and HIEs due and payable on the date falling six (6) months after the Effective Date as compensation for Basic Support and Training as described in ANNEX 2 hereto, and
iv. a one-time fee of 100,000 US Dollars for Sublicensees from LIE and LMIEs, or a onetime payment of 200,000 US Dollars for the Sublicensees from UMIEs and HIEs due upon notice from MEDIGEN that the Materials are ready for pick up as compensation for Materials preparation work.
[…]
3.3 Additional payment obligations for Additional MEDIGEN New Developments. If at any time during the Base Period, there shall occur one or more transfers of technology arising out of an Additional MEDIGEN New Development, the technology fees and term (“Additional MEDIGEN New Development Term”) therefor shall be agreed between the Parties and MEDIGEN in consultation with WHO C-TAP, at the time of such transfer.
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).
5.2 The Material will be provided at cost (including manufacturing and direct overhead), which costs will be disclosed to MPP and Sublicensee upon request in advance. Risks of loss shall pass to the Sublicensee, Ex-Factory, factory location as defined by MEDIGEN at time of shipment. All transportation from MEDIGEN designated factory and all matters related to import into country of destination shall be for the account, and at the cost, of the Sublicensee.
5.3 Sublicensee agrees to:
i. accept remote (telephone, e-mail, on-line, etc.) assistance where applicable; and
ii. allocate a sufficient and technically capable workload to knowledge transfer activities and ensuring that its contract manufacturer does the same.
5.4 Save as expressly provided in Clause 3 above, or ANNEX 2 hereto, each of MPP, Sublicensee and MEDIGEN will carry its own costs related to knowledge and material transfer under this clause 4.