Provision Language
Definitions
“Additional Technologies” means the stabilised prefusion spike protein (S-2P) of the SARS-CoV-2 spike protein owned or controlled by United States National Institutes of Health, the CpG 1018 adjuvant owned or controlled by Dynavax Technologies; and the Expi-CHO cell owned or controlled by Thermo Fisher Scientific, which are all necessary for the development of the Products.
“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
2. SCOPE OF THE GRANT
Subject to the terms and conditions of this Agreement, MEDIGEN hereby grants a worldwide, nonexclusive, non-transferable, license to MPP to grant sublicences to sublicensees mutually selected by MPP and WHO C-TAP to use the Licenced Technology to:
i. Develop, or have developed, Products in the Field, and
ii. Make and have made, use, Commercialise, export or import the Products exclusively for ultimate use in the Field.
No rights are hereby granted for the Additional Technologies and the Sublicensees will require the prior written approval of each owner thereof.
The entering into of each Sublicense hereunder shall require the prior written approval of MEDIGEN, which shall not be unreasonably withheld or delayed. MPP shall not agree to any amendment or modification of any Sublicence or waive any obligation of the Sublicensee thereunder without the prior written consent of MEDIGEN, which shall not be unreasonably withheld or delayed.
4. KNOWLEDGE AND MATERIALS TRANSFER
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4.6 MEDIGEN shall notify WHO C-TAP and MPP in writing of each MEDIGEN New Developments, specifying whether such is an Inscope MEDIGEN New Development or Additional MEDIGEN New Development (all as defined in Schedule 3) at MEDIGEN’s earliest convenience and, in any case, annually or at MPP’s reasonable request and each Sublicensee may elect, by written notice given to MPP and MEDIGEN to include such MEDIGEN New Development in the licence grant under the relevant Sublicense whereupon the relevant know how and materials (if any) shall be transferred to the Sublicensee as contemplated in Schedule 2 hereto on the terms provided for in the relevant Sublicence or, if applicable, as separately agreed.
5. CONFIDENTIALITY AND IP RIGHTS
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5.4 IP RIGHTS
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ii. If, at any time during the term of this Agreement any Sublicensee (or any of their respective employees, agents, or other persons acting under their authority) makes, develops, conceives, acquires, reduces to practice, becomes entitled to or secures control over any Improvement, MPP shall request such Sublicensee or any of their employee, agent or other person (each, an “Improvement Creator”) to communicate such Improvement to MEDIGEN in full together with all available information concerning the mode of working and using the same. MEDIGEN shall treat this information as Confidential Information;
iii. MPP shall, and shall cause any such Improvement Creator to grant to MEDIGEN a perpetual, irrevocable, worldwide, royalty free, non-exclusive licence to use any Improvement, Improvement Patent and related Know-How (and shall promptly execute and cause to be executed such documents as MEDIGEN may reasonably request accordingly) in the Field. MEDIGEN shall be entitled to grant sublicences (without further right to sublicence) under such licence only to its Affiliates; and/or contract manufacturers, distributors and service providers solely for use in connection with their engagement of Commercialising MEDIGEN products. No Improvement Creator shall have any rights in relation to the conduct of any matter relating to the Patent Rights, including the filing, prosecution and maintenance thereof;
7. ASSIGNMENT AND SUBLICENCES
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7.2 Sublicences. MPP/ WHO C-TAP and MEDIGEN will discuss and agree, acting reasonably, upon the interested and suitable Third Parties to whom MPP shall grant sublicences for the purposes of developing, manufacturing and/or Commercialising the Product. MPP will require in the Sublicences that Sublicensee(s) use commercially reasonable efforts to ensure that the Product(s) be made available worldwide at affordable pricing.
7.3 MPP shall take all actions necessary to facilitate MEDIGEN’s exercise of any rights granted to MEDIGEN under each Sublicence including without limitation the inspection and audit rights under clause 11.3 thereof.
9. CONSIDERATIONS AND FOLLOW-UP REPORTS
As consideration for the rights conveyed by MEDIGEN under this Agreement, MPP shall use reasonable efforts to sublicence the rights to develop, use and Commercialise the Licensed Technology to companies interested to manufacture and/or Commercialise the Product. MPP will keep MEDIGEN regularly informed of the progress in the search for Sublicensees.
FORM OF SUBLICENSE
2. SCOPE OF THE GRANT
2.1 Subject to the terms and conditions of this Agreement, MPP hereby grants a worldwide, nonexclusive, non-transferable, licence to the Sublicensee to use the Licensed Technology, to:
i. Develop, or have developed Products in the Field, and
ii. Make and have made, use, Commercialise, export or import the Products exclusively for ultimate use in the Field.
2.2 No rights are hereby granted for the Additional Technologies, as defined in the Medigen-MPP Agreement, and the Sublicensee will require the prior written approval of each owner.
2.3 The Sublicensee shall ensure that the Products are made available worldwide at affordable pricing.
3. FEES and ROYALTIES
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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.
9. INTELLECTUAL PROPERTY RIGHTS
9.1 MEDIGEN will own the entire right, title and interest in and to any and all inventions conceived solely by MEDIGEN (or its Affiliates) or on its behalf, by its respective employees and agents after the Effective Date relating to the Product in the Field, including any adaptation of any manufacturing process or proprietary drug delivery or formulation technology of MEDIGEN or its Affiliates for the production of the Product in the Field, and any patents covering such invention (“MEDIGEN New Developments”), subject to the license grant to the Sublicensee set out in Clause 2 hereof. MPP shall notify Sublicensee in writing of any MEDIGEN New Developments as soon as it receives relevant information from MEDIGEN pursuant to the MEDIGEN-MPP Agreement.
9.2
(i) If the MEDIGEN New Developments do not involve an adjustment in antigen or adjuvant amount, change in vaccine composition to bivalent or multivalent vaccine containing multiple antigens, a delivery method other than intramuscular delivery or a combination vaccine, such shall be considered “Inscope MEDIGEN New Developments”.
(ii) If such Inscope MEDIGEN New Developments require comprehensive additional phase 3 clinical efficacy study(ies) such developments shall be considered Significant Inscope MEDIGEN New Developments and may be made available to the Sublicensee at the Sublicensee’s election as provided in Clause 3.1(vi) above and ANNEX 2 hereto. If such Inscope MEDIGEN New Developments are not Significant Inscope MEDIGEN New Developments, they will be made available without additional charge or extension of the Expiry Date.
(iii) If such MEDIGEN New Developments are other than Inscope MEDIGEN New Developments such shall be considered an Additional MEDIGEN New Developments and may be made available to the Sublicensee at the Sublicensee’s election as provided in Clause 3.3 above and ANNEX 2 hereto.
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9.4 The Sublicensee hereby grants to MPP and MEDIGEN a perpetual, irrevocable, worldwide, royalty free, non-exclusive licence to use any Improvement, Improvement Patent and related Know-How (and shall promptly execute such document as MEDIGEN may reasonably request accordingly) in the Field. MEDIGEN shall be entitled to grant sublicences (without further right to sublicence) under such licence only to its Affiliates; and/or contract manufacturers, distributors and service providers solely for use in connection with their engagement of Commercialising MEDIGEN products. The Sublicensee shall have no rights in relation to the conduct of any matter relating to the Patent Rights, including the filing, prosecution and maintenance thereof.
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9.7 The Sublicensee shall have the right to apply any trademark or brand name on vaccines based on Licensed Technology which vaccines are Commercialised by MEDIGEN in the Field and worldwide so long as none thereof infringe the trademarks or brands of MEDIGEN.