Medigen – MPP (C-TAP), COVID-19 Vaccine, Patent and Know How License Agreement

Intellectual Property | Protection of IP

Summary of Approaches

Medigen – MPP Agreement & Form of Sublicense

Who has the decision-making authority and responsibility for patent prosecution, maintenance and enforcement? How should IP protection expenses be allocated between the parties?
- Medigen has the sole right, but not the obligation, to bring or defend an infringement action, at its own expense.
- MPP, WHO C-TAP, and Sublicensees are not entitled in any circumstances to bring infringement actions in relation to the Patent Rights and Licensed Know-how.
Is there a mechanism for information sharing and cooperation between the parties in relation to patent prosecution, maintenance and enforcement activities?
- MPP will promptly notify Medigen in writing of any patent infringement suit or claim against MPP, WHO C-TAP or any Sublicensee involving the Products.
- MPP shall, and shall request WHO C-TAP and each Sublicensee to, assist Medigen and co-operate in any litigation at Medigen’s request and expense.

Annotations

This Patent and Know-How License Agreement is between Medigen Vaccine Biologics Corporation (“Medigen”), a private corporation located in Taipei, and the Medicines Patent Pool (“MPP”), a United Nations-backed nongovernmental organization that pools licenses from intellectual property owners and sublicences technology for generic production and distribution in low-income and lower-middle-income countries (“LMICs”). MPP is the “implementing arm” of the World Health Organization’s COVID-19 Technology Access Pool (“C-TAP”), which facilitates equitable access to COVID-19 products. The Agreement concerns a list of materials including a cell line or working cell bank, a stable clone including clinical data, technical dossiers, and SOPs, and reasonable quantities of reference product (“Material”), as well as proprietary know-how and other technical knowledge (“Licensed Know-How”), all related to Medigen’s MVC-COV1901 COVID-19 vaccine. The Agreement is effective as of July 2023.

The Agreement provides a worldwide, non-exclusive license that permits the MPP to sublicense Medigen Materials and Licensed Know-how (together the “Licensed Technology”) to generic manufacturers who will develop and commercialize COVID-19 vaccines using the Licensed Technology (“Products”) for any use related to COVID-19 (“Field”), with the goal of making them accessible worldwide. MPP and Medigen must agree on the selection of sublicensees, and Sublicensees are required to use commercially reasonable efforts to make Products available worldwide at an affordable price. Sublicenses will pay technology fees and patent royalties to Medigen which are tiered depending on the income level classification of the country in which the Sublicensee is located (for technology fees), or the country of product sale (for patent royalties).

The Form of Sublicense Agreement is attached as Schedule 3 to the Medigen-MPP agreement. We have included terms from both agreements in our analysis in order to provide a complete overview of how key issues are addressed – the provision sections are sub-titled with either Medigen-MPP Agreement or Form of Sublicense.

Provision Language

MEDIGEN – MPP AGREEMENT

5. CONFIDENTIALITY AND IP RIGHTS

5.4 IP RIGHTS

[…]

iv. If any suit or claim by a Third Party is instituted against MPP, WHO C-TAP or any Sublicensee for patent infringement involving the Products, MPP shall promptly notify MEDIGEN in writing. MEDIGEN shall have the right, but not the obligation, to defend or to conduct the defense of such suit or claim at its own expense. MPP shall and shall request WHO C-TAP (if relevant) and the relevant Licensee assist MEDIGEN and co-operate in any such litigation at MEDIGEN’s request and expense;

v. MEDIGEN (and in no circumstances MPP, WHO C-TAP nor any Sublicensee) shall be entitled to bring infringement actions in relation to the Patent Rights and Licensed Know-How at its own expense. To the extent MEDIGEN decides not to bring any such infringement action, MEDIGEN shall not be liable to MPP, WHO C-TAP, or any Sublicensee in any respect for such decision. MPP shall, and shall request WHO C-TAP and each Sublicensee to, assist MEDIGEN and co-operate in any such litigation at MEDIGEN’s request without expense to the cooperating party.

FORM OF SUBLICENSE

9.INTELLECTUAL PROPERTY RIGHTS

[…]

9.5 If any suit or claim by a Third Party is instituted against MPP or the Sublicensee for patent infringement involving the Products, the Party sued shall promptly notify MPP and MEDIGEN in writing. MEDIGEN shall have the right, but not the obligation, to defend or to conduct the defense of such suit or claim at its own expense. The Sublicensee shall assist MEDIGEN and co-operate in any such litigation at MEDIGEN’s request and expense.

9.6 MEDIGEN (and in no circumstances the Sublicensee) shall be entitled to bring infringement action in relation to the Patent Rights and Licensed Know-How at its own expense. To the extent MEDIGEN decides not to bring any such infringement action, MEDIGEN shall not be liable to the Sublicensee in any respect for such decision. The Sublicensee shall assist MEDIGEN and co-operate in any such litigation at MEDIGEN’s request without expense to the Sublicensee.

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Master Alliance Provisions Guide (MAPGuide)

Medigen – MPP (C-TAP), COVID-19 Vaccine, Patent and Know How License Agreement

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