Master Alliance Provisions Guide (MAPGuide)

DNDi Template Development Collaboration and License Agreement

  • Equitable Access | Ensuring continuity

21. REPRESENTATIONS AND WARRANTIES

[…]

21.2 Partner represents and warrants the following: […]

b) to its knowledge as of the Effective Date: […]

iii. has not granted and will not grant to any Third Party any of its rights relating to Partner Background Technology or Partner Collaboration Technology that would conflict with, limit or adversely affect the rights granted to DNDi hereunder;

23. TERM AND EARLY TERMINATION

[…]

23.2 Either Party may terminate this Agreement in its entirety or with respect to any Product at any time upon twelve (12) months’ written notice to the other Party, without thereby incurring any liability to the other Party. For the avoidance of doubt, termination by a Party because it is not satisfied with the results of its safety data assessment shall not impact the continuation of the development of the Product(s) by the other Party.

23.3 Either Party may terminate this Agreement in its entirety at any time, as follows:

a) if the other Party is in material breach of this Agreement, upon thirty (30) days’ written notice stating its intent to terminate if such breach has not been cured within such thirty (30) day period;

b) with immediate effect if the other Party is declared insolvent or has an administrator or receiver appointed over all or any part of its assets;

c) with immediate effect if the other Party is in breach of Section 21.3; or

d) in case of a Force Majeure event with respect to the other Party pursuant to Article 29.

23.4 If in the reasonable opinion of DNDi, Partner fails to use Reasonable Efforts to promote access to the Product in the Territory in accordance with the timelines and milestones agreed by the Parties under the Access and Implementation Plan(s), DNDi shall give notice to Partner requiring curing such failure. If, in the reasonable opinion of DNDi, Partner fails to present an acceptable plan within sixty (60) days and report reasonable progress within one hundred and eighty (180) days after receiving written notice with respect to the default, DNDi shall have the right to terminate this Agreement in respect to such Product with immediate effect by giving written notice to Partner.

24. EFFECT OF EXPIRATION OR EARLY TERMINATION

24.2 Upon termination by Partner pursuant to Section 23.2 or termination by DNDi pursuant to Section 23.3 or Section 23.4:

[…]

c) Partner shall grant to DNDi a non–exclusive, perpetual, irrevocable, fully paid, royalty–free license, with the right to sublicense, under Partner’s rights to and interests in Partner Background Technology and Partner Collaboration Technology, to sell, offer to sell, import and distribute the Product within the Field outside of the Territory;

[…]

g) Partner shall make available to and/or transfer to DNDi, copies of such information, documentation and materials in its possession relating to the Development and Distribution Program so that DNDi may proceed with further research and development, manufacture, registration and/or commercialisation of the Product. In particular, Partner shall transfer, to the extent owned, licensed or controlled by Partner, copies of the Partner Collaboration Technology, and provide the necessary training (including onsite), free of charge, to any Third Party appointed by DNDi on Product manufacture. To ensure continuity in the supplies of the Product, Partner shall continue to manufacture and supply the Product in accordance with the terms of this Agreement until such time as the technology transfer to the Third Party appointed by DNDi is complete and such Third Party is manufacturing and supplying the Product. Partner shall transfer all existing stocks of the Product to the Third Party following the completion of such technology transfer and launch of manufacture and supply by such Third Party as described in the preceding sentence;

h) Partner shall transfer to DNDi the Regulatory Dossier and any supporting documentation, including the Marketing Authorization(s) and Regulatory Approvals in its possession; and

i) in the case of termination by Partner under Section 23.2 with respect to any part of the Development Plan or the Access and Implementation Plan (as opposed to the Agreement in its entirety), the provisions of sub.sections a) to h) of this Section 24.2 shall apply only with respect to such terminated part of the Collaboration Plans.