Provision Language
Definitions
“Charitable Objectives” mean the charitable goals, principles and objectives of FNIH which are (i) to promptly and broadly disseminate new scientific information to the scientific community subject to prior protection of intellectual property and (ii) to ensure that innovations and related rights arising out of the Project are managed in a manner that furthers the objectives of enabling the subsequent accessibility of the developed products and health solutions (with respect to cost, quantity and applicability) by the people most in need within the Disease Endemic Countries as listed in Annex 4 of the world for the control of human diseases transmitted by insect vectors, including those spreading dengue and malaria.
Background
[…]
D. The Foundation for the National Institutes of Health (“FNIH“) is providing funding for projects related to insect chemosensation and olfaction for the control of human diseases transmitted by insect vectors, on the condition that the activities associated with the projects (including the managing of technologies and related patents arising out of the projects) are conducted in a manner that is consistent with Charitable Objectives and the Global Access Plan as defined and set forth below. FNIH has agreed to make a grant award (the “FNIH Funding“) to Columbia University for the Project as defined in the Project Plan, as defined below. Bayer will receive FNIH Funding as a grantee of Columbia University.
2. The Pilot Project/ Proof-of-Concept
2.1 Performance of the Project.
(a) The Parties each agree to organize and perform the Project in accordance with the terms of this Agreement (including the Project Plan), the Global Access Plan, the Charitable Objectives, and all other applicable terms of reference and documents referred to herein.
Annex 3. Global Access Plan
1. Duration. The terms of this Global Access Plan shall remain binding throughout the duration of the Agreement or, if longer, for a period of 10 years after the first commercialisation of the Product.
2. Supply Principles. The Parties agree that Bayer will supply the Product according to the principles of the Charitable Objectives and details set out below.
2.1. Pricing [***]
2.2. Geographical. The pricing policy set out above will not apply outside the Disease Endemic Countries, or in relation to sales of the Product for purposes other than control of vectors of human disease consistent with the Charitable Objectives. Bayer will exert its commercially reasonable efforts to obtain country registrations and bid for appropriate tenders in Disease Endemic Countries in a timely manner.
2.3. Volumes. The volumes of the Product that are to be made available to the Disease Endemic Countries will be sufficient to meet their national supply requirements as long as the lead-time remains commercially reasonable. In the event of restrictions of supply of Product or its raw materials required therefor which would affect Bayer’s ability to fulfill such requirements, Bayer will promptly notify the other parties of the same. The parties shall discuss in good faith about the ways to mitigate any possible supply issues to the Disease Endemic Countries.
3. Dissemination agreement
3.1. Publication. The Parties will publish the scientific and technological results of the work performed under this Project in order to make the information available to the wider vector control community, so as to disseminate the information in accordance with the Charitable Objectives and the Global Access Strategy, while preserving the need for prior protection of inventions (e.g. patent) before any publication is made. The mode of publication must be appropriate to effective and timely communication with that community (subject to any prior change to the publication to protect inventions), and the support of the FNIH should be acknowledged in any such publication.
3.2. Scrutiny before Publication. Prior to any publication or public disclosure of information generated within the Project the Party wishing to publish that information must obtain the written agreement of the other parties within that Project and the Project Management Team (bound by secrecy undertakings not less strict than those contained in the Agreement); such agreement shall not be unreasonably withheld. Either Party or the Project Management Team may object to the publication if, in their reasonable opinion, it would:
-
- prevent or interfere with the effective protection of any intellectual property in this Project; or
- damage or prevent the achievement of the Charitable Objectives or the Global Access Strategy; or
- bring into disrepute the Parties.
The information to be published must be submitted for approval to the Project Management Team at least 21 days before it is placed in the public domain.
The Project Management Team must provide written approval or objection within the period of 21 days. Absence of an answer shall not be deemed an approval.
When publication is delayed to allow filing of patents the delay shall not extend beyond the filing of the relevant patent.
If anyone of the Project Management Team does not approve the publication within this time, release will be delayed and the Parties will meet to resolve the objections. If the Parties are unable to resolve the objection the persons designated as Top Managers of the respective Parties and the Project Management Team shall promptly discuss the matter to determine whether or not publication should continue, in a consensual way.
4. Freedom to Operate
4.1. The Parties represent and warrant that, to the best of their knowledge, they may conduct the Project free from any intellectual property rights created by any third parties or that they have obtained appropriate licenses to any third party intellectual property rights that may be required to conduct the Project.
4.2. The Parties represent and warrant that, to the best of their knowledge, their own intellectual property is free from any encumbrances that might restrict the conduct of the Project or prevent the supply of the Product in accordance with the supply principles in clause 2 or that might prevent or restrict it from being used for the Charitable Objectives and that they will not permit the creation of any such encumbrance.
5. Force majeure. Neither Party shall be liable for its delay in performing or failure to perform hereunder (other than to make payments of amounts due) as a result of any contingency beyond its reasonable control, including acts of God, droughts, fires, floods, wars, civil insurrection, general military obligation, sabotage, accidents, lockouts, labor disputes or shortages, any governmental laws, ordinances, rules, regulations, bans, action or inaction (whether valid or invalid, including but not limited to, priorities, requisitions, allocations and price adjustment restrictions), delay or inability to obtain supplies, labor, raw materials, energy, transportation, and any other similar contingency. The Party suffering the inability to perform shall notify the other Party of the existence of such delay within 20 days of the first day of such force majeure.