Attachment 6: Research Subaward Agreement
6. Intellectual Property
6.04 Project IP Rights and Strategy. All rights are subject in all cases to the provisions of the PTE NOA, applicable Federal laws and regulations governing patents and inventions, including government-wide regulations at 37 CFR part 401 (per 45 CFR 75.322(c)) and, in particular, and without limitation, to U.S. Government march-in rights set forth in 37 CFR Sect. 401.6 and 401.14 (j) (collectively, the “U.S. Government Bayh-Dole Rights”). The NOA, applicable U.S. laws and regulations are not superseded or limited by any additional special terms or conditions imposed on the Subrecipient regarding IP. The process set out in this Section is intended to design and implement a credible IP strategy that enables the development and deployment of the Product in a manner consistent with the Wellcome Trust’s equitable access principles.
(a) The Commercialization Plan for Targeted Territories
(i) No later than six (6) months after the First Approval, unless otherwise agreed by the Parties, the Subrecipient will describe in a confidential commercialization plan (the “Commercialization Plan”) the key countries where it intends to market the Product (the “Targeted Territories”). The list of Targeted Territories shall not be inconsistent with the Subrecipient’s most recent Stewardship and Access Plan and will be updated by the Subrecipient from time to time based on actual developments. The Commercialization Plan should be reasonably detailed as appropriate for a marketed Product.
(ii) For the Targeted Territories, particularly for high-income countries with National Action Plans on Antimicrobial Resistance, the Wellcome Trust will not exercise its Access Rights in such Targeted Territories for so long as the Subrecipient markets the Product in such Territory, or is taking steps towards marketing the product in such Territory as set forth in the Commercialization Plan and the Stewardship and Access Plan.
(b) Negotiation of Voluntary Mechanisms for Other Territories
(i) For countries that are not Targeted Territories (the “Other Territories”), the Subrecipient and the Wellcome Trust will explore mechanisms to achieve stewardship and access objectives. This process will begin with a joint business plan addressing the Other Territories. This business plan will lay out reasonable goals and mechanisms for making the Product available in such Other Territories consistent with access and stewardship objectives. While informed by the Wellcome Trust’s overall stewardship and access objectives, this negotiation process will set the metrics and goals in the Other Territories that are acceptable to both Wellcome Trust and the Subrecipient.
(ii) This business plan should include a mechanism for the Wellcome Trust (or the Wellcome Trust’s nominee) to access all intellectual property required to commercialize the Product in the Other Territories, including Project IP Rights and background intellectual property (including intellectual property which may block the exploitation of Project IP rights).
(iii) The Subrecipient and the Wellcome Trust may consider the following potential mechanisms for accessing intellectual property rights referenced in Section 6.04(b)(ii):
(1) A voluntary sublicensing agreement process between the Subrecipient and the Wellcome Trust (or the Wellcome Trust’s nominee);
(2) A Subrecipient supply arrangement between the Subrecipient and the Wellcome Trust (or the Wellcome Trust’s nominee) to ensure the Product is made available to ensure access is provided to the Wellcome Trust, or another party specified by the Wellcome Trust, with a specified number of doses at an agreed upon cost for distribution solely in the Other Territories;
(3) Creation of a joint venture between the Subrecipient and the Wellcome Trust (or the Wellcome Trust’s nominee) to promote access to the Product within an appropriate stewardship framework;
(4) The voluntary transfer by the Subrecipient to the Wellcome Trust (or its nominee) of intellectual property rights necessary for the Wellcome Trust to develop and exploit the Product in the Other Territories, consistent with its access and stewardship objectives; and (5) Payment of a reasonable royalty by the Wellcome Trust for background intellectual property.
(iv) In all cases, care will be taken in the business plan to prevent Product distributed in the Other Territories from being sold without the Subrecipient’s authorization in the Targeted Territories. Techniques could include distinct packaging, branding and other differentiating characteristics.
(c) Access Rights. Should the Wellcome Trust and the Subrecipient with respect to any Other Territory attempt but fail to agree on a mechanism and business plan as described in Section 6.04(b) by the third anniversary of the First Approval, then the Subrecipient shall, with respect to Project IP Rights, be subject to Access Rights for the sole purpose of making the Product available in such Other Territory.
(d) For purposes of this Section 6.04, the Wellcome Trust is an intended third-party beneficiary of this Subaward Agreement, and is entitled to enforce the Access Rights as described in this section 6.04 as if it were a party hereto.
(e) Section 6.04 shall survive termination or expiry of this Subaward Agreement and shall continue in force until the Project IP Expiration.