“Background Intellectual Property” shall mean any and all information, data (including research data), know–how, methods, formulas, formulations, compositions, materials, manufacturing know–how (including methods and standard operating procedures), computer programs, test results and trade secrets, owned or controlled by Aridis as of the Effective Date of this Agreement for which a license is required in order to practice the Project Intellectual Property for the manufacture, use or sale of the Primary Formulation or Optional Formulation developed under the scope of the Project. Specifically excluded from this definition are (i) those rights held by Aridis under license to the U.S. DHHS National Institute of Health technology known as “Multivalent Human Bovine Rotavirus Vaccine,” DHHS reference No. E–015–98/0; (ii) those intellectual property rights owned, controlled or licensed by Aridis where the practice of such intellectual property would require the payment of consideration or fulfillment of obligations to a third party; (iii) rights to technologies unrelated to formulation which cover distinct therapeutic compounds, methods or product types (such as a Shigella vaccine form, for example); and (iv) clinical data.
“Project Intellectual Property” shall mean any and all inventions (whether patentable or not), proprietary information, know–how, technology, formulae, processes (including all SOPs), trade secrets, materials, technical data and any other information for or related to the formulations developed for Rotavirus Vaccine, or as invented, developed or acquired by, or come into the possession or control (by licensure or otherwise) of Aridis, all where arising out of performance by Aridis of the work under the Project Plan.
4. Ownership of Intellectual Property, Data and Information
4.2 Enabling Technology. It is understood and agreed to by Aridis that Project Intellectual Property and the underlying Background Intellectual Property as licensed to PVS by Aridis hereunder shall be used by PVS for the advancement of the Primary Formulation and/or the Optional Formulation developed by Aridis under the Project Plan and shall be made available in accordance with Article 5 to PVS designated manufacturers for the advancement of a Rotavirus Vaccine in Developing Countries.
4.2.1 Information, reagents and materials, including but not limited to (a) qualified cell lines, (b) production processes and formulations, (c) assay design and reagents, and (d) packaging design, some or all of which may be made available to Aridis by PVS or its designees or, in the case of a formulation, developed by Aridis under the Project Plan is defined as “Enabling Technology“.
5. Grant of License; Field of Use
5.1 Grant of Rights to PVS. In consideration for the funding and indirect support provided by PVS to Aridis hereunder, Aridis hereby grants to PVS a non–exclusive license, with right to sublicense, at no additional fee, charge or royalty obligation, under the Aridis Project Intellectual Property and underlying Aridis Background Intellectual Property to the extent necessary for PVS, its Affiliates and sublicensees to make, use and sell the Primary Formulation and the Optional Formulation in the Field within the Territory and with the Scope as specified in Table 1 below. License rights as granted by Aridis to PVS hereunder as applied to the Field of pneumococcal disease and enteric disease shall be limited to Developing Countries; however, Aridis shall discuss with PVS in good faith possible partnering or licensing opportunities with designated PVS commercial collaborators to extend the license rights proposed by PVS to such commercial collaborator to include Developed Country rights to the extent such rights are available from Aridis at that time.
|Rotavirus Vaccine||Developing Countries||Non–Exclusive|
|Pneumococcal disease and enteric disease:
Shigellae (all forms)
Entertoxogenic E. coli (multiple components of ETEC)
5.2 Grant of Rights to Aridis. Pursuant to Section 4.1, ownership of Project Intellectual Property shall be held by Aridis, provided however, use of the Project Intellectual Property and the underlying Background Intellectual Property by Aridis shall be in conformance with the license rights granted to PVS as set forth in Section 5.1 and as further defined by the terms of this Agreement. Should Aridis elect to make, use or sell a Rotavirus Vaccine in Developing Countries as formulated using the Enabling Technology, Aridis shall undertake the commercial terms for global access as set forth in Article 6. Table II summarizes the obligations of Aridis hereunder.
|Rotavirus Vaccine||Developed Countries||Exclusive (non–exclusive with respect to PVS manufacturing rights asset forth in Section 5. I)|
|Rotavirus vaccine||Developing Countries||Non–exclusive (subject to commercial terms for global access as set forth in Article 6)|
|Pneumococcal and enteric disease vaccines||Worldwide||Non–exclusive (exclusive as to Developed Countries rights but subject to good faith discussion obligations as set forth in Section 5.1)|
|Other diseases and other fields of use||Worldwide||Exclusive|
5.3 Sublicense under PVS–ATCC License Agreement. In order to facilitate the work to be conducted by Aridis under the Project Plan, PVS may by mutual agreement with Aridis provide certain ATCC [American Type Culture Collection] materials to Aridis. Such ATCC materials would be provided to Aridis as a sublicensee of PVS under the PVS–ATCC License Agreement dated as of February 7, 2007 (the “ATCC License’’), and the use of such ATCC materials would be limited to those activities as set forth in the Project Plan.
5.3.1 In conformance with the terms of the ATCC License, Aridis will agree in writing prior to receipt of such ATCC materials to be bound by all applicable terms, conditions, obligations (including reporting, and inspections) and other restrictions of the rights granted by ATCC to PVS under the ATCC License that protect or benefit ATCC’s rights and interests.
5.3.2 Prior to the receipt of ATCC materials by Aridis hereunder, Aridis shall execute a material transfer agreement with ATCC, substantially in the form attached hereto as [omitted appendix], before any ATCC material is transferred to Aridis. The transfer of ATCC material from ATCC to Aridis shall be direct from ATCC’s storage facility.