Master Alliance Provisions Guide (MAPGuide)

License and Collaboration Agreement between Merck and Bioprotection Systems Corp. (wholly owned subsidiary of NewLink Genetic Corporation)

  • Information sharing & data safety | Technology transfer

§2.9.1 General. As soon as reasonably practicable following Effective Date (but in all cases within [*] after the Effective Date or such other period of time as agreed to by the Parties), NewLink shall disclose to Merck in English (in writing and in an electronic format) all NewLink Know-How. Thereafter on an ongoing basis during the Term upon the reasonable request of Merck, NewLink shall cooperate with Merck and promptly disclose to Merck in English (and deliver in writing and in an electronic format) (i) any other NewLink Know-How (including any Program Know-How) relating to Compound or Product (or the Development, Manufacture, use or Commercialization thereof) as may be developed or identified by or on behalf of NewLink (or its Affiliates), and (ii) from the Effective Date until [*], any other materials and documentation (including [*]) in NewLink’s (or its Affiliate’s or subcontractor’s) possession or Control as may be reasonably requested by Merck from time to time that relate to Compounds or Products and are to be used by or on behalf of Merck in the performance of its activities under this Agreement, including [*]. Without limiting the generality of the foregoing, [*], NewLink shall [*] to provide [*] pursuant to, and in accordance with, [*].

§2.9.2: Technology Transfer; Transition of Activities

As soon as reasonably practicable following the Effective Date (but in all cases within [*] or such other period of time as agreed to by the Parties), NewLink shall (i) transfer to Merck (or its designee) all materials (other than Inventory) related to Compound or Product in NewLink’s (or any of its Affiliate’s or contractor’s) possession or Control, including [*], and (ii) transfer and assign to Merck (or its designee), and NewLink hereby does transfer and assign to Merck, all Regulatory Documentation (other than the Existing IND) related to Compound or Product (including the transfer to Merck of a database that contains all relevant information regarding adverse events that have been observed during any clinical trials or studies with respect to Compound or Product prior to the Effective Date). In addition, upon Merck’s request, NewLink shall transfer and assign to Merck (or its designee) [*] (the “Existing IND”). NewLink shall assist Merck, and each Party shall reasonably cooperate, to ensure [*], including providing [*] in connection therewith. As used herein, the term “Regulatory Documentation” means all applications, registrations, licenses, authorizations and approvals (including all Marketing Authorizations), all correspondence submitted to or received from Regulatory Authorities (including [*]) and all supporting documents in connection therewith, and all reports and documentation in connection with clinical studies and tests (including [*]), and [*] in any of the foregoing, including all INDs, BLAs, [*], in each case related to a Compound and/or Product.

§2.9.3 Inventory Transfer and Manufacturing Technology Transfer.

(a)    Inventory Transfer. At the request of Merck from time to time as set forth in the Transition Plan, NewLink shall promptly transfer title to Merck and deliver to Merck (or its designee) (at a location to be [*]), [*] any or all (as and to the extent [*]) inventory of Compound and Product (including [*]) held by or on behalf of NewLink or any of its Affiliates (including any such inventory [*]) (the “Inventory”).

(b)   Manufacturing Technology Transfer. Without limiting the provisions of Sections 2.9.1 and 2.9.2, as soon as reasonably practicable following the Effective Date (but in all cases within [*] after the Effective Date or such other period of time as agreed to by the Parties), NewLink shall transfer or cause to be transferred (including from its Third Party contract manufacturers) to Merck or its Affiliate (or a Third Party manufacturer designated by Merck), copies in English (in writing and in an electronic format) of all [*] that is related to the manufacture of the Compounds and/or Products, in order to enable Merck (or its designee) to manufacture the Compounds and Products, including [*] to manufacture Compounds and Products, including [*]. In addition, at the request of Merck from time to time, NewLink shall make its (and its Affiliates’) employees and consultants (including personnel of its Third Party contract manufacturers) available to Merck to provide reasonable consultation and technical assistance in order to ensure an orderly transition of the manufacturing technology and operations to Merck (or its designee) and to assist Merck (or its designee) in the start-up of its manufacture of Compound and Product (such consultation, the “Manufacturing Consultation”). For clarity, the Manufacturing Consultation shall be [*].

§2.9.4 Assignment of Certain Existing Agreements. At the written request of Merck, NewLink shall, to the extent legally permissible (and, to the extent consent is required from the relevant counterparty, [*]), (i) assign to Merck (or its Affiliate) any or all (as designated by Merck) of [*] and/or (ii) assist Merck (or its Affiliate) in [*] to cover the subject matter of such [*], as applicable, in each case of (i) and/or (ii), [*]; provided that NewLink shall not be obligated to assign any such [*] if such [*] is [*]. In the event that any [*] is assigned to Merck, NewLink shall [*], or related to, any such [*] as a result of, or in connection with, [*] of such [*], but which [*]. In the event that a given [*] is assigned to Merck in accordance with this Section 2.9.4, then such [*] shall [*]

§2.9.5 Transition and Transition Plan; Ongoing Assistance. Without limiting the foregoing provisions of this Section 2.9, NewLink shall perform the activities to be performed by NewLink as set forth in the Transition Plan (including technology transfer). NewLink shall, during the period from the Effective Date [*], perform such other reasonable activities and provide such other reasonable assistance as Merck may reasonably request from time to time, in order to transition the Development, Manufacturing and Commercialization of Compound and Product to Merck and [*] Develop, Manufacture and Commercialize Compound and Product, including [*]; provided, that if Merck requests any such assistance after the end of the Transition Period, the Parties will agree on the scope and plan for such activities (including a plan for addressing the costs and expenses of such activities) prior to NewLink’s performance thereof, [*]. 

§2.9.6 Data From Third Party Studies. To the extent that any Development activities (including clinical trials) are being conducted by, or sponsored by, a Third Party (including [*]) with respect to Compound or Product, [*] to obtain [*], and to [*], including the [*].