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20-F
MESOBLAST LTD filed this Form 20-F on 08/31/2018
Entire Document
 

 

2.6.2Guiding Principles.  Each Committee shall perform its responsibilities under this Agreement, including with respect to Development, Manufacture of and Commercialization of Product for the Field in the Territory, consistent with good pharmaceutical practices (including applicable cGxP) and consistent with using Commercially Reasonable Efforts.

2.7Alliance Managers.  Promptly after the Effective Date, each Party shall appoint an individual to act as alliance manager for that Party (each, an “Alliance Manager”).  Each Party’s Alliance Manager shall be a member of the JSC.  The Alliance Managers shall be the primary point of contact for the Parties with respect to the activities to be conducted under this Agreement.  The name and contact information for the Alliance Managers, as well as any replacement(s) chosen by either Party in their sole discretion from time to time, shall be promptly provided to the other Party in writing.

2.8Day-to-Day Responsibilities.  Each Party shall: (a) be responsible for day-to-day implementation and operation of the activities hereunder for which it has or is otherwise assigned responsibility under this Agreement, provided that such implementation is not inconsistent with the express terms of this Agreement or the decisions of a Committee within the scope of its authority specified herein; and (b) keep the other Party informed as to the progress of such activities as reasonably requested by the other Party and as otherwise determined by the JSC.

ARTICLE 3
RIGHTS AND EXCLUSIVITY

3.1Rights of Collaborator.

3.1.1General.  Subject to the terms and conditions of this Agreement, MSB hereby grants Collaborator the following rights under the Product Technology: (a) the exclusive (subject to MSB’s reservation of rights as set forth herein) right to conduct Development of Product for the Field for the Territory; (b) the exclusive right to Commercialize (including to use, sell, offer for sale and import) and conduct Medical Affairs Activities for Product solely for the Field in the Territory; (c) the exclusive right to conduct regulatory activities in support of Collaborator’s activities described in (a) and (b) of this Section 3.1.1 and Article 6; and (d) the right to Manufacture the Product to support the Commercialization of the Product for the Field in the Territory (such rights collectively, the “Collaborator Rights”).  Collaborator’s exercise of the Collaborator Rights (i) to conduct Development shall be in accordance with the Development Plan and Article 4; (ii) to conduct Commercialization and Medical Affairs Activities shall be in accordance with the Commercialization Plan and Article 5; (iii) to Manufacture the Product shall be in accordance with the Manufacturing Plan and Article 6; and (iv) to conduct regulatory activities shall be in accordance with Article 7.  Furthermore, notwithstanding the exclusivity of the rights granted to Collaborator:  (A) MSB shall continue to have the right to practice Collaborator Rights for purposes of performing the Development activities assigned to MSB under the Development Plan and the regulatory activities for which MSB is expressly responsible for or assigned to conduct under this Agreement and (B) MSB shall continue to have the right to Develop and Manufacture Product in the Territory to support the Development and Commercialization of Product outside the Territory as set forth in Section 6.2.

 

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Confidential material omitted and filed separately with the Commission.



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