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20-F
MESOBLAST LTD filed this Form 20-F on 08/31/2018
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Territory for the purpose of MSB Developing and Commercializing Product outside the Territory, provided that the Parties acknowledge that the Collaborator shall prioritize the Development, Commercialization and use in the Territory in accordance with this Agreement; provided (a) neither Party shall have liability of any kind for any failure to agree on such commercial terms and (b) such obligation shall be subject to any existing obligations of MSB to Third Parties.

6.3Manufacturing Costs.  Unless and until ****, all costs (both internal and external) of carrying out the activities under the Manufacturing Plan shall be the responsibility of and borne by Collaborator unless otherwise set out in the Manufacturing Plan.

ARTICLE 7
REGULATORY AND RELATED MATTERS

7.1Regulatory Matters.

7.1.1Responsibility for Regulatory Filings.  Except as otherwise expressly provided otherwise, each Party shall be responsible, at its expense, for filing, obtaining and maintaining Regulatory Approvals for those activities assigned to such Party hereunder in connection with the Development, Manufacture and Commercialization of and conduct of Medical Education Activities for Product for the Field in the Territory.  The Parties acknowledge that unless the JSC designates otherwise, Collaborator shall have the right and responsibility for preparing, filing and defending MAAs for Product for the Field in the Territory, provided that MSB shall provide reasonable support to Collaborator with respect to such filings.  All activities under this Section 7.1.1 shall be done subject to the oversight and in full consultation with the JSC and the DWG provided that the Collaborator will have the ultimate decision making right at the JSC on what registration strategy and route will be applied to the Product in the Territory.  Without limiting the foregoing, prior to the filing any MAA for Product for the Field in the Territory, Collaborator shall provide a copy thereof to MSB for its review and comment (including any associated proposed labeling).

7.1.2Right of Reference.  Collaborator hereby grants MSB (and its designees) a right of reference and full use and access to Regulatory Materials of Collaborator and its Affiliates with respect to Product for purposes of obtaining and maintaining Regulatory Approvals for Product outside the Territory and (subject to Section 3.5) for allogenic cell products outside of the Field.  Collaborator shall, at MSB’s request and expense, take actions reasonably necessary to effect such grant of right of reference and use to MSB, including by making such filings as may be required with Regulatory Authorities in the Territory that may be necessary to record such grant.

7.2Regulatory Cooperation.  Subject to the oversight of the JSC and the DWG, Collaborator shall be responsible for liaising with and managing all interactions with applicable Regulatory Authorities with respect to Product for the Field in the Territory and MSB shall be entitled to participate in such interactions as provided in this Section 7.2.

 

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Confidential material omitted and filed separately with the Commission.



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